Journal of Regulatory Science最新文献

{"title":"A national probabilistic characterization of local crop proximity and density for refining US screening level exposure estimates of pesticides in surface water arising from agricultural use","authors":"","doi":"10.21423/jrs-v10a216","DOIUrl":"https://doi.org/10.21423/jrs-v10a216","url":null,"abstract":"Rising world population and changing diets are increasing the need for efficient and effective food and fiber production. Pesticides are used across the US to control pests and improve food yield and quality, but these benefits are offset by their potential to reach and possibly impact aquatic or terrestrial ecosystems. Regulatory agencies rely on prospective exposure models that often start with conservative simplifying assumptions that are refined with additional information if needed. The USEPA ecological risk assessment framework for pesticides assumes, at screening level, that 100% of the area draining to a water body is cropped. However, at the grower’s real-world scale, this simplifying assumption is generally not realistic and should be refined for higher tier assessment. The present study developed a US-wide spatially explicit analysis of crop density and proximity to surface waters to characterize the potential for pyrethroid insecticides to enter flowing surface waters. Reliable, transparent, and publicly available government spatial cropping and hydrology datasets were employed at the catchment-scale across the full extent of agricultural production in the US were used to generate fifteen novel crop-specific probabilistic distributions describing the extent and proximity of each crop to the flowing water body defining small catchments. These were used to refine estimated environmental concentrations using USEPA standard regulatory scenarios to evaluate the importance of considering agricultural landscapes when refining aquatic pesticide concentrations. Incorporating these real-world probabilities of crop occurrence and proximity showed that, while potential maximal aquatic exposure concentrations are unchanged, the probability of exceeding regulatory decision-making concentration endpoints is much lower than predicted by standard assumptions (e.g., 1.9 to ~50-fold reductions by crop for 90% of catchments). Additionally, we show that the relative ranking of crops by their aquatic pesticide exposure potential may change from that indicated when cropping density and proximity are considered.","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"42 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116682792","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"United States Biostimulant Industry Recommendations to Assess the Efficacy, Composition, and Safety of Plant Biostimulant Products","authors":"Biological Products Industry Alliance","doi":"10.21423/jrs-v10a247","DOIUrl":"https://doi.org/10.21423/jrs-v10a247","url":null,"abstract":"Plant biostimulant products are gaining significant traction as valuable tools in the agricultural and horticultural sectors, facilitating sustainable crop production and environmentally conscious operations while bettering plant growth, quality, and yield. These unique products cannot be classified as fertilizers, nor do they work directly on pests like pesticides. Working to enhance plant nutritional processes, they offer invaluable aid to producers, sustainably improving the efficiency of inputs and natural resources. Unlike widely used agrochemicals, plant biostimulant products lack consistent regulatory oversight in the United States, thus limiting their use. \u0000In this article, members of the Biostimulant Industry Workgroup (BIW) recommend guiding criteria when verifying plant biostimulant product claims. It is anticipated these principles will strengthen the credibility of developed and emerging plant biostimulant products and help prepare technology developers for the foreseeable measures enacted as governmental regulations come about in the United States.","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"86 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123192985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The American Spice Trade Association’s response to New York State’s new regulatory policies for heavy metals in spices","authors":"Shannen Kelly, Laura Shumow, Carolyn Scrafford, N. Beru","doi":"10.21423/jrs-v10a261","DOIUrl":"https://doi.org/10.21423/jrs-v10a261","url":null,"abstract":"Not Applicable","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"22 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129346890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rapid, field-deployable method for determination of seafood decomposition by compact mass spectrometry","authors":"Randy L. Self, Michael G. McLendon, C. Lock, Jinxin Hu","doi":"10.21423/jrs-v10a233","DOIUrl":"https://doi.org/10.21423/jrs-v10a233","url":null,"abstract":"Seeking alternatives to sensory which can be performed in non-laboratory field environments has been a recent emphasis in regulatory assessment of seafood decomposition.  To this end, an international sampling effort produced samples of 23 different seafood products, which were subjected to controlled decomposition of varying levels on ice. This produced samples of each product for a wide range of decomposition states, and these were scored by a sensory expert on a standard 1-100 scale. Samples were then analyzed by a novel technique involving headspace analysis and compact mass spectrometry. The mass spectrometry data was used to create computer models, guided by the sensory data, to generate a calculated score analogous to a sensory score. Models based on a training set of samples were then used to calculate scores for a test set, and accuracy was assessed by comparing these calculated scores to original sensory data. Calculated scores agreed with sensory findings with respect to overall decomposition state for 96.3% of samples (n=547), with seven false positive (1.3%) and 13 false negative (2.4%) findings. Reproducibility was also assessed via triplicate analysis on separate days for low, middle, and high decomposition states. All sample ranges for these replicates were within 20 points, with 89% (n=66) within 15 points, 73% within 10, and 35% within five. Given the performance of the method, along with the small form factor and manageable operation requirements of the instrument as well as simplicity of sample preparation, this appears to offer a potentially useful technique for field testing of seafood decomposition.","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"50 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"117206734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rapid-field-deployable DART-MS screening technique for 87 opioids and drugs of abuse, including fentanyl and fentanyl analogs","authors":"Sara Kern, Valerie M Toomey, Lisa M. Lorenz","doi":"10.21423/jrs-v10i2kern","DOIUrl":"https://doi.org/10.21423/jrs-v10i2kern","url":null,"abstract":"Fentanyl and fentanyl analogs are playing an increasing role in the opioid health crisis that is sweeping America. These synthetic opioids are much more potent and lethal than morphine or heroin and must be treated with extreme caution. Many of these substances are entering the country through International Mail Facilities (IMFs) and Express Courier Hubs (ECHs) in the form of counterfeit prescription drugs and bulk powders, resulting in a critical need for field-deployable techniques that can safely provide rapid screening to prevent these products from reaching the public.  Here we describe a direct analysis in real time thermal desorption mass spectrometer (DART-MS) with database searching capabilities that allows quick detection of numerous target compounds. Minimum detectable levels for 87 opioids and drugs of abuse have been determined. This technique was applied to eight samples sent to the Food and Drug Administration’s (FDA) Forensic Chemistry Center for analysis and the results are compared to those collected using gas chromatography with mass spectral detection (GC-MS) and liquid chromatography with mass spectral detection (LC-MS).","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"15 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129880452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Introduction to a Special Issue on Regulatory Applications of Portable Tools and Methods to Monitor Toxic Substances in Consumer Products","authors":"","doi":"10.21423/jrs-v10i2palmer","DOIUrl":"https://doi.org/10.21423/jrs-v10i2palmer","url":null,"abstract":"No abstract","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"92 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131483706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Food safety priority, a critical gap and a window for effective food, nutrition security and sustainable development in Rwanda","authors":"","doi":"10.21423/jrs-v10i1hagenimana","DOIUrl":"https://doi.org/10.21423/jrs-v10i1hagenimana","url":null,"abstract":"Food safety is globally an important issue and a priority for a sustainable food system and health and essential for achieving several United Nations Sustainable Development Goals (SDGs) outlined in the 2030 agenda. The present study aimed at identifying the critical gaps in the role of food safety in achieving agriculture, food and nutrition security along with the implementation of SDGs in Rwanda. The review of the Rwandan context showed that food safety was not considered and integrated within the development programs for agriculture, food and nutrition security. This lack of food safety integration affected the success of these programs and had a potential negative impact on the achievement ofthe ten SDGs, namely SDG 1, SDG 2, SDG 3, SDG 5, SDG 6, SDG 8, SDG 11, SDG 12, SDG13 and SDG 17. With available food safety opportunities in Rwanda, food safety should be a priority because it plays a critical role in implementing effective sustainable development programs. There is a need for food safety strategic integration by an evidence-based food safety decision-making approach through involving all concerned stakeholders.","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"19 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133775919","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analytical Uncertainty in Animal Feed Laboratories: A Current Evaluation of AAFCO Proficiency Testing Data for Select Analytes","authors":"T. Herrman, Kyung-min Lee, Y. Hsieh, Sara Williams","doi":"10.21423/jrs-v10i1herrman","DOIUrl":"https://doi.org/10.21423/jrs-v10i1herrman","url":null,"abstract":"The animal feed regulatory community utilizes analytical variations (AVs) that account for the normal variability that occurs within and between laboratories.  The AV was created using the Association of American Feed Control Officials (AAFCO) proficiency testing (PT) program results and represent the coefficient of variation times 2 (2 CV). This study was performed to assess the accuracy of the published AVs within the association’s Official Publication (OP) using AAFCO PT data from 2014 to 2020. This study also reevaluated the current AV values by applying the concept of the measurement uncertainties including the expanded uncertainty (U), Horwitz value, and 2 CV for the assessment of the label guarantees. Although greater variations were observed at lower concentrations, the majority of data points from the PT rounds showed an acceptable reproducibility for the select analytical methods except for cobalt, fat, fiber, moisture, and selenium where 2 CV was higher than the current AAFCO AV.  Regression models were developed based on the 95% tolerance interval of expanded uncertainty and 2 CV and were validated using the 2019-2020 AAFCO PT data. The validation data fell within the expanded uncertainty and 2 CV model bounds indicating the new models were fit-for-purpose and accurately characterized current AAFCO PT data.  The study results imply the AAFCO AV and its issues need to be better understood to improve an accuracy and traceability of the laboratory’s measurement and thus regulatory decisions to help animal feed producers and processors lower economic losses.","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"32 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125540914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulatory Compliance Monitoring Paradigms and the Relationship of Regulatory Compliance/Licensing with Program Quality: A Policy Commentary","authors":"Richard Fiene","doi":"10.21423/jrs-v10a239","DOIUrl":"https://doi.org/10.21423/jrs-v10a239","url":null,"abstract":"This policy commentary deals with two key issues within regulatory science related to the best methods for measuring regulatory compliance: Program monitoring paradigms and the relationship of regulatory compliance/licensing with program quality. Examples from program monitoring paradigms include: 1) Substantial versus Monolithic. 2) Differential Monitoring versus One size fits all monitoring. 3) “Not all standards are created equal” versus “All standards are created equal”. 4) “Do things well” versus “Do no harm”. 5) Strength based versus Deficit based. 6) Formative versus Summative. 7) Program Quality versus Program Compliance. 8) 100-0 scoring versus 100 or 0 scoring. 9) QRIS versus Licensing. 10) Non-Linear versus Linear. Examples from the relationship of regulatory compliance/licensing with program quality include: 1) “Do no harm” versus “Do good”. 2) Closed system versus Open system. 3) Rules versus Indicators. 4) Nominal versus Ordinal measurement. 5) Full versus Partial compliance. 6) Ceiling effect versus No Ceiling effect. 7) Gatekeeper versus Enabler. 8) Risk versus Performance.","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"104 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132282589","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulatory policies for heavy metals in spices – a New York approach","authors":"Maria L. Ishida, Virginia Greene, T. King, Robert Sheridan, John Luker, Debra Oglesby, Jennifer Trodden, Jon Greenberg","doi":"10.21423/jrs-v10i1ishida","DOIUrl":"https://doi.org/10.21423/jrs-v10i1ishida","url":null,"abstract":"The New York State Department of Agriculture and Markets (NYSAGM) Division of Food Safety and Inspection (NYSAGM-FSI), observed high levels of heavy metals in spices through its routine food surveillance program. There are no federal action levels for heavy metals in spices. In consultation with the NYSAGM Food Laboratory (NYSAGM-FL) and using results from a devised targeted sampling plan, NYSAGM-FSI instituted a State Class II action level of 1 ppm for Pb, arsenic (As) and cadmium (Cd) and a State Class I action level of 25 ppm for Pb in spices. In 2018, NYSAGM and the New York State Department of Health’s Bureau of Toxic Substance Assessment (NYSDOH-BTSA) created the Center of Excellence on Food Research to determine actionable limits of contaminants commonly found in spices, particularly heavy metals. NYSDOH-BTSA performed an assessment of relevant literature published and derived health-based guidance values for As, Cd, chromium (Cr), and Pb in spices. Consequently, NYSAGM lowered the State’s Class II action levels for Pb, As and Cd in spices by a factor of almost 5 times and is the first State in the nation to establish action levels for heavy metals in spices providing better protection to New York State consumers.\u0000https://doi.org/10.21423/jrs-v10i1ishida","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2022-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129442720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}