化学和生物技术法规(TSCA) -美国

的 Toxic Substances Control Act of 1976 (TSCA) grants EPA authority to collect data on chemicals used to evaluate, 评估, mitigate and control risks that might be posed by their manufacture, 处理和使用. TSCA provides a variety of control methods to prevent chemicals and microorganisms from posing unreasonable risks, 包括报告, recordkeeping and testing 需求 and restrictions related to chemical and microbial substances and mixtures.

利记网址在TSCA的各个方面协助客户, including the notification of new chemicals and microorganisms, 污染合规审计, 和培训, 报告和记录的保存.

理解TSCA要求

有毒物质控制法(TSCA) gives the Environmental Protection Agency (EPA) the authority to regulate new and existing chemicals. 虽然最初是在1976年通过的, the Act was amended in 2016 to include updated provisions that require the EPA to evaluate existing chemicals in a timely fashion, 概述新的基于风险的安全标准, increase public transparency on chemical substances and differentiate chemical risk evaluations based on whether they present a high or low risk. 作为一个结果, t在这里 are deadlines for manufacturers and importers of chemical substances to meet in 2019 and beyond.

Different sections of TSCA provide EPA with various authorities, a few of which are listed below:

  • 第五节: Require pre-manufacture notification for "new chemical substances" 之前生产/导入
  • 第四节: 测试的化学物质 by manufacturers, importers, and processors w在这里 risks or exposures of concern are found
  • 第五部分:问题 重大新使用规则(SNURs) when it identifies a significant new use that could result in exposures to, 或释放, 值得关注的东西
  • 8节(b): 维护TSCA清单
  • Sections 13 and 12(b) respectively: Require importers and exporters of chemicals, to comply with certification reporting and/or other 需求
  • Section 8(a): Require manufacturers (including importers) to provide EPA with information on the production and use of chemicals in commerce in large quantities
  • Section 8(e): Require that any person who manufactures (including imports), 流程, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment to immediately inform EPA, except w在这里 EPA has been adequately informed of such information

EPA also regulates the use of intergeneric organisms – ‘‘new’’ microorganisms formed by deliberate combinations of genetic material from organisms classified in different taxonomic genera. Intergeneric microorganisms require notification under Section 5 of TSCA:

  • 第五节: Require Microbial Commercial Activity Notice (MCAN) for commercial purposes of intergeneric microorganisms before manufacturer/import
  • 第五部分:认识到研究人员的需要, TSCA Experimental Release Application (TERA) must be submitted prior to initiating field trials which provides a high measure of flexibility and a shorter review period

利记在线网址可以帮助

We can help with all aspects of chemical compliance under TSCA including:

  • 准备TSCA合规手册
  • 准备制造前通知(PMN)
  • 协助同意令的谈判
  • 拟备重要的新用途公告
  • 进行聚合物豁免测定
  • 准备少量豁免申请
  • 提供化学品进出口建议
  • 协助化学品数据报告(CDR)
  • 执行TSCA符合性审核和培训
  • 准备TSCA清单NOA表格B
  • 拟备微生物商业活动公告
  • 拟备《利记在线网址》环境豁免申请
  • Assisting with Confidential Business Information (CBI) substantiation
  • Assisting with microbial characterization for MCAN and TERA
  • Assisting with genetic manipulation data per 需求
  • Assisting with production process and determine the Quality Control (QC) check points
  • Determining if client qualifies for Tier I and Tier II exemptions
  • Determining whether client qualifies for biotechnological Test Market Exemption Applications (TMEAs)

为什么利记在线网址

利记网址 provides 公司 with high-quality regulatory and scientific consulting services. 利记在线网址的目标是了解客户的目标和目的, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. 利记网址's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, 较强的项目管理能力, and take great measure to cultivate long-term partnerships with clients.

利记在线网址的专业人员

利记网址有一个科学家团队, regulatory and environmental compliance 咨询顾问 who manage all aspects of TSCA compliance. TSCA团队由 Saadia Eltayeb who has over 20 years of experience preparing and submitting premanufacture notices (PMNs), 低容量豁免(LVEs), polymer exemption determinations and consent order negotiations under Section 5 of TSCA and NSNs under CEPA. She also routinely audits chemical facilities to ensure compliance and provides import and export guidance. 

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