Notice2021-14554
Availability of Revised Compliance Guidelines for Controlling Salmonella and Campylobacter in Raw Poultry
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Published
July 8, 2021
Issuing agencies
Agriculture DepartmentFood Safety and Inspection Service
Abstract
The Food Safety and Inspection Service (FSIS) is announcing the availability of revised guidelines to assist poultry establishments in controlling Salmonella and Campylobacter in raw poultry. The Agency has revised the content of the guidelines in light of new scientific and technical information, public comments received on the 2015 guideline, and the Agency's decision to issue two separate guidelines-- one on controlling Salmonella and the other on controlling Campylobacter. The guidelines provide "best practice" recommendations that poultry establishments may follow to reduce Salmonella and Campylobacter contamination of raw products.
Full Text
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[Federal Register Volume 86, Number 128 (Thursday, July 8, 2021)]
[Notices]
[Pages 36086-36090]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14554]
[[Page 36086]]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2014-0034]
Availability of Revised Compliance Guidelines for Controlling
Salmonella and Campylobacter in Raw Poultry
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
the availability of revised guidelines to assist poultry establishments
in controlling Salmonella and Campylobacter in raw poultry. The Agency
has revised the content of the guidelines in light of new scientific
and technical information, public comments received on the 2015
guideline, and the Agency's decision to issue two separate guidelines--
one on controlling Salmonella and the other on controlling
Campylobacter. The guidelines provide ``best practice'' recommendations
that poultry establishments may follow to reduce Salmonella and
Campylobacter contamination of raw products.
ADDRESSES: Downloadable versions of the revised guidelines are
available at <a href="https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/guidelines">https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/guidelines</a>. The Agency has not published hard
copies of these documents.
FOR FURTHER INFORMATION CONTACT: Rachel A. Edelstein, Assistant
Administrator, Office of Policy and Program Development, FSIS;
Telephone: (202) 205-0495.
SUPPLEMENTARY INFORMATION:
Background
On December 16, 2015, FSIS published a Federal Register notice (80
FR 78166) announcing the availability of and opportunity to comment on
a revised Agency compliance guideline for controlling Salmonella and
Campylobacter in raw poultry. This revision was the fourth edition of
the guideline the Agency had developed to assist establishments that
slaughter or process raw poultry products to minimize or prevent the
risk of Salmonella and Campylobacter in their operations.
Updated Guidelines
FSIS has updated the guideline contents to reflect the most recent
best practices, supported by current peer-reviewed literature and
analyses of FSIS data. Updates include information on using
neutralizing agents in sampling to prevent carryover of antimicrobial
substances and a current list of antimicrobials for establishment use.
Also included are improvements in the information on pre-harvest
practices, with a comprehensive revision of the litter/bedding section.
With the updated information, establishments of various sizes and
configurations have practical options for reducing and inhibiting the
growth of pathogens commonly found in raw poultry.
In response to the comments, FSIS also reviewed the recommendations
in the previous version of the guideline and assessed each section for
utility and effectiveness. The resulting changes include a complete
revision of the sections on litter and bedding and updates to FSIS data
on the rate at which Salmonella or Campylobacter contamination can be
attributed to source materials of different composition. Also, the
Agency is now issuing the revised document as two separate guidelines,
one focused on control of Salmonella, and the other on Campylobacter.
The guidelines are posted at <a href="https://www.fsis.usda.gov/policy/fsis-guidelines">https://www.fsis.usda.gov/policy/fsis-guidelines</a>. Although comments will no longer be accepted through
<a href="http://regulations.gov">regulations.gov</a> on these guidelines, FSIS will update these documents
as necessary if new information becomes available.
Comments and Responses
FSIS received fifteen comments in response to the December 16,
2015, Federal Register notice and guideline. The commenters included
consumer and industry associations, individuals, and firms that
specialize in providing technology and services to the regulated
industry. The comments and the Agency's responses, discussed below,
have been grouped by topic area.
Pre-Harvest
Comment: A poultry industry association remarked that
considerations and sampling for Salmonella and Campylobacter should not
affect the Hazard Analysis and Critical Control Point (HACCP) system of
the receiving establishment. The same association stated that, while
good husbandry practices are important, the goal of obtaining pathogen-
free flocks and many of the recommendations for doing so are
unrealistic and unnecessary. According to the association, the Agency
should revise the discussion of pre-harvest practices in the guideline
to reflect currently available, commercially proven methods that can be
practically implemented.
Response: Information about pre-harvest conditions and
particularly, pathogen levels on incoming flocks, can inform the
establishment's hazard analysis and decisions on controls to include in
its HACCP plan. In the guideline, FSIS acknowledges that there may be
no single pre-harvest intervention that eliminates Salmonella and
Campylobacter as pre-harvest hazards. The Agency recommends instead a
multi-hurdle approach involving successive interventions that can have
a cumulative effect in reducing the pathogen contamination of birds.
The Agency has modified some language in the pre-harvest section of the
guideline to reflect current scientific literature.
Comment: The poultry industry association said that another area of
concern is the recommendation to change bedding between each flock.
According to the poultry industry association, that is not always the
best way to control Salmonella growth because new litter can be a
bigger risk factor for Salmonella than old litter, depending on the pH
profile involved. The poultry industry association argued that the
section on transportation crate maintenance is similarly impractical.
Response: Litter, or bedding, can be considered a potential
reservoir for contamination with Salmonella and other pathogens. The
presence or absence of contamination in litter is among the pre-harvest
conditions of which a prudent establishment should be aware, along with
clean transport crates. FSIS has updated the pre-harvest and
transportation sections of the guideline with practical suggestions,
based on informative studies, and also updated the section on scheduled
slaughter (taking account of pathogen loads on incoming flocks).
Sanitation
Comment: An animal health and food-safety technology and services
provider recommended changes in the guideline discussion of cleaning
procedures by adding, after the removal of debris, dry-pickup of gross
soils and pre-rinsing to remove remaining soil before using a cleaning
agent, such as a detergent. This commenter also recommended that the
guideline include a table (provided by the commenter) showing the
factors to consider when choosing a sanitizer for a particular
application.
Response: FSIS has accepted the recommended edits to the discussion
of cleaning procedures in the sanitation section. The Agency has also
removed some outdated references that the commenter noted and added the
table of sanitizer characteristics.
[[Page 36087]]
Comment: The poultry industry association said that the guideline
includes prescriptive practices that are neither reasonable nor
necessary and that are not conducive to chicken processing. For
example, the association stated that sanitizing hand-held knives
between each carcass is not reasonable, nor would it result in
significant pathogen reduction on final products. According to the
association, sanitization between each carcass would increase handling
time and create more opportunity for pathogen outgrowth, thereby
increasing food-safety risks.
Response: The guideline recommends sanitizing knives in 180-degree
water or an antimicrobial solution after cutting or trimming each
carcass, which should result in the reduced transfer of pathogens from
one carcass to the next.
FSIS guidance is intended to offer practical solutions to food
safety problems, with some recommendations likely more useful in small
and very small establishments and others more suitable for large
establishments. Most of the information in this guidance should be
useful to all establishments, including small and very small
establishments. Although bacterial outgrowth is not a result of time
alone, it would certainly be one consideration for an establishment
contemplating this factor in its process.
Comment: The poultry industry association added that other
recommendations in the guidelines, such as that to limit solution reuse
during injection marinating to prevent contamination, is not supported
by scientific evidence.
Response: FSIS updated the guidelines to include citations to
scientific studies indicating that marination of non-heat-treated
poultry parts can result in larger bacterial populations on the
poultry,\1\ depending on the type of marinade used.\2\ Injection or
other contact across carcasses can introduce a potential point for
cross-contamination. A prime example in the guidance showing this
mechanism of internalizing pathogens is an outbreak of Escherichia coli
O157:H7 in beef steaks that occurred in 2007.\3\ Establishments should
consider the effects of injected solutions in their hazard analyses (9
CFR 417.2(a)) and support all decisions made in the hazard analysis, 9
CFR 417.5(a)(1). At this step in a process, an establishment could
address the risk in several ways, depending on its process. One
approach described in the guidelines is the use of an ultraviolet light
intervention applied to the marinade solution between uses.\4\
Additionally, the formulation of a marinade may include antimicrobial
components, to achieve a specific pH or antimicrobial activity;
examples of acceptable ingredients for this use are listed in the
lookup table of FSIS Directive 7120.1, ``Safe and Suitable
Ingredients.''
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\1\ See Hinton, et al., (ARS) abstract for International
Association for Food Protection (2004), ``Comparison of
psychrotrophic bacterial flora of fresh and marinated chicken breast
fillets during refrigerated storage.''
\2\ See R. Thanissery and D.P. Smith, ``Effect of Marinade
Containing Thyme and Orange Oils on Broiler Breast Fillet and Whole
Wing Aerobic Bacteria During Refrigerated Storage,'' in The Journal
of Applied Poultry Research 23 (2): 228-232; May 2014
\3\ See FSIS. 2007. ``Pennsylvania Firm Recalls Beef Products
for Possible E. coli O157:H7'' Recall Release. Available at: <a href="https://www.fsis.usda.gov/wps/wcm/connect/5a217ede-de72-474a-b384-6643a8ac12f8/Recall_019_2007_Release.pdf?MOD=AJPERES">https://www.fsis.usda.gov/wps/wcm/connect/5a217ede-de72-474a-b384-6643a8ac12f8/Recall_019_2007_Release.pdf?MOD=AJPERES</a>.
\4\ Beers KL, Cook PE, Coleman CW, and Waldroup AL. 2010.
Efficacy of ultraviolet light systems for control of microorganisms
in poultry and beef brine and marinade solutions. Poult Sci. 89 (E-
Supplement 1): 615.
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Lotting Practices
Comment: A poultry industry association asked the Agency to revise
its recommendations on lotting practices to remove the emphasis on
``microbiological independence'' relating to pathogens that do not
legally adulterate raw product by their presence alone, or per se.
Response: FSIS did not make changes to its recommendations on
lotting practices. Concepts related to microbiological independence, or
the unlikelihood of cross-contamination, apply to all pathogens.
Considering lotting practices in such cases can help to maximize the
value of testing and process control throughout production. Under
HACCP, establishments may test for pathogens to verify that they are
adequately addressing microbial hazards.
Also, as discussed in the December 6, 2012, Federal Register Notice
on HACCP-plan reassessment for not-ready-to-eat (NRTE) comminuted
poultry products (77 FR 72686, at 72689), when a NRTE product is
credibly linked to an outbreak of illness caused by a pathogen, FSIS
may consider the product to be adulterated, even if the pathogen does
not adulterate the implicated NRTE product per se.
Comment: The poultry industry association said that, in addition to
the above concerns regarding microbiologically-based lotting practices,
the Agency should be aware that: Lot-traceback information may be
commercially sensitive; separation in time and space is difficult in
establishments running multiple lines and mixing flocks; and
microbiological testing takes days to complete--too late for processed
poultry already in commerce. For these reasons, according to the
poultry industry association, the Agency should remove these
recommendations from the guideline.
Response: As mentioned in the previous response, in situations
where pathogenic organisms in NRTE products have been linked to
foodborne illness outbreaks, FSIS has deemed the products to be
adulterated. FSIS and members of the regulated industry have been
interested in preventing situations like those. Accordingly, the
guideline contains recommendations for lot separation, traceback, and
microbiological testing. These approaches to monitoring, tracking, and
controlling potentially contaminated products can help in preventing
pathogen spread and illness outbreaks.
Comment: The poultry industry association said that recordkeeping
recommendations must be relevant to establishment operations and must
allow for flexibility according to establishment size and resources.
Response: The recordkeeping recommendations in the guideline are
premised on the assumption that the establishment already has records
that meets the HACCP, Sanitation Standard Operating Procedures, and
other regulatory requirements. Establishments have significant
flexibility in meeting these recordkeeping requirements and
recordkeeping will vary in technical and other aspects from
establishment to establishment. Additionally, the guideline sets out
recordkeeping elements that are associated with sampling and testing
and that are fairly basic and general. As such, FSIS has not revised
the recordkeeping guidance.
Process Control
Comment: A poultry industry association requested that the Agency
clarify key concepts and terms used in the guidance. For example, the
association said that, while FSIS states throughout the guidance that
establishments should reduce pathogens to ``acceptable levels,'' the
guideline is not clear enough about what those acceptable levels are.
The poultry industry association suggested that FSIS use its pathogen
reduction performance standards as examples of acceptable levels and
state that other metrics than prevalence might be used in evaluating
acceptable levels.
Response: In the context used in the guidelines, ``acceptable
levels'' of pathogens are defined by an establishment for use as
control
[[Page 36088]]
parameters in its HACCP system. These upper and lower control limits
may use prevalence to measure control of a hazard over time. As defined
in the 2009 review of FSIS public health risk-based systems by the
Institute of Medicine, ``[a] process is in control when, within the
limits of a stable and predictable process variation, all hazards are
controlled to an acceptable level.'' \5\
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\5\ IOM (Institute of Medicine). 2009. Review of the Use of
Process Control Indicators in the FSIS Public Health Risk-Based
Inspection System: A Letter Report. Washington, DC: The National
Academies Press. P.12.
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Data collected initially by the establishment can be used in
process mapping for HACCP validation. The establishment can compare
pathogen levels on incoming and final product to determine whether the
process is achieving the desired reduction in microbial loads. Then, if
the pathogen testing results demonstrate that the process is
functioning correctly, the establishment can use the testing results
for indicator bacteria to set a maximum limit for each indicator at
each collection point. FSIS agrees with the commenter, however, that
where the Agency's pathogen-reduction performance standards apply, an
acceptable level would be one that is at or below the pathogen limit of
a standard. Just as in the 2015 guidance, the updated guidance
continues to advise an establishment seeking to reduce microbial
hazards to consider FSIS's applicable Salmonella and Campylobacter
performance standards for carcasses, parts, and comminuted poultry.
Comment: The poultry industry association said that, additionally,
the guideline frequently instructs establishments to reevaluate their
processes if they are resulting in ``high numbers'' of Campylobacter or
Salmonella subtypes more commonly associated with human illness,
without defining what the Agency views as a ``high level'' of these
serotypes. Further, the poultry industry association argued that
serotypes have little or no practical impact on HACCP systems.
According to the commenter, a good HACCP system should work to control
all Salmonella serotypes or Campylobacter species regardless of their
serotype.
Response: Under HACCP, criteria for additional testing or actions
are defined by the establishment. These criteria could be derived from
the establishment's own baseline data, as well as the frequency at
which serotypes of human-health concern are identified in that
baseline. While FSIS agrees that HACCP systems should address all
pathogens, FSIS uses characterization data, including serotypes of
increased human health concern, to prioritize further evaluation and
assessment of an establishment's HACCP system. Specifically, if an
establishment does not meet FSIS performance standards, as part of the
public health review evaluation (PHRE), FSIS will assess whether the
Agency has found frequent serotypes of public health concern in the
establishment's product. If so, FSIS will also likely conduct a food
safety assessment (FSA) at the establishment.
Comment: A poultry industry association noted that the 2015
guidance appears to conflate the terms ``prevalence'' and ``load'' when
referring to recommendations for decreasing Salmonella and
Campylobacter. According to the poultry industry association, the
``prevalence'' of a pathogen on raw poultry product is a distinctly
different microbial sampling metric than the ``load,'' or quantity, of
pathogen on a raw poultry product. The prevalence of a pathogen refers
to the presence or absence of a pathogen, regardless of quantity and is
usually expressed as a percentage or rate of occurrence over time. By
contrast, the microbial load of a pathogen refers to the concentration
of bacteria (for example, in colony-forming units) in or on a unit of
product. Yet, according to the poultry industry association, the
guideline uses the terms ``prevalence'' and ``load'' interchangeably
when recommending practices to decrease the ``prevalence'' or ``load''
of Salmonella and Campylobacter on raw poultry products. The poultry
industry association argued that these two metrics are not, in fact,
interchangeable. Since FSIS had reiterated that the Agency will focus
on the presence of Salmonella or Campylobacter rather than on load, the
poultry industry association recommended that the Agency revise the
guidance for consistency in referring to ``prevalence'' rather than
``load.'' According to the poultry industry association, the guidance
should refer to ``prevalence'' rather than ``load.''
Response: FSIS disagrees that it conflated the terms ``prevalence''
and ``load'' and did not make the poultry association's recommended
changes to the guidelines. Establishments are not limited to
considering only prevalence, which may be derived from qualitative test
results over time, when designing and implementing a HACCP system.
Available tools for enumeration can help inform a prudent establishment
so that it can consider the impact of pathogen load, or the actual
levels of contamination in positive samples, along with the prevalence
information in order to improve process-control systems.
Comment: The poultry industry association offered several
recommendations intended to improve discussion in the guidance of data
analysis techniques. Thus, in the area of process mapping, the poultry
industry association recommended that FSIS give establishments the
flexibility to use process indicators that reliably reflect their
operations and environments. The poultry industry association also
suggested edits to make the text more consistent with tables that show
median values for indicator organisms on poultry carcasses and parts.
The poultry industry association remarked that linking a product with
human illness is not necessarily evidence of a loss of control by the
establishment that prepared the product. The poultry industry
association also stated that the use of (microbiological) performance
standards is not the only way to evaluate process controls. The
commenter also stated that the ``moving window'' approach to monitoring
and assessing whether establishments meet performance standards and use
of the category-ranking system has not been evaluated for assessing
process control.
Response: Establishments are free to choose appropriate
microbiological indicators for determining process-control
effectiveness. FSIS has removed some of the material about sampling for
specific indicator organisms, including the sections regarding median
indicator values, as more detail is provided in the FSIS Compliance
Guideline: Modernization of Poultry Slaughter Inspection--
Microbiological Sampling of Raw Poultry \6\ to assist small and very
small establishments that may not have their own baseline information.
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\6\ Available at: <a href="https://www.fsis.usda.gov/guidelines/2015-0013">https://www.fsis.usda.gov/guidelines/2015-0013</a>.
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While microbiological performance standards may not be the only
measures of process control, they do help focus industry attention on
the public health aspects of poultry processing and the need to improve
processes as necessary to prevent foodborne illnesses. During the past
two years, FSIS has been employing the ``moving window'' data-frame for
microbiological test results on poultry products as a way of
determining whether establishments meet performance standards over
time. FSIS has evaluated the technique as a more consistent replacement
for sampling sets that can better identify trends, such as seasonality,
over time.
Comment: The poultry industry association recommended that FSIS
[[Page 36089]]
adjust its picture caption concerning optimal application of
antimicrobial spray to a conveyor belt and products on the belt. The
poultry industry association also noted that application of the spray
does reduce pathogens even if the coverage of the spray is less than
complete.
Response: FSIS has modified the language of the caption in question
in the guidance to clarify the point that not all the belt is being
treated. The Agency acknowledges that there will be some pathogen-
reduction effects like those in the illustration but recommends that
the spray adequately cover the belt and products.
Comment: The poultry industry association stated that the 2015
guidance instructed establishments to evaluate their process if they
encountered ``high numbers'' of serotypes of public health concern.
According to the poultry industry association, the Agency should
instead advise establishments to work at controlling all species of
Salmonella or Campylobacter, regardless of serotype.
Response: The guidance encourages establishments to control all
Salmonella and Campylobacter throughout their process. Establishments
should consider all available information about hazards identified from
their operations. This may include information about the point in the
process where hazards are most often recovered, the lot or flock
information, and characterization of the hazard recovered, including
serotype. FSIS provides Salmonella serotype results to establishments
to facilitate their efforts in identifying the appropriate response,
which could include both serotype-specific interventions at pre-harvest
(e.g., vaccines) as well as Salmonella controls in the establishment.
Comment: The poultry industry association said in the section of
the guidance on sampling and testing, it appeared that the Agency
expected sampling and testing results for pathogens to be available in
real time to assess bacterial load just before processing. The poultry
industry association noted that this is not possible.
Response: FSIS has clarified the language in this section of the
guidance to note that these testing options would need to be performed
with adequate time allowed for the results to be used as effective
tools. A number of rapid-testing methodologies may be fit-for-purpose
for this use.
Comment: The poultry industry association stated that the Agency
should provide additional information relating to its exploratory
sampling results for raw, comminuted chicken in the guidance. The
associated noted that Table 6 presents the prevalence rates of
Salmonella and Campylobacter in mechanically separated chicken and
ground and comminuted chicken products, organized by whether the source
material had bone or skin in it. According to the poultry industry
association, it would be useful to know how many samples were available
for each of the statistics generated for the percent prevalence for
these products, given the limited number of samples in the 2015
guideline dataset.
Response: FSIS has updated the statistics reported in Table 6 of
the guidance with additional data points to strengthen the analysis.
These updated tables represent 934 comminuted turkey samples and 2,688
comminuted chicken samples, more than 10 times the data points for
chicken and 40 times the data points for turkey versus the data points
used for the 2015 guidance. Analyses of FSIS comminuted poultry
exploratory sampling results shows that it is more likely that
comminuted chicken will be positive for Salmonella when its source
materials contain both bone and skin (56.0%). However, for
Campylobacter, comminuted chicken products made from bone-in and
skinless source materials were highest. Comminuted chicken made from
deboned and skinless source materials had the lowest prevalence for
both pathogens (34.8% for Salmonella, and 1.7% for Campylobacter).
Statistical analyses, including that for independence and for
significance, were used to evaluate the data before compiling the
relative risk tables that have been updated in this edition of the
guidance.
Antimicrobial Interventions
Comment: An environmental advocacy group questioned the Agency's
continued support for food irradiation.
Response: The guidance includes irradiation among the safe and
effective physical interventions available. While FSIS does not
recommend the use of specific interventions or lethality treatments,
food irradiation has been demonstrated to be both safe and effective in
controlling pathogens. FSIS and the Food and Drug Administration (FDA)
regulations authorize its use in the treatment of ready-to-cook poultry
(9 CFR 424.22(c), citing 21 CFR 179.26)).
Comment: The same advocacy group noted that the Agency continues to
recommend the use of various chemical agents to reduce the levels of
Salmonella and Campylobacter in poultry processing. It asked about the
role played by the Occupational Safety and Health Administration (OSHA)
in determining permissible exposure levels (PELs) for these substances
and their impact on FSIS inspectors and on plant employees.
Response: While FSIS does not recommend the use of specific
interventions, many chemical products have been demonstrated to be both
safe and effective. Chemical substances used in the processing of meat,
poultry, and egg products are approved by both FDA and FSIS before they
can be used in official establishments. They are listed in the on-line
table referred to in FSIS Directive 7120.1, ``Safe and Suitable
Ingredients used in the Production of Meat, Poultry, and Egg
Products,'' \7\ which is updated regularly.
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\7\ Available at: <a href="https://www.fsis.usda.gov/wps/wcm/connect/bab10e09-aefa-483b-8be8-809a1f051d4c/7120.1.pdf?MOD=AJPERES">https://www.fsis.usda.gov/wps/wcm/connect/bab10e09-aefa-483b-8be8-809a1f051d4c/7120.1.pdf?MOD=AJPERES</a>.
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FSIS does not allow the use of chemicals in a manner that may be a
health risk to inspection personnel. Inspectors in every establishment
verify that establishments use only approved chemicals as ingredients
and only within approved limits, as outlined in FSIS Directive 7120.1.
In addition, the Agency has a network of occupational safety and health
experts in its inspection districts and distributes information on
health hazards to its workforce. The information includes the OSHA PELs
and other exposure limits applying to chemicals that may be used in
meat, poultry, and egg products plants. (See <a href="https://www.fsis.usda.gov/wps/portal/informational/aboutfsis/audience-employees/employee-safety/environmental-safety-health">https://www.fsis.usda.gov/wps/portal/informational/aboutfsis/audience-employees/employee-safety/environmental-safety-health</a>.)
Comment: A poultry industry association advised FSIS to replace the
``requirement'' to wait ``at least 60 seconds'' for drip time before
collecting a product sample with ``a drip time appropriate to prevent
excessive antimicrobial carryover.'' According to the poultry industry
association, establishments are familiar with the antimicrobial
treatments applied to products in their operations and the appropriate
neutralization periods for each treatment.
Response: FSIS has edited the language in the guidance to be more
inclusive of the many antimicrobial interventions available and the
manufacturers' instructions specific to each.
Comment: A poultry industry association recommended that the
guidance reflect differences between Salmonella and Campylobacter.
According to the association, the guideline's assertion (in the section
on actions to take in response to test
[[Page 36090]]
results) that an intervention to prevent, eliminate, or reduce
Salmonella will also reduce or prevent Campylobacter is not
scientifically accurate.
Response: The Agency has modified the language in question to
account for the different effects of different interventions. Also, the
Agency has divided the guidance into two separate documents--one
addressing Salmonella, the other Campylobacter--with the aim of
accounting for differences between the pathogens and ensuring that
recommended controls will be effective. FSIS also revised the guidance
to include additional literature supporting controls for the pathogens.
The updated references may assist establishments in identifying the
best process controls for Salmonella and Campylobacter in their
operations.
FSIS agrees that an intervention for controlling one microorganism
will not necessarily have a similar effect on the other. For example,
hard freezing is likely to be more effective against Campylobacter than
Salmonella. On the other hand, vaccine development for controlling
Salmonella in flocks is clearly in advance of that for controlling
Campylobacter.
New Technology Review
Comment: The poultry industry association said that FSIS has
recommended several interventions that the industry has sought but that
are still awaiting review or approval by FSIS. According to the poultry
industry association, the Agency should consider an expedited review
and approval process.
Response: The Agency does not have a backlog of new technology
submissions. The Agency reviews a new technology to determine whether
it may express its ``non-disapproval'' for use of the technology. The
technology should be safe to use, compliant with pertinent regulations,
not interfere with inspection procedures, and help the establishment
achieve the objectives of its HACCP system. FSIS has made available a
guideline to assist the industry in preparing and submitting new-
technology notifications and protocols to the Agency (See <a href="https://www.fsis.usda.gov/guidelines/2015-0012">https://www.fsis.usda.gov/guidelines/2015-0012</a>). By following the advice in the
guideline, the submitter can assist the Agency in completing its review
within a reasonable timeframe. FSIS Directive 7,120.1, on ''Safe and
Suitable Ingredients,'' is updated every month to incorporate newly
approved entries, including new interventions (See <a href="https://www.fsis.usda.gov/wps/wcm/connect/bab10e09-aefa-483b-8be8-809a1f051d4c/7120.1.pdf?MOD=AJPERES">https://www.fsis.usda.gov/wps/wcm/connect/bab10e09-aefa-483b-8be8-809a1f051d4c/7120.1.pdf?MOD=AJPERES</a>).
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this notice
on-line through the FSIS web page located at: <a href="http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register">http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register</a>.
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 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: <a href="http://www.fsis.usda.gov/subscribe">http://www.fsis.usda.gov/subscribe</a>. 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.
USDA Non-Discrimination Statement
In accordance with Federal civil rights law and U.S. Department of
Agriculture (USDA) civil rights regulations and policies, the USDA, its
Agencies, offices, and 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.
Persons with disabilities who require alternative means of
communication for program information (e.g., Braille, large print,
audiotape, American Sign Language, etc.) should contact the responsible
Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or
contact USDA through the Federal Relay Service at (800) 877-8339.
Additionally, program information may be made available in languages
other than English.
To file a program discrimination complaint, complete the USDA
Program Discrimination Complaint Form, AD-3027, found online at <a href="https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint">https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint</a> and
at any USDA office or write a letter addressed to USDA and provide in
the letter all of the information requested in the form. To request a
copy of the complaint form, call (866) 632-9992. Submit your completed
form or letter 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; (2) fax: (202) 690-7442; or (3)
email: <a href="/cdn-cgi/l/email-protection#fa8a88959d889b97d493948e9b919fba8f899e9bd49d958c"><span class="__cf_email__" data-cfemail="91e1e3fef6e3f0fcbff8ffe5f0faf4d1e4e2f5f0bff6fee7">[email protected]</span></a>.
USDA is an equal opportunity provider, employer, and lender.
Done, at Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2021-14554 Filed 7-7-21; 8:45 am]
BILLING CODE 3410-DM-P
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</html>Indexed from Federal Register on July 8, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.