Overview
Title
Submission for OMB Review; Comment Request
Agencies
ELI5 AI
The government wants to make it easier for people who create special plants or foods using science to ask questions and get help using a website shared by three big agencies—Agriculture, Environmental Protection, and Food and Drug Administration. They want to know if this idea is good and if people find it easy to use the website by January 2025.
Summary AI
The Department of Agriculture is seeking feedback on an information collection request as part of its regulatory duties under the Coordinated Framework for the Regulation of Biotechnology. This effort involves a web-based platform established in partnership with the Environmental Protection Agency and the Food and Drug Administration to facilitate queries and provide guidance on biotechnology products. Public comments on the necessity, practicality, and burden of this information collection, which gathers minimal personal contact information through a voluntary web form, are invited until January 2, 2025. The goal is to ensure that federal biotechnology regulations are both effective and accessible to innovators.
Abstract
In 1986, the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) was published by the Office of Science and Technology Policy and explained the regulatory roles for the U.S. Department of Agriculture, the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA), (herein, the Agencies) and how Federal agencies use existing Federal statutes to ensure public health and environmental safety while maintaining regulatory flexibility to avoid impeding the growth of the biotechnology industry. The Coordinated Framework was subsequently updated in 1992 (57 FR 6753-6762; February 27, 1992) and 2017, taking into account advances that had occurred in the field of biotechnology. Within the USDA, the Animal and Plant Health Inspection Service's (APHIS') Biotechnology Regulatory Services unit is responsible for ensuring that organisms developed using genetic engineering, such as genetically modified plants, insects, and microbes do not pose a plant pest risk. APHIS derives its authority to promulgate its biotechnology regulations from provisions of the Plant Protection Act (PPA, 7 U.S.C. 7701 et seq.) and the Virus-Serum-Toxin Act (VRTA, 21 U.S.C. 151-159). The EPA is charged with protecting human health and the environment through ensuring the safety of pesticides and other chemicals, including those developed using genetic engineering. The EPA derives its regulatory authority from provisions of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA, 7 U.S.C. 136 et seq.) and the Toxic Substances Control Act (TSCA, 15 U.S.C. 2601 et seq.). The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation, which includes oversight of food and feed. FDA derives its regulatory authority from provisions of the Federal Food, Drug and Cosmetic Act (FFDCA, 21 U.S.C. 301-392). Together with the USDA's Food Safety and Inspection Service (FSIS), FDA has oversight of certain chemicals modified using genetic engineering. FSIS derives its regulatory authority from the Federal Meat Inspection Act (FMIA, 21 U.S.C. 601 et seq.) and the Poultry Products Protection Act (PPIA, 21 U.S.C. ch.10, 451 et seq.). On September 12, 2022, Executive Order (E.O.) 14081, Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy, was published and directed the Agencies, among other things, to build on the Unified website for Biotechnology Regulation developed pursuant to E.O. 13874, Modernizing the Regulatory Framework for Agricultural Biotechnology Products, June 11, 2019, by including on the website the information developed under subsection (b) of section 8 of E.O. 14081, and by enabling developers of biotechnology products to submit inquiries about a particular product and promptly receive a single, coordinated response that provides, to the extent practicable, information and, when appropriate, informal guidance regarding the process that the developers must follow for Federal regulatory review. Need and Use of Information: The necessity for this information collection arises from E.O. 13874, Section 5, Unified Biotechnology Web-Based Platform, and E.O. 14081, Section 8(d). These provisions seek to ensure that innovators can easily navigate the Federal regulatory system for products of biotechnology by directing USDA, EPA, and FDA to jointly establish a web-based platform that contains and provides links to relevant United States Government regulatory information for biotechnology products. USDA-APHIS, EPA, and FDA will use a web-form on the contact page of the Unified website to enable site visitors to ask questions, make comments, or request a meeting with one or all of the sponsoring agencies. The web-form will collect basic contact information such as the name and email address of contact page respondents, as well as the respondents' questions or comments and their meeting requests. Respondent use of the contact page is voluntary. Description of Respondents: Business. Number of Respondents: 30. Frequency of Responses: Reporting: On occasion; Annual. Total Burden Hours: 15.
Keywords AI
Sources
AnalysisAI
The Department of Agriculture (USDA) has issued a notice inviting public comments on a proposed information collection requirement. This effort is part of the federal government's ongoing regulation of biotechnology, guided by the Coordinated Framework established in 1986. The framework involves collaboration with the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA). The primary goal is to streamline public access to information and guidance on biotechnology products via a new web-based platform.
General Summary
The USDA, along with the EPA and FDA, aims to make the regulatory process for biotechnology products more transparent and accessible. The initiative involves an online platform where developers of biotechnology products can gain insights into the regulatory process by submitting inquiries or meeting requests through a web form. The proposal requires collecting basic contact information such as names and email addresses, ensuring developers can navigate the regulatory system efficiently. Comments on this proposal are welcome until the beginning of January 2025, providing an opportunity for public input on its necessity, practicality, and any potential burdens.
Significant Issues and Concerns
Several issues arise from the document. First, there is a lack of detailed information regarding the costs or budgetary allocations needed for implementing the web platform. This omission may lead to concerns about whether the initiative receives adequate oversight to prevent wasteful spending. Additionally, the document does not explain how it will assess the platform's effectiveness, potentially resulting in inefficient use of resources.
Moreover, the document employs technical jargon and legal references like the Plant Protection Act (PPA) and the Toxic Substances Control Act (TSCA), without providing simplified explanations. This might make it difficult for a general audience to fully understand the document's implications or the broader regulatory framework. Additionally, there is some ambiguity regarding the real-world impact or scope, as the number of anticipated respondents (30) and total estimated burden hours (15) seem unusually low for a federal undertaking.
Impact on the Public and Stakeholders
Overall, the document's intentions appear positive, aiming to simplify interactions with federal biotechnology regulations. For the general public, this platform could enhance transparency and facilitate better understanding of the biotechnology regulatory landscape. However, due to complex language and inadequate context or clarification, ordinary citizens may struggle to understand the broader impacts of these efforts without further explanation.
For specific stakeholders, particularly those in the biotechnology industry, the web-based platform promises a more streamlined process for navigating regulatory requirements. This could lead to more efficient product development cycles and potentially accelerate innovation within the industry. On the downside, if key stakeholders do not find the web platform user-friendly or if its utility is not properly evaluated, it might underperform or fail to meet industry needs adequately.
In summary, while the initiative aims to improve processes for biotech stakeholders and ensure safe application of biotechnology, a clearer articulation of its aspects and benefits would aid in garnering broader public and industry support. Enhanced clarity and detailed accountability measures would further bolster the document's effectiveness and accessibility.
Issues
• The document does not provide detailed information on potential costs or budgetary allocations for implementing the Unified Biotechnology Web-Based Platform, which could raise concerns about possibly wasteful spending without oversight.
• There is no specific mention of how the effectiveness or utility of the contact page will be evaluated, which could lead to ineffective use of resources.
• The document uses technical terms and references to various laws (such as PPA, FIFRA, and TSCA) without providing explanations or summaries, which may make it difficult for laypersons to understand.
• Some regulatory frameworks (such as the Coordinated Framework and Executive Orders 13874 and 14081) are mentioned without clear explanation of their scope or impact, which could lead to ambiguity or misunderstanding.
• The number of respondents (30) and total burden hours (15) seem low for a federal initiative, potentially indicating that the impact or scope of the effort might be limited or understated.
• The language used for describing the responsibilities of USDA-APHIS, EPA, and FDA might be perceived as overly complex, potentially hindering comprehension by a wider audience.