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2021-2023 NATIONAL ADVISORY COMMITTEE ON MICROBIOLOGICAL CRITERIA FOR FOODS
(NACMCF)
FSIS CHARGE: ENHANCING SALMONELLA CONTROL IN POULTRY PRODUCTS
FSIS is seeking guidance on the overarching risk management question: What types
of microbiological criteria (e.g., Salmonella performance standards) might FSIS
use to encourage reductions in Salmonella in poultry products so that they are
more effective in preventing human Salmonella infections associated with these
products?
SUBCOMMITTEE MEMBERS
1. Kathleen Glass, Chair
2. Elisabetta Lambertini, Co-chair
3. Janell Kause
4. Francisco Zagmutt
5. Bing Wang
6. Tanya Roberts
7. Robert Tauxe
8. Scott Stillwell
9. James Dickson
10. Omar Oyarzabal
11. Wendy McMahon
12. Joseph ‘Stan’ Bailey
13. Haley Oliver
14. Teshome Yehualaeshet
15. Randy Worobo
16. Valentina Trinetta
EXECUTIVE SUMMARY
According to the Centers for Disease Control and Prevention (CDC), Salmonella is
responsible for approximately 1.35 million cases of foodborne illness each year
in the United States. The U.S. Department of Agriculture (USDA) Food Safety and
Inspection Service (FSIS) has established qualitative performance standards to
limit the occurrence of Salmonella in poultry products (i.e., carcasses, parts,
and comminuted products). The goal of these performance standards is to allow
FSIS to verify each regulated establishment’s control for this pathogen in raw
products throughout the slaughter process, and, by meeting these standards,
achieve national food safety goals. Over the past 25 years, there have been
significant reductions in the proportion of poultry contaminated with
Salmonella, but no meaningful reduction in human Salmonella infections
attributed to poultry products1,2. Therefore, FSIS is seeking guidance on how to
improve the current system for reducing Salmonella in poultry to better protect
public health.
In 2019, the National Advisory Committee on Microbiological Criteria for Food
(NACMCF) recommended that FSIS move toward risk-based disposition of finished
raw poultry product, informed by Salmonella amount and serotype. Since then,
several studies suggest that setting microbiological criteria (e.g., performance
standards) to limit the amount of Salmonella in products and/or to address
serotypes more frequently associated with foodborne illness would better protect
public health than the current approach. In addition, several studies have
demonstrated the feasibility of developing quantitative microbiological criteria
based on a change in the concentration of indicator organisms correlated to
Salmonella occurrence. These findings, along with new technologies and
advancements in rapid quantification of pathogens in products, present
opportunities for FSIS to enhance the microbiological criteria it establishes to
measure industry control of Salmonella in poultry products. FSIS seeks input
from the NACMCF on the best options for using quantification and/or particular
pathogen characteristics, along with a relevant pathogen indicator, to enhance
its microbiological criteria and reduce Salmonella illnesses attributed to
poultry products consumed in the U.S.
--------------------------------------------------------------------------------
1WILLIAMS, M.S., EBEL, E.D., SAINI, G., NYIRABAHIZI, E. 2020. CHANGES IN
SALMONELLA CONTAMINATION IN MEAT AND POULTRY SINCE THE INTRODUCTION OF THE
PATHOGEN REDUCTION; HAZARD ANALYSIS AND CRITICAL CONTROL POINT RULE. JOURNAL OF
FOOD PROTECTION 83 (10): 1707–1717.
2PUBLICLY AVAILABLE FSIS SAMPLING VERIFICATION TESTING DATA ON SALMONELLA IN
CHICKEN ANALYZED TO SHOW PERCENTAGE DECLINE FROM 2015−2020 (SEE: SAMPLING
RESULTS FOR FSIS REGULATED PRODUCTS | FOOD SAFETY AND INSPECTION SERVICE
(USDA.GOV)). PERCENT CHANGE IN CONSUMER ILLNESSES ATTRIBUTED TO POULTRY BASED
ON THE INTERAGENCY FOOD SAFETY ANALYTICS COLLABORATION REPORTS FROM 2012−2020.
TACK D.M., MARDER E.P., GRIFFIN P.M. ET AL., 2019. PRELIMINARY INCIDENCE AND
TRENDS OF INFECTIONS WITH PATHOGENS TRANSMITTED COMMONLY THROUGH FOOD —
FOODBORNE DISEASES ACTIVE SURVEILLANCE NETWORK, 10 U.S. SITES, 2015–2018. MMWR
MORBIDITY AND MORTALITY WEEKLY REPORT 68: 369-373.
BACKGROUND
Salmonella bacteria are a leading cause of foodborne illness. According to CDC
estimates, Salmonella is responsible for approximately 1.35 million illnesses,
26,500 hospitalizations, and 420 deaths every year in the United States. Using
weighted outbreak data from 1998–2018, the Interagency Food Safety Analytics
Collaboration, a joint effort between CDC, the U.S. Food and Drug
Administration, and USDA, estimates that over 20 percent of foodborne
salmonellosis is attributed to poultry products.3
FSIS established limits, referred to as performance standards, on the occurrence
of Salmonella in poultry products as part of the Pathogen Reduction, Hazard
Analysis and Critical Control Point (PR/HACCP) Systems Final Rule. These
standards were designed to improve food safety, reducing the risk of foodborne
illness, and enable FSIS to verify process control. Process control is a defined
procedure or set of procedures designed by an establishment to provide control
of those operating conditions that are necessary for the production of safe,
wholesome food. The procedures typically include some means of observing or
measuring system performance, analyzing the results generated in order to define
a set of control criteria, and taking action when necessary to ensure that the
system continues to perform within the control criteria. FSIS has since updated
those original performance standards. FSIS relies on qualitative
(presence/absence) pathogen sampling data to apply performance standards for
Salmonella in poultry products. These standards are based on quantitative
microbiological risk assessments4 and are designed to achieve the national food
safety goals. The Healthy People 2020 food safety goal was a 25 percent
reduction in foodborne Salmonella illnesses, to achieve fewer than 11.5
Salmonella infections per 100,000 population per year. In 2020, the case rate
for Salmonella infection was 13.3 per 100,000 population5. FSIS has proposed
performance standards for beef products and intends to propose performance
standards for pork products.
Since the implementation of Salmonella performance standards for poultry, FSIS
has measured a substantively lower occurrence of this pathogen in raw poultry
products, but the incidence of human illness associated with consumption of
poultry products has not decreased. FSIS is interested in developing
microbiological criteria (i.e., an alternative type of performance standard(s))
that will result in a substantively reduced level of human illness from
Salmonella in poultry. FSIS is considering microbiological criteria such as the
quantity of Salmonella in products, and the presence of Salmonella serotypes
more frequently associated with human illness, rather than presence/absence of
any Salmonella. Criteria could be set at various points in the food safety
system to better assess industry control over Salmonella in these products, for
example, prior to establishment interventions and after establishment
interventions, to evaluate the effectiveness of an establishment’s food safety
system in mitigating Salmonella in products during the slaughter process.
Several recent studies showed a correlation between indicator organisms and
Salmonella in poultry. Specifically, a correlation was shown between a change in
the quantity of an indicator (i.e., Aerobic Plate Count (APC)) from the carcass
to finished product and the occurrence of Salmonella in beef, pork, and
poultry6. Based on these findings, FSIS is considering developing a quantitative
“log-reduction” microbiological criterion (e.g., performance standard) to
measure the effectiveness of an establishment’s food safety system in
controlling Salmonella in products. FSIS believes this type of performance
standard would allow for continued monitoring of industry performance in
achieving the Healthy People national food safety goals, thereby improving
public health outcomes, while providing better insights on pathogen control
throughout the food safety system. As part of this consideration, FSIS would
also like to know how the Agency could address Salmonella serotypes more
frequently associated with human illness, strain characteristics (e.g.,
virulence factors), and/or the quantity of Salmonella in a subset of products
tested, prior to and after interventions, when evaluating industry’s control of
Salmonella.
FSIS is considering the following microbiological criteria to assess industry
control:
1. the presence of any Salmonella or only specific serotypes more likely to
cause illness, at preharvest (e.g., as measured at the receiving step in the
slaughter process) (see question 1)
2. the amount of Salmonella and/or presence of serotypes more likely to cause
illness, throughout the slaughter process (see questions 2, 3, 5); and
3. a relevant indicator for Salmonella, throughout the slaughter process (see
question 4).
FSIS would like NACMCF to consider these options – or suggest others -- and
provide insights to assist FSIS decision making.
--------------------------------------------------------------------------------
3INTERAGENCY FOOD SAFETY ANALYTICS COLLABORATION, 2020. FOODBORNE ILLNESS SOURCE
ATTRIBUTION ESTIMATES FOR 2018 FOR SALMONELLA, ESCHERICHIA COLI O157, LISTERIA
MONOCYTOGENES, AND CAMPYLOBACTER USING MULTI-YEAR OUTBREAK SURVEILLANCE DATA,
UNITED STATES. ATLANTA, GEORGIA AND WASHINGTON, DISTRICT OF COLUMBIA: U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES, CDC, FDA, USDA/FSIS.
4EBEL, E.D., WILLIAMS, M.S., GOLDEN, N.J., MARKS, H.M., 2012. SIMPLIFIED
FRAMEWORK FOR PREDICTING CHANGES IN PUBLIC HEALTH FROM PERFORMANCE STANDARDS
APPLIED IN SLAUGHTER ESTABLISHMENTS. FOOD CONTROL 28, 250-257; WILLIAMS, M.S.,
EBEL, E.D., VASE, D., 2011. FRAMEWORK FOR MICROBIOLOGICAL FOOD-SAFETY RISK
ASSESSMENTS AMENABLE TO BAYESIAN MODELING. RISK ANALYSIS 31, 548-565.
5RAY L.C., COLLINS J.P., GRIFFIN P.M. ET AL., 2021. DECREASED INCIDENCE OF
INFECTIONS CAUSED BY PATHOGENS TRANSMITTED COMMONLY THROUGH FOOD DURING THE
COVID-19 PANDEMIC — FOODBORNE DISEASES ACTIVE SURVEILLANCE NETWORK, 10 U.S.
SITES, 2017–2020. MMWR MORBIDITY AND MORTALITY WEEKLY REPORT 70: 1332-1336.
6WILLIAMS M.S., EBEL E.D., ALLENDER H.D. 2015. INDUSTRY-LEVEL CHANGES IN
MICROBIOLOGICAL CONTAMINATION ON MARKET HOG AND
BROILER CHICKEN CARCASSES BETWEEN TWO LOCATIONS IN THE SLAUGHTER PROCESS. FOOD
CONTROL 51: 361-370; WILLIAMS M.W., EBEL E.D., GOLDEN N.J. 2017. USING INDICATOR
ORGANISMS IN PERFORMANCE STANDARDS FOR REDUCING PATHOGEN OCCURRENCE IN BEEF
CARCASSES IN THE UNITED STATES. MICROBIOLOGICAL RISK ANALYSIS 6: 44-56.
CHARGE QUESTIONS FOR THE SUBCOMMITTEE
FSIS is seeking guidance on the overarching risk management question: What types
of microbiological criteria (e.g., Salmonella performance standards) might FSIS
use to encourage reductions in Salmonella in poultry products so that they are
more effective in preventing human Salmonella infections associated with these
products?
Specific risk management questions posed to NACMCF are:
1. Can we assess the public health impact (e.g., reduction in salmonellosis) of
controlling specific Salmonella serotypes and/or amount (levels) in poultry
products? What types of approaches could be used?
2. What types of microbiological criteria could be established to encourage
control of Salmonella at preharvest (i.e., in live birds on-farm)?
a. Should FSIS consider qualitative microbiological criteria for control of
the presence of Salmonella in a flock when they are presented for
slaughter?
b. How could FSIS use these criteria to address Salmonella serotypes most
frequently associated with human illness?
c. What industry data would provide evidence of control?
3. What types of microbiological criteria could be established for poultry
carcasses, parts, and comminuted products prior to applying interventions
and after interventions, considering current technology?
a. Could the quantity of Salmonella or quantity of microbiological indicator
organisms (e.g., APC) be used? What are the key parameters that need to
be considered? What data analysis techniques could be used? How would
these criteria be linked to human illness?
b. How could serotypes frequently associated with human illness be
considered in the development of microbiological criteria?
4. How might foodborne illness surveillance data on human Salmonella illnesses,
data from foodborne outbreaks associated with Salmonella in poultry, and
data on Salmonella serotypes in poultry products be used to identify the
Salmonella serotypes of greatest public health concern associated with
specific poultry products?
a. Should only the most current data (e.g., 5-years) of foodborne illness
surveillance, outbreak and/or pathogen testing data be used?
b. Going forward, what methodology and criteria would focus on those
Salmonella serotypes most frequently associated with human illness and
attributable to poultry products?
c. How frequently should the priority Salmonella serotypes associated with
poultry be revised considering changes in their occurrence while still
ensuring continuity in industry and regulatory testing?
5. There is a documented correlation between a reduction in the quantity of APC
between carcasses and finished products and the occurrence of Salmonella in
finished products for beef, pork, and poultry. How might this information be
used to set microbiological criteria to assess process (pathogen) control in
poultry?
6. What rapid methods and technologies are available for the quantification of
Salmonella? How should FSIS make the best use of these methods?
7. Are there particular approaches that would result in selective
identification of the serotypes of public health concern?
a. For example, are there approaches to mitigate a potential strain
selection bias introduced by the laboratory method?
b. If needed, what type of research could be conducted to ensure performance
characteristics of current laboratory methods (e.g., enrichment,
incubation, pre-screening) do not result in a biased serotype detection?
8. How should pathogen characteristics derived from whole genome sequencing
(e.g., serotype, virulence, antimicrobial resistance) be considered in the
development of microbiological criteria?
9. What research is needed to support FSIS’ new Salmonella strategy in terms of
setting microbiological criteria?
SUBCOMMITTEE REPORT
Pending completion of committee work.
UPCOMING MEETINGS
April 25, 2022, Subcommittee Meeting
Nov 17, 2021 Plenary meeting
FDA CHARGE: CYCLOSPORA CAYETANENSIS
FDA is seeking information on the factors that can contribute to C. cayetanensis
contamination of domestically grown and imported produce, and recommendations
for developing an effective prevention and management strategy.
SUBCOMMITTEE MEMBERS
1. Max Teplitski, Chair
2. Peggy Cook, Co-chair
3. Betty Feng
4. Audrey McMillan-Cole
5. Joelle Mosso
6. Mahipal Kunduru
7. Philip Elliott
8. De Ann Davis
9. Joseph Eifert
10. Francisco Diez-Gonzalez
11. Patty Lewandowski
12. Shannara Lynn
13. Angela Melton-Celsa
EXECUTIVE SUMMARY
Cyclospora cayetanensis is a coccidian protozoan parasite, belonging to the
phylum Apicomplexan, order Eucoccidiorida, family Eimeriidae, described between
1993 to 1994 as a newly identified human gastrointestinal pathogen. C.
cayetanensis is the only species of the genus Cyclospora known to infect humans.
The parasite produces oocysts that are resistant to harsh environmental
conditions, as well as resistant to many common chemical treatments to reduce
the presence of bacterial pathogens in the produce production environment and in
agricultural inputs (e.g. agricultural water). C. cayetanensis is the etiologic
agent of the gastrointestinal illness called cyclosporiasis. Detected in
association with human illness in many different parts of the world, C.
cayetanensis previously was considered to be a pathogen acquired during
childhood in developing nations. In the U.S., cyclosporiasis previously was
associated with travel outside of the US or consumption of contaminated imported
foods. However, in recent years, the U.S. has seen an increase in cases and
positive samples associated with produce, both as raw agricultural commodities,
and fresh-cut produce, grown in the US. In the last three years, the number of
cyclosporiasis cases has increased approximately 300%, often linked to fresh
produce consumption, specifically leafy herbs and ready-to-eat salads.
Awareness of the factors that can contribute to C. cayetanensis contamination
of domestically grown and imported produce, is key to developing an effective
prevention and management strategy.
BACKGROUND
Cyclospora spp. are protozoan parasites in the phylum Apicomplexan that can
parasitize different species of mammals with remarkable host-specificity.
Cyclospora has a complex life cycle and can only multiply within the infected
hosts. Among the Cyclospora species, only Cyclospora cayetanensis is known to
infect humans; all other species are associated with infections in other
animals. This parasite is characterized by environmentally-hardy oocysts that
are shed in stool by the infected persons. These oocysts are shed unsporulated
and are not infectious. Once released into the environment, unsporulated oocysts
require approximately 7 to 14 days under certain environmental conditions to
sporulate and become infectious. The oocysts are thought to be transferred to
the surface of foods through environmental routes (e.g., through human fecal
pollution carried by agricultural water) subsequently infect the host after
produce is consumed. Once consumed, the sporulated oocysts replicate in the
human gastrointestinal tract and continue the infection cycle as unsporulated
oocysts are shed in stool. The cycle continues as human fecal pollution again
contaminates the environment. A limitation to widespread Cyclospora
cayetanensis research is the inability to directly culture or propagate the
organism. Researchers rely solely on acquired oocysts to conduct research. Some
work has been done to use surrogate organisms to mimic the life cycle of
Cyclospora cayetanensis, however with limited positive results. A positive C.
cayetanensis finding is indicative of the presence of human fecal contamination,
as humans are the only known reservoir. Cyclosporiasis is characterized by
symptoms such as explosive diarrhea, vomiting, fatigue, and weight loss. C.
cayetanensis has become a major public health and food safety concern during the
last few years. Outbreaks of cyclosporiasis affect thousands of individuals in
the U.S. annually, with a steady increase in reported cases over recent years.
In 2020, CDC reported 1,241 laboratory-confirmed cases of cyclosporiasis in
people who had no history of international travel. In 2019 and 2018, there were
2,408 and 2,299 cases reported each year, respectively. Comparatively, between
2000–2017, the total number of cases reported for cyclosporiasis in the US was
1,730. Additionally, cyclosporiasis typically results in symptomatic illness in
the general population regardless of age in the US, whereas in endemic areas,
young children and immunocompromised individuals are most at risk for severe
illness. Outbreaks of cyclosporiasis generally occur during the warmer months of
May – September for the northern hemisphere, and November – March for the
southern hemisphere. Historically, these outbreaks have been linked to
ingestion of contaminated berries, fresh cilantro, basil and, more recently,
ready-to-eat bagged salads. Several efforts have been implemented to develop
molecular detection methods for C. cayetanensis in both food vehicles and
environmental water. These methods have been used to assist epidemiological
investigations and surveys to estimate the prevalence of C. cayetanensis in
commodities and growing regions. Despite these scientific efforts, there are
still several significant knowledge and data gaps that hamper the implementation
of effective measures to prevent the contamination of produce with the oocysts
of this parasite.
CHARGE QUESTIONS FOR THE SUBCOMMITTEE
1. What is known about the prevalence, incidence, and burden of disease of
cyclosporiasis in the U.S. and internationally?
a. Are there specific segments of the U.S. population that may be at higher
risk for infection? What is the geographic distribution of cases in the
U.S.?
b. What is the diversity of Cyclospora cayetanensis genotypes in the US and
internationally?
c. What factors (e.g., food safety practices, location of the farms) may
contribute to contamination with Cyclospora cayetanensis?
d. Are certain factors (e.g., type of food, seasonality, where the food is
produced, degree of hand contact during growing and harvesting) more
significant than others?
2. How does the seasonality, incidence and prevalence of cyclosporiasis
compare throughout the United States and internationally and what factors
may contribute?
a. Extrinsic factors that may influence sporulation and survival (e.g.,
extrinsic factors influencing sporulation and survival);
b. Environmental factors influencing movement (e.g., rainfall);
c. Other?
3. What sampling data exists for Cyclospora cayetanensis in food products and
environmental samples, domestically and internationally?
a. What trends have been observed?
b. What methods of detection were used?
4. What types of foods have been attributed to outbreaks of cyclosporiasis
domestically and internationally and what (if any) contributing factors,
sources or routes of contamination that have been identified?
5. Is monitoring for Cyclospora cayetanensis by testing food products,
agricultural environment and agricultural inputs being applied as a
management strategy currently (e.g., by industry, government)?
a. Are there best practices for monitoring for the presence of Cyclospora
cayetanensis in agricultural production (including matrices [e.g. water,
product], frequency, timing of sample collection (pre vs. post-harvest),
and sample numbers)?
b. Has monitoring led to development and implementation of effective
preventive measures? If so, how effective have they been?
6. What are available approaches for characterizing the relatedness of
different strains of Cyclospora cayetanensis (e.g., subtyping)?
7. What are currently available test methods (and comparative
sensitivity/specificity) for detecting and/or isolating Cyclospora
cayetanensis in different matrices (e.g., food, water, environmental
samples)? What type of validation has the method(s) undergone? What are the
matrices for which the methods have been validated?
8. What information exists on assessing viability of oocysts?
9. What preventive measures exist for the control of Cyclospora cayetanensis
(e.g., using filtration)?
a. How effective have they been?
b. What are the impediments to development of effective preventive measures
for Cyclospora cayetanensis and how can they be overcome?
10. What is known about Cyclospora cayetanensis persistence/survival in
food, such as produce, and the environment (e.g., soil, water, food contact
surfaces)?
11. What is known about transfer and attachment of Cyclospora cayetanensis from
environmental samples (water and soil) to produce?
12. What other coccidian parasites could serve as a surrogate research model
for Cyclospora cayetanensis behavior (e.g., for evaluation of control
measures)?
13. Are there indicator organisms that can be used to determine the likely
presence or absence of Cyclospora cayetanensis in various matrices?
14. What is known about the role of vectors (such as non-human organisms), if
any, in the transmission of Cyclospora cayetanensis?
15. What role do farm workers play in the transfer of Cyclospora cayetanensis
contamination during pre-harvest, harvest and post-harvest handling?Are
there particular approaches that would result in selective identification
of the serotypes of public health concern?
a. How might farm workers serve as both sources and routes of contamination
(such as through contamination of agricultural water, or transfer of
contaminated soil to food contact surfaces or produce)?
b. What are strategies that have been utilized to mitigate the
contamination from farm workers? Have efforts to mitigate contamination
from farm workers been successful?
16. Are there practices for the maintenance and conveyance of wastewater,
septage or human waste that may increase the incidence of Cyclospora
cayetanensis contamination? Are there practices that may be useful in the
management of waste to reduce the potential for contamination by Cyclospora
cayetanensis (e.g., third-party toilet service or municipal wastewater
treatment)?
a. Which wastewater, septage, and human waste treatments in the U.S. are
effective against Cyclospora cayetanensis? Which treatments may not be
effective against Cyclospora cayetanensis?
b. Does municipal water treatment adequately reduce, control or eliminate
Cyclospora cayetanensis?
c. Can effective municipal water treatments systems be scaled to treat
agricultural water used in produce production?
d. How do practices compare for domestic growers versus international
growers who export to the U.S.?
17. What elements or points in the parasite's life cycle are potential targets
of strategies to disrupt its progression, eliminate or destroy oocysts,
stop dissemination into the environment, and prevent food contamination?
a. What are control measures that should be evaluated for effectiveness
against Cyclospora cayetanensis? Including control measures that can be
applied to the environment and/or foods that may be consumed in the raw
form.
b. What is a recommended protocol for evaluating the effectiveness of
control measures against Cyclospora cayetanensis?
18. What are the relevant factors, available data, and data gaps needed to
develop an informative quantitative risk assessment model for Cyclospora
cayetanensis contamination and risk of illness?
SUBCOMMITTEE REPORT
Pending completion of committee work.
UPCOMING MEETINGS
May 24, 2022, Subcommittee Meeting
Nov 17, 2021 Plenary meeting
FDA CHARGE: CRONOBACTER SPP. IN POWDERED INFANT FORMULA
EXECUTIVE SUMMARY
Cronobacter spp. (formerly Enterobacter sakazakii) are microorganisms present in
the environment and can survive in dry foods, such as powdered infant formula.
Cronobacter spp. infections among infants younger than 12 months have high
case-fatality rates. Historical surveys of powdered infant formula have
reported a relatively high prevalence rate, ranging from 2 to 15% of Cronobacter
spp. contamination in these products. FDA regulations specify that
manufacturers of infant formula must establish a system of production and
in-process controls, covering all stages of processing, that is designed to
ensure that infant formula does not become adulterated due to the presence of
Cronobacter spp (see 21 CFR parts 106 and 107). In late 2021 and early 2022, a
series of Cronobacter spp. illnesses among infants in the U.S. was associated
with feeding powdered infant formula. In each illness, the formula was produced
by a specific manufacturer at one facility. The resulting voluntary recall (and
the temporary shutdown of the plant) was a major contributing factor to the
infant formula shortage experienced across the U.S. in 2022. Better
understanding of the factors that contribute to Cronobacter spp. contamination
of powdered infant formula and the production environment is needed to increase
the effectiveness of prevention and management strategies.
BACKGROUND
Cronobacter spp. (formerly Enterobacter sakazakii) are microorganisms present in
the environment and can survive in dry foods, such as powdered infant formula.
Cronobacter spp. infections among infants younger than 12 months have high
case-fatality rates. Historical surveys of powdered infant formula have reported
a relatively high prevalence rate, ranging from 2 to 15% of Cronobacter spp.
contamination in these products. FDA regulations specify that manufacturers of
infant formula must establish a system of production and in-process controls,
covering all stages of processing, that is designed to ensure that infant
formula does not become adulterated due to the presence of Cronobacter spp (see
21 CFR parts 106 and 107). In late 2021 and early 2022, a series of Cronobacter
spp. illnesses among infants in the U.S. was associated with feeding powdered
infant formula. In each illness, the formula was produced by a specific
manufacturer at one facility. The resulting voluntary recall (and the temporary
shutdown of the plant) was a major contributing factor to the infant formula
shortage experienced across the U.S. in 2022. Better understanding of the
factors that contribute to Cronobacter spp. contamination of powdered infant
formula and the production environment is needed to increase the effectiveness
of prevention and management strategies.
CHARGE QUESTIONS FOR THE NACMCF SUBCOMMITTEE:
1. What is the current prevalence and level of Cronobacter spp. contamination
in powdered infant formula in the U.S. market? What is known about
Cronobacter spp. in other foods and in the home environment and the
frequency with which these foods and environmental sources contribute to
human infections?
2. What factors (e.g., virulence factors, host factors, dose of exposure) place
an infant at greater risk for Cronobacter spp. infection and serious adverse
health consequences or death?
3. What food safety management practices (e.g., facility and equipment design,
hygienic zoning and packaging, preventive controls, verification activities)
should manufacturers of powdered infant formula employ to further reduce the
risk of Cronobacter spp. contamination of formula and/or the production
environment?
4. Given that powdered infant formula is not sterile, how could food safety
messaging be improved for infant care providers, with emphasis on use of
sterile, ready-to-use formulas for infants at greatest risk and safe infant
formula preparation and storage for infant formula in general?
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