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This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 2604 - Manufacturing and processing notices
§ 2607 - Reporting and retention of information
§ 2613 - Confidential information
§ 2625 - Administration
Title 40 published on 10-May-2017 04:28
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 40 CFR Part 725 after this date.
EPA is taking direct final action to amend the Toxic Substances Control Act (TSCA) section 5 electronic reporting regulations. These electronic reporting regulations establish standards and requirements for use of EPA's Central Data Exchange (CDX) to electronically submit premanufacture notices (PMNs), other TSCA section 5 notices, and support documents to the Agency. This rule provides the user community with new methods for accessing the e-PMN software, new procedures for completing the electronic-PMN (e-PMN) form, changes to the CDX registration process, adds the requirement to submit “ bona fide intents to manufacture” electronically, and changes to the procedure for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA. This action is intended to further streamline and reduce the administrative costs and burdens of TSCA section 5 notifications for both industry and EPA.
EPA is amending certain reporting requirements that were promulgated under the Toxic Substances Control Act (TSCA) to require the use electronic reporting. EPA is requiring the use of electronic reporting in order to minimize the paperwork burden associated with the underlying regulatory requirements and to minimize the cost to the Federal Government of the creation, collection, maintenance, use, dissemination, and disposition of information. This action will also improve the quality and use of information to strengthen decisionmaking, accountability, and openness in government and society, as well as provide for the timely dissemination of public information and in a manner that promotes the utility of the information to the public and makes effective use of information technology.
EPA received petitions to add Trichoderma reesei and Bacillus amyloliquefaciens to the list of microorganisms that may be used as recipient microorganisms in order to qualify for the exemption from full notification and reporting procedures under the Toxic Substances Control Act (TSCA) for new microorganisms that are being manufactured for introduction into commerce. Based on EPA's evaluation of these petitions, EPA has made a preliminary determination that certain strains of both microorganisms will not present an unreasonable risk of injury to health or the environment when used as a recipient microorganism provided that certain criteria for the introduced genetic material and the physical containment conditions are met. Therefore, EPA is proposing to add two additional microorganisms to the list of recipient microorganisms that are eligible for exemptions from full reporting for the manufacture (including import) of new microorganisms.
This document contains minor amendments to regulations under the Federal Insecticide, Fungicide (FIFRA), and Rodenticide Act, the Federal Food, Drug, and Cosmetic Act (FFDCA), and the Toxic Substances Control Act (TSCA). These amendments will make EPA's regulations more accurate and user friendly with regard to the name of the EPA office that administers these statutes and various Agency addresses.
EPA is proposing a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) for the genetically modified microorganism identified generically as Trichoderma reesei ( T. reesei ). This microorganism was the subject of a Microbial Commercial Activity Notice (MCAN). EPA believes this action is necessary because the use of this genetically modified T. reesei under certain conditions may be hazardous to human health and the environment. This proposed rule would also establish a mechanism to allow EPA to evaluate an intended use and its conditions, and to prohibit or limit that activity before it occurs, if EPA determines it may be hazardous.
EPA is proposing to require electronic reporting for information that must be submitted under Toxic Substances Control Act (TSCA) section 4 (pursuant to test rules and enforceable consent agreements (ECAs)), TSCA section 8(a) Preliminary Assessment Information Rule (PAIR), and TSCA section 8(d) Health and Safety Data Reporting rules. Additionally, EPA is proposing amendments to certain TSCA section 5 reporting regulations that would extend electronic reporting requirements to Notices of Commencement of Manufacture or Import (NOCs) and support documents ( e.g., correspondence, amendment, and test data) relating to TSCA section 5 notices submitted to EPA before April 6, 2010. This proposed rule would require the use of EPA's Central Data Exchange (CDX) and the Chemical Information Submission System (CISS) web-based reporting tool for the submission of forms, reports, and other documents except for TSCA section 5 submissions, which would use existing e-PMN software. This action is intended to streamline the reporting process and reduce the administrative costs associated with information submission and recordkeeping.