Intergeneric organisms are ‘‘new’’ microorganisms formed by deliberate combinations of genetic material from organisms classified in different taxonomic genera. 被认为是生物技术的微生物产物, intergeneric microorganisms require notification under section 5 of the Toxic Substances Control Act (TSCA).
希望将一种属间微生物商业化的公司, or introduce such a microorganism into the environment for research purposes, must submit certain information to the US Environmental Protection Agency (EPA). 提交选择包括:
TSCA实验发布应用(TERA): For intergeneric microorganisms still in the research and development phase, 公司 should submit a TSCA Experimental Release Application (TERA) to EPA. This will allow for the intergeneric microorganism to be released into the environment, 受控条件下, 测试其安全性.
微生物商业活动通告(MCAN): 为即将商业化的属间微生物, 公司 should submit a Microbial Commercial Activity Notice (MCAN) (40 CFR 725 subpart D). EPA reviews these submissions to determine if the intergeneric microorganism may impose any unreasonable risk to human health or the environment.
第一层 & 二世豁免
经过研发阶段, US Environmental Protection Agency (EPA) regulations establish two exemptions for new microorganisms being manufactured for commerce – 第一层 and Tier 二世豁免 (40 CFR 725 subpart G). To qualify for either exemption, the new microorganism must meet the following criteria:
- 使用40 CFR§725中包含的微生物之一.420
- 引入的遗传物质必须在大小上受到限制, 良好的, 可活动的差, 没有某些能够产生毒素的序列(40 CFR§725).421)
- Comply with the requirements for physical containment and control technologies (40 CFR §725.422)
如果满足了这些要求, 公司可申请第一级豁免, which allows them to manufacture or 进口 the new microorganism without EPA review. 要做到这一点, the manufacturer/进口er should submit to EPA a certification of compliance with the requirements, 他们的姓名和地址, 预计开始生产或进口的日期, and identification of the genus and species of the recipient organism that will be used to create the new organism. This certification must be submitted to EPA 10 days prior to manufacturing/进口ing a new microorganism that qualifies for this exemption. 某些记录也必须保存(40 CFR§725).400).
A manufacturer/进口er who meets the first two conditions of the 第一层 exemption may modify the specified containment restrictions or level of inactivation provided it submits a 第一层I exemption notification (40 CFR §725.请求批准其他程序. 该通知有45天的审查期(40 CFR§725).450年和725年§.470). The manufacturer/进口er may not proceed until EPA approves the exemption.
制造的人, 进口, or processes a microorganism solely for research and development activities, is not subject to the reporting requirements under 40 CFR 725 subpart D), 提供了40 CFR§725中描述的所有标准.234年得到满足, or the activities are subject to the jurisdiction of other federal programs or agencies (40 CFR §725.232).
TSG’s consultants are experienced in all aspects of biotechnology submissions under TSCA. Our scientists understand the requirements for 第一层 and Tier 二世豁免 and are experienced in determining whether submissions require MCAN or TERA.
- Assist with production process and determine the Quality Control (QC) check points
TSG provides 公司 with high-quality regulatory and scientific consulting services. 千赢国际娱乐登录中心的目标是了解千赢国际娱乐登录中心客户的目标和目的, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. 千赢国际娱乐登录中心对工作的保密性有极大的尊重, 较强的项目管理能力, and take great measure to cultivate long-term partnerships with clients.
TSG’s team of scientists and regulatory consultants manage all aspects of biotechnology compliance for our customers. 这个领域的主要专业人员包括 博士Saadia Eltayeb.
Microbial biotechnology can be used in a wide range of industries and products for both commercial and research purposes. Examples include: treatment of biological waste; field application to enhance nitrogen fixation on crops; and ethanol (bio-based) biodiesel.
就TSCA管辖权而言, EPA interprets the definition of the term "chemical substance" (40 CFR §710.3)包括微生物. Manufacturers, 进口ers or processors of "new" microorganisms intended for use in commercial R&D在环境中必须提交一个TERA. 商业用途的豁免不是R&D包括第一级和第二级豁免. 人制造, 进口, or process new intergenetic microorganisms for commercial purposes must submit a Microbial Commercial Activity Notice (MCAN) to EPA.
Your product is regulated if you have made any kind of genetic alteration to the intended microorganism, 用于商业或研究目的. TSG’s experts can assist with making sure all requirements are fulfilled prior to contacting US EPA.
An intergeneric microorganism is formed by deliberately combining genetic material first isolated in a different taxonomic genus; or by deliberate combination of certain mobile genetic elements (DNA).
No. Non-intergeneric organisms are not considered “new” organisms and are already listed on the TSCA Inventory. 因此，他们不受TSCA第5节的报告.