[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Rules and Regulations]
[Pages 28153-28172]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11916]



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  Federal Register / Vol. 80, No. 95 / Monday, May 18, 2015 / Rules and 
Regulations  

[[Page 28153]]



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: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the 
Federal meat inspection regulations to require the use of the 
descriptive designation ``mechanically tenderized,'' ``blade 
tenderized,'' or ``needle tenderized'' on the labels of raw or 
partially cooked needle- or blade-tenderized beef products, including 
beef products injected with a marinade or solution, unless the products 
are to be fully cooked or to receive another full lethality treatment 
at an official establishment. Under these final regulations, the 
product names of the affected products will have to include the 
descriptive designation ``mechanically tenderized,'' ``blade 
tenderized,'' or ``needle tenderized'' and an accurate description of 
the beef component. The print for all words in the descriptive 
designation and the product name will have to be in a single easy-to-
read type style and color and must appear on a single-color contrasting 
background. The print may appear in upper and lower case letters, with 
the lower case letters not smaller than one-third (\1/3\) the size of 
the largest letter. In addition, the labels of raw and partially cooked 
needle- or blade-tenderized beef products destined for household 
consumers, hotels, restaurants, or similar institutions will have to 
bear validated cooking instructions. The instructions will have to 
specify the minimum internal temperatures and any hold or ``dwell'' 
times for the products to ensure that they are fully cooked.
    FSIS is amending the regulations because of scientific evidence 
that mechanically tenderized beef products need to be fully cooked in 
order to reduce the risk of pathogenic bacteria that may be transferred 
to the interior of the meat during mechanical tenderization.
    FSIS is also announcing the availability of updated guidance for 
the use of federally inspected establishments in developing validated 
cooking instructions for mechanically tenderized product.

DATES: The effective date is May 17, 2016. As discussed below in the 
preamble, FSIS has established this effective date based on the 
potential public health benefits.

FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Assistant 
Administrator, Office of Policy and Program Development, Food Safety 
and Inspection Service, 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 tenderizing beef with a needle or blade has the 
potential to transfer pathogens that may occur on the exterior of the 
product into its interior. In such circumstances, it is important that 
the interior of the beef product be fully cooked. Not all mechanically 
tenderized products are readily distinguishable from non-tenderized 
products. Recent outbreak data indicate that consumers and food service 
facilities sometimes do not cook mechanically tenderized raw beef 
products to a temperature and for a time sufficient to destroy harmful 
bacteria that may have been transferred to the tenderized interior of 
the product. FSIS has, therefore, determined that labeling to state 
that the beef product is tenderized, along with validated cooking 
instructions, are necessary to provide consumers and food service 
workers the essential information to safely prepare the product.
    On June 10, 2013, FSIS proposed new labeling requirements for raw 
or partially cooked needle- or blade-tenderized beef products, 
including beef products injected with a marinade or solution (78 FR 
34589). Having reviewed and considered all comments received on the 
proposal, FSIS is finalizing all the proposed regulatory requirements 
with minor changes.
    FSIS is requiring the labels of raw or partially cooked needle- or 
blade-tenderized beef products, including beef products injected with 
marinade or solution, to bear a descriptive designation that clearly 
indicates that the product has been mechanically tenderized, unless 
such product is destined to be fully cooked or to receive another full 
lethality treatment \1\ that renders the product ready-to-eat, as 
defined in 9 CFR 430.1, in an official establishment.\2\ To provide 
flexibility and respond to comments, FSIS is requiring in the final 
rule that the terms ``needle tenderized'' or ``mechanically 
tenderized'' be used as the descriptive designation for needle 
tenderized beef products and the terms ``mechanically tenderized'' or 
``blade tenderized'' be used as the descriptive designation for blade 
tenderized beef products.
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    \1\ Examples of full lethality treatments other than cooking 
that render a product ready-to-eat can include high pressure 
processing and irradiation, provided the establishment has 
supporting documentation that shows the treatment achieves at least 
a 5-log reduction for Salmonella and Shiga Toxin-producing E.coli 
organisms (including E.coli O157:H7), and applies the treatment 
consistent with its critical operational parameters.
    \2\ 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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    In addition, to ensure that the descriptive designation is readily 
apparent on the label, FSIS is requiring the print for all words in the 
descriptive designation must appear in a single easy-to-read type style 
and color and on a single-color contrasting background. The print may 
appear in upper and lower case letters, with the lower case letters not 
smaller than \1/3\ the size of the largest letter.
    FSIS also is requiring that labels of raw and partially cooked 
needle- and blade-tenderized beef products destined for household 
consumers, hotels, restaurants, and similar institutions include 
cooking instructions that have been validated to ensure that any 
pathogens that may be on or in the

[[Page 28154]]

product are destroyed. To clarify requirements and respond to comments, 
FSIS is providing in the final rule that these validated cooking 
instructions may appear anywhere on the product label.
    FSIS proposed to use the January 1, 2016, uniform compliance date 
as the effective date of this final rule (79 FR 34597). However, 
according to the uniform compliance date final rule,\3\ if any food 
labeling regulation involves special circumstances that justify a 
compliance date other than the uniform compliance date, FSIS will 
determine an appropriate compliance date and will publish that 
compliance date in the rulemaking (79 FR 71008). Because of the 
potential public health benefits of this rule, the effective date of 
this rule will be May 17, 2016. Had the final rule published on 
December 31, 2014, the effective date would have been January 1, 2016, 
according to the uniform compliance date for food labeling regulations 
final rule. By establishing a compliance date of May 17, 2016 FSIS is 
providing establishments with the same 365-day compliance period that 
they would have had if the final rule had published on December 31, 
2014. Therefore, this rule will not be subject to the 2018 uniform 
compliance date for new meat and poultry product labeling regulations. 
In addition, FSIS will delay enforcing the labeling requirements for 
beef products with added solutions \4\ until the effective date of this 
final rule.
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    \3\ On December 1, 2014, FSIS issued a final rule that 
established January 1, 2018, as the uniform compliance date for new 
meat and poultry product labeling regulations that are issued 
between January 1, 2015 and December 31, 2016 (79 FR 71007).
    \4\ 79 FR 79044; Dec. 31, 2014.
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    Finally, after consideration of the difference between branded 
(sold in multiple stores) and private labels (sold in only stores with 
the label name), FSIS reevaluated the label design costs to industry. 
Based on this analysis, FSIS increased estimated costs associated with 
the final rule. Even so, FSIS predicts the final rule to have a 
positive net benefit. In Table 1 (below), FSIS estimates the 
quantifiable benefits, costs, and net benefits of the final rule.

            Table 1--Summary of Estimated Costs and Benefits
------------------------------------------------------------------------
 
------------------------------------------------------------------------
       Estimated Quantified Benefits, Costs, and Net Benefits \a\
------------------------------------------------------------------------
Benefits \b\.........................  $688,286.
                                       ($430,178 to $1,606,000).
Costs \c\............................  $476,932 to $784,053.
Net Benefits.........................  -$95,768 to $211,353.
                                       (-$357,163 to $3,022,369).
------------------------------------------------------------------------
                    Non-Quantified Benefits and Costs
------------------------------------------------------------------------
Benefits.............................   Avoided pain and
                                        suffering associated with
                                        prevented non-fatal foodborne
                                        illnesses.
                                        Increased producer
                                        surplus to producers who sell
                                        intact beef or other meats
                                        consumers may substitute for
                                        mechanically-tenderized beef.
                                        Cost savings accruing to
                                        food service establishments that
                                        will more readily obtain the
                                        information on whether beef
                                        product has been mechanically
                                        tenderized, which will better
                                        enable them to comply with State
                                        law.
Costs................................   Cost to validate cooking
                                        instructions.
                                        Loss in producer surplus
                                        to producers who sell
                                        mechanically tenderized beef.
                                        Loss in consumer surplus
                                        to consumers who start cooking
                                        their beef to a higher
                                        temperature, which they prefer
                                        less than cooking rare.
                                        Loss in consumer surplus
                                        to consumers who either spend
                                        more time cooking or wait longer
                                        to eat in food service settings.
                                        Loss in consumer surplus
                                        to consumers who might
                                        substitute other meats or other
                                        cuts of meat, which they prefer
                                        less.
                                        Time cost associated
                                        with revised cooking procedures
                                        and training on thoroughly
                                        cooking mechanically tenderized
                                        beef products in the food
                                        service industry.
------------------------------------------------------------------------
\a\ Annualized over 10 years at a 7 percent discount rate.
\b\ Assumes that on the low end, 15% of consumers and 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 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\ The upper and lower bound estimated costs fall to $407,946 and
  $670,643 when annualized with a 3 percent discount rate.
Source: FSIS Policy Analysis Staff.

Background

    As explained in the proposed rule, consumers consider product 
tenderness to be a key factor when purchasing meat products. Thus, the 
tenderness of a roast or steak is a key selling point for the meat 
industry (78 FR at 34591). Mechanically tenderized product is product 
that has been pierced with a set of needles or blades, which breaks up 
muscle fiber and tough connective tissue, resulting in increased 
tenderness. As was also explained in the proposed rule, such product 
may also be injected with a solution or marinade.
    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 
\5\ FSIS to issue a mandatory labeling provision for

[[Page 28155]]

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. In April 2014, CFP expressed their support of FSIS moving 
forward with final rulemaking at a meeting for the Conference of Food 
Protection.
---------------------------------------------------------------------------

    \5\ The incoming petition is available on FSIS's Web site at 
http://www.fsis.usda.gov/wps/wcm/connect/7da02e44-712f-4779-aa10-fb1760493261/Petition_CFP_071710.pdf?MOD=AJPERES.
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    Published research suggests that pathogens can be translocated from 
the surface of mechanically tenderized beef products to the interior of 
the products during processing because of the piercing of the beef by 
the needle or blade.\6\ The potential for this translocation of 
pathogens suggests that the interior of mechanically tenderized beef 
would have to be more fully cooked than a piece of intact beef with a 
similar amount of pathogens on the surface.\7\ Mechanically tenderized 
meat products are widely available to consumers in the marketplace (78 
FR at 34591).
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    \6\ Luchansky, JB, Phebus RK, Thippareddi H, Call JE 2008. 
Translocation of surface-inoculated Escherichia coli O157:H7 into 
beef subprimals following blade tenderization. J. Food Prot. 2008 
Nov.; 71(11): 2190-7.
    \7\ Sporing, Sarah B. 1999. Escherichia coli O157:H7 Risk 
Assessment for Production and Cooking of Blade Tenderized Beef 
Steak. Thesis. Kansas State University.
---------------------------------------------------------------------------

    Since 2000, the Centers for Disease Control and Prevention (CDC) 
has received reports of six outbreaks determined to be attributable to 
needle- or blade-tenderized beef products prepared in restaurants and 
consumers' homes. These outbreaks included a total of 176 Escherichia 
coli (E. coli) O157:H7 cases that resulted in 32 hospitalizations and 4 
cases of hemolytic uremic syndrome (HUS).\8\
---------------------------------------------------------------------------

    \8\ Compilation of USDA-FSIS Data, 2010.
---------------------------------------------------------------------------

    In addition, in 2012, 18 cases of food-borne illness caused by E. 
coli O157:H7 were reported as part of a Canadian outbreak. During the 
food safety investigation associated with the outbreak, it was 
determined that a few cases were likely associated with the consumption 
of mechanically tenderized beef which had been tenderized at the retail 
level.\9\ On May 21, 2014, the Canadian Food Inspection Agency 
announced that it was amending its regulations to mandate Canadian 
establishments that produce mechanically tenderized beef to label those 
products as ``mechanically tenderized'' and provide cooking 
instructions. The Canadian regulations were effective on August 21, 
2014, and are consistent with this final rule.
---------------------------------------------------------------------------

    \9\ Catford, A., Lavoie, M., Smith, B., Buenaventura, E., 
Couture, H., Fazil, A., and J.M. Farber.2013. ``Findings of the 
Health Risk Assessment of Escherichia coli O157 in Mechanically 
Tenderized Beef Products in Canada.'' Int. Food Risk Anal. J. 
3:2013.
---------------------------------------------------------------------------

Proposed Regulatory Requirements

    The Federal Meat Inspection Act (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.
    In proposed 9 CFR 317.2(e)(i), FSIS proposed new requirements for 
raw or partially cooked needle- or blade-tenderized beef products, 
including beef products injected with a marinade or solution. FSIS 
proposed that the product name for these beef products include the 
descriptive designation ``mechanically tenderized'' and an accurate 
description of the beef component.
    In proposed 9 CFR 317.2(e)(3)(ii), FSIS proposed that the print for 
all words in the product name be in the same style, color, and size and 
on a single-color contrasting background.
    In proposed 9 CFR 317.2(e)(3)(iii)), FSIS proposed that the 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. FSIS also proposed 
that the validated cooking instructions include the cooking method, 
inform consumers that these products need to be cooked to a specified 
minimum internal temperature, state whether the product needs to be 
held for a specified time at that temperature or higher before 
consumption to ensure destruction of potential pathogens throughout the 
product, and contain a statement that the internal temperature should 
be measured by a thermometer.
    FSIS explained in the proposed rule that should the rule be 
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)) (78 FR 34595).
    FSIS also announced in the proposal that it had posted on its Web 
site draft guidance on developing validated cooking instructions for 
mechanically tenderized product.

Final Rule

    FSIS is finalizing the proposed regulations with minor changes to 
provide additional clarification and flexibility. In response to 
comments, this final rule requires the descriptive designation 
``mechanically tenderized'' or ``needle tenderized'' be used on raw or 
partially cooked needle tenderized beef products and the descriptive 
designation ``mechanically tenderized'' or ``blade tenderized'' be used 
on raw or partially cooked blade tenderized beef products. By 
permitting the terms ``needle tenderized'' and ``blade tenderized'' to 
be used as the descriptive designation, FSIS is providing additional 
flexibility to establishments to use more specific terms regarding the 
method of mechanical tenderization as part of the product name.
    This final rule requires a descriptive designation as part of the 
product name, not as part of the common or usual name of the product. 
Thus, for a steak that has been tenderized, the common or usual name 
would be ``steak.'' It would not be ``mechanically tenderized steak.'' 
However, the descriptive designation needs to be in close proximity to 
the common or usual name. The descriptive designation may be above, 
below, or next to the rest of the product name (without intervening 
text or graphics) on the principal display panel. In response to 
comments on the proposed rule on mechanically tenderized beef products 
and on the proposed rule for raw meat and poultry

[[Page 28156]]

products containing added solutions (76 FR 44855), this final rule 
provides that the print for all words in the product name and 
descriptive designation on raw or partially cooked mechanically 
tenderized products must appear in a single easy-to-read type style and 
color and on a single-color contrasting background. In addition, the 
final rule allows additional flexibility by providing that the print 
may appear in upper and lower case letters, with the lower case letters 
not smaller than \1/3\ the size of the largest. These requirements are 
consistent with those in the final rule for raw meat and poultry 
products containing added solutions.\10\
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    \10\ Except that the applicability date for raw meat and 
products containing added solutions that prescribes that the 
descriptive designation appear with the lower case letters not 
smaller than \1/3\ the size of the largest letter will be delayed 
until January 1, 2018.
---------------------------------------------------------------------------

    In response to comments, the final rule also clarifies that 
validated cooking instructions may appear anywhere on the product label 
and that a descriptive designation will not be required for 
mechanically tenderized beef products destined for a full lethality 
treatment at an official establishment.
    FSIS has carefully considered the available information on 
mechanically tenderized beef and has concluded that, without specific 
labeling, consumers and industry may be purchasing and preparing raw or 
partially cooked mechanically tenderized beef products without knowing 
that these products have been needle- or blade-tenderized. Because 
illnesses could be reduced if the Agency required more specific 
labeling, the final rule requires the product name of raw or partially 
cooked, mechanically tenderized beef products include the name of the 
beef component and a descriptive designation that the product has been 
``mechanically tenderized,'' ``needle tenderized,'' or ``blade 
tenderized,'' unless the product is destined to be fully cooked or to 
receive another full lethality treatment in an official establishment. 
The descriptive designation will provide household consumers, official 
establishments, restaurants, and retail stores with the information 
they need to distinguish a cut of beef that is an intact, non-
tenderized product, from a non-intact, mechanically tenderized product.
    Based on the requirements in 9 CFR 317.2(c)(1), all of this 
information will need to appear on the principal display panel of the 
immediate container. FSIS is requiring that the descriptive designation 
be a part of the product name so that the statement is prominently 
placed on the label and with such conspicuousness as to render it 
likely to be read and understood by the ordinary individual under 
customary conditions of purchase and use (see 21 U.S.C. 601(n)(6)).
BILLING CODE 3410-DM-P

[[Page 28157]]

[GRAPHIC] [TIFF OMITTED] TR18MY15.006

BILLING CODE 3410-DM-C

    Note: Validated cooking instructions may appear anywhere on the 
label.

    The descriptive designation will 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. Moreover, most establishments already label cubed 
products as such.
    FSIS is requiring the terms ``mechanically tenderized,'' ``needle 
tenderized,'' or ``blade tenderized'' because they accurately and 
truthfully describe the nature of the product. These terms also clearly 
differentiate needle- or blade-tenderized beef products from non-
tenderized, intact beef products.
    As explained in the proposed rule, 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, must bear safe handling instructions as 
prescribed in 9 CFR 317.2(l). Although the safe handling instructions 
in the regulations include ``cook thoroughly,'' the regulations do not 
require that these instructions specify a dwell time or internal 
temperature parameters necessary to ensure that the product is fully 
cooked.
    The safe preparation of this product requires that consumers know 
to handle the mechanically tenderized product differently than product 
in which there

[[Page 28158]]

is potential for transfer of any exterior contamination into the 
interior of the beef product.
    Some consumers of beef products consider a product to be thoroughly 
cooked product even if it has been prepared to a degree of doneness 
that is not sufficient for safety.11 12 13 Moreover, because 
mechanically tenderized beef products have the same appearance as 
intact beef products, household consumers, hotels, restaurants, and 
similar institutions may incorrectly assume that products that in fact 
have been mechanically tenderized products can be prepared similarly to 
intact products (i.e., that it is okay to cook them to be ``rare'' or 
``medium-rare''). Thus, in addition to a descriptive designation that 
identifies that needle- or blade-tenderized beef products have been 
mechanically tenderized, under this final rule, FSIS is requiring 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 support claims that potential pathogens throughout the 
product would be destroyed.
---------------------------------------------------------------------------

    \11\ 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.
    \12\ 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.
    \13\ 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. ``Beef 
Customer Satisfaction: Cooking Method and Degree of Doneness Effects 
on the Top Round Steak''. J. Animal Science 77:653-660.
    .
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    FSIS is requiring that the validated cooking instructions include, 
at a minimum: (1) The method of cooking; (2) a validated minimum 
internal temperature that would destroy pathogens throughout the 
product; (3) a statement as to whether the product cooked in the manner 
described also needs to be held for a specified time at the specified 
temperature or higher before consumption; and (4) instruction that the 
internal temperature should be measured by use of a thermometer. The 
cooking instructions included on the label should be practical and 
easily followed by consumers. In response to comments discussed below, 
the final rule provides that validated cooking instructions may appear 
anywhere on the product label.
    Consistent with the regulation on Hazard Analysis and Critical 
Control Point (HACCP) validation (9 CFR 417.4), to validate the cooking 
instructions, the establishment will 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. Just as establishments have to 
validate their HACCP plans' adequacy in controlling food safety hazards 
identified during the hazard analysis, so too, under this final rule, 
establishments that produce raw or partially cooked mechanically 
tenderized beef products will have to validate their recommended 
cooking instructions. The scientific support would need to demonstrate 
that the cooking instructions provided can repeatedly achieve the 
desired minimum internal temperature and time at that temperature and 
would need to support that the product is fully cooked to destroy 
pathogens present in 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 Federal 
Register notice on HACCP Systems Validation (77 FR 27135; May 9, 
2012).\14\
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    \14\ Available at http://www.fsis.usda.gov/wps/wcm/connect/d000cb67-23bc-4303-8f7b-71dcba5e7cd7/2009-0019.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

    In response to comments, FSIS has revised its guidance for 
developing validated cooking instructions for mechanically tenderized 
products. The Agency has posted the revised guidance on its Significant 
Guidance Documents Web page. This guidance represents current FSIS 
thinking. Establishments could collect their own scientific data to 
support the cooking instruction, use a study from an outside source, or 
use the revised guidance provided by FSIS. An establishment could use 
the recommended cooking instructions from the revised guidance on its 
product labels, without having to conduct additional experiments or 
provide any further scientific support, if the products it is producing 
are similar to those in the guidance.
    If establishments are unable to use the specific examples in the 
revised guidance (e.g., because the product is a different thickness or 
is to be cooked using a method different from one previously studied), 
the revised guidance also contains instructions on how to develop such 
support.

Summary of and Response to Comments

    In the proposal, FSIS requested comment on specific issues: How it 
defined ``mechanically tenderized,'' whether the definition should be 
incorporated into the regulations, whether the term should include 
products that have been vacuum tumbled or formed, whether the term 
would be understood by consumers, on how the proposed labeling changes 
would impact restaurants and other food service operations, and on the 
cost estimates outlined in the proposal. FSIS received 122 comments in 
response to these and other issues in the proposed rule. A majority of 
the comments (approximately 75) were form letters submitted by 
individuals. The remaining comments were from individuals, consumer 
advocacy groups, organizations representing the meat industry, meat 
processors, retail trade associations, and an organization representing 
food and drug officials.
    FSIS did not receive any comments on whether it should require 
fully cooked needle- or blade-tenderized beef products to have the 
descriptive designation on their labels, on how food service workers 
will likely respond to the proposed labeling changes, on the number of 
cuts per establishment that would require validated cooking 
instructions, or on estimated costs for developing validated cooking 
instructions.
    FSIS has summarized and responded to the relevant issues raised by 
commenters below.

A. Broadly Opposed to the Proposal

    Comment: An individual stated that all of the proposed changes are 
unnecessary because the safe handling instructions required in 9 CFR 
317.2(l) clearly state that raw beef products, including those that are 
tenderized, must be cooked thoroughly before being consumed. As an 
alternative to the proposed labeling changes, several organizations 
representing the meat industry suggested that FSIS focus its resources 
on improving the safe-handling instructions.
    Response: FSIS disagrees that the changes are unnecessary. As FSIS 
stated in the preamble to the proposed rule, the literature suggests 
that many consumers are aware of the safe handling instruction labels 
(see 78 FR at 34592). However, the same literature also suggests that 
only a portion of consumers reported reading these instructions on raw 
meat product labels and changing their meat preparation

[[Page 28159]]

methods because of the labels.\15\ Furthermore, although the required 
safe-handling instructions include ``cook thoroughly'' in raw and 
partially cooked beef products, the regulations do not require that 
these instructions specify the dwell time or internal temperature 
parameters required to support that the product is fully cooked. In 
addition, despite the safe handling instructions to ``cook 
thoroughly,'' consumers, restaurants, and retail stores do not always 
cook these products fully by using a temperature-and-time combination 
sufficient to destroy harmful bacteria that may be in the product. They 
may incorrectly assume that it is safe to cook these products ``rare'' 
or ``medium-rare.'' CDC and other governmental investigators reported 
that failure to fully cook a mechanically tenderized raw or partially 
cooked beef product was likely a significant contributing factor in 
several of the outbreaks.16 17 18 In addition, consumer 
preference for steaks that are not thoroughly cooked \19\ along with 
the time span of the illness reports suggests undercooking was likely a 
significant contributing factor in the other investigations as opposed 
to post-cooking cross-contamination in which illnesses would be more 
likely to occur at the same time. FSIS has, therefore, determined that 
labeling to indicate that the beef product is mechanically tenderized, 
along with validated cooking instructions, is necessary to help inform 
consumers and industry of a key feature of the product and to instruct 
them that such products need to be thoroughly cooked.
---------------------------------------------------------------------------

    \15\ 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.)
    \16\ 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).
    \17\ 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. Presented at the 
International Conference on Emerging and Infectious Diseases. March 
19-22, 2006. Atlanta, GA.
    \18\ 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.
    \19\ Reicks, A.L., Brooks, J.C., Garmyn, A.J., Thompson, L.D., 
Lyford, C.L., Miller, M.F. 2011. ``Demographics and beef preferences 
affect consumer motivation for purchasing fresh beef steaks and 
roasts.'' Meat Science. 87: 403-411.
---------------------------------------------------------------------------

    In addition, in January, 2014, FSIS sought input from the National 
Advisory Committee on Meat and Poultry Inspection \20\ to fully explore 
whether there is a need for enhancing the safe food handling label on 
meat and poultry packages (78 FR 77643; Dec. 24, 2013). The Committee 
recommended that FSIS pursue changes to the existing safe handling 
instructions. FSIS has initiated a project to research how we might 
modify the current safe-handling instruction requirements to improve 
consumer food safety behaviors.
---------------------------------------------------------------------------

    \20\ For more information on the National Advisory Committee on 
Meat and Poultry Inspection, visit http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/advisory-committees/nacmpi.
---------------------------------------------------------------------------

    Comment: Several comments stated that the proposed labeling changes 
will be ineffective in influencing consumer behavior to reduce relative 
risk. Moreover, an organization representing meat and poultry 
processors and a trade association stated that the Agency failed to 
provide any data to support that the proposed labeling changes can or 
will positively impact public health; thus, creating an unnecessary 
burden on industry.
    Response: FSIS recognizes that not all consumers will change their 
behavior in response to the presence of the descriptive designation 
``mechanically tenderized,'' ``needle tenderized,'' or ``blade 
tenderized,'' and validated cooking instructions on the product label. 
However, FSIS disagrees that the labeling changes will not positively 
impact public health. Public health is characterized on a population 
level. As discussed below, on the basis of available studies on the 
impacts of food product labels on consumer behavior, FSIS used 24 
percent as the primary estimate for the impact of labels on consumer 
behavior. Therefore, FSIS estimates that 24 percent of consumers that 
previously cooked mechanically tenderized beef to a lower temperature 
will change their behavior and cook that product to the endpoint 
temperature that appears in the cooking instructions, which is 
equivalent to 210 illnesses averted or prevented per year, with a range 
of 131 to 489 (See Table 5).

B. Defining ``Mechanically Tenderized''

    Comment: An organization representing the meat industry and a 
retail trade association characterized the Agency's proposed use of the 
term ``mechanically tenderized'' as overly broad and inaccurate. Both 
commenters stated that adding solutions by needle injection does not 
``mechanically tenderize'' the product. A trade association requested 
that vacuum-tumbled products not be considered ``mechanically 
tenderized.''
    Consumer organizations requested that ``mechanically tenderized'' 
product include vacuum-tumbled, vacuum-marinated, marinade-injected, 
and enzyme-formed beef products. An individual and a meat processor 
requested that mechanically tenderized product include products that 
are vacuum-tumbled because they stated the potential health risk to 
consumers is similar to that for needle- or blade-tenderized beef 
products. One consumer advocacy group remarked that, although enzyme-
formed beef is now required to be labeled ``formed,'' the designation 
does not inform the consumer on how the meat should be prepared or on 
the higher risk of exposure to pathogens that these products present.
    Several meat processors and trade associations stated that use of 
the descriptive designation ``mechanically tenderized'' on the label 
will be misunderstood by consumers as a negative term and, therefore, 
may discourage customers from purchasing such beef products, resulting 
in a negative economic impact to small businesses. In addition, several 
organizations representing the meat industry requested that FSIS 
conduct targeted consumer research to determine whether the public 
perceives the descriptive designation ``mechanically tenderized'' as 
negative before finalizing the proposed changes.
    As alternatives to ``mechanically tenderized,'' commenters 
suggested ``tenderized and packaged,'' ``tenderized,'' ``marinated,'' 
``injection marinated,'' ``solution enhanced,'' ``cubed,'' and ``blade 
tenderized.''
    Response: After review and consideration of the alternative 
descriptive designations provided by commenters, FSIS is finalizing the 
proposed regulations with minor changes. FSIS has concluded the 
descriptive designations ``mechanically tenderized,'' ``needle 
tenderized,'' and ``blade tenderized'' accurately and truthfully 
describe the nature of the product. Additionally, these term clearly 
and completely identify the preparation process that the product 
underwent, as required by 9 CFR 317.2(e). FSIS has previously described 
mechanically tenderized beef products in a similar manner, notably in 
its Federal Register notice, HACCP Plan Reassessment for Mechanically 
Tenderized Beef Products (May 26, 2005; 70 FR 30331). Moreover, 
comments and other data do not support that the descriptive 
designations

[[Page 28160]]

``mechanically tenderized,'' ``needle tenderized,'' or ``blade 
tenderized'' would be misunderstood by consumers, restaurants, retail 
stores, and official establishments or that the other alternatives 
would be better understood by these parties. Furthermore, FSIS's 
definition of ``mechanically tenderized'' for raw and partially cooked 
beef products is consistent with that contained in the Canadian Food 
and Drug Regulations.\21\ To provide flexibility, FSIS is requiring the 
terms ``needle tenderized'' or ``mechanically tenderized'' be used as 
the descriptive designation for needle-tenderized beef products and the 
terms ``mechanically tenderized'' or ``blade tenderized'' be used as 
the descriptive designation for blade-tenderized beef products. The 
terms ``needle tenderized'' and ``blade tenderized'' merely provide 
more specific information on the mechanical methods used to tenderize 
the product. The terms ``needle tenderized'' and ``blade tenderized'' 
are not interchangeable. Only blade-tenderized product will be allowed 
to bear that descriptive designation, and only needle-tenderized 
product will be allowed to bear that descriptive designation. 
``Mechanically tenderized'' could be used on either needle- or blade-
tenderized product.
---------------------------------------------------------------------------

    \21\ Section B.01.001(1) of the Canadian Food and Drug 
Regulations defines ``mechanically tenderized beef'' as uncooked 
solid cut beef that is prepared in either of the following ways: (a) 
The integrity of the surface of the beef is compromised by being 
pierced by blades, needles or other similar instruments; or (b) the 
beef is injected with a marinade or other tenderizing solution (P.C. 
2014-478; May 1, 2014).
---------------------------------------------------------------------------

    Even though vacuum-tumbled or enzyme-formed beef products are 
processed in a manner that may introduce pathogens (if present) below 
the product's surface, this final rule will not apply to them. FSIS 
regulations (9 CFR 317.8(b)(39)) already require labeling for meat 
products that are formed or re-formed with an enzyme binder as part of 
the product name, e.g., ``Formed Beef Tenderloin.'' As such, formed 
beef products are already labeled in a manner that distinguishes them 
from other products. In addition, FSIS has concluded that there is not 
sufficient data to understand whether the risk that pathogens may be 
introduced into product as a result of vacuum tumbling or enzyme formed 
beef product is similar to that associated with needle- and blade-
tenderized beef.
    As stated in the preamble of the proposal, FSIS will conduct a 
public education campaign to explain the significance of the terms 
``mechanically tenderized,'' ``needle tenderized,'' and ``blade 
tenderized'' to consumers (78 FR at 34593). Thus, FSIS disagrees that 
additional consumer research is needed before moving forward with a 
final rule.

C. How the New Information Appears on the Label

    Comment: Several consumer advocacy groups requested that the 
descriptive designation appear on the label in distinguishing typeface. 
Other consumer advocacy groups suggested that the descriptive 
designation be added to the package as a brightly-colored sticker, 
separate from the existing label, placed on the front of the packaging. 
Several meat processors and organizations representing the meat 
industry requested that the descriptive designation be permitted to 
appear on the label in a smaller font size than that of the product 
name. A trade association opposed the addition of the descriptive 
designation to the product name because it has found that consumers pay 
the least attention to tenderization information when it is included in 
the product's name. Noting that other FSIS labeling requirements to 
enhance food safety (for example, the safe handling instructions) 
effectively convey useful information that is not part of the product 
name, a meat processor and several trade associations requested that, 
rather than in the product name, the descriptive designation be 
permitted to appear elsewhere on the label.
    Response: To make the descriptive designation readily apparent on 
the label but provide flexibility and address the comments discussed 
above, FSIS is requiring that the print for all words in the product 
name and descriptive designation appear in a single easy-to-read type 
style and color and on a single-color contrasting background. In 
addition, the print may appear in upper and lower case letters, with 
the lower case letters not smaller than \1/3\ the size of the largest 
letter.
    Establishments or retail stores will be permitted to add the 
required information to existing label designs, or they can apply a 
separate sticker with the required information to existing labels. 
Regardless, the product name must contain the term ``mechanically 
tenderized,'' ``needle tenderized,'' or ``blade tenderized'' as an 
accurate description of the beef component of the product.
    The labels of raw and partially cooked mechanically tenderized beef 
products as required in this final rule will be considered to be 
generically approved. The labels will not have to be submitted to FSIS 
for approval prior to their use, provided that they meet the 
requirements in this rule, display all mandatory features in a 
prominent manner in compliance with part 317, and are not otherwise 
false or misleading in any particular manner (9 CFR 412.2).
    Comment: A retail trade association requested that FSIS provide 
options for the descriptive designation for those labels that are under 
a certain size (e.g., if a label has less than or equal to six (6) 
square inches of available printing).
    Response: FSIS is not aware of any raw or partially cooked 
mechanically tenderized beef product marketed in a package too small 
(i.e., with less than six square inches of available labeling space) to 
accommodate the requirements of this final rule.

D. Mandatory Labeling for Restaurants

    Comment: So that restaurant patrons can make informed decisions as 
to how their beef product should be prepared, several individuals 
requested that restaurants be required to disclose on their menus when 
products are made from mechanically tenderized beef. A trade 
association recommended that FSIS align any proposed labeling 
requirements for restaurants with the Food and Drug Administration 
(FDA). A consumer advocacy group urged FSIS, in partnership with retail 
or restaurant associations, to develop an ``information system'' 
targeted at those preparing mechanically tenderized beef products 
served at restaurants.
    Response: FSIS expects that, by requiring the use of the 
descriptive designation ``mechanically tenderized,'' ``needle 
tenderized,'' or ``blade tenderized,'' and validated cooking 
instructions, food service personnel will be able to identify 
mechanically tenderized beef as such and to safely prepare the product 
using the cooking instructions provided on the label.
    Food service personnel should contact their local or State health 
department for information on the rules and regulations governing the 
preparation of food in restaurant, retail, or institutional settings.
    FSIS plans to share issues raised in comments received on 
restaurant menu labeling in response to the proposed rule with FDA.

E. Estimated Costs and Benefits of the Proposed Rule

    Comment: An industry trade association stated that FSIS failed to 
assign a dollar value to many of the purported benefits and costs 
discussed in the proposed rule.
    Response: FSIS made every effort to quantify all known costs and 
benefits of the proposed rule. However, because of the uncertainty in 
determining producer

[[Page 28161]]

and consumer response to the proposed rule, FSIS acknowledges that it 
was unable to monetize some potential costs and benefits. FSIS did not 
forecast, nor did it receive data to quantify, in the final rule the 
loss to producers that sell mechanically tenderized beef products, the 
loss to consumers when cooking the products to a higher temperature, 
the loss to consumers who may substitute products that they may like 
less than mechanically tenderized products because of cooking the 
mechanically tenderized beef product to a higher temperature, or the 
loss to food service providers that change their processes.
    Comment: Several meat processors and organizations representing the 
meat industry stated that FSIS underestimated the costs to industry to 
comply with the proposed labeling requirements.
    Response: FSIS based the proposal's mid-point label design 
modification costs estimate ($310 per label) on the most detailed study 
available on the costs associated with the labeling of consumer 
products, the March 2011 FDA report.\22\ However, after consideration 
of the differences between branded and private labels, FSIS updated the 
cost estimates after determining that 60 percent of the private label 
modifications would be uncoordinated changes. The cost for a minor 
uncoordinated label is $4,380 per label (with a range of $2,417 and 
$7,330), an increase from $310 per label in the proposal estimate. Even 
with the increased estimate, FSIS predicts the final rule to have a 
positive net benefit (see Table 5).
---------------------------------------------------------------------------

    \22\ Model to Estimate Costs of Using Labeling as a Risk 
Reduction Strategy for Consumer Products Regulated by the Food and 
Drug Administration, FDA, March 2011 (Contract No. GS-10F-0097L, 
Task Order 5).
---------------------------------------------------------------------------

    In addition, the effective date allows establishments time to use 
existing labels and will, therefore, result in minimal loss of 
inventory of labels.

F. High Pressure Processing

    Comment: An individual requested that mechanically tenderized beef 
subjected to High Pressure Processing (HPP) be exempted from the 
mandatory labeling requirements outlined in the proposal.
    Response: Any mechanically tenderized beef product treated at an 
official establishment with an intervention or process, including HPP, 
that has been validated to achieve at least a 5-log reduction for 
Salmonella and Shiga Toxin-producing E. coli (STEC) organisms 
(including E. coli 0157:H7) would not be subject to the requirements in 
this final rule because it has received a full lethality treatment.
    In response to this comment, FSIS has modified the proposed 
codified language (9 CFR 317.2(e)(3)(i)) to clarify that a descriptive 
designation will not be required on mechanically tenderized beef 
products destined to receive a full lethality treatment at an official 
establishment.

G. Validated Cooking Instructions/Associated Guidance

    Comments: According to commenters, consumers may serve the cooked, 
mechanically tenderized products without the benefit of a stand time, 
thereby becoming vulnerable to foodborne illness. Therefore, several 
comments urged FSIS to require cooking instructions with an endpoint 
temperature of 160 degrees Fahrenheit. Many comments requested that the 
method of cooking not appear within the cooking instructions, to 
prevent confusion among consumers. Likewise, rather than requiring the 
four elements proposed, several organizations representing the meat 
industry and a retail trade association stated that the validated 
cooking instructions should be required to include only two elements--
an internal temperature at which pathogens can effectively be destroyed 
and the recommended use of a meat thermometer to verify this 
temperature.
    Response: FSIS disagrees that the inclusion of the method of 
cooking within the cooking instructions will confuse consumers. Based 
on the Agency's experience addressing questions from consumers and 
based on consumer information from outbreak investigations, FSIS has 
concluded that the most explicit way to inform consumers as to how to 
prepare a product that is safe for consumption is to include the 
cooking method by which the endpoint temperature is achieved within the 
cooking instructions. Consistent with HACCP requirements, FSIS is 
providing establishments the flexibility to design cooking 
instructions. However, in response to comments from consumer groups, 
FSIS revised its compliance guidance to include a recommendation that 
if establishments use one of the temperature and time combinations from 
the FSIS Guidance on Safe Cooking of Non-Intact Meat Chops, Roasts, and 
Steaks \23\ with a temperature less than 145 degrees Fahrenheit and a 
rest time longer than three minutes (for example, 144 degrees 
Fahrenheit for four minutes, 143 degrees Fahrenheit for five minutes), 
then they should consider whether it is practical for consumers to 
achieve the longer rest time.
---------------------------------------------------------------------------

    \23\ Available at http://www.fsis.usda.gov/wps/wcm/connect/6d2ee97-3fd1-4186-b1e7-656e7a57beb2/time-temperature-table-042009.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

    The first draft of the compliance guideline for validating cooking 
instructions recommended establishments consider, among other factors, 
the state of the product at the start of cooking (e.g., frozen vs. 
refrigerated vs. room temperature), product thickness, type of cut, 
rotation of product, method of cooking to include a cold spot 
determination, and number and location of temperature measurement sites 
during cooking to ensure the cooking instructions consistently achieve 
the desired endpoint temperature. However, new research demonstrates 
the importance of turning steaks multiple times during cooking to 
ensure consumers consistently achieve the desired endpoint temperature 
throughout the steak.\24\ Accordingly, FSIS has revised its guidance to 
recommend that establishments design cooking instructions for steaks to 
include turning the product at least twice.
---------------------------------------------------------------------------

    \24\ Gill, C.O., Yang, X., Uttaro, B., Badoni, M. and Liu, T. 
2013. ``Effects on survival of Escherichia coli O157:H7 in non-
intact steaks of the frequency of turning over steaks during 
grilling.'' Journal of Food Research. 2(5): 77-89.
---------------------------------------------------------------------------

    Comment: Several commenters indicated that steaks are more commonly 
merchandised by weight in ounces, rather than by thickness.
    Response: FSIS has revised its compliance guidance for validated 
cooking instructions to recommend that if an establishment packages 
products by portion size (e.g., 10, 12, or 14 ounces), it should 
determine the variability in thickness of products packaged at that 
portion size and conduct the validation study using a product that 
represents the thickest product. The guidance now states that products 
from at least three lots should be measured to determine the worst case 
scenario.
    Comment: Several consumer groups requested that FSIS recommend 
(within the guidance document) that the statement ``fully thaw before 
cooking'' appear on product labels. The commenters cited research that 
showed that frozen or partially thawed patties took longer to cook to 
the desired internal temperature of 160 degrees Fahrenheit than fully 
thawed patties.
    Response: FSIS agrees that research has found that patties cooked 
from the frozen state take longer to achieve the target endpoint 
temperature than those

[[Page 28162]]

that have been thawed.\25\ Moreover, research with patties has shown 
that temperatures tend to be more consistent across patties that are 
cooked from the thawed rather than the frozen state.\26\ Thus, FSIS has 
revised its guidance to include a recommendation that the instructional 
statement ``fully thaw before cooking'' appear on the labels of 
mechanically tenderized beef products.
---------------------------------------------------------------------------

    \25\ Luchansky, J.B., Porto-Fett, A.C.S., Shoyer, B.A., 
Phillips, J., Chen, V., Eblen, D.R., Cook, V., Mohr, T.B., Esteban, 
E. and Bauer, N. 2013. ``Fate of Shiga Toxin-producing O157:H7 and 
non-O157:H7 Escherichia coli cells within refrigerated, frozen, or 
frozen then thawed ground beef patties cooked on a commercial open-
flame gas or a clamshell electric grill.'' Journal of Food 
Protection. 76(9): 1500-1512.
    \26\ Berry, B.W. 2000. ``Use of infrared thermography to assess 
temperature variability in beef patties cooked from the frozen and 
thawed states.'' Foodservice Research International. 12(4): 255-262.
---------------------------------------------------------------------------

    Comment: An organization representing the meat industry argued that 
there is not enough space on most mechanically tenderized beef product 
labels for the level of detail proposed for cooking instructions.
    Response: As stated above, FSIS is not aware of any raw or 
partially cooked mechanically tenderized beef product marketed in a 
package too small to accommodate the requirements of this final rule, 
including those for validated cooking instructions. Based on this 
concern, FSIS has clarified in the final rule that validated cooking 
instructions may appear anywhere on the product label.

H. Risk of Illness Related to Mechanical Tenderization

    Comment: Several meat processors and organizations representing the 
meat industry stated that the proposed changes are unnecessary and will 
not function to promote public health because the risk of illness 
associated with mechanical tenderization is ``very low,'' and 
``generally equivalent'' to that associated with intact cuts of beef. 
To support these claims, several comments referenced the Agency's 2002 
risk assessment, preliminary information provided by FSIS concerning 
its 2010 work, and the 2013 Canadian risk assessment. Many comments 
requested that FSIS conduct (and make available to the public) a 
comparative risk assessment for intact and non-intact beef using 
current data before finalizing the rule.
    Response: The proposed and final benefit analysis used the recently 
published study by the Centers for Disease Control and Prevention that 
attributed foodborne illnesses by pathogens to general types of 
foods.\27\ This study, along with reports of outbreaks attributable to 
mechanically tenderized products, allowed FSIS to base its estimate 
predicting 1,965 illnesses from mechanically tenderized products on 
analysis of recently observed illness data.
---------------------------------------------------------------------------

    \27\ 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.
---------------------------------------------------------------------------

    The FSIS attribution analysis is based on the latest published 
estimates of illness from the Centers for Disease Control and 
Prevention and for this pathogen product pair allows an estimate of the 
current risk of illness. No updates to this dataset became available 
between the proposed and final rule, and therefore, no corresponding 
changes to the attribution analysis were necessary. The details of this 
analysis are included in this final rule.
    Comment: Several meat processors and organizations representing the 
meat industry stated that additional labeling is unnecessary because 
present day intervention strategies, like applying interventions 
directly before tenderization and following best manufacturing 
practices, have effectively lowered the risk associated with 
mechanically tenderized beef products since the outbreaks cited in the 
proposal.
    Response: In the 11-year study cited in the proposed rule, 
outbreaks of E. coli O157:H7 accounted for 4,844 illnesses.\28\ The 
Centers for Disease Control and Prevention estimate 63,153 illnesses 
from E. coli O157:H7 occur annually. Over an 11-year period this 
amounts to nearly 700,000 illnesses. Reported outbreaks account for 
less than 1 percent of these. Thus, the absence of outbreaks in the 
time after the period studied by Painter, et al., which captured 
outbreaks through 2008, would not be sufficient to conclude that 
mechanically tenderized beef has ceased to pose a risk. Since 2008, an 
additional 2009 outbreak has been attributed to blade-tenderized 
steaks, which resulted in 10 hospitalizations and one death. 
Additionally, the 2013 Canadian risk assessment, cited by some 
commenters, reports a Canadian outbreak attributed to mechanically 
tenderized beef occurring in 2012. Therefore, data continue to support 
the need for the rule.
---------------------------------------------------------------------------

    \28\ 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.
---------------------------------------------------------------------------

    Comment: An organization representing the meat industry and a meat 
processor opposed the Agency's approach of combining mechanically 
tenderized product not containing added solutions with mechanically 
tenderized product injected with a marinade or solution, because, in 
their assessment, mechanically tenderized products injected with a 
solution pose a clearly different risk profile.
    Response: Production of both mechanically tenderized product not 
containing added solutions and mechanically tenderized product injected 
with a marinade or solution involve piercing the surface of the 
product, which allows translocation of bacteria that may reside on the 
surface into the interior of the product. The 2013 Canadian risk 
assessment noted above includes both types of products in its analysis 
but does not distinguish between the two types in its reported results 
in which it concludes that the risk of illness from mechanically 
tenderized products is higher than for non-tenderized products. 
Therefore, FSIS concludes that its approach is consistent with 
available data.

I. Mandatory Labeling for Other Species

    Comment: Several comments requested that FSIS require similar 
mandatory labeling for mechanically tenderized pork and poultry 
products.
    Response: FSIS considered the option to amend the labeling 
regulations to include a new requirement for labeling all mechanically 
tenderized meat and poultry products. However, FSIS has concluded that 
there is not sufficient data on the production practices and risks of 
consuming mechanically tenderized poultry products or mechanically 
tenderized meat products, other than beef, to proceed with this option. 
For example, there have been no known outbreaks for mechanically 
tenderized poultry or non-beef products.

Implementation Issues

    The final new descriptive designation requirement will 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 final requirements for validated cooking instructions will 
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 will be responsible for applying the validated 
cooking instructions to the

[[Page 28163]]

product label. If retail stores repackage the product, they will be 
required to include the descriptive designation and validated cooking 
instructions from the official establishment on the retail label.
    Under the final rule, establishments or retail stores may add the 
required information to existing label designs, or they can apply a 
separate sticker with the required information to existing labels. 
Under the provisions for generic approval in 9 CFR 412.2(a)(1), the 
modifications made to the labels for needle- or blade-tenderized beef 
products from official establishments are generically approved.
    To inform consumers that the nature of needle- or blade-tenderized 
beef is not the same as that of an intact cut of beef, to make them 
aware that the consequences of the tenderization process may include 
the intake of bacteria, and to assure consumers that these products can 
be prepared safely, FSIS plans to conduct consumer education and 
awareness efforts as part of its implementation strategy. The Agency 
will develop webinars and PowerPoint presentations for industry to 
assist establishments and retail facilities in complying with the new 
labeling requirements. FSIS staff will also be available to answer 
questions pertaining to the labeling of mechanically tenderized beef 
products.
    When the rule becomes effective, FSIS inspection program personnel 
will verify that establishments meet the labeling requirements in this 
rule. FSIS inspection program personnel review labels and compare them 
to actual product formulations to verify that, when applicable, the 
processes used in the production of the product are listed accurately 
on the label; that the label is not misleading; and that the label is 
otherwise in compliance with all labeling requirements. If the label 
does not meet the labeling requirements in this rule, the product will 
be misbranded (under 21 U.S.C. 601(n)(1), 601(n)(2), 601(n)(6) or 
601(n)(12)). FSIS will inform the establishment that it needs to make 
corrections to its label. In limited circumstances, if the label is 
particularly problematic (e.g., the label presents potential health, 
safety, or dietary problems for the consumer), FSIS would rescind the 
label's approval under 9 CFR 500.8.

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 submission to FSIS and 
FSIS review prior to using the label. Rather, FSIS would generically 
approve the labels with the statement based on the provisions for 
generic approval in 9 CFR 412.2(a)(1).

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 final rule has been designated a ``significant 
regulatory action,'' though not economically significant, under section 
3(f) of Executive Order 12866. Accordingly, the rule has been reviewed 
by the Office of Management and Budget.
    FSIS updated the Preliminary Regulatory Impact Analysis to take 
into account recently updated source data and modified timelines for 
implementation of the final rule. The changes to the costs and benefits 
sections incorporate the following factors:

     Information Resources, Inc., (IRI) scanner data was 
used to calculate the number of raw meat and poultry products in the 
retail market and the number of private and branded products. IRI 
gathers data by scanners in supermarkets, drugstores, and mass 
merchandisers and maintains a panel of consumer households that 
record purchases at outlets by scanning UPC codes on the products 
purchased.
     FSIS used the more up-to-date model from the secondary 
cost analysis in the proposed rule to estimate the cost of label 
changes for the industry. The label design costs were determined 
utilizing a March, 2011, FDA report that provides a model for 
determining label design costs.
     Also, FSIS adjusted the percentage of coordinated and 
uncoordinated label changes which resulted in greater proportion of 
labels incurring additional costs.

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),\29\ estimates that there are 555 official 
establishments that produce blade-, needle-, and both blade- and 
needle- tenderized beef products.\30\ 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.\31\ 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 were 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.\32\
---------------------------------------------------------------------------

    \29\ 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.
    \30\ The February 2012 report estimates that 490 establishments 
produce products that are both mechanically tenderized and 
containing added solutions.
    \31\ 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.
    \32\ 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 did not estimate 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.\33\ However, in 
the Agency's estimation, very few retail facilities are producing 
mechanically tenderized beef. FSIS requested comments on the number of 
retailers who would be involved with repackaging raw or partially 
cooked mechanically tenderized beef products, but received none.
---------------------------------------------------------------------------

    \33\ FSIS believes that the number of retailers involved in 
repackaging mechanically tenderized beef is small and declining, 
with large retailers and warehouse clubs moving toward ordering 
case-ready packaged beef products.
---------------------------------------------------------------------------

    The new descriptive designation requirement will apply to all raw 
or partially cooked needle- or blade-tenderized beef products going to 
retail stores, restaurants, hotels, or similar

[[Page 28164]]

institutions, or other official establishments for further processing, 
unless such product is destined to be fully cooked or receive another 
full lethality treatment at an official establishment. The requirements 
for validated cooking instructions will apply to raw or partially 
cooked mechanically tenderized products destined for household 
consumers, hotels, restaurants, or similar institutions. If a second 
establishment repackages the product for household consumers, hotels, 
restaurants, or similar institutions, the second establishment will 
also be responsible for applying the validated cooking instructions to 
the product label. If retail stores repackage the product, they will 
have to include the descriptive designation and validated cooking 
instructions from the official establishment on the retail label.

Expected Cost of the Final Rule

    This final rule requires all official establishments that produce 
raw or partially cooked mechanically tenderized beef products to modify 
their product labels to include the term ``mechanically tenderized,'' 
``needle tenderized,'' or ``blade tenderized'' as part of the products' 
descriptive name and to add validated cooking instructions to the 
labels of all raw or 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.

Cost Analysis

    IRI scanner data indicate that there are 4,148 \34\ raw beef labels 
in retail, approximately 11.55 percent (or 479) of which are private 
label, with the remainder (3,669) branded. Although IRI's geographic 
coverage--which includes the largest urban areas in the U.S. and a few 
whole states--may yield a reasonable estimate of the universe of 
branded retail labels, a substantial number of chains that are large 
enough to have their own private labels but that only serve small or 
medium-sized cities may be missed. For this reason, the IRI results 
will be used as a lower bound on the number of retail labels affected 
by this rule. To estimate an upper bound, we make use of the estimates 
in FSIS's 2012 expert elicitation (see Table 2, below) to calculate 
that 46 percent (22%/[16% + 22% + 10%]) of retail labels may be private 
label. In this case, there are an estimated 3,152 private retail labels 
and 6,821 (3,669 + 3,152) total retail labels. Next, these estimates 
must be adjusted upward to account for food service labels (because the 
IRI scanner data do not capture food service labels); based on the 
contents of Table 2, about 52 percent of all mechanically tenderized 
beef products are for food service. From this, FSIS estimates about 52 
percent of beef labels are for food service and the remaining 48 
percent of labels are for retail, yielding estimates of 8,616 (4,148/
48.14%) to 14,169 (6,821/48.14%) raw beef product labels in the 
marketplace.
---------------------------------------------------------------------------

    \34\ IRI scanner data was used to calculate the number of raw 
meat products in the retail market. IRI gathers data by scanners in 
supermarkets, drugstores, and mass merchandisers and maintains a 
panel of consumer households that record purchases at outlets by 
scanning UPC codes on the products purchased.

   Table 2--Percent of Mechanically Tenderized Only and Mechanically Tenderized and Enhanced Beef Products by
                                           Packaging and Labeling Type
----------------------------------------------------------------------------------------------------------------
                                                                Share of        Mechanically      Share of all
                                            Mechanically      mechanically     tenderized and     mechanically
       Packaging or labeling type          tenderized only   tenderized only      enhanced         tenderized
                                              (pounds)          (percent)         (pounds)          (percent)
----------------------------------------------------------------------------------------------------------------
Brand Name Label for Retail Sales.......               318                10               829                16
Private Label for Retail Sales..........               640                21               934                22
Foodservice.............................             1,594                53             2,075                52
Retail..................................               479                16               206                10
----------------------------------------------------------------------------------------------------------------
Source: Expert Elicitation on the Market Shares for Raw Meat and Poultry Products Containing Added Solutions and
  Mechanically Tenderized Raw Meat and Poultry Products. Final Report. Tables 3-14 and 3-16. Available at: http://www.fsis.usda.gov/wps/wcm/connect/3a97f0b5-b523-4225-8387-c56a1eeee189/Market_Shares_MTB_0212.pdf?MOD=AJPERES.

    Using the 10.5-percent estimate for the share of beef products that 
are mechanically tenderized but do not contain added solutions,\35\ and 
the 8,616 to 14,169 estimated range for number of beef labels (with 
brand and private allocations as shown in the previous paragraph), the 
estimated number of labels for mechanically tenderized beef products 
without added solutions is 905 (800 brand and 104 private) to 1,488 
(1,316 branded and 172 private), as shown in Table 3.
---------------------------------------------------------------------------

    \35\ 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, Table 3-6. In this report, products containing 
added solution are referred to as ``enhanced.''
---------------------------------------------------------------------------

    There are an additional 15.8 percent (or 1,338 to 2,199) of all 
beef products that are mechanically tenderized and also contain added 
solutions. The cost of label changes for these products is included in 
another FSIS final rule, finalized in December of 2014, which requires 
label changes for products with added solutions. These costs were 
overestimated by using a 12 month compliance period, although changes 
are required in some cases by January 1, 2016, and in other cases by 
January 1, 2018. For the products required by the added solutions rule 
to have label changes by January 1, 2016, if such label changes have 
not already been completed, this rule will delay by a few months the 
imposition of labeling change costs. For products required by the added 
solutions rule to have label changes by January 1, 2018, this rule's 
requirements related to mechanical tenderization would generate non-
negligible costs because the shortening of the compliance period (from 
36 months as required by the added solutions rule alone to 12 months as 
required by this rule). However, the added solutions rule's estimates 
captured the difference in cost from the 12 and 36 month compliance 
periods by overestimating the cost of labeling changes for these 
products under a 12 month compliance period.\36\
---------------------------------------------------------------------------

    \36\ If any label changes for mechanically tenderized beef 
products with added solutions have already been completed in 
response to the added solutions rule, a second label revision is 
required to achieve compliance with this rule. The cost of a second 
label revision for mechanically tenderized beef products with added 
solutions was not captured in the added solutions rule.

[[Page 28165]]



           Table 3--Relabeling Cost for Beef Only Mechanically Tenderized, 12-Month Compliance Period
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
                                   Branded
                                   Private
                                         Cost
                             -----------------------------------------------------------------------------------
         Lower bound                 800
                                     104         Lower     Mid         Upper
----------------------------------------------------------------------------------------------------------------
Coor Chg....................       88      11%        5       5%         $15,857         $28,916         $41,042
Uncoor Chg..................      712      89%       99      95%       1,961,931       3,555,341       5,949,920
----------------------------------------------------------------------------------------------------------------
    Total Lower Bound Cost......................................       1,977,789       3,584,257       5,990,962
    Annualized Cost (3% DR, 10 Year)............................         225,104         407,946         681,868
    Annualized Cost (7% DR, 10 Year)............................         263,171         476,932         797,176
----------------------------------------------------------------------------------------------------------------
                                   Branded
                                   Private
                                         Cost
                             -----------------------------------------------------------------------------------
         Upper bound                1,316
                                     172         Lower     Mid         Upper
----------------------------------------------------------------------------------------------------------------
Coor Chg....................      145      11%        9       5%         $26,069         $47,538         $67,473
Uncoor Chg..................    1,171      89%      163      95%       3,225,318       5,844,804       9,781,374
----------------------------------------------------------------------------------------------------------------
    Total Upper Bound Cost......................................       3,251,387       5,892,342       9,848,847
    Annualized Cost (3% DR, 10 Year)............................         370,060         670,643       1,120,957
    Annualized Cost (7% DR, 10 Year)............................         432,640         784,053       1,310,518
----------------------------------------------------------------------------------------------------------------
    Minor Coordinated...........................................             170             310             440
    Minor Uncoordinated.........................................           2,417           4,380           7,330
----------------------------------------------------------------------------------------------------------------

    This final rule will require the product name to include the 
descriptive designation ``mechanically tenderized,'' ``needle 
tenderized,'' or ``blade tenderized.''
    The number of labels was not tracked by the FSIS Labeling 
Submission and Approval System,\37\ which replaced the Agency's earlier 
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 thinks that the amount of these products is small and 
therefore has not included them in the cost calculations.
---------------------------------------------------------------------------

    \37\ Labeling Submission and Approval System (LSAS) replaced the 
Labeling Information System Database. LSAS, an electronic system 
designed to expedite many aspects of the prior label approval system 
by offering electronic submission and status checks for labels and 
Generic Label Adviser to assist establishments in determining 
whether labels can be approved generically or require sketch 
approval.
---------------------------------------------------------------------------

    This cost analysis uses the mid-point label design modification 
costs for a minor coordinated label change and a minor uncoordinated 
label change, as provided in a March 2011 FDA report.\38\ 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 will be required by this final rule is a minor change 
because the words ``mechanically tenderized,'' ``needle tenderized,'' 
or ``blade 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).
---------------------------------------------------------------------------

    \38\ 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).
---------------------------------------------------------------------------

    For comparison purposes, in 2011, the Food and Drug Administration 
estimated that the required labeling costs for its final rule \39\ 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.
---------------------------------------------------------------------------

    \39\ Labeling for Bronchodilators To Treat Asthma; Cold, Cough, 
Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-
the-Counter Human Use (76 FR 44475; Jul. 26, 2011); available at 
http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/pdf/2011-18347.pdf.
---------------------------------------------------------------------------

    FSIS anticipates that 11 percent of branded label (a label bearing 
the ``brand'' or name of the manufacturer of the product) changes will 
be coordinated. Five percent of the private label (a label branded by a 
contract manufacturer for a retailer under the name of the retailer 
rather than that of the manufacturer) changes will be coordinated and 
that 95 percent of the private label changes will be uncoordinated with 
the required changes.\40\ A coordinated label change is one that occurs 
when a regulatory label change takes place along with other labeling 
changes planned by the firm. Moreover, this allows time to use existing 
labels and results in minimal losses of inventories of labels. An 
uncoordinated label change occurs when establishments make non-
regulatory labeling changes because of an ingredient change or product 
reformulation; promotional text or graphics purposes; brand images or 
graphics update, science update, package changes (because of changes in 
the size, type or vendor); corporate contact, distributor, or country 
of origin update; and product claims addition or deletion. These 
labeling changes may be minor, major or extensive, and they may also 
apply to changing or adding a package insert. Uncoordinated label 
changes costs include (not necessarily in this order) administrative 
activities,

[[Page 28166]]

recordkeeping activities, analytical testing, graphic design 
alteration, market testing, prepress activities, engraving new plates, 
and printing and manufacturing labels.
---------------------------------------------------------------------------

    \40\ According to the 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), Table 3-1, Assumed Percentages of Changes to 
Branded and Private-label UPCs that Cannot be Coordinated with a 
Planned Changed, for private labels for food that has a compliance 
period of 30 months, it is assumed that 60% of the changes are not 
coordinated. Thus, 40% of the changes are coordinated. Private 
labels are not frequently changed. As such, the cost is much higher 
than for branded labels.
---------------------------------------------------------------------------

    The mid-point label design modification costs for a minor 
coordinated label change is an estimated $310 per label (with a range 
of $170 to $440) and $4,380 per label (with a range of $2,417 and 
$7,330) for a minor uncoordinated change. Using these costs for the 
number of minor coordinated and uncoordinated changes in branded and 
private labels, Table 3, FSIS estimates that the one-time total cost of 
modifying labels for all federally inspected processors is $3,584,257 
to $5,892,342 as an upper and lower bound mid-point estimate. Over a 
ten-year period, the upper and lower bound annualized cost for the 
industry is $407,946 and $670,643 at a 3-percent discount rate over ten 
years and $476,932 and $784,053 at a 7-percent discount rate over ten 
years.
    This final rule will require validated cooking instructions on the 
labels of packages for beef that is only mechanically tenderized and 
beef that is both mechanically tenderized and contains added solutions. 
Establishments may also incur costs to validate the required cooking 
instructions for raw and partially cooked needle- or blade-tenderized 
beef products. These costs may 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 will be contracted out to universities or 
conducted by trade associations or large establishments. FSIS estimates 
that a validation study will 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 will 
be between $10,000 -$20,000.\41\ However, industry cost will likely be 
relatively small because FSIS is issuing guidance along with this final 
rule that establishments can use to develop cooking instructions. For 
purposes of this analysis, FSIS assumes that the costs of developing 
validated cooking instructions will be minimal because FSIS assumes 
that most establishments will follow FSIS's guidance. FSIS requested 
data on the costs of developing validated cooking instructions; 
however, none were received.
---------------------------------------------------------------------------

    \41\ Per telephone conversation with the Grocery Manufacturers 
Association Director of Science Operations, Food Protection.
---------------------------------------------------------------------------

    Various types of time costs are associated with this rule. For 
example, there may be costs due to changes in cooking procedures, as 
kitchen staff may prepare products differently once the product is 
labeled to indicate that it has been mechanically tenderized and once 
the labeling includes validated cooking instructions (e.g., staff may 
place a product in foil and keep it in a warm oven until it reaches the 
rest time established in the validated cooking instructions). The 
changes could potentially lead to training costs for kitchen staff to 
properly prepare mechanically tenderized beef products.
    There may be additional wait time for consumers in both food 
service settings and at home before eating their meals due to increased 
cooking or holding product. In the absence of data with which to 
reliably estimate the time cost associated with this rule, we have not 
attempted to quantify this cost.

FSIS Budgetary Impact of the Final Rule

    This final 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 expenditure 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 FSIS Web site in fewer 
than six staff-hours.

Expected Benefits and Miscellaneous Impacts of the Final Rule

    The Agency has determined that the final new labeling requirements 
will improve public awareness of product identities. The final 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, tenderness is a key factor in deciding to 
purchase a beef product. Yet it is not often easy to distinguish the 
more tender from the less tender, and especially the blade-tenderized 
from the non-tenderized beef products. The mandatory descriptive 
designation ``mechanically tenderized,'' ``needle tenderized,'' or 
``blade tenderized'' on the labels of the needle- or blade-tenderized 
or similar products will inform consumers of the additional product 
attributes when they are making their purchase decisions.
    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 if the 
price for mechanically tenderized beef were to decrease, while 
consumers purchasing intact beef in the absence of the rule would 
experience a loss of surplus because of the increase in price for 
intact beef. Some producers of intact beef or other meats will realize 
a surplus increase if consumers 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.
    Additionally, the Food Code for the food service industry, which 
most states have adopted into State law, recommends cooking 
mechanically tenderized and injected meats to a minimum temperature of 
145 [deg]F for a minimum of 3 minutes. In the absence of readily 
available information on the label as to how to cook the beef product 
and whether it is intact or mechanically tenderized, the food service 
industry likely now spends time determining whether the beef products 
it purchases have been mechanically tenderized. The final rule will 
require that raw or partially-cooked mechanically tenderized beef be 
labeled to indicate that it has been tenderized and to include 
validated cooking instructions.

[[Page 28167]]

Therefore, the final rule will save the food service industry time to 
meet State requirements based on the Food Code. In addition, the new 
labeling requirements will lead to improved public health as a result 
of less mistakes in the food service industry meeting the State 
requirements to adequately cook mechanically tenderized beef products.
    In addition, in this final analysis, FSIS did not include benefits 
associated with reduced illness associated with mechanically tenderized 
product prepared at food service establishments. First, FSIS recognizes 
that even when the food service industry can more readily determine 
whether beef has been mechanically tenderized, consumers may continue 
to request that the product be served to degree of doneness that is 
less than fully cooked. In most States, as long as the restaurant has 
noted on the menu the risk of consuming meat products that are 
undercooked, the food service establishment may serve the product less 
than fully cooked and be in compliance with State law. In addition, 
FSIS does not have data to estimate the percentage of total food 
service establishments that currently may not have sufficient 
information concerning whether beef product they serve is mechanically 
tenderized or currently may not have adequate cooking instructions for 
such product. Therefore, FSIS cannot effectively estimate the 
percentage of product that will be routinely prepared differently at 
food service establishments as a result of this rule.
    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 final 
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 [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 [deg]F with 3 
minutes dwell time for cooking steaks and whole roasts because data 
support that this would be equivalent to cooking at 160 [deg]F without 
holding a product at that temperature for any dwell time. FSIS's 
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 the cooking practices and 
temperature and dwell time combinations recommended in the guidance, 
the results would be comparable to their cooking product to 160 [deg]F 
but not holding product at that temperature for any dwell 
time.42 43 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.
---------------------------------------------------------------------------

    \42\ 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 [deg]F (70 
[deg]C) E. coli O157:H7 had a D-value of about 3.3 seconds, at 144.5 
[deg]F (62.5 [deg]C) the D-value was 52.8 seconds. Three minutes at 
145 [deg]F would be equivalent to more than 10 seconds at 160 
[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 [deg]F (5.43 
[deg]C). Changing the temperature from 160 [deg]F to 145 [deg]F 
would then represent an increase in D-value of about 1.5 log10. 
Thus, 3 minutes at 145 [deg]F would be equivalent to 5.7 seconds at 
160 [deg]F. In either case, three minutes at 145 [deg]F is more than 
equivalent to an instantaneous temperature (<1 sec) at 160 [deg]F.
    \43\ 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.
---------------------------------------------------------------------------

    The 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.\44\ As a consequence 
of this analysis, Painter, et al., attributed 39.4% of illnesses or 
1,909 (4,844 x 0.394) to beef.
---------------------------------------------------------------------------

    \44\ 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 the preamble 
of the proposed rule (78 FR at 34592), 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.'swork 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 in the United States attributable to 
E. coli O157 from all sources.\45\ 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:
---------------------------------------------------------------------------

    \45\ 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 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.\46\ CDC estimates that 58% of laboratories 
would routinely test for STEC O157.
---------------------------------------------------------------------------

    \46\ 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.47 48
---------------------------------------------------------------------------

    \47\ 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.
    \48\ 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.

---------------------------------------------------------------------------

[[Page 28168]]

    CDC also adjusted the value 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.\49\ 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.
---------------------------------------------------------------------------

    \49\ 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.\50\ The estimated annual illnesses due to 
mechanically tenderized product is given by 63,153 (annual estimated 
illnesses of E. coli O157:H7 \51\) x 0.394 (proportion of E. coli 
O157:H7 illnesses attributable to beef \52\) x 0.079 (proportion of 
beef attributable illnesses due to tenderized product \53\) = 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).
---------------------------------------------------------------------------

    \50\ Scallan, E., R.M. Hoekstra, et al. (2011). ``Foodborne 
illness acquired in the United States--major pathogens.'' Emerg 
Infect Dis 17(1): 7-15.
    \51\ Ibid.
    \52\ 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.
    \53\ 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.\54\ After accounting for the proportion of all beef that was 
ground, FSIS estimates that 21.0% of non-ground product is 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.
---------------------------------------------------------------------------

    \54\ 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 to 
dose.
    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.\55\ 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.\56\ 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.
---------------------------------------------------------------------------

    \55\ Powell, M., USDA-FSIS. 2002. ``Comparative Risk Assessment 
for Intact (Non Tenderized) and Non-Intact (Tenderized Beef): 
Technical Report''. fsis.usda.gov. Retrieved April 27, 2011, from: 
http://www.fsis.usda.gov/wps/wcm/connect/7afddc93-f812-42fb-92b7-52455124bbe0/Beef_Risk_Assess_ExecSumm_Mar2002.pdf?MOD=AJPERES.
    \56\ 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 \57\ 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 [deg]F to 212 [deg]F for 
beef (not ground). Table 4 shows the number of observations for each 
recorded cooking temperature.
---------------------------------------------------------------------------

    \57\ EcoSure-EcoLab. (2007). ``EcoSure 2007 Cold Temperature 
Database.'' FoodRisk.org. Retrieved May 26, 2010, from http://foodrisk.org/exclusives/EcoSure/.

   Table 4--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.,\58\ looked at the relationship between final cooking temperatures 
and log10 reductions for mechanically tenderized beef. An 
additional ARS study by Luchansky, et al.,\59\ also examined the 
relationship between final cooking temperatures and

[[Page 28169]]

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 4 estimate that an average pre-cooking dose of 0.0432 E. 
coli O157:H7 bacteria per serving \60\ would result in an average post-
cooking dose of 0.0001. Thus, a pre-cooking dose of 0.0432 corresponds 
with the estimate of 1,965 illnesses. Given the current cooking 
distribution, about 93% of the 1,965 illnesses are attributed to 
cooking temperatures below 160 [deg]F and about 7% to cooking 
temperatures equal to or greater than 160 [deg]F.
---------------------------------------------------------------------------

    \58\ 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.
    \59\ Ibid.
    \60\ The previous estimate for an average pre-cooking dose was 
0.0188 E. coli O157:H7 bacteria per serving. Both estimates were 
derived using an attribution estimate of 1,965 illnesses and cooking 
data from the 2007 EcoSure study. The previous estimate, however, 
used data from two ARS studies (Luchansky 2011 and Luchansky 2012) 
provided to FSIS prior to their publication. After their 
publication, we substituted the data as published. This had the 
effect of decreasing the effect of cooking. Thus, in the previous 
submission, cooking to 160 [deg]F resulted in a decrease from 1,965 
illnesses to 78 illnesses. With the change to the published data, 
cooking to 160 [deg]F results in a decrease from 1,965 illnesses to 
144 illnesses. The change of the pre-cooking dose from 0.0188 to 
0.0432 is a result of this recalculation.
---------------------------------------------------------------------------

    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 0.0432. This changed the 
post-cooking average dose from 0.0001 E. coli O157:H7 bacteria per 
serving to an average dose of 0.0000073, which corresponds to a 
frequency of illness of 23 per billion. With this change, the predicted 
number of illnesses decreases from 1,965 to 144. Thus, if all consumers 
cook all mechanically tenderized beef to at least 160 [deg]F, the 
resulting total number of illness will be 144. Analogous calculations 
yield illness estimates of 40 and 341 illness, respectively, if the 
baseline annual illness totals are 547 and 4,657 (the lower and upper 
values of illnesses that could be attributed to mechanically tenderized 
beef when we consider the original uncertainty in CDC estimates of all 
foodborne O157 illnesses (from 17,587 to 149,631)).
    The annual estimated number of illnesses averted or prevented is 
estimated at 1,821 (1,965 illnesses less 144 illnesses), with a range 
of 507 illnesses (547 illnesses--40 illnesses) to 4,316 illnesses 
(4,657 illnesses--341 illnesses), 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 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 consumer response rate, as well as 
using the range for the estimated number of illnesses if all consumers 
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.\61\ 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).\62\ 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.\63\ We use the range (15 to 56 
percent) as the estimate for the impact of labels on consumer behavior 
in retail and food service, with our primary estimate equaling the 
average of available estimates, or 24 percent.
---------------------------------------------------------------------------

    \61\ 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).
    \62\ 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.
    \63\ 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 market share for 
mechanically tenderized beef and beef containing added solution is 
estimated at 48 percent at retail.\64\
---------------------------------------------------------------------------

    \64\ RTI, pp. 3-12 and 3-14.
---------------------------------------------------------------------------

    Table 5 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 131 illness (1,821 illnesses (mid-point estimate 
from the risk analysis) x 48% (retail share of mechanically tenderized 
beef market) x 15% (lower end of the range for percent of consumer 
using validated cooking instructions) to 489 illness averted (1,821 
illnesses (mid-point estimate from the risk analysis) x 48% (retail 
share of mechanically tenderized beef market) x 56% (upper end of the 
range for percent of consumers using validated cooking instructions). 
The primary estimate is 210 illnesses.

                       Table 5--Response Rate and Resulting Averted Illnesses From Retail
----------------------------------------------------------------------------------------------------------------
                                                                       Lower          Primary          Upper
----------------------------------------------------------------------------------------------------------------
Estimated Preventable Illnesses.................................             507           1,821           4,316
Response to Label...............................................             15%         \1\ 24%             56%
                                                                 -----------------------------------------------
Share of Mechanically Tenderized Beef in Retail.................                        48%
                                                                 -----------------------------------------------
Total Estimated Illnesses Averted--Lower Bound..................              37              58             136
Total Estimated Illnesses Averted--Primary......................             131             210             489
Total Estimated Illnesses Averted--Upper Bound..................             311             497           1,160

[[Page 28170]]

 
Expected Benefits--Lower Bound..................................        $119,770        $191,631        $447,140
Expected Benefits--Primary......................................        $430,178        $688,286      $1,606,000
Expected Benefits--Upper Bound..................................      $1,019,577      $1,631,324      $3,806,422
----------------------------------------------------------------------------------------------------------------
\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.

    Using the FSIS estimate for the average cost per case for an E. 
coli O157:H7 illness of $3,281,\65\ the expected benefits from this 
final rule are $688,286 per year (with a range of $430,178 to 
$1,606,000). Using the credible interval from Scallan, et al., provides 
expected benefits of $191,631 per year for 58 illnesses prevented (with 
a range of $119,770 to $447,140) for the lower bound of the credible 
interval and expected benefit of $1,631,324 per year for 497 illnesses 
prevented (with a range of $1,019,577 to $3,806,422) 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 2010 version of ERS Cost 
calculator (for E. coli) and replacing the case numbers with new case 
numbers based on Scallan's report.
---------------------------------------------------------------------------

    \65\ 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). http://webarchives.cdlib.org/sw1rf5mh0k/http:/www.ers.usda.gov/Data/FoodborneIllness/ (archived link--calculator currently being 
updated). 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) ``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 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 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 upper and lower bound cost to produce labels for mechanically 
tenderized beef is a one-time cost of $3,584,257 and $5,892,342. The 
upper and lower bound annualized cost is $476,932 and $784,053 for 10 
years at a 7-percent discount rate or $407,946 and $670,643 over 10 
years at a 3-percent discount rate.
    The expected number of illnesses prevented would be 210 per year, 
with a range of 131 to 489, if the predicted percentages of beef steaks 
and roasts are cooked to an internal temperature of 160 [deg]F (which 
is equivalent to 145 [deg]F and 3 minutes of dwell time). These 
prevented illnesses amount to $688,286 per year in benefits with a 
range of $430,178 to $1,606,000. The expected annualized net benefits, 
given the lower and upper bound cost estimate are -$95,768 to $211,353 
as reflected in Table 6.
    Using the lower end of the credible interval from Scallan, et al., 
provides an expected number of illness prevented of 58 per year, with a 
range of 37 to 136, as discussed earlier. These prevented illnesses 
amount to $191,631 in benefits, with a range of $119,770 to $447,140. 
The expected annualized net benefits for the lower end of the Scallan's 
credible interval, given the lower and upper bound cost are -$592,422 
to -$285,301.
    Using the upper end of the credible interval from Scallan, et al., 
provides an expected number of illnesses prevented of 497 per year, 
with a range of 311 to 1,160 as discussed earlier. These prevented 
illnesses amount to $1,631,324 in benefits, with a range of $1,019,577 
to $3,806,422. The expected annualized net benefits for the upper end 
of the Scallan's credible interval given the upper and lower bound 
costs are $847,270 to $1,154,391.

                                         Table 6--Estimated Net Benefits
----------------------------------------------------------------------------------------------------------------
                                                                                    Lower bound     Upper bound
                                                     Benefits          Cost        net benefits    net benefits
----------------------------------------------------------------------------------------------------------------
                                       Scallan Midpoint Credible Interval
----------------------------------------------------------------------------------------------------------------
Midpoint........................................        $688,286  ..............        $211,353        -$95,768
Lower...........................................         430,178         476,932         -46,754        -353,875
Upper...........................................       1,606,000         784,053       1,129,067         821,946
----------------------------------------------------------------------------------------------------------------
                                         Scallan Lower Credible Interval
----------------------------------------------------------------------------------------------------------------
Midpoint........................................         191,631  ..............        -285,301        -592,422
Lower...........................................         119,770         476,932        -357,163        -664,284
Upper...........................................         447,140         784,053         -29,792        -336,913
----------------------------------------------------------------------------------------------------------------
                                         Scallan Upper Credible Interval
----------------------------------------------------------------------------------------------------------------
Midpoint........................................       1,631,324  ..............       1,154,391         847,270
Lower...........................................       1,019,577         476,932         542,645         235,524
Upper...........................................       3,806,422         784,053       3,329,490       3,022,369
----------------------------------------------------------------------------------------------------------------


[[Page 28171]]

    In addition to the quantified net benefits mentioned above, the 
rule will 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 will be modified as a result of this final 
rule.
    Additionally, FSIS did not estimate the number of validation 
studies that will be necessary to develop cooking instructions for raw 
and partially cooked needle- or blade-tenderized beef products. FSIS 
requested comments on the number of validation studies; however, no 
data was received.

Alternatives

    FSIS considered several alternatives to the final rule:
    Option 1. Extend labeling requirements to include vacuum tumbled 
beef products and enzyme-formed beef products. FSIS considered the 
option 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, nor was it provided with, 
sufficient data on the production practices and risks of consuming 
vacuum-tumbled and enzyme-formed beef products to proceed with this 
option.
    Option 2. Extend the labeling requirements to all needle- or blade-
tenderized meat and poultry products. FSIS considered the option 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, nor was it provided 
with, sufficient data on 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 amending 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 certifies that, for the purposes of the 
Regulatory Flexibility Act (5 U.S.C. 601-602), the final rule will not 
have a significant impact on a substantial number of small entities in 
the United States. 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 final 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 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, will incur the costs associated with modifying product 
labels to add on the labels ``mechanically tenderized,'' ``needle 
tenderized,'' or ``blade tenderized,'' and validated cooking 
instructions needed to ensure adequate pathogen destruction.
    Based on the upper bound estimated number of labels that will be 
required by the establishments, the cost will add an average of $0.0038 
per package ($5,892,342/951,000,000 packages of needle- or blade-
tenderized beef).\66\ The average cost per establishment will be 
$10,616 per establishment ($5,892,342/555). 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, resulting 
in less labeling cost.
---------------------------------------------------------------------------

    \66\ 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 section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or record 
keeping requirements included in this final rule have been submitted 
for approval to the Office of Management and Budget (OMB). This 
information collection request is at OMB awaiting approval. FSIS will 
collect no information associated with this rule until the information 
collection is approved by OMB.
    Copies of this information collection assessment can be obtained 
from Gina Kouba, Paperwork Reduction Act Coordinator, Food Safety and 
Inspection Service, USDA, 1400 Independence Avenue SW., Room 6083, 
South Building, Washington, DC 20250-3700; (202) 690-6510.

Executive Order 13175

    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, ``Consultation and Coordination with Indian 
Tribal Governments.'' Executive Order 13175 requires Federal agencies 
to consult and coordinate with tribes on a government-to-government 
basis on policies that have tribal implications, including regulations, 
legislative comments or proposed legislation, and other policy 
statements or actions that have substantial direct effects on one or 
more Indian tribes, on the relationship between the Federal Government 
and Indian tribes or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes.
    FSIS has assessed the impact of this rule on Indian tribes and 
determined that this rule does not, to our knowledge, have tribal 
implications that require tribal consultation under E.O. 13175. If a 
Tribe requests consultation, FSIS will work with the Office of Tribal 
Relations to ensure meaningful consultation is provided where changes, 
additions and modifications identified herein are not expressly 
mandated by Congress.

Executive Order 12988, Civil Justice Reform

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. Under this rule: (1) All State and local laws and 
regulations that are inconsistent with this rule will be

[[Page 28172]]

preempted; (2) no retroactive effect will be given to this rule; and 
(3) no administrative proceedings will be required before parties may 
file suit in court challenging this 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.

USDA Nondiscrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.
    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410.
    Fax: (202)690-7442/
    Email: [email protected]
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.) should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce it on-line 
through the FSIS Web page located at: http://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, and other types of information 
that could affect or would be of interest to our constituents and 
stakeholders. The Update is available on the FSIS Web page. Through the 
Web page, FSIS is able to provide information to a much broader, more 
diverse audience. In addition, FSIS offers an email 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/subscribe. Options range from recalls to export 
information, 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 amends 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 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 or to receive 
another full lethality treatment 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,'' ``needle tenderized,'' or ``blade 
tenderized,'' as a descriptive designation and an accurate description 
of the beef component.
    (ii) The product name must appear in a single easy-to-read type 
style and color and on a single-color contrasting background. The print 
may appear in upper and lower case letters, with the lower case letters 
not smaller than \1/3\ the size of the largest letter.
    (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, and a 
statement that the internal temperature should be measured by a 
thermometer. These validated cooking instructions may appear anywhere 
on the label.
* * * * *

    Done, at Washington, DC, on May 13, 2015.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2015-11916 Filed 5-15-15; 8:45 am]
 BILLING CODE 3410-DM-P