A5046642601- Genetically Modified Organisms Research
- Insect Resistance and Genetics
- Transgenic Plants and Applications
- CRISPR and Genetic Engineering
- Agricultural safety and regulations
- Food Allergy and Anaphylaxis Research
- Animal Genetics and Reproduction
- Allergic Rhinitis and Sensitization
- Effects and risks of endocrine disrupting chemicals
BirdLife International
2020-2021
Conservation International
2021
Since the commercial introduction of genetically modified (GM) plants in agriculture over two decades ago, technology developers and regulatory authorities have gained significant experience assessing their safety based on potential impact to humans, animals environment. Over 3500 independent agency reviews positively concluded GM for food feed. Yet, divergent increased requirements led delayed asynchronous approvals, restricted access innovative products farmers consumers. With accumulated...
Genetically modified (GM) plants used for food and feed have an established history of safe use over more than 25 years their commercialization. Developers regulatory authorities accumulated extensive experience in evaluating safety time. The studies required the assessment GM should now be re-defined to leverage this increased scientific knowledge. This paper, a companion paper Waters et al. also published issue, presents systematic approach newly expressed proteins (NEPs) by two components...
Genetically modified (GM) crops have been cultivated safely for more than 25 years, and the framework conducting an environmental risk assessment (ERA) is well-established. Currently, there alignment of broadly-stated protection goals across global jurisdictions; however, a lack consistency data that are required by regulators. Risk assessors over years collective experience assessing safety GM conducted hundreds ERAs to evaluate crop safety. This provides scientific basis help determine...
Laboratory and field data generated on genetically modified (GM) plants in one country can inform the environmental risk assessment support regulatory decision-making for GM being cultivated another country. Well-designed studies that test clear hypotheses follow well-established methods allow conclusions to be made about potential effects from cultivation of a plant relative its conventional counterparts. Following principle transportability, if no biologically relevant differences between...
Based on experience and scientific advancements over the past two decades, a revised approach for assessment of allergenic potential newly expressed proteins (NEPs) in genetically modified (GM) plants is warranted. NEPs are most often not native to crop genome, thus regulatory reviews safety GM include an NEPs. International standards allergenicity first developed mid-1990s required series characterization studies be conducted that are, some extent, still applicable today risk plants, with...
This paper details the weight of evidence (WOE) and stepwise approaches used to assess food feed safety newly expressed proteins (NEPs) in genetically modified (GM) plants, based on previously reported principles. The WOE approach is critical, as a vast majority cases no single assay or biochemical characteristic can identify protein hazard. A recommended evaluate NEPs taking totality information into account. Potential triggers for need supplementary toxicology studies are discussed, an...
International safety assessments and independent publications conclude that stacking genetically modified (GM) traits (events) through conventional breeding poses no greater risk to food or feed than multiple non-GM by breeding. Stacked trait products are not substantially different from their comparator GM parent plants. Additional assessment of a stacked product produced should be required unless there is plausible testable hypothesis for interaction the traits. However, approaches...
Risk assessment of genetically modified (GM) crops includes an evaluation hazard and exposure to newly expressed crop constituents, exemplified herein by proteins (NEPs). Guidance directing dietary assessments (DEAs) is limited and/or globally inconsistent. Best practices for conducting DEAs are presented include a preliminary problem formulation step determine if formal DEA necessary support the risk assessment. If deemed necessary, type (acute or chronic) availability food consumption data...
An investigation of the potential allergenicity newly expressed proteins in genetically modified (GM) crops comprises part assessment GM crop safety. However, is not completely predictable from a definitive assay result or set protein characteristics, and scientific opinions regarding data that should be used to assess are continuously evolving. Early studies supported correlation between stability exposed digestive enzymes such as pepsin protein's status allergen, but over time conclusions...
More than 25 years of 90-day rat feeding studies with GM crops have consistently shown that these provide no additional value to safety assessments in the absence a testable hypothesis. However, some regulatory authorities continue require while also specifying test material should be relevant product consumed and tested at maximum incorporation rate not causing nutritional imbalance. In known or suspected adverse effects, dose range-finding are feasible, yet scientifically justified rates...