Barry S Michaels | Independent Researcher (original) (raw)

Papers by Barry S Michaels

Research paper thumbnail of Potential for Glove Risk Amplification via Direct Physical, Chemical, and Microbiological Contamination

Journal of food protection, Apr 1, 2024

This review focuses on the potential direct physical, chemical, and microbiological contamination... more This review focuses on the potential direct physical, chemical, and microbiological contamination from disposable gloves when utilized in food environments, inclusive of the risks posed to food products as well as worker safety. Unrecognized problems endemic to glove manufacturing were magnified during the COVID-19 pandemic due to high demand, increased focus on PPE performance, availability, supply chain instability, and labor shortages. Multiple evidence-based reports of contamination, toxicity, illness, deaths, and related regulatory action linked to contaminated gloves in food and healthcare have highlighted problems indicative of systemic glove industry shortcomings. The glove manufacturing process was diagramed with sources and pathways of contamination identified, indicating weak points with documented occurrences detailed. Numerous unsafe ingredients can introduce chemical contaminants, potentially posing risks to food and to glove users. Microbial hazards present significant challenges to overall glove safety as contaminants appear to be introduced via polluted water sources or flawed glove manufacturing processes, resulting in increased risks within food and healthcare environments. Frank and opportunistic pathogens along with food spoilage organisms can be introduced to foods and wearers. When the sources and pathways of glove−borne contamination were explored, it was found that physical failures play a pivotal role in the release of sweat build-up, liquefaction of chemical residues, and incubation of microbial contaminants from hands and gloves. Thus, with glove physical integrity issues, including punctures in new, unused gloves that can develop into significant rips and tears, not only can direct physical food contamination occur but also chemical and microbiological contamination can find their way into food. Enhanced regulatory requirements for Acceptable Quality Limits of food −grade gloves, and the establishment of appropriate bioburden standards would enhance safety in food applications. Based on the information provided, together with a false sense of security associated with glove use, the unconditional belief in glove chemical and microbiological purity may be unfounded.

Research paper thumbnail of Role of the Spleen in Interferon Production in Mice

Experimental Biology and Medicine, 1966

Summary The effect of splenectomy on interferon formation in mice following intravenous injection... more Summary The effect of splenectomy on interferon formation in mice following intravenous injection of Newcastle disease virus is described. Serum from splenectomized mice had markedly lower protective activity than serum from control animals. Organ cultures of spleens and livers removed from these animals after injection of NDV showed interferon production in the spleen but not in the liver.

Research paper thumbnail of Potential for Glove Risk Amplification via Direct Physical, Chemical, and Microbiological Contamination

J Food Prot., 2024

This review focuses on the potential direct physical, chemical, and microbiological contamination... more This review focuses on the potential direct physical, chemical, and microbiological contamination from disposable gloves when utilized in food environments, inclusive of the risks posed to food products as well as worker safety. Unrecognized problems endemic to glove manufacturing were magnified during the COVID-19 pandemic due to high demand, increased focus on PPE performance, availability, supply chain instability, and labor shortages. Multiple evidence-based reports of contamination, toxicity, illness, deaths, and related regulatory action linked to contaminated gloves in food and healthcare have highlighted problems indicative of systemic glove industry shortcomings. The glove manufacturing process was diagramed with sources and pathways of contamination identified, indicating weak points with documented occurrences detailed. Numerous unsafe ingredients can introduce chemical contaminants, potentially posing risks to food and to glove users. Microbial hazards present significant challenges to overall glove safety as contaminants appear to be introduced via polluted water sources or flawed glove manufacturing processes, resulting in increased risks within food and healthcare environments. Frank and opportunistic pathogens along with food spoilage organisms can be introduced to foods and wearers. When the sources and pathways of glove−borne contamination were explored, it was found that physical failures play a pivotal role in the release of sweat build-up, liquefaction of chemical residues, and incubation of microbial contaminants from hands and gloves. Thus, with glove physical integrity issues, including punctures in new, unused gloves that can develop into significant rips and tears, not only can direct physical food contamination occur but also chemical and microbiological contamination can find their way into food. Enhanced regulatory requirements for Acceptable Quality Limits of food −grade gloves, and the establishment of appropriate bioburden standards would enhance safety in food applications. Based on the information provided, together with a false sense of security associated with glove use, the unconditional belief in glove chemical and microbiological purity may be unfounded.

Research paper thumbnail of Use limitations of alcoholic instant hand sanitizer as part of a food service hand hygiene program

Food Service Technology, Jun 1, 2003

Research paper thumbnail of Environmental surface cleanliness and the potential for contamination during handwashing

American Journal of Infection Control, Apr 1, 2003

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 9. Washing and Drying of Hands To Reduce Microbial Contamination

Journal of Food Protection, Oct 1, 2010

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 4. Infective Doses and Pathogen Carriage

Journal of Food Protection, Nov 1, 2008

Research paper thumbnail of CLEAN OPERATION Understanding the Glove Risk Paradigm: Part II

Research paper thumbnail of Skin-Sampling Techniques

... Rev Epidemiolo Sante Publique 25: 297–313, 1977. 117. JD Jarvis, CD Wynne, L Enwright, JD Wil... more ... Rev Epidemiolo Sante Publique 25: 297–313, 1977. 117. JD Jarvis, CD Wynne, L Enwright, JD Williams. Handwashing and antiseptic-con-taining soaps in hospital. ... 120. ME Stiles, AZ Sheena. Efficacy of germicidal hand wash agents in use in a meat processing plant. ...

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 11. Use of Antiseptics and Sanitizers in Community Settings and Issues of Hand Hygiene Compliance in Health Care and Food Industries

Journal of Food Protection, Dec 1, 2010

Research paper thumbnail of A Comparison of Hand Washing Techniques To Remove Escherichia coli and Caliciviruses under Natural or Artificial Fingernails

Journal of Food Protection, Dec 1, 2003

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 5. Sources of Contamination and Pathogen Excretion from Infected Persons

Journal of Food Protection, Dec 1, 2008

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 6. Transmission and Survival of Pathogens in the Food Processing and Preparation Environment

Journal of Food Protection, 2009

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 3. Factors Contributing to Outbreaks and Description of Outbreak Categories

Journal of Food Protection, Sep 1, 2007

Research paper thumbnail of Viral Inhibitory Activity of Polyvinylpyrrolidone

Research paper thumbnail of Handling money and serving ready-to-eat food

Food Service Technology, Mar 1, 2002

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 7. Barriers To Reduce Contamination of Food by Workers

Journal of Food Protection, Aug 1, 2010

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 8. Gloves as Barriers To Prevent Contamination of Food by Workers

Journal of Food Protection, Sep 1, 2010

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 10. Alcohol-Based Antiseptics for Hand Disinfection and a Comparison of Their Effectiveness with Soaps

Journal of Food Protection, Nov 1, 2010

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 1. Description of the Problem, Methods, and Agents Involved

Journal of Food Protection, Jul 1, 2007

Research paper thumbnail of Potential for Glove Risk Amplification via Direct Physical, Chemical, and Microbiological Contamination

Journal of food protection, Apr 1, 2024

This review focuses on the potential direct physical, chemical, and microbiological contamination... more This review focuses on the potential direct physical, chemical, and microbiological contamination from disposable gloves when utilized in food environments, inclusive of the risks posed to food products as well as worker safety. Unrecognized problems endemic to glove manufacturing were magnified during the COVID-19 pandemic due to high demand, increased focus on PPE performance, availability, supply chain instability, and labor shortages. Multiple evidence-based reports of contamination, toxicity, illness, deaths, and related regulatory action linked to contaminated gloves in food and healthcare have highlighted problems indicative of systemic glove industry shortcomings. The glove manufacturing process was diagramed with sources and pathways of contamination identified, indicating weak points with documented occurrences detailed. Numerous unsafe ingredients can introduce chemical contaminants, potentially posing risks to food and to glove users. Microbial hazards present significant challenges to overall glove safety as contaminants appear to be introduced via polluted water sources or flawed glove manufacturing processes, resulting in increased risks within food and healthcare environments. Frank and opportunistic pathogens along with food spoilage organisms can be introduced to foods and wearers. When the sources and pathways of glove−borne contamination were explored, it was found that physical failures play a pivotal role in the release of sweat build-up, liquefaction of chemical residues, and incubation of microbial contaminants from hands and gloves. Thus, with glove physical integrity issues, including punctures in new, unused gloves that can develop into significant rips and tears, not only can direct physical food contamination occur but also chemical and microbiological contamination can find their way into food. Enhanced regulatory requirements for Acceptable Quality Limits of food −grade gloves, and the establishment of appropriate bioburden standards would enhance safety in food applications. Based on the information provided, together with a false sense of security associated with glove use, the unconditional belief in glove chemical and microbiological purity may be unfounded.

Research paper thumbnail of Role of the Spleen in Interferon Production in Mice

Experimental Biology and Medicine, 1966

Summary The effect of splenectomy on interferon formation in mice following intravenous injection... more Summary The effect of splenectomy on interferon formation in mice following intravenous injection of Newcastle disease virus is described. Serum from splenectomized mice had markedly lower protective activity than serum from control animals. Organ cultures of spleens and livers removed from these animals after injection of NDV showed interferon production in the spleen but not in the liver.

Research paper thumbnail of Potential for Glove Risk Amplification via Direct Physical, Chemical, and Microbiological Contamination

J Food Prot., 2024

This review focuses on the potential direct physical, chemical, and microbiological contamination... more This review focuses on the potential direct physical, chemical, and microbiological contamination from disposable gloves when utilized in food environments, inclusive of the risks posed to food products as well as worker safety. Unrecognized problems endemic to glove manufacturing were magnified during the COVID-19 pandemic due to high demand, increased focus on PPE performance, availability, supply chain instability, and labor shortages. Multiple evidence-based reports of contamination, toxicity, illness, deaths, and related regulatory action linked to contaminated gloves in food and healthcare have highlighted problems indicative of systemic glove industry shortcomings. The glove manufacturing process was diagramed with sources and pathways of contamination identified, indicating weak points with documented occurrences detailed. Numerous unsafe ingredients can introduce chemical contaminants, potentially posing risks to food and to glove users. Microbial hazards present significant challenges to overall glove safety as contaminants appear to be introduced via polluted water sources or flawed glove manufacturing processes, resulting in increased risks within food and healthcare environments. Frank and opportunistic pathogens along with food spoilage organisms can be introduced to foods and wearers. When the sources and pathways of glove−borne contamination were explored, it was found that physical failures play a pivotal role in the release of sweat build-up, liquefaction of chemical residues, and incubation of microbial contaminants from hands and gloves. Thus, with glove physical integrity issues, including punctures in new, unused gloves that can develop into significant rips and tears, not only can direct physical food contamination occur but also chemical and microbiological contamination can find their way into food. Enhanced regulatory requirements for Acceptable Quality Limits of food −grade gloves, and the establishment of appropriate bioburden standards would enhance safety in food applications. Based on the information provided, together with a false sense of security associated with glove use, the unconditional belief in glove chemical and microbiological purity may be unfounded.

Research paper thumbnail of Use limitations of alcoholic instant hand sanitizer as part of a food service hand hygiene program

Food Service Technology, Jun 1, 2003

Research paper thumbnail of Environmental surface cleanliness and the potential for contamination during handwashing

American Journal of Infection Control, Apr 1, 2003

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 9. Washing and Drying of Hands To Reduce Microbial Contamination

Journal of Food Protection, Oct 1, 2010

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 4. Infective Doses and Pathogen Carriage

Journal of Food Protection, Nov 1, 2008

Research paper thumbnail of CLEAN OPERATION Understanding the Glove Risk Paradigm: Part II

Research paper thumbnail of Skin-Sampling Techniques

... Rev Epidemiolo Sante Publique 25: 297–313, 1977. 117. JD Jarvis, CD Wynne, L Enwright, JD Wil... more ... Rev Epidemiolo Sante Publique 25: 297–313, 1977. 117. JD Jarvis, CD Wynne, L Enwright, JD Williams. Handwashing and antiseptic-con-taining soaps in hospital. ... 120. ME Stiles, AZ Sheena. Efficacy of germicidal hand wash agents in use in a meat processing plant. ...

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 11. Use of Antiseptics and Sanitizers in Community Settings and Issues of Hand Hygiene Compliance in Health Care and Food Industries

Journal of Food Protection, Dec 1, 2010

Research paper thumbnail of A Comparison of Hand Washing Techniques To Remove Escherichia coli and Caliciviruses under Natural or Artificial Fingernails

Journal of Food Protection, Dec 1, 2003

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 5. Sources of Contamination and Pathogen Excretion from Infected Persons

Journal of Food Protection, Dec 1, 2008

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 6. Transmission and Survival of Pathogens in the Food Processing and Preparation Environment

Journal of Food Protection, 2009

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 3. Factors Contributing to Outbreaks and Description of Outbreak Categories

Journal of Food Protection, Sep 1, 2007

Research paper thumbnail of Viral Inhibitory Activity of Polyvinylpyrrolidone

Research paper thumbnail of Handling money and serving ready-to-eat food

Food Service Technology, Mar 1, 2002

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 7. Barriers To Reduce Contamination of Food by Workers

Journal of Food Protection, Aug 1, 2010

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 8. Gloves as Barriers To Prevent Contamination of Food by Workers

Journal of Food Protection, Sep 1, 2010

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 10. Alcohol-Based Antiseptics for Hand Disinfection and a Comparison of Their Effectiveness with Soaps

Journal of Food Protection, Nov 1, 2010

Research paper thumbnail of Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 1. Description of the Problem, Methods, and Agents Involved

Journal of Food Protection, Jul 1, 2007

Research paper thumbnail of Validation of Single-Use Glove Microbiome Shotgun WGS Metagenomic Analysis

Journal of Food Protection, 2022

Introduction: Until the current multi-year research project, previous studies on single-use glove... more Introduction: Until the current multi-year research project, previous studies on single-use gloves (SUGs) employed in food & healthcare environments have suffered from technical limitations preventing adequate microbial hazard identification. Eagle Protect PBC w/ partners have developed an effective methodology enabling 16S & shotgun sequencing of SUG isolates using the NCBI BLAST nt sequence analysis platform.
Purpose: Having overcome multiple technical challenges reported previously, robust bioinformatic validation of WGS sequence read findings is the important final step in data analysis.
Methods: Isolates from pooled rinsate (inside &/or outside) of 26 (25 nitrile & 1 vinyl) SUG brands consisting of positive MPN enrichment broth samples had previously been subjected to 16S/ITS1 amplicon & Shotgun sequencing. Being reported here is BLAST-based validation that was employed in tandem w/ an ensemble concordance between BLAST, Sourmash 3.5.0, MetaPhlAn 3 (default parameters & database). BLAST annotations were quality-filtered using a read-level implementation of the Bazinet et al. (2018) protocol designed for bioforensic casework. This included a prefiltering of annotations against a set of negative controls, initial quality-filtering using protocol-specific cutoffs for e-value and bit score ranges, and the establishment of bit score (b-s) thresholds for non-target taxa. With non-target taxa chosen for each target taxon amongst pathogens, fecal indicators or specific taxonomic groups, the completed validation parameters were selected and used for benchmarking.
Results: Approximately 6.4% of 25 million reads were qualified prior to b-s filtering. Including identification of human specific fecal indicators (~50% /samples), 16 enterotoxigenic strains of Bacillus cereus & B. anthracis were validated along with the presence of Listeria monocytogenes, Clostridoides difficile, Staphylococcus aureus, Pseudomonas aeruginosa & Streptococcus pneumoniae.
Significance: Frank & opportunistic pathogens identified on gloves in this study may represent public health issues for glove users, food or healthcare entities that rely on these hand surrogates for safe operation.

Research paper thumbnail of Hand & Glove Surface Cross-Contamination Potential Based on Nitrile & Vinyl Glove Surface Characteristics

IAFP 2019 Annual Meeting Program, 2019

Introduction: Between 2006 to 2015, data assembled indicates that glove-hand cross-contamination ... more Introduction: Between 2006 to 2015, data assembled indicates that glove-hand cross-contamination (C-C) or bare-hand contact was a contributory cause in approximately 16% and 36% of outbreaks respectively. Purpose: Recognition of the hazards posed by bare-hand contact and use of disposable gloves (DG) as a mitigation strategy is relatively recent, with mechanisms of CC for both needing elucidation. Methods: In an independent study partially funded by Eagle Protect PBC, the surface free energy (SFE) of nitrile (n=8) and vinyl (PVC) DG were determined with Zisman plots of SFE standards. This data was compared to published information on glove CC , transfer coefficients determined for different DG types, the SFE of hands and surface tensions (ST) of foods/human soils to investigate critical correlations. Also investigated were DG puncture characteristics that would affect CC. Statistical Evaluation: Digital photographs for each of the (in date) 5 Ac-cudyne Test surface tension test liquids were taken in order to determine contact angles from drop shape analysis for the 15 samples (n=8 Nitrile) (n=7 Vinyl). The mean, median, standard deviation, regression analyses, box and whisker plots, and appropriate statistical analyses were performed using Wizard (v1.9.32, jmcnamara@cpan.org., 2016), Excel (v16.26, Microsoft, 2019, Box-Plot (Vertex42LLC., 2018). Statistical analyses comparison of all contact angles for nitrile glove group to the vinyl glove group showed that the difference was very significant (P < 0.001). Background:

Research paper thumbnail of Food Contact Polymer Safety Vulnerabilities & Use of Failure Mode Effects Criticality Analysis (FMECA) for Effective Wor ker, Food Safety & Chemo-Bioterrorism Management

IAFP 2019 Annual Meeting Program, 2019

Introduction: The safety of food contact polymers (FCPs) in food packaging (FP) and disposable gl... more Introduction: The safety of food contact polymers (FCPs) in food packaging (FP) and disposable gloves (DG) are regulated and assured for safety similarly with reliable estimates of $16 billion in flexible food packaging and 40 billion pairs of disposable gloves utilized in the US/year.

Purpose: While integral to the safety of the food supply, failure modes, critical control or defense points have seldom been compared to evaluate adequacy of the safety/regulatory framework involved in production and use.

Methods: In work supported by Eagle Protect PBC scenario modelling employed FMECA and root cause analysis (RCA) to understand the various failure modes, their resulting effects and criticality. Following data collection, deductive failure analysis was employed with multiple accidental and intentional events evaluated to identify improvement of current approaches and targets for mitigation.

Results: When materials involved, production processes, facility type/geographic location, work force implications and quality/safety assurance standard operating procedures are reviewed, the two product categories are seen to have differing risk profiles. In a documented meta-analysis of possible costs related to risks of foodborne illness, food spoilage, worker safety/efficiency/turnover and chemo-bioterrorism, that could involve FP and DG, potential impact magnitudes of <$1/2 trillion were seen possible. For FP, FCPs are varied, production automated, 87% produced in US, with frequent inspection and shelf-life testing. Poor manufacturing, storage or use of FP may result in worker injury, physical, chemical and microbiological contamination. For DG, all factories are in SE Asia where labor conditions are poor and bioterrorism risks extensive. RCA indicates that employee security maintenance programs and third-party auditing, are key to of risk mitigation.

Significance: The data developed suggests that for FP risks are being managed or are low based on circumstances, but that for DG there is in an accumulation of chemical, microbiological, user safety/efficiency risks where control mechanisms are lacking.

Research paper thumbnail of J Food Processing & Tech 2018 Ed

Journal of Food Processing & Technology, 2018

Disposable gloves & flexible packaging in the food industry: An under-appreciated WMD risk Statem... more Disposable gloves & flexible packaging in the food industry: An under-appreciated WMD risk Statement of the Problem: With HACCP regulations, food packaging and disposable gloves are accepted for food contact when compliance to mandated safety standards. Safety assured via "Letters of Guarantee" that while protecting the supplier is a Pandora's black box. Given low incidence of physical, chemical and microbiological contamination, the capacity for bioterrorism has not been fully recognized as a $ 447 billion risk. Food worker gloves and packaging meant to deliver protection, longer shelf life, convenience & portion control is often faulty. Food contamination that occurs within food facilities has for the most part been unintentional. WMD coordinators are aware that a big concern is disgruntled employees intentionally contaminating food or tools of production, but the risk of bioterrorism at glove or food packaging point of origin is vastly under-appreciated. Methodology & Theoretical Orientation: HACCP provides the systematic methods for analyzing glove and food packaging manufacture, possible hazards, critical control points (CCPs) and testing necessary to protect the food chain. Findings: Impact costs and variables in surface types with respect to surface free energy and microbial physico-chemical characteristics were investigated. Results explain why and how microbial species attach to plastic surfaces and potential impact magnitude. Hazard analysis shows weak points, steps needed to disrupt microbe and intent, identifying CCPs that are required for target hardening to enable enhanced global food security w/ prevention of negative endpoints. Conclusion & Significance: Currently the food industry utilizes over 22 billion pairs of disposable gloves & $16 billion in flexible food packaging per year. Much of this production is outsourced to factories where labor conditions are poor, bioterrorism risks extensive and life sciences governance lacking. Performing a hazard analysis of the glove or food packaging manufacturing process revealed critical control points and mitigation strategies important in normal production and highly significant in preventing intentional events. Biography Barry Michaels has over 50 years of experience in the field of infectious disease investigation, control and prevention. His research work has involved a wide variety of viral, bacterial, fungal and protozoan pathogens in which he has focused a variety of technical intervention strategies. After initial research on viral / cancer inhibitory substances and marine microbiology, he went to work for industry. This brought him into contact with issues of product safety, regulatory affairs and product development in the fields of food and healthcare infection control where safety, efficacy and regulatory issues are simultaneously interwoven. He has been active in various scientific organizations and founded the B. Michaels Group Inc; a consultant group active in the areas of personal hygiene, glove use, food contact surfaces and cross-contamination. Considered the "Guru of Hand Hygiene" he has published or participated in hundreds of articles, abstracts, book chapters & presentations on infection control.