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中国生物工程杂志

China Biotechnology
China Biotechnology  2021, Vol. 41 Issue (9): 126-135    DOI: 10.13523/j.cb.2106017
    
An Analysis of the U.S. SECURE Rule and Its Enlightenment to China
LIU Xu-xia(),YANG An-ke
College of Humanities and Law, Huazhong Agricultural University,Wuhan 430070, China
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Abstract  

In the latest revision of biotechnology regulations, the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture revised the original regulations on the import, interstate movement and environmental release of organisms developed by genetic engineering to a greater extent. APHIS names it SECURE rule. This rule adopts a new safety evaluation method, shifting the focus of evaluation from the original production method to the characteristics of the product. In addition, the new rules further simplify the supervision method through procedures such as exemption procedures and supervision status review. However, the SECURE rule also has problems such as insufficient coordination between departmental legislation and imperfect construction of supporting mechanisms, which may bring certain challenges to the implementation of the new rules. As a major country of genetically modified technology, China can critically learn from the latest U.S. legislative practice in the legislation of agricultural biotechnology and its product supervision to provide legal protection for the development of the Chinese biotechnology industry.



Key wordsBiotechnology      Plant pest      Safety evaluation      Exemption from supervision     
Received: 10 June 2021      Published: 30 September 2021
ZTFLH:  Q819  
Corresponding Authors: Xu-xia LIU     E-mail: liuxuxia@mail.hzau.edu.cn
Cite this article:

LIU Xu-xia,YANG An-ke. An Analysis of the U.S. SECURE Rule and Its Enlightenment to China. China Biotechnology, 2021, 41(9): 126-135.

URL:

https://manu60.magtech.com.cn/biotech/10.13523/j.cb.2106017     OR     https://manu60.magtech.com.cn/biotech/Y2021/V41/I9/126

Fig.1 The Regulatory process of the SECURE rule Confirming the qualification for exemption is not the prepositional procedure. Developers may choose to start any of the three procedures. In addition, APHIS has the authority to initiate regulatory status review procedures to assess the possibility of plant pest risks caused by relevant organisms
2020年5月18日
(规则正式发布)
2020年6月17日
(规则发布后30天)
2020年8月17日
(规则发布后90日)
2021年4月5日 2021年10月1日
原有的监管活动在此
之后90天内仍有效
AIR咨询程序终止,
APHIS不再受理
相关申请
豁免与确认程序
正式生效
许可程序生效 规则全面生效
监管状态审查程序开始对部分作物生效
通知程序终止
Table 1 The implementation timeline of the SECURE rule
[1]   U.S. Department of Agriculture-Animal and Plant Health Inspection Service. Movement of certain genetically engineered organisms:proposed rules. [2021-03-17]. https://www.govinfo.gov/content/pkg/FR-2019-06-06/pdf/2019-11704.pdf.
[2]   U.S.Department of Agriculture-Animal and Plant Health Inspection Service. Movement of certain genetically engineered organisms:final rules. [2021-03-17]. https://www.aphis.usda.gov/brs/fedregister/BRS_2020518.pdf.
[3]   Board for International Food and Agricultural Development (BIFAD), International Food Policy Research Institute (IFPRI), Association of Public and Land-Grant Universities (APLU). How the United States benefits from agricultural and food security investments in developing countries. [2021-03-24]. https://ebrary.ifpri.org/digital/collection/p15738coll2/id/133419.
[4]   Emma Kovak. USDA relaxed its GMO, gene-edited crop rules-but not enough to foster biotech innovation. [2021-04-09]. https://geneticliteracyproject.org/2020/06/11/viewpoint-usda-relaxed-its-gmo-gene-edited-crop-rules-but-not-enough-to-foster-biotech-innovation/.
[5]   Health Canada-Food and Nutrition. List of non-novel determinations for food and food ingredients. [2021-04-11]. https://www.canada.ca/en/health-canada/services/food-nutrition/genetically-modified-foods-other-novel-foods/requesting-novelty-determination/list-non-novel-determinations.html.
[6]   Greg Jaffe. Analysis: Problematic provisions in new USDA rule for GE plants. [2021-04-06]. https://geneticliteracyproject.org/2020/10/15/analysis-problematic-provisions-in-new-usda-rule-for-ge-plants/.
[7]   Smyth S J, McDonald J, Falck-Zepeda J. Investment, regulation, and uncertainty. GM Crops & Food, 2014, 5(1):44-57.
[8]   U.S.Department of Agriculture-Animal and Plant Health Inspection Service. USDA's biotechnology notification process. [2021-05-07]. https://scholarworks.iupui.edu/bitstream/handle/1805/822/Biotechnology%20notification%20process%20-%20BRS%20factsheet.pdf.
[9]   U.S.Department of Agriculture-Animal and Plant Health Inspection Service. Proposed rule: movement of certain genetically engineered organisms. [2021-05-07]. https://www.federalregister.gov/documents/2019/06/06/2019-11704/movement-of-certain-genetically-engineered-organisms.
[10]   U.S.Department of Agriculture. Questions & answers:sustainable, ecological, consistent, uniform, responsible, efficient (secure) rule confirmation process. [2021-04-17]. https://www.aphis.usda.gov/brs/pdf/q-a-confirmation-process.pdf.
[11]   U.S. Department of Agriculture. Questions & answers:sustainable, ecological, consistent, uniform, responsible, efficient (secure) rule. [2021-04-17]. https://www.aphis.usda.gov/biotechnology/340-secure-rule-qa.pdf.
[12]   刘旭霞, 冯冠南. 美国《国家生物工程食品信息披露标准(实施细则)》制定中公众参与的经验及启示. 华中农业大学学报(社会科学版), 2020(1):153-160, 170.
[12]   Liu X X, Feng G N. Experience and enlightenment of public participation in the formulation of the national bio-engineered food disclosure standard(regulations). Journal of Huazhong Agricultural University (Social Sciences Edition), 2020(1):153-160, 170.
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