“Fat can be extracted even from thousand-year-old pottery,” says V. Brychová

WASHINGTON – Today, May 8, 2024, in response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration and the U.S. Department of Agriculture have <a href="https://usbiotechnologyregulation.mrp.usda.gov/eo14081-section8c-plan-reg-reform.pdf">developed</a> a plan to update, streamline and clarify their regulations and oversight mechanisms for products of biotechnology.
The plan helps meet the President’s goals of ensuring public confidence in the biotechnology regulatory system and improving its transparency, predictability, coordination and efficiency. Through engagement with developers and stakeholders, as well as horizon scanning for novel biotechnology products, the agencies worked collaboratively to develop a cohesive plan. The plan incorporates processes and timelines to implement regulatory reform, such as identifying guidance and regulations to update, streamline, or clarify, and identifying the potential need for new guidance or regulations. The plan supports a whole-of-government approach to the regulation of biotechnology products.
The agencies have identified five major areas of biotechnology product regulation where these actions will focus:
<ol>
<li>Modified plants</li>
<li>Modified animals</li>
<li>Modified microorganisms</li>
<li>Human drugs, biologics and medical devices</li>
<li>Cross-cutting issues</li>
</ol>
EPA, the FDA and USDA intend to implement the following joint efforts:
<ul>
<li>Clarify and streamline regulatory oversight for genetically engineered plants, animals and microorganisms;</li>
<li>Update and expand their information sharing through an MOU to improve and broaden communication and coordination of oversight of modified microbes; and</li>
<li>Undertake a pilot project focused on modified microbes to explore and consider the feasibility and costs of developing a web-based tool that informs developers about which agency may regulate a given product category.</li>
</ul>
The federal government established the Coordinated Framework for the Regulation of Biotechnology in 1986 and most recently updated it in 2017. It describes the comprehensive federal regulatory policy for ensuring the safety of biotechnology products, including how EPA, the FDA and USDA share responsibility for regulating many of the products of biotechnology in the United States. The Executive Order directs the three agencies to improve how they implement the Coordinated Framework. 
In response to the Executive Order, the three regulatory agencies, in consultation with the Office of Science and Technology Policy, issued a Request for Information to the public to solicit information on regulatory ambiguities, gaps, uncertainties or inefficiencies in the Coordinated Framework. The agencies received 88 distinct public comments, including a sign-on letter from over 6,000 members from biotechnology developers, producers, manufacturers, non-governmental organizations and academia. The agencies will continue to engage with all interested stakeholders as they implement the plan.
Visit the <a href="https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home">Unified Website for Biotechnology Regulation</a> for additional information on modernizing the regulatory system for biotechnology products and Executive Order 14081.

EPA, FDA and USDA Issues Updates to the Joint Regulatory Plan for Biotechnology

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A groundbreaking study from the <a target="_blank" rel="noopener noreferrer" href="https://journals.plos.org/plosone/">SPRINT</a> project has revealed a concerning fact: residues of plant protection products (pesticides) are widespread in both agricultural and residential environments of farms, raising concerns about environmental and human health. These new findings are significant for the decision-making bodies of the European Union. They highlight the urgent need for regulatory measures to address the issue of co-occurrence of pesticide residues in mixtures, both in environmental components, including indoor environments, and in human bodies. Recent publications of results reveal the potential negative impacts of such mixtures on human health and ecosystem functioning.<div><div>For decades, pesticides have been used worldwide to increase agricultural productivity, but the cumulative effects caused by their residues occurring in mixtures in the environment have been largely overlooked. The scientific community is increasingly uncovering an alarming trend: pesticide residues, often assessed for risk based on individual substances, actually mix extensively in ecosystems. This issue is not limited to agricultural fields and water bodies but also extends to the homes of farmers and their neighbors.<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/RECETOX_Environmental_monitoring_ff3ef6c342.jpg" alt="RECETOX: Fig 1 - Environmental monitoring.jpg" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_RECETOX_Environmental_monitoring_ff3ef6c342.jpg 156w," sizes="100vw" width="575" height="575">As part of the SPRINT project, environmental, agricultural crop, livestock, and human samples (from those farming or living near fields, or completely outside agricultural landscapes) were collected in 2021 in 10 European countries. The study plan was published in the prestigious journal <a target="_blank" rel="noopener noreferrer" href="https://journals.plos.org/plosone/">Plos One</a>.Recently, <a target="_blank" rel="noopener noreferrer" href="https://journals.plos.org/plosone/">the first peer-reviewed article</a> was published, presenting the summary results of analyses of more than 200 pesticide residues in over 600 environmental samples from both organic and conventional farms. The collected samples included soil, water, sediments, crops, outdoor air, and indoor dust. Notably, the study revealed that 86% of the tested samples contained pesticide residues and 76% contained pesticide mixtures (i.e., two or more substances together). The total number of different pesticides found in various matrices ranged from 76 in outdoor air, 78 in crops, 99 in sediments, 100 in soil, to 197 in indoor dust. Most of these pesticides are on the list of substances permitted in the EU, but a&nbsp;significant portion of the pesticide mixtures also includes recently and long-banned residues. Glyphosate residues were most frequently detected, with high concentrations in all studied environmental samples.Particularly striking are the findings related to indoor dust, as this could have potential health implications for people living on farms and in rural areas. Dust in one house contained residues of up to 121 different pesticides.<img src="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/RECETOX_Pesticide_pathway_ba4b7c17e9.jpg" alt="RECETOX: Fig 2 - Pesticide pathway.jpg" srcset="https://storage.googleapis.com/labrulez-bucket-strapi-h3hsga3/thumbnail_RECETOX_Pesticide_pathway_ba4b7c17e9.jpg 245w," sizes="100vw" width="2213" height="832">Although the study did not assess the specific level of exposure of residents or the subsequent health risks, it is concerning that more than two-thirds of the residues found in dust are classified as highly hazardous to mammals according to the Pesticide Properties Database (PPDB*) and are associated with adverse effects on human health. Based on the study results, a&nbsp;new pesticide hazard indicator has been proposed, based on priorities for assessing ecosystems and human health, which can be used in achieving the goal of pesticide reduction within the <a target="_blank" rel="noopener noreferrer" href="https://journals.plos.org/plosone/">“farm to fork</a>” strategy.Professor Violette Geissen from Wageningen University, the coordinator of the SPRINT project, emphasized the far-reaching significance of these findings: “Our research shows that the problem of pesticide mixtures extends beyond the boundaries of agricultural fields and into the homes of farm workers and their neighbors. The results indicate that mixtures of pesticide residues are not only quite common in both agricultural and residential environments but can also be very complex and vary in composition depending on the environment. To better understand the risks to the ecosystem and human health, we need a&nbsp;deeper understanding of the impact of chemical mixtures in the field and related exposure and effect data. We urgently need integrated risk assessment practices that reflect the complexity of real-world situations and the existence of such widespread pesticide mixtures.”The next phase of the SPRINT project will focus on assessing the risks to ecosystems and human health that the identified pesticide mixtures might pose. The project is collecting extensive data and aims to develop new indicators that will provide EU decision-making bodies with information and tools to address the growing problems posed by pesticide mixtures.*The Pesticide Properties Database (PPDB) is a&nbsp;comprehensive relational database of more than 1800 pesticides and their metabolites. It was created primarily to support risk assessments. The stored data include registration information, physicochemical properties, toxicological endpoints, human health data, and commercial information.</div></div>

New findings regarding pesticide residues in both agricultural and residential environments of farms raise concerns

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The Czech Academy of Sciences (CAS) was established by Act No. 283/1992 Coll. as the Czech successor of the former Czechoslovak Academy of Sciences. It is set up as a complex of 54 public research institutions.

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RECETOX (Research Centre for Toxic Compounds in the Environment) is an independent department of the Faculty of Science of Masaryk University in Brno, which has been established in 1983. RECETOX is focused on the research and education in cross-cutting area of Environment and Health. It addresses interactions among chemicals, environment, and biological systems, including consequences at local, regional, and global levels.

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U.S. Environmental Protection Agency’s (EPA) mission is to protect human health and the environment. EPA works to ensure that: Americans have clean air, land and water; National efforts to reduce environmental risks are based on the best available scientific information; Federal laws protecting human health and the environment are administered and enforced fairly, effectively and as Congress intended; Environmental stewardship is integral to U.S. policies concerning natural resources, human health, economic growth, energy, transportation, agriculture, industry, and international trade, and these factors are similarly considered in establishing environmental policy; All parts of society--communities, individuals, businesses, and state, local and tribal governments--have access to accurate information sufficient to effectively participate in managing human health and environmental risks; Contaminated lands and toxic sites are cleaned up by potentially responsible parties and revitalized; and Chemicals in the marketplace are reviewed for safety.

New findings regarding pesticide residues in both agricultural and residential environments of farms raise concerns

Human milk macro- and trace-elements: Simultaneous analysis in sub-milliliter amounts by ICP-MS and application to assessing acute supplementation effects

Direct detection of beer photodegradation in commercial bottles and introduction of a new Light-Struck Flavour Susceptibility Index

Characterization of packaging ability to protect beer from light degradation and introduction of a new Packaging Riboflavin Index

EPA, FDA and USDA Issues Updates to the Joint Regulatory Plan for Biotechnology

“Fat can be extracted even from thousand-year-old pottery,” says V. Brychová

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