Food Safety Modernization Act Research Articles

Produce safety alliance grower training knowledge assessment results

The Produce Safety Alliance (PSA) Grower Training (GT) curriculum was developed to provide produce growers with training that meets requirements in §112.22(c) of the Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR). Four regional food safety centers evaluated course attendees’ knowledge change over four years (2019 to 2022) using a pre- and post-test quiz. Knowledge assessment results showed (a) respondents gained knowledge on each of the seven modules presented in the curriculum; (b) the curriculum content had a large effect on knowledge gain; (c) knowledge gain differed significantly between years, but the differences were not of practical importance; (d) remote participants learned significantly more than in-person participants, but differences were not of practical importance; and (e) the quiz consisted of low and moderate difficulty questions (no questions were high difficulty) and had generally acceptable discriminant properties. Implementation of the FSMA PSR has progressed from an educational to a regulatory phase, and the authors recommend replacing the knowledge assessment with a tool that measures how the PSA course prepares growers for compliance.

Contaminated water and the Food Safety Modernization Act

AbstractWe develop a theoretical framework and present a corresponding empirical analysis of the Food and Drug Administration’s irrigation water quality regulatory standard under the Food Safety Modernization Act using lettuce as a case study. We develop a stochastic price endogenous partial equilibrium model with recourse to examine the standard’s efficacy under various scenarios of foodborne illness severity, standard implementation, demand response to foodborne outbreaks, and irrigation costs. The stringency of regulation is evaluated with endogenous producer response to regulatory requirements and corresponding implications for economic surplus. The baseline results show that in the case of the lettuce market, the proposed microbial irrigation water quality regulation in the Food Safety Modernization Act (FSMA) is not cost effective relative to the existing Leafy-Greens Marketing Agreements relying on water treatment for mitigation of microbial contamination. However, FSMA can be cost effective if water treatment is sufficiently expensive.

Increasing Food Safety Preparedness of Small and Emerging Food Businesses with Targeted Food Safety Training

There is strong consumer demand for local, value- added food products; however, these smaller scale food manufacturing operations tend to face more challenges in understanding and complying with food safety regulations, specifically, the Food Safety Modernization Act (FSMA) Preventive Controls for Human Food (PCHF) rule. An eight- module educational program was developed to introduce food safety throughout the product development life cycle and included concepts related to the FSMA PCHF rule. The program was offered in person (n = 2) and virtually (n = 6) to 143 participants in total, who were mostly early-stage food developers. Most (74%, n = 90) had little to no prior food safety-related training and experience. The majority (93%, n = 90) agreed they will apply the knowledge and skills learned in the course to food applications, such as developing food safety plans, label review, and good manufacturing practices. Self-rated level understanding for each module ranged from 4.4 to 4.6 on a 5-point Likert scale. Overall, participants felt better prepared to conduct various food safety activities after taking the course, supporting the need for non-mandatory training opportunities to enhance FSMA PCHF regulatory compliance. These types of training may be important for small-scale operations to improve the learning outcome and regulatory compliance.

On-Farm Readiness Review Tool and Training Curriculum to Help Farmers Assess Their Readiness to Comply with the FSMA Produce Safety Rule

A team of extension professionals and state and national regulatory staff convened by the National Association of State Departments of Agriculture developed the On-Farm Readiness Review (OFRR) to support farm personnel on compliance with the Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR). The OFRR tool was created to align the FSMA PSR provisions with relevant farming practices in time and space; it also linked recommendations for implementation of PSR requirements and offered evaluation criteria to assess PSR compliance before inspection. The developed tool is composed of a decision tree, walk-around questions, and a resource manual. The tool is the foundation of the training curriculum. The tool and curriculum were piloted and evaluated by participants to inform additional development of the final product. OFRR trainings were held nationally, and participants were trained on how to use the tool to conduct a confidential on-farm assessment of a farm’s readiness for a FSMA PSR inspection. The tools and training have had a beneficial impact on participants understanding of the FSMA PSR, have increased the assessors’ ability to apply the PSR to the farm, and have developed trained assessor teams that are able to evaluate inspectional readiness in their home state.

Uncooked rice consumption: Causes, implications, regulation, and interventions

AbstractBackground and ObjectivesUncooked rice is not classified as produce under the Food Safety Modernization Act (FSMA) of the United States Food and Drug Administration produce safety rule because it is considered a food grain that is typically processed before consumption. However, uncooked rice is eaten by members of the raw food movement, pregnant pica patients, refugees in war zones, and young women as a perceived beauty treatment.FindingsThe consumption of raw rice may pose serious health risks such as foodborne illness, gastrointestinal issues, exposure to lectin and heavy metals, dental problems, and poor nutrition in consumers, especially those with low immunity including children and pregnant women. This review identifies the various circumstances under which raw rice is eaten or may be eaten, the possible health risks associated with raw rice consumption, and interventions that can be made to prevent the consumption of raw rice.ConclusionsMany interventions are available to curb the raw rice consumption problem, including providing alternative sources of energy for cooking, medical interventions like iron therapy and psychological counseling for pica patients, and public education on the risks associated with the consumption of raw foods, and clearly differentiating foods that can be eaten raw from those that should not be eaten raw.Significance and NoveltyThis review raises awareness and provides vital multifaceted interventions that may influence policy changes that lead to a reduction in risk.

“There Are Certain Things Only Government Can Do”: Barack Obama’s Rhetoric on Food Safety and the Role of Government

In January 2011, President Barack Obama signed the FoodSafety Modernization Act (FSMA) into law, representing the mostsignificant upgrade to U.S. food safety laws since the 1930s. In thisessay, we explore Obama’s rhetoric on food safety by analyzing hisremarks prior to and directly following the passage of the FSMA. Asa collection, these texts offer insight into Obama’s reinterpretationof the role of government. Obama’s pragmatic rhetoric on foodsafety demonstrates how the issue of food safety can be used toargue for a broader and more responsible role of government writlarge.

Development of Add-on Materials to Supplement Food Safety Modernization Act Trainings in the Western U.S.

During the 2017 annual meeting of the Western Regional Center to Enhance Food Safety, 52 representatives from 15 western states/territories, regional centers funded through USDA-NIFA Food Safety Outreach Program, federal and state government agencies, and non-governmental organizations prioritized topics for the Food Safety Modernization Act (FSMA) training materials that address region-specific agricultural production and processing systems. This article describes supplemental materials or “add-ons” developed to support FSMA-related food safety trainings. Although the materials were developed for the western region stakeholders, they can be applied or adapted to other regions in or outside the U.S. to enhance food safety trainings.

Impact of irrigation water type and sampling frequency on Microbial Water Quality Profiles required for compliance with U.S. Food Safety Modernization Act Produce Safety Rule standards

The U.S. Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) requires that farmers generate a Microbial Water Quality Profile (MWQP) from 20 samples per agricultural water source, taken over 2–4 years and five annual samples thereafter. Farmers must use the MWQP to ascertain a geometric mean (GM) of ≤126 CFU/100 mL and statistical threshold value (STV) of ≤410 CFU/100 mL of generic Escherichia coli. Farmers are responsible for collecting samples and paying for testing, incurring a financial and time burden. To determine if testing frequency can be reduced without compromising accuracy, water samples (n = 279) were collected from twelve sites in the U.S. Mid-Atlantic region from 2016 to 2018 comprising tidal brackish river, non-tidal fresh river, pond, vegetable processing, and reclaimed water. The GM and STV were calculated for all sites and water types using all samples, and for multiple sub-samples of <20 from each site and water type. A Monte Carlo simulation was used to determine the proportion of sub-sample sizes that yielded the same determination as the entire sample size of PSR standard compliance. Four sites, two pond and two reclaimed water sites, complied with PSR GM and STV requirements when using the entire sample set. When a water source's calculated GM and STV using the entire sample set hovered close to the PSR thresholds, sub-sample sizes approached the recommended 20 samples to reach a congruent compliance determination. However, 99% agreement was obtained with a sub-sample of five when the absolute difference between the GM and STV from total samples and the PSR thresholds was ≥2.6 and 4.5 log CFU/100 mL E. coli, respectively. These findings suggest that under certain conditions the MWQP may be generated with well below 20 samples, reducing the economic burden on farmers while still maintaining a representative MWQP.

Assessing the food safety risk of ochratoxin A in coffee: A toxicology-based approach to food safety planning.

Under the Food Safety Modernization Act (FSMA) and preventive controls (PCs) regulations, food manufacturers must consider whether PCs are needed for potential hazards present in food. The mycotoxin ochratoxin A (OTA) is considered a chemical hazard under FSMA. It is produced by several fungal species and can be present in various agricultural commodities, including coffee. OTA presents a unique scenario in food safety, because it is known to be a potential risk; because heating may destroy it, but not completely; and because the hazard profile suggests it is not acutely toxic at the occurrence levels in coffee, although at high exposure levels, it is potentially nephrotoxic and carcinogenic in animal models. In the absence of US compliance levels, it is important for the risk assessor and risk manager to determine whether PCs are warranted. To address this complex situation in the coffee industry, we combined food safety and toxicology risk assessment principles to examine the available information on OTA hazard and risk in coffee. Exposure and health-based benchmarks for OTA in coffee, established by reviewing peer-reviewed literature, food recall databases, and authoritative reviews, resulted in large margins-of-exposure for both single and repeated exposure scenarios. Furthermore, no evidence was identified from historical data to suggest OTA is acutely toxic in humans from coffee consumption or other exposure sources. Therefore, findings from this assessment indicate that no PC is warranted for US coffee manufactures, based on the low severity and likelihood of risk according to margin-of-exposure estimates and historical data.

Participant characteristics and learning outcomes: Lessons from international food safety capacity building

The U.S. Food Safety Modernization Act (FSMA) requires monitoring and evaluating (M&E) of the Food and Drug Administration (FDA) food safety capacity building programs. M&E provides feedback to the agency on the impact of capacity building. This paper evaluates the direct impacts of International Good Agricultural Practices trainings delivered to trainers in Latin American countries from 2013 to 2017 and discusses policy implications. The evaluations consisted of in-class knowledge tests and questionnaires. Analyses of tests scores and improvements and participant characteristics show how specific characteristics affected classroom learning outcomes. The evaluation points to the usefulness of objective measurements and toward the need for close collaboration and communication with country partners on training needs and participant recruitment. The findings suggest that candidate screening could be useful to distribute scarce training resources to trainers who benefit better from the program and thereby facilitate food safety capacity building. The evaluation approach used in this paper is the first step of the Joint Institute for Food Safety and Applied Nutrition’s (JIFSAN) “Chain of Impacts” M&E framework. The same approach will be used for evaluating the impact of international Produce Safety Rule (PSR) training under FSMA. The approach can be applied more widely to other global food safety capacity building efforts.

Food quality assurance-lack of preventive controls in food processing and preparation operations

The Food Safety Modernization Act (FSMA), and associated regulations, is the most sweeping reform of the food safety regulatory system in the USA in more than 70 years. The FSMA confirms the primary role of the food manufacturing industry in assuring food safety, requires the food industry to conduct risk-based hazard analysis and implement preventive controls to minimize identified hazards, and applies to domestic as well as imported foods.

Persistence of Escherichia coli O157:H12 and Escherichia coli K12 as Non-pathogenic Surrogates for O157:H7 on Lettuce Cultivars Irrigated With Secondary-Treated Wastewater and Roof-Collected Rain Water in the Field

Treated wastewater (TW) and roof-collected rain water (RW) that meet the required microbial quality as per Food Safety Modernization Act (FSMA) regulation may serve as alternative irrigation water sources to decrease the pressure on the current water scarcity. Alternative water sources may have different water characteristics that influence the survival and transfer of microorganisms to the irrigated produce. Further, these water sources may contain pathogenic bacteria such as Shiga-toxigenicEscherichia coli. To evaluate the risk associated with TW and RW irrigation on the fresh produce safety, the effect of TW and RW irrigation on the transfer of two non-pathogenicE. colistrains as surrogates forE. coliO157:H7 to different lettuce cultivars grown in the field was investigated. Lettuce cultivars “Annapolis,” “Celinet,” and “Coastline” were grown in the field at the Fulton farm (Chambersburg, PA). Approximately 10 days before harvest, lettuce plants were spray-irrigated with groundwater (GW), TW, or RW containing 6 log CFU ml−1of a mixture of nalidixic acid-resistantE. coliO157:H12 and chloramphenicol-resistantE. coliK12 in fecal slurry as non-pathogenic surrogates forE. coliO157:H7. On 0, 1, 3, 7, and 10 days post-irrigation, four replicate lettuce leaf samples (30 g per sample) from each group were collected and pummeled in 120 ml of buffered peptone water for 2 min, followed by spiral plating on MacConkey agars with antibiotics. Results showed that the recovery ofE. coliO157:H12 was significantly greater than the populations ofE. coliK12 recovered from the irrigated lettuce regardless of the water sources and the lettuce cultivars. The TW irrigation resulted in the lowest recovery of theE. colisurrogates on the lettuce compared to the populations of these bacteria recovered from the lettuce with RW and GW irrigation on day 0. The difference in leaf characteristics of lettuce cultivars significantly influenced the recovery of these surrogates on lettuce leaves. Populations ofE. coliO157:H12 recovered from the RW-irrigated “Annapolis” lettuce were significantly lower than the recovery of this bacterium from the “Celinet” and “Coastline” lettuce (P&amp;lt; 0.05). Overall, the recovery of specificE. colisurrogates from the RW and TW irrigated lettuce was comparable to the lettuce with the GW irrigation, where GW served as a baseline water source.E. coliO157:H12 could be a more suitable surrogate compared toE. coliK12 because it is an environmental watershed isolate. The findings of this study provide critical information in risk assessment evaluation of RW and TW irrigation on lettuce in Mid-Atlantic area.

Longitudinal Assessment of the Dynamics of Escherichia coli, Total Coliforms, Enterococcus spp., and Aeromonas spp. in Alternative Irrigation Water Sources: a CONSERVE Study.

As climate change continues to stress freshwater resources, we have a pressing need to identify alternative (nontraditional) sources of microbially safe water for irrigation of fresh produce. This study is part of the center CONSERVE, which aims to facilitate the adoption of adequate agricultural water sources. A 26-month longitudinal study was conducted at 11 sites to assess the prevalence of bacteria indicating water quality, fecal contamination, and crop contamination risk (Escherichia coli, total coliforms [TC], Enterococcus, and Aeromonas). Sites included nontidal freshwater rivers/creeks (NF), a tidal brackish river (TB), irrigation ponds (PW), and reclaimed water sites (RW). Water samples were filtered for bacterial quantification. E. coli, TC, enterococci (∼86%, 98%, and 90% positive, respectively; n = 333), and Aeromonas (∼98% positive; n = 133) were widespread in water samples tested. Highest E. coli counts were in rivers, TC counts in TB, and enterococci in rivers and ponds (P < 0.001 in all cases) compared to other water types. Aeromonas counts were consistent across sites. Seasonal dynamics were detected in NF and PW samples only. E. coli counts were higher in the vegetable crop-growing (May-October) than nongrowing (November-April) season in all water types (P < 0.05). Only one RW and both PW sites met the U.S. Food Safety Modernization Act water standards. However, implementation of recommended mitigation measures of allowing time for microbial die-off between irrigation and harvest would bring all other sites into compliance within 2 days. This study provides comprehensive microbial data on alternative irrigation water and serves as an important resource for food safety planning and policy setting.IMPORTANCE Increasing demands for fresh fruit and vegetables, a variable climate affecting agricultural water availability, and microbial food safety goals are pressing the need to identify new, safe, alternative sources of irrigation water. Our study generated microbial data collected over a 2-year period from potential sources of irrigation (rivers, ponds, and reclaimed water sites). Pond water was found to comply with Food Safety Modernization Act (FSMA) microbial standards for irrigation of fruit and vegetables. Bacterial counts in reclaimed water, a resource that is not universally allowed on fresh produce in the United States, generally met microbial standards or needed minimal mitigation. We detected the most seasonality and the highest microbial loads in river water, which emerged as the water type that would require the most mitigation to be compliant with established FSMA standards. This data set represents one of the most comprehensive, longitudinal analyses of alternative irrigation water sources in the United States.

Evaluating the Behavior of Staphylococcus aureus and Bacillus cereus in Dairy- and Non-Dairy–Based Aqueous Slurries during Manufacturing of Table Spreads

High-moisture slurries used in the production of table spreads may permit growth of Staphylococcus aureus and Bacillus cereus and subsequent production of heat-stable enterotoxins. Compliance with the Food Safety Modernization Act (FSMA), specifically 21 CFR Part 117, subpart B and section 117.80 (c)(2) and (c)(3), requires a hazard analysis to determine whether preventive controls are needed. This study estimates the risk of potential growth of S. aureus and B. cereus in eight different dairy- and non-dairy-based slurries during extended storage and use. Mathematical models were used to screen which slurries might support the growth of S. aureus and B. cereus. Samples were individually inoculated with multiple strains of S. aureus and B. cereus to achieve a target level of 102 to 103 CFU/g. Inoculated and uninoculated slurry samples were incubated at typical holding temperatures of 35°C (95°F), 46.1°C (115°F), and 54.4°C (130°F). Samples were removed and tested following inoculation (time zero), after 4 and 12 h, and after 1, 2, 3, 4, 5, 6, 7, and 10 days of incubation at the target temperatures. All experiments were repeated in triplicate. Samples were analyzed for S. aureus and B. cereus using Baird-Parker agar and mannitol yolk polymyxin agar, respectively. Neither S. aureus nor B. cereus exceeded (P < 0.05) proposed food safety limits (105 CFU/g) at the evaluated experimental conditions. The study highlights the role of multiple hurdles (e.g., pH, potassium sorbate and sodium benzoate, salt, and other ingredients) in assuring microbiological safety of in-process dairy- and non-dairy-based slurries used in the production of table spreads. This study also found that mathematical models representative of product composition, intrinsic parameters, and experimental conditions can help risk managers make informed decisions during product development. Finally, the study findings indicate no significant risk of growth of the target pathogens associated with the dairy- and non-dairy-based aqueous slurries used in the routine manufacturing of table spreads.

Effect of Weather on the Die-Off of Escherichia coli and Attenuated Salmonella enterica Serovar Typhimurium on Preharvest Leafy Greens following Irrigation with Contaminated Water.

The Food Safety Modernization Act (FSMA) includes a time-to-harvest interval following the application of noncompliant water to preharvest produce to allow for microbial die-off. However, additional scientific evidence is needed to support this rule. This study aimed to determine the impact of weather on the die-off rate of Escherichia coli and Salmonella on spinach and lettuce under field conditions. Standardized, replicated field trials were conducted in California, New York, and Spain over 2 years. Baby spinach and lettuce were grown and inoculated with an ∼104-CFU/ml cocktail of E. coli and attenuated Salmonella Leaf samples were collected at 7 time points (0 to 96 h) following inoculation; E. coli and Salmonella were enumerated. The associations of die-off with study design factors (location, produce type, and bacteria) and weather were assessed using log-linear and biphasic segmented log-linear regression. A segmented log-linear model best fit die-off on inoculated leaves in most cases, with a greater variation in the segment 1 die-off rate across trials (-0.46 [95% confidence interval {95% CI}, -0.52, -0.41] to -6.99 [95% CI, -7.38, -6.59] log10 die-off/day) than in the segment 2 die-off rate (0.28 [95% CI, -0.20, 0.77] to -1.00 [95% CI, -1.16, -0.85] log10 die-off/day). A lower relative humidity was associated with a faster segment 1 die-off and an earlier breakpoint (the time when segment 1 die-off rate switches to the segment 2 rate). Relative humidity was also found to be associated with whether die-off would comply with FSMA's specified die-off rate of -0.5 log10 die-off/day.IMPORTANCE The log-linear die-off rate proposed by FSMA is not always appropriate, as the die-off rates of foodborne bacterial pathogens and specified agricultural water quality indicator organisms appear to commonly follow a biphasic pattern with an initial rapid decline followed by a period of tailing. While we observed substantial variation in the net culturable population levels of Salmonella and E. coli at each time point, die-off rate and FSMA compliance (i.e., at least a 2 log10 die-off over 4 days) appear to be impacted by produce type, bacteria, and weather; die-off on lettuce tended to be faster than that on spinach, die-off of E. coli tended to be faster than that of attenuated Salmonella, and die-off tended to become faster as relative humidity decreased. Thus, the use of a single die-off rate for estimating time-to-harvest intervals across different weather conditions, produce types, and bacteria should be revised.

Zero-Valent Iron-Sand Filtration Reduces Escherichia coli in Surface Water and Leafy Green Growing Environments

Surface water is used for irrigation by farmers. However, surface waters may be a source of bacterial foodborne pathogens which contaminate fresh produce intended for human consumption. Proposed but not finalized standards for microbial quality of irrigation water through the Produce Safety Rule (PSR) of the Food Safety Modernization Act (FSMA) in the US emphasize the need for effective reduction of levels of pathogens in surface water intended to be used on fruit and vegetable crops. This study evaluated a zero-valent iron (ZVI)-sand filtration system to reduce E. coli populations in pond water and those transferred to growing spinach plants in a field trial. Six filtration events were conducted with the same ZVI-sand or sand (S) laboratory filtration systems. Filtration systems were constructed by connecting 4 PVC pipes (1.25 L) together. ZVI-sand filters contained 50% ZVI/ 50% sand (0.43-0.60 mm particle size), while sand filters contained 100% sand (0.45-55 mm particle size). In each event, autoclaved pond water (PW) inoculated with E. coli (ca. 4 log CFU/ml) – 8 L - was pumped (1 L/min) through each filter followed by uninoculated autoclaved PW (15 L) with samples taken throughout the filtering process for enumeration of E. coli. Data were fit to a linear model to determine reductions of E. coli levels. ZVI-sand filtration removed significantly (p < 0.05) more E. coli (1.1 log CFU) compared to sand filtration. For ZVI-sand-filtered water, there was a statistically significant (p < 0.05) difference of E. coli removal from early trials (trials 1-3, average removal 96%) than in later trials (trial 4-6, average removal 44%), suggesting that age of the ZVI-sand filters influences E. coli inactivation. Overall, ZVI-sand and sand filtration reduced E. coli populations by 70% and -10%, respectively, indicating that ZVI filtration lowered or inactivated E. coli populations while sand filters accumulated E. coli. Field trials showed that soil and spinach plant samples irrigated with ZVI-sand-filtered water had significantly lower E. coli levels than soils irrigated with sand-filtered water or unfiltered control water. Overall, ZVI-sand filtration significantly reduced E. coli populations in water compared to sand filtration.

Financially able and willing to invest in food safety practices? The example of produce growers in New England states (USA)

The 2011 Food Safety Modernization Act (FSMA) exempts most small- and medium-scale growers in the U.S. from the new produce safety rule that creates a set of minimum safety standards for producing and processing fresh fruits and vegetables. While the exemption may limit the financial burden of growers in the short term, growers not willing or unable to meet food safety standards could lose out on market opportunities. In this article, we draw on a primary dataset of 301 survey responses from small- and medium-scale produce growers in New England (NE) and develop a conceptual framework for analyzing both objective and subjective factors associated with the on-farm adoption of food safety practices. We begin our analysis by exploring the extent to which growers report being financially able and willing to invest in food safety practices, and continue with an assessment of factors associated with the financial ability and willingness to adopt these practices. Regarding ability, we find that 24% of growers were able to adopt practices regardless of cost, while 64% were able to invest if not cost prohibitive. The odds of being able to invest increased 4% for every one-unit increase in the food safety knowledge test score and increased 20% for every one-unit increase in the number of practices implemented. In addition, the odds were 84% lower for those who reported financial barriers to adoption compared to those who did not. With respect to willingness, 46% of growers were willing to adopt practices regardless of cost, while 49% were willing if not cost prohibitive. The odds of being willing to invest increased 4% for every one-unit increase in food safety knowledge test score, were 4.9 times more likely for those who perceived no barriers to the implementation of practices, and were 2.7 times more likely for those who perceive that growers have a role to play in food safety. We conclude with a discussion of the practical implications for technical assistance providers, policy makers, and government agencies, as well as avenues for future research. These are centered around three points: (1) the high potential for adoption of food safety practices where cost remains a limiting factor, (2) a potential disconnect between the commonly used knowledge deficit approach to food safety training and what growers want and need to know, and (3) the importance of adopting a systemic approach to understand the realities of growers and the diversity of factors that shape the adoption of food safety practices.

Rapid detection of Escherichia coli using bacteriophage-induced lysis and image analysis.

Rapid detection of bacterial pathogens is a critical unmet need for both food and environmental samples such as irrigation water. As a part of the Food safety Modernization Act (FSMA), The Produce Safety rule has established several requirements for testing for the presence of generic Escherichia coli in water, but the current method available for testing (EPA M1603) demands specified multiple colony verification and highly trained personnel to perform these tests. The purpose of the study was to assess a phage induced bacterial lysis using quantitative image analysis to achieve rapid detection of E. coli at low concentrations within 8 hours. This study aimed to develop a simple yet highly sensitive and specific approach to detect target bacteria in complex matrices. In the study, E. coli cells were first enriched in tryptic soy broth (TSB), followed by T7 phage induced lysis, concentration, staining and fluorescent imaging. Image analysis was conducted including image pre-processing, image segmentation and quantitatively analysis of cellular morphological features (area, eccentricity and full width at half maximum). Challenge experiments using realistic matrices, including simulated fresh produce wash water, coconut water and spinach wash water, demonstrated the method can be applied for use in situations that occur in food processing facilities. The results indicated E. coli cells that are lysed by T7 phages demonstrated significantly (P < 0.05) higher extracellular DNA release, altered cellular shape (from rod to circular) and diffused fluorescent signal intensity. Using this biosensing strategy, a sensitivity to detect Escherichia coli at 10 CFU/ml within 8 hours was achieved, both in laboratory medium and in complex matrices. The proposed phage based biosensing strategy enables rapid detection of bacteria and is applicable to analysis of food systems. Furthermore, the steps involved in this assay can be automated to enable detection of target bacteria in food facilities without extensive resources.

Assessment of Biological Soil Amendments of Animal Origin Use, Research Needs, and Extension Opportunities in Organic Production

The use of biological soil amendments of animal origin (BSAAOs) to improve soil fertility and quality plays an important role in organic agriculture in the U.S. However, organic practices, such as untreated manure application, may introduce foodborne pathogens and consequently increase the risk of fresh produce contamination. Certified organic farms follow the USDA-National Organic Program (NOP) standards, which stipulate a 90- or 120-day waiting period between incorporating raw manure into the soil and crop harvest, depending on whether the edible portions of the crops come into indirect or direct contact, respectively, with the soil. To determine knowledge, attitudes, behaviors, and practices of organic farmers related to use of biological soil amendments, we employed three evaluation tools: a national workshop held at the University of California-Davis (UC-Davis); multiple in-person focus groups (listening sessions) conducted around the United States, and an online survey. Results reveal that untreated BSAAOs (untreated manure and immature composted manure) are critical tools in organic production for managing soil fertility and improving soil quality. Overall, organic producers surveyed in this study agreed that there is a need for more science-based data to evaluate and establish an appropriately protective time interval between untreated manure application and crop harvest to reduce the risk of surviving foodborne pathogens contaminating organic fresh produce. This study highlights the need for development of outreach and educational tools intended to help organic producers implement mitigation strategies to reduce food safety risks related to BSAAOs in organically grown produce covered by the Produce Safety Rule (PSR) of the U.S. Food and Drug Administration Food Safety Modernization Act (FSMA). This study informs and will aid prioritization of research (e.g., on a time interval protective of fresh produce food safety when soil is amended with animal-biological amendments in organic fresh produce systems) and outreach programs (e.g., GAPs, food safety programs, soil testing, pre-harvest food safety mitigation strategies, and organic rules and regulations) aimed at improving food safety for organic vegetable, fruit, and nut growers who use animal-based soil inputs, including amendments and rotational grazing.

Assisting Food Processors with Food Safety Modernization Act Compliance

The Food Safety Modernization Act (FSMA) Human Food Audit Checklist was developed as a tool for assisting food processors with implementation of FSMA. This 70-page checklist incorporates Title 21 Code of Federal Regulations (CFR) Part 1 Subparts H (Registration of Food Facilities) and O (Sanitary Transportation of Human and Animal Food) and 21 CFR 117 (Preventive Controls for Human Food Hazard Analysis and Risk-Based Preventive Controls and Current Good Manufacturing Practices) with hints, comments, and definitions. The checklist was reviewed by Food and Drug Administration experts and food company personnel to validate its usefulness. It can be modified to fit any food processor or regulation.