[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">[email protected]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