A current state analysis of preventive control requirements and traceability infrastructure in small U.S. food facilities

In 2011, the U.S. government enacted the Food Safety Modernization Act (FSMA). The goal of the new legislation was to reduce the 48 million people per year in the U.S. who are affected by food borne illnesses through the requirement of preventive controls in food supply chains. Compliance dates for small food businesses started in 2017, when the new preventive control measures were required to be implemented. This research focuses on understanding the current state of FSMA preventive control requirements in relationship to small food facilities. Also, an assessment of the traceability infrastructure within small food facilities was performed. A questionnaire based survey was developed from using the FDA’s FSMA Final Rule for Preventive Controls for Human Food and Animal Food along with the Institute of Food Technologist pilot study for FSMA traceability. The questionnaire was distributed to small food facilities in the state of Iowa. Fourteen different factors were analyzed from the questionnaire data: (i) food allergen controls, (ii) verification activities, (iii) current good manufacturing practices, (iv) food safety plan, (v) training records (vi) standard operating procedures, (vii) hazard analysis, (viii) recall plan, (ix) preventive controlled qualified individual, (x) operational control, (xi) accounting programs, (xii) inventory records, (xiii) lot coding, (xiv) business management software. Results were compared against the type of manufacturing, the size of the company, and how many years the company has been in business. A significant factor affecting the adoption of FSMA within the small business category proved to be company size. Chi-square analysis revealed significant results in preventive control practices and traceability infrastructure at divisions of 0-24 employees, and 25-499 employees. Companies that had 25-499 employees showed better preparation in implementing preventive controls for distinct FSMA compliance requirements. Also, companies that had 25-499 employees showed a leading advancement in technology adoption for establishment of traceability infrastructure versus companies that had 0-24 employees. The small business category spans a large range of employee sizes (499 or less). The results indicate that a special focus may be needed on businesses with less than 25 employees for FSMA preventive control requirements to be successful in small businesses

Beyond handover: supporting awareness for continuous coverage

Abstract Hospitals are required to operate as a continuous system because patient care cannot be temporarily suspended and handover is seen as a key method for enabling this. This paper reports a study of handover in a medical admissions unit. We draw on the notion of awareness as conceptualised within the Computer Supported Cooperative Work literature to explore the role played by a variety of cognitive artifacts in supporting continuous coverage. While such awareness is typically characterised as being ‘effortless’, our study reveals that maintaining awareness in a context such as the medical admissions unit is effortful due to invisible work. We suggest that the notion of awareness is beneficial for exploring the practices of continuous coverage because it moves attention away from the moment of handover, instead encouraging consideration of the variety of practices through which clinicians display their work to, and monitor the work of, colleagues on different shifts. We argue that efforts to support continuous coverage should focus on improving awareness by increasing the visibility of information

Transition, Integration and Convergence. The Case of Romania

This volume comprises several studies and papers published in the last decades. They have been selected and ranged so that to provide a minimum of coherence concerning the phases which Romania has crossed in her way to the advanced socio-economic system of European type: transition to the market economy, accession to the EU, the economic convergence in the three fundamental domains: institutions, real economy, and nominal economy. The readers may find in this volume a description of debates, difficulties and solutions adopted for building-up the market economy by a state being in a profound transformation from weak transition institutions towards hard democratic institutions. Because the transition to the market economy and the association of Romania with the EU and then the integration presenting strategic political decisions, I have included in this work two studies devoted to the political forces state and political parties that elaborated and applied these strategic decisions underlining their structure, role and function and their transformation. Integration into the EU of a country like Romania, which emerged from a different system comparing with the West-European one, has proved to be difficult and lasting many years because of the structural transformations. In five chapters I am referring to the essential characteristics of the integration process, such as: market liberalization, competitiveness of the local (national) firms on the national and EU markets, institutional reforms so that the institutions of candidate countries have to become compatible with those of the EU and finally the perspective assessment to find out the real and nominal convergence. Putting into practice the EU competitivity and cohesion principles, Romania has good prospects to close, in a reasonable time, the economic gap and to be admitted into the Euro Zone. Although the real convergence of Romania with the EU requires higher growth rates for the former, a new approach is compulsory to take into consideration the environment quality, the natural resources and the equity between the present and the future generations as natural resource consumers. Just these problems have determined me to include in this volume the last two chapters which, on the one hand, try to prove the necessity of the economy growth harmonization with the environment evolution as well as the saving of the energy resources, and, on the other hand, to point out the main ways to be followed and instruments to be used

A current state analysis of preventive control requirements and traceability infrastructure in small U.S. food facilities

In 2011, the U.S. government enacted the Food Safety Modernization Act (FSMA). The goal of the new legislation was to reduce the 48 million people per year in the U.S. who are affected by food borne illnesses through the requirement of preventive controls in food supply chains. Compliance dates for small food businesses started in 2017, when the new preventive control measures were required to be implemented. This research focuses on understanding the current state of FSMA preventive control requirements in relationship to small food facilities. Also, an assessment of the traceability infrastructure within small food facilities was performed. A questionnaire based survey was developed from using the FDA’s FSMA Final Rule for Preventive Controls for Human Food and Animal Food along with the Institute of Food Technologist pilot study for FSMA traceability. The questionnaire was distributed to small food facilities in the state of Iowa. Fourteen different factors were analyzed from the questionnaire data: (i) food allergen controls, (ii) verification activities, (iii) current good manufacturing practices, (iv) food safety plan, (v) training records (vi) standard operating procedures, (vii) hazard analysis, (viii) recall plan, (ix) preventive controlled qualified individual, (x) operational control, (xi) accounting programs, (xii) inventory records, (xiii) lot coding, (xiv) business management software. Results were compared against the type of manufacturing, the size of the company, and how many years the company has been in business. A significant factor affecting the adoption of FSMA within the small business category proved to be company size. Chi-square analysis revealed significant results in preventive control practices and traceability infrastructure at divisions of 0-24 employees, and 25-499 employees. Companies that had 25-499 employees showed better preparation in implementing preventive controls for distinct FSMA compliance requirements. Also, companies that had 25-499 employees showed a leading advancement in technology adoption for establishment of traceability infrastructure versus companies that had 0-24 employees. The small business category spans a large range of employee sizes (499 or less). The results indicate that a special focus may be needed on businesses with less than 25 employees for FSMA preventive control requirements to be successful in small businesses.</p

Circulating immunoglobulin-bound transforming growth factor β at a late tumour-bearing stage impairs antigen-specific responses of CD4+ T cells

In order to elucidate the mechanisms by which tumour-specific CD4+ T-cell responses are impaired during tumour development, an attempt was made to identify factors which impair CD4+ T-cell responses at a late tumour-bearing stage. Plasma from mice bearing B16 melanoma for 30 days (plasma d30) showed a more profound immunosuppressive effect on the in vitro proliferation of unrelated antigen-specific CD4+ T cells in the presence of both antigen and antigen-presenting cells (APC) than plasma from naïve mice. The level of plasma transforming growth factor (TGF)-β was elevated in mice bearing B16 melanoma for 30 days compared with naïve mice, and the suppressive effect of plasma d30 was partially diminished by the neutralization of TGF-β. Interestingly, immunoglobulin (IgG)-bound TGF-β, but not IgG-unbound TGF-β, in plasma d30 was suggested to be responsible for the immunosuppressive activity. In addition, no suppressive effect of plasma d30 was observed when antigen was added as a class II peptide, thus suggesting that the impaired proliferation of CD4+ T cells in the presence of plasma d30 was due to a dysfunction of antigen uptake/processing by APC. Furthermore, dissociation between IgG and TGF-β resulted in a loss of the suppressive activity of plasma d30. Taken together, these results suggest that circulating IgG-bound TGF-β is, at least in part, responsible for the impaired responses of CD4+ T cells at the late tumour-bearing stage by suppressing antigen uptake/processing by APC