Brazilian Regulations Research Articles

A study on the migration of primary aromatic amines in packaged açaí-based (Euterpe oleracea Mart.) products

An analytical method was developed to determine primary aromatic amines (PAAs) from açaí-based product packaging. First, the migration potential of 19 PAAs was investigated in the packaging using a food simulant (3% acetic acid). Then, the detection of migrants was performed in the açaí-based products. Both analyzes were performed by ultra-performance liquid chromatography-triple quadrupole mass spectrometry (UPLC-QqQ-MS). The proposed methods presented calibration curves with correlation coefficients ≥0.991, limit of detection ranging from 0.05 to 0.67 ug kg−1, appropriate recovery with values between 80% and 112%, and good precision (< 17.3% RSD), under repeatability and within-laboratory reproducibility conditions. The results showed that benzidine, o-toluidine, and 4,4′-methylenedianiline have migrated to food simulants with levels ranging from 0.0015 to 0.0033 mg kg−1. Therefore, these samples do not comply with the Brazilian and European regulations on PAAs, since these PAAs should not be detected in food simulants. In the real matrix, no PAAs were detected.

How transnational rules can contribute to the improvement of the Brazilian regulatory system for unitization—an analysis under the transnational legal order perspective

Abstract Unitization is the most effective method to avoid irrational, wasteful and environmentally unsustainable production of oil and natural gas. Therefore, it is important to notice that unitization is a complex practice. It is effective for the equitable production division of a deposit shared by different owners. However, compulsory membership can result in costly negotiation and make exploration and production projects less attractive. In the pre-salt, the most productive Brazilian oil province, unitization processes are common and even more complex due to the following factors: (i) there are three different tax regimes in the pre-salt polygon; (ii) when the reservoir is shared with an area not granted yet (referred to as an open area), the Brazilian regulation establishes that the unitization process must be carried out with the public company, Pré-sal Petróleo S.A., representing the Government; (iii) moreover, due to the high productivity of the pre-salt layer, the financial values involved in this process are substantial, even with a participation of less than 1 per cent in the shared reservoir. Brazil established a robust regulation on unitization in 2013, which was amended in 2017 and, again, in 2020. This demonstrates that the regulatory improvement process, in the search for a more efficient regulation—that balances the attraction of investments and protection of the public interest—is continuous. This article proposes that in this process of regulatory improvement, good international petroleum industry practices (good practices), contractual models drawn up by industry associations and codes of conduct shall be used as a reference. These non-state rules, which are the result of self-regulation by the upstream sector of the oil industry, will be considered in this article as transnational rules, following the approach of Halliday and Shaffer, who propose the existence of a transnational legal order.

Metrological Evaluation of the Compatibility of Two Different Digital Density Meter Adjustment Methods

Brazilian regulation requires the test methods for analysing the shrinkage factor, and the solubility ratio in crude oils must be estimated under the measurement conditions for appropriation. Since these physicochemical parameters depend upon the density, a Brazilian oil company proposed an adapted and more user-friendly methodology for adjusting the digital density meter under high pressure and temperature conditions. This study aimed to evaluate the metrological compatibility of this proposal by comparing it with the fit model presented by a manufacturer of a digital densimeter and with the tabulated reference values of fluid density. Since the density data behaviour presented non-normal distributions, the Wilcoxon signed-rank test showed metrological compatibility between the approaches studied in the pressure range from 0 psi to 1200 psi (8.273709 MPa) and the temperature range from 5 °C to 70 °C.

On-farm Production of Microbial Entomopathogens for use in Agriculture: Brazil as a Case Study.

In Brazil, the production of beneficial microorganisms by growers exclusively for their own use is a practice known as "on-farm production". Regarding on-farm bioinsecticides, they were initially deployed for pests of perennial and semi-perennial crops in the 1970s but, since 2013, their use has extended to pests of annual crops such as maize, cotton, and soybean. Millions of hectares are currently being treated with these on-farm preparations. Local production reduces costs, meets local needs, and reduces inputs of environmentally damaging chemical pesticides, facilitating establishment of more sustainable agroecosystems. Critics argue that without implementation of stringent quality control measures there is the risk that the on-farm preparations: (1) are contaminated with microbes which may include human pathogens or (2) contain very little active ingredient, impacting on field efficacy. The on-farm fermentation of bacterial insecticides predominates, especially that of Bacillus thuringiensis targeting lepidopteran pests. However, there has been a rapid growth in the past 5years in the production of entomopathogenic fungi, mostly for the control of sap-sucking insects such as whitefly (Bemisia tabaci (Gennadius)) and the corn leafhopper (Dalbulus maidis (DeLong and Wolcott)). In contrast, on-farm production of insect viruses has seen limited growth. Most of the ca. 5 million rural producers in Brazil own small or medium size properties and, although the vast majority still do not practice on-farm production of biopesticides, the topic has aroused interest among them. Many growers who adopt this practice usually use non-sterile containers as fermenters, resulting in poor-quality preparations, and cases of failure have been reported. On the other hand, some informal reports suggest on-farm preparations may be efficacious even when contaminated, what could be explained, at least partially, by the insecticidal secondary metabolites secreted by the pool of microorganisms in the liquid culture media. Indeed, there is insufficient information on efficacy and mode of action of these microbial biopesticides. It is usually the large farms, some with > 20,000ha of continuouscultivated lands, that produce biopesticides with low levels of contamination, as many of them possess advanced production facilities and have access to specialized knowledge and trained staff. Uptake of on-farm biopesticides is expected to continue but the rate of adoption will depend on factors such as the selection of safe, virulent microbial strains and implementation of sound quality control measures (compliance with emerging Brazilian regulations and international standards). The challenges and opportunities of on-farm bioinsecticidesare presented and discussed.

Does the initial C/N ratio interfere with the performance of sewage sludge composting and cotton waste?

ABSTRACT The effects of the initial C/N ratio on the composting of sewage sludge and cotton residues are not reported in the literature. Understanding the main composting control parameters is essential for the good stabilization of these wastes. Therefore, this study sought to evaluate different initial C/N ratios for the composting of sewage sludge and cotton waste, aiming to find the ranges with the best performance for the process and quality of the final organic compost. In this sense, five mixtures of sewage sludge (S) and cotton residues (C) were prepared and composted with three replications for each treatment in a completely randomized design. Physicochemical parameters were evaluated during composting and in the final organic compounds. A Multivariate Principal Component Analysis (PCA) was applied to evaluate the agronomic quality of organic compounds. The thermal behaviour of the mixtures presented differences. The treatments 90C10S, 80C20S and 67C33S showed the highest EXI² index (3566.64, 3448.39 and 2738.89), longer duration of thermophilic phase (12 and 13 days) and better potential for maximum degradation (A) of organic matter (67.5, 61.2 and 65.6%C). The final compounds of 90C10S and 80C20S showed higher pH values (7.9 and 7.5) and higher CEC (123.6 and 114.0 meq/100 g OM). PCA showed similarity in the agronomic quality of organic compounds for 90C10S, 80C20S and 67C33S. The treatment 28C72S (initial C/N ratio of 16.6) presented final pH of 5.3 and did not meet the minimum limit required by Brazilian regulations. Initial C/N relations between 24.9 and 35.2 showed better stabilization of waste and final organic compound with better agronomic quality.

Geochemical characterization and assessment of contamination in mud depocenters from the southern Brazilian shelf

Continental shelves hold ecological, environmental and economic importance. Mud depocenters found on continent shelves are able to adsorb and incorporate organic and inorganic pollutants into the surface of their grains, creating an effective record of anthropogenic influence and environmental changes in a region. The aim of this study is to perform a chemical characterization of mud depocenters on the southern Brazilian shelf, providing an inventory of elements and evaluation of their distribution and potential contamination or enrichment. The sediments from seven short cores were analyzed by Inductively Coupled Plasma-Optical Emission Spectrometry (ICP-OES) and X-Ray Fluorescence (XRF). The high correlation of metals such as Fe, K, Ti and V with PC 1 of PCA indicated the predominance of a terrigenous signal in the region. This signal was more evident in the cores collected further south and closer to the continent, because they were better related to PC 1 in the scatter plot of PCA. Furthermore, they presented the highest concentration of terrigenous elements, Fe/Ca and Fe/K ratios. The results corroborate the importance of Rio de la Plata discharge and local inputs, such as Patos Lagoon, to the southern Brazilian shelf. A period of decreased terrigenous input, identified by low element ratios from one of the cores, correlated with a drought that occurred in Rio Grande do Sul in 1943. The results of the pollution indices with almost all enrichment factors (EF) below 2, modified degree of contamination index (mCd) below 1.2, sediment quality guideline quotient (SQG-Q) around 0.1, and the elements with concentrations below those established by Brazilian regulation as safe, demonstrated the absence of potential risks to the biota and contamination levels by Cr, Cu, Ni, Pb and Zn. Nonetheless, increases in some EF vertical profiles after 1928 and 1988, which may be associated with the beginning of the Industrial Revolution in Brazil and the establishment of Neoliberal politics in Brazil and Latin America, respectively, and the differentiated results for As, suggest that the influence of anthropogenic activities in the sediments of the region must not be neglected.

Brazilian Corporate Sustainability Regulation in the Green Transition: Missing the Forest for the Trees

The article describes and analyses new regulatory and governance rules regarding corporate sustainability regulation in Brazil, including the new provisions by the capital markets, the financial authorities, and private frameworks. This is done through the theoretical lens of a critical approach to socio-ecological transformation, shedding light on the broader context in which the institutional innovations take place: the political project of relying on finance to guide the transformation and the current transformations (i.e., the dismantling) of the traditional apparatus for environmental protection. In so doing, the contributions are twofold: on an empirical level, the article presents an overview of new rules regarding corporate governance and climate change in Brazil, serving as a useful source for comparison with other jurisdictions and a critical analysis of trends and differences in Northern and Southern Countries. On the theoretical level, we argue in favour of the need for a holistic approach that considers the broader regulatory context including the political agenda boosting the reforms in internal corporate governance and the circumstances of external environmental regulation. As such, we stress the interplay between extra-corporate and intra corporate governance tools in fostering corporate sustainability.

Subsea pipelines incidents prevention: A case study in Brazil

There are more than 4000 subsea pipelines in Brazil. These pipes include umbilicals, drilling risers, flexible risers, rigid risers, hybrid risers, flowlines, and export pipelines. Despite all standards, regulations, guides, and risk management tools designed to avoid events, subsea pipeline incidents still occur, revealing possible failures in companies' risk control. Identifying similarities between different subsea pipeline failure events is crucial to improving the design, risk management practices, and regulation requirements, besides promoting accident prevention. This paper proposes applying the life cycle and management practices combined to analyze subsea pipeline incidents from the RDI (Detailed Incident Report) and investigations reported to ANP (Brazilian National Agency of Petroleum, Gas, and Biofuels), the Brazilian safety regulatory agency. Furthermore, subsea pipeline incidents data were analyzed: correlated circumstances, consequences, and causes. The results show that most riser and flowlines causal factors are related to equipment failures, and recurrent root causes are design errors and integrity control. Based on the proposed approach, it was possible to identify gaps in most riser and flowlines accident investigations since there are few causal factors, root causes, and the absence of riser and flowlines failure mode and mechanisms. Therefore, the development of accident recommendations can be compromised. Thus, this paper proposes improvements to current Brazilian regulations to clarify the minimal subsea pipeline accident investigation requirements.

Comparison of the drinking water standard for pesticides of the Brazil with other countries

The objective was to compare the types and concentrations of pesticides allowed in the water potability standard for human supply in Brazil with other countries considered to be the largest consumers of pesticides in dollars invested in purchase/trade. This is a descriptive and documentary study, with data collection in regulations available in official government websites in Brazil, USA, China, Japan, France, Germany, Canada, Argentina, India, Italy, and World Health Organization (WHO). Since Germany, France and Italy are part of the European Union (EU), the legislative resolution of the European Parliament was adopted. Pesticides number and maximum permitted values (MPV) differ between the countries and WHO. In the Brazilian ordinance there are forty pesticides, a number like the USA, Canada, China, and WHO, but that represents only 8% of the total pesticides registered for agricultural use in Brazil. When comparing the ordinance of Brazil with EU the values are only the same for Aldrin + Dieldrin. For other, amounts between 2 and 5000 times more are allowed in Brazil. Brazilian regulations do not establish a total value for the mixture of pesticides in water, only individual limits, which together can reach 1677.13 μg/L, while in EU standards it is only 0.5 μg/L. The study showed discrepancies of the pesticides allowed in water potability standard of the Brazil with other countries, but features 12 pesticides with the same concentrations as WHO guidelines, thus, a worldwide standardization in water potability regulations is necessary to promote health and reducing risk of exposure.

The policy dimension of energy transition: The Brazilian case in promoting renewable energies (2000–2022)

Policies can play a central role in the energy transition by promoting renewable sources. The successful implementation of sustainable energy and climate policies requires political will and public support. Governments in many countries are taking measures to drive changes in energy systems and incentivize renewable energies. Drawing on the Brazilian regulations and the database from the National Agency of Electric Energy, in this article, we examine the public policy design and implementation to boost renewable energy, as well as the emerging configuration of the sectoral governance that stems from energy policies. The installed electricity capacity in Brazil is mostly renewable due to hydropower. However, territorial matters of hydropower plant locations in areas with high biodiversity, the uncertainty about future water availability, and the impact of climate change on water resources impose a challenge on sectoral planning for understanding the spatial and water-energy nexus to avoid unintended consequences, as well as to promote alternative renewable energies. Strategies for expanding alternative sources need to consider, the growing presence of private agents (national and international) in the electricity sectoral configuration, which can shape national policies seeking their interest. Thus, the sectoral policy must seek to engage them in the decarbonization policy. On the other hand, adequate territorial planning, regulations, and policies that may shape the nature of the expansion, pace, and direction of the low-carbon energy transition also need to be considered.

Phantom comparison for MRI quality control tests according to manufacturers and national standards

Quality control tests are mandatory and essential to monitor Magnetic Resonance Imaging equipment. These assist in determining improper functioning or parameters below established reference levels. The objective of this study was to perform quality control tests in magnetic resonance imaging equipment and to compare their methodology with both FLUKE and KONEX phantoms. Different protocols were used for their evaluation, including the American Association of Physics in Medicine, the American College of Radiologists, and the Brazilian National Health Surveillance Agency. In this study, we demonstrated the results for the most critical tests: slice thickness accuracy, slice position accuracy, high-contrast spatial resolution, low-contrast resolution, magnetic field, and slice thickness uniformity. The results are that, although both phantom objects are efficient for carrying out the tests required in Brazilian regulations, the KONEX phantom consumes less time, as it requires less to image all its structures. The FLUKE phantoms need a longer acquisition time to obtain all test structures and object images. Nevertheless, the results obtained in both are within limits required by Brazilian regulations and limits suggested by the manufacturers' manuals. This work is expected to be a basis for other physicians and services using similar phantoms.

Chemical properties of Oxisol cultivated with corn in management systems of soil irrigated with swine production wastewater.

Waste generated from agribusiness, such as swine production, can be used in agricultural soil; however, certain technical criteria should be followed. The objective of this study was to evaluate the effects of different depths of irrigation with swine wastewater (SW), associated with the soil management system, on soil chemical attributes after two corn crop cycles. The experiments were conducted in the field, in an arrangement with two soil management systems (conventional tillage system - CTS and no-tillage system - NTS) and five depths of irrigation with SW (50%, 75%, 100%, 125% and 150% of evapotranspiration from the crop - ETc). Soil samples were collected at depths of 0-0.1 and 0.1-0.2 m to determine the pH, Ca, Mg, K, Na, Al, P, Fe, Cu and Zn at the end of each crop cycle. Soil nutrient contents increased with the application of SW irrigation in the two crop cycles and in the depths of 0-0.1 and 0.1-0.2 m, mainly with an increase of irrigation depths. No effect of the management systems was observed for the majority of the nutrients evaluated. The content of the heavy metals Cu and Zn remained below the critical limits established by the Brazilian Regulations.

Competition Law and Access to Medicines: Lessons from Brazilian Regulation and Practice

Competition Law and Access to Medicines: Lessons from Brazilian Regulation and Practice

Manatee watching is widespread and seasonally affected in Northeast Brazil: a case of the Endangered Trichechus manatus manatus (Sirenia: Trichechidae)

Marine mammal watching is a non-consumptive wildlife-oriented tourism practice. Trichechus manatus manatus (hereinafter – Antillean manatee) belongs to the charismatic marine megafauna and is subject to this practice at many places. Here we investigated the Antillean manatee watching in Brazil, focusing on mapping this activity across the country, identifying hotspot areas, analysing the potential seasonality of this practice, and assessing the interactions between people and Antillean manatees. We used a social network as data source since this species often appears on social media. The species is charismatic and have characteristics, which attract public affection such as large body size, gentle behaviour, and distinct physical appearance. We detected Antillean manatee watching in 91 localities distributed across 19 municipalities and nine states in northern and north-eastern Brazil. We considered six localities as Antillean manatee watching hotspots because of their high number of associated images. Five of the hotspots were located within three Protected Areas for sustainable use. We found up to 23 people depicted in a single manatee-related picture posted on social network, but up to five people appeared in most posts (photos and videos). Furthermore, images were significantly posted mostly during the summer months, indicating seasonality in Antillean manatee watching. We classified the manatee-watching interactions collected as either prohibited or permitted by the Brazilian law. Permitted interactions were significantly more frequent, but the occurrence of prohibited interactions reveals the current lack of compliance with Brazilian regulations. We suggest that tourism management strategies prioritise Antillean manatee watching hotspot areas, focusing on reinforcing compliance with local regulations and preferably involving local residents to ensure the sustainability of this practice in Brazil.

Policy diffusion in practice: the case of Brazilian medicinal products regulation

Resumo O presente estudo busca contribuir para a melhor compreensão de processos de difusão de política com base em arenas transnacionais - mais especificamente, do processo de difusão que influenciou a regulação das Boas Práticas de Fabricação (BPF) de medicamentos no Brasil num contexto envolto por atores internacionais. Por meio de pesquisa qualitativa, analisamos o processo de adesão da Agência Nacional de Vigilância Sanitária (Anvisa) ao arranjo de cooperação Pharmaceutical Inspection Co-operation Scheme (PIC/S), iniciado em 2010 e alcançado em 2021. Foi identificado um processo influenciado por 2 constelações de difusão, motivado por interesses da agência nacional em manter sua relevância e por atores que integram o Sistema Nacional de Vigilância Sanitária, no qual o modelo de equivalência e convergência regulatória do PIC/S se mostrou fundamental para a adaptação da referência internacional em nível nacional, mantendo o sistema em funcionamento. Tal processo de difusão de política ficou mais relevante nos últimos anos por ampliar a convergência regulatória e, potencialmente, tornar mais eficiente a avaliação das BPF de medicamentos pelas diversas autoridades sanitárias.

Fit-for-Purpose MIP OES Method to Meet the Requirements of the Brazilian Regulations for K and Na in Coconut Water, and Nutritional Assessment

The Brazilian regulations for processed coconut water establish the range concentrations of Na and K, being necessary high-throughput analytical methods, as microwave-induced plasma optical emission spectrometry (MIP OES) for quality control. Samples of natural (green and mature) and processed coconut water were treated by acid decomposition assisted by microwave radiation before their MIP OES analysis. Recoveries for Na and K were 103 and 95%, whereas the relative standard deviation (RSDs) were 7.6 and 1.3%, respectively. The limit of detection (LOD) was 1.77 mg kg-1 for K and 2.31 mg kg-1 for Na. Sodium and K were determined in the ranges of, respectively, 27-490 and 1,600-3,500 mg L-1 in natural samples, whereas in processed samples the ranges were 26-168 and 814-2,054 mg L-1. K-means cluster analysis identified a group of processed samples with compositions similar to green coconut water. All the processed samples were in accordance with the established regulation, except one dehydrated sample for which K content was below the accepted range. Natural coconut water is an excellent source of K in the diet as its daily consumption can supply more than 20% of the recommended daily ingestion of K for adults and 30% for children.

Impacto nas condenações de carcaças bovídeas por tuberculose e cisticercose após as modificações na legislação federal no estado do Rio Grande do Sul (2014-2020)

Abstract The inspection of products of animal origin, carried out by veterinarian agricultural inspectors, is based on the Brazilian legislation described in the Brazilian Regulation for the Industrial and Sanitary Inspection of Animal Origin Products (RIISPOA) of the Ministry of Agriculture, Livestock, and Food Supply (MAPA). Decree No. 9,013, which revokes Decree No. 30,691 of 1952, was published on March 29, 2017, and major changes occurred in the legislation described in RIISPOA, such as the criteria for judging carcasses. This study aimed to verify whether these changes had an impact on the condemnations of bovine carcasses due to tuberculosis and cysticercosis in the State of Rio Grande do Sul, RS, Brazil. The number of slaughtered animals and the number of carcasses condemned due to tuberculosis and cysticercosis from 2014 to 2020 were obtained from the Agricultural Defense System (SDA) database, the official data system of the Secretariat of Agriculture, Livestock, and Rural Development (SEAPDR). An increase in the number of cases of carcasses condemned due to cysticercosis and a reduction of animals affected by the disease were observed in the period after changes in the regulation. The number of carcasses condemned due to tuberculosis and the number of animals affected by the disease remained stable after changes in the regulation. The results showed that changes in federal legislation had a real impact on the historical series of condemnations of bovine carcasses due to cysticercosis in the State of Rio Grande do Sul, while the impact of condemnations on carcasses affected by tuberculosis was not significant.

브라질 개인정보보호법제와 EU GDPR의 입법적 조화

Recently, major countries and international organizations, including the European Union, are reforming their personal data protection system, which is understood to seek the reasonable balance between the protection of personal information and communication technologies that have developed rapidly over the past three decades. The General Data Protection Regulation (GDPR), enacted by the EU in May 2016, is the world's most powerful privacy system now, and since the GDPR was enacted, EU trade partners have been actively striving to align their own data protection legislations with the GDPR by adopting and amending theirs to meet the global data protection standards. Brazil, as Latin America's economic giant, has also spent a long time finding the balance point between creating economic profits and protecting human rights under the pressure of mediating the conflicting values of using and protecting personal information. As a result of the conflict, the Brazilian General Data Protection Regulation(LGPD), affected by the EU GDPR, was passed on August 15, 2018 after eight years of discussion. This study began with questions about how specific the Brazilian LGPD was influenced by the European GDPR and how these two legislations were harmonized in the global society. We examined the system and status of Brazil's personal information legislation, as well as the legislative progress of the new legislation, and went on to conduct comparative legal reviews of the two legislations to find out the similarities and differences between them. Furthermore, we looked at the implications of Brazilian legislation for our legislation and sought compatibility between the value of privacy protection and the development of information technology.

Mercury in tuna from the western equatorial Atlantic Ocean and health risk assessment

This study analyses the mercury (Hg) concentration in the meat of Thunnus albacares and Thunnus obesus caught from the western equatorial Atlantic Ocean. The objective was to estimate the Hg intake via tuna ingestion and presents the possible health risk assessment. For T. albacares and T. obesus, the median concentration was 212 ng·g-1 and 475.1 ng·g-1 wet weight, respectively. The Hg concentrations were below the maximum tolerable limit established by international and Brazilian regulations for fishery products. The consumption would pose a risk for human populations that ingest more than 80 g·day-1. Regular monitoring of both human consumption rates and Hg levels in fish are recommended.

Physicochemical composition and microbiological quality of honey produced from Tiúba, Melipona fasciculata (Apidae, Meliponini) in Brazil

The Melipona fasciculata is a stingless bee and her honey has properties and flavor appreciated by different consumers. Its production provides a source of income for poor communities in Maranhão, Brazil. However, the absence of Brazilian legislation for this type of honey, as it exists for Apis mellifera, prevents the expansion of the commercialization of M. fasciculata honey. This study was carried out to identify microbiological and physicochemical patterns of honey in seven important locations in the Baixada Maranhense, in the north of Brazil. The honeys showed good hygienic-sanitary quality, in line with Brazilian legislation for A. mellifera honey and the proposal for regulation of stingless bee (SLB) honey. However, 16% of samples belonging to five locations showed contamination by mesophilic bacteria. The physicochemical parameters were variable, mainly moisture indexes (%), with means between 19.35 to 21.22. The HMF content of São Bento (70.70 mg.kg−1) was above current Brazilian legislation. Total acidity showed higher averages in half of São Bento, Viana and Palmeirândia when compared to legislation and the SLB (Max: 50 mEq.kg−1). As for the principal component analysis, HMF and TA showed a positive correlation. With regards to reducing sugar content, only the mean in Peri-Mirim city reached values registered with the Apis legislation and the proposed SLB. In general, the honeys in this study showed rates compatible with those of other SLB, however, in disagreement with parameters required by the Brazilian regulation of Apis, motivating the establishment of specific legislation for honey in Maranhão.