[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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Rules and Regulations
Federal Register
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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.
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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
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Estimated Quantified Benefits, Costs, and Net Benefits \a\
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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).
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Non-Quantified Benefits and Costs
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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.
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\a\ Annualized over 10 years at a 7 percent discount rate.
\b\ Assumes that on the low end, 15% of consumers and 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.
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\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.
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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\
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\8\ Compilation of USDA-FSIS Data, 2010.
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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.
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\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.
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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.
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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.
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\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.
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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.
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\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.
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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.
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\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.
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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.
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\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).
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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).
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\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).
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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.
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\23\ Available at http://www.fsis.usda.gov/wps/wcm/connect/6d2ee97-3fd1-4186-b1e7-656e7a57beb2/time-temperature-table-042009.pdf?MOD=AJPERES.
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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.
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\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.
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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.
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\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.
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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.
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\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.
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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.
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\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\
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\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.
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\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.
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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\
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\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.
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[[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.
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\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.
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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