Federal Register, Volume 78 Issue 111 (Monday, June 10, 2013)

[Federal Register Volume 78, Number 111 (Monday, June 10, 2013)]
[Proposed Rules]
[Pages 34589-34604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13669]

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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.

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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.

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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\
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\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).
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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
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Benefits \b\ Costs Net Benefits
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Estimated Quantified Benefits, Costs, and Net Benefits \a\
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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)
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Non-Quantified Benefits and Costs
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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.
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\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.
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\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).
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An increasing number of establishments use mechanical tenderization
processes for beef.\7\ The mechanically tenderized products are widely
available to consumers in the marketplace.
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\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.
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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\
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\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)
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Case patients/ Epi. Hospitalizations/
Year Product link Deaths FSIS Recall number
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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\
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Total........................... ...................... 176/168............... 32/1 ...............................................
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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\
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\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.
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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\.
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\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).
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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\
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\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.
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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.
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\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.
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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.''
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\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.
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\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\
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\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.
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\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.
---------------------------------------------------------------------------

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.
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\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.
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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.
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\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.
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\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)).
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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