Regulatory Aspects of Food Ingredients in the United States: Focus on the Safety of Enzyme Preparations Used in Food

Author(s):  
Shayla West-Barnette ◽  
Jannavi R. Srinivasan
2020 ◽  
Vol 29 (3) ◽  
pp. 476-490
Author(s):  
Vinaya Manchaiah ◽  
George Vlaescu ◽  
Srinivas Varadaraj ◽  
Elizabeth Parks Aronson ◽  
Marc A. Fagelson ◽  
...  

Objective Although tinnitus is one of the most commonly reported symptoms in the general population, patients with bothersome tinnitus are challenged by issues related to accessibility of care and intervention options that lack strong evidence to support their use. Therefore, creative ways of delivering evidence-based interventions are necessary. Internet-based cognitive behavioral therapy (ICBT) demonstrates potential as a means of delivering this support but is not currently available in the United States. This article discusses the adaptation of an ICBT intervention, originally used in Sweden, Germany, and the United Kingdom, for delivery in the United States. The aim of this study was to (a) modify the web platform's features to suit a U.S. population, (b) adapt its functionality to comply with regulatory aspects, and (c) evaluate the credibility and acceptability of the ICBT intervention from the perspective of health care professionals and patients with bothersome tinnitus. Materials/Method Initially, the iTerapi ePlatform developed in Sweden was adopted for use in the United States. Functional adaptations followed to ensure that the platform's functional and security features complied with both institutional and governmental regulations and that it was suitable for a U.S. population. Following these adaptations, credibility and acceptance of the materials were evaluated by both health care professionals ( n = 11) and patients with bothersome tinnitus ( n = 8). Results Software safety and compliance regulatory assessments were met. Health care professionals and patients reported favorable acceptance and satisfaction ratings regarding the content, suitability, presentation, usability, and exercises provided in the ICBT platform. Modifications to the features and functionality of the platform were made according to user feedback. Conclusions Ensuring that the ePlatform employed the appropriate features and functionalities for the intended population was essential to developing the Internet-based interventions. The favorable user evaluations indicated that the intervention materials were appropriate for the tinnitus population in the United States.


2018 ◽  
Vol 81 (7) ◽  
pp. 1171-1186 ◽  
Author(s):  
MIN LI ◽  
CHRISTOPHER A. BAKER ◽  
MICHELLE D. DANYLUK ◽  
PHILIPPE BELANGER ◽  
FRANK BOELAERT ◽  
...  

ABSTRACT Microbial contamination of fresh produce (fresh fruits and vegetables) poses serious public health concerns worldwide. This study was conducted as a comprehensive analysis of biological hazards in the global fresh produce chain. Data about produce-related outbreaks and illness were collected from the annual reports and databases of foodborne outbreak surveillance systems in different regions and countries from 2010 to 2015. The global patterns of and regional differences in documented outbreaks and cases were analyzed, and produce commodities and pathogens of greatest concern were identified. Data on sporadic illnesses were also collected through a comprehensive literature review of case-control studies. We found 988 produce-related outbreaks (with known agents) and 45,723 cases in all regions and countries. The numbers of produce-related outbreaks per million person-years were approximately 0.76, 0.26, 0.25, 0.13, 0.12, and 0.05 in New Zealand, Australia, the United States, the European Union, Canada, and Japan, respectively. The top three food categories and pathogens contributing to produce-related outbreaks were vegetables and nonfruits (i.e., food other than fruits; 27.0%), unspecified vegetables (12.2%), and vegetable row crops (11.7%) and norovirus (42.4%), Salmonella enterica (19.9%), and Staphylococcus aureus (7.9%), respectively. Produce consumption was identified as a protective factor, a risk factor, and either a protective or risk factor for sporadic illnesses in 11, 5, and 5 studies, respectively, among 21 case-control studies. Risks associated with produce consumption in the United States and the European Union have been linked to various factors such as irrigation water, cross-contamination, storage time and temperature abuse, infected food handlers, and unprocessed contaminated ingredients. The results of the current study indicate the complexity of produce products consumed across the globe and the difficulty in tracing illnesses back to specific food ingredients.


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