[Federal Register Volume 87, Number 224 (Tuesday, November 22, 2022)]
[Notices]
[Pages 71291-71294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25333]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2022-0019]


Use of a Non-Destructive Surface Sampling Device To Sample 
Domestic Beef Manufacturing Trimmings and Bench Trim

AGENCY: Food Safety and Inspection Service (FSIS), U.S. Department of 
Agriculture (USDA).

ACTION: Notice and request for comments.

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SUMMARY: On February 1, 2023, FSIS intends to stop using the N60 
excision sampling method to sample domestic beef manufacturing 
trimmings and bench trim for adulterant Shiga toxin-producing 
Escherichia coli (E. coli) (STEC) and Salmonella. FSIS intends to 
replace the N60 excision sampling method with a non-destructive surface 
sampling method that uses a cloth manual sampling device. FSIS has 
found that the cloth sampling method is as effective as the N60 
excision sampling method at recovering organisms in beef manufacturing 
trimmings. Additionally, the cloth sampling method is faster and safer 
for FSIS inspection program personnel (IPP) to use because it does not 
require IPP to use hooks or knives to collect samples. Moreover, the 
cloth sampling method allows FSIS to sample without destroying product, 
which reduces food waste.

DATES: FSIS will implement the cloth sampling on February 1, 2023, 
unless the Agency receives substantive comments that warrant further 
review. Submit comments on or before January 23, 2023.

ADDRESSES: FSIS invites interested persons to submit comments on this 
notice. Comments may be submitted by one of the following methods:
     Federal eRulemaking Portal: This website provides 
commenters the ability to type short comments directly into the comment 
field on the web page or to attach a file for lengthier comments. Go to 
https://www.regulations.gov. Follow the on-line instructions at that 
site for submitting comments.
     Mail: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 1400 Independence 
Avenue SW, Mailstop 3758, Washington, DC 20250-3700.
     Hand- or Courier-Delivered Submittals: Deliver to 1400 
Independence Avenue SW, Jamie L. Whitten Building, Room 350-E, DC 
20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2022-0019. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to https://www.regulations.gov.
    Docket: For access to background documents or comments received, 
call (202) 205-0495 to schedule a time to visit the FSIS Docket Room at 
1400 Independence Avenue SW, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant 
Administrator, Office of Policy and Program Development by telephone at 
(202) 205-0495.

SUPPLEMENTARY INFORMATION: 

Background

    Under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), FSIS 
carries out an inspection program to ensure that carcasses, parts, and 
products of amenable species of livestock are wholesome, not 
adulterated, and properly marked, labeled, and packaged. FSIS conducts 
microbiological sampling to verify that establishments maintain control 
of their production processes and meet regulatory requirements, 
including requirements under the hazard analysis and critical control 
point (HACCP) regulations. Ongoing FSIS sampling and testing at 
official establishments allows FSIS to verify that establishments 
effectively address pathogens reasonably likely to occur in their 
products. The HACCP regulations (9 CFR part 417) require that 
establishments conduct a hazard analysis to determine the food safety 
hazards reasonably likely to occur in the production process and to 
identify the preventive measures an establishment can apply to control 
those hazards in the production of particular products.
    Currently, FSIS samples and tests for E. coli O157:H7, non-O157 
STEC (O26, O45, O103, O111, O121, or O145), and Salmonella in raw beef 
manufacturing trimmings and E. coli O157:H7 and Salmonella in bench 
trim verification samples using the N60 excision sampling method, as 
described in FSIS Directive 10,010.1, Sampling Verification Activities 
for Shiga Toxin-Producing Escherichia coli (STEC) in Raw Beef 
Products.\1\ The N60 excision sampling method is a destructive sampling 
method that requires inspection personnel to use knives or hooks to cut 
and collect at least 60 thin slices (approximately 3 inches long by 1 
inch wide and \1/8\ inch thick) from the external surface of beef 
tissues in a product lot.\2\ The 60 samples are combined into one or 
more 325-gram units for analytical testing.
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    \1\ https://www.fsis.usda.gov/policy/fsis-directives/10010.1.
    \2\ Establishments determine their lot size. A lot is usually 
made up of no more than five, 2,000-pound combo bins of beef 
trimmings or less than 10,000 pounds if the establishment is using 
boxes.
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    In recent years, FSIS and other agencies have been researching 
different methods for collecting samples from beef manufacturing 
trimmings that are less destructive and safer for inspectors to 
collect, yet still produce comparable results to the N60 excision 
sampling method.\3\ Findings from these studies provide strong 
scientific support for the use of cloth-based sampling for verification 
testing. Below is a discussion of the findings from different studies.
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    \3\ See 85 FR 34397 and FSIS' Constituent Update--December 18, 
2020  Food Safety and Inspection Service (usda.gov), which 
is available at: https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-december-18-2020.
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Agricultural Research Service (ARS) Sampling Studies

    In 2018, USDA's ARS performed studies comparing the N60 excision 
sampling method and the N60 Plus \4\ to the cloth sampling method using 
a continuous sampling device and a manual sampling device.\5\ The 
continuous sampling device used a cloth held by a cassette attached to 
a bracket at the end of a conveyor line to collect samples as the meat 
rubbed across the cloth \6\ and fell into the combo bins. The manual 
sampling device used the same type of cloth as the continuous sampling 
device, and it was used to manually rub all trim across the entire top 
surface of the combo bin to collect a sample. The manual sampling 
device

[[Page 71292]]

was found to be best for hand-picked and other bin-fill stations where 
the continuous sampling device could not be installed. ARS conducted 
experiments testing for naturally occurring E. coli O157:H7 and 
Salmonella, inoculated surrogates (green fluorescent protein-labeled 
(GFP) E. coli), and indicator organisms (aerobic plate count (APC), 
generic E. coli, and coliforms) in five different processing 
establishments, on multiple days, across multiple lean percentages (50, 
80, 90, and 93 percent lean). Experiments with natural contamination 
(substances already in the environment) found no E. coli O157:H7, no 
statistically significant difference in prevalence of Salmonella 
(continuous sampling device 9.2 percent versus N60 excision sampling 
device 6.0 percent) and similar levels of indicator organisms for the 
continuous sampling device compared with both the N60 excision and N60 
Plus sampling methods . In additional experiments, the continuous 
sampling device found the same or higher prevalence of naturally 
occurring E. coli O157:H7 and GFP E. coli, as well as similar levels of 
indicator organisms compared with the N60 method. In the next 
experiment, the manual sampling device found similar prevalence of E. 
coli O157:H7 surrogate organisms, and slightly lower (P < 0.05) levels 
of indicator organisms compared with N60 Plus. An additional experiment 
showed the manual sampling device found similar prevalence of naturally 
occurring E. coli O157:H7 and the same or slightly higher (P < 0.05) 
levels of naturally occurring indicator organisms compared with N60 
Plus. In a further experiment, the manual sampling device detected the 
same prevalence of naturally occurring Salmonella as the N60 excision 
sampling method. ARS concluded that the results of their experiments 
collectively demonstrated that sampling beef trim using the cloth 
sampling method (using either a continuous sampling device or manual 
sampling device) provides organism recovery that is similar, comparable 
to or better than the N60 excision sampling method.
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    \4\ N60 Plus is similar to the N60 excision sampling method, but 
it uses a stainless-steel sampling device on a drill to collects 
surface tissue.
    \5\ Wheeler, T.L. & Arthur T.M. (2018). Novel Continuous and 
Manual Sampling Methods for Beef Trim Microbiological Testing. 
Journal of Food Protection, 81(10), 1605-1613. https://doi.org/10.4315/0362-028X.JFP-18-197.
    \6\ ARS initially used the continuous sampling device with a 
cellulose sponge. However, ARS quickly determined that the cellulose 
sponge was too expensive for commercial implementation.
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    In 2021, ARS conducted another study to determine the efficacy of 
the cloth sampling method in scenarios that included smaller combo 
bins.\7\ ARS collected 1,650 matched (cloth and N60) samples collected 
at the same time from 540 individual combo bins at six commercial beef 
processing establishments, comparing the cloth sampling method (using 
both continuous and manual sampling devices) to the N60 excision 
sampling method and N60 Plus. In this second study, ARS analyzed the 
presence of select virulence associated genes (hemolysin, five non-
adulterant O serogroups (O55, O113, O117, O126, and O146), intimin, 
heme receptor, adhesion siderophore, tetA and tetB) to act as index 
targets--measures that would correlate with the percent positive of 
STEC and Salmonella. One experiment observed no difference in the 
percent positive for pathogen index targets from product at two lean 
types, between the cloth manual sampling device and N60 excision method 
(n=185). When evaluated on combo bins with a smaller surface area 
([ap]0.93 m\2\ [ca. 1,439 in\2\] instead of 1 m\2\ [ca. 1,600 in\2\]), 
the manual sampling device had a higher percent positive for the heme 
receptor gene target (52.5 versus 25 percent) and recovered 0.3 
log10 more aerobic bacteria (APC) than the N60 Plus method 
(P < 0.05; n=40).
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    \7\ Arthur T.M. & Wheeler T.L. (2021). Validation of Additional 
Approaches and Applications for Using the Continuous and Manual 
Sampling Devices for Raw Beef Trim. Journal of Food Protection, 
84(4), 536-544. https://doi.org/10.4315/JFP-20-345.
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    In a further experiment on smaller surface area combo bins, the 
cloth manual sampling device method recovered more O serogroup positive 
samples than the N60 Plus (86.3 percent and 63.8 percent respectively; 
P < 0.05). The cloth manual sampling device also recovered 0.2 
log10 more Enterobacteriaceae than N60 Plus (n=80). There 
was no difference between the cloth manual sampling device and N60 Plus 
recovery of five other pathogen index target genes and aerobic plate 
count (APC).
    In one final experiment, 80 combo bins were sampled to compare the 
continuous sampling device, manual sampling device, and N60 Plus 
methods. There were no significant differences among the three sample 
collection methods for any of the pathogen index gene targets. As a 
result, ARS concluded that their study supports various alternative 
applications of the cloth sampling method for robust pathogen 
detection. Based on ARS' research, FSIS issued a letter of no objection 
in March 2017 to allow industry to use cloth sampling methods for 
microbiological sampling of raw beef trim and a second letter of no 
objection in March 2020 for specific in-plant validation procedures.

FSIS In-Field Studies

    Starting in December 2019, and still ongoing, FSIS performed a 
combination of laboratory and field studies to compare the N60 excision 
sampling method to the cloth sampling method. The project began with an 
initial laboratory study to compare Salmonella and STEC recovery using 
polyurethane sponge and cloth sampling methods against the current N60 
excision sampling method. The laboratory used raw beef trim reserves 
that previously tested negative for Salmonella and STEC to prepare 
samples simulating IPP collected product. FSIS laboratory 
microbiologists inoculated the beef trim with E. coli O157:H7, and non-
O157 (O103 and O121)) and Salmonella at low levels (3.5-7.5 cfu/2--
pound test bin). Microbiologists used a dry cloth to sample and 
simulate the shipment of samples. After reviewing analyte recovery of 
each technique, the cloth sampling method was selected for additional 
review in the field because there was no difference in E. coli O157:H7 
or O103 recovery. Although the cloth recovered significantly less O121, 
there was no difference in Salmonella recovery. Overall, the cloth 
sampling method recovered pathogens when present in the product sampled 
that had been inoculated at very low levels.
    FSIS then conducted an exploratory field study to directly compare 
the manual cloth sampling method as developed by ARS, to the N60 
excision sampling method when performing inspection verification of 
establishment beef trim. IPP collected the beef trim samples in the 
exploratory study matched with routine N60 samples and analyzed both 
for APC and Salmonella. Based on preliminary results, FSIS considered 
if the cloth manual sampling method may be improved by addition of a 
neutralizing buffer before shipping.
    The second laboratory study evaluated neutralizing buffer options 
for the cloth sampling method. FSIS laboratory microbiologists 
inoculated beef trim with E. coli O157:H7 at concentrations of 5-10 
cfu/cloth and Salmonella ~5 x 10\4\ cfu/cloth. FSIS tested three 
treatments: (1) 25 mL neutralizing Buffered Peptone Water (nBPW) (2), 
25mL buffered peptone water (BPW), and (3) a dry cloth. Adding the 
transport buffer nBPW to the cloth after inoculation and before 
simulated shipping improved analyte recovery by 0.16 log more than when 
the dry cloth (i.e., no transport buffer) was used. Using nBPW did not 
inhibit screening or survival or recovery of E. coli O157:H7 compared 
with the dry cloth.
    This led to a final field study where IPP began adding 25 ml of 
nBPW as a transport buffer to cloth samples after collection and before 
shipping to further protect sample integrity during transit. This study 
showed that the cloth

[[Page 71293]]

sampling method plus the addition of the transport buffer recovered 
significantly more bacteria (0.38 log Aerobic Count) than the N60 
sampling method (see diagram below).\8\
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    \8\ The units on the y-axis are probability densities that are 
calculated for normal distributions with mean and standard error 
(se) values as shown. Probability density--or density--can be 
interpreted as relative likelihood of the x-axis values.
[GRAPHIC] [TIFF OMITTED] TN22NO22.000

    FSIS also tested for Salmonella, based on the current data, the 
differences in results were not significantly different (N60 2.0 
percent; cloth 1.7 percent).
    FSIS conducted a qualitative review of noncompliance reports (NRs) 
for establishments failing to detect STEC when FSIS verification 
sampling detected a STEC positive sample result. FSIS used data from 
samples of beef manufacturing trimmings and bench trim collected 
between April 2015 and December 2021 to determine if establishments 
using the cloth sampling method failed to detect STEC when concurrent 
FSIS testing found a positive sample collected using N60. Some 
establishments began using the cloth sampling method in 2017, but 
industry more widely adopted cloth sampling after March 2020 when FSIS 
issued a second letter of no objection for in-plant validation 
procedures for cloth sampling. NRs, from a total of 15 establishments, 
citing 9 CFR 310.2 and 417.4(a) issued during three periods were 
reviewed: before cloth implementation (8 NRs), during the transition 
period (11 NRs), and after establishments began cloth sampling (4 NRs). 
The analysis showed that industry adopting cloth sampling did not 
increase NRs due to missed STEC positive lots. Most of the NRs that 
were issued after cloth implementation were due to the establishments 
only testing for E. coli O157:H7 and failing to detect non-O157 
adulterant STEC-positive product. Careful consideration of these 
various studies \9\ have led FSIS to conclude that there is no 
significant difference in microbial recovery between cloth manual 
sampling and N60 excision methods. FSIS has determined the cloth 
sampling method with nBPW is equivalent to N60 excision sampling.
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    \9\ Scientific Support for FSIS to Use a Surface Sampling Method 
for Beef Trim PowerPoint available at: https://www.fsis.usda.gov/sites/default/files/media_file/documents/FSIS_N60vClothSampling-RawBeefTrim_20221107_v2.7B.ppt.
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FSIS Implementation Plan

    FSIS will replace the N60 excision sampling of domestic beef 
manufacturing trimmings and bench trim with the cloth sampling method, 
including nBPW transport buffer. At this time, FSIS does not intend to 
implement any changes to the sample collection method for frozen 
imported products or any domestic raw beef processed products other 
than beef manufacturing trimmings and bench trim using the cloth 
sampling method. No one has evaluated the cloth's ability to recover 
bacteria from frozen beef products. USDA ARS researchers recommend 
against sampling frozen beef trim with the cloth since there is no 
liquid for the cloth to absorb and collect. Also, FSIS will continue to 
use the current directions in FSIS Directive 10,010.1, Sampling 
Verification Activities for Shiga Toxin Producing Escherichia coli 
(STEC) in Raw Beef Products \10\ for sampling ground beef and other raw 
ground beef components including head meat, cheek meat, weasand 
(esophagus) meat, product from advanced meat recovery (AMR) systems, 
partially defatted chopped beef and partially defatted beef fatty 
tissue, low temperature rendered lean finely textured beef, and heart 
meat.
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    \10\ FSIS Directive 10,010.1 Revision 4--Sampling Verification 
Activities for Shiga Toxin-Producing Escherichia Coli (STEC) in Raw 
Beef Products available at: https://www.fsis.usda.gov/sites/default/files/media_file/2020-07/10010.1.pdf.
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Costs and Benefits Analysis

    The Agency does not expect the implementation of cloth sampling for 
the sampling of beef manufacturing trimmings and bench trim by FSIS to 
have a cost impact on the industry. As described before, both ARS 
studies and FSIS in-field studies have found no statistically 
significant change in testing results.
    The change will enable FSIS to allocate some resources, including 
supplies, shipping costs, and analysis time, to other sampling 
verification activities. It may also reduce inspector injuries as they 
will no longer be using knives to sample product, as well as decrease 
sample collection time. Finally, the non-destructive sampling will also 
save food (meat) from being cut

[[Page 71294]]

and wasted, at about 2 pounds per sample.

Conclusion

    Based on the above studies showing the effectiveness of cloth 
sampling in recovering indicator organisms and pathogens and the 
resources saved by FSIS, the Agency plans to move forward with using 
cloth sampling in lieu of N60 excision sampling on beef manufacturing 
trimmings and bench trim. FSIS also anticipates saving resources by 
adopting this change.

USDA Non-Discrimination Statement

    In accordance with Federal civil rights law and U.S. Department of 
Agriculture (USDA) civil rights regulations and policies, USDA, its 
Mission Areas, agencies, staff offices, employees, and institutions 
participating in or administering USDA programs are prohibited from 
discriminating based on race, color, national origin, religion, sex, 
gender identity (including gender expression), sexual orientation, 
disability, age, marital status, family/parental status, income derived 
from a public assistance program, political beliefs, or reprisal or 
retaliation for prior civil rights activity, in any program or activity 
conducted or funded by USDA (not all bases apply to all programs). 
Remedies and complaint filing deadlines vary by program or incident.
    Program information may be made available in languages other than 
English. Persons with disabilities who require alternative means of 
communication to obtain program information (e.g., Braille, large 
print, audiotape, American Sign Language) should contact the 
responsible Mission Area, agency, or staff office; the USDA TARGET 
Center at (202) 720-2600 (voice and TTY); or the Federal Relay Service 
at (800) 877-8339.
    To file a program discrimination complaint, a complainant should 
complete a Form AD-3027, USDA Program Discrimination Complaint Form, 
which can be obtained online at https://www.ocio.usda.gov/document/ad-3027, from any USDA office, by calling (866) 632-9992, or by writing a 
letter addressed to USDA. The letter must contain the complainant's 
name, address, telephone number, and a written description of the 
alleged discriminatory action in sufficient detail to inform the 
Assistant Secretary for Civil Rights (ASCR) about the nature and date 
of an alleged civil rights violation. The completed AD-3027 form or 
letter must be submitted to USDA by:
    (1) Mail: U.S. Department of Agriculture, Office of the Assistant 
Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 
20250-9410; or
    (2) Fax: (833) 256-1665 or (202) 690-7442; or
    (3) Email: usda.gov">program.intake@usda.gov
    USDA is an equal opportunity provider, employer, and lender.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS web page located at: 
https://www.fsis.usda.gov/federal-register.
    FSIS will also announce and provide a link to it 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 
Constituent 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: https://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.

    Done at Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2022-25333 Filed 11-21-22; 8:45 am]
BILLING CODE 3410-DM-P