Higentec assisted China Agricultural University's GM corn to obtain the US Environmental Protection Agency (EPA) regulatory exemption for plant endogenous protective agents (PIPs)

US EPA

Exemption from residue limits of mCry1Ab protein, mCry2Ab protein and Bar protein in transgenic maize transformants 2A-7 and CC-2 of China Agricultural University

Since September 2019, the scientific research team of Professor Lai Jinsheng of China Agricultural University and the international regulation team of Higentec Biotechnology Co., Ltd. have decided to open the plant endogenous protective agent for transgenic corn transformants 2A-7 and CC-2 by the US EPA. Exemption from consulting work (application filing number 95664PA1). After nearly two years of data preparation, application submission and continuous communication, the U.S. EPA officially replied on August 18, 2021 and made a clear statement: "mCry1Ab/mCry2Ab/Bar protein contained in maize transformants 2A-7 and CC-2 Residue limit exemptions for Cry1Ab, Cry2Ab, and Bar under the Federal Regulations Environmental Protection Act 40 CFR §174.511, 40 CFR §174.519, and 40 CFR §174.522 apply."

Research Team of Professor Lai Jinsheng of China Agricultural University

Obtained US EPA regulatory exemption for two years

Under the funding of the National Science and Technology Major Project, China Agricultural University has long been committed to cultivating insect-resistant and herbicide-resistant genetically modified corn with independent intellectual property rights in my country. The herbicide tolerance gene maroACC (patent authorization number: ZL201210406176.8), the insect resistance gene mcry1Ab (patent authorization number: ZL201710701976.5), mcry2Ab (patent authorization number: ZL201410483143.2), etc. were cloned successively. Expression of constitutive promoter (patent authorization number: ZL201710702435.4) and chloroplast efficient transporter (Zhao Haiming et al., 2013), using the excavated functional elements and cloned genes to breed insect-resistant transgenic maize 2A-7 ( Patent application number: PCT/CN2020/126452) and herbicide-tolerant transgenic corn CC-2 (patent grant number: ZL201510856966.X). In order to promote the process of industrialization, we will actively cooperate with downstream breeding units to carry out new variety transfer, and more than 90 varieties transferred in 2021 will participate in multi-point testing. At present, the two transformants have applied for the domestic production and application safety certificate, and obtained the exemption from the US EPA, which has laid a good foundation for the subsequent industrial application.

Higentec Co., Ltd. | GMO International Regulatory Team

Professional and efficient teamwork boosts the sustainable development of international regulatory business

Before the cooperation between the two parties, Higentec Biotechnology Co., Ltd. GMO International Regulatory Team (hereinafter referred to as GMO International Regulatory Team) organized the design and approval schedule according to the EPA declaration process. After confirming the plan, the GM international regulation team standardized and checked the authenticity and completeness of the relevant experimental data submitted by China Agricultural University to EPA, and communicated with EPA officials via email, telephone and video conference and wrote the declaration. Book. The North American Office of Higentec Biotechnology Co., Ltd. is responsible for contacting and confirming the US agent and submitting the EPA declaration form through the agent. After submitting the declaration, it maintains communication with the EPA until the exemption approval is successfully passed.

Next, the GM International Regulatory Team will continue to advance the FDA's consultation work, which is planned to be completed in 2022.