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| Study Title / Description |
Additional Information |
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Investigate and/or develop emerging screening technologies to reduce time for detection. |
| About this Topic:
Microbiological methods that expeditiously provide information may facilitate FSIS responses for controlling
and/or recalling contaminated products in a timely manner. Improvements may result in significant public
health benefits and may reduce cost to both the Agency and industry by decreasing the amount of sample needed
to detect pathogens and shortening the time that product is required to be held pending test results.
Examples may include approaches to correlate molecular and cultural analysis of microbial communities in raw
meat and poultry products for pathogens of concern. | Related Topic
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| Develop a non-culture-based technology to reliably
differentiate viable (infectious) and non-viable agents. |
While non-culture techniques offer the possibility of
rapid analysis times, it would be desirable if these techniques could also distinguish between viable and
non-viable microbial contamination. |
| Validation of Clostridium botulinum toxin detection assay
in FSIS regulated meat products using the MAGPIX system by Luminex |
Rapid response to Clostridium botulinum toxin
contamination incidents requires the availability of reagents, methods, equipment and expertise. |
| Study Title / Description |
Additional Information |
| Investigate
and/or develop emerging screening technologies for enhanced subtype/virulence characterization of pathogens. |
| About this Topic:
Microbiological methods that provide more robust information will expedite FSIS responses for controlling and/or
recalling contaminated product in a timely manner. Potential examples include refinement of FSIS Multi-Locus
Genotyping (MLGT) methods. Expanding the applicability of MLGT methods to a larger number of products
may increase the Agency's ability to expeditiously identify subtypes and conduct trace backs. |
| Determine prevalence of E. coli O157:H7 clades
and "top 6" non-O157 STEC subtypes in FSIS samples. |
Development of alterative subtyping approaches and
subsequent characterization of STEC strains associated with FSIS products will provide potential useful
information for traceback investigations (cluster detection, source tracking), risk profiling (identifying
particularly virulent strains) and managing risk. Proposed studies could also apply existing methodology
(PFGE, MLVA, SNPs) to FSIS isolates. |
| Relate virulence (Dose-Response) to genetic lineage for
Lm. |
Understanding variability of Lm strain
prevalence (MLGT) and associated virulence will facilitate accurate risk assessments and the development of
effective management strategies. |
| Further develop and apply subtyping methods for
"clonal" Salmonella serovars (including S. Enteritidis). |
Development of alterative subtyping approaches provides
potential advances for tracebacks (cluster detection, source tracking), risk profiling and managing risk. |
| Study Title / Description |
Additional Information |
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Investigate and/or develop emerging screening technologies to provide multi-analyte detection from a single
analytical sample portion. |
| About this Topic:
Microbiological methods that provide information for multiple analytes may increase efficiency of FSIS response
for controlling and/or recalling contaminated product in a timely manner. Improvements may result in significant
public health benefits and will reduce cost to both the Agency and industry by decreasing the amount of resources
and time needed to detect pathogens and shortening the time that product is required to be held pending test
results. |
| Study Title / Description |
Additional Information |
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Investigate and/or develop emerging screening technologies which are applicable to FSIS regulated products
(meat, poultry, egg products and foods containing these products). |
About this Topic:
Development and validation of rapid, sensitive, resource-efficient methods to quantify pathogens such as
Salmonella, pathogenic E. coli (O157:H7 and "top 6" non-O157 STECs) and
Listeria would
- allow for better risk assessment studies by improving estimations of the levels of pathogens associated with specific food products;
- make it more feasible for the Agency to regulate on levels of pathogens associated with a product instead of qualitative presence/absence data; 3) allow for the identification of high bacterial loads on incoming products and/or rapid assessment of lapses in process control. Expanding validated methods for pathogen detection to include challenging matrices may result in significant public health benefits. Examples of such matrices include low pH (e.g., fermented products) and high pH products (e.g., ammoniated beef). | Related Topic
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| Develop a non-culture based technology to reliably
differentiate viable (infectious) and non-viable agents. |
While non-culture techniques offer the possibility of
rapid analysis times, it would be desirable if these techniques could also distinguish between viable and
non-viable microbial contamination. |
| Study Title / Description |
Additional Information |
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Develop rapid methods for screening of "high-risk" compounds such as environmental contaminants. |
| About this Topic:
Screening methods (similar to KIS and FAST) increase FSIS' efficiency to monitor chemical residues in regulated products. |
| Study Title / Description |
Additional Information |
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Develop or refine testing methods for quantifying target pathogens in meat, poultry and egg products. |
| About this Topic:
Development and validation of sensitive and efficient methods to quantify pathogens such as Salmonella,
E. coli (O157 and non-O157 STECs) and Listeria would contribute to the Agency's public
health mission. |
| Determine prevalence and bacterial load for E. coli O157: H7
and "top 6" non-O157 STECs in ground beef. |
Pathogenic E. coli can cause severe illnesses
at very low doses. A better understanding of the prevalence and levels of E. coli O157:H7 and
"top 6" non-O157 STECs in ground beef will allow the Agency to assess the actual risk of consumer
exposure to pathogenic E. coli from this product class. These data could also be used to inform the
industry of the levels of reductions needed by interventions to produce a safe product. |
| Determine the presence of Shiga toxin and
intimin on beef carcasses, trim, and ground beef. |
E. coli strains that contain both Shiga
toxin and intimin are likely pathogens of public health concern. Monitoring the presence of strains
containing these virulence factors will allow the Agency to be proactive in identifying emerging strains of
pathogenic E. coli before they cause significant public health issues. Additionally, monitoring the
presence of these markers at different processing points may permit the Agency to identify steps in the
process that may introduce or eliminate pathogens into the final product. |
| Determine microbiological and production volume data
on all components of raw ground beef of E. coli O157 and non-O157 Shiga toxigenic E. coli
(non-O157 STEC). |
STEC are potentially significant pathogens in
FSIS regulated products. These data will assist FSIS in accurately estimating the total risk associated with
these pathogens. |
| Characterize non-O157 screen positives that are not
"top six" serotypes. |
It is likely that there are "non-top 6"
STEC serotypes that are significant pathogens. Identification of these serotypes may lead to improved risk
assessments and risk management strategies. Priority products of concern: Trim and ground beef. |
| Study Title / Description |
Additional Information |
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Identify and evaluate alternative approaches to N60 sampling. |
| About this Topic:
N60 E. coli trim sampling for E. coli is labor intensive and may result in loss of significant
quantities of product (due to time required for sampling/analysis/reporting). Development of an improved
(time and resource efficient) approach would benefit industry and FSIS.
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| Develop an easy to use device to obtain excision or core
samples of beef trimmings with the same sensitivity and surface area collected as N60 sample collection method
that is quicker, more efficient, economical, and durable. |
N60 E. coli trim sampling for E. coli is labor
intensive and may result loss of significant quantities of product (due to time required for
sampling/analysis/reporting). Development of an improved approach may benefit industry and FSIS. |
| Study Title / Description |
Additional Information |
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Develop PBPK models to estimate chemical concentrations in beef, pork and chicken tissues. |
| About this Topic:
Physiologically Based Pharmacokinetic (PBPK) models permit the timely estimation of chemical tissue concentrations resulting from livestock exposure to
chemicals (e.g., environmental contaminants and drugs). These estimates are essential for risk evaluations
and risk management decision making. |
| Study Title / Description |
Additional Information |
| Identify and/or develop emerging
technologies for real-time testing for higher levels of contamination prior to slaughter. |
About this Topic: Identification of
highly contaminated animals prior to slaughter may lead to intervention strategies (e.g., segregation) to minimize cross contamination
and/or pathogen reduction interventions designed for highly contaminated animals. Potential targets include:
- E. coli O157:H7 and Non-O157 STEC on carcass hides or droppings
- Salmonella and/or Campylobacter on pre-harvest chicken and turkey
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| Develop and evaluate a systematic mechanism to sample cattle pre-harvest to determine prevalence of O157:H7. |
If pathogenic E. coli status of animals could be determined prior to slaughter, ante mortem slaughter procedures could be developed to minimize cross contamination. These data could be used to develop management strategies to minimize cross contamination of carcasses (e.g., positives could be slaughtered last or have specific interventions). |
| Develop a model to estimate the effect of pre-harvest practices and interventions on pathogen contamination of ground beef. |
Pre-harvest interventions have the potential to minimize pathogen concentrations in meat. Potential interventions include manipulation of feeding strategies, transportation, vaccine, source (feedlot), time of year of slaughter. |
| Determine pre-harvest prevalence of E. coli O157:H7 and non-O157 STEC. |
STEC are potentially significant pathogens in FSIS regulated products. Pre-harvest populations may impact pathogen concentrations in finished products. Suggested studies include: (1) Determine prevalence on hides or droppings of cattle coming into slaughter. (2) Determine prevalences for feed lot and range cattle. (3) Determine prevalences for different size slaughter establishments. |
| Determine the national prevalence of Salmonella serotypes associated with shell eggs. |
Pathogen concentrations in shell eggs impact the risks and associated need for intervention strategies associated with FSIS regulated egg products. |
| Develop and evaluate a systematic mechanism to sample poultry flocks at pre-harvest to determine prevalence of Salmonella and Campylobacter. |
If Salmonella and Campylobacter status of poultry flocks could be determined prior to slaughter, slaughter procedures could be implemented to minimize cross contamination (e.g., slaughter positive flocks slaughtered last, freeze Campylobacter contaminated tissues). |
| Study Title / Description |
Additional Information |
| Develop non-targeted methods to
detect chemical contaminants in FSIS regulated products. |
| About this Topic:
Development of analytical methods which detect chemical moieties which are common to widely used classes of drugs and pesticides
may permit labs to detect compounds for which standards are not included in methods.
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| Identification and Validation of Quality Assurance Methods for FSIS
Products that are Susceptible to Economically Motivated Adulteration |
Economically motivated adulterants can negatively
impact public health. The ability to detect and rapidly respond to adulterant incidents requires the
availability of expertise, validated methods and equipment which are applicable to high risk scenarios. |
| Study Title / Description |
Additional Information |
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Further develop the use of indicator/surrogate organisms in processing establishments to validate and monitor
intervention effectiveness. |
| About this Topic:
Identification of indicator and/or surrogate organisms (easily quantified, highly correlated with pathogens)
offer a potential means to efficiently evaluate intervention effectiveness. |
| Conduct a prospective cross-sectional study to further
examine the correlation between the magnitude of indicator/surrogate reduction (e.g., between carcass re-hang
and post-chill) and the magnitude of pathogen reduction on carcasses. |
Reductions of indicator and/or surrogate organisms
may be useful to assess the effectiveness of interventions and the safety of finished products. Analysis to
the level of species requires less resources than sub-typing. |
| Study Title / Description |
Additional Information |
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Evaluate the potential effectiveness of pre-harvest interventions on finished products. |
| About this Topic:
Determining if pre-harvest interventions can significantly reduce pathogen contamination of FSIS regulated
products will provide valuable information for controlling pathogens and improving public health. |
| Determine the impact of climatic and weather conditions affecting shedding of O157:H7. |
As environmental conditions (e.g., temperature, humidity)
may influence pathogen concentrations, tailoring sampling and intervention strategies to environmental
conditions may provide increased efficiency and public health benefit. |
| Verify whether E. coli 0157:H7 vaccination
will allow other pathogenic organisms (e.g., E. coli non-O157:H7 Shiga toxigenic organisms) to
proliferate and cause new illnesses. |
Determination of the range of E. coli subtypes
impacted by the O157:H7 vaccine will permit FSIS to assess the public health benefits of the vaccine. |
| Determine the impact of pre- and post-harvest
interventions commonly used by the poultry industry on Campylobacter jejuni colonization and
contamination of poultry and poultry products. |
Determination of the effectiveness of
Campylobacter intervention may facilitate the evaluation of HACCP plans and assessment of risk to poultry
consumers. |
| Customize/optimize intervention strategies to industry
segments (feedlots/range/large-small) as they relate to need of pre-harvest and post-harvest pathogen
interventions. |
Tailoring pre-harvest and post-harvest interventions
and sampling strategies to feedlot group (size, product) may offer increased efficiently and/or public health
benefits. |
| Study Title / Description |
Additional Information |
| Develop a screen for
the detection of hormone and hormone-like compounds. |
| About this Topic:
Developing the ability to screen hormone and hormone-like compounds in products will increase FSIS' ability to monitor
potentially adverse chemicals such as trenbolone, estradiol and melengestrol acetate.
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| Study Title / Description |
Additional Information |
| Determine
retail use statistics/practices which could contribute chemicals (insecticide, rodenticide, fungicide, antimicrobial)
or pathogens to FSIS regulated products. |
| About this Topic:
Identification of plant and retail practices that lead to contamination of products may provide valuable
information for development of effective HACCP plans. Current chemical and pathogen sampling procedures may
not detect products which are contaminated due to retail practices. |
| Documentation of Salmonella and Campylobacter
transfer to and colonization of carcasses and cuts. |
Identification of critical steps in cross contamination
of carcasses and carcass cuts may lead to the development of process modifications to reduce cross contamination. |
| Determine prevalence of Salmonella serotype and genotype isolates from chicken products at retail. |
Post-plant changes in pathogen concentration may
impact risk to consumers. Analytical considerations include: PFGE pattern analysis and/or consideration for
serotype bias introduced by enrichment-based methods. |
| Ascertain consumer and retail (restaurants, institutions,
etc.) behaviors (and frequency) that may impact cross contamination. |
Post plant handling of products can impact contamination
and consumer risk. Suggested areas of concern include retail and consumer storage, handling and cooking
impacts on pathogens (e.g., Listeria monocytogenes) that may be present in raw and ready-to-eat
(RTE) meat and poultry. Processes of potential concern include slicing process and handling. |
| Assess the impact of the use of "gloves"
on cross contamination in the retail environments. |
A variety of practices in the retail environment may
contribute to cross contamination of FSIS regulated products. Identifying and modifying such practices may
lead to interventions that reduce contamination. |
| Estimate the contribution of non-food contact
surface interactions (drains, sinks, etc) on L. monocytogenes contamination of FSIS regulated products. |
Identification of pathogen reservoirs in the food
processing environments may lead to improved best practices and/or intervention strategies. |
| Determine the potential for spices and/or non-FSIS regulated ingredients to
contribute pathogens to FSIS regulated products. |
When FSIS regulated products are combined with
chemical and/or microbial contaminated spices or other ingredients, the products may become contaminated,
thereby increasing the risk of foodborne illness for consumers. There is need to determine (1) the magnitude
of risk for FSIS regulated products which contain potentially contaminated ingredients and (2) develop risk
management approaches where warranted. |
| Study Title / Description |
Additional Information |
| Determine the
magnitude and significance of migration of chemicals (e.g., endocrine disruptors) from packaging into FSIS regulated products. |
| About this Topic:
Current chemical residue sampling procedures would not detect products which are contaminated due to migration of
chemicals from packaging into food.
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| Study Title / Description |
Additional Information |
| Determine the effectiveness
of parallel and/or simultaneous application of more than one pre-harvest and/or post-harvest intervention as a control strategy. |
| About this Topic:
Most previous research has focused on individual intervention strategies. Additional information regarding interactions
between individual strategies may lead to improved HACCP plans. | Related Topic |
| Determine the growth inhibitor effectiveness on Listeria monocytogenes
in RTE products from time of production through consumption. |
Determining the effectiveness of growth inhibitors (in conjunction with
other interventions) may permit increased accuracy in the estimation of risk to consumers and lead to the production of safer products. |
| Determine the effect of low levels of relative humidity on survival of
E. coli O157:H7 and Salmonella in beef jerky. |
Elucidating the impact of humidity on pathogen survival in FSIS regulated
products may lead to improved processing guidelines and reduced risk for these products. |
| Develop scientific documents for a variety of meat and poultry products that
take into consideration differences in product composition (e.g., fat, protein and sodium levels) which may affect time-temperature
lethality relationships. |
Scientific documents, called "safe harbors," for the meat and
poultry industry may provide small meat and poultry processors (who do not have the resources, facilities and/or the expertise to
perform food safety experiments to identify appropriate interventions for their specific processes) guidance for the identification
of suitable interventions. |
| Study Title / Description |
Additional Information |
| Conduct ex post
evaluation of regulatory initiatives. |
| About this Topic:
Determining the impact of regulations may provide valuable guidance for potential adjustments and/or the development of future policy. |
| Study Title / Description |
Additional Information |
| Determine the
presence and contributing factors for antimicrobial resistant strains in poultry and cattle. |
| About this Topic:
Increased understanding of the ecology (farm through plant) of antimicrobial resistant pathogens on livestock
and poultry may lead to improved pathogen management strategies. |
| Study the survival characteristics for Salmonella
and STEC (including O157:H7) serotypes to identify serotypes which are resistant to pre- and/or post-harvest
interventions. |
Identification of intervention resistant serotypes
provide important data for developing effective intervention procedures. |
| Obtain additional predictive microbiology data of
multi-drug resistant (MDR) Salmonella spp. such as Salmonella Typhimurium DT104. |
An increased understanding of the growth and
temperature susceptibility characteristics of MDR Salmonella will increase the Agency's ability to
estimate human exposure and risk to MDR Salmonella. |
| Identify optimal methodology and apply to determine
the prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) and C. difficile
prevalence in FSIS regulated products. |
Increased understanding of S. aureus
and C. difficile in FSIS regulated products (especially pork and beef rte products) may facilitate
the development of improved pathogen management strategies. |
| Study Title / Description |
Additional Information |
| Develop or refine cooking and cooling models. |
About this Topic:
Temperature–time growth and death curves are valuable tools for developing safe processing procedures
and HACCP plans. Models should be validated for a variety of FSIS regulated products. Suggested pathogen-product
combinations include:
- Clostridium perfringens and Bacillus cereus in processed egg products
- C. perfringens and B. cereus during cooling of cooked ground pork and chicken with antimicrobial additives and variable pH
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| Determine the amount of Clostridium botulinum
growth required to produce detectable levels of the botulinum neurotoxin in cooked/heat-treated, uncured
meat and poultry products. |
Clostridium botulinum
(organism and its spores) are widely distributed in nature. Sausages, meat products, canned vegetables
and seafood products have been the most frequent vehicles for human botulism. |
| Develop validated predictive microbial models that
predict the growth of Clostridium botulinum during cooling. |
Cooling models may be used by FSIS to estimate the
impact of deviations in product handling procedures on pathogen populations and/or to develop processing
criteria for a variety of FSIS regulated products. The models should be based on dynamic (changing)
temperature experiments addressing variable product temperature profiles (e.g., single, dual and multiple
cooling rates) for cooked, uncured ground meat and poultry products (e.g., ground beef, ground pork,
ground chicken and ground turkey) containing no food additives (e.g., salt, phosphates, nitrite, sodium
and potassium lactate, sodium and potassium diacetate) that would impact on the growth of the pathogen
during cooling. |
| Determine the impact of holding temperatures on pathogens in eggs. |
Significant pathogen growth during unrefrigerated egg
holding may result in unacceptable post-pasteurization pathogen (e.g., Salmonella) survival. |
| Develop validated dynamic growth models for
S. aureus, C. perfringens, and B. cereus to evaluate heating deviations
(e.g., product with slow heating come-up times, products held at elevated sub-lethal temperatures for
an extended period of time, and products that achieve incomplete lethality during the heating or cooking
step) in cooked/heat-treated, cured and uncured meat and poultry products. |
The proposed growth models would assist FSIS in
estimating the public health impact of process deviations of FSIS regulated products. These dynamic
growth models should take into consideration the potential growth-affecting interactions between the
bacterial pathogens and low levels of non-pathogenic bacteria indigenous to commercial products. |
| Develop predictive models for Bacillus cereus
and Clostridium perfringens in enzyme modified egg processes with prolonged incubation times. |
Models to estimate pathogen growth and lethality
in FSIS products aid in development of HACCP plans and evaluating the potential impact of processing
deviations. |
| Study Title / Description |
Additional Information |
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Develop or refine dose-response curves for pathogens (including specific subtypes) of interest. |
| About this Topic:
Dose-Response curves are critical inputs for estimating risk associated with ingestion of pathogens
(and chemicals) of concern. |
| Obtain human dose-response data of multi-drug resistant
Salmonella spp., such as Salmonella Typhimurium DT104. |
Dose-Response data are critical inputs for critical
for accurately assessing the risk associated with FSIS regulated products. |
| Ascertain the dose-response relationship for L. monocytogenes. |
Dose-Response curves are a critical input for risk assessments. |
| Determine the dose-response curve for a variety of non-O157 serotypes. |
As a subset of non-O157 E. coli serotypes are
associated with outbreaks, it is likely that potency varies with subtype. Accurate dose-response curves are
required to estimate risk associated with pathogenic non-O157 strains. |
| Study Title / Description |
Additional Information |
| Determine (validate) the
effectiveness (log-reduction) of interventions used by industry to reduce levels of pathogens on FSIS regulated products. |
| About this Topic: Determining the effectiveness
of pathogen reduction treatments is critical to the development of effective HACCP plans and exposure/risk assessments.
Pathogen-Product of particular interest: Salmonella on poultry (including poultry parts) and E. coli O157:H7 and
Non-O157 STEC in beef. | Related Topic |
| Determine the translocation and thermal inactivation of Salmonella and Campylobacter in tenderized and/or injected poultry products. |
Campylobacter-Poultry and Salmonella-Poultry have been
cited as the first and fourth highest Pathogen-Product combination with respect to annual foodborne disease burden. (UF Emerging Pathogens Institute, 2011) |
| Determine the growth inhibitor effectiveness on Listeria monocytogenes in RTE products from time of production through consumption. |
Determining the effectiveness of growth inhibitors (in conjunction with other interventions) may permit increased accuracy in the estimation of risk to consumers and lead to the production of safer products. |
| Determine the efficacy of organic acids applied using handheld sprayers to beef trim. |
This study could provide guidance to processing plants (especially small plants) for designing food safety systems that address E. coli O157:H7 on beef trimmings that are intended for grinding. |
| Determine the effect of low levels of relative humidity on survival of E. coli O157:H7 and Salmonella in beef jerky. |
Elucidating the impact of humidity on pathogen survival in FSIS regulated products may lead to improved processing guidelines and reduced risk for these products. |
| Develop scientific documents for a variety of meat and poultry products that take into consideration differences in product composition (e.g., fat, protein, and sodium levels) which may affect time-temperature lethality relationships. |
Scientific documents, called "safe harbors," for the meat and poultry industry may provide small meat and poultry processors (who do not have the resources, facilities and/or the expertise to perform food safety experiments to identify appropriate interventions for their specific processes) guidance for the identification of suitable interventions. |
| Determine the susceptibility of Salmonella enterica
(Hadar and Heidelberg) ground turkey associated outbreak strains to heat, hydrostatic pressure and acid. |
FSIS investigations suggest that Salmonella
strains were able to survive poultry slaughter processing interventions and consumer preparation to ultimately
cause illness. FSIS would like to determine if these outbreak associated strains show unique characteristics
(e.g. resistance to heat, pressure pasteurization and/or acid) which may contribute to virulence and the
breadth of the outbreaks. |
| Identify and quantify the transfer of pathogenic hide and/or surface
contaminants and gastrointestinal contents to carcasses during sanitary dressing. |
Identification and quantification of sources of
contamination during processing of carcasses provide the basis for the development of (1) processing procedures
that minimize contamination of meat and (2) effective and efficient HACCP plans. |
| Study Title / Description |
Additional Information |
| Identify consumer practices
which compromise the safety of FSIS regulated products and/or generate data to develop public education and outreach to improve
food-handling practices. |
| About this Topic:
Mishandling of FSIS regulated products by consumers can increase the probability of foodborne illnesses associated
with the consumption of FSIS regulated products. |
| Determine the correlation between ground turkey consumer preferences and
undercooked/increased risk products. |
Consumers' preferences for moist ground turkey may
result in products that are not fully cooked. FSIS is interested in determining whether consumer preference for
finished ground poultry products corresponds with a product not receiving adequate lethality for microbial
contaminants. Such a correlation could indicate increased risk of human illness. |
| Review and evaluation of FSIS' Safe Lunch Packing Recommendations |
Preliminary findings indicate that a significant portion
of home packed lunches deviate from the Agency's safe temperature handling recommendations, suggesting increased
risk of foodborne illness to school children and other sub-populations which bring their lunches from home.
Further research is needed to substantiate these preliminary findings and, if warranted, to develop means to
assure the safety of home packed meals. |
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Last Modified: December 6, 2012 |
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