[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Notices]
[Pages 68843-68846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27418]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2010-0023]


Shiga Toxin-Producing Escherichia coli (STEC) in Certain Raw Beef 
Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice of availability and response to comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
that it has completed and is making available its analysis on the 
estimated costs and benefits associated with the implementation of its 
non-O157 STEC testing on beef manufacturing trimmings and the costs and 
benefits associated with the potential expansion of its non-O157 STEC 
testing to ground beef and ground beef components other than beef 
manufacturing trimmings. In addition, FSIS is responding to comments 
that it received on the previous cost benefits analysis.

DATES: To receive full consideration, comments should be received by 
January 20, 2015.

ADDRESSES: FSIS invites interested persons to submit comments on this 
notice and the cost benefit analysis. Comments may be submitted by one 
of the following methods:
    <bullet> Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on this 
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for 
submitting comments.
    <bullet> Mail, including CD-ROMs: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, Patriots 
Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163A, 
Washington, DC 20250-3700.
    <bullet> Hand- or courier-delivered submittals: Deliver to Patriots 
Plaza 3, 355 E Street SW., Room 8-163A, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS 2010-0023. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, go 
to the FSIS Docket Room at Patriot Plaza 3, 355 E Street SW., Room 8-
164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., Monday 
through Friday.

FOR FURTHER INFORMATION CONTACT: Daniel L. Engeljohn, Ph.D., Assistant 
Administrator, Office of Policy and Program Development, Food Safety 
and Inspection Service, U.S. Department of Agriculture; Telephone: 
(202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    On September 20, 2011, FSIS announced in the Federal Register its 
determination that raw, non-intact beef products or raw, intact beef 
products that are intended for use in raw, non-intact product, that are 
contaminated with Shiga toxin-producing Escherichia coli (STEC) O26, 
O45, O103, O111, O121, or O145 are adulterated within the meaning of 21 
U.S.C. 601(m)(1)(76 FR 58157; Sep. 20, 2011). In support of its 
determination, the Agency cited evidence of the STEC organisms' high 
pathogenicity, low infectious dose, transmissibility from person to 
person, and thermal resistance high enough for them to survive ordinary 
cooking (76 FR 51858-51859). FSIS stated that raw, non-intact beef 
products that are contaminated with these STEC are also unhealthful and 
unwholesome (under 21 U.S.C. 601(m)(3)) (76 FR 58159).
    In this 2011 Federal Register notice, FSIS included an estimate of 
costs and benefits of testing for non-O157 STEC in all non-intact beef 
product subject to Agency testing (76 FR 58157; Sept. 20, 2011, at 
58162-58164). The Agency asked for comments on its plans for 
implementing the program, including cost estimates (76 FR 58164), which 
included costs to FSIS laboratories for analyzing trim samples for non-
O157 STEC (approximately $204,050 to $338,270 per year in 2010 
dollars), cost of additional establishments testing for non-O157 (about 
$12.3 million to $16.4 million per year), and the loss to the industry 
from diverting the contaminated products (about $12.1 to $16.1 million 
per year). FSIS also announced in this notice its plan to conduct a new 
``checklist'' survey of its field inspection personnel who are 
stationed in beef slaughter and processing establishments.
    FSIS implemented a verification sampling and testing program for 
the six adulterant non-O157 STEC in raw beef manufacturing trimmings on 
June 4, 2012, as announced in a 2012 Federal Register notice (77 FR 
9889; Feb. 2012). The Agency also announced (75 FR 31975 at 31976; May 
31, 2012) that it would update and revise the September

[[Page 68844]]

20, 2011, economic analysis, respond to comments received on the 
analysis, and assess the economic effects of testing for the specified 
STECs on raw beef manufacturing trimmings, other raw ground beef 
components, and ground beef. FSIS also announced that when the economic 
analysis was complete, the Agency would announce its availability, 
request comments on it, assess the comments, and make any necessary 
changes to the analysis before finalizing the analysis and expanding 
FSIS testing to include other raw ground beef components and ground 
product.

Summary of the Economic Analysis

    FSIS has estimated the cost to the regulated industry and FSIS 
associated with the implementation of its non-O157 STEC testing on beef 
manufacturing trimmings since June 2012, based on Agency testing data 
and information collected through the FSIS 2013 Pathogen Controls in 
Beef Operations Survey. This survey is available at: [http://www.fsis.usda.gov/wps/wcm/connect/184a3baa-2f73-4651-8aba-68124580f4e0/Pathogen_Controls_in_Beef_Operations_Survey.pdf?MOD=AJPERES. The survey 
report is at: [http://www.fsis.usda.gov/wps/wcm/connect/6d37a1fc-a3e1-40b6-90cc-719bdb391522/STEC_Survey_Comments_Summary.pdf?MOD=AJPERES], 
and the cost-benefit analysis is at: [http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/federal-register-notices]. The cost for the current testing of beef manufacturing 
trimmings (including Agency and the industry testing) is about $1.37 
million. If the Agency expands the testing to bench trim, other 
components, and raw ground beef, it will add another $1 million to the 
cost and bring up the grand total to about $2.37 million. Of the $2.37 
million, $1.38 million is for FSIS and $0.99 million for the industry.
    FSIS also assessed the benefits associated with the new testing. 
Benefits would accrue from reduced illnesses and deaths, reduced 
outbreak-related recalls, and improved business practices. FSIS has 
concluded that the benefits accruing to industry, Government, and 
consumers from this new testing policy will result in net economic 
benefits. However, FSIS was not able to quantify the benefits of 
expanding the testing.

Summary of the New Checklist Survey Results

    In May-July 2013, FSIS conducted the checklist survey entitled, 
``The Pathogen Controls in Beef Operations Survey.'' The purpose of the 
survey was to gather information on the controls that beef slaughtering 
and processing establishments have in place to reduce STEC and 
Salmonella contamination. The survey questions covered a wide range of 
topics, including establishment pre-harvest management controls, 
establishment sanitary dressing procedures, establishment carcass 
sampling and testing, establishment use of high event periods, 
information on which beef products are produced at particular 
establishments, and controls that establishments use to address STEC. 
FSIS sent surveys to inspectors in 486 establishments out of a total of 
approximately 2,300 beef slaughter or beef processing establishments to 
collect the information. The survey results related to non-O157 STEC 
testing include that about 29 percent of the beef establishments 
reassessed their HACCP plans for raw beef products based on FSIS's new 
non-O157 STEC policy, and about 43 percent of the establishments that 
tested for non-O157 STEC took more than one action (such as 
confirmatory testing following presumptive positive results or cooking) 
with products that screened positive. FSIS used the survey results and 
an updated risk assessment to develop the updated economic analysis.

Response to Comments on the 2011 Federal Register Notice

    Comment: A trade association stated that the FSIS verification 
sampling and testing for non-O157 STEC will lead to additional costs 
for taxpayers and consumers because of increased testing and 
destruction or diversion of meat.
    Response: FSIS recognizes that FSIS testing will likely result in 
additional costs to establishments. The Agency understands that the 
industry is likely to transfer some of its costs to consumers. The 
Agency has determined, however, that the benefits resulting from 
reduced illness and deaths, reduced outbreak-related recalls, and 
improved business practices justify the costs.
    Comment: A trade association stated that FSIS underestimated the 
cost to the Agency and to the industry of implementing this new 
program. According to the commenter, the true cost of Agency testing, 
including the cost for testing ground beef, would total $1,170,564 per 
year in additional expenses. The commenter also stated that adding the 
costs attendant on a ``for-cause Food Safety Assessment,'' which FSIS 
conducts when ground beef is confirmed to contain STEC, would add an 
additional $854,000. According to the comment, FSIS has grossly 
underestimated the cost of implementing this policy testing.
    Response: The Agency has updated the cost estimate to include the 
costs of expanding testing to raw ground beef products and other raw 
ground beef components (other than manufacturing trimmings). FSIS found 
that there will be additional benefits, as well as additional costs, 
should the Agency begin testing additional product for non-O157 STEC. 
As mentioned in the Summary of Economic Analysis, the cost for the 
current testing of beef manufacturing trimmings (including Agency and 
the industry testing) is about $1.37 million. If the Agency expands the 
testing to bench trim, other components, and raw ground beef, it will 
add another $1 million to the cost and bring the grand total to about 
$2.37 million. Of the $2.37 million, $1.38 is for FSIS and $0.99 for 
the industry.
    FSIS also estimated the benefits associated with the new testing 
policy. Benefits would accrue from reduced illnesses and deaths, 
reduced outbreak-related recalls, and improved business practices. The 
Agency still concludes that the costs are low for new testing that is 
warranted, and that the benefits justify the costs.
    Comment: A trade association stated that the Agency grossly 
miscalculated the costs to industry and made seriously flawed 
assumptions in its cost analysis when it concluded that only 33 percent 
of beef slaughter establishments test for E. coli O157:H7. The trade 
association stated that the better measure for this analysis would be 
to use the data in Table 5.2.10 in FSIS' 2007 checklist study--
``Testing of Source Materials for 03B Establishments.''
    Response: The Agency has updated the cost analysis adopting a 
slightly different approach with information from our 2013 Pathogen 
Controls in Beef Operations Survey. Thus, there is no reason to use the 
outdated data from the 2007 checklist study any more. Details are in 
the updated cost-benefit analysis.
    Comment: A trade association stated that FSIS estimated in the 2011 
Federal Register notice that approximately 20 percent of establishments 
were testing for non-O157 STEC and did not adequately support that 
estimate. The comment further stated that the Agency failed to account 
properly for added laboratory costs for the industry. The commenter 
stated that industry analysis estimates added laboratory costs to the 
industry to range from $2.5 million to almost $2.9 million annually.
    Response: The Agency has updated the cost analysis using 
information from the 2013 Pathogen Controls in Beef Operations Survey 
and used a slightly different approach from the approach used in the 
earlier estimate. This

[[Page 68845]]

approach is based on the number of samples tested by the industry and 
accounts for the added laboratory costs as well. The commenter did not 
provide information on how the laboratory costs of $2.5 million to $2.9 
million were derived. As is explained in the revised cost benefit 
analysis, FSIS estimates that these costs to industry would be $0.99 
million, and these costs to FSIS would be $1.38 million.
    Comment: A trade association commented that the Agency's estimate 
of total beef trimmings production--2.05 billion pounds--is inaccurate. 
The trade association claimed that, for the year ending June 30, 2010, 
the industry produced 6.96 billion pounds of ground beef, and that, 
since ground beef is only produced from raw ground beef components, 
i.e., trimmings, the more realistic volume of beef trimmings is also 
approximately 6.96 billion pounds. Additionally, the trade association 
stated that because the amount of trimmings is approximately 3.4 times 
greater than the Agency estimate, a more accurate range of the cost of 
diverted products is approximately $13.24 million to $17.65 million 
dollars. A foreign government stated that the value of product that is 
confirmed positive and diverted for cooking will be reduced by 
approximately 70 to 75 percent.
    Response: The Agency has updated the cost analysis and does not use 
estimated production volume or the value lost for products diverted for 
cooking in the updated analysis. In examining the 2013 Pathogen 
Controls in Beef Operations Survey data, we found that 43 percent of 
the establishments that tested for non-O157 STEC took more than one 
action, including proceeding to confirmation testing, cooking, 
destroying, and others, with products that screened positive. The 
Agency believes that it is not possible to get the total volume of the 
products disposed under any of the actions, even if we asked that 
question, because the actions the establishments choose are often based 
on their particular circumstances. For example, if the establishment is 
very confident with its screening test methodology, it will probably 
cook the products that screen positive subject to available cooking 
capacity. If the establishment is not confident about its screening 
methodology, and there is not enough cooking capacity, it will probably 
proceed to confirmation or destroy the products, depending on the 
relative costs of conducting confirming tests versus destroying the 
products. Empirical literature on industry behavior shows that industry 
behaves strategically to maximize profits or minimize losses.
    Therefore, establishments' choice of action with regard to product 
that screened positive will be based on particular circumstances, and 
whatever actions an establishment takes, the incentive is to avoid 
recalls and potential outbreaks at the minimum cost. Furthermore, if 
industry focused more on using the data from the verification testing 
conducted by the establishment and FSIS to improve the prevention 
efforts at slaughter, there would be even less contaminated product to 
be diverted.
    Comment: Several industry commenters stated that the Agency 
improperly calculates the cost of holding tested product and fails to 
consider the additional time needed to complete the STEC test through 
the final stage of confirmation and the other costs attendant thereto.
    Response: If industry decides to hold product that screened 
positive in their own testing until confirmed positive results are 
attained, then this is a business decision not driven by FSIS. Today, 
establishments do not typically await a confirmed positive result 
before taking action on the affected production lot. Industry responds 
to the screen positive result, as stated by another commenter below. 
The new non-O157 STEC screen method that FSIS uses takes the same 
amount of time as the method for E. coli O157:H7. Agency data for 
FY2013 showed that the screen positive sample rate for non-O157 STEC in 
beef manufacturing trimming is only 2 percent. Therefore, the 
additional cost of holding products because of additional FSIS testing 
and additional positive samples is likely to be minimal.
    Comment: A trade association representing the meat industry stated 
that there will be more recalls based on testing, and that the Agency's 
economic analysis failed to consider recalls. The industry, however, 
estimates that the new testing will result in at least 24 additional 
recalls annually and perhaps as many as 48 additional recalls. 
According to the commenter, using Agency data, those added recalls will 
cost the industry between $72 million and $144 million annually.
    Response: For FSIS testing, the establishments have to hold 
products that screened positive, and therefore there should be no 
recalls. Recalls should only happen when establishments failed to hold 
positive products from their own testing. Since FSIS started testing in 
June 2012, there have been only two Class-I recalls associated with raw 
beef products with non-O157 STEC, and in both cases products were 
recalled before any illness was reported. These early-stage recalls 
actually carried the benefit of preventing potential outbreaks and 
outbreak-related recalls, which are more costly to the industry as well 
as the consumers and the government. The goal of the new policy is to 
better ensure that adulterated product does not enter commerce and, 
hence, will not have to be recalled.
    Comment: A trade association representing the meat industry 
suggested that there will be significant impact on a significant number 
of small and very small businesses from increased cost of raw 
materials, holding tested product, resources needed for supporting 
documentation, validation, and verification that current control 
programs for O157 are effective against the six additional STEC 
strains, and from reassessing HACCP plans.
    Response: Any increase in the cost of raw materials would be borne 
by large establishments as well. The Agency believes that the increased 
cost from holding the tested product because of additional testing and 
additional positive samples will not be significant because Agency test 
data for FY 2013 showed that the screen positive sample rate for non-
O157 STEC in beef manufacturing trimming is only 2 percent. The cost of 
documentation and reassessment of HACCP plans will be minimal too, as 
the small and very small businesses have to reassess their HACCP plans 
at least annually. Again, a focus on preventing contamination is likely 
to be more effective than reliance on testing.
    Comment: A trade association representing the meat industry has 
estimated that the cost per test is $19, plus an additional $9 if the 
sample is a presumptive positive during the screen. An estimate for 
final confirmatory testing was not completed by the commenter, as the 
commenter noted that the beef industry generally makes disposition 
decisions based upon potential positive results.
    Response: The cost per test is more complicated than just one 
dollar figure. There are many methodologies available to the industry, 
and some establishments use different methodologies for different time-
periods (such as high-prevalence season and other time-periods). For 
those establishments that are already testing for E. coli O157:H7, 
adding non-O157 will, in most cases, involve switching to new test 
kits. Market information and Agency expert opinion indicate that the 
new test kits will only cost about $1 or $2 more per test. If an 
establishment has to contract out to a different laboratory

[[Page 68846]]

for non-O157 STEC analysis, we used $30 for average cost per test based 
on the cost of FSIS testing methodology, which is available in the 
market for the industry.
    Comment: Some countries exporting beef that commented have 
estimated the direct cost increase to be around $2.4 million per annum 
for new non-O157 STEC testing. Three commenters from Australia stated 
that the costs will be significant; two of them said that the cost of 
testing, storage, and documentation could amount to AUD 1.8 million per 
annum. One commenter from another country stated that having to test 
United States-destined trimmings for non-O157 STEC as well as for E. 
coli O157:H7 would impose an additional multi-million dollar cost 
burden.
    Response: FSIS does not require foreign establishments to test, 
just as we did not require domestic establishments to test. The foreign 
establishments, as well as the U.S. establishments, have many 
alternatives to control for non-O157 STECs. It is the foreign 
establishments' business decision as to what control measure(s) will be 
the most cost-effective for them to adopt. FSIS testing policy does not 
create any unfair burden on the foreign establishments.

USDA Nondiscrimination Statement

    The U.S. Department of Agriculture (USDA) prohibits discrimination 
in all its programs and activities on the basis of race, color, 
national origin, gender, religion, age, disability, political beliefs, 
sexual orientation, and marital or family status. (Not all prohibited 
bases apply to all programs.) Persons with disabilities who require 
alternative means for communication of program information (Braille, 
large print, audiotape, etc.) should contact USDA's Target Center at 
202-720-2600 (voice and TTY).
    To file a written complaint of discrimination, write USDA, Office 
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue 
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY). 
USDA is an equal opportunity provider and employer.

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, export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

    Done, at Washington, DC, November 14, 2014.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2014-27418 Filed 11-18-14; 8:45 am]
BILLING CODE 3410-DM-P