Modernizing and harmonizing regulatory data requirements for genetically modified crops-perspectives from a workshop.

Genetically modified (GM) crops that have been engineered to express transgenes have been in commercial use since 1995 and are annually grown on 200 million hectares globally. These crops have provided documented benefits to food security, rural economies, and the environment, with no substantiated case of food, feed, or environmental harm attributable to cultivation or consumption. Despite this extensive history of advantages and safety, the level of regulatory scrutiny has continually increased, placing undue burdens on regulators, developers, and society, while reinforcing consumer distrust of the technology.

Genetically modified DP915635 maize is agronomically and compositionally comparable to non-genetically modified maize.

DP915635 maize was genetically modified (GM) to express the IPD079Ea protein for corn rootworm (Diabrotica spp.) control. DP915635 maize also expresses the phosphinothricin acetyltransferase (PAT) protein for tolerance to glufosinate herbicide and the phosphomannose isomerase (PMI) protein that was used as a selectable marker.

Early Experience With an Occupational JYNNEOS ( Orthopoxvirus ) Vaccination Program.

Objective: The aim of the study is to identify lessons learned implementing JYNNEOS vaccination for laboratory workers exposed to orthopoxviruses such as mpox.

Methods: Workers at risk of laboratory exposure were offered vaccine in a carefully planned occupational health program. Vaccine was procured from the Centers for Disease Control and Prevention (CDC) Drug Service, which has special requirements.

Medical Device-related Pressure Injury Due to Urinary Catheterization: A Case Report.

Background: Urethral erosion secondary to a medical device-related pressure injury (MDRPI) is preventable, understudied, not well understood, and often overlooked.

Purpose: This case report describes a patient who sustained an MDRPI secondary to indwelling urinary catheter placement for urinary retention.

Case Study: A 93-year-old man with prostate cancer and pneumonia received an indwelling urinary catheter for retention during a 2-week hospitalization.

Environmental risk assessment of the DvSSJ1 dsRNA and the IPD072Aa protein to non-target organisms.

Event DP-Ø23211-2 (hereafter referred to as DP23211) maize expresses the DvSSJ1 double-stranded RNA (DvSSJ1 dsRNA) and the IPD072Aa protein, encoded by the gene. DvSSJ1 dsRNA and the IPD072Aa protein each provide control of corn rootworms ( spp.) when expressed in plants.

Transparency in risk-disproportionate regulation of modern crop-breeding techniques.

Despite over 25 years of safe deployment of genetically engineered crops, the number, complexity, and scope of regulatory studies required for global approvals continue to increase devoid of adequate scientific justification. Recently, there have been calls to further expand the scope of study and data requirements to improve public acceptance. However, increased regulation can actually generate consumer distrust due to the misperception that risks are high.

Hypothesis-based food, feed, and environmental safety assessment of GM crops: A case study using maize event DP-202216-6.

Event DP-2Ø2216-6 (referred to as DP202216 maize) was genetically modified to increase and extend the expression of the introduced gene relative to endogenous gene expression, resulting in plants with enhanced grain yield potential. The gene expresses the ZMM28 protein, a MADS-box transcription factor. The safety assessment of DP202216 maize included an assessment of the potential hazard of the ZMM28 protein, as well as an assessment of potential unintended effects of the genetic insertion on agronomics, composition, and nutrition.

Agronomic and compositional assessment of genetically modified DP23211 maize for corn rootworm control.

DP23211 maize was genetically modified (GM) to express DvSSJ1 double-stranded RNA and the IPD072Aa protein for control of corn rootworm ( spp.). DP23211 maize also expresses the phosphinothricin acetyltransferase (PAT) protein for tolerance to glufosinate herbicide, and the phosphomannose isomerase (PMI) protein that was used as a selectable marker.

Evaluation of the History of Safe Use of the Maize ZMM28 Protein.

The ZMM28 protein encoded by the zmm28 gene is endogenous to maize. DP202216 maize was genetically modified to increase and extend expression of the zmm28 gene relative to native zmm28 gene expression, resulting in plants with enhanced grain yield potential. Evaluation of the history of safe use (HOSU) is one component of the safety assessment framework for a newly expressed protein in a GM crop.

Composition of forage and grain from genetically modified DP202216 maize is equivalent to non-modified conventional maize ( L.).

DP202216 maize was genetically modified to increase and extend the expression of the gene relative to native gene expression, resulting in plants with enhanced grain yield potential. Standard nutritional and compositional parameters for maize grain and forage (e.g.

Genetically Engineered Crops: Importance of Diversified Integrated Pest Management for Agricultural Sustainability.

As the global population continues to expand, utilizing an integrated approach to pest management will be critically important for food security, agricultural sustainability, and environmental protection. Genetically engineered (GE) crops that provide protection against insects and diseases, or tolerance to herbicides are important tools that complement a diversified integrated pest management (IPM) plan. However, despite the advantages that GE crops may bring for simplifying the approach and improving efficiency of pest and weed control, there are also challenges for successful implementation and sustainable use.

Safety of Pseudomonas chlororaphis as a gene source for genetically modified crops.

Genetically modified crops undergo extensive evaluation to characterize their food, feed and environmental safety prior to commercial introduction, using a well-established, science-based assessment framework. One component of the safety assessment includes an evaluation of each introduced trait, including its source organism, for potential adverse pathogenic, toxic and allergenic effects. Several Pseudomonas species have a history of safe use in agriculture and certain species represent a source of genes with insecticidal properties.

Emerging Agricultural Biotechnologies for Sustainable Agriculture and Food Security.

As global populations continue to increase, agricultural productivity will be challenged to keep pace without overtaxing important environmental resources. A dynamic and integrated approach will be required to solve global food insecurity and position agriculture on a trajectory toward sustainability. Genetically modified (GM) crops enhanced through modern biotechnology represent an important set of tools that can promote sustainable agriculture and improve food security.

Transgenic maize event TC1507: Global status of food, feed, and environmental safety.

Maize (Zea mays) is a widely cultivated cereal that has been safely consumed by humans and animals for centuries. Transgenic or genetically engineered insect-resistant and herbicide-tolerant maize, are commercially grown on a broad scale. Event TC1507 (OECD unique identifier: DAS-Ø15Ø7-1) or the Herculex®(#) I trait, an insect-resistant and herbicide-tolerant maize expressing Cry1F and PAT proteins, has been registered for commercial cultivation in the US since 2001.

Work-associated irritable larynx syndrome.

Purpose Of Review: The purpose of this study is to review the relevant literature concerning work-associated irritable larynx syndrome (WILS), a hyperkinetic laryngeal disorder associated with occupational irritant exposure. Clinical symptoms are variable and include dysphonia, cough, dyspnoea and globus pharyngeus. WILS is a clinical diagnosis and can be difficult to differentiate from asthma.

Pitch elevation in trangendered patients: anterior glottic web formation assisted by temporary injection augmentation.

Unlabelled: Pitch elevation surgery is most often indicated to assist male-to-female transgendered individuals seeking a more feminine voice quality. Behavioral therapy is primary management but if the desired voice quality is not achieved, surgery is offered. Procedures described that raise vocal pitch alter one or more of the main parameters known to physiologically control pitch; vocal fold tension, length, and mass.

Comparison of small interfering RNA (siRNA) delivery into bovine monocyte-derived macrophages by transfection and electroporation.

The manipulation of the RNA interference pathway using small interfering RNA (siRNA) has become the most frequently used gene silencing method. However, siRNA delivery into primary cells, especially primary macrophages, is often considered challenging. Here we report the investigation of the suitability of two methodologies: transient transfection and electroporation, to deliver siRNA targeted against the putative immunomodulatory gene Mediterranean fever (MEFV) into primary bovine monocyte-derived macrophages (bMDM).

Novel Smad proteins localize to IR-induced double-strand breaks: interplay between TGFβ and ATM pathways.

Cellular damage from ionizing radiation (IR) is in part due to DNA damage and reactive oxygen species, which activate DNA damage response (DDR) and cytokine signaling pathways, including the ataxia telangiectasia mutated (ATM) and transforming growth factor (TGF)β/Smad pathways. Using classic double-strand breaks (DSBs) markers, we studied the roles of Smad proteins in DDR and the crosstalk between TGFβ and ATM pathways. We observed co-localization of phospho-Smad2 (pSmad2) and Smad7 with DSB repair proteins following low and high linear energy transfer (LET) radiation in human fibroblasts and epithelial cells.

Fate of atrazine in switchgrass-soil column system.

Atrazine, a broad-leaf herbicide, has been used widely to control weeds in corn and other crops for several decades and its extensive used has led to widespread contamination of soils and water bodies. Phytoremediation with switchgrass and other native prairie grasses is one strategy that has been suggested to lessen the impact of atrazine in the environment. The goal of this study is to characterize: (1) the uptake of atrazine into above-ground switchgrass biomass; and (2) the degradation and transformation of atrazine over time.

The dynamics of Ku70/80 and DNA-PKcs at DSBs induced by ionizing radiation is dependent on the complexity of damage.

DNA double-strand breaks (DSBs) are biologically one of the most important cellular lesions and possess varying degrees of chemical complexity. The notion that the repairability of more chemically complex DSBs is inefficient led to the concept that the extent of DSB complexity underlies the severity of the biological consequences. The repair of DSBs by non-homologous end joining (NHEJ) has been extensively studied but it remains unknown whether more complex DSBs require a different sub-set of NHEJ protein for their repair compared with simple DSBs.

Evaluation of spectrophotometric and HPLC methods for shikimic acid determination in plants: models in glyphosate-resistant and -susceptible crops.

Endogenous shikimic acid determinations are routinely used to assess the efficacy of glyphosate in plants. Numerous analytical methods exist in the public domain for the detection of shikimic acid, yet the most commonly cited comprise spectrophotometric and high-pressure liquid chromatography (HPLC) methods. This paper compares an HPLC and two spectrophotometric methods (Spec 1 and Spec 2) and assesses the effectiveness in the detection of shikimic acid in the tissues of glyphosate-treated plants.

Participation of DNA-PKcs in DSB repair after exposure to high- and low-LET radiation.

Cellular lesions (e.g. DSBs) are induced into DNA upon exposure to radiation, with DSB complexity increasing with radiation ionization density.

Radiation induced DNA DSBs: Contribution from stalled replication forks?

When cells are exposed to radiation serious lesions are introduced into the DNA including double strand breaks (DSBs), single strand breaks (SSBs), base modifications and clustered damage sites (a specific feature of ionizing radiation induced DNA damage). Radiation induced DNA damage has the potential to initiate events that can lead ultimately to mutations and the onset of cancer and therefore understanding the cellular responses to DNA lesions is of particular importance. Using gammaH2AX as a marker for DSB formation and RAD51 as a marker of homologous recombination (HR) which is recruited in the processing of frank DSBs or DSBs arising from stalled replication forks, we have investigated the contribution of SSBs and non-DSB DNA damage to the induction of DSBs in mammalian cells by ionizing radiation during the cell cycle.