https://regsci-ojs-tamu.tdl.org/regsci/issue/feed 2024-02-05T16:58:37+00:00 Prabha Vasudevan JRSorg@otsc.tamu.edu Open Journal Systems <p>The Journal of Regulatory Science (JRS) is an online open-access journal intended for scholars with an interest in regulatory science. JRS publishes free of charge, peer-reviewed scientific manuscripts, proposed standard evaluations and rapid communications to advance the discipline of regulatory science. Authors who submit articles for publising are <strong>not</strong> charged an submission and/or article processing fees. In addition, readers and subscribers are not charged any fees for accessing the articles published by the JRS.</p> <div style="clear: both;"> <div style="clear: both;"> <p>JRS is devoted to the consideration of risk management tools, standards and practices to improve the protection and compliance of regulated products. It is the mission of the Journal of Regulatory Science to facilitate an open dialogue among regulatory scientists from the global community.</p> <p>The JRS follows a continuous publication model, which allows for quicker publication of manuscripts, benefitting both contributors and readers. This publication model also includes the issuance of digital object identifiers, or DOIs. Beginning in January, articles will be published throughout the year, as soon as they go through the usual peer review and production process. You can read more about the peer review process <a href="https://journals.tdl.org/regsci/index.php/regsci/about/editorialPolicies#peerReviewProcess">here</a>. In December of the same year, the issue will be closed, and the next year’s issue will begin again the following January. View this year's continuous issue on our <a href="https://journals.tdl.org/regsci/index.php/regsci">home page</a> or by visiting our <a href="https://journals.tdl.org/regsci/index.php/regsci/issue/archive" target="_blank" rel="noopener">archives</a>.</p> <p>The Journal of Regulatory Science is indexed in the <a href="https://doaj.org/">Directory of Open Access Journals</a> (DOAJ). DOAJ indexes and provides access to high-quality, open-access, peer-reviewed journals. </p> <p>The JRS is published by the <a href="http://otscweb.tamu.edu/" target="_blank" rel="noopener">Office of the Texas State Chemist</a> using <a href="https://www.tdl.org/" target="_blank" rel="noopener">Texas Digital Library</a>'s publishing platform.</p> </div> </div> https://regsci-ojs-tamu.tdl.org/regsci/article/view/269 2023-08-10T17:39:06+00:00 Ivan Birukou ivan.birukou@syngenta.com Kathryn Bailey katie.bailey@syngenta.com James Sugar James.Sugar@SYNGENTA.COM Scott McClain Scott.Mcclain@sas.com Scott Young scott.young@syngenta.com

<p>Rigorous safety assessments are required for genetically modified (GM) crops to support their use as food or feed.&nbsp; These assessments include bioinformatics analysis of the amino acid sequences of all potential open reading frames (ORFs) encoded in the exogenous DNA introduced into the plant through genetic modification.&nbsp; Sequence similarities of potential DNA products to known or potential toxins and allergens trigger subsequent assessments of potential hazards for the consumer or the environment.&nbsp; The bioinformatic analysis of Syngenta maize event MZIR098 insert DNA revealed a total of 415 ORFs.&nbsp; One putative ORF (ORF-130) triggered further risk assessment based on its sequence similarities with known allergens, including peanut allergen Ara h 1, wheat glutenin, and others. We examined the potential expression of ORF-130 at a protein level to exclude the possibility of exposure during consumption of MZIR098 maize.&nbsp; Specifically, we developed and validated a liquid chromatography approach coupled to a tandem mass spectrometry (LC-MS/MS) method, called parallel reaction monitoring (PRM). This measure of expression was quantitative and targeted against the peptides unique to ORF-130.&nbsp; The linear range of the method was 25-5000 amol ORF-130/µl.&nbsp; Both, limit of detection (LOD) and lower limit of quantitation (LLOQ) of the method, were 12 μg ORF-130 per gram of dry MZIR098 maize leaf.&nbsp; The method was accurate and specific to ORF-130.&nbsp; PRM analysis of MZIR098 extracts did not detect putative ORF-130 above the limits of detection/quantitation.&nbsp; Furthermore, the broad proteomic data dependent acquisition (DDA) analysis of the MZIR098 extracts demonstrated no evidence of ORF-130 corroborating the PRM analysis.&nbsp; Our results confirm that ORF-130 is not characterized as a functional gene in Syngenta maize event MZIR098 insert DNA and does not express gene products at detectable levels.</p>

2024-03-04T00:00:00+00:00 Copyright (c) 2024 Ivan Birukou, Kathryn Bailey, James Sugar, Scott McClain, Scott Young https://regsci-ojs-tamu.tdl.org/regsci/article/view/274 2023-08-01T20:06:16+00:00 Bradley Grant brgrant@utmb.edu Michael Laposata milaposa@utmb.edu Christopher Zahner cjzahner@utmb.edu

<p>The Food and Drug Administration (FDA) has been a key actor in the USA’s response to the Covid-19 pandemic. The extensive use of Emergency Use Authorizations (EUAs) during the pandemic as part of its broader strategy to protect the health of the country has raised this federal agency to the public psyche. The FDA’s response has been guided by its position within the national governing framework as well as its own unique history. A review of this framework and the FDA’s history can be illuminating in understanding this agency’s response during a national crisis.</p>

2024-02-28T00:00:00+00:00 Copyright (c) 2024 Bradley Grant, Michael Laposata, Christopher Zahner