Overview
Title
Chemical Category for Octahydro-Tetramethyl-Naphthalenyl-Ethanone (OTNE); Manufacturer Request for Risk Evaluation Under the Toxic Substances Control Act (TSCA); Notice of Availability and Request for Comments
Agencies
ELI5 AI
The EPA wants to check if a chemical called OTNE is safe to use and is asking people to share what they know about it. They want to hear from everyone by April 5, 2021, to make sure they make the right decision.
Summary AI
The Environmental Protection Agency (EPA) is seeking public comments on a request from several companies, including International Flavors and Fragrances, Inc. (IFF) and DRT America, Inc. (DRT), to conduct a risk evaluation of a chemical known as OTNE under the Toxic Substances Control Act (TSCA). This evaluation aims to determine if OTNE poses an unreasonable risk to health or the environment. The EPA invites feedback on the potential conditions of OTNE's use and any other relevant information that may assist in its evaluation. Comments must be submitted by April 5, 2021.
Abstract
The Environmental Protection Agency (EPA) is announcing the availability of and soliciting public comment on a manufacturer request for a risk evaluation under the Toxic Substances Control Act (TSCA) of ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2- naphthalenyl), ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8- tetramethyl-2-naphthalenyl), ethanone, 1-(1,2,3,4,6,7,8,8a-octahydro- 2,3,8,8-tetramethyl-2-naphthalenyl), and ethanone, 1-(1,2,3,5,6,7,8,8a- octahydro-2,3,8,8-tetramethyl-2-naphthalenyl) (collectively, "OTNE"). The request was made by International Flavors and Fragrances, Inc. (IFF), Privi Organics USA Corporation (Privi), and DRT America, Inc. (DRT) through the OTNE Consortium. EPA conducts risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment without consideration of costs or other non-risk factors, including an unreasonable risk to potentially exposed or susceptible subpopulations, under the conditions of use. In the docket associated with this request is the manufacturer request for an EPA-conducted risk evaluation and possible additional conditions of use EPA has identified for inclusion within the scope of a risk evaluation of OTNE. EPA specifically invites public comment on the inclusion of any additional conditions of use and potentially exposed or susceptible subpopulations. The Agency is in the process of broadly re-examining how it intends to implement these and other provisions of amended TSCA including determining how new executive orders and other direction provided by the Biden-Harris Administration will be addressed. This process would benefit greatly from stakeholder feedback. After considering comments received in response to this solicitation, EPA will determine whether to grant or deny the manufacturer request. All TSCA risk evaluations, whether EPA-initiated or manufacturer-requested, will be conducted in the same manner.
Keywords AI
Sources
AnalysisAI
The document in question is a formal notice from the Environmental Protection Agency (EPA) published in the Federal Register. This notice seeks public input on a proposed risk evaluation of a chemical known as OTNE. The EPA evaluates chemicals like OTNE to determine if their use presents any unreasonable risk to human health or the environment.
General Summary
The EPA’s announcement invites comments on whether the use of OTNE could pose a health or environmental risk. The request for a risk evaluation comes from a group of manufacturers, including International Flavors and Fragrances, Inc., Privi Organics, and DRT America, Inc. The public has until April 5, 2021, to submit opinions and information that could help in determining the safety of OTNE’s use.
Significant Issues and Concerns
One prominent issue is the complexity of the chemical names involved. The document repeatedly refers to OTNE as four different chemical variations, each with lengthy, technical names. Such jargon can be challenging for the general public to understand. Additionally, references to specific sections of the Toxic Substances Control Act (TSCA) and the Code of Federal Regulations (CFR) assume a level of legal familiarity that many readers might not possess.
Another concern is the lack of clear explanation on what “conditions of use” means. This term is pivotal for the risk evaluation process, yet it is not fully explained, which could lead to confusion for those not versed in regulatory terminology. Furthermore, while the document provides CASRNs (Chemical Abstracts Service Registry Numbers) for the substances, it does not explain their significance, potentially leaving non-expert readers puzzled.
Impact on the Public
This document may impact the public broadly by potentially altering the regulatory landscape surrounding OTNE. If the chemical is determined to pose an unreasonable risk, it could lead to stricter regulations or usage limitations, impacting products that contain this substance. Consumers who use products with OTNE might experience changes in product formulation or availability.
Impact on Specific Stakeholders
For stakeholders such as manufacturers and chemical processors, this notice has significant implications. They could face increased operational costs if additional safety measures or substitutes for OTNE are required. Conversely, the environmental and public health sectors may view this risk evaluation as a positive step toward ensuring safer consumer products and a cleaner environment.
Moreover, the notice's technical content and submission instructions, particularly concerning confidential business information (CBI), are complex. This complexity might hinder some stakeholders, especially those with less experience in regulatory matters, from effectively participating in the comment process.
In summary, while the EPA’s notice is a crucial step toward understanding the risks posed by OTNE, it could benefit from clearer language and accessible explanations to facilitate better public engagement and comprehension.
Issues
• The document uses technical and complex chemical names and terms that may be difficult for the general public to understand.
• The document repeatedly mentions specific chemical substances with long and complex names without providing simpler or alternative names for reference.
• The document references specific sections of the Toxic Substances Control Act (TSCA) and the Code of Federal Regulations (CFR), which might be unclear to readers who are not familiar with these legal texts.
• The document lacks a clear definition or explanation of what 'conditions of use' entail, which could lead to confusion for someone not familiar with the term.
• The document contains specific CASRNs (Chemical Abstracts Service Registry Numbers) without explanation of their significance, which may not be understood by all readers.
• There is no mention of potential impacts or past implications of the chemicals being evaluated on health or the environment, which could provide useful context.
• The process for submitting comments, particularly regarding the marking of confidential business information (CBI), is detailed but might still be confusing to stakeholders not experienced in similar submissions.
• The document encourages stakeholder feedback but might not effectively reach all potentially affected or interested parties due to its technical nature and publication medium.