Proficiency testing for event-specific quantification of genetically modified maize MON87427: Performance assessment based on the metrologically traceable reference values as assigned values.

The Asia Pacific Metrology Program and the Accreditation Cooperation joint Proficiency Testing (PT) program for the quantification of genetically modified maize MON87427 was organized by the National Institute of Metrology, China, to enhance the measurement accuracy and metrological traceability in the region. Certified reference materials were employed as test samples; metrologically traceable certified reference values served as PT reference values (PTRVs) for evaluating the participants results. The consensus values obtained from the participants were higher than the assigned values, potentially due to the systematic effects of DNA extraction process. The participants' relatively poor overall performance by the ζ-score compared with z-score demonstrates their need to thoroughly investigate quantification bias to elevate the measurement capability of genetically modified (GM) content and deepen their understanding of uncertainty estimation. This program confirmed the importance of using metrologically traceable reference values instead of consensus values as PTRV for reliable performance assessment.

Comparative safety assessment of genetically modified crops: focus on equivalence with reference varieties could contribute to more efficient and effective field trials.

The initial compositional analysis of plants plays an important role within the internationally harmonized comparative safety assessment approach for genetically modified plants. Current EFSA guidance prescribes two types of comparison, namely difference tests with regard to a conventional comparator or control, and equivalence tests with regard to a collection of commercial reference varieties. The experience gained so far shows that most of the statistically significant differences between the test and control can be discounted based on the fact that they are still within equivalence limits of reference varieties with a presumed history of safe use. Inclusion of a test variety and reference varieties into field trial design, and of the statistical equivalence test would already suffice for the purpose of finding relevant parameters that warrant further assessment, hence both the inclusion of a conventional counterpart and the performance of difference testing can be omitted. This would also allow for the inclusion of safety testing regimes into plant variety testing VCU (value for cultivation and use) or other, independent variety trials.

"Somos a terra lutando para sobreviver": histórias de vida de mulheres agroecologistas / "We are the earth struggling to survive": life stories of female agroecologists / "Somos la tierra luchando por sobrevivir": historias de vida de mujeres agroecólogas

A luta pela terra e seu uso incide na forma como as subjetividades têm sido produzidas no Brasil. No contexto capitalista, patriarcal e machista, vive-se um processo de exploração da mão de obra de mulheres e de recursos naturais da Terra. Este estudo objetivou conhecer histórias de vida de mulheres agricultoras rurais que participam de movimentos sociais agroecológicos no Rio Grande do Sul. Participaram do estudo três mulheres agricultoras, com idades entre 21 e 53 anos, residentes e trabalhadoras em zonas rurais das cidades de Viamão e Rolante, escolhidas por conveniência. Os instrumentos utilizados foram: questionário sociodemográfico, entrevista de história de vida e observação participante, os quais foram, posteriormente, submetidos à análise temática. Os resultados demonstram que as histórias de vida das mulheres relatadas são marcadas por lutas e formas de resistência. Para além das situações de conflitos e falta de recursos, avistam-se questões próprias de gênero, como a invisibilidade feminina e a desigualdade no acesso à terra por mulheres. A construção de base e o fortalecimento do papel político das mulheres nos movimentos sociais permite inferir que existem melhorias significativas nas desigualdades e injustiças no meio rural. Contudo, pontua-se a necessidade de se promover o diálogo entre os movimentos sociais, as mulheres e a sociedade política sobre os modelos atuais de políticas públicas existentes, possibilitando, assim, avançar nas discussões a respeito da promoção da equidade de gênero nos espaços rurais, bem como potencializar o avanço das práticas agroecológicas em direção à superação do capitalismo.(AU)

The struggle for land and its use affects the way subjectivities have been produced in Brazil. In the capitalist, patriarchal, and male-chauvinist context, women's labor and the Earth's natural resources are strongly exploited. This study aimed to know the life stories of female farmers who participate in agroecological social movements in the state of Rio Grande do Sul. Three female farmers, aged from 21 to 53, residents and workers in rural areas of the municipalities of Viamão and Rolante, chosen by convenience, participated in the study. The instruments used were: sociodemographic questionnaire, a life story interview, and participant observation, which were later subjected to thematic analysis. The results show that the participants' life stories are marked by struggles and means of resistance. In addition to conflicts and lack of resources, there are specific gender issues, such as female invisibility and inequality in women's access to land. The grassroots construction and the strengthening of the political role of women in social movements allow us to infer that there are significant improvements in inequalities and injustices in rural areas. However, it is necessary to promote dialogue between social movements, women, and political society about the current models of existing public policies, thus making it possible to advance in discussions about gender equity in rural spaces, as well as to enhance the advancement of agroecological practices to overcoming capitalism.(AU)

La lucha por la tierra y su uso afecta a la forma en que se han producido las subjetividades en Brasil. En el contexto capitalista, patriarcal y machista, hay un proceso de explotación del trabajo de las mujeres y de los recursos naturales de la tierra. Este estudio tuvo como objetivo conocer las historias de vida de agricultoras rurales que participan en movimientos sociales agroecológicos en Rio Grande do Sul (Brasil). Participaron en el estudio tres agricultoras, de entre 21 y 53 años, residentes y trabajadoras en áreas rurales de las ciudades de Viamão y Rolante, elegidas por conveniencia. Los instrumentos utilizados fueron: cuestionario sociodemográfico, entrevista de historia de vida y observación participante, cuyos datos posteriormente se sometieron a análisis temático. Los resultados muestran que las historias de vida de las mujeres relatadas están marcadas por luchas y formas de resistencia. A las situaciones de conflicto y falta de recursos se suman cuestiones específicas de género, como la invisibilidad femenina y la desigualdad en el acceso de las mujeres a la tierra. La construcción popular y el fortalecimiento del papel político de las mujeres en los movimientos sociales permiten inferir que hay mejoras significativas en las desigualdades e injusticias en las zonas rurales. Sin embargo, es necesario promover el diálogo entre los movimientos sociales, las mujeres y la sociedad sobre los modelos actuales de las políticas públicas existentes, para posibilitar avances en las discusiones sobre la promoción de la equidad de género en los espacios rurales y potenciar el avance de las prácticas agroecológicas hacia la superación del capitalismo.(AU)

Multivariate equivalence testing for food safety assessment.

Products for food and feed derived from genetically modified (GM) crops are only allowed on the market when they are deemed to be safe for human health and the environment. The European Food Safety Authority (EFSA) performs safety assessment including a comparative approach: the compositional characteristics of a GM genotype are compared to those of reference genotypes that have a history of safe use. Statistical equivalence tests are used to carry out such a comparative assessment. These tests are univariate and therefore only consider one measured variable at a time. Phenotypic data, however, often comprise measurements on multiple variables that must be integrated to arrive at a single decision on acceptance in the regulatory process. The surge of modern molecular phenotyping platforms further challenges this integration, due to the large number of characteristics measured on the plants. This paper presents a new multivariate equivalence test that naturally extends a recently proposed univariate equivalence test and allows to assess equivalence across all variables simultaneously. The proposed test is illustrated on plant compositional data from a field study on maize grain and on untargeted metabolomic data of potato tubers, while its performance is assessed on simulated data.

Reflections on proposed modifications to the regulation of genetically modified food labeling in Brazil. / Reflexões sobre a proposta de modificação da regulamentação de rotulagem de alimentos transgênicos no Brasil.

Given the uncertainty surrounding the safety of genetically modified organisms (GMOs), the precautionary principle and constitution provide that consumers should have the right to access adequate information on the presence of transgenics through food labelling. This article discusses the implications of proposed modifications to GM food labelling in Brazil. Current labelling legislation and the government agencies involved in labelling do not guarantee that food products not bearing GMO labels are free of transgenics. The approval of Chamber of Deputies Bill No. 34/2015 goes against the Consumer Protection Code by undermining consumer autonomy and choice. In addition, it is likely to weaken the country's biosurveillance capabilities to identify and seize products that have a harmful effect on the health of humans, animals and the environment. The proposed changes constitute a retrograde step in the regulation of food labelling in Brazil and violate the individual and collective rights enshrined in the Federal Constitution, Consumer Protection Code, and international agreements signed by Brazil.

Diante da existência de incertezas científicas em relação à segurança dos transgênicos para a saúde humana e considerando o Princípio da Precaução e preceitos constitucionais em vigor, o consumidor deve ter o direito de ser informado de maneira adequada sobre a presença de transgênicos nos alimentos, por meio da rotulagem. Este ensaio tem por objetivo apresentar as implicações acerca da nova proposta de rotulagem de transgênicos no Brasil. A atual legislação brasileira de rotulagem de alimentos transgênicos e agências governamentais envolvidas não garantem que os produtos não identificados como tal sejam livres de transgênicos. A aprovação do PLC nº 34/2015 contraria dispositivos do Código de Defesa do Consumidor, indo na contramão da escolha e autonomia do consumidor. Além disso, a biovigilância será mais ainda inepta a executar uma atividade de identificação e apreensão de produtos que venham causar danos à saúde humana, animal e ao meio ambiente. A mudança proposta representa um retrocesso na regulamentação de rotulagem de transgênicos vigente no Brasil e um desrespeito aos direitos individuais e coletivos previstos na Constituição Federal, no Código de Defesa do Consumidor e em acordos internacionais assinados pelo Brasil.

Reflexões sobre a proposta de modificação da regulamentação de rotulagem de alimentos transgênicos no Brasil / Reflections on proposed modifications to the regulation of genetically modified food labeling in Brazil

Resumo Diante da existência de incertezas científicas em relação à segurança dos transgênicos para a saúde humana e considerando o Princípio da Precaução e preceitos constitucionais em vigor, o consumidor deve ter o direito de ser informado de maneira adequada sobre a presença de transgênicos nos alimentos, por meio da rotulagem. Este ensaio tem por objetivo apresentar as implicações acerca da nova proposta de rotulagem de transgênicos no Brasil. A atual legislação brasileira de rotulagem de alimentos transgênicos e agências governamentais envolvidas não garantem que os produtos não identificados como tal sejam livres de transgênicos. A aprovação do PLC nº 34/2015 contraria dispositivos do Código de Defesa do Consumidor, indo na contramão da escolha e autonomia do consumidor. Além disso, a biovigilância será mais ainda inepta a executar uma atividade de identificação e apreensão de produtos que venham causar danos à saúde humana, animal e ao meio ambiente. A mudança proposta representa um retrocesso na regulamentação de rotulagem de transgênicos vigente no Brasil e um desrespeito aos direitos individuais e coletivos previstos na Constituição Federal, no Código de Defesa do Consumidor e em acordos internacionais assinados pelo Brasil.

Abstract Given the uncertainty surrounding the safety of genetically modified organisms (GMOs), the precautionary principle and constitution provide that consumers should have the right to access adequate information on the presence of transgenics through food labelling. This article discusses the implications of proposed modifications to GM food labelling in Brazil. Current labelling legislation and the government agencies involved in labelling do not guarantee that food products not bearing GMO labels are free of transgenics. The approval of Chamber of Deputies Bill No. 34/2015 goes against the Consumer Protection Code by undermining consumer autonomy and choice. In addition, it is likely to weaken the country's biosurveillance capabilities to identify and seize products that have a harmful effect on the health of humans, animals and the environment. The proposed changes constitute a retrograde step in the regulation of food labelling in Brazil and violate the individual and collective rights enshrined in the Federal Constitution, Consumer Protection Code, and international agreements signed by Brazil.

The role of genetic essentialism and genetics knowledge in support for eugenics and genetically modified foods.

People are regularly exposed to discussions about the role of genes in their lives, despite often having limited understanding about how they operate. The tendency to oversimplify genetic causes, and ascribe them with undue influence is termed genetic essentialism. Two studies revealed that genetic essentialism is associated with support for eugenic policies and social attitudes based in social inequality, and less acceptance of genetically modified foods. These views about eugenics and genetically-modified foods were especially evident among people who had less knowledge about genes, potentially highlighting the value of education in genetics.

Equivalence tests for safety assessment of genetically modified crops using plant composition data.

The evaluation of compositional characteristics of plants harvested from field trials is an important step in the safety assessment of a genetically modified crop and its derived products for food and feed. The European Food Safety Authority (EFSA) evaluates safety by testing for equivalence between the GM genotype and other genotypes, typically with a history of safe use. Here, a new equivalence test is proposed, which addresses issues with the EFSA test. The method is motivated by a recently proposed equivalence test for analysis of data from animal feeding trials. In order to be suitable for practical safety assessment, the new method has a statistical power set to a desired value, e.g. 95%, by construction. In addition, we assess distributions rather than average values. This way, equivalence limits can also be established when there is limited genotypic variation. The original EFSA equivalence test breaks down in this case. The method is illustrated by its application to data from a field study on maize grain. Simulation studies indicate that the proposed test has appropriate performance characteristics and is competitive with respect to recently proposed alternatives, including the EFSA/EU equivalence test.

Mass spectrometric analysis of digesta does not improve the allergenicity assessment of GM crops.

An investigation of the potential allergenicity of newly expressed proteins in genetically modified (GM) crops comprises part of the assessment of GM crop safety. However, allergenicity is not completely predictable from a definitive assay result or set of protein characteristics, and scientific opinions regarding the data that should be used to assess allergenicity are continuously evolving. Early studies supported a correlation between the stability of a protein exposed to digestive enzymes such as pepsin and the protein's status as a potential allergen, but over time the conclusions of these earlier studies were not confirmed. Nonetheless, many regulatory authorities, including the European Food Safety Authority (EFSA), continue to require digestibility analyses as a component of GM crop risk assessments. Moreover, EFSA has recently investigated the use of mass spectrometry (MS), to make digestion assays more predictive of allergy risk, because it can detect and identify small undigested peptides. However, the utility of MS is questionable in this context, since known allergenic peptides are unlikely to exist in protein candidates intended for commercial development. These protein candidates are pre-screened by the same bioinformatics processes that are normally used to identify MS targets. Therefore, MS is not a standalone allergen identification method and also cannot be used to predict previously unknown allergenic epitopes. Thus, the suggested application of MS for analysis of digesta does not improve the poor predictive power of digestion assays in identifying allergenic risk.

Safety assessment of genetically modified rice expressing Cry1Ab protein in Sprague-Dawley rats.

Rice is considered one of the most important staple food crops. Genetically modified (GM) Bt rice, harbored cry1Ab gene expressing the insect-resistance protein has been developed to resistance to the insects. In this study, we assessed the safety of the GM Bt rice on Sprague-Dawley rats for 90 days. Totally, 120 rats in both sexes were used for three different diets, including 50% GM Bt rice, feeding with 50% rice, and standard feeding. Each 40 SD rats including 20 males and 20 females were considered as each diet. The clinical variables such as body weight and food consumption were measured and a range of clinical tests was examined, including hematology, serum chemistry parameters, urinalysis profile, thyroid, and sex hormone levels. Pathological assessments were also done. The results showed that the mean weekly feed utilization (%) had no significant difference among the studied groups. Also, blood biochemistry, hematological parameters, urine analysis, and hormonal levels had no significant differences among the groups. However, alanine aminotransferase was less in males versus female feeding with GM Bt rice. No histopathological changes were observed among the groups. In conclusion, this study demonstrated that GM Bt rice had no obvious adverse effects on rats' health.

Allergenicity Assessment of Novel Food Proteins: What Should Be Improved?

Allergenicity prediction is one of the most challenging aspects in the safety assessment of foods derived from either biotechnology or novel food proteins. Here we present a bottom-up strategy that defines a priori the specific risk assessment (RA) needs based on a database appropriately built for such purposes.

Evaluation of the use of untargeted metabolomics in the safety assessment of genetically modified crops.

BACKGROUND: The safety assessment of foods and feeds from genetically modified (GM) crops includes the comparison of key characteristics, such as crop composition, agronomic phenotype and observations from animal feeding studies compared to conventional counterpart varieties that have a history of safe consumption, often including a near isogenic variety. The comparative compositional analysis of GM crops has been based on targeted, validated, quantitative analytical methods for the key food and feed nutrients and antinutrients for each crop, as identified by Organization of Economic Co-operation and Development (OCED). As technologies for untargeted metabolomic methods have evolved, proposals have emerged for their use to complement or replace targeted compositional analytical methods in regulatory risk assessments of GM crops to increase the number of analyzed metabolites. AIM OF REVIEW: The technical opportunities, challenges and strategies of including untargeted metabolomics analysis in the comparative safety assessment of GM crops are reviewed. The results from metabolomics studies of GM and conventional crops published over the last eight years provide context to enable the discussion of whether metabolomics can materially improve the risk assessment of food and feed from GM crops beyond that possible by the Codex-defined practices used worldwide for more than 25 years. KEY SCIENTIFIC CONCEPTS OF REVIEW: Published studies to date show that environmental and genetic factors affect plant metabolomics profiles. In contrast, the plant biotechnology process used to make GM crops has little, if any consequence, unless the inserted GM trait is intended to alter food or feed composition. The nutritional value and safety of food and feed from GM crops is well informed by the quantitative, validated compositional methods for list of key analytes defined by crop-specific OECD consensus documents. Untargeted metabolic profiling has yet to provide data that better informs the safety assessment of GM crops than the already rigorous Codex-defined quantitative comparative assessment. Furthermore, technical challenges limit the implementation of untargeted metabolomics for regulatory purposes: no single extraction method or analytical technique captures the complete plant metabolome; a large percentage of metabolites features are unknown, requiring additional research to understand if differences for such unknowns affect food/feed safety; and standardized methods are needed to provide reproducible data over time and laboratories.

Options to Reform the European Union Legislation on GMOs: Risk Governance.

Here, we discuss options to reform the EU genetically modified organism (GMO) regulatory framework, to make risk assessment and decision-making more consistent with scientific principles, and to lay the groundwork for international coherence. We discussed the scope and definitions in a previous article and, thus, here we focus on the procedures for risk assessment and risk management.

Consideration of familiarity accumulated in the confined field trials for environmental risk assessment of genetically modified soybean (Glycine max) in Japan.

To date, there have been 160 regulatory approvals for environmental safety in Japan for the major genetically modified (GM) crops, including corn, soybean, canola and cotton. Confined field trials (CFTs) have been conducted in Japan for all single events, which contain various traits. The accumulated information from these previously conducted CFTs, as well as the agronomic field study data from other countries, provides a rich source of information to establish "familiarity" with the crops. This familiarity can be defined as the knowledge gained through experience over time, and used to inform the environmental risk assessments (ERA) of new GM crops in Japan. In this paper, we compiled agronomic data from the CFTs performed in Japan for 11 GM soybean events which obtained food, feed and environmental safety approvals from regulatory agencies in Japan. These CFTs were conducted by multiple developers according to Japan regulations to support the ERA of these GM soybean, covering standard measurement endpoints evaluated across developers in Japan. With this dataset, we demonstrate how familiarity gained from the CFTs of GM soybeans in Japan can be used to inform on the ERA of new GM soybean events. By leveraging this concept of familiarity, we discuss potential enhancements to the ERA process for GM soybean events in Japan.

Molecular characterization and safety assessment of biofortified provitamin A rice.

Part of the studies involved in safety assessment of genetically engineered crops includes characterizing the organization, integrity, and stability of the inserted DNA and evaluating the potential allergenicity and toxicity of newly-expressed proteins. Molecular characterization of the introduced DNA in provitamin A biofortified rice event GR2E confirmed insertion of a single copy of the transfer-DNA in the genome and its inheritance as a single locus. Nucleotide sequencing of the inserted DNA confirmed it was introduced without modifications. The phytoene synthase, and carotene desaturase proteins did not display sequence similarity with allergens or toxins. Both proteins were rapidly digested in simulated gastric fluid and their enzymatic activity was inhibited upon heat treatment. Acute oral toxicity testing of the protein in mice demonstrated lack of adverse effects. These evidences substantiated the lack of any identifiable hazards for both proteins and in combination with other existing comparative analyses provided assurance that food derived from this rice is safe. This conclusion is in line with those of the regulatory agencies of US Food and Drug Administration, Health Canada and Food Standard Australia and New Zealand.

Mini-Disk Capillary Array Coupling with LAMP for Visual Detection of Multiple Nucleic Acids using Genetically Modified Organism Analysis as an Example.

Convenient, portable, and low-cost multiplex nucleic acid testing (NAT) systems are the trends in the fields of food safety, environmental microorganisms, molecular diagnosis, etc. In this study, we developed a novel system for visual monitoring of multiple nucleic acids combining a mini-disk capillary array (diameter = 17 mm, embedded with 6-10 capillaries), visual loop-mediated isothermal amplification (LAMP), and quick DNA extraction called mDC-LAMP. The performance and applicability of mDC-LAMP in testing multiple nucleic acids were evaluated and verified employing genetically modified contents analysis as an example. All of the results confirmed that mDC-LAMP has the advantages of high specificity without any cross contamination, high sensitivity with a limit of detection of 25 copies/reaction, high throughput with flexible channel sensors, easy fabrication, and low costs. We believe that mDC-LAMP is a competitive choice for on-spot monitoring of multiple nucleic acids in terms of the easy fabrication/operation, low costs, and suitable performance presented in the nucleic acids test.

Homologous tropomyosins from vertebrate and invertebrate: Recombinant calibrator proteins in functional biological assays for tropomyosin allergenicity assessment of novel animal foods.

BACKGROUND: Novel foods may provide new protein sources for a growing world population but entail risks of unexpected food-allergic reactions. No guidance on allergenicity assessment of novel foods exists, while for genetically modified (GM) crops it includes comparison of sequence identity with known allergens, digestibility tests and IgE serum screening. OBJECTIVE: As a proof of concept, to evaluate non-/allergenic tropomyosins (TMs) regarding their potential as new calibrator proteins in functional biological in vitro assays for the semi-quantitative allergy risk assessment of novel TM-containing animal foods with mealworm TM as an example. METHODS: Purified TMs (shrimp, Penaeus monodon; chicken Gallus gallus; E coli overexpression) were compared by protein sequencing, circular dichroism analysis and in vitro digestion. IgE binding was quantified using shrimp-allergic patients' sera (ELISA). Biological activities were investigated (skin testing; titrated basophil activation tests, BAT), compared to titrated biological mediator release using humanized rat basophil leukaemia (RBL) cells. RESULTS: Shrimp and chicken TMs showed high sequence homology, both alpha-helical structures and thermal stability. Shrimp TM was stable during in vitro gastric digestion, chicken TM degraded quickly. Both TMs bound specific IgE from shrimp-allergic patients (significantly higher for shrimp TM), whereas skin reactivity was mostly positive with only shrimp TM. BAT and RBL cell assays were positive with shrimp and chicken TM, although at up to 100- to 1000-times lower allergen concentrations for shrimp than chicken TM. In RBL cell assays using both TM as calibrators, an activation of effector cells by mealworm TM similar to that by shrimp TM confirmed the already reported high allergenic potency of mealworm TM as a novel protein source. CONCLUSIONS & CLINICAL RELEVANCE: According to current GM crops' allergenicity assessment, non-allergenic chicken TM could falsely be considered an allergen on a weight-of-evidence approach. However, calibrating allergenic potency in functional BAT and RBL cell assays with clinically validated TMs allowed for semi-quantitative discrimination of novel food protein's allergenicity. With TM calibration as a proof of concept, similar systems of homologous protein might be developed to scale on an axis of allergenicity.

Conflicting Messages on Food and Beverage Packages: Front-of-Package Nutritional Labeling, Health and Nutrition Claims in Brazil.

We assessed the prevalence of front-of-package (FoP) claims in the Brazilian packaged food supply and examined whether foods with claims were more likely to be high in critical nutrients. Using data from a random 30% subsample of 11,434 foods and beverages collected in the five largest food retailers in Brazil in 2017 (n = 3491), we classified claims into nutrition, health, and environment. We examined whether foods with claims were more likely to be high in critical nutrients using 95% confidence intervals. Claims were found in 41.2% of the products. Nutrition claims were the most prevalent (28.5%), followed by health (22.1%), and environment-related claims (5.2%). More than 85% of the breakfast cereals, granola bars, and nectars contained claims, which were found in 51% of the dairy beverages. Foods with nutrition claims were more likely to be high in critical nutrients (65.3%; 95% CI 62.3, 68.2% vs. 54.1% 95% CI 52.1, 56.0). Products with health (52.9%; 95% CI 49.3, 56.4% vs. 58.5%; 95% CI 56.6, 60.3) and environment-related claims (33.5%; 95% CI 27.0, 40.8% vs. 58.6%; 95% CI 56.9, 60.2%) were less likely to be high in critical nutrients. FoP claims are prevalent in Brazil, and nutrition claims are more likely to have a poorer nutritional profile. Policymakers should consider restricting the presence of claims on unhealthy products.

Equivalence Testing Approaches in Genetically Modified Organism Risk Assessment.

Since 2011, the European Food Safety Authority (EFSA) has implemented combined difference and equivalence testing of agronomic, phenotypic, and composition data in the risk assessment of genetically modified crops. A short perspective is provided on misunderstandings that have shown up in published criticisms of the approach to equivalence testing, different viewpoints regarding the questions to be answered, and new developments in statistical modeling.

Signaling impacts of GMO labeling on fruit and vegetable demand.

Food labels may have both informational and signaling influences on consumer demand. We conduct a choice experiment with over 1,300 subjects to examine the signaling effect of the food product labels on consumer demand for other competing products in the market. Specifically, we focus on the genetically modified (GM) text labeling for fresh produce (strawberries, apples, and potatoes) in the United States. Contrary to some previous studies, our results indicate that the absence-claim label (Not-GM) does not have a negative impact on the demand for related conventional products. Instead, we find that consumer demand for unlabeled products is significantly enhanced with the introduction of presence-claimed GM labels. Our results contribute to the ongoing discussion of the enactment of mandatory labeling for GM foods by the federal U.S. government. Our results suggest that, in the case of direct text disclosure labels, consumers may no longer differentiate between unlabeled products and Not-GM-labeled products after the mandatory GM labeling law is in effect.