Descriptive Designation for Needle- or Blade-Tenderized (Mechanically Tenderized) Beef Products, 34589-34604 [2013-13669]
Download as PDF
<![CDATA[
34589
Proposed Rules
Federal Register
Vol. 78, No. 111
Monday, June 10, 2013
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 317
[Docket No. FSIS–2008–0017]
RIN 0583–AD45
Descriptive Designation for Needle- or
Blade-Tenderized (Mechanically
Tenderized) Beef Products
Food Safety and Inspection
Service, USDA.
ACTION: Proposed rule.
AGENCY:
The Food Safety and
Inspection Service (FSIS) is proposing
to require the use of the descriptive
designation ‘‘mechanically tenderized’’
on the labels of raw or partially cooked
needle- or blade-tenderized beef
products, including beef products
injected with marinade or solution,
unless such products are destined to be
fully cooked at an official establishment.
Beef products that have been needle- orblade-tenderized are referred to as
‘‘mechanically tenderized’’ products.
FSIS is proposing that the product name
for such beef products include the
descriptive designation ‘‘mechanically
tenderized’’ and an accurate description
of the beef component. By including
this descriptive designation consumers
will be informed that this product is
non-intact. Non-intact products need to
be fully cooked in order to be rendered
free of pathogenic bacteria because
bacteria may become translocated from
the surface of the meat during
mechanical tenderization. FSIS is also
proposing that the print for all words in
the descriptive designation as the
product name appear in the same style,
color, and size and on a single-color
contrasting background. In addition,
FSIS is proposing to require that labels
of raw and partially cooked needle- or
blade-tenderized beef products destined
for household consumers, hotels,
restaurants, or similar institutions
include validated cooking instructions
that inform consumers that these
mstockstill on DSK4VPTVN1PROD with PROPOSALS
SUMMARY:
VerDate Mar<15>2010
16:04 Jun 07, 2013
Jkt 229001
products need to be cooked to a
specified minimum internal
temperature, and whether they need to
be held at that minimum temperature
for a specified time before consumption,
i.e., dwell time or rest time, to ensure
that they are fully cooked.
Based on the scientific evidence that
indicates that mechanically tenderized
beef products need to be cooked more
thoroughly than intact beef products,
FSIS is proposing these amendments to
the regulations.
FSIS is also announcing that it has
posted on its Web site guidance for
developing validated cooking
instructions for mechanically tenderized
product. The recommendations in the
guidance document are based on the
results from published research
designed to identify minimum internal
temperature and time combinations
sufficient to render a product and
studies designed to validate cooking
instructions.
Comments must be received by
August 9, 2013.
ADDRESSES: FSIS invites interested
persons to submit comments on this
proposed rule and on the guidance for
validated cooking instructions.
Comments may be submitted by one 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. Go
to http://www.regulations.gov. Follow
the on-line instructions at that site for
submitting comments.
• Mail, including CD–ROMs, etc.:
Send to Docket Clerk, U.S. Department
of Agriculture, Food Safety and
Inspection Service, Docket Clerk,
Patriots Plaza 3, 1400 Independence
Avenue SW., Mailstop 3782, Room 8–
163B, Washington, DC 20250–3700.
• Hand- or Courier-Delivered
Submittals: Deliver to Patriots Plaza 3,
355 E. Street SW., Room 8–163B,
Washington, DC 20250–3700.
Instructions: All items submitted by
mail or electronic mail must include the
Agency name and docket number FSIS–
2012–0013. Comments received in
response to this docket will be made
available for public inspection and
posted without change, including any
personal information, to http://
www.regulations.gov.
DATES:
PO 00000
Frm 00001
Fmt 4702
Sfmt 4702
Docket: For access to background
documents or comments received, go to
the FSIS Docket Room at Patriots Plaza
3, 355 E. Street SW., Room 8–164,
Washington, DC 20250–3700 between
8:00 a.m. and 4:30 p.m., Monday
through Friday.
FOR FURTHER INFORMATION CONTACT:
Rachel Edelstein, Assistant
Administrator, Office of Policy and
Program Development, FSIS, U.S.
Department of Agriculture, 1400
Independence Avenue SW.,
Washington, DC 20250–3700;
Telephone: (202) 205–0495; Fax: (202)
720–2025.
SUPPLEMENTARY INFORMATION:
Executive Summary
Mechanically tenderized beef
products are products that have been
needle- or blade-tenderized, or have
been injected with a marinade or a
solution. The act of mechanically
tenderizing a beef product potentially
pushes pathogens from the exterior of
the product into its interior. Because
mechanically tenderized beef products
are non-intact products, they need to be
more fully cooked than intact beef
products where potential pathogens are
generally limited to the product’s
surface. The time-and-temperature
combination needed to destroy
pathogens on the surface of the intact
product is less than that necessary to
destroy pathogens that may reside in the
interior of the non-intact product.
Requiring mechanically tenderized
beef products to be labeled with a
descriptive designation that identifies
them as mechanically tenderized and
accompanied with validated cooking
instructions is intended to help inform
consumers and instruct them that such
products need to be fully cooked.
Under the Federal Meat Inspection
Act (FMIA) the labels of meat products
must be truthful and not misleading,
and the labels must accurately disclose
to consumers what they are buying
when they purchase any meat product.
The FMIA gives FSIS broad authority to
promulgate rules and regulations
necessary to carry out its provisions.
FSIS is proposing that the labeling of
raw or partially cooked mechanically
tenderized beef products bear a
descriptive designation that clearly
identifies that the product has been
mechanically tenderized, unless such
E:\FR\FM\10JNP1.SGM
10JNP1
34590
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 / Proposed Rules
product is destined to be fully cooked
in an official establishment.1
To ensure that the descriptive
designation is readily apparent on the
label, FSIS is proposing that the print
for all words in the descriptive
designation, as well as the words in the
description of the product, appear in the
same font style, color, and size as the
product name and on a single-color
contrasting background.
FSIS is also proposing to require that
labels of raw and partially cooked
needle- or blade-tenderized beef
products destined for household
consumers, hotels, restaurants and
similar institutions include cooking
instructions that have been validated to
ensure that a sufficient number of
potential pathogens throughout the
product are destroyed. FSIS will
provide a Compliance Guide to help
establishments develop validated
cooking instructions.
TABLE 1—SUMMARY OF ESTIMATED COSTS AND BENEFITS
Benefits b
Costs
Net Benefits
Estimated Quantified Benefits, Costs, and Net Benefits a
If this proposed rule is finalized
after the final rule for products
with added solutions.
If this proposed rule is finalized before the final rule for products
with added solutions.
$1,511,000 ....................................
($121,000 to $11,641,000) ...........
$140,000 c .....................................
.......................................................
$1,371,000
(¥$19,000 to $11,501,000)
$1,511,000 ....................................
($121,000 to $11,641,000) ...........
$349,000 d .....................................
.......................................................
$1,162,000
(¥$228,000 to $11,292,000)
Non-Quantified Benefits and Costs
• Truthful and accurate labeling ..
• Increased public awareness of
product identities.
• Better market information to
consumers.
• Increased producer surplus to
producers who sell intact beef
or other meats consumers may
substitute for mechanically-tenderized beef.
• Cost to validate cooking instructions.
• Loss in producer surplus to producers who sell mechanically
tenderized beef.
• Loss in consumer surplus to
consumers who start cooking
their beef to a higher temperature, which they prefer less
than cooking rare.
• Loss in consumer surplus to
consumers who might substitute other meats or other cuts
of meat, which they prefer less.
• Costs incurred by food service
providers that change their
standard operating procedures
related to intact and mechanically-tenderized beef.
a Annualized
over 10 years at a 7 percent discount rate.
that on the low end, 15% of consumers and 0% of food service providers will use validated cooking instructions and using the lower
bound of the credibility interval from Scallan while on the high end, 56% of consumers and 100% of food service providers and using the upper
bound of the credibility interval from Scallan will use validated cooking instructions, with an average estimate of 24% for consumers and 24% for
food service providers.
c Estimated costs fall to $120,000 and net benefits rise by $20,000 when annualized with a 3 percent discount rate.
d Estimated costs fall to $298,000 and net benefits rise by $51,000 when annualized with a 3 percent discount rate.
Source: FSIS Policy Analysis Staff.
mstockstill on DSK4VPTVN1PROD with PROPOSALS
b Assumes
Background
The Federal Meat Inspection Act
(FMIA) (21 U.S.C. 601–695, at 21 U.S.C.
607) provides for the approval by the
Secretary of Agriculture of the labels of
meat and meat food products before
these products can enter commerce. The
FMIA also prohibits the distribution in
commerce of meat or meat food
products that are adulterated or
misbranded.
The FMIA provides that a product is
misbranded if its labeling is false or
misleading in any particular, or if it is
offered for sale under the name of
another food (21 U.S.C.
601(n)(1),601(n)(2)). Thus, under the
FMIA, the labels of meat or meat food
products must be truthful and not
misleading, and the labels must
accurately disclose to consumers what
they are buying when they purchase any
meat product. The FMIA gives FSIS
broad authority to promulgate rules and
regulations necessary to carry out its
provisions (21 U.S.C. 621).
To prevent meat or meat food
products from being misbranded, the
meat inspection regulations require that
the labels of meat products contain
specific information and that such
information be displayed as prescribed
in the regulations (9 CFR part 317).
Under the regulations, the principal
1 Any slaughtering, cutting, boning, meat canning,
curing, smoking, salting, packing, rendering, or
display panel on the label of a meat
product must include, among other
information, the name of the product.
For products that purport to be or are
represented by a regulatory standard of
identity, the name of the product on the
label must be the name of the food
specified in the standard. For any other
product, the name on the label must be
‘‘the common or usual name of the food,
if any there be.’’ If there is no common
or usual name, the name on the label
must be a ‘‘truthful, descriptive
designation’’ (9 CFR 317.2(c)(1)). In
addition, the meat inspection
regulations require that the descriptive
designations for products that have no
similar establishment at which inspection is
maintained under [FSIS] regulations (9 CFR 301.2).
VerDate Mar<15>2010
16:04 Jun 07, 2013
Jkt 229001
PO 00000
Frm 00002
Fmt 4702
Sfmt 4702
E:\FR\FM\10JNP1.SGM
10JNP1
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 / Proposed Rules
common or usual name completely
identify the product, including the
method of preparation, such as salting,
smoking, drying, cooking, or chopping,
unless the product name implies, or the
manner of packaging shows, that the
product was subject to such preparation
(9 CFR 317.2(e)).
mstockstill on DSK4VPTVN1PROD with PROPOSALS
Petition Related to Mechanically
Tenderized Products
In 2009, the Safe Food Coalition sent
a petition to the Secretary of Agriculture
to request, among other issues,
regulatory action to require that the
labels of mechanically tenderized beef
products disclose the fact that the
products have been mechanically
tenderized. The petition stated that, (1)
consumers and restaurants do not have
sufficient information to ensure that
these products are cooked safely
because FSIS does not provide
recommended cooking temperatures for
mechanically tenderized products, (2)
the recommended cooking temperatures
for intact products are not appropriate
for non-intact, mechanically tenderized
products, and (3) a labeling requirement
for mechanically tenderized products is
critical for consumers and retail outlets,
so that they have the information
necessary to safely prepare these
products.
In June 2010, the Conference for Food
Protection (CFP) petitioned FSIS to
issue a mandatory labeling provision for
mechanically tenderized beef that
would require labels to specify that a
cut has been mechanically tenderized.
The petition stated that mechanically
tenderized beef, especially when frozen,
could be mistakenly perceived by
consumers to be a whole, intact muscle
cut. The petition asserted that without
clear labeling, food retailers and
consumers do not have the information
necessary to prepare these products
safely. According to the petition, if
labeling does not indicate that the
product is mechanically tenderized,
consumers are not aware of the potential
risk created when these products are
less than fully cooked. The petition
stated that mandatory labeling of these
products would reduce the number of
foodborne illnesses in the United States.
Mechanically Tenderized Beef
Mechanically tenderized beef
products are products that have been
VerDate Mar<15>2010
16:04 Jun 07, 2013
Jkt 229001
needle- or blade-tenderized, or have
only been injected with a marinade or
solution. FSIS has previously described
mechanically tenderized beef products
in this manner, notably in its Federal
Register notice, HACCP Plan
Reassessment for Mechanically
Tenderized Beef Products (May 26,
2005; 70 FR 30331). FSIS is asking for
comment on this definition of
mechanically tenderized beef products
and on whether it should be
incorporated into the regulations.
Consumers consider product
tenderness to be a key factor when
purchasing meat products, and the
tenderness of a roast or steak is a key
selling point for the meat industry. The
tenderness of a meat product depends
on the cut of the meat, and there are
various techniques that companies can
use to improve the tenderness of the less
tender cuts, including mechanical
tenderization.
The mechanical tenderization process
involves piercing the product with a set
of needles or blades, which breaks up
muscle fiber and tough connective
tissue, resulting in increased
tenderness.2 Research has shown that
needle or blade mechanical
tenderization can improve the
tenderness of less tender, and typically
less expensive, beef cuts.3 4 5 6 The
process makes the less tender cuts of
beef more marketable to consumers.
An increasing number of
establishments use mechanical
tenderization processes for beef.7 The
2 Maddock, Robert 2008. Mechanical
Tenderization of Beef, National Cattleman’s Beef
Association.
3 Jeremiah, L.E., L.L. Gibson, B. Cunningham
1999. The Influence of Mechanical Tenderization
on the Palatability of Certain Bovine Muscle Food
Research International 32: (585–591).
4 Pietrasik, Z., Shand, P.J. 2004. Effect of Blade
Tenderization and Tumbling Time on the
Processing Characteristics and Tenderness of
Injected Cooked Roast Beef. Meat Science 66: (871–
879).
5 King, D.A., Wheeler, T.L. Shackelford, S.D.,
Pfeiffer, K.D., Nickelson, R., Koolmaraie, M. 2009.
Effect of Blade Tenderization, Aging Time, and
Aging Temperature on tenderness of Beef
Lumborum and Gluteus Medius. J. Animal Science
87:(2962–2960).
6 Pietrasik, Z., Aslhus, J.L., Gibson, L.L., Shand,
P.J. 2010. Influence of Blade Tenderization,
Moisture Enhancement and Pancretin Enzyme
Treatment on the Processing Characteristics and
Tenderness of Beef Semitendinosus Muscle. Meat
Science 84: (512–517).
7 According to FSIS’s Checklist and Reassessment
of Control for E. coli O157:H7 in Beef Operations,
PO 00000
Frm 00003
Fmt 4702
Sfmt 4702
34591
mechanically tenderized products are
widely available to consumers in the
marketplace.
Mechanically tenderized products are
referred to as ‘‘non-intact’’ and have
different physical attributes than intact,
non-tenderized products. A beef
product that has been subjected to the
mechanical tenderization process is
more tender than it would have been
had it not been mechanically
tenderized, but it is no longer an intact
cut of meat. Significantly, products that
have been needle- or blade-tenderized
are typically indistinguishable in
appearance from whole, intact products.
Furthermore, under the current
regulatory approach, intact and
mechanically tenderized beef products
are permitted to have the same product
name, and products that have been
mechanically tenderized need not
disclose this fact in their labeling. Thus,
the labeling of mechanically tenderized
beef products is not required to reveal
a significant material fact about the
nature of the product. Without
information about this fact on the
product labeling, consumers and
industry may be purchasing these
products without knowing that they
have been needle- or blade-tenderized.
Since 2000, the Centers for Disease
Control and Prevention has received
reports of six outbreaks attributable to
needle- or blade-tenderized beef
products prepared in restaurants and
consumers’ homes. The outbreaks
included steaks that were mechanically
tenderized with added solutions and
one outbreak involving mechanically
tenderized steaks in which no
information was available concerning
whether the product contained added
solutions. Among these outbreaks, there
were a total of 176 Escherichia coli (E.
coli) O157:H7 cases that resulted in 32
hospitalizations and 4 cases of
hemolytic uremic syndrome (HUS).8
850 of 2323 establishments indicated that they had
a mechanical tenderizing operation, http://www.
fsis.usda.gov/PDF/Ecoli_Reassessment_&_
Checklist.pdf. In addition, a 2003 National
Cattleman’s Beef Association survey found that 188
of 200 processors used mechanical tenderization,
http://docserver.ingentaconnect.com/deliver/
connect/iafp/0362028x/v71n11/s4.pdf?expires=
1300291287&id=61762965&titleid=5200021&
accname=NAL-Group3&checksum=57C4A9F3F7
3D2022F0EEFFA2568826BF.
8 Compilation of USDA–FSIS Data, 2010.
E:\FR\FM\10JNP1.SGM
10JNP1
34592
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 / Proposed Rules
TABLE 2—OUTBREAKS LINKED TO TENDERIZED/MARINATED STEAKS ORIGINATING IN THE UNITED STATES (COMPILATION
OF FSIS GENERATED DATA)
Year
Product
Case patients/
Epi. link
Hospitalizations/Deaths
2009 ....................................
25/17-steak .....
10/1a
067–2009 (USDA–FSIS, 2009).
8/8 ...................
124/124 ...........
4/4 ...................
6/0
8/0
1/0
019–2007 (USDA–FSIS, 2007).
No Recall.b c
033–2004 (USDA–FSIS, 2004).
May–June 2003 (Laine et
al., 2005).
Aug. 2000 ...........................
Blade tenderized steaks, vacuum tumbled
with marinade.
Needle injected and marinated steaks ............
Needle tenderized, seasoned tri-tip beef ........
Blade tenderized steaks exposed to marinade
in vacuum tumbler.
Bacon wrapped steaks, mechanically tenderized, injected flavoring.
Needle tenderized ...........................................
13/13 ...............
7/0
028–2003 (USDA–FSIS, 2003).
2/2 ...................
0/0
No Recall.d e
Total .............................
..........................................................................
176/168 ...........
32/1
April–May 2007 ...................
May–Aug. 2007 ..................
July–Aug. 2004 ...................
FSIS Recall number
a. Patient who died did not eat steak.
b. Illnesses were all associated with product served through the restaurant/food-to-go operation that had some sanitary violations.
c. Notes indicate that a seasoning/marinade was used in the needling process.
d. Unknown whether solution was added.
e. FSIS was not involved in the original investigation.
mstockstill on DSK4VPTVN1PROD with PROPOSALS
Five of the six outbreaks listed in
Table 2 had solutions added to the
tenderized beef. These five outbreaks
accounted for 174 of the 176 illnesses.
The remaining two illnesses occurred in
an outbreak in which steak was
mechanically tenderized, but it was not
known if solution was added.
Follow up investigations suggested
that failure to fully cook a mechanically
tenderized raw or partially cooked beef
product was likely a significant
contributing factor in all of these
outbreaks. In many cases, patients
associated with outbreaks reported
preparing or ordering steaks as ‘‘rare’’ or
‘‘medium-rare.’’ 9 10 Published research
suggests that pathogens can be
translocated from the surface of
mechanically tenderized beef products
to the interior during processing
because of the piercing of the beef by
the needle or blade.11 The potential for
translocation of pathogens to the
interior of the product suggests that the
interior of mechanically tenderized beef
would need to be more fully cooked
than a piece of intact beef with a similar
9 Culpepper, W., Ihry, T., Medus, C., Ingram, A.,
Von Stein, D., Stroika, S., Hyytia-Trees, E., Seys, S.,
Sotir, M.J. 2010. Multi-state outbreak of Escherichia
coli O157:H7 infections associated with
consumption of mechanically-tenderized steaks in
restaurants—United States, 2009. Presented at
International Association for Food Protection;
August 1–4, 2010; Anaheim, CA.
10 Haubert, N., Cronquist, A., Parachini, S.,
Lawrence, J., Woo-Ming, A., Volkman, T., Moyer,
S., Watkins, A. 2006. Outbreak of Escherichia coli
O157:H7 Associated with Consuming Needle
Tenderized Undercooked Steak from a Restaurant
Chain—Denver Area, Colorado, 2004. Presented at
International Conference of Emerging Infectious
Diseases; March 19–22, 2006; Atlanta, GA.
11 Luchansky, JB, Phebus RK, Thippareddi H, Call
JE 2008. Translocation of surface-inoculated
Escherichia coli 0157:H7 into beef subprimals
following blade tenderization. J. Food Prot. 2008
Nov.; 71(11):2190–7.
VerDate Mar<15>2010
16:04 Jun 07, 2013
Jkt 229001
amount of pathogens only on the
surface.12
This research led FSIS to recommend
on its Web site that mechanically
tenderized beef products should be
cooked to 145 °F with a three-minute
dwell time because it will result in a
5.0-log reduction of Salmonella
throughout the product.13 14 Salmonella
is an indicator for lethality because it is
more heat-resistant than other
pathogens such as E. coli O157:H7.
Therefore, if a 5.0-log reduction of
Salmonella is achieved, at least a 5-log
reduction of E. coli O157:H7 should be
achieved as well 15.
Consumers often prefer to eat their
steaks ‘‘rare’’ or ‘‘medium rare.’’
Generally, intact cuts of muscle such as
steaks should be free of pathogenic
bacteria such as E. coli O157:H7 and
other Shiga-toxin producing E. coli
(STEC) organisms if cooked to these
desired levels of doneness because
contamination with pathogenic bacteria,
if present, would likely only occur on
the surface of the product. The National
Advisory Committee on Microbiological
Criteria for Foods (1997) stated that
‘‘due to the low probability of
pathogenic organisms being present in
or migrating from the external surface to
the interior of beef muscle, cuts of intact
muscle (steaks) should be safe if the
12 Sporing, Sarah B. 1999. Escherichia coli
O157:H7 Risk Assessment for Production and
Cooking of Blade Tenderized Beef Steak. Thesis.
Kansas State University.
13 http://askfsis.custhelp.com/ci/fattach/get/
4648/.
14 Goodfellow, S. J. and Brown. W. L. 1978. Fate
of Salmonella Inoculated into Beef for Cooking J. of
Food Protect. 41: (598–605).
15 Line, J.E. Fain, A.R. Moran, A.B, Martin, L.M.,
Lechowch, R.V., Carosella, J.M., and Brown, W.L.
1991. Lethality of heat to Escherichia coli O157:H7:
D-value and Z-value determinations in ground beef
J Food Protect. 54:(762–766).
PO 00000
Frm 00004
Fmt 4702
Sfmt 4702
external surfaces are exposed to
temperatures sufficient to effect a
cooked color change’’.16 To date, no
outbreaks or sporadic illnesses from
consuming intact product have been
reported to CDC.17
Descriptive Designation
FSIS has carefully considered the
available information on mechanically
tenderized beef, including the petitions
submitted by the Safe Food Coalition
and by CFP, and has concluded that
without specific labeling, raw or
partially cooked mechanically
tenderized beef products could be
mistakenly perceived by consumers to
be whole, intact muscle cuts. The fact
that a cut of beef has been needle- or
blade-tenderized is a characterizing
feature of the product and, as such, a
material fact that is likely to affect
consumers’ purchase decisions and that
should affect their preparation of the
product. The literature suggests that
many consumers are aware of and a
portion of these read the safe handling
instructions labels, and reported
changing their meat preparation
methods because of the
labels.18 19 20 21 22 23 Because of the
16 National Advisory Committee on
Microbiological Criteria for Foods (NACMCF). 1997.
Recommendations for Appropriate Cooking
Temperatures for Intact Beef Steaks & Cooked Beef
Patties for the Control of Vegetative Enteric
Pathogens. U.S. Department of Agriculture, Food
Safety and Inspection Service, Washington, DC.
17 National Advisory Committee on
Microbiological Criteria for Foods (NACMCF). 1997.
Recommendations for Appropriate Cooking
Temperatures for Intact Beef Steaks & Cooked Beef
Patties for the Control of Vegetative Enteric
Pathogens. U.S. Department of Agriculture, Food
Safety and Inspection Service, Washington, DC.
18 Yang et al (1999) show that 15% of consumers
changed their behavior based on reading safe
handling instruction labels. (Evaluation of Safe
Food-Handling Instructions on Raw Meat and
E:\FR\FM\10JNP1.SGM
10JNP1
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS
likelihood that illness rates would be
reduced if more specific labeling were
required, FSIS proposes that the
labeling of raw or partially cooked
mechanically tenderized beef products
bear a descriptive designation that
clearly identifies the product has been
mechanically tenderized unless such
product is destined to be fully cooked
in an official establishment. The
proposed descriptive designation will
provide household consumers, official
establishments, restaurants, and retail
stores with the information they need to
identify whether a cut of beef is an
intact, non-tenderized product, or
whether it is a non-intact, mechanically
tenderized product. Should this rule
become final, FSIS will conduct a
public education campaign to explain
the significance of the term
‘‘mechanically tenderized’’ to
consumers.
FSIS is proposing that if raw or
partially cooked mechanically
tenderized beef product is destined to
be fully cooked at an official
establishment, the descriptive
designation would not be required on
the product label. Therefore, if one
establishment produces raw or partially
cooked product and sends it to a second
establishment for cooking, the first
establishment would not be required to
include the descriptive designation on
the product label.
The descriptive designation that FSIS
is proposing would only apply to raw or
partially cooked beef products that have
been needle tenderized or blade
tenderized, including beef products
injected with marinade or solution.
Other tenderization methods such as
pounding and cubing change the
appearance of the product, putting
consumers on notice that the product is
not intact. Additionally, a majority of
establishments already identify
Poultry Products. J of Food Protect. 63: (1321–
1325.)
19 Bruhn (1997) shows that 17% of consumers
changed their behavior based on reading safe
handling instructions. Consumer Concerns
Motivating to Action, Emerging Infectious Diseases.
3(4): 511–515.
20 Adul-Nyako et al (2003) show a significant
positive influence of labels on safe handling
practices. Safe Handling Labels and Consumer
Behavior in the Southern U.S.
21 Cates, Sheryl C., Cignetti, Connie, Kosa,
Katherine M. March 22, 2002. RTI: Consumer
Research on Food Safety Labeling Features for the
Development of Responsive Labeling Policy.
22 Cates, Sheryl C., Cignetti, Connie, Kosa,
Katherine M. March 22, 2002. RTI: Consumer
Research on Food Safety Labeling Features for the
Development of Responsive Labeling Policy.
23 Cates, Sheryl C., Carter-Young, Heather L.,
Gledhill, Erica C. April 25, 2001. RTI: Consumer
Perceptions of Not-Ready-to-Eat Meat and Poultry
Labeling Terminology.
VerDate Mar<15>2010
16:04 Jun 07, 2013
Jkt 229001
products that have been cubed on the
label.
FSIS is proposing to require that the
label of needle- or blade-tenderized beef
products contain the designated
description ‘‘mechanically tenderized’’
because this term accurately and
truthfully describes the nature of the
product. Additionally, this term clearly
and completely identifies the
preparation process that the product
underwent. FSIS’s goal is to choose a
term that will not affect consumers’
perception of the quality, or cost, of the
product. Rather, FSIS sought to simply
differentiate mechanically tenderized
beef products from non-tenderized,
intact beef products. The term
‘‘mechanically tenderized’’ is nontechnical and likely will be understood
by consumers, restaurants, retail stores,
and official establishments, although
FSIS is taking comment on this
assumption.
To ensure that the descriptive
designation is readily apparent on the
label, FSIS is proposing that the print
for all words in the descriptive
designation, as well as the words in the
description of the product, appear in the
same font style, color, and size as the
product name and on a single-color
contrasting background.
At this time, FSIS is not proposing
similar labeling requirements for
mechanically tenderized poultry
products or for other mechanically
tenderized meat products, such as pork.
While FSIS has the checklist data
discussed above for beef products, FSIS
does not have similar data for other
products necessary to assess production
practices for mechanically tenderized
products. There have been no known
outbreaks for mechanically tenderized
poultry or non-beef products.
FSIS is not proposing to require the
descriptive designation on needle- or
blade-tenderized beef products that are
fully cooked in an official establishment
because such products do not pose the
same pathogen hazard as the raw or
partially cooked products. Further,
consumers can recognize that a product
has been cooked. FSIS requests
comment on whether it should require
fully cooked needle- or blade-tenderized
beef products to have the descriptive
designation on their labels.
Validated Cooking Instructions for Raw
and Partially Cooked Mechanically
Tenderized Products
FSIS is proposing to amend the
regulations to require validated cooking
instructions on the labels of
mechanically tenderized beef products.
Under current regulations, to prevent
raw and partially cooked meat products
PO 00000
Frm 00005
Fmt 4702
Sfmt 4702
34593
from being misbranded, the labels of all
meat products, including those that
have been mechanically tenderized, are
required to include safe handling
instructions as prescribed in 9 CFR
317.2(l). These regulations require that
the labels of raw and partially cooked
meat that are not intended for further
processing at an official establishment
include the statement: ‘‘This product
was prepared from inspected and
passed meat and/or poultry. Some food
product may contain bacteria that could
cause illness if the product is
mishandled or cooked improperly. For
your protection, follow these safe
handling instructions’’ (9 CFR
317.2(l)(2)). One of the instructions
required under the regulations is to
‘‘cook thoroughly’’ (9 CFR
317.2(l)(3)(iii)).
Although the safe handling
instructions in the regulations include
‘‘cook thoroughly’’ in the labeling of raw
and partially cooked meat and poultry
products, the regulations do not require
that these instructions specify the dwell
time or internal temperature parameters
required to ensure that the product is
fully cooked. Because mechanically
tenderized products have the same
appearance as intact products,
household consumers, hotels,
restaurants, and similar institutions may
incorrectly assume that mechanically
tenderized products may be prepared
similarly to intact products (i.e., that it
is ok to cook the product ‘‘rare’’ or
‘‘medium-rare’’), even if the product
label shows that the product is
mechanically tenderized. This increases
the likelihood that household
consumers, hotels, restaurants, and
similar institutions will undercook a
mechanically tenderized product.
Despite the safe handling instructions
to ‘‘cook thoroughly,’’ recent outbreak
data suggest that for needle- or bladetenderized raw beef products,
consumers, restaurants, and retail stores
do not always fully cook these products
using a temperature-and-time
combination sufficient to destroy
harmful bacteria, such as Escherichia
coli O157:H7 (E. coli O157:H7), in the
product. CDC and other governmental
investigators have found that failure to
fully cook a mechanically tenderized
raw or partially cooked beef product
was likely a significant contributing
factor in the outbreaks.24 25 In many
24 Swanson, L. E., Scheftel, J.M., Boxrud, D.J.,
Vought, K.J., Danila, R.N., Elfering, K.M., and
Smith, K.E. 2005. Outbreak of Escherichia coli
O157:H7 infections associated with nonintact
blade-tenderized frozen steaks sold by door-to-door
vendors. J. Food Prot 68:(1198–1202).
E:\FR\FM\10JNP1.SGM
Continued
10JNP1
34594
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS
cases, patients reported preparing or
ordering steaks as ‘‘rare’’ or ‘‘medium
rare.’’
Because restaurants may not know
that products are mechanically
tenderized, they may prepare for their
customers mechanically tenderized beef
products that are ‘‘rare’’ or ‘‘mediumrare.’’ Indeed, their customers may ask
them to do so. Research on the sensory
and cooking characteristics of various
beef cuts suggests that the palatability of
beef cuts decreases as the internal
endpoint temperature increases. Other
research has shown that consumers tend
to prefer beef products that are cooked
to a lower degree of doneness than that
needed to reach the necessary internal
temperature for a mechanically
tenderized product, which needs to be
fully cooked throughout its interior.26 In
some studies, consumers have given
highest ratings to such underdone beef
products.27 28 29 Consumers thus may
order steaks that are cooked to a lesser
degree of doneness than that necessary
to fully cook them and restaurateurs
may consequently serve the less-done
products. FSIS requests comments on
how the proposed labeling changes are
likely to impact restaurants and other
food service operations.
On the basis of these studies,
scientific evidence referred to earlier in
this document, and other studies 30 31 32
25 Culpepper W, Ihry T, Medus C, Ingram A, Von
Stein D, Stroika S, Hyytia-Trees E, Seys S, Sotir MJ.
2010. Multi-state outbreak of Escherichia coli
O157:H7 infections associated with consumption of
mechanically-tenderized steaks in restaurants—
United States, 2009. Presented at International
Association for Food Protection; August 1–4, 2010;
Anaheim, CA.
26 Schmidt, T.B., Keene, M.P, and Lorenzen, C.L.
2002. Improving Consumer Satisfaction of Beef
Through the use of Thermometers and Consumer
Education by Wait Staff. J. Food Sci. 67: (3190–
3193).
27 Lorenzen, C.L., T.R. Neely, R.K. Miller, J.D.
Tatum, J.W. Wise, J.F. Taylor, M.J. Buyck, J.O.
Reagan, and J.W. Savell. 1999. Beef Customer
Satisfaction: Cooking Methods and Degree of
Doneness Effects on the Top Loin Steaks. J. Animal
Science 77:637–644.
28 Savell, J.W., Lorenzen, C.L., Neely, T.R., Miller,
R.K., Tatum, J.D., Wise, J.W., Taylor, J.F., Buyck,
M.J., Reagan, J.O. 1999. Beef Customer Satisfaction:
Cooking Methods and Degree of Doneness Effects
on the Top Sirloin Steaks. J. Animal Science
77:645–652.
29 Neely, T.E., Lorenzen,C.L., Miller,R.K.,
Tatum,J.D., Wise, J.W.,Taylor, J.F., Buyck,M.J., and
Savell, J.W.. 1999. J. Animal Science 77:653–660.
Beef Customer Satisfaction: Cooking Method and
Degree of Doneness Effects on the Top Round Steak.
30 Luchansky, J.B., Porto-Fett, A.C.S., Shoyer,
B.A., Call, J.E., Schlosser, W., Shaw, W., Bauer, N.,
Latimer, H. 2012. Fate of Shiga toxin-Producing
O157:H7 and non-O157:H7 Escherichia coli Cells
within Blade-Tenderized Beef Steaks after Cooking
on a Commercial Open-Flame Gas Grill. J. of Food
Protect 75: (62–70).
31 Johnston, R.W., M.E. Harris, A.B. Moran. 1978.
The Effect of Mechanically Tenderization on Beef
Rounds Inoculated with Salmonella. J. Food Safety
1:201–209.
VerDate Mar<15>2010
16:04 Jun 07, 2013
Jkt 229001
that indicate that mechanically
tenderized beef products need to be
cooked more thoroughly than intact beef
products, FSIS is making an additional
proposal. Thus, in addition to a
descriptive designation that identifies
that needle- or blade-tenderized beef
products have been mechanically
tenderized, FSIS is proposing to require
that labels of raw and partially cooked
needle- or blade-tenderized beef
products destined for household
consumers, hotels, restaurants and
similar institutions include cooking
instructions that have been validated to
ensure that potential pathogens
throughout the product are destroyed.
Under this proposal, needle- or bladetenderized beef products that are
destined to be fully cooked at an official
establishment would not be required to
include validated cooking instructions
on product labels. Official
establishments are required to follow
regulatory performance standards to
ensure that ready-to-eat products
receive a full lethality treatment (for
cooked beef, roast beef, and cooked
corned beef products, see 9 CFR 318.17)
and use controls to prevent postlethality contamination with Listeria
monocytogenes (9 CFR 430.4).
FSIS is proposing to require that the
validated cooking instructions include,
at a minimum: (1) the method of
cooking; (2) a minimum internal
temperature validated to ensure that
potential pathogens are destroyed
throughout the product; (3) whether the
product needs to be held for a specified
time at that temperature or higher before
consumption; and (4) instruction that
the internal temperature should be
measured by the use of a thermometer.
The Agency is proposing to require that
the cooking instruction statement
include the cooking method because
consumers need explicit information
about how to cook a product in order to
ensure that it is safe for consumption.
The cooking instructions included on
the label should be practical and likely
to be followed by consumers. FSIS is
proposing that cooking instructions
must be validated to ensure that
potential pathogens are destroyed
throughout the product as determined
by the specified minimum internal
temperature and dwell time for the
product before consumption.
Consistent with the regulation on
HACCP validation (9 CFR 417.4), to
validate the cooking instructions,
should this rule become final, the
32 Johnston, R.W., M.E. Harris, A.B. Moran. 1978.
The Effect of Mechanically Tenderization on Beef
Rounds Inoculated with Salmonella. J. Food Safety
1:201–209.
PO 00000
Frm 00006
Fmt 4702
Sfmt 4702
establishment would be required to
obtain scientific or technical support for
the judgments made in designing the
cooking instructions, and in-plant data
to demonstrate that it is, in fact,
achieving the critical operational
parameters documented in the scientific
or technical support. HACCP does not
require establishments that produce
mechanically tenderized product to
have validated cooking instructions. But
just as establishments have to validate
their HACCP plans’ adequacy in
controlling the food safety hazards
identified during the hazard analysis, so
too, under this proposed rule,
establishments that produce
mechanically tenderized beef products
will have to validate their cooking
instructions. The scientific support
would need to demonstrate that: (1) The
cooking instructions provided can
repeatedly achieve the desired
minimum internal temperature and, if
applicable, rest time and (2) the
minimum internal time and, if
applicable, rest time achieved by the
instructions will ensure that the product
is fully cooked to destroy potential
pathogens throughout the product. The
in-plant data would need to
demonstrate that the establishment is, in
fact, achieving the critical operational
parameters documented in the scientific
or technical support. For additional
information on validation see the
following Federal Register notice on
HACCP Systems Validation (77 FR
27135; May 10, 2012) available at:
http://
www.fsis.usda.gov/Frame/Frame
Redirect.asp?main=http://
www.fsis.usda.gov/OPPDE/rdad/
FRPubs/2009–0019.htm.
Guidance on Validated Cooking
Instructions
The Agency has posted on its
Significant Guidance Documents Web
page (http://www.fsis.usda.gov/
Significant_Guidance/index.asp)
guidance on validated cooking
instructions for mechanically tenderized
product. This guidance, drawing heavily
on the findings of the two recent ARS
studies (Luchansky 2011 and 2012)
represents current FSIS thinking;
however, FSIS requests comment on it
and intends to update it as necessary
before this rule becomes final. In
addition to requesting comments on the
guidance document, FSIS specifically
requests additional scientifically valid
data on cooking instructions developed
for various mechanically tenderized
beef products that have been found to
consistently meet an endpoint
temperature and rest time sufficient to
ensure the product is fully cooked.
E:\FR\FM\10JNP1.SGM
10JNP1
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS
Should this rule become final,
establishments could collect their own
scientific data to support the cooking
instruction, use a study from an outside
source, or use the guidance provided by
FSIS. The guidance document provided
by FSIS includes a summary of cooking
instructions (e.g., place product in an
oven heated to X degrees F for X
minutes to achieve the desired endpoint
temperature of X degrees F for X
minutes) drawn from the peer reviewed
literature to achieve endpoint
temperatures sufficient to ensure the
product is fully cooked and the risk of
contamination with a pathogen is
sufficiently reduced. The format and
wording of the instructions are based on
best practices seen by the FSIS Labeling
and Program Delivery Division (LPDD).
The critical operational parameters from
each study (e.g., the cut of meat, method
of tenderization, product thickness, and
cooking method) are included in the
summary so that establishments can
select cooking instructions that will be
applicable to their product.
Establishments could utilize these
cooking instructions on the labels of
their products, without needing to
conduct any additional experiments or
provide any further scientific support,
provided that the actual product being
produced and labeled is similar to the
product the instructions were developed
for.
In the event that establishments are
unable to use the specific examples in
the guidance (e.g., because the product
is of a different thickness or is to be
cooked using a different method than
was previously studied), the guidance
document also contains instructions on
how to develop such support. The
protocol provided is based on the
experimental design employed in the
recent ARS studies. Specifically, the
document addresses the factors that
should be considered when designing a
validation study (e.g., number of
replicates, factors that affect heat
transfer, testing methodology, etc.).
Affected Industry
The proposed new descriptive
designation requirement would apply to
all raw or partially cooked needle- or
blade-tenderized beef products going to
retail stores, restaurants, hotels, or
similar institutions or to other official
establishments for further processing
other than cooking. The proposed
requirements for validated cooking
instructions would apply to raw or
partially cooked mechanically
tenderized beef products destined for
household consumers, hotels,
restaurants, or similar institutions. If a
second establishment repackages the
VerDate Mar<15>2010
16:04 Jun 07, 2013
Jkt 229001
product for household consumers,
hotels, restaurants or similar
institutions, the second establishment
would be responsible for applying the
validated cooking instructions to the
product label. If retail stores repackage
the product, they would be required to
include the descriptive designation and
validated cooking instructions from the
official establishment on the retail label.
If this proposal is adopted as a final
rule, establishments or retail stores
would be permitted to add the required
information to existing label designs, or
they could apply a separate sticker with
the required information to existing
labels. FSIS would generically approve
the modifications made to the labels for
needle- or blade-tenderized beef
products from official establishments
based on the provisions for generic
approval in 9 CFR 317.5(a)(1).
If this proposal is finalized, raw or
partially cooked needle- or bladetenderized beef products would have
descriptive designations that are
different from those of whole, intact
products. Once implemented, raw or
partially cooked beef products subject to
this rule whose labels do not include
the descriptive designation
‘‘mechanically tenderized,’’ and such
products destined for household
consumers, hotels, restaurants, or
similar institutions whose labels do not
include validated cooking instructions,
would be misbranded because the
product labels would be false or
misleading, because the products would
be offered for sale under the name of
another food, and because the product
labels would fail to bear the required
handling information necessary to
maintain the products’ wholesome
condition (21 U.S.C. 601(n)(1),
601(n)(2), and 601(n)(12)).
Of the 555 official establishments that
produce mechanically tenderized beef
products that could be affected by this
proposed rule, 542 are small or very
small according to the FSIS HACCP
definition. There are about 251 very
small establishments (with fewer than
10 employees) and 291 small
establishments (with more than 10 but
less than 500 employees). Therefore, a
total of 542 small and very small
establishments could possibly be
affected by this rule. The FSIS HACCP
definition assigns a size based on the
total number of employees in each
official establishment. The Small
Business Administration definition of a
small business applies to a firm’s parent
company and all affiliates as a single
entity. These small and very small
manufacturers, like the large
manufacturers, would incur the costs
associated with modifying product
PO 00000
Frm 00007
Fmt 4702
Sfmt 4702
34595
labels to add on the labels
‘‘mechanically tenderized’’ and
validated cooking instructions needed
to ensure adequate pathogen
destruction.
Descriptive Designations on Intact
Product
Note that intact beef products may
bear a descriptive designation of
‘‘intact,’’ consistent with 9 CFR 317.2(e).
However, such a descriptive designation
is not required. If producers want to use
such a descriptive designation on labels
of intact product to distinguish it from
non-intact product, FSIS would allow
the designation and would not consider
it a special statement requiring label
approval by the Agency. Rather, FSIS
would generically approve the labels
with the statement based on the
provisions for generic approval in 9 CFR
317.5(a)(1).
Executive Order 12988
This proposed rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. Under this proposed
rule: (1) All State and local laws and
regulations that are inconsistent with
this rule will be preempted, (2) no
retroactive effect will be given to this
rule, and (3) no retroactive proceedings
will be required before parties may file
suit in court challenging this rule.
Executive Order 12866 and Executive
Order 13563
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. This
proposed rule has been designated an
‘‘significant regulatory action’’ although
not economically significant, under
section 3(f) of Executive Order 12866.
Accordingly, the rule has been reviewed
by the Office of Management and
Budget.
Baseline: The Final Report of the
Expert Elicitation on the Market Shares
for Raw Meat and Poultry Products
Containing Added Solutions and
Mechanically Tenderized Raw Meat and
Poultry Product, February 2012
(February 2012 Report),33 estimates that
33 Muth, Mary K., Ball, Melanie, and Coglaiti,
Michaela Cimini February 2012.: RTI International
E:\FR\FM\10JNP1.SGM
Continued
10JNP1
34596
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS
there are 555 official establishments that
produce blade, needle, and both blade
and needle mechanically tenderized
beef products.34 In terms of assigned
HACCP processing size, the 555
establishments are comprised of 251
very small, 291 small, and 13 large
establishments. Total U.S. beef
production was 24.3 billion pounds in
2010.35 The February 2012 Report
estimates that the proportion of beef
products that is mechanically
tenderized is about 10.5 percent of total
beef products sold, or 2.6 billion
pounds. Of these products, an estimated
318 million pounds were brand name
packaged by the establishment for retail
sales; 640 million pounds private label
packaged by the establishment for retail
sales; 1,594 million pounds were
packaged by the establishment for food
service, and 479 million pounds were
packaged in retail operations.36
Retail establishments would be
involved in repackaging products to be
sold at retail. FSIS has not estimated the
number of retail establishments that
would be involved with repackaging
raw or partially cooked mechanically
tenderized beef products or the number
of labels they would require to be in
compliance with this rule.37 FSIS
expects that very few retail facilities are
producing mechanically tenderized
beef. FSIS requests data on the number
and size distribution of retail
establishments that could be possibly
affected by this proposed rule.
The proposed new descriptive
designation requirement would apply to
all raw or partially cooked needle- or
blade-tenderized beef products going to
retail stores, restaurants, hotels, or
similar institutions, or other official
establishments for further processing,
unless such product is destined to be
Final Report—Expert Elicitation on the Market
Shares for Raw Meat and Poultry Products
Containing Added Solutions and Mechanically
Tenderized Raw Meat and Poultry Products, Table
3–11 on p. 3–17.
34 The February 2012 report estimates that 490
establishments produce products that are both
mechanically tenderized and containing added
solutions.
35 Based on slaughter volumes multiplied by
average carcass weights in the Expert Elicitation on
the Market Shares for Raw Meat and Poultry
Products Containing Added Solutions and
Mechanically Tenderized Meat and Poultry
Products, RTI International, February 2012.
36 Ibid. Table 3–8 Proportions of Mechanically
Tenderized-only Beef Product pounds by Packaging
and labeling Type on p. 3–13, and Table 3–14
Estimated Pounds of Mechanically Tenderized-only
Beef Products by Packaging and Labeling Type
(Millions), p. 3–18.
37 FSIS believes that the number of retailers
involved in repackaging mechanically tenderized
beef is small and declining, with large retailers and
warehouse clubs moving toward ordering caseready packaged beef products.
VerDate Mar<15>2010
16:04 Jun 07, 2013
Jkt 229001
fully cooked at an official establishment.
The proposed requirements for
validated cooking instructions would
apply to raw or partially cooked
mechanically tenderized products
destined for household consumers,
hotels, restaurants, or similar
institutions. If a second establishment
repackages the product for household
consumers, hotels, restaurants, or
similar institutions, the second
establishment would also be responsible
for applying the validated cooking
instructions to the product label. If retail
stores repackage the product, they
would have to include the descriptive
designation and validated cooking
instructions from the official
establishment on the retail label.
This rule would affect foreign
establishments that manufacture and
export to the United States raw or
partially cooked beef products that are
mechanically tenderized, because
foreign establishments that manufacture
and export these products to the United
States will be required to follow these
same labeling requirements. FSIS
requests information on the number of
foreign establishments that would be
affected if this proposed rule is
finalized.
Expected Cost of the Proposed Rule
The proposed rule would require all
official establishments that produce raw
mechanically tenderized beef products
to modify their product labels to include
the term ‘‘mechanically tenderized’’ as
part of the products’ descriptive name
and to add validated cooking
instructions to the labels of all raw and
partially cooked needle- or bladetenderized beef products destined for
household consumers, hotels,
restaurants, or similar institutions. To
incorporate this information,
establishments may add the required
information to existing label designs
with minor changes. As discussed
below, establishments’ and stores’ costs
likely would be mitigated because the
uniform compliance date may result in
a number of labeling rules going into
effect at the same time. Therefore, the
establishments will have additional
time to comply based on the delayed
effective date provided by the uniform
compliance labeling rule and will be
able to limit label supplies based on the
day that the labels will need to be
modified. In addition, the uniform
compliance date allows establishments
time to use existing labels and will,
therefore, result in minimal loss of
inventory of labels.
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
Cost Analysis
On the basis of data provided by the
FSIS Labeling and Program Delivery
Staff, the Agency estimates that there
are approximately 270,000 meat and
poultry labels in the marketplace.38 Of
those, FSIS estimates that 50 percent of
the total labels, or 135,000, are unique
labels for raw meat and poultry
products labeled at official
establishments. This estimate of 135,000
may be an overestimate because it
assumes an exclusive label for each
variation of a product. Of the 135,000
labels, FSIS assumes that 23.8 percent,39
or 32,130 labels, are for beef products.
Using the 10.5-percent estimate for the
share of beef products that are
mechanically tenderized, and the 32,130
estimated number of beef labels, the
estimated number of labels for
mechanically tenderized beef products
is 3,374. This proposed rule would
require these products to add
‘‘mechanically tenderized’’ to their
labels.
FSIS is developing a final rule that
would require additional labeling of
products with added solutions. If this
proposed rule becomes final before the
added solutions rule is in effect, then an
additional 15.8 percent of all beef
products, or 5,077 labels, would require
the ‘‘mechanically tenderized’’
designation on their labels. (See
proposed rule ‘‘Common or Usual Name
Requirements for Meat and Poultry
Products with Added Solutions’’ (76 FR
44855.) If both this rule on mechanically
tenderized products and products with
added solutions are in effect,
establishments are likely to make all
labeling changes at the same time.
The number of labels was not tracked
by the FSIS Labeling Information
System Database because many
mechanically tenderized beef products
are single ingredient products, and
establishments may be eligible for
generic approval of these labels. FSIS
does not have data on partially cooked
mechanically tenderized beef products
but expects that the amount of these
products is small and therefore has not
included them in the cost calculations.
38 In the proposed rule for Prior Label Approval
System: Generic Label Approval (Docket FSIS–
2005–0016), FSIS estimated that there were
approximately 266,061 approved meat and poultry
product labels in the marketplace. For the purpose
of this analysis, FSIS chose to round the number of
approved meat and poultry product labels in the
marketplace to 270,000.
39 From Muth, Mary K., Ball, Mary K., and
Coglaiti, Michaela Cimini February 2012.: RTI
International Final Report—Expert Elicitation on
the Market Shares for Raw Meat and Poultry
Products Containing Added Solutions and
Mechanically Tenderized Raw Meat and Poultry
Products, p. 3–8.
E:\FR\FM\10JNP1.SGM
10JNP1
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS
FSIS requests comments on the number
of labels approved by establishments for
raw and partially cooked mechanically
tenderized beef products.
This cost analysis uses the mid-point
label design modification costs for a
minor coordinated label change, as
provided in a March 2011 FDA report.40
This report defines a minor change as
one in which only one color is affected
and the label does not need to be
redesigned. We conclude that the
labeling change that would be required
by this proposed rule is a minor change
because the words ‘‘mechanically
tenderized’’ need to be added to the
label, which is comparable to the
addition of an ingredient to the
ingredient list and the addition of
validated cooking instructions is
comparable to minimal changes to a
facts panel (e.g. nutrition facts,
supplement facts, or drug facts). For
comparison purposes, in 2011, the Food
and Drug Administration estimated that
the required labeling costs for its final
rule 41 on the labeling of
bronchodilators were deemed minor.
The FDA required revisions to the
‘‘Indications,’’ ‘‘Warnings,’’ and
‘‘Directions’’ sections of the Drug Fact
label. Using the RTI labeling model
described in the March 2011 report, the
FDA concluded that the revisions would
be deemed minor. FSIS assumes that the
addition of validated cooking
instruction is similar to the
aforementioned changes to the drug fact
panel, and is therefore deemed minor.
FSIS requests comments on these cost
estimates.
FSIS expects that all label changes
resulting from this proposed rule will be
coordinated with planned label changes.
The mid-point label design modification
costs for a minor coordinated label
change are an estimated $310 per label.
A coordinated label change is when a
regulatory label change is coordinated
with planned labeling changes by the
firm. A coordinated change is likely
because of uniform compliance labeling
rules. These rules help affected
establishments minimize the economic
impact of labeling changes because
affected establishments can incorporate
multiple label redesigns required by
multiple Federal rulemakings into one
modification at 2-year intervals, to
40 Model to Estimate Costs of Using Labeling as
a Risk Reduction Strategy for Consumer Products
Regulated by the Food and Drug Administration,
FDA, March 2011. (Contract No. GS–10F–0097L,
Task Order 5).
41 Labeling for Bronchodilators To Treat Asthma;
Cold, Cough, Allergy, Bronchodilator, and
Antiasthmatic 2011.
Drug Products for Over-the-Counter Human Use,
76 FR 143
VerDate Mar<15>2010
16:04 Jun 07, 2013
Jkt 229001
reduce the cost of complying with the
final regulation.42 Moreover, this allows
time to use existing labels and results in
minimal losses of inventories of labels.
In the case of a coordinated label
change, only administrative and
recordkeeping costs are attributed to the
regulation, and all other costs are not.43
FSIS estimates the cost to be $1.05
million (3,374 labels × $310) for
mechanically tenderized beef products
only; such products do not contain
added solution. The annualized cost to
the industry for products that are
mechanically tenderized only is
estimated to be $140 thousand at 7
percent for 10 years ($120 thousand
when annualized at 3 percent for 10
years).
FSIS is developing a final rule that
would require additional labeling of
products with added solutions. If this
proposed rule becomes final before the
added-solution rule is finalized, the cost
estimated would be higher to reflect an
additional 15.8 percent (or 5,077 labels)
of all beef products that are both
mechanically tenderized and containing
added solutions. This would result in an
additional one-time total cost (for all
affected labels for mechanically
tenderized beef containing added
solutions) of $1.57 million or $209
thousand when annualized at 7 percent
for 10 years ($179 thousand when
annualized at 3 percent for 10 years).
42 On December 14, 2004, FSIS issued a final rule
that provided that the Agency will set uniform
compliance dates for new meat and poultry product
labeling regulations in 2-year increments and will
periodically issue final rules announcing those
dates. FSIS established January 1, 2016 as the
uniform compliance date for new meat and poultry
product labeling regulations that are issued between
January 1, 2013, and December 31, 2014 (See 77 FR
76824). The final mechanically tenderized beef rule
will likely be issued during this period. The March
2011 FDA report states that changes in labels for
food products can be coordinated with firms’
planned label changes within 42 months (see Table
3–1, Model to Estimate Costs of Using Labeling as
a Risk Reduction Strategy for Consumer Products
Regulated by the Food and Drug Administration,
FDA, March 2011 (Contract No. GS–10F–0097L,
Task Order 5)).
43 From the 2011 FDA labeling model paper, the
costs of a label change (p. 3–3) include
administrative and recordkeeping activities, graphic
design, market testing (organizing focus groups),
prepress (convert design to plates), engraving,
printing, and disposing of old inventory. The
regulatory costs of a coordinated label change are
administrative and recordkeeping costs ‘‘associated
with understanding the regulation, determining
their responses, tracking the required change
throughout the labeling change process, and
reviewing and updating their records of product
labels. The costs other than administrative and
recordkeeping are not attributable to the regulation
if the labeling change is coordinated with a planned
change.’’ (p. 3–5). Model to Estimate Costs of Using
Labeling as a Risk Reduction Strategy for Consumer
Products Regulated by the Food and Drug
Administration, FDA, March 2011. (Contract No.
GS–10F–0097L, Task Order 5).
PO 00000
Frm 00009
Fmt 4702
Sfmt 4702
34597
This proposed rule would require
validated cooking instructions on
packages for beef that is only
mechanically tenderized and beef that is
both mechanically tenderized and
contains added solutions.
Establishments could also incur costs to
validate the required cooking
instructions for raw and partially
cooked needle- or blade-tenderized beef
products. These costs would be incurred
to ensure that the cooking instructions
are adequate to destroy any potential
pathogens that may remain in the beef
products after being tenderized. Most
cooking instruction validations would
be contracted out to universities or
conducted by trade associations or large
establishments. It is estimated that a
validation study would cost between
$5,000 and $10,000 per product line
with one formulation. Most studies will
validate cooking instructions for beef
products with two formulations:
injected with or without solution;
therefore, the total cost per validation
study would be between $10,000–
$20,000.44 Industry cost would likely be
relatively small because FSIS is issuing
guidance along with this NPRM that
establishments can use to develop
cooking instructions. FSIS is requesting
comments on the number of cuts per
establishment that would require
validated cooking instructions and
comment on whether establishments
would use FSIS’ guidance to develop
the validated cooking instructions. In
addition, FSIS requests comments on
the estimated costs for developing
validated cooking instructions. For
purposes of this analysis, FSIS has
assumed that the costs of developing
validated cooking instructions would be
minimal because FSIS assumes that
most establishments will follow FSIS’
guidance.
FSIS Budgetary Impact of the Proposed
Rule
This proposed rule will result in no
impact on the Agency’s operational
costs because the Agency will not need
to add any staff or incur any non-labor
expenditures since inspectors
periodically perform tasks to verify the
presence of mandatory label features
and to ensure that the label is an
accurate representation of the product.
The Agency’s cost to develop guidance
material that establishments can use to
develop cooking instructions will be
minimal because such guidance exists
and can be modified and posted on the
44 Per telephone conversation with the Grocery
Manufacturers Association Director of Science
Operations, Food Protection.
E:\FR\FM\10JNP1.SGM
10JNP1
34598
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS
FSIS Web site in fewer than six staffhours.
FSIS is soliciting comments and data
on any other potential federal costs that
might result from finalizing this rule.
Expected Benefits and Miscellaneous
Impacts of the Proposed Rule
The Agency has determined that the
proposed new labeling requirements
will improve public awareness of
product identities. The proposed rule
will clearly differentiate non-intact,
mechanically tenderized beef products
from intact products, thereby providing
truthful and accurate labeling of beef
products.
As stated earlier, when purchasing a
beef product, tenderness is a key factor.
However, not all needle- or bladetenderized beef products are readily
distinguished from non-tenderized beef
products. Therefore, by requiring the
descriptive designation ‘‘mechanically
tenderized’’ on the labels of this
product, the consumers will be
informed of the additional attributes of
the product when deciding whether to
purchase the product. Although the
benefits of having such additional
information cannot be quantified,
providing better market information to
consumers could promote better
competition among establishments that
produce beef products. In addition, if
the new label causes a divergence in
price between intact and mechanicallytenderized beef, there would be a
number of changes in consumer and
producer surplus. Consumers who
purchase mechanically-tenderized beef
in the absence of the rule and would
continue doing so in its presence would
gain surplus due to the decrease in price
for mechanically-tenderized beef, while
consumers purchasing intact beef in the
absence of the rule would experience a
loss of surplus due to the increase in
price for intact beef. Some producers of
intact beef or other meats would realize
a surplus increase because consumers
may substitute such products for
mechanically tenderized beef.
FSIS has concluded that labeling
information on needle- or bladetenderized beef products may help
consumers and retail establishments
better understand the product they are
purchasing. This knowledge is the first
step in helping consumers and retail
establishments become aware that they
need to cook these products differently
than intact beef products before the
products can be safely consumed.
Additionally, by including cooking
instructions, the food service industry
and household consumers will be made
aware that a mechanically tenderized
beef product or injected beef product
VerDate Mar<15>2010
16:04 Jun 07, 2013
Jkt 229001
needs to be cooked to a minimum
internal temperature and may need to be
maintained at this temperature for a
specific period of time to sufficiently
reduce the presence of potential
pathogens in the interior of the beef
product.
FSIS generated an estimate of the
annual number of illnesses from
mechanically (needle- or blade-)
tenderized beef steaks and roasts and
mechanically tenderized beef steaks and
roasts that contain added solutions that
could potentially be avoided as a result
of this proposed rule. FSIS evaluated
the effect of additional cooking of nonintact product by first determining the
implied concentration of organisms
prior to cooking given current
information, then determining the effect
of adding additional cooking.
Additional cooking is modeled to a
minimum temperature of 160 °F.
Current cooking practices as captured in
the EcoSure dataset do not specifically
include the time from when the final
cooking temperature was recorded to
when consumption occurred. It is likely
that product in this data set encountered
a range of dwell times. FSIS
recommends in its guidance concerning
steaks and roasts a cooking temperature
of 145 °F with 3 minutes resting time for
cooking steaks and whole roasts because
data support that this would be
equivalent to cooking at 160 °F without
holding a product at that temperature
for any dwell time.45 FSIS’ guidance
concerning cooking steaks and whole
roasts is located at http://
blogs.usda.gov/2011/05/25/cookingmeat-check-the-new-recommendedtemperatures/. If consumers adopt such
practices, results would be comparable
to consumers cooking product to 160° F
but not holding product at that
temperature for any dwell time.46
46 Equivalency in cooking temperatures and times
can be estimated using D and Z-values. The D-value
is a measure of how long bacteria must be exposed
to a particular temperature to effect a 1 log10
reduction. The Z-value is a measure of how much
temperature change is necessary to effect a 1 log10
change in the D-value. Although these values have
not been measured for E. coli O157:H7 in steaks,
they have been measured in ground beef. At 158 °F
(70° C) E. coli O157:H7 had a D-value of about 3.3
seconds, at 144.5 °F (62.5 °C) the D-value was 52.8
seconds. (Murphy, R. Y., E. M. Martin, et al. (2004).
‘‘Thermal process validation for Escherichia coli
O157:H7, Salmonella, and Listeria monocytogenes
in ground turkey and beef products.’’ J Food Prot
67(7): 1394–1402.) Three minutes at 145 °F would
be equivalent to more than 10 seconds at 160 °F.
Using the Z-value for E. coli O157:H7 in ground
beef yields similar estimates. The Z-value was given
as 9.8 °F (5.43°C). Changing the temperature from
160 °F to 145 °F would then represent an increase
in D-value of about 1.5 log10. Thus, 3 minutes at
145 °F would be equivalent to 5.7 seconds at 160 °F.
In either case, three minutes at 145 °F is more than
equivalent to an instantaneous temperature (< 1 sec)
at 160 °F.
PO 00000
Frm 00010
Fmt 4702
Sfmt 4702
Therefore, FSIS used the results from
the risk analysis that estimate the
benefits of consumers cooking
mechanically tenderized product to
160° F without a dwell time because
they are equivalent to 145° F with 3
minutes of dwell time and because the
Agency did not have information about
dwell time from the risk analysis.
The Centers for Disease Control and
Prevention (CDC) recently completed an
analysis attributing foodborne illnesses
to their sources. Painter, et al.,
examined outbreak data from 1998
through 2008 and identified 186
outbreaks of E. coli O157 resulting in
4,844 illnesses during that period.47 As
a consequence of this analysis, Painter,
et al., attributed 39.4% of illnesses or
1,909 (4,844 × 0.394) to beef.
Of the 6 outbreaks in tenderized
products described in Table 2, 5
occurred during the time frame
analyzed by Painter, et al. These 5
outbreaks (occurring between 2000 and
2007) resulted in 151 illnesses. Thus,
approximately 7.9% (151/1,909) of E.
coli O157 illnesses are attributable to
tenderized beef product.
Painter et al.’s work includes the
illnesses associated with outbreaks,
which constitute only a fraction of the
overall E. coli O157 illnesses that occur
each year. For an estimate of overall
illness numbers, we turn to another CDC
study, whose authors estimate that there
are 63,153 annual illnesses due to E. coli
O157 in the United States from all
sources.48 To determine the annual
number of illnesses from E. coli O157
(STEC O157), CDC begins with the
annual incidence of STEC O157
infections reported to CDC’s Foodborne
Diseases Active Surveillance Network
(FoodNet) sites from 2005 to 2008. This
value is adjusted up using an underdiagnosis multiplier that is based on the
following factors:
1. Whether a person with diarrhea
seeks medical care. CDC bases this on
unpublished surveys of persons with
bloody or non-bloody diarrhea
conducted in 2000–2001, 2002–2003,
and 2006–2007. CDC estimates that
about 35% of persons with bloody
diarrhea (about 90% of STEC O157
illnesses) would seek medical care and
about 18% of persons with non-bloody
diarrhea would seek medical care.
2. Whether a person seeking medical
care submits a stool specimen. This is
47 Painter, J., R. Hoekstra, et al. (2013).
‘‘Attribution of foodborne illnesses,
hospitalizations, and deaths to food commodities by
using outbreak data, United States, 1998–2008.’’
Emerg Infect Dis 9(3): 407–415.
48 Scallan, E., R.M. Hoekstra, et al. (2011).
‘‘Foodborne illness acquired in the United States—
major pathogens.’’ Emerg Infect Dis 17(1): 7–15.
E:\FR\FM\10JNP1.SGM
10JNP1
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 / Proposed Rules
mstockstill on DSK4VPTVN1PROD with PROPOSALS
also based on unpublished surveys of
persons with bloody or non-bloody
diarrhea conducted in 2000–2001,
2002–2003, and 2006–2007. CDC
estimates that about 36% of persons
with bloody diarrhea seeking medical
care and about 19% of persons with
non-bloody diarrhea seeking medical
care would submit stool specimens.
3. Whether a laboratory receiving a
stool specimen would routinely test it
for STEC O157. This is based on a
published study from the FoodNet
Laboratory Survey.49 CDC estimates that
58% of laboratories would routinely test
for O157 STEC.
4. How sensitive the testing procedure
is. CDC used a laboratory test sensitivity
rate of 70% based on studies of
Salmonella.50 51
5. CDC also adjusted for geographical
coverage of the FoodNet sites and for
the changing United States population
for the years 2005–2008.
The value was also adjusted down for
the following factors:
1. The proportion of illnesses that
were acquired outside of the United
States. Based on the proportion of
FoodNet cases of STEC O157 infection
who reported travel outside the United
States within 7 days of illness onset
(2005–2008), CDC estimated that 96.5%
of illnesses were domestically acquired.
2. The proportion of STEC O157
outbreak-associated illnesses that was
due to foodborne transmission. Based
on reported outbreaks CDC estimated
that 68% were foodborne.52 The overall
effect of the upward and downward
adjustments is a multiplier of 26.1 that
is applied to the reported number of
illness which is then adjusted down by
about 35% to account for domestically
acquired foodborne illness.
CDC’s credible interval surrounding
this point estimate ranges from 17,587
to 149,631.53 The estimated annual
illnesses due to mechanically
tenderized product is given by 63,153
49 Voetsch, A.C., F.J. Angulo, et al. (2004).
‘‘Laboratory practices for stool-specimen culture for
bacterial pathogens, including Escherichia coli
O157:H7, in the FoodNet sites, 1995–2000.’’ Clin
Infect Dis 38 Suppl 3: S190–197.
50 Chalker, R.B. and M.J. Blaser (1988). ‘‘A review
of human salmonellosis: III. Magnitude of
Salmonella infection in the United States.’’ Rev
Infect Dis 10(1): 111–124.
51 Voetsch, A.C., T.J. Van Gilder, et al. (2004).
‘‘FoodNet estimate of the burden of illness caused
by nontyphoidal Salmonella infections in the
United States.’’ Clin Infect Dis 38 Suppl 3: S127–
134.
52 Rangel, J.M., P.H. Sparling, et al. (2005).
‘‘Epidemiology of Escherichia coli O157:H7
outbreaks, United States, 1982–2002.’’ Emerg Infect
Dis 11(4): 603–609.
53 Scallan, E., R.M. Hoekstra, et al. (2011).
‘‘Foodborne illness acquired in the United States—
major pathogens.’’ Emerg Infect Dis 17(1): 7–15.
VerDate Mar<15>2010
16:04 Jun 07, 2013
Jkt 229001
(annual estimated illnesses of E. coli
O157:H7 54) × 0.394 (proportion of E.
coli O157:H7 illnesses attributable to
beef 55) × 0.079 (proportion of beef
attributable illnesses due to tenderized
product 56) = 1,965. This gives a range
of estimated annual illnesses from 547
(= 17,587 × 0.394 × 0.079) to 4,657 (=
149,631 × 0.394 × 0.079). FSIS requests
comments on the methods used,
including the application of the
underlying datasets, to estimate
illnesses attributable to mechanically
tenderized beef and alternative methods
for making this estimate. Because,
combining three sources of information
introduces uncertainty around the
precision of these estimates, we are
particularly interested in approaches to
quantifying the uncertainty inherent in
the method used.
An analysis of the NHANES 2005–
2006 Dietary Interview, Individual
Foods, First Day, and Second Day files
estimated approximately 11.7 billion
servings annually of steaks and roasts.
FSIS contracted with Research Triangle
Institute to estimate market shares for
mechanically tenderized beef and
mechanically tenderized beef with
added solutions.57 After accounting for
the proportion of all beef that was
ground, FSIS estimated that 21.0% of
non-ground product was mechanically
tenderized only and that 31.6% of nonground product was mechanically
tenderized with added solutions. Thus,
FSIS estimates that mechanically
tenderized beef accounts for 6.2 billion
servings annually. FSIS also estimates
that the frequency of illness for
mechanically tenderized product is
1,965/6.2 billion or 320 illnesses per
billion servings, with a range from 88 (=
547/6.2 billion) to 751 (= 4,657/6.2
billion) illnesses per billion servings.
The dose response function for a
pathogen associates an average dose
with a corresponding frequency of
illness. For E. coli O157:H7 the dose
response function is characterized by a
linear part in which the predicted
probability of illness per serving across
all exposures is proportional with
respect to an average dose and by a non-
34599
linear part in which the predicted
probability of illness is not proportional.
In the case of E. coli O157 illnesses
attributable to mechanically tenderized
beef, the frequency of illness is very
low; therefore the mean dose across the
population of servings that could
account for this frequency of illness is
also low. For one set of parameters the
dose response function for E. coli
O157:H7 corresponds to an average dose
of 0.0001 E. coli O157:H7 bacteria per
serving with a frequency of illness of
320 per billion.58 This average dose is
more than 5 log10 below the point at
which the dose response function
becomes non-linear. This makes the
average dose an appropriate surrogate
for the distribution of all doses.59 At the
lower end of the range of illnesses, a
dose of 0.000028 E. coli O157:H7
bacteria per serving corresponds to a
frequency of illness of 88 per billion
servings. At the upper end of the range
of illnesses, a dose of 0.00024 E. coli
O157:H7 bacteria per serving
corresponds to a frequency of illness of
751 per billion servings. Both of these
values also fall well below the point at
which the dose response function
becomes non-linear.
From a post-cooking dose of 0.0001, a
pre-cooking dose of E. coli O157:H7
bacteria can be calculated by
determining the average contamination
level needed to survive cooking. The
2007 EcoSure consumer cooking
temperature audit 60 involved the
collection of data from primary
shoppers of over 900 households
geographically dispersed across the
country. Participants were asked to
record the final cooking temperature
and name or main ingredient of any
´
entree they prepared during the week of
the study. Of the 3,257 recorded
consumer cooking temperatures in the
database for all products, 318 recorded
consumer cooking temperatures ranging
from 82 °F to 212 °F for beef (not
ground). Table 3 shows the number of
observations for each recorded cooking
temperature.
54 Ibid.
55 Painter, J., R. Hoekstra, et al. (2013).
‘‘Attribution of foodborne illnesses,
hospitalizations, and deaths to food commodities by
using outbreak data, United States, 1998–2008.’’
Emerg Infect Dis 9(3): 407–415.
56 151 outbreak illnesses attributable to
tenderized beef out of 1,909 outbreak illnesses
attributable to all beef (151/1,909 = 0.079).
57 Muth, M.K., M. Ball, et al. (2012). Expert
Elicitation on the Market Shares for Raw Meat and
Poultry Products Containing Added Solutions and
Mechanically Tenderized Raw Meat and Poultry
Products. Research Triangle Park, NC 27709, RTI
International, 3040 Cornwallis Road.
PO 00000
Frm 00011
Fmt 4702
Sfmt 4702
58 Powell, M., E. Ebel, et al. (2001). ‘‘Considering
uncertainty in comparing the burden of illness due
to foodborne microbial pathogens.’’ Int J Food
Microbiol 69(3): 209–215.
59 Williams, M.S., E.D. Ebel, et al. (2011).
‘‘Methodology for determining the appropriateness
of a linear dose-response function.’’ Risk Anal
31(3): 345–350.
60 EcoSure-EcoLab. (2007). ‘‘EcoSure 2007 Cold
Temperature Database.’’ FoodRisk.org Retrieved
May 26, 2010, from http://foodrisk.org/exclusives/
EcoSure/.
E:\FR\FM\10JNP1.SGM
10JNP1
34600
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 / Proposed Rules
modified cooking temperature
distribution with the pre-cooking dose
of 0.0188. This changes the post-cooking
average dose from 0.0001 E. coli
O157:H7 bacteria per serving to an
average dose of 0.0000039, which
corresponds to a frequency of illness of
13 per billion. With this change, the
Final cooking
Observations Percent predicted number of illnesses decreases
temperature
from 1,965 to 78. Thus, if all consumers
80–89 ....................
1
0.3 cook all mechanically tenderized beef to
90–99 ....................
3
0.9 at least 160 °F, the resulting total
100–109 ................
6
1.9 number of illness will be 78. Analogous
110–119 ................
11
3.5 calculations yield illness estimates of 22
120–129 ................
19
6.0 and 184 illness, respectively, if the
130–139 ................
27
8.5 baseline annual illness totals are 547
140–149 ................
38
11.9
and 4,657.
150–159 ................
54
17.0
The annual estimated number of
160–169 ................
61
19.2
170–179 ................
31
9.7 illness averted or prevented is estimated
180–189 ................
45
14.2 at 1,887 (1,965 illness less 78 illness),
190–199 ................
14
4.4 with a range of 525 illness (547 illness
200–209 ................
7
2.2 ¥ 22 illness) to 4,473 illnesses (4,657
210–219 ................
1
0.3 illness ¥ 184 illness), if mechanically
tenderized and mechanically tenderized
Sixty seven (21%) of the recorded
beef containing added solution is
cooking temperatures were below 140 °F cooked to a minimum temperature of
and 159 (50%) of the temperatures were 160 °F (which is equivalent to cooking
below 160 °F. A 2010 USDA
to a minimum internal temperature of
Agricultural Research Service (ARS)
145 °F with 3 minutes of dwell time).
study by Luchansky et al.,61 looked at
However, FSIS knows that not all
the relationship between final cooking
consumers or food service providers
temperatures and log10 reductions for
will change their behavior based on
mechanically tenderized beef. An
reading the labels and, therefore, the
additional ARS study by Luchansky, et
Agency has estimated the uncertainty
al.,62 also examined the relationship
surrounding the number of illnesses that
between final cooking temperatures and will be averted by obtaining ranges for
log10 reductions for chemically injected
both the consumer and food service
beef (mechanically tenderized beef with provider response rate, as well as using
added solutions). Equations derived
the range for the estimated number of
from these studies combined with the
illnesses if all consumers and food
distribution of final cooking
service providers cooked the product at
temperatures shown in Table 3 estimate a minimum recommended temperature.
that an average pre-cooking dose of
To determine this, FSIS used studies
0.0188 E. coli O157:H7 bacteria per
on the impacts of food product labels on
serving would result in an average post- consumer behavior. These studies
cooking dose of 0.0001. Thus, a preestimated the proportion of consumers
cooking dose of 0.0188 corresponds
changing their behavior in response to
with the estimate of 1,965 illnesses.
the presence of cooking instructions
Given the current cooking distribution,
(safe handling instructions) ranging
more than 98% of the 1,965 illnesses are from 15 to 19 percent. 63 In a study of
attributed to cooking temperatures
the nutrition fact panel on food
below 160 °F and less than 1% to
products, the American Dietetic
cooking temperatures equal to or greater Association (ADA) conducted a survey
than 160 °F.
which indicated that 56 percent of the
To evaluate the effect of using a
people interviewed claimed to have
higher minimum cooking temperature,
modified their food choices after using
FSIS modified the distribution derived
this nutrition fact labeling (American
from the EcoSure (2007) data set so that Dietetic Association, 1995).64 Finally,
all of the observations that were
63 Yang states that 15% (51% of respondents seen
originally below 160 °F were set to 160
the Safe Handling Instruction labels × 79%
°F. FSIS then calculated a new
× 37%
predicted number of illnesses using this remembered reading the labels readingchanging
their behavior after seeing and
the labels),
mstockstill on DSK4VPTVN1PROD with PROPOSALS
TABLE 3—FINAL RECORDED CONSUMER COOKING TEMPERATURES
FOR BEEF (NOT GROUND) IN 2007
ECOSURE CONSUMER COOKING
TEMPERATURE AUDIT
[EcoSure-EcoLab, 2007]
61 Luchansky,
J.B., A.C. Porto-Fett, et al. (2012).
‘‘Fate of Shiga toxin-producing O157:H7 and nonO157:H7 Escherichia coli cells within bladetenderized beef steaks after cooking on a
commercial open-flame gas grill.’’ J Food Prot 75(1):
62–70.
62 Ibid.
VerDate Mar<15>2010
16:04 Jun 07, 2013
Jkt 229001
and Bruhn states that 17% (60% of respondents
seen the labels × 65% said that their awareness was
increased × 43% said that they changed their
behavior). Ralston states that 19% (67% of
respondents seen the label × 29% who changed
their behavior).
64 America’s Eating Habits: Changes and
Consequences. U.S. Department of Agriculture,
PO 00000
Frm 00012
Fmt 4702
Sfmt 4702
the Food Marketing Institute (FMI) in
early 1995 indicated that the nutrition
fact label may be causing some dietary
change. Fifteen percent of the shoppers
indicated that they had stopped buying
products they had regularly purchased,
after reading the label.65 We use the
range (15 to 56 percent) as the estimate
for the impact of labels on consumer
behavior in retail, with our primary
estimate equaling the average of
available estimates, or 24 percent. FSIS
requests comments on the percentage of
consumers who would change their
behavior after reading the labels.
In addition, the RTI study indicates
that the food service industry market
share for mechanically tenderized beef
and beef containing added solution is
estimated at 53 percent and the market
share for retail for the same products is
estimated at 47 percent.66 In the absence
of data, FSIS assumes for its primary
estimate that the rule-induced
percentage reduction in illness will be
the same for food service establishments
as for mechanically-tenderized beef
purchased at retail (24 percent), and
presents a range in which between 0%
and 100% of food service providers will
follow the validated cooking
instructions. Should the rule become
final, food service providers will be able
to identify mechanically tenderized beef
product as such and will therefore be
able to follow the Food Code cooking
instructions. The Food Code (developed
by the Conference for Food Protection
and adopted by 49 states, which
represent 96 percent of the population)
recommends cooking mechanically
tenderized and injected meats to a
minimum temperature of 145°F for a
minimum of 3 minutes. The Food Code,
however, states that retail service
facilities may serve such product rare if
they notify consumers of the risk.67
Therefore, FSIS assumes that at a
minimum, zero food service providers
will follow the cooking instructions.
Economic Research Service, Food and Rural
Economics Division. Agriculture Information
Bulletin No. 750.
65 Food Marketing Institute (FMI) states that of the
43 percent of the shoppers interviewed, who had
seen the label, 22 percent indicated it had caused
them to start buying and using food products they
had not used before, and 34 percent said they had
stopped buying products they had regularly. We use
the higher percentage of 15% (43% × 34%) in our
estimate. FMI and Prevention Magazine Report
Shopping for Health: Balancing, Convenience,
Nutrition and Taste, 1997.
66 RTI, pp. 3–12 and 3–14.
67 In the U.S. Department of Health and Human
Services, Public Health Service, FDA Food Code,
2009, S3–411.11 (D), a rare animal food such as rare
meat other than whole-muscle, intact steaks, may be
served or offered for sale upon consumer request or
selection in a ready-to-eat form if the consumer is
informed that to ensure its safety, the food is to be
more fully cooked.
E:\FR\FM\10JNP1.SGM
10JNP1
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 / Proposed Rules
FSIS is including the lower end to
recognize that some food service
providers may recognize customers’
requests that the meat be cooked rare.
FSIS is requesting comments on food
service providers’ likely response to
new labeling of mechanicallytenderized beef, including any cost that
would be incurred by such
establishments as a result of changing
standard operating procedures related to
intact and mechanically-tenderized
beef.
Table 4 shows the estimated
reduction in illness numbers based on
these assumptions for consumer and
food service provider behavior. To
derive the estimated number of illnesses
averted and focusing first on inputs
derived from Scallan et al.’s primary
estimate, the range for the estimate
would be 133 illness (1,887 illnesses
(mid-point estimate from the risk
analysis) * 47% (retail share of
mechanically tenderized beef market) *
15% (lower end of the range for percent
of consumer using validated cooking
instructions) + 53% (food service share
of mechanically tenderized beef) * 0%
34601
(lower end of the range for food service
compliance with validated cooking
instructions)) to 1,497 illness averted
(1,887 illnesses (mid-point estimate
from the risk analysis) * 47% (retail
share of mechanically tenderized beef
market) * 56% (upper end of the range
for percent of consumers using
validated cooking instructions) + 53%
(food service share of mechanically
tenderized beef) * 100% (upper end of
the range for food service compliance
with validated cooking instructions)).
The primary estimate is 460 illnesses.
TABLE 4—RESPONSE RATE AND RESULTING AVERTED ILLNESSES
Category
Retail
Food service
Total
Averted illnesses
Share of Mechanically
Tenderized Beef in
Retail vs. Food Service.
Response to Label ........
Primary 2 ........................
Lower Bound 3 ...............
47% ..................
53% ..................
100% ..............................
........................................
15 to 56% 1 .......
24% 1 ................
...........................
0% to 100% ......
24% 1 ................
...........................
7% to 79% .....................
24% ................................
24% (7% to 79%) ..........
133 to 1,497 ...................
460 .................................
128 (37 to 416) ..............
Upper Bound 4 ...............
...........................
...........................
24% (7% to 79%) ..........
1,091 (315 to 3,548) ......
1 The average of the percentages of consumer
FMI 15% as discussed in the benefits section.
2 Using estimated mechanically tenderized beef
3 Using estimated mechanically tenderized beef
4 Using estimated mechanically tenderized beef
mstockstill on DSK4VPTVN1PROD with PROPOSALS
With the primary estimate, 24% of all
mechanically tenderized beef previously
cooked to a lower temperature is cooked
to the suggested temperature, which is
equivalent to 460 illnesses averted or
prevented.
Using the FSIS estimate for the
average cost per case for an E. coli
O157:H7 illness of $3,281,68 expected
benefits from this proposed rule are
$1,511,000 per year (with a range of
$436,000 to $4,911,000). Using the
credible interval from Scallan et. al
provides expected benefits of $420,000
per year for 128 illnesses prevented
(with a range of $121,000 to $1,366,000)
for the lower bound of the credible
interval and expected benefits of
$3,581,000 per year for 1,091 illnesses
prevented (with a range of $1,035,000 to
$11,641,000) in the upper bound of the
credible interval. This estimate for the
average cost of an E. coli O157:H7
illness is derived by using the current
68 The FSIS estimate for the cost of E. coli
O157:H7 ($3,281 per case,—2010 dollars) was
developed using the USDA, ERS Foodborne Illness
Cost Calculator: STEC O157 (June 2011). FSIS
updated the ERS calculator to incorporate the
Scallan (2011) case distribution for STEC O157.
Scallan E. Hoekstra, Angulo FJ, Tauxe RV,
Widdowson MA, Roy SL, et. al. 2011 January.
‘‘Foodborne Illness Acquired in the United States—
Major Pathogens’’. Emerging Infectious Diseases.
VerDate Mar<15>2010
16:04 Jun 07, 2013
Jkt 229001
Expected benefits
$436,000 to $4,911,000.
$1,511,000.
$420,000 ($121,000 to
$1,366,000).
$3,581,000 ($1,035,000
to $11,641,000).
response rate: Yang 15%, Bruhn 17%, Ralston 19%, American Dietetic Association 56%, and
preventable illnesses of 1,887 illnesses.
preventable illnesses of 128 illnesses.
preventable illnesses of 1,091 illnesses.
version of ERS Cost calculator (for E.
coli) and replacing the case numbers
with new case numbers based on
Scallan’s report.
For E. coli, FSIS adjusted Scallan’s
case distribution to fit the ERS Cost
Calculator because Scallan reported
each illnesses in three categories (doctor
visits, hospitalization, and death) while
the ERS Cost Calculator for E. coli O157
has seven severity categories. By
changing only the case numbers, FSIS
kept all other assumptions in the ERS
Cost Calculator. ERS has recently
updated the dollar units to 2010 dollars
and FSIS is using these estimates.
These estimates represent a minimal
estimate for an average cost of illness
because they only include medical costs
and loss-of-productivity costs. They do
not include pain and suffering costs.
FSIS believes that consumers prefer
lower cooking temperatures 69 and
therefore they may substitute other meat
choices rather than cooking at a higher
recommended temperature included in
cooking instructions. This welfare loss
associated with substituting to lesspreferred meats or cooking to
temperatures that are higher than ideal
(from a taste perspective) was not
quantified in the analysis.
PO 00000
Frm 00013
Fmt 4702
Sfmt 4702
Conclusion
The cost to produce labels for
mechanically tenderized beef is a onetime cost of $1.05 million or $2.62
million if this rule is in effect before the
added solutions rule. The annualized
cost is $140,000 for 10 years at a 7
percent discount rate or $349,000 over
10 years at a 7 percent discount rate if
this rule is in effect before the added
solutions rule.
The expected number of illnesses
prevented would be 460 per year, with
a range of 133 to 1,497, if the predicted
percentages of beef steaks and roasts are
cooked to an internal temperature of 160
°F (or 145 °F and 3 minutes of dwell
time). These prevented illnesses amount
to $1,511,000 per year in benefits with
a range of $436,000 to $4,911,000. The
expected annualized net benefits are
$296,000 to $4,771,000 with a primary
estimate of $1,371,000.
If, however, this rule is in effect
before the added solutions rule, the
expected annualized net benefits are
then $1,162,000, with a range of $87,000
to $4,562,000.
Using the lower end of the credible
interval from Scallan et. al provides an
expected number of illness prevented of
128 per year, with a range of 37 to 416,
as discussed earlier. These prevented
E:\FR\FM\10JNP1.SGM
10JNP1
34602
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 / Proposed Rules
illnesses amount to $420,000 in
benefits, with a range of $121,000 to
$1,366,000. The expected annualized
net benefits for the lower end of the
Scallan’s credible interval are $280,000,
with a range of ¥$19,000 to $1,226,000,
if this rule goes into effect before the
added solutions rule.
Using the upper end of the credible
interval from Scallan et. al provides an
expected number of illness prevented of
1,091 per year, with a range of 315 to
3,548 as discussed earlier. These
prevented illnesses amount to
$3,581,000 in benefits, with a range of
$1,035,000 to $11,641,000. The
expected annualized net benefits for the
upper end of the Scallan’s credible
interval are $3,441,000, with a range of
$895,000 to $11,501,000, if this rule
goes into effect after the added solutions
rule.
In addition to the quantified net
benefits mentioned above, the rule
would generate the unquantifiable
benefits of increased consumer
information and market efficiency, an
unquantified consumer surplus loss and
an unquantified cost associated with
food service establishments changing
their standard operating procedures.
As mentioned above, FSIS is using an
estimate of the number of
establishments producing needle- or
blade-tenderized beef products and the
number of labels that would need to be
modified as a result of this proposed
rule. FSIS requests comments on the
number of official and retail
establishments that are producing or
packaging mechanically tenderized beef
products and the number of labels that
they might need to modify should this
proposal be finalized.
Additionally, FSIS cannot estimate
the number of validation studies that
would be necessary to develop cooking
instructions for raw and partially
cooked needle- or blade-tenderized beef
products. In addition, FSIS requests
comments on the costs of conducting
these validation studies.
Alternatives
mstockstill on DSK4VPTVN1PROD with PROPOSALS
Vacuum-Tumbled Beef Products
Some beef products are vacuumtumbled to marinate and tenderize the
product. The vacuum increases
absorption of the marinade, while
tumbling both tenderizes the product
and increases absorption of the
marinade. Vacuum-tumbled beef is a
non-intact product, though its
appearance is similar to whole, intact
product. Research shows that the
process of vacuum tumbling a product
increases bacterial migration into the
VerDate Mar<15>2010
16:04 Jun 07, 2013
Jkt 229001
interior of the product.70 71 However,
FSIS does not have sufficient data to
understand the magnitude of the risk of
pathogens that may be introduced into
product as a result of vacuum tumbling.
Therefore, the Agency is requesting that
the public submit data concerning the
safety of vacuumed tumbled beef
products. In addition, FSIS is asking for
comments to see whether vacuum
tumbled beef product should be
considered mechanically tenderized
product and thus subject to the
provisions of this proposed rule if it
becomes final.
Enzyme-Formed Product
Some meat and poultry products are
formed with transglutaminase enzyme
(TG enzyme). TG enzyme is approved
for use as a cross-linking binder to form
product, e.g., through binding pieces of
beef tenderloin together to form a larger
beef tenderloin steak or roast. FSIS
regulations (9 CFR 317.8(b)(39) and
381.129(e)) require labeling for meat and
poultry products that are formed or reformed with TG enzyme as a binder as
part of the product name, e.g., ‘‘Formed
Turkey Thigh Roast.’’ Formed products
are non-intact. However, the formed
products are already labeled in a
manner that distinguishes them from
other products. FSIS requests comment
on whether this labeling is sufficient to
inform consumers of the nature of
formed product and on whether any
final rulemaking should include
additional labeling requirements, such
as validated cooking instructions on any
not-ready-to-eat formed product. FSIS
requests data on the volume of formed
product, the volume of formed product
sold at retail stores versus food service
facilities, and any available data on
whether consumers typically cook
formed product at time and temperature
combinations sufficient to destroy
pathogens.
FSIS considered several alternatives
to the proposed rule:
Option 1. Extend labeling
requirements to include vacuum
tumbled beef products and enzymeformed beef products. FSIS considered
the option of proposing to amend the
labeling regulations to include a new
requirement for labeling all vacuum
tumbled and enzyme-formed beef
products. But, as discussed earlier, FSIS
70 Warsaw, CR, Orta-Ramirez A, Marks BP, Ryser
ET, Booren AM. 2008. Single directional migration
of Salmonella into marinated whole muscle turkey
breast. Journal of Food Protection. 71(1):13–156.
71 Warsow, C.R., Marks, B.P., Ryser, E.T., OrtaRamirez, A., Booren, A.M., Effects of vacuum
tumbling on Salmonella migration into the interior
of intact, marinated turkey breasts. http://
ift.confex.com/ift/2003/techprogram/
paper_19598.htm.
PO 00000
Frm 00014
Fmt 4702
Sfmt 4702
does not have sufficient data concerning
the production practices and risks of
consuming vacuum tumbled beef
products and enzyme-formed beef
products to proceed with this option.
FSIS is requesting comments and data
on these products.
Option 2. Extend the proposed
labeling requirements to all needle- or
blade-tenderized meat and poultry
products. FSIS considered the option of
proposing to amend the labeling
regulations to include a new
requirement for labeling all
mechanically tenderized meat and
poultry products. However, as discussed
above, FSIS does not have sufficient
data concerning the production
practices and risks of consuming
mechanically tenderized poultry
products or mechanically tenderized
meat products, other than beef, to
proceed with this option.
Option 3. Validated cooking
instructions for needle or bladetenderized beef, needle-injected beef,
and all beef containing solutions. FSIS
considered the option of proposing to
amend the labeling regulations to
require validated cooking instructions
for needle or blade tenderized beef,
needle-injected, and all beef containing
solutions. However, FSIS did not find
any outbreak data for products that
contain added solutions but are not
injected. In addition, if products are
marinated but not injected, the pathogen
remains on the surface of the product
and would typically be eliminated, even
if the product is cooked to rare
temperatures. Therefore, FSIS does not
have any data necessary to substantiate
the need for this alternative.
Regulatory Flexibility Analysis
The FSIS Administrator has made a
preliminary determination that this
proposed rule would not have a
significant economic impact on a
substantial number of small entities in
the United States, as defined by the
Regulatory Flexibility Act (5 U.S.C. 601
et seq.). This determination was made
because the rule will affect the labeling
of about 10.5% of 24.3 billion pounds
of beef products. Over 97 percent of the
555 federal establishments that produce
mechanically tenderized beef products
could possibly be affected by this
proposed rule are small or very small
according to the FSIS HACCP
definition. There are about 251 very
small establishments (with fewer than
10 employees) and 291 small
establishments (with more than 10 but
less than 500 employees). Therefore, a
total of 542 small and very small
establishments could possibly be
affected by this rule. The FSIS HACCP
E:\FR\FM\10JNP1.SGM
10JNP1
34603
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 / Proposed Rules
definition assigns a size based on the
total number of employees in each
official establishment. The Small
Business Administration definition of a
small business applies to a firm’s parent
company and all affiliates as a single
entity.
These small and very small
manufacturers, like the large
manufacturers, would incur the costs
associated with modifying product
labels to add on the labels
‘‘mechanically tenderized’’ and
validated cooking instructions needed
to ensure adequate pathogen
destruction.
Based on the estimated number of
labels that will be required by the
establishments, the cost will add an
average of $0.001 per package ($1.05
million/951 million packages of needleor blade-tenderized beef).72 The average
cost per establishment would be $1,884
per establishment ($1.05 million/555).
Also, small and very small
establishments will tend to have a
smaller number of unique products and
will therefore have a smaller number of
labels to modify, and therefore less
labeling cost.
The labeling costs discussed above are
one-time costs. FSIS believes these onetime costs will not be a financial burden
on small entities.
Paperwork Reduction Act
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501,
et seq.), the information collection
requirement included in this proposed
rule has been submitted for approval to
OMB.
Title: Mechanically Tenderized Beef
Products.
Type of Collection: New.
Abstract: FSIS is proposing to require
the use of the descriptive designation
‘‘mechanically tenderized’’ on the labels
of needle- or blade-tenderized beef
products, including beef products
injected with marinade or solution, that
do not fall under a regulatory standard
of identity. FSIS is also proposing that
the print for all words in the descriptive
designation appear as the product name
in the same style, color, and size and on
a single-color contrasting background.
In addition, FSIS is proposing to require
that labels of raw and partially cooked
needle- or blade-tenderized beef
products include validated cooking
Estimated
number of
respondents
Number of
responses per
respondent
instructions that inform consumers that
these products need to be cooked to a
specified minimum internal
temperature and whether they need to
be held at that minimum temperature or
higher for a specified time before
consumption, i.e., dwell time or rest
time, to ensure that they are fully
cooked.
The average burden per response and
the annual burden hours are explained
below and summarized in the charts
which follow.
Estimated Annual Burden:
Mechanically Tenderized Beef Products
Recordkeeping:
Estimated Annual Recordkeeping
Burden for Mechanically Tenderized
Beef Products
Respondents: Official meat
establishments.
Estimated Number of Respondents:
555.
Estimated Number of Responses per
Respondent: 30.454.
Estimated Total Annual Responses:
16,902.
Estimated Total Annual
Recordkeeping Burden: 985.95 hours.
Total annual
responses
Time for
responses
in minutes
Total annual
burden hours
Establishments maintain labels on file ..............................
Establishments maintain validated cooking instructions
on file ..............................................................................
555
15.227
8,451
2
281.7
555
15.227
8,451
5
704.25
Total Recordkeeping Burden ......................................
555
30.454
16,902
7
985.95
Reporting
Estimated Annual Reporting Burden for
Mechanically Tenderized Beef Products
Respondents for this Proposed Rule:
Official meat establishments.
Estimated Total Annual Reporting
Burden on Respondents: 18,733.05
hours.
Estimated Number of Respondents:
555.
Estimated Number of Responses per
Respondent: 30.454.
Estimated Total Annual Responses:
16,902.
Estimated
number of
respondents
Number of
responses per
respondent
Total annual
responses
Time for
responses
in minutes
Total annual
burden hours
555
15.227
8,451
13
555
15.227
8,451
120
16,902
Total Reporting Burden ..............................................
mstockstill on DSK4VPTVN1PROD with PROPOSALS
Establishments are to prepare labels with descriptive
designation and validated cooking instructions .............
Establishments are to develop validated cooking instructions ................................................................................
555
30.454
16,902
133
18,733.05
SUMMARY OF BURDEN—MECHANICALLY TENDERIZED BEEF PRODUCTS
Total No. Respondents ...................
Average No. Responses per Respondent .....................................
Total Annual Responses ................
555
60.908
33,804
72 FSIS estimates that the annual quantity of
mechanically tenderized beef at is about 951
VerDate Mar<15>2010
18:29 Jun 07, 2013
Jkt 229001
1,831.05
Copies of this information collection
assessment can be obtained from John
O’Connell, Paperwork Reduction Act
Coordinator, Food Safety and Inspection
2.417 Service, USDA, 1400 Independence
Avenue SW., Room 6083, South
19,719
Building, Washington, DC 20250.
SUMMARY OF BURDEN—MECHANICALLY TENDERIZED BEEF PRODUCTS—Continued
Average Hours per Response ........
Total Burden Hours .....................
million packages (2.6 billion pounds of mechanical
tenderized beef produced/2.735 average weight of a
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
retail package according to the National Cattlemen’s
Beef Association).
E:\FR\FM\10JNP1.SGM
10JNP1
34604
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 / Proposed Rules
Comments are invited on: (a) whether
the proposed collection of information
is necessary for the proper performance
of FSIS’s functions, including whether
the information will have practical
utility; (b) the accuracy of FSIS’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (c) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Comments may be sent to both John
O’Connell, Paperwork Reduction Act
Coordinator, at the address provided
above, and the Desk Officer for
Agriculture, Office of Information and
Regulatory Affairs, Office of
Management and Budget, Washington,
DC 20253. To be most effective,
comments should be sent to OMB
within 60 days of the publication date
of this proposed rule.
E-Government Act
FSIS and USDA are committed to
achieving the purposes of the EGovernment Act (44 U.S.C. 3601, et
seq.) by, among other things, promoting
the use of the Internet and other
information technologies and providing
increased opportunities for citizen
access to Government information and
services, and for other purposes.
Executive Order 13175
This proposed rule has been reviewed
in accordance with the requirements of
Executive Order 13175, Consultation
and Coordination with Indian Tribal
Governments. The review reveals that
this proposed regulation will not have
substantial and direct effects on Tribal
governments and will not have
significant Tribal implications.
mstockstill on DSK4VPTVN1PROD with PROPOSALS
The U.S. Department of Agriculture
(USDA) prohibits discrimination in all
its programs and activities on the basis
of race, color, national origin, gender,
religion, age, disability, political beliefs,
sexual orientation, and marital or family
status. (Not all prohibited bases apply to
all programs.)
Persons with disabilities who require
alternative means for communication of
program information (Braille, large
.print, audiotape, etc.) should contact
USDA’s Target Center at 202–720–2600
(voice and TTY).
16:04 Jun 07, 2013
Jkt 229001
Additional Public Notification
FSIS will announce this proposed
rule online through the FSIS Web page
located at http://www.fsis.usda.gov/
regulations_&_policies/Proposed_Rules/
index.asp.
FSIS will also 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 groups, consumer
interest groups, health professionals,
and other individuals who have asked
to be included. The Update is also
available on the FSIS Web page. In
addition, FSIS offers an electronic 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_&_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 accounts.
List of Subjects in 9 CFR Part 317
Food labeling, Food packaging, Meat
inspection, Nutrition, Reporting and
recordkeeping requirements.
For the reasons discussed in the
preamble, FSIS is proposing to amend 9
CFR Chapter III as follows:
PART 317—LABELING, MARKING
DEVICES, AND CONTAINERS
USDA Nondiscrimination Statement
VerDate Mar<15>2010
To file a written complaint of
discrimination, write USDA, Office of
the Assistant Secretary for Civil Rights,
1400 Independence Avenue SW,
Washington, DC 20250–9410 or call
202–720–5964 (voice and TTY).
1. The authority citation for Part 317
continues to read as follows:
■
Authority: 21 U.S.C. 601–695; 7 CFR 2.18,
2.53.
2. Amend § 317.2 by adding and
reserving paragraphs (e)(1) and (2), and
adding a new paragraph (e)(3) to read as
follows:
■
§ 317.2 Labels: definition; required
features.
*
PO 00000
*
*
(e) * * *
Frm 00016
*
Fmt 4702
*
Sfmt 4702
(3) Product name and required
validated cooking instructions for
needle- or blade-tenderized beef
products. (i) Unless the product is
destined to be fully cooked at an official
establishment, the product name for a
raw or partially cooked beef product
that has been mechanically tenderized,
whether by needle or by blade, must
contain the term ‘‘mechanically
tenderized’’ as a descriptive designation
and an accurate description of the beef
component.
(ii) The product name must be printed
in a single font style, color, and size and
must appear on a single-color
contrasting background.
(iii) The labels on raw or partially
cooked needle- or blade-tenderized beef
products destined for household
consumers, hotels, restaurants, or
similar institutions must contain
validated cooking instructions,
including the cooking method, that
inform consumers that these products
need to be cooked to a specified
minimum internal temperature, whether
the product needs to be held for a
specified time at that temperature or
higher before consumption to ensure
that potential pathogens are destroyed
throughout the product, a statement that
the internal temperature should be
measured by a thermometer.
*
*
*
*
*
Done at Washington, DC on: June 3, 2013.
Alfred V. Almanza,
Administrator.
[FR Doc. 2013–13669 Filed 6–7–13; 8:45 am]
BILLING CODE 3410–DM–P
NUCLEAR REGULATORY
COMMISSION
10 CFR Part 50
[Docket No. PRM–50–107; NRC–2013–0077]
Submitting Complete and Accurate
Information
Nuclear Regulatory
Commission.
ACTION: Petition for rulemaking;
acceptance, docketing, and request for
comments.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) is publishing for
comment a petition for rulemaking
(PRM) filed with the Commission by Mr.
James Lieberman (the petitioner) on
April 15, 2013. The petitioner requests
that the NRC expand its ‘‘regulatory
framework to make it a legal obligation
for those non-licensees who seek NRC
regulatory approvals be held to the same
legal standards for the submittal of
SUMMARY:
E:\FR\FM\10JNP1.SGM
10JNP1
]]>Agencies
[Federal Register Volume 78, Number 111 (Monday, June 10, 2013)]
[Proposed Rules]
[Pages 34589-34604]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13669]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 78, No. 111 / Monday, June 10, 2013 /
Proposed Rules
[[Page 34589]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 317
[Docket No. FSIS-2008-0017]
RIN 0583-AD45
Descriptive Designation for Needle- or Blade-Tenderized
(Mechanically Tenderized) Beef Products
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
require the use of the descriptive designation ``mechanically
tenderized'' on the labels of raw or partially cooked needle- or blade-
tenderized beef products, including beef products injected with
marinade or solution, unless such products are destined to be fully
cooked at an official establishment. Beef products that have been
needle- or- blade-tenderized are referred to as ``mechanically
tenderized'' products. FSIS is proposing that the product name for such
beef products include the descriptive designation ``mechanically
tenderized'' and an accurate description of the beef component. By
including this descriptive designation consumers will be informed that
this product is non-intact. Non-intact products need to be fully cooked
in order to be rendered free of pathogenic bacteria because bacteria
may become translocated from the surface of the meat during mechanical
tenderization. FSIS is also proposing that the print for all words in
the descriptive designation as the product name appear in the same
style, color, and size and on a single-color contrasting background. In
addition, FSIS is proposing to require that labels of raw and partially
cooked needle- or blade-tenderized beef products destined for household
consumers, hotels, restaurants, or similar institutions include
validated cooking instructions that inform consumers that these
products need to be cooked to a specified minimum internal temperature,
and whether they need to be held at that minimum temperature for a
specified time before consumption, i.e., dwell time or rest time, to
ensure that they are fully cooked.
Based on the scientific evidence that indicates that mechanically
tenderized beef products need to be cooked more thoroughly than intact
beef products, FSIS is proposing these amendments to the regulations.
FSIS is also announcing that it has posted on its Web site guidance
for developing validated cooking instructions for mechanically
tenderized product. The recommendations in the guidance document are
based on the results from published research designed to identify
minimum internal temperature and time combinations sufficient to render
a product and studies designed to validate cooking instructions.
DATES: Comments must be received by August 9, 2013.
ADDRESSES: FSIS invites interested persons to submit comments on this
proposed rule and on the guidance for validated cooking instructions.
Comments may be submitted by one 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. Go to http://www.regulations.gov. Follow the on-line instructions at that site for
submitting comments.
Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S.
Department of Agriculture, Food Safety and Inspection Service, Docket
Clerk, Patriots Plaza 3, 1400 Independence Avenue SW., Mailstop 3782,
Room 8-163B, Washington, DC 20250-3700.
Hand- or Courier-Delivered Submittals: Deliver to Patriots
Plaza 3, 355 E. Street SW., Room 8-163B, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2012-0013. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to http://www.regulations.gov.
Docket: For access to background documents or comments received, go
to the FSIS Docket Room at Patriots Plaza 3, 355 E. Street SW., Room 8-
164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., Monday
through Friday.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant
Administrator, Office of Policy and Program Development, FSIS, U.S.
Department of Agriculture, 1400 Independence Avenue SW., Washington, DC
20250-3700; Telephone: (202) 205-0495; Fax: (202) 720-2025.
SUPPLEMENTARY INFORMATION:
Executive Summary
Mechanically tenderized beef products are products that have been
needle- or blade-tenderized, or have been injected with a marinade or a
solution. The act of mechanically tenderizing a beef product
potentially pushes pathogens from the exterior of the product into its
interior. Because mechanically tenderized beef products are non-intact
products, they need to be more fully cooked than intact beef products
where potential pathogens are generally limited to the product's
surface. The time-and-temperature combination needed to destroy
pathogens on the surface of the intact product is less than that
necessary to destroy pathogens that may reside in the interior of the
non-intact product.
Requiring mechanically tenderized beef products to be labeled with
a descriptive designation that identifies them as mechanically
tenderized and accompanied with validated cooking instructions is
intended to help inform consumers and instruct them that such products
need to be fully cooked.
Under the Federal Meat Inspection Act (FMIA) the labels of meat
products must be truthful and not misleading, and the labels must
accurately disclose to consumers what they are buying when they
purchase any meat product. The FMIA gives FSIS broad authority to
promulgate rules and regulations necessary to carry out its provisions.
FSIS is proposing that the labeling of raw or partially cooked
mechanically tenderized beef products bear a descriptive designation
that clearly identifies that the product has been mechanically
tenderized, unless such
[[Page 34590]]
product is destined to be fully cooked in an official establishment.\1\
---------------------------------------------------------------------------
\1\ Any slaughtering, cutting, boning, meat canning, curing,
smoking, salting, packing, rendering, or similar establishment at
which inspection is maintained under [FSIS] regulations (9 CFR
301.2).
---------------------------------------------------------------------------
To ensure that the descriptive designation is readily apparent on
the label, FSIS is proposing that the print for all words in the
descriptive designation, as well as the words in the description of the
product, appear in the same font style, color, and size as the product
name and on a single-color contrasting background.
FSIS is also proposing to require that labels of raw and partially
cooked needle- or blade-tenderized beef products destined for household
consumers, hotels, restaurants and similar institutions include cooking
instructions that have been validated to ensure that a sufficient
number of potential pathogens throughout the product are destroyed.
FSIS will provide a Compliance Guide to help establishments develop
validated cooking instructions.
Table 1--Summary of Estimated Costs and Benefits
----------------------------------------------------------------------------------------------------------------
Benefits \b\ Costs Net Benefits
----------------------------------------------------------------------------------------------------------------
Estimated Quantified Benefits, Costs, and Net Benefits \a\
----------------------------------------------------------------------------------------------------------------
If this proposed rule is finalized $1,511,000............. $140,000 \c\........... $1,371,000
after the final rule for products ($121,000 to ....................... (-$19,000 to
with added solutions. $11,641,000). $11,501,000)
If this proposed rule is finalized $1,511,000............. $349,000 \d\........... $1,162,000
before the final rule for products ($121,000 to ....................... (-$228,000 to
with added solutions. $11,641,000). $11,292,000)
----------------------------------------------------------------------------------------------------------------
Non-Quantified Benefits and Costs
----------------------------------------------------------------------------------------------------------------
Truthful and Cost to
accurate labeling. validate cooking
Increased instructions.
public awareness of Loss in
product identities. producer surplus to
Better market producers who sell
information to mechanically
consumers. tenderized beef.
Increased Loss in
producer surplus to consumer surplus to
producers who sell consumers who start
intact beef or other cooking their beef to
meats consumers may a higher temperature,
substitute for which they prefer less
mechanically- than cooking rare.
tenderized beef. Loss in
consumer surplus to
consumers who might
substitute other meats
or other cuts of meat,
which they prefer less.
Costs incurred
by food service
providers that change
their standard
operating procedures
related to intact and
mechanically-
tenderized beef.
----------------------------------------------------------------------------------------------------------------
\a\ Annualized over 10 years at a 7 percent discount rate.
\b\ Assumes that on the low end, 15% of consumers and 0% of food service providers will use validated cooking
instructions and using the lower bound of the credibility interval from Scallan while on the high end, 56% of
consumers and 100% of food service providers and using the upper bound of the credibility interval from
Scallan will use validated cooking instructions, with an average estimate of 24% for consumers and 24% for
food service providers.
\c\ Estimated costs fall to $120,000 and net benefits rise by $20,000 when annualized with a 3 percent discount
rate.
\d\ Estimated costs fall to $298,000 and net benefits rise by $51,000 when annualized with a 3 percent discount
rate.
Source: FSIS Policy Analysis Staff.
Background
The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601-695, at 21
U.S.C. 607) provides for the approval by the Secretary of Agriculture
of the labels of meat and meat food products before these products can
enter commerce. The FMIA also prohibits the distribution in commerce of
meat or meat food products that are adulterated or misbranded.
The FMIA provides that a product is misbranded if its labeling is
false or misleading in any particular, or if it is offered for sale
under the name of another food (21 U.S.C. 601(n)(1),601(n)(2)). Thus,
under the FMIA, the labels of meat or meat food products must be
truthful and not misleading, and the labels must accurately disclose to
consumers what they are buying when they purchase any meat product. The
FMIA gives FSIS broad authority to promulgate rules and regulations
necessary to carry out its provisions (21 U.S.C. 621).
To prevent meat or meat food products from being misbranded, the
meat inspection regulations require that the labels of meat products
contain specific information and that such information be displayed as
prescribed in the regulations (9 CFR part 317). Under the regulations,
the principal display panel on the label of a meat product must
include, among other information, the name of the product. For products
that purport to be or are represented by a regulatory standard of
identity, the name of the product on the label must be the name of the
food specified in the standard. For any other product, the name on the
label must be ``the common or usual name of the food, if any there
be.'' If there is no common or usual name, the name on the label must
be a ``truthful, descriptive designation'' (9 CFR 317.2(c)(1)). In
addition, the meat inspection regulations require that the descriptive
designations for products that have no
[[Page 34591]]
common or usual name completely identify the product, including the
method of preparation, such as salting, smoking, drying, cooking, or
chopping, unless the product name implies, or the manner of packaging
shows, that the product was subject to such preparation (9 CFR
317.2(e)).
Petition Related to Mechanically Tenderized Products
In 2009, the Safe Food Coalition sent a petition to the Secretary
of Agriculture to request, among other issues, regulatory action to
require that the labels of mechanically tenderized beef products
disclose the fact that the products have been mechanically tenderized.
The petition stated that, (1) consumers and restaurants do not have
sufficient information to ensure that these products are cooked safely
because FSIS does not provide recommended cooking temperatures for
mechanically tenderized products, (2) the recommended cooking
temperatures for intact products are not appropriate for non-intact,
mechanically tenderized products, and (3) a labeling requirement for
mechanically tenderized products is critical for consumers and retail
outlets, so that they have the information necessary to safely prepare
these products.
In June 2010, the Conference for Food Protection (CFP) petitioned
FSIS to issue a mandatory labeling provision for mechanically
tenderized beef that would require labels to specify that a cut has
been mechanically tenderized. The petition stated that mechanically
tenderized beef, especially when frozen, could be mistakenly perceived
by consumers to be a whole, intact muscle cut. The petition asserted
that without clear labeling, food retailers and consumers do not have
the information necessary to prepare these products safely. According
to the petition, if labeling does not indicate that the product is
mechanically tenderized, consumers are not aware of the potential risk
created when these products are less than fully cooked. The petition
stated that mandatory labeling of these products would reduce the
number of foodborne illnesses in the United States.
Mechanically Tenderized Beef
Mechanically tenderized beef products are products that have been
needle- or blade-tenderized, or have only been injected with a marinade
or solution. FSIS has previously described mechanically tenderized beef
products in this manner, notably in its Federal Register notice, HACCP
Plan Reassessment for Mechanically Tenderized Beef Products (May 26,
2005; 70 FR 30331). FSIS is asking for comment on this definition of
mechanically tenderized beef products and on whether it should be
incorporated into the regulations.
Consumers consider product tenderness to be a key factor when
purchasing meat products, and the tenderness of a roast or steak is a
key selling point for the meat industry. The tenderness of a meat
product depends on the cut of the meat, and there are various
techniques that companies can use to improve the tenderness of the less
tender cuts, including mechanical tenderization.
The mechanical tenderization process involves piercing the product
with a set of needles or blades, which breaks up muscle fiber and tough
connective tissue, resulting in increased tenderness.\2\ Research has
shown that needle or blade mechanical tenderization can improve the
tenderness of less tender, and typically less expensive, beef cuts.\3\
\4\ \5\ \6\ The process makes the less tender cuts of beef more
marketable to consumers.
---------------------------------------------------------------------------
\2\ Maddock, Robert 2008. Mechanical Tenderization of Beef,
National Cattleman's Beef Association.
\3\ Jeremiah, L.E., L.L. Gibson, B. Cunningham 1999. The
Influence of Mechanical Tenderization on the Palatability of Certain
Bovine Muscle Food Research International 32: (585-591).
\4\ Pietrasik, Z., Shand, P.J. 2004. Effect of Blade
Tenderization and Tumbling Time on the Processing Characteristics
and Tenderness of Injected Cooked Roast Beef. Meat Science 66: (871-
879).
\5\ King, D.A., Wheeler, T.L. Shackelford, S.D., Pfeiffer, K.D.,
Nickelson, R., Koolmaraie, M. 2009. Effect of Blade Tenderization,
Aging Time, and Aging Temperature on tenderness of Beef Lumborum and
Gluteus Medius. J. Animal Science 87:(2962-2960).
\6\ Pietrasik, Z., Aslhus, J.L., Gibson, L.L., Shand, P.J. 2010.
Influence of Blade Tenderization, Moisture Enhancement and Pancretin
Enzyme Treatment on the Processing Characteristics and Tenderness of
Beef Semitendinosus Muscle. Meat Science 84: (512-517).
---------------------------------------------------------------------------
An increasing number of establishments use mechanical tenderization
processes for beef.\7\ The mechanically tenderized products are widely
available to consumers in the marketplace.
---------------------------------------------------------------------------
\7\ According to FSIS's Checklist and Reassessment of Control
for E. coli O157:H7 in Beef Operations, 850 of 2323 establishments
indicated that they had a mechanical tenderizing operation, http://www.fsis.usda.gov/PDF/Ecoli_Reassessment_&_Checklist.pdf. In
addition, a 2003 National Cattleman's Beef Association survey found
that 188 of 200 processors used mechanical tenderization, http://docserver.ingentaconnect.com/deliver/connect/iafp/0362028x/v71n11/s4.pdf?expires=1300291287&id=61762965&titleid=5200021&accname=NAL-Group3&checksum=57C4A9F3F73D2022F0EEFFA2568826BF.
---------------------------------------------------------------------------
Mechanically tenderized products are referred to as ``non-intact''
and have different physical attributes than intact, non-tenderized
products. A beef product that has been subjected to the mechanical
tenderization process is more tender than it would have been had it not
been mechanically tenderized, but it is no longer an intact cut of
meat. Significantly, products that have been needle- or blade-
tenderized are typically indistinguishable in appearance from whole,
intact products. Furthermore, under the current regulatory approach,
intact and mechanically tenderized beef products are permitted to have
the same product name, and products that have been mechanically
tenderized need not disclose this fact in their labeling. Thus, the
labeling of mechanically tenderized beef products is not required to
reveal a significant material fact about the nature of the product.
Without information about this fact on the product labeling, consumers
and industry may be purchasing these products without knowing that they
have been needle- or blade-tenderized.
Since 2000, the Centers for Disease Control and Prevention has
received reports of six outbreaks attributable to needle- or blade-
tenderized beef products prepared in restaurants and consumers' homes.
The outbreaks included steaks that were mechanically tenderized with
added solutions and one outbreak involving mechanically tenderized
steaks in which no information was available concerning whether the
product contained added solutions. Among these outbreaks, there were a
total of 176 Escherichia coli (E. coli) O157:H7 cases that resulted in
32 hospitalizations and 4 cases of hemolytic uremic syndrome (HUS).\8\
---------------------------------------------------------------------------
\8\ Compilation of USDA-FSIS Data, 2010.
[[Page 34592]]
Table 2--Outbreaks Linked to Tenderized/Marinated Steaks Originating in the United States (Compilation of FSIS Generated Data)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Case patients/ Epi. Hospitalizations/
Year Product link Deaths FSIS Recall number
--------------------------------------------------------------------------------------------------------------------------------------------------------
2009................................ Blade tenderized 25/17-steak........... 10/1\a\ 067-2009 (USDA-FSIS, 2009).
steaks, vacuum
tumbled with marinade.
April-May 2007...................... Needle injected and 8/8................... 6/0 019-2007 (USDA-FSIS, 2007).
marinated steaks.
May-Aug. 2007....................... Needle tenderized, 124/124............... 8/0 No Recall.\b\ \c\
seasoned tri-tip beef.
July-Aug. 2004...................... Blade tenderized 4/4................... 1/0 033-2004 (USDA-FSIS, 2004).
steaks exposed to
marinade in vacuum
tumbler.
May-June 2003 (Laine et al., 2005).. Bacon wrapped steaks, 13/13................. 7/0 028-2003 (USDA-FSIS, 2003).
mechanically
tenderized, injected
flavoring.
Aug. 2000........................... Needle tenderized..... 2/2................... 0/0 No Recall.\d\ \e\
-------------------------------------------------------------------------------------------------------------------
Total........................... ...................... 176/168............... 32/1 ...............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
a. Patient who died did not eat steak.
b. Illnesses were all associated with product served through the restaurant/food-to-go operation that had some sanitary violations.
c. Notes indicate that a seasoning/marinade was used in the needling process.
d. Unknown whether solution was added.
e. FSIS was not involved in the original investigation.
Five of the six outbreaks listed in Table 2 had solutions added to
the tenderized beef. These five outbreaks accounted for 174 of the 176
illnesses. The remaining two illnesses occurred in an outbreak in which
steak was mechanically tenderized, but it was not known if solution was
added.
Follow up investigations suggested that failure to fully cook a
mechanically tenderized raw or partially cooked beef product was likely
a significant contributing factor in all of these outbreaks. In many
cases, patients associated with outbreaks reported preparing or
ordering steaks as ``rare'' or ``medium-rare.'' \9\ \10\ Published
research suggests that pathogens can be translocated from the surface
of mechanically tenderized beef products to the interior during
processing because of the piercing of the beef by the needle or
blade.\11\ The potential for translocation of pathogens to the interior
of the product suggests that the interior of mechanically tenderized
beef would need to be more fully cooked than a piece of intact beef
with a similar amount of pathogens only on the surface.\12\
---------------------------------------------------------------------------
\9\ Culpepper, W., Ihry, T., Medus, C., Ingram, A., Von Stein,
D., Stroika, S., Hyytia-Trees, E., Seys, S., Sotir, M.J. 2010.
Multi-state outbreak of Escherichia coli O157:H7 infections
associated with consumption of mechanically-tenderized steaks in
restaurants--United States, 2009. Presented at International
Association for Food Protection; August 1-4, 2010; Anaheim, CA.
\10\ Haubert, N., Cronquist, A., Parachini, S., Lawrence, J.,
Woo-Ming, A., Volkman, T., Moyer, S., Watkins, A. 2006. Outbreak of
Escherichia coli O157:H7 Associated with Consuming Needle Tenderized
Undercooked Steak from a Restaurant Chain--Denver Area, Colorado,
2004. Presented at International Conference of Emerging Infectious
Diseases; March 19-22, 2006; Atlanta, GA.
\11\ Luchansky, JB, Phebus RK, Thippareddi H, Call JE 2008.
Translocation of surface-inoculated Escherichia coli 0157:H7 into
beef subprimals following blade tenderization. J. Food Prot. 2008
Nov.; 71(11):2190-7.
\12\ Sporing, Sarah B. 1999. Escherichia coli O157:H7 Risk
Assessment for Production and Cooking of Blade Tenderized Beef
Steak. Thesis. Kansas State University.
---------------------------------------------------------------------------
This research led FSIS to recommend on its Web site that
mechanically tenderized beef products should be cooked to 145 [deg]F
with a three-minute dwell time because it will result in a 5.0-log
reduction of Salmonella throughout the product.\13\ \14\ Salmonella is
an indicator for lethality because it is more heat-resistant than other
pathogens such as E. coli O157:H7. Therefore, if a 5.0-log reduction of
Salmonella is achieved, at least a 5-log reduction of E. coli O157:H7
should be achieved as well \15\.
---------------------------------------------------------------------------
\13\ http://askfsis.custhelp.com/ci/fattach/get/4648/.
\14\ Goodfellow, S. J. and Brown. W. L. 1978. Fate of Salmonella
Inoculated into Beef for Cooking J. of Food Protect. 41: (598-605).
\15\ Line, J.E. Fain, A.R. Moran, A.B, Martin, L.M., Lechowch,
R.V., Carosella, J.M., and Brown, W.L. 1991. Lethality of heat to
Escherichia coli O157:H7: D-value and Z-value determinations in
ground beef J Food Protect. 54:(762-766).
---------------------------------------------------------------------------
Consumers often prefer to eat their steaks ``rare'' or ``medium
rare.'' Generally, intact cuts of muscle such as steaks should be free
of pathogenic bacteria such as E. coli O157:H7 and other Shiga-toxin
producing E. coli (STEC) organisms if cooked to these desired levels of
doneness because contamination with pathogenic bacteria, if present,
would likely only occur on the surface of the product. The National
Advisory Committee on Microbiological Criteria for Foods (1997) stated
that ``due to the low probability of pathogenic organisms being present
in or migrating from the external surface to the interior of beef
muscle, cuts of intact muscle (steaks) should be safe if the external
surfaces are exposed to temperatures sufficient to effect a cooked
color change''.\16\ To date, no outbreaks or sporadic illnesses from
consuming intact product have been reported to CDC.\17\
---------------------------------------------------------------------------
\16\ National Advisory Committee on Microbiological Criteria for
Foods (NACMCF). 1997. Recommendations for Appropriate Cooking
Temperatures for Intact Beef Steaks & Cooked Beef Patties for the
Control of Vegetative Enteric Pathogens. U.S. Department of
Agriculture, Food Safety and Inspection Service, Washington, DC.
\17\ National Advisory Committee on Microbiological Criteria for
Foods (NACMCF). 1997. Recommendations for Appropriate Cooking
Temperatures for Intact Beef Steaks & Cooked Beef Patties for the
Control of Vegetative Enteric Pathogens. U.S. Department of
Agriculture, Food Safety and Inspection Service, Washington, DC.
---------------------------------------------------------------------------
Descriptive Designation
FSIS has carefully considered the available information on
mechanically tenderized beef, including the petitions submitted by the
Safe Food Coalition and by CFP, and has concluded that without specific
labeling, raw or partially cooked mechanically tenderized beef products
could be mistakenly perceived by consumers to be whole, intact muscle
cuts. The fact that a cut of beef has been needle- or blade-tenderized
is a characterizing feature of the product and, as such, a material
fact that is likely to affect consumers' purchase decisions and that
should affect their preparation of the product. The literature suggests
that many consumers are aware of and a portion of these read the safe
handling instructions labels, and reported changing their meat
preparation methods because of the labels.18 19 20 21 22 23
Because of the
[[Page 34593]]
likelihood that illness rates would be reduced if more specific
labeling were required, FSIS proposes that the labeling of raw or
partially cooked mechanically tenderized beef products bear a
descriptive designation that clearly identifies the product has been
mechanically tenderized unless such product is destined to be fully
cooked in an official establishment. The proposed descriptive
designation will provide household consumers, official establishments,
restaurants, and retail stores with the information they need to
identify whether a cut of beef is an intact, non-tenderized product, or
whether it is a non-intact, mechanically tenderized product. Should
this rule become final, FSIS will conduct a public education campaign
to explain the significance of the term ``mechanically tenderized'' to
consumers.
---------------------------------------------------------------------------
\18\ Yang et al (1999) show that 15% of consumers changed their
behavior based on reading safe handling instruction labels.
(Evaluation of Safe Food-Handling Instructions on Raw Meat and
Poultry Products. J of Food Protect. 63: (1321-1325.)
\19\ Bruhn (1997) shows that 17% of consumers changed their
behavior based on reading safe handling instructions. Consumer
Concerns Motivating to Action, Emerging Infectious Diseases. 3(4):
511-515.
\20\ Adul-Nyako et al (2003) show a significant positive
influence of labels on safe handling practices. Safe Handling Labels
and Consumer Behavior in the Southern U.S.
\21\ Cates, Sheryl C., Cignetti, Connie, Kosa, Katherine M.
March 22, 2002. RTI: Consumer Research on Food Safety Labeling
Features for the Development of Responsive Labeling Policy.
\22\ Cates, Sheryl C., Cignetti, Connie, Kosa, Katherine M.
March 22, 2002. RTI: Consumer Research on Food Safety Labeling
Features for the Development of Responsive Labeling Policy.
\23\ Cates, Sheryl C., Carter-Young, Heather L., Gledhill, Erica
C. April 25, 2001. RTI: Consumer Perceptions of Not-Ready-to-Eat
Meat and Poultry Labeling Terminology.
---------------------------------------------------------------------------
FSIS is proposing that if raw or partially cooked mechanically
tenderized beef product is destined to be fully cooked at an official
establishment, the descriptive designation would not be required on the
product label. Therefore, if one establishment produces raw or
partially cooked product and sends it to a second establishment for
cooking, the first establishment would not be required to include the
descriptive designation on the product label.
The descriptive designation that FSIS is proposing would only apply
to raw or partially cooked beef products that have been needle
tenderized or blade tenderized, including beef products injected with
marinade or solution. Other tenderization methods such as pounding and
cubing change the appearance of the product, putting consumers on
notice that the product is not intact. Additionally, a majority of
establishments already identify products that have been cubed on the
label.
FSIS is proposing to require that the label of needle- or blade-
tenderized beef products contain the designated description
``mechanically tenderized'' because this term accurately and truthfully
describes the nature of the product. Additionally, this term clearly
and completely identifies the preparation process that the product
underwent. FSIS's goal is to choose a term that will not affect
consumers' perception of the quality, or cost, of the product. Rather,
FSIS sought to simply differentiate mechanically tenderized beef
products from non-tenderized, intact beef products. The term
``mechanically tenderized'' is non-technical and likely will be
understood by consumers, restaurants, retail stores, and official
establishments, although FSIS is taking comment on this assumption.
To ensure that the descriptive designation is readily apparent on
the label, FSIS is proposing that the print for all words in the
descriptive designation, as well as the words in the description of the
product, appear in the same font style, color, and size as the product
name and on a single-color contrasting background.
At this time, FSIS is not proposing similar labeling requirements
for mechanically tenderized poultry products or for other mechanically
tenderized meat products, such as pork. While FSIS has the checklist
data discussed above for beef products, FSIS does not have similar data
for other products necessary to assess production practices for
mechanically tenderized products. There have been no known outbreaks
for mechanically tenderized poultry or non-beef products.
FSIS is not proposing to require the descriptive designation on
needle- or blade-tenderized beef products that are fully cooked in an
official establishment because such products do not pose the same
pathogen hazard as the raw or partially cooked products. Further,
consumers can recognize that a product has been cooked. FSIS requests
comment on whether it should require fully cooked needle- or blade-
tenderized beef products to have the descriptive designation on their
labels.
Validated Cooking Instructions for Raw and Partially Cooked
Mechanically Tenderized Products
FSIS is proposing to amend the regulations to require validated
cooking instructions on the labels of mechanically tenderized beef
products. Under current regulations, to prevent raw and partially
cooked meat products from being misbranded, the labels of all meat
products, including those that have been mechanically tenderized, are
required to include safe handling instructions as prescribed in 9 CFR
317.2(l). These regulations require that the labels of raw and
partially cooked meat that are not intended for further processing at
an official establishment include the statement: ``This product was
prepared from inspected and passed meat and/or poultry. Some food
product may contain bacteria that could cause illness if the product is
mishandled or cooked improperly. For your protection, follow these safe
handling instructions'' (9 CFR 317.2(l)(2)). One of the instructions
required under the regulations is to ``cook thoroughly'' (9 CFR
317.2(l)(3)(iii)).
Although the safe handling instructions in the regulations include
``cook thoroughly'' in the labeling of raw and partially cooked meat
and poultry products, the regulations do not require that these
instructions specify the dwell time or internal temperature parameters
required to ensure that the product is fully cooked. Because
mechanically tenderized products have the same appearance as intact
products, household consumers, hotels, restaurants, and similar
institutions may incorrectly assume that mechanically tenderized
products may be prepared similarly to intact products (i.e., that it is
ok to cook the product ``rare'' or ``medium-rare''), even if the
product label shows that the product is mechanically tenderized. This
increases the likelihood that household consumers, hotels, restaurants,
and similar institutions will undercook a mechanically tenderized
product.
Despite the safe handling instructions to ``cook thoroughly,''
recent outbreak data suggest that for needle- or blade-tenderized raw
beef products, consumers, restaurants, and retail stores do not always
fully cook these products using a temperature-and-time combination
sufficient to destroy harmful bacteria, such as Escherichia coli
O157:H7 (E. coli O157:H7), in the product. CDC and other governmental
investigators have found that failure to fully cook a mechanically
tenderized raw or partially cooked beef product was likely a
significant contributing factor in the outbreaks.24 25 In
many
[[Page 34594]]
cases, patients reported preparing or ordering steaks as ``rare'' or
``medium rare.''
---------------------------------------------------------------------------
\24\ Swanson, L. E., Scheftel, J.M., Boxrud, D.J., Vought, K.J.,
Danila, R.N., Elfering, K.M., and Smith, K.E. 2005. Outbreak of
Escherichia coli O157:H7 infections associated with nonintact blade-
tenderized frozen steaks sold by door-to-door vendors. J. Food Prot
68:(1198-1202).
\25\ Culpepper W, Ihry T, Medus C, Ingram A, Von Stein D,
Stroika S, Hyytia-Trees E, Seys S, Sotir MJ. 2010. Multi-state
outbreak of Escherichia coli O157:H7 infections associated with
consumption of mechanically-tenderized steaks in restaurants--United
States, 2009. Presented at International Association for Food
Protection; August 1-4, 2010; Anaheim, CA.
---------------------------------------------------------------------------
Because restaurants may not know that products are mechanically
tenderized, they may prepare for their customers mechanically
tenderized beef products that are ``rare'' or ``medium-rare.'' Indeed,
their customers may ask them to do so. Research on the sensory and
cooking characteristics of various beef cuts suggests that the
palatability of beef cuts decreases as the internal endpoint
temperature increases. Other research has shown that consumers tend to
prefer beef products that are cooked to a lower degree of doneness than
that needed to reach the necessary internal temperature for a
mechanically tenderized product, which needs to be fully cooked
throughout its interior.\26\ In some studies, consumers have given
highest ratings to such underdone beef products.27 28 29
Consumers thus may order steaks that are cooked to a lesser degree of
doneness than that necessary to fully cook them and restaurateurs may
consequently serve the less-done products. FSIS requests comments on
how the proposed labeling changes are likely to impact restaurants and
other food service operations.
---------------------------------------------------------------------------
\26\ Schmidt, T.B., Keene, M.P, and Lorenzen, C.L. 2002.
Improving Consumer Satisfaction of Beef Through the use of
Thermometers and Consumer Education by Wait Staff. J. Food Sci. 67:
(3190-3193).
\27\ Lorenzen, C.L., T.R. Neely, R.K. Miller, J.D. Tatum, J.W.
Wise, J.F. Taylor, M.J. Buyck, J.O. Reagan, and J.W. Savell. 1999.
Beef Customer Satisfaction: Cooking Methods and Degree of Doneness
Effects on the Top Loin Steaks. J. Animal Science 77:637-644.
\28\ Savell, J.W., Lorenzen, C.L., Neely, T.R., Miller, R.K.,
Tatum, J.D., Wise, J.W., Taylor, J.F., Buyck, M.J., Reagan, J.O.
1999. Beef Customer Satisfaction: Cooking Methods and Degree of
Doneness Effects on the Top Sirloin Steaks. J. Animal Science
77:645-652.
\29\ Neely, T.E., Lorenzen,C.L., Miller,R.K., Tatum,J.D., Wise,
J.W.,Taylor, J.F., Buyck,M.J., and Savell, J.W.. 1999. J. Animal
Science 77:653-660. Beef Customer Satisfaction: Cooking Method and
Degree of Doneness Effects on the Top Round Steak.
---------------------------------------------------------------------------
On the basis of these studies, scientific evidence referred to
earlier in this document, and other studies 30 31 32 that
indicate that mechanically tenderized beef products need to be cooked
more thoroughly than intact beef products, FSIS is making an additional
proposal. Thus, in addition to a descriptive designation that
identifies that needle- or blade-tenderized beef products have been
mechanically tenderized, FSIS is proposing to require that labels of
raw and partially cooked needle- or blade-tenderized beef products
destined for household consumers, hotels, restaurants and similar
institutions include cooking instructions that have been validated to
ensure that potential pathogens throughout the product are destroyed.
---------------------------------------------------------------------------
\30\ Luchansky, J.B., Porto-Fett, A.C.S., Shoyer, B.A., Call,
J.E., Schlosser, W., Shaw, W., Bauer, N., Latimer, H. 2012. Fate of
Shiga toxin-Producing O157:H7 and non-O157:H7 Escherichia coli Cells
within Blade-Tenderized Beef Steaks after Cooking on a Commercial
Open-Flame Gas Grill. J. of Food Protect 75: (62-70).
\31\ Johnston, R.W., M.E. Harris, A.B. Moran. 1978. The Effect
of Mechanically Tenderization on Beef Rounds Inoculated with
Salmonella. J. Food Safety 1:201-209.
\32\ Johnston, R.W., M.E. Harris, A.B. Moran. 1978. The Effect
of Mechanically Tenderization on Beef Rounds Inoculated with
Salmonella. J. Food Safety 1:201-209.
---------------------------------------------------------------------------
Under this proposal, needle- or blade-tenderized beef products that
are destined to be fully cooked at an official establishment would not
be required to include validated cooking instructions on product
labels. Official establishments are required to follow regulatory
performance standards to ensure that ready-to-eat products receive a
full lethality treatment (for cooked beef, roast beef, and cooked
corned beef products, see 9 CFR 318.17) and use controls to prevent
post-lethality contamination with Listeria monocytogenes (9 CFR 430.4).
FSIS is proposing to require that the validated cooking
instructions include, at a minimum: (1) the method of cooking; (2) a
minimum internal temperature validated to ensure that potential
pathogens are destroyed throughout the product; (3) whether the product
needs to be held for a specified time at that temperature or higher
before consumption; and (4) instruction that the internal temperature
should be measured by the use of a thermometer. The Agency is proposing
to require that the cooking instruction statement include the cooking
method because consumers need explicit information about how to cook a
product in order to ensure that it is safe for consumption. The cooking
instructions included on the label should be practical and likely to be
followed by consumers. FSIS is proposing that cooking instructions must
be validated to ensure that potential pathogens are destroyed
throughout the product as determined by the specified minimum internal
temperature and dwell time for the product before consumption.
Consistent with the regulation on HACCP validation (9 CFR 417.4),
to validate the cooking instructions, should this rule become final,
the establishment would be required to obtain scientific or technical
support for the judgments made in designing the cooking instructions,
and in-plant data to demonstrate that it is, in fact, achieving the
critical operational parameters documented in the scientific or
technical support. HACCP does not require establishments that produce
mechanically tenderized product to have validated cooking instructions.
But just as establishments have to validate their HACCP plans' adequacy
in controlling the food safety hazards identified during the hazard
analysis, so too, under this proposed rule, establishments that produce
mechanically tenderized beef products will have to validate their
cooking instructions. The scientific support would need to demonstrate
that: (1) The cooking instructions provided can repeatedly achieve the
desired minimum internal temperature and, if applicable, rest time and
(2) the minimum internal time and, if applicable, rest time achieved by
the instructions will ensure that the product is fully cooked to
destroy potential pathogens throughout the product. The in-plant data
would need to demonstrate that the establishment is, in fact, achieving
the critical operational parameters documented in the scientific or
technical support. For additional information on validation see the
following Federal Register notice on HACCP Systems Validation (77 FR
27135; May 10, 2012) available at: http://www.fsis.usda.gov/Frame/FrameRedirect.asp?main=http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/2009-0019.htm.
Guidance on Validated Cooking Instructions
The Agency has posted on its Significant Guidance Documents Web
page (http://www.fsis.usda.gov/Significant_Guidance/index.asp)
guidance on validated cooking instructions for mechanically tenderized
product. This guidance, drawing heavily on the findings of the two
recent ARS studies (Luchansky 2011 and 2012) represents current FSIS
thinking; however, FSIS requests comment on it and intends to update it
as necessary before this rule becomes final. In addition to requesting
comments on the guidance document, FSIS specifically requests
additional scientifically valid data on cooking instructions developed
for various mechanically tenderized beef products that have been found
to consistently meet an endpoint temperature and rest time sufficient
to ensure the product is fully cooked.
[[Page 34595]]
Should this rule become final, establishments could collect their
own scientific data to support the cooking instruction, use a study
from an outside source, or use the guidance provided by FSIS. The
guidance document provided by FSIS includes a summary of cooking
instructions (e.g., place product in an oven heated to X degrees F for
X minutes to achieve the desired endpoint temperature of X degrees F
for X minutes) drawn from the peer reviewed literature to achieve
endpoint temperatures sufficient to ensure the product is fully cooked
and the risk of contamination with a pathogen is sufficiently reduced.
The format and wording of the instructions are based on best practices
seen by the FSIS Labeling and Program Delivery Division (LPDD). The
critical operational parameters from each study (e.g., the cut of meat,
method of tenderization, product thickness, and cooking method) are
included in the summary so that establishments can select cooking
instructions that will be applicable to their product. Establishments
could utilize these cooking instructions on the labels of their
products, without needing to conduct any additional experiments or
provide any further scientific support, provided that the actual
product being produced and labeled is similar to the product the
instructions were developed for.
In the event that establishments are unable to use the specific
examples in the guidance (e.g., because the product is of a different
thickness or is to be cooked using a different method than was
previously studied), the guidance document also contains instructions
on how to develop such support. The protocol provided is based on the
experimental design employed in the recent ARS studies. Specifically,
the document addresses the factors that should be considered when
designing a validation study (e.g., number of replicates, factors that
affect heat transfer, testing methodology, etc.).
Affected Industry
The proposed new descriptive designation requirement would apply to
all raw or partially cooked needle- or blade-tenderized beef products
going to retail stores, restaurants, hotels, or similar institutions or
to other official establishments for further processing other than
cooking. The proposed requirements for validated cooking instructions
would apply to raw or partially cooked mechanically tenderized beef
products destined for household consumers, hotels, restaurants, or
similar institutions. If a second establishment repackages the product
for household consumers, hotels, restaurants or similar institutions,
the second establishment would be responsible for applying the
validated cooking instructions to the product label. If retail stores
repackage the product, they would be required to include the
descriptive designation and validated cooking instructions from the
official establishment on the retail label.
If this proposal is adopted as a final rule, establishments or
retail stores would be permitted to add the required information to
existing label designs, or they could apply a separate sticker with the
required information to existing labels. FSIS would generically approve
the modifications made to the labels for needle- or blade-tenderized
beef products from official establishments based on the provisions for
generic approval in 9 CFR 317.5(a)(1).
If this proposal is finalized, raw or partially cooked needle- or
blade-tenderized beef products would have descriptive designations that
are different from those of whole, intact products. Once implemented,
raw or partially cooked beef products subject to this rule whose labels
do not include the descriptive designation ``mechanically tenderized,''
and such products destined for household consumers, hotels,
restaurants, or similar institutions whose labels do not include
validated cooking instructions, would be misbranded because the product
labels would be false or misleading, because the products would be
offered for sale under the name of another food, and because the
product labels would fail to bear the required handling information
necessary to maintain the products' wholesome condition (21 U.S.C.
601(n)(1), 601(n)(2), and 601(n)(12)).
Of the 555 official establishments that produce mechanically
tenderized beef products that could be affected by this proposed rule,
542 are small or very small according to the FSIS HACCP definition.
There are about 251 very small establishments (with fewer than 10
employees) and 291 small establishments (with more than 10 but less
than 500 employees). Therefore, a total of 542 small and very small
establishments could possibly be affected by this rule. The FSIS HACCP
definition assigns a size based on the total number of employees in
each official establishment. The Small Business Administration
definition of a small business applies to a firm's parent company and
all affiliates as a single entity. These small and very small
manufacturers, like the large manufacturers, would incur the costs
associated with modifying product labels to add on the labels
``mechanically tenderized'' and validated cooking instructions needed
to ensure adequate pathogen destruction.
Descriptive Designations on Intact Product
Note that intact beef products may bear a descriptive designation
of ``intact,'' consistent with 9 CFR 317.2(e). However, such a
descriptive designation is not required. If producers want to use such
a descriptive designation on labels of intact product to distinguish it
from non-intact product, FSIS would allow the designation and would not
consider it a special statement requiring label approval by the Agency.
Rather, FSIS would generically approve the labels with the statement
based on the provisions for generic approval in 9 CFR 317.5(a)(1).
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. Under this proposed rule: (1) All State and local
laws and regulations that are inconsistent with this rule will be
preempted, (2) no retroactive effect will be given to this rule, and
(3) no retroactive proceedings will be required before parties may file
suit in court challenging this rule.
Executive Order 12866 and Executive Order 13563
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This proposed rule has been designated an ``significant
regulatory action'' although not economically significant, under
section 3(f) of Executive Order 12866. Accordingly, the rule has been
reviewed by the Office of Management and Budget.
Baseline: The Final Report of the Expert Elicitation on the Market
Shares for Raw Meat and Poultry Products Containing Added Solutions and
Mechanically Tenderized Raw Meat and Poultry Product, February 2012
(February 2012 Report),\33\ estimates that
[[Page 34596]]
there are 555 official establishments that produce blade, needle, and
both blade and needle mechanically tenderized beef products.\34\ In
terms of assigned HACCP processing size, the 555 establishments are
comprised of 251 very small, 291 small, and 13 large establishments.
Total U.S. beef production was 24.3 billion pounds in 2010.\35\ The
February 2012 Report estimates that the proportion of beef products
that is mechanically tenderized is about 10.5 percent of total beef
products sold, or 2.6 billion pounds. Of these products, an estimated
318 million pounds were brand name packaged by the establishment for
retail sales; 640 million pounds private label packaged by the
establishment for retail sales; 1,594 million pounds were packaged by
the establishment for food service, and 479 million pounds were
packaged in retail operations.\36\
---------------------------------------------------------------------------
\33\ Muth, Mary K., Ball, Melanie, and Coglaiti, Michaela Cimini
February 2012.: RTI International Final Report--Expert Elicitation
on the Market Shares for Raw Meat and Poultry Products Containing
Added Solutions and Mechanically Tenderized Raw Meat and Poultry
Products, Table 3-11 on p. 3-17.
\34\ The February 2012 report estimates that 490 establishments
produce products that are both mechanically tenderized and
containing added solutions.
\35\ Based on slaughter volumes multiplied by average carcass
weights in the Expert Elicitation on the Market Shares for Raw Meat
and Poultry Products Containing Added Solutions and Mechanically
Tenderized Meat and Poultry Products, RTI International, February
2012.
\36\ Ibid. Table 3-8 Proportions of Mechanically Tenderized-only
Beef Product pounds by Packaging and labeling Type on p. 3-13, and
Table 3-14 Estimated Pounds of Mechanically Tenderized-only Beef
Products by Packaging and Labeling Type (Millions), p. 3-18.
---------------------------------------------------------------------------
Retail establishments would be involved in repackaging products to
be sold at retail. FSIS has not estimated the number of retail
establishments that would be involved with repackaging raw or partially
cooked mechanically tenderized beef products or the number of labels
they would require to be in compliance with this rule.\37\ FSIS expects
that very few retail facilities are producing mechanically tenderized
beef. FSIS requests data on the number and size distribution of retail
establishments that could be possibly affected by this proposed rule.
---------------------------------------------------------------------------
\37\ FSIS believes that the number of retailers involved in
repackaging mechanically tenderized beef is small and declining,
with large retailers and warehouse clubs moving toward ordering
case-ready packaged beef products.
---------------------------------------------------------------------------
The proposed new descriptive designation requirement would apply to
all raw or partially cooked needle- or blade-tenderized beef products
going to retail stores, restaurants, hotels, or similar institutions,
or other official establishments for further processing, unless such
product is destined to be fully cooked at an official establishment.
The proposed requirements for validated cooking instructions would
apply to raw or partially cooked mechanically tenderized products
destined for household consumers, hotels, restaurants, or similar
institutions. If a second establishment repackages the product for
household consumers, hotels, restaurants, or similar institutions, the
second establishment would also be responsible for applying the
validated cooking instructions to the product label. If retail stores
repackage the product, they would have to include the descriptive
designation and validated cooking instructions from the official
establishment on the retail label.
This rule would affect foreign establishments that manufacture and
export to the United States raw or partially cooked beef products that
are mechanically tenderized, because foreign establishments that
manufacture and export these products to the United States will be
required to follow these same labeling requirements. FSIS requests
information on the number of foreign establishments that would be
affected if this proposed rule is finalized.
Expected Cost of the Proposed Rule
The proposed rule would require all official establishments that
produce raw mechanically tenderized beef products to modify their
product labels to include the term ``mechanically tenderized'' as part
of the products' descriptive name and to add validated cooking
instructions to the labels of all raw and partially cooked needle- or
blade-tenderized beef products destined for household consumers,
hotels, restaurants, or similar institutions. To incorporate this
information, establishments may add the required information to
existing label designs with minor changes. As discussed below,
establishments' and stores' costs likely would be mitigated because the
uniform compliance date may result in a number of labeling rules going
into effect at the same time. Therefore, the establishments will have
additional time to comply based on the delayed effective date provided
by the uniform compliance labeling rule and will be able to limit label
supplies based on the day that the labels will need to be modified. In
addition, the uniform compliance date allows establishments time to use
existing labels and will, therefore, result in minimal loss of
inventory of labels.
Cost Analysis
On the basis of data provided by the FSIS Labeling and Program
Delivery Staff, the Agency estimates that there are approximately
270,000 meat and poultry labels in the marketplace.\38\ Of those, FSIS
estimates that 50 percent of the total labels, or 135,000, are unique
labels for raw meat and poultry products labeled at official
establishments. This estimate of 135,000 may be an overestimate because
it assumes an exclusive label for each variation of a product. Of the
135,000 labels, FSIS assumes that 23.8 percent,\39\ or 32,130 labels,
are for beef products. Using the 10.5-percent estimate for the share of
beef products that are mechanically tenderized, and the 32,130
estimated number of beef labels, the estimated number of labels for
mechanically tenderized beef products is 3,374. This proposed rule
would require these products to add ``mechanically tenderized'' to
their labels.
---------------------------------------------------------------------------
\38\ In the proposed rule for Prior Label Approval System:
Generic Label Approval (Docket FSIS-2005-0016), FSIS estimated that
there were approximately 266,061 approved meat and poultry product
labels in the marketplace. For the purpose of this analysis, FSIS
chose to round the number of approved meat and poultry product
labels in the marketplace to 270,000.
\39\ From Muth, Mary K., Ball, Mary K., and Coglaiti, Michaela
Cimini February 2012.: RTI International Final Report--Expert
Elicitation on the Market Shares for Raw Meat and Poultry Products
Containing Added Solutions and Mechanically Tenderized Raw Meat and
Poultry Products, p. 3-8.
---------------------------------------------------------------------------
FSIS is developing a final rule that would require additional
labeling of products with added solutions. If this proposed rule
becomes final before the added solutions rule is in effect, then an
additional 15.8 percent of all beef products, or 5,077 labels, would
require the ``mechanically tenderized'' designation on their labels.
(See proposed rule ``Common or Usual Name Requirements for Meat and
Poultry Products with Added Solutions'' (76 FR 44855.) If both this
rule on mechanically tenderized products and products with added
solutions are in effect, establishments are likely to make all labeling
changes at the same time.
The number of labels was not tracked by the FSIS Labeling
Information System Database because many mechanically tenderized beef
products are single ingredient products, and establishments may be
eligible for generic approval of these labels. FSIS does not have data
on partially cooked mechanically tenderized beef products but expects
that the amount of these products is small and therefore has not
included them in the cost calculations.
[[Page 34597]]
FSIS requests comments on the number of labels approved by
establishments for raw and partially cooked mechanically tenderized
beef products.
This cost analysis uses the mid-point label design modification
costs for a minor coordinated label change, as provided in a March 2011
FDA report.\40\ This report defines a minor change as one in which only
one color is affected and the label does not need to be redesigned. We
conclude that the labeling change that would be required by this
proposed rule is a minor change because the words ``mechanically
tenderized'' need to be added to the label, which is comparable to the
addition of an ingredient to the ingredient list and the addition of
validated cooking instructions is comparable to minimal changes to a
facts panel (e.g. nutrition facts, supplement facts, or drug facts).
For comparison purposes, in 2011, the Food and Drug Administration
estimated that the required labeling costs for its final rule \41\ on
the labeling of bronchodilators were deemed minor. The FDA required
revisions to the ``Indications,'' ``Warnings,'' and ``Directions''
sections of the Drug Fact label. Using the RTI labeling model described
in the March 2011 report, the FDA concluded that the revisions would be
deemed minor. FSIS assumes that the addition of validated cooking
instruction is similar to the aforementioned changes to the drug fact
panel, and is therefore deemed minor. FSIS requests comments on these
cost estimates.
---------------------------------------------------------------------------
\40\ Model to Estimate Costs of Using Labeling as a Risk
Reduction Strategy for Consumer Products Regulated by the Food and
Drug Administration, FDA, March 2011. (Contract No. GS-10F-0097L,
Task Order 5).
\41\ Labeling for Bronchodilators To Treat Asthma; Cold, Cough,
Allergy, Bronchodilator, and Antiasthmatic 2011.
Drug Products for Over-the-Counter Human Use, 76 FR 143
---------------------------------------------------------------------------
FSIS expects that all label changes resulting from this proposed
rule will be coordinated with planned label changes. The mid-point
label design modification costs for a minor coordinated label change
are an estimated $310 per label. A coordinated label change is when a
regulatory label change is coordinated with planned labeling changes by
the firm. A coordinated change is likely because of uniform compliance
labeling rules. These rules help affected establishments minimize the
economic impact of labeling changes because affected establishments can
incorporate multiple label redesigns required by multiple Federal
rulemakings into one modification at 2-year intervals, to reduce the
cost of complying with the final regulation.\42\ Moreover, this allows
time to use existing labels and results in minimal losses of
inventories of labels.
---------------------------------------------------------------------------
\42\ On December 14, 2004, FSIS issued a final rule that
provided that the Agency will set uniform compliance dates for new
meat and poultry product labeling regulations in 2-year increments
and will periodically issue final rules announcing those dates. FSIS
established January 1, 2016 as the uniform compliance date for new
meat and poultry product labeling regulations that are issued
between January 1, 2013, and December 31, 2014 (See 77 FR 76824).
The final mechanically tenderized beef rule will likely be issued
during this period. The March 2011 FDA report states that changes in
labels for food products can be coordinated with firms' planned
label changes within 42 months (see Table 3-1, Model to Estimate
Costs of Using Labeling as a Risk Reduction Strategy for Consumer
Products Regulated by the Food and Drug Administration, FDA, March
2011 (Contract No. GS-10F-0097L, Task Order 5)).
---------------------------------------------------------------------------
In the case of a coordinated label change, only administrative and
recordkeeping costs are attributed to the regulation, and all other
costs are not.\43\ FSIS estimates the cost to be $1.05 million (3,374
labels x $310) for mechanically tenderized beef products only; such
products do not contain added solution. The annualized cost to the
industry for products that are mechanically tenderized only is
estimated to be $140 thousand at 7 percent for 10 years ($120 thousand
when annualized at 3 percent for 10 years).
---------------------------------------------------------------------------
\43\ From the 2011 FDA labeling model paper, the costs of a
label change (p. 3-3) include administrative and recordkeeping
activities, graphic design, market testing (organizing focus
groups), prepress (convert design to plates), engraving, printing,
and disposing of old inventory. The regulatory costs of a
coordinated label change are administrative and recordkeeping costs
``associated with understanding the regulation, determining their
responses, tracking the required change throughout the labeling
change process, and reviewing and updating their records of product
labels. The costs other than administrative and recordkeeping are
not attributable to the regulation if the labeling change is
coordinated with a planned change.'' (p. 3-5). Model to Estimate
Costs of Using Labeling as a Risk Reduction Strategy for Consumer
Products Regulated by the Food and Drug Administration, FDA, March
2011. (Contract No. GS-10F-0097L, Task Order 5).
---------------------------------------------------------------------------
FSIS is developing a final rule that would require additional
labeling of products with added solutions. If this proposed rule
becomes final before the added-solution rule is finalized, the cost
estimated would be higher to reflect an additional 15.8 percent (or
5,077 labels) of all beef products that are both mechanically
tenderized and containing added solutions. This would result in an
additional one-time total cost (for all affected labels for
mechanically tenderized beef containing added solutions) of $1.57
million or $209 thousand when annualized at 7 percent for 10 years
($179 thousand when annualized at 3 percent for 10 years).
This proposed rule would require validated cooking instructions on
packages for beef that is only mechanically tenderized and beef that is
both mechanically tenderized and contains added solutions.
Establishments could also incur costs to validate the required cooking
instructions for raw and partially cooked needle- or blade-tenderized
beef products. These costs would be incurred to ensure that the cooking
instructions are adequate to destroy any potential pathogens that may
remain in the beef products after being tenderized. Most cooking
instruction validations would be contracted out to universities or
conducted by trade associations or large establishments. It is
estimated that a validation study would cost between $5,000 and $10,000
per product line with one formulation. Most studies will validate
cooking instructions for beef products with two formulations: injected
with or without solution; therefore, the total cost per validation
study would be between $10,000-$20,000.\44\ Industry cost would likely
be relatively small because FSIS is issuing guidance along with this
NPRM that establishments can use to develop cooking instructions. FSIS
is requesting comments on the number of cuts per establishment that
would require validated cooking instructions and comment on whether
establishments would use FSIS' guidance to develop the validated
cooking instructions. In addition, FSIS requests comments on the
estimated costs for developing validated cooking instructions. For
purposes of this analysis, FSIS has assumed that the costs of
developing validated cooking instructions would be minimal because FSIS
assumes that most establishments will follow FSIS' guidance.
---------------------------------------------------------------------------
\44\ Per telephone conversation with the Grocery Manufacturers
Association Director of Science Operations, Food Protection.
---------------------------------------------------------------------------
FSIS Budgetary Impact of the Proposed Rule
This proposed rule will result in no impact on the Agency's
operational costs because the Agency will not need to add any staff or
incur any non-labor expenditures since inspectors periodically perform
tasks to verify the presence of mandatory label features and to ensure
that the label is an accurate representation of the product. The
Agency's cost to develop guidance material that establishments can use
to develop cooking instructions will be minimal because such guidance
exists and can be modified and posted on the
[[Page 34598]]
FSIS Web site in fewer than six staff-hours.
FSIS is soliciting comments and data on any other potential federal
costs that might result from finalizing this rule.
Expected Benefits and Miscellaneous Impacts of the Proposed Rule
The Agency has determined that the proposed new labeling
requirements will improve public awareness of product identities. The
proposed rule will clearly differentiate non-intact, mechanically
tenderized beef products from intact products, thereby providing
truthful and accurate labeling of beef products.
As stated earlier, when purchasing a beef product, tenderness is a
key factor. However, not all needle- or blade-tenderized beef products
are readily distinguished from non-tenderized beef products. Therefore,
by requiring the descriptive designation ``mechanically tenderized'' on
the labels of this product, the consumers will be informed of the
additional attributes of the product when deciding whether to purchase
the product. Although the benefits of having such additional
information cannot be quantified, providing better market information
to consumers could promote better competition among establishments that
produce beef products. In addition, if the new label causes a
divergence in price between intact and mechanically-tenderized beef,
there would be a number of changes in consumer and producer surplus.
Consumers who purchase mechanically-tenderized beef in the absence of
the rule and would continue doing so in its presence would gain surplus
due to the decrease in price for mechanically-tenderized beef, while
consumers purchasing intact beef in the absence of the rule would
experience a loss of surplus due to the increase in price for intact
beef. Some producers of intact beef or other meats would realize a
surplus increase because consumers may substitute such products for
mechanically tenderized beef.
FSIS has concluded that labeling information on needle- or blade-
tenderized beef products may help consumers and retail establishments
better understand the product they are purchasing. This knowledge is
the first step in helping consumers and retail establishments become
aware that they need to cook these products differently than intact
beef products before the products can be safely consumed. Additionally,
by including cooking instructions, the food service industry and
household consumers will be made aware that a mechanically tenderized
beef product or injected beef product needs to be cooked to a minimum
internal temperature and may need to be maintained at this temperature
for a specific period of time to sufficiently reduce the presence of
potential pathogens in the interior of the beef product.
FSIS generated an estimate of the annual number of illnesses from
mechanically (needle- or blade-) tenderized beef steaks and roasts and
mechanically tenderized beef steaks and roasts that contain added
solutions that could potentially be avoided as a result of this
proposed rule. FSIS evaluated the effect of additional cooking of non-
intact product by first determining the implied concentration of
organisms prior to cooking given current information, then determining
the effect of adding additional cooking. Additional cooking is modeled
to a minimum temperature of 160[emsp14][deg]F. Current cooking
practices as captured in the EcoSure dataset do not specifically
include the time from when the final cooking temperature was recorded
to when consumption occurred. It is likely that product in this data
set encountered a range of dwell times. FSIS recommends in its guidance
concerning steaks and roasts a cooking temperature of 145[emsp14][deg]F
with 3 minutes resting time for cooking steaks and whole roasts because
data support that this would be equivalent to cooking at
160[emsp14][deg]F without holding a product at that temperature for any
dwell time.\45\ FSIS' guidance concerning cooking steaks and whole
roasts is located at http://blogs.usda.gov/2011/05/25/cooking-meat-check-the-new-recommended-temperatures/. If consumers adopt such
practices, results would be comparable to consumers cooking product to
160[deg] F but not holding product at that temperature for any dwell
time.\46\ Therefore, FSIS used the results from the risk analysis that
estimate the benefits of consumers cooking mechanically tenderized
product to 160[deg] F without a dwell time because they are equivalent
to 145[deg] F with 3 minutes of dwell time and because the Agency did
not have information about dwell time from the risk analysis.
---------------------------------------------------------------------------
\46\ Equivalency in cooking temperatures and times can be
estimated using D and Z-values. The D-value is a measure of how long
bacteria must be exposed to a particular temperature to effect a 1
log10 reduction. The Z-value is a measure of how much temperature
change is necessary to effect a 1 log10 change in the D-value.
Although these values have not been measured for E. coli O157:H7 in
steaks, they have been measured in ground beef. At 158[emsp14][deg]F
(70[deg][emsp14]C) E. coli O157:H7 had a D-value of about 3.3
seconds, at 144.5[emsp14][deg]F (62.5[emsp14][deg]C) the D-value was
52.8 seconds. (Murphy, R. Y., E. M. Martin, et al. (2004). ``Thermal
process validation for Escherichia coli O157:H7, Salmonella, and
Listeria monocytogenes in ground turkey and beef products.'' J Food
Prot 67(7): 1394-1402.) Three minutes at 145[emsp14][deg]F would be
equivalent to more than 10 seconds at 160[emsp14][deg]F. Using the
Z-value for E. coli O157:H7 in ground beef yields similar estimates.
The Z-value was given as 9.8[emsp14][deg]F (5.43[deg]C). Changing
the temperature from 160[emsp14][deg]F to 145[emsp14][deg]F would
then represent an increase in D-value of about 1.5 log10. Thus, 3
minutes at 145[emsp14][deg]F would be equivalent to 5.7 seconds at
160[emsp14][deg]F. In either case, three minutes at
145[emsp14][deg]F is more than equivalent to an instantaneous
temperature (< 1 sec) at 160[emsp14][deg]F.
---------------------------------------------------------------------------
The Centers for Disease Control and Prevention (CDC) recently
completed an analysis attributing foodborne illnesses to their sources.
Painter, et al., examined outbreak data from 1998 through 2008 and
identified 186 outbreaks of E. coli O157 resulting in 4,844 illnesses
during that period.\47\ As a consequence of this analysis, Painter, et
al., attributed 39.4% of illnesses or 1,909 (4,844 x 0.394) to beef.
---------------------------------------------------------------------------
\47\ Painter, J., R. Hoekstra, et al. (2013). ``Attribution of
foodborne illnesses, hospitalizations, and deaths to food
commodities by using outbreak data, United States, 1998-2008.''
Emerg Infect Dis 9(3): 407-415.
---------------------------------------------------------------------------
Of the 6 outbreaks in tenderized products described in Table 2, 5
occurred during the time frame analyzed by Painter, et al. These 5
outbreaks (occurring between 2000 and 2007) resulted in 151 illnesses.
Thus, approximately 7.9% (151/1,909) of E. coli O157 illnesses are
attributable to tenderized beef product.
Painter et al.'s work includes the illnesses associated with
outbreaks, which constitute only a fraction of the overall E. coli O157
illnesses that occur each year. For an estimate of overall illness
numbers, we turn to another CDC study, whose authors estimate that
there are 63,153 annual illnesses due to E. coli O157 in the United
States from all sources.\48\ To determine the annual number of
illnesses from E. coli O157 (STEC O157), CDC begins with the annual
incidence of STEC O157 infections reported to CDC's Foodborne Diseases
Active Surveillance Network (FoodNet) sites from 2005 to 2008. This
value is adjusted up using an under-diagnosis multiplier that is based
on the following factors:
---------------------------------------------------------------------------
\48\ Scallan, E., R.M. Hoekstra, et al. (2011). ``Foodborne
illness acquired in the United States--major pathogens.'' Emerg
Infect Dis 17(1): 7-15.
---------------------------------------------------------------------------
1. Whether a person with diarrhea seeks medical care. CDC bases
this on unpublished surveys of persons with bloody or non-bloody
diarrhea conducted in 2000-2001, 2002-2003, and 2006-2007. CDC
estimates that about 35% of persons with bloody diarrhea (about 90% of
STEC O157 illnesses) would seek medical care and about 18% of persons
with non-bloody diarrhea would seek medical care.
2. Whether a person seeking medical care submits a stool specimen.
This is
[[Page 34599]]
also based on unpublished surveys of persons with bloody or non-bloody
diarrhea conducted in 2000-2001, 2002-2003, and 2006-2007. CDC
estimates that about 36% of persons with bloody diarrhea seeking
medical care and about 19% of persons with non-bloody diarrhea seeking
medical care would submit stool specimens.
3. Whether a laboratory receiving a stool specimen would routinely
test it for STEC O157. This is based on a published study from the
FoodNet Laboratory Survey.\49\ CDC estimates that 58% of laboratories
would routinely test for O157 STEC.
---------------------------------------------------------------------------
\49\ Voetsch, A.C., F.J. Angulo, et al. (2004). ``Laboratory
practices for stool-specimen culture for bacterial pathogens,
including Escherichia coli O157:H7, in the FoodNet sites, 1995-
2000.'' Clin Infect Dis 38 Suppl 3: S190-197.
---------------------------------------------------------------------------
4. How sensitive the testing procedure is. CDC used a laboratory
test sensitivity rate of 70% based on studies of
Salmonella.50 51
---------------------------------------------------------------------------
\50\ Chalker, R.B. and M.J. Blaser (1988). ``A review of human
salmonellosis: III. Magnitude of Salmonella infection in the United
States.'' Rev Infect Dis 10(1): 111-124.
\51\ Voetsch, A.C., T.J. Van Gilder, et al. (2004). ``FoodNet
estimate of the burden of illness caused by nontyphoidal Salmonella
infections in the United States.'' Clin Infect Dis 38 Suppl 3: S127-
134.
---------------------------------------------------------------------------
5. CDC also adjusted for geographical coverage of the FoodNet sites
and for the changing United States population for the years 2005-2008.
The value was also adjusted down for the following factors:
1. The proportion of illnesses that were acquired outside of the
United States. Based on the proportion of FoodNet cases of STEC O157
infection who reported travel outside the United States within 7 days
of illness onset (2005-2008), CDC estimated that 96.5% of illnesses
were domestically acquired.
2. The proportion of STEC O157 outbreak-associated illnesses that
was due to foodborne transmission. Based on reported outbreaks CDC
estimated that 68% were foodborne.\52\ The overall effect of the upward
and downward adjustments is a multiplier of 26.1 that is applied to the
reported number of illness which is then adjusted down by about 35% to
account for domestically acquired foodborne illness.
---------------------------------------------------------------------------
\52\ Rangel, J.M., P.H. Sparling, et al. (2005). ``Epidemiology
of Escherichia coli O157:H7 outbreaks, United States, 1982-2002.''
Emerg Infect Dis 11(4): 603-609.
---------------------------------------------------------------------------
CDC's credible interval surrounding this point estimate ranges from
17,587 to 149,631.\53\ The estimated annual illnesses due to
mechanically tenderized product is given by 63,153 (annual estimated
illnesses of E. coli O157:H7 \54\) x 0.394 (proportion of E. coli
O157:H7 illnesses attributable to beef \55\) x 0.079 (proportion of
beef attributable illnesses due to tenderized product \56\) = 1,965.
This gives a range of estimated annual illnesses from 547 (= 17,587 x
0.394 x 0.079) to 4,657 (= 149,631 x 0.394 x 0.079). FSIS requests
comments on the methods used, including the application of the
underlying datasets, to estimate illnesses attributable to mechanically
tenderized beef and alternative methods for making this estimate.
Because, combining three sources of information introduces uncertainty
around the precision of these estimates, we are particularly interested
in approaches to quantifying the uncertainty inherent in the method
used.
---------------------------------------------------------------------------
\53\ Scallan, E., R.M. Hoekstra, et al. (2011). ``Foodborne
illness acquired in the United States--major pathogens.'' Emerg
Infect Dis 17(1): 7-15.
\54\ Ibid.
\55\ Painter, J., R. Hoekstra, et al. (2013). ``Attribution of
foodborne illnesses, hospitalizations, and deaths to food
commodities by using outbreak data, United States, 1998-2008.''
Emerg Infect Dis 9(3): 407-415.
\56\ 151 outbreak illnesses attributable to tenderized beef out
of 1,909 outbreak illnesses attributable to all beef (151/1,909 =
0.079).
---------------------------------------------------------------------------
An analysis of the NHANES 2005-2006 Dietary Interview, Individual
Foods, First Day, and Second Day files estimated approximately 11.7
billion servings annually of steaks and roasts. FSIS contracted with
Research Triangle Institute to estimate market shares for mechanically
tenderized beef and mechanically tenderized beef with added
solutions.\57\ After accounting for the proportion of all beef that was
ground, FSIS estimated that 21.0% of non-ground product was
mechanically tenderized only and that 31.6% of non-ground product was
mechanically tenderized with added solutions. Thus, FSIS estimates that
mechanically tenderized beef accounts for 6.2 billion servings
annually. FSIS also estimates that the frequency of illness for
mechanically tenderized product is 1,965/6.2 billion or 320 illnesses
per billion servings, with a range from 88 (= 547/6.2 billion) to 751
(= 4,657/6.2 billion) illnesses per billion servings.
---------------------------------------------------------------------------
\57\ Muth, M.K., M. Ball, et al. (2012). Expert Elicitation on
the Market Shares for Raw Meat and Poultry Products Containing Added
Solutions and Mechanically Tenderized Raw Meat and Poultry Products.
Research Triangle Park, NC 27709, RTI International, 3040 Cornwallis
Road.
---------------------------------------------------------------------------
The dose response function for a pathogen associates an average
dose with a corresponding frequency of illness. For E. coli O157:H7 the
dose response function is characterized by a linear part in which the
predicted probability of illness per serving across all exposures is
proportional with respect to an average dose and by a non-linear part
in which the predicted probability of illness is not proportional.
In the case of E. coli O157 illnesses attributable to mechanically
tenderized beef, the frequency of illness is very low; therefore the
mean dose across the population of servings that could account for this
frequency of illness is also low. For one set of parameters the dose
response function for E. coli O157:H7 corresponds to an average dose of
0.0001 E. coli O157:H7 bacteria per serving with a frequency of illness
of 320 per billion.\58\ This average dose is more than 5
log10 below the point at which the dose response function
becomes non-linear. This makes the average dose an appropriate
surrogate for the distribution of all doses.\59\ At the lower end of
the range of illnesses, a dose of 0.000028 E. coli O157:H7 bacteria per
serving corresponds to a frequency of illness of 88 per billion
servings. At the upper end of the range of illnesses, a dose of 0.00024
E. coli O157:H7 bacteria per serving corresponds to a frequency of
illness of 751 per billion servings. Both of these values also fall
well below the point at which the dose response function becomes non-
linear.
---------------------------------------------------------------------------
\58\ Powell, M., E. Ebel, et al. (2001). ``Considering
uncertainty in comparing the burden of illness due to foodborne
microbial pathogens.'' Int J Food Microbiol 69(3): 209-215.
\59\ Williams, M.S., E.D. Ebel, et al. (2011). ``Methodology for
determining the appropriateness of a linear dose-response
function.'' Risk Anal 31(3): 345-350.
---------------------------------------------------------------------------
From a post-cooking dose of 0.0001, a pre-cooking dose of E. coli
O157:H7 bacteria can be calculated by determining the average
contamination level needed to survive cooking. The 2007 EcoSure
consumer cooking temperature audit \60\ involved the collection of data
from primary shoppers of over 900 households geographically dispersed
across the country. Participants were asked to record the final cooking
temperature and name or main ingredient of any entr[eacute]e they
prepared during the week of the study. Of the 3,257 recorded consumer
cooking temperatures in the database for all products, 318 recorded
consumer cooking temperatures ranging from 82[emsp14][deg]F to
212[emsp14][deg]F for beef (not ground). Table 3 shows the number of
observations for each recorded cooking temperature.
---------------------------------------------------------------------------
\60\ EcoSure-EcoLab. (2007). ``EcoSure 2007 Cold Temperature
Database.'' FoodRisk.org Retrieved May 26, 2010, from http://foodrisk.org/exclusives/EcoSure/.
[[Page 34600]]
Table 3--Final Recorded Consumer Cooking Temperatures for Beef (Not
Ground) in 2007 EcoSure Consumer Cooking Temperature Audit
[EcoSure-EcoLab, 2007]
------------------------------------------------------------------------
Final cooking temperature Observations Percent
------------------------------------------------------------------------
80-89........................................... 1 0.3
90-99........................................... 3 0.9
100-109......................................... 6 1.9
110-119......................................... 11 3.5
120-129......................................... 19 6.0
130-139......................................... 27 8.5
140-149......................................... 38 11.9
150-159......................................... 54 17.0
160-169......................................... 61 19.2
170-179......................................... 31 9.7
180-189......................................... 45 14.2
190-199......................................... 14 4.4
200-209......................................... 7 2.2
210-219......................................... 1 0.3
------------------------------------------------------------------------
Sixty seven (21%) of the recorded cooking temperatures were below
140 [deg]F and 159 (50%) of the temperatures were below 160 [deg]F. A
2010 USDA Agricultural Research Service (ARS) study by Luchansky et
al.,\61\ looked at the relationship between final cooking temperatures
and log10 reductions for mechanically tenderized beef. An
additional ARS study by Luchansky, et al.,\62\ also examined the
relationship between final cooking temperatures and log10
reductions for chemically injected beef (mechanically tenderized beef
with added solutions). Equations derived from these studies combined
with the distribution of final cooking temperatures shown in Table 3
estimate that an average pre-cooking dose of 0.0188 E. coli O157:H7
bacteria per serving would result in an average post-cooking dose of
0.0001. Thus, a pre-cooking dose of 0.0188 corresponds with the
estimate of 1,965 illnesses. Given the current cooking distribution,
more than 98% of the 1,965 illnesses are attributed to cooking
temperatures below 160[emsp14][deg]F and less than 1% to cooking
temperatures equal to or greater than 160 [deg]F.
---------------------------------------------------------------------------
\61\ Luchansky, J.B., A.C. Porto-Fett, et al. (2012). ``Fate of
Shiga toxin-producing O157:H7 and non-O157:H7 Escherichia coli cells
within blade-tenderized beef steaks after cooking on a commercial
open-flame gas grill.'' J Food Prot 75(1): 62-70.
\62\ Ibid.
---------------------------------------------------------------------------
To evaluate the effect of using a higher minimum cooking
temperature, FSIS modified the distribution derived from the EcoSure
(2007) data set so that all of the observations that were originally
below 160 [deg]F were set to 160 [deg]F. FSIS then calculated a new
predicted number of illnesses using this modified cooking temperature
distribution with the pre-cooking dose of 0.0188. This changes the
post-cooking average dose from 0.0001 E. coli O157:H7 bacteria per
serving to an average dose of 0.0000039, which corresponds to a
frequency of illness of 13 per billion. With this change, the predicted
number of illnesses decreases from 1,965 to 78. Thus, if all consumers
cook all mechanically tenderized beef to at least 160 [deg]F, the
resulting total number of illness will be 78. Analogous calculations
yield illness estimates of 22 and 184 illness, respectively, if the
baseline annual illness totals are 547 and 4,657.
The annual estimated number of illness averted or prevented is
estimated at 1,887 (1,965 illness less 78 illness), with a range of 525
illness (547 illness - 22 illness) to 4,473 illnesses (4,657 illness -
184 illness), if mechanically tenderized and mechanically tenderized
beef containing added solution is cooked to a minimum temperature of
160 [deg]F (which is equivalent to cooking to a minimum internal
temperature of 145 [deg]F with 3 minutes of dwell time). However, FSIS
knows that not all consumers or food service providers will change
their behavior based on reading the labels and, therefore, the Agency
has estimated the uncertainty surrounding the number of illnesses that
will be averted by obtaining ranges for both the consumer and food
service provider response rate, as well as using the range for the
estimated number of illnesses if all consumers and food service
providers cooked the product at a minimum recommended temperature.
To determine this, FSIS used studies on the impacts of food product
labels on consumer behavior. These studies estimated the proportion of
consumers changing their behavior in response to the presence of
cooking instructions (safe handling instructions) ranging from 15 to 19
percent. \63\ In a study of the nutrition fact panel on food products,
the American Dietetic Association (ADA) conducted a survey which
indicated that 56 percent of the people interviewed claimed to have
modified their food choices after using this nutrition fact labeling
(American Dietetic Association, 1995).\64\ Finally, the Food Marketing
Institute (FMI) in early 1995 indicated that the nutrition fact label
may be causing some dietary change. Fifteen percent of the shoppers
indicated that they had stopped buying products they had regularly
purchased, after reading the label.\65\ We use the range (15 to 56
percent) as the estimate for the impact of labels on consumer behavior
in retail, with our primary estimate equaling the average of available
estimates, or 24 percent. FSIS requests comments on the percentage of
consumers who would change their behavior after reading the labels.
---------------------------------------------------------------------------
\63\ Yang states that 15% (51% of respondents seen the Safe
Handling Instruction labels x 79% remembered reading the labels x
37% changing their behavior after seeing and reading the labels),
and Bruhn states that 17% (60% of respondents seen the labels x 65%
said that their awareness was increased x 43% said that they changed
their behavior). Ralston states that 19% (67% of respondents seen
the label x 29% who changed their behavior).
\64\ America's Eating Habits: Changes and Consequences. U.S.
Department of Agriculture, Economic Research Service, Food and Rural
Economics Division. Agriculture Information Bulletin No. 750.
\65\ Food Marketing Institute (FMI) states that of the 43
percent of the shoppers interviewed, who had seen the label, 22
percent indicated it had caused them to start buying and using food
products they had not used before, and 34 percent said they had
stopped buying products they had regularly. We use the higher
percentage of 15% (43% x 34%) in our estimate. FMI and Prevention
Magazine Report Shopping for Health: Balancing, Convenience,
Nutrition and Taste, 1997.
---------------------------------------------------------------------------
In addition, the RTI study indicates that the food service industry
market share for mechanically tenderized beef and beef containing added
solution is estimated at 53 percent and the market share for retail for
the same products is estimated at 47 percent.\66\ In the absence of
data, FSIS assumes for its primary estimate that the rule-induced
percentage reduction in illness will be the same for food service
establishments as for mechanically-tenderized beef purchased at retail
(24 percent), and presents a range in which between 0% and 100% of food
service providers will follow the validated cooking instructions.
Should the rule become final, food service providers will be able to
identify mechanically tenderized beef product as such and will
therefore be able to follow the Food Code cooking instructions. The
Food Code (developed by the Conference for Food Protection and adopted
by 49 states, which represent 96 percent of the population) recommends
cooking mechanically tenderized and injected meats to a minimum
temperature of 145[deg]F for a minimum of 3 minutes. The Food Code,
however, states that retail service facilities may serve such product
rare if they notify consumers of the risk.\67\ Therefore, FSIS assumes
that at a minimum, zero food service providers will follow the cooking
instructions.
[[Page 34601]]
FSIS is including the lower end to recognize that some food service
providers may recognize customers' requests that the meat be cooked
rare. FSIS is requesting comments on food service providers' likely
response to new labeling of mechanically-tenderized beef, including any
cost that would be incurred by such establishments as a result of
changing standard operating procedures related to intact and
mechanically-tenderized beef.
---------------------------------------------------------------------------
\66\ RTI, pp. 3-12 and 3-14.
\67\ In the U.S. Department of Health and Human Services, Public
Health Service, FDA Food Code, 2009, S3-411.11 (D), a rare animal
food such as rare meat other than whole-muscle, intact steaks, may
be served or offered for sale upon consumer request or selection in
a ready-to-eat form if the consumer is informed that to ensure its
safety, the food is to be more fully cooked.
---------------------------------------------------------------------------
Table 4 shows the estimated reduction in illness numbers based on
these assumptions for consumer and food service provider behavior. To
derive the estimated number of illnesses averted and focusing first on
inputs derived from Scallan et al.'s primary estimate, the range for
the estimate would be 133 illness (1,887 illnesses (mid-point estimate
from the risk analysis) * 47% (retail share of mechanically tenderized
beef market) * 15% (lower end of the range for percent of consumer
using validated cooking instructions) + 53% (food service share of
mechanically tenderized beef) * 0% (lower end of the range for food
service compliance with validated cooking instructions)) to 1,497
illness averted (1,887 illnesses (mid-point estimate from the risk
analysis) * 47% (retail share of mechanically tenderized beef market) *
56% (upper end of the range for percent of consumers using validated
cooking instructions) + 53% (food service share of mechanically
tenderized beef) * 100% (upper end of the range for food service
compliance with validated cooking instructions)). The primary estimate
is 460 illnesses.
Table 4--Response Rate and Resulting Averted Illnesses
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Category Retail Food service Total Averted illnesses Expected benefits
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Share of Mechanically Tenderized 47%........................ 53%........................ 100%................................ .................................... .....................
Beef in Retail vs. Food Service.
Response to Label.................. 15 to 56% \1\.............. 0% to 100%................. 7% to 79%........................... 133 to 1,497........................ $436,000 to
$4,911,000.
Primary \2\........................ 24% \1\.................... 24% \1\.................... 24%................................. 460................................. $1,511,000.
Lower Bound \3\.................... ........................... ........................... 24% (7% to 79%)..................... 128 (37 to 416)..................... $420,000 ($121,000 to
$1,366,000).
Upper Bound \4\.................... ........................... ........................... 24% (7% to 79%)..................... 1,091 (315 to 3,548)................ $3,581,000
($1,035,000 to
$11,641,000).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The average of the percentages of consumer response rate: Yang 15%, Bruhn 17%, Ralston 19%, American Dietetic Association 56%, and FMI 15% as discussed in the benefits section.
\2\ Using estimated mechanically tenderized beef preventable illnesses of 1,887 illnesses.
\3\ Using estimated mechanically tenderized beef preventable illnesses of 128 illnesses.
\4\ Using estimated mechanically tenderized beef preventable illnesses of 1,091 illnesses.
With the primary estimate, 24% of all mechanically tenderized beef
previously cooked to a lower temperature is cooked to the suggested
temperature, which is equivalent to 460 illnesses averted or prevented.
Using the FSIS estimate for the average cost per case for an E.
coli O157:H7 illness of $3,281,\68\ expected benefits from this
proposed rule are $1,511,000 per year (with a range of $436,000 to
$4,911,000). Using the credible interval from Scallan et. al provides
expected benefits of $420,000 per year for 128 illnesses prevented
(with a range of $121,000 to $1,366,000) for the lower bound of the
credible interval and expected benefits of $3,581,000 per year for
1,091 illnesses prevented (with a range of $1,035,000 to $11,641,000)
in the upper bound of the credible interval. This estimate for the
average cost of an E. coli O157:H7 illness is derived by using the
current version of ERS Cost calculator (for E. coli) and replacing the
case numbers with new case numbers based on Scallan's report.
---------------------------------------------------------------------------
\68\ The FSIS estimate for the cost of E. coli O157:H7 ($3,281
per case,--2010 dollars) was developed using the USDA, ERS Foodborne
Illness Cost Calculator: STEC O157 (June 2011). FSIS updated the ERS
calculator to incorporate the Scallan (2011) case distribution for
STEC O157. Scallan E. Hoekstra, Angulo FJ, Tauxe RV, Widdowson MA,
Roy SL, et. al. 2011 January. ``Foodborne Illness Acquired in the
United States--Major Pathogens''. Emerging Infectious Diseases.
---------------------------------------------------------------------------
For E. coli, FSIS adjusted Scallan's case distribution to fit the
ERS Cost Calculator because Scallan reported each illnesses in three
categories (doctor visits, hospitalization, and death) while the ERS
Cost Calculator for E. coli O157 has seven severity categories. By
changing only the case numbers, FSIS kept all other assumptions in the
ERS Cost Calculator. ERS has recently updated the dollar units to 2010
dollars and FSIS is using these estimates.
These estimates represent a minimal estimate for an average cost of
illness because they only include medical costs and loss-of-
productivity costs. They do not include pain and suffering costs.
FSIS believes that consumers prefer lower cooking temperatures \69\
and therefore they may substitute other meat choices rather than
cooking at a higher recommended temperature included in cooking
instructions. This welfare loss associated with substituting to less-
preferred meats or cooking to temperatures that are higher than ideal
(from a taste perspective) was not quantified in the analysis.
Conclusion
The cost to produce labels for mechanically tenderized beef is a
one-time cost of $1.05 million or $2.62 million if this rule is in
effect before the added solutions rule. The annualized cost is $140,000
for 10 years at a 7 percent discount rate or $349,000 over 10 years at
a 7 percent discount rate if this rule is in effect before the added
solutions rule.
The expected number of illnesses prevented would be 460 per year,
with a range of 133 to 1,497, if the predicted percentages of beef
steaks and roasts are cooked to an internal temperature of 160 [deg]F
(or 145 [deg]F and 3 minutes of dwell time). These prevented illnesses
amount to $1,511,000 per year in benefits with a range of $436,000 to
$4,911,000. The expected annualized net benefits are $296,000 to
$4,771,000 with a primary estimate of $1,371,000.
If, however, this rule is in effect before the added solutions
rule, the expected annualized net benefits are then $1,162,000, with a
range of $87,000 to $4,562,000.
Using the lower end of the credible interval from Scallan et. al
provides an expected number of illness prevented of 128 per year, with
a range of 37 to 416, as discussed earlier. These prevented
[[Page 34602]]
illnesses amount to $420,000 in benefits, with a range of $121,000 to
$1,366,000. The expected annualized net benefits for the lower end of
the Scallan's credible interval are $280,000, with a range of -$19,000
to $1,226,000, if this rule goes into effect before the added solutions
rule.
Using the upper end of the credible interval from Scallan et. al
provides an expected number of illness prevented of 1,091 per year,
with a range of 315 to 3,548 as discussed earlier. These prevented
illnesses amount to $3,581,000 in benefits, with a range of $1,035,000
to $11,641,000. The expected annualized net benefits for the upper end
of the Scallan's credible interval are $3,441,000, with a range of
$895,000 to $11,501,000, if this rule goes into effect after the added
solutions rule.
In addition to the quantified net benefits mentioned above, the
rule would generate the unquantifiable benefits of increased consumer
information and market efficiency, an unquantified consumer surplus
loss and an unquantified cost associated with food service
establishments changing their standard operating procedures.
As mentioned above, FSIS is using an estimate of the number of
establishments producing needle- or blade-tenderized beef products and
the number of labels that would need to be modified as a result of this
proposed rule. FSIS requests comments on the number of official and
retail establishments that are producing or packaging mechanically
tenderized beef products and the number of labels that they might need
to modify should this proposal be finalized.
Additionally, FSIS cannot estimate the number of validation studies
that would be necessary to develop cooking instructions for raw and
partially cooked needle- or blade-tenderized beef products. In
addition, FSIS requests comments on the costs of conducting these
validation studies.
Alternatives
Vacuum-Tumbled Beef Products
Some beef products are vacuum-tumbled to marinate and tenderize the
product. The vacuum increases absorption of the marinade, while
tumbling both tenderizes the product and increases absorption of the
marinade. Vacuum-tumbled beef is a non-intact product, though its
appearance is similar to whole, intact product. Research shows that the
process of vacuum tumbling a product increases bacterial migration into
the interior of the product.70 71 However, FSIS does not
have sufficient data to understand the magnitude of the risk of
pathogens that may be introduced into product as a result of vacuum
tumbling. Therefore, the Agency is requesting that the public submit
data concerning the safety of vacuumed tumbled beef products. In
addition, FSIS is asking for comments to see whether vacuum tumbled
beef product should be considered mechanically tenderized product and
thus subject to the provisions of this proposed rule if it becomes
final.
---------------------------------------------------------------------------
\70\ Warsaw, CR, Orta-Ramirez A, Marks BP, Ryser ET, Booren AM.
2008. Single directional migration of Salmonella into marinated
whole muscle turkey breast. Journal of Food Protection. 71(1):13-
156.
\71\ Warsow, C.R., Marks, B.P., Ryser, E.T., Orta-Ramirez, A.,
Booren, A.M., Effects of vacuum tumbling on Salmonella migration
into the interior of intact, marinated turkey breasts. http://ift.confex.com/ift/2003/techprogram/paper_19598.htm.
---------------------------------------------------------------------------
Enzyme-Formed Product
Some meat and poultry products are formed with transglutaminase
enzyme (TG enzyme). TG enzyme is approved for use as a cross-linking
binder to form product, e.g., through binding pieces of beef tenderloin
together to form a larger beef tenderloin steak or roast. FSIS
regulations (9 CFR 317.8(b)(39) and 381.129(e)) require labeling for
meat and poultry products that are formed or re-formed with TG enzyme
as a binder as part of the product name, e.g., ``Formed Turkey Thigh
Roast.'' Formed products are non-intact. However, the formed products
are already labeled in a manner that distinguishes them from other
products. FSIS requests comment on whether this labeling is sufficient
to inform consumers of the nature of formed product and on whether any
final rulemaking should include additional labeling requirements, such
as validated cooking instructions on any not-ready-to-eat formed
product. FSIS requests data on the volume of formed product, the volume
of formed product sold at retail stores versus food service facilities,
and any available data on whether consumers typically cook formed
product at time and temperature combinations sufficient to destroy
pathogens.
FSIS considered several alternatives to the proposed rule:
Option 1. Extend labeling requirements to include vacuum tumbled
beef products and enzyme-formed beef products. FSIS considered the
option of proposing to amend the labeling regulations to include a new
requirement for labeling all vacuum tumbled and enzyme-formed beef
products. But, as discussed earlier, FSIS does not have sufficient data
concerning the production practices and risks of consuming vacuum
tumbled beef products and enzyme-formed beef products to proceed with
this option. FSIS is requesting comments and data on these products.
Option 2. Extend the proposed labeling requirements to all needle-
or blade-tenderized meat and poultry products. FSIS considered the
option of proposing to amend the labeling regulations to include a new
requirement for labeling all mechanically tenderized meat and poultry
products. However, as discussed above, FSIS does not have sufficient
data concerning the production practices and risks of consuming
mechanically tenderized poultry products or mechanically tenderized
meat products, other than beef, to proceed with this option.
Option 3. Validated cooking instructions for needle or blade-
tenderized beef, needle-injected beef, and all beef containing
solutions. FSIS considered the option of proposing to amend the
labeling regulations to require validated cooking instructions for
needle or blade tenderized beef, needle-injected, and all beef
containing solutions. However, FSIS did not find any outbreak data for
products that contain added solutions but are not injected. In
addition, if products are marinated but not injected, the pathogen
remains on the surface of the product and would typically be
eliminated, even if the product is cooked to rare temperatures.
Therefore, FSIS does not have any data necessary to substantiate the
need for this alternative.
Regulatory Flexibility Analysis
The FSIS Administrator has made a preliminary determination that
this proposed rule would not have a significant economic impact on a
substantial number of small entities in the United States, as defined
by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). This
determination was made because the rule will affect the labeling of
about 10.5% of 24.3 billion pounds of beef products. Over 97 percent of
the 555 federal establishments that produce mechanically tenderized
beef products could possibly be affected by this proposed rule are
small or very small according to the FSIS HACCP definition. There are
about 251 very small establishments (with fewer than 10 employees) and
291 small establishments (with more than 10 but less than 500
employees). Therefore, a total of 542 small and very small
establishments could possibly be affected by this rule. The FSIS HACCP
[[Page 34603]]
definition assigns a size based on the total number of employees in
each official establishment. The Small Business Administration
definition of a small business applies to a firm's parent company and
all affiliates as a single entity.
These small and very small manufacturers, like the large
manufacturers, would incur the costs associated with modifying product
labels to add on the labels ``mechanically tenderized'' and validated
cooking instructions needed to ensure adequate pathogen destruction.
Based on the estimated number of labels that will be required by
the establishments, the cost will add an average of $0.001 per package
($1.05 million/951 million packages of needle- or blade-tenderized
beef).\72\ The average cost per establishment would be $1,884 per
establishment ($1.05 million/555). Also, small and very small
establishments will tend to have a smaller number of unique products
and will therefore have a smaller number of labels to modify, and
therefore less labeling cost.
---------------------------------------------------------------------------
\72\ FSIS estimates that the annual quantity of mechanically
tenderized beef at is about 951 million packages (2.6 billion pounds
of mechanical tenderized beef produced/2.735 average weight of a
retail package according to the National Cattlemen's Beef
Association).
---------------------------------------------------------------------------
The labeling costs discussed above are one-time costs. FSIS
believes these one-time costs will not be a financial burden on small
entities.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501, et seq.), the information collection requirement included in this
proposed rule has been submitted for approval to OMB.
Title: Mechanically Tenderized Beef Products.
Type of Collection: New.
Abstract: FSIS is proposing to require the use of the descriptive
designation ``mechanically tenderized'' on the labels of needle- or
blade-tenderized beef products, including beef products injected with
marinade or solution, that do not fall under a regulatory standard of
identity. FSIS is also proposing that the print for all words in the
descriptive designation appear as the product name in the same style,
color, and size and on a single-color contrasting background. In
addition, FSIS is proposing to require that labels of raw and partially
cooked needle- or blade-tenderized beef products include validated
cooking instructions that inform consumers that these products need to
be cooked to a specified minimum internal temperature and whether they
need to be held at that minimum temperature or higher for a specified
time before consumption, i.e., dwell time or rest time, to ensure that
they are fully cooked.
The average burden per response and the annual burden hours are
explained below and summarized in the charts which follow.
Estimated Annual Burden: Mechanically Tenderized Beef Products
Recordkeeping:
Estimated Annual Recordkeeping Burden for Mechanically Tenderized Beef
Products
Respondents: Official meat establishments.
Estimated Number of Respondents: 555.
Estimated Number of Responses per Respondent: 30.454.
Estimated Total Annual Responses: 16,902.
Estimated Total Annual Recordkeeping Burden: 985.95 hours.
----------------------------------------------------------------------------------------------------------------
Estimated Number of Time for
number of responses per Total annual responses in Total annual
respondents respondent responses minutes burden hours
----------------------------------------------------------------------------------------------------------------
Establishments maintain labels 555 15.227 8,451 2 281.7
on file........................
Establishments maintain 555 15.227 8,451 5 704.25
validated cooking instructions
on file........................
-------------------------------------------------------------------------------
Total Recordkeeping Burden.. 555 30.454 16,902 7 985.95
----------------------------------------------------------------------------------------------------------------
Reporting
Estimated Annual Reporting Burden for Mechanically Tenderized Beef
Products
Respondents for this Proposed Rule: Official meat establishments.
Estimated Number of Respondents: 555.
Estimated Number of Responses per Respondent: 30.454.
Estimated Total Annual Responses: 16,902.
Estimated Total Annual Reporting Burden on Respondents: 18,733.05
hours.
----------------------------------------------------------------------------------------------------------------
Estimated Number of Time for
number of responses per Total annual responses in Total annual
respondents respondent responses minutes burden hours
----------------------------------------------------------------------------------------------------------------
Establishments are to prepare 555 15.227 8,451 13 1,831.05
labels with descriptive
designation and validated
cooking instructions...........
Establishments are to develop 555 15.227 8,451 120 16,902
validated cooking instructions.
-------------------------------------------------------------------------------
Total Reporting Burden...... 555 30.454 16,902 133 18,733.05
----------------------------------------------------------------------------------------------------------------
Summary of Burden--Mechanically Tenderized Beef Products
------------------------------------------------------------------------
------------------------------------------------------------------------
Total No. Respondents......................................... 555
Average No. Responses per Respondent.......................... 60.908
Total Annual Responses........................................ 33,804
Average Hours per Response.................................... 2.417
---------
Total Burden Hours.......................................... 19,719
------------------------------------------------------------------------
Copies of this information collection assessment can be obtained
from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety
and Inspection Service, USDA, 1400 Independence Avenue SW., Room 6083,
South Building, Washington, DC 20250.
[[Page 34604]]
Comments are invited on: (a) whether the proposed collection of
information is necessary for the proper performance of FSIS's
functions, including whether the information will have practical
utility; (b) the accuracy of FSIS's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on those who
are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology.
Comments may be sent to both John O'Connell, Paperwork Reduction
Act Coordinator, at the address provided above, and the Desk Officer
for Agriculture, Office of Information and Regulatory Affairs, Office
of Management and Budget, Washington, DC 20253. To be most effective,
comments should be sent to OMB within 60 days of the publication date
of this proposed rule.
E-Government Act
FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things,
promoting the use of the Internet and other information technologies
and providing increased opportunities for citizen access to Government
information and services, and for other purposes.
Executive Order 13175
This proposed rule has been reviewed in accordance with the
requirements of Executive Order 13175, Consultation and Coordination
with Indian Tribal Governments. The review reveals that this proposed
regulation will not have substantial and direct effects on Tribal
governments and will not have significant Tribal implications.
USDA Nondiscrimination Statement
The U.S. Department of Agriculture (USDA) prohibits discrimination
in all its programs and activities on the basis of race, color,
national origin, gender, religion, age, disability, political beliefs,
sexual orientation, and marital or family status. (Not all prohibited
bases apply to all programs.)
Persons with disabilities who require alternative means for
communication of program information (Braille, large .print, audiotape,
etc.) should contact USDA's Target Center at 202-720-2600 (voice and
TTY).
To file a written complaint of discrimination, write USDA, Office
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue
SW, Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY).
Additional Public Notification
FSIS will announce this proposed rule online through the FSIS Web
page located at http://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp.
FSIS will also 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 groups,
consumer interest groups, health professionals, and other individuals
who have asked to be included. The Update is also available on the FSIS
Web page. In addition, FSIS offers an electronic 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_&_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 accounts.
List of Subjects in 9 CFR Part 317
Food labeling, Food packaging, Meat inspection, Nutrition,
Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, FSIS is proposing to
amend 9 CFR Chapter III as follows:
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS
0
1. The authority citation for Part 317 continues to read as follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
0
2. Amend Sec. 317.2 by adding and reserving paragraphs (e)(1) and (2),
and adding a new paragraph (e)(3) to read as follows:
Sec. 317.2 Labels: definition; required features.
* * * * *
(e) * * *
(3) Product name and required validated cooking instructions for
needle- or blade-tenderized beef products. (i) Unless the product is
destined to be fully cooked at an official establishment, the product
name for a raw or partially cooked beef product that has been
mechanically tenderized, whether by needle or by blade, must contain
the term ``mechanically tenderized'' as a descriptive designation and
an accurate description of the beef component.
(ii) The product name must be printed in a single font style,
color, and size and must appear on a single-color contrasting
background.
(iii) The labels on raw or partially cooked needle- or blade-
tenderized beef products destined for household consumers, hotels,
restaurants, or similar institutions must contain validated cooking
instructions, including the cooking method, that inform consumers that
these products need to be cooked to a specified minimum internal
temperature, whether the product needs to be held for a specified time
at that temperature or higher before consumption to ensure that
potential pathogens are destroyed throughout the product, a statement
that the internal temperature should be measured by a thermometer.
* * * * *
Done at Washington, DC on: June 3, 2013.
Alfred V. Almanza,
Administrator.
[FR Doc. 2013-13669 Filed 6-7-13; 8:45 am]
BILLING CODE 3410-DM-P
