Team:NYMU-Taipei/HP/Gold-Law and Policy

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• Achievement
• Project
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  • Design
  • Experiment
  • Model
  • Parts
  • Characterization
• Prototype
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• Team
  • Attributions
  • Team
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Law and Policy

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Sustainable agriculture is a global trend. Currently, many countries are joining this trend by adjusting their law for the purpose of establishing an eco-friendly farming environment. However, Taiwan’s laws on biological control agents are slightly outdated. Thus, we compared laws and regulations on biological control agents of US, European Union, and China, hoping to find out which part of Taiwan’ s law should be changed.

Comparison of pesticide registration application

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	US	European Union	China	Taiwan
Applicant infomation	V	V	V	V
Product Chemistry	V	V	V	V
Data from Studies that Determine Hazard to Humans and Domestic Animals	V	V	V	V
Residue Chemistry	V	V
Data from Studies that Determine Hazard to Non-target Organisms	V	V		V
Environmental Fate	V	V
Product Performance		V	V	V
Applicator/User Exposure		V
Studies
Advertisements		V	V

According the table above, we suggested that Taiwan’s lawmakers should be aware of the regulation of Residue Chemistry and advertisement since there were more than two countries in the world that have regulations on those aspects of biological pest control agents.

Let us examine in more detail about the law and regulation of those three countries and the European Union!

US Regulations

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What are Biological pesticides(Biopesticides)?

Biological pesticides are types of pesticides derived from natural materials, such as animals, plants, bacteria, and certain minerals.

Requirements

New pesticide application has to pass the “pre-registration meeting” first. The applicant also need to hand in the required datarequired datato proceed to the assessment stage.

Reference

Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)

Federal Food, Drug, and Cosmetic Act (FFDCA)

40 CFR 158.2120: (1) Product Chemistry (2) Specifications

40 CFR 158.2130: Residue Chemistry

40 CFR 158.2140: Data from Studies that Determine Hazard to Humans and Domestic Animals

40 CFR 158.2150: Data from Studies that Determine Hazard to Non-target Organisms and Environmental Fate

European Union Regulations

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What are Biological pesticides(Biopesticides)?

None. They use “active substances” to classify the pesticide. According to Regulation 1107/2009, there are “chemical substance” and “microbial” two classes.

Requirements

First, new pesticides are required to pass the active substances test. Then, it is handed to the European Food Safety Authority(EFSA), then transferred to the European Commission (EC). After it passed all the assessments, EU members will perform product checks before the pesticide is recognized as a product fit for commercialization in their country.

Reference

Commission Regulation No. 544/2011

Commission Regulation No. 545/2011

Commission Regulation No. 396/2005

http://ec.europa.eu/food/plant/pesticides/index_en.htm

China Regulations

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What are Biological pesticides(Biopesticides)?

Biological Pesticides are microbial including bacteria, fungi, virus, and genetically modified microbial, in origin.

Requirements

Assessment of product chemistry and hazard to humans and domestic animals are required. Furthermore, the data of the pesticide efficiency and residue chemistry in other countries are also required. The special requirement of microbial is to provide the characteristic of the microbial.

Reference

农药管理条例

http://www.moa.gov.cn/ztzl/zjyqwgz/zcfg/201007/t20100717_1601261.htm

农药登记资料要求

http://www.moa.gov.cn/zwllm/zcfg/qtbmgz/200601/t20060123_540594.htm

Law and Policy

---

Sustainable agriculture is a global trend. Many countries are keeping up changing their law in order to build up an eco-friendly farming environment. However, Taiwan’s law is a little outdated. Thus, we compare law and regulation of biological control of US, European Union, and China. Hope to find out which part is Taiwan’ s law needed to take close look of.

Comparison of pesticide registration application

---

　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　 　

	US	European Union	China	Taiwan
Applicant infomation	V	V	V	V
Product Chemistry	V	V	V	V
Data from Studies that Determine Hazard to Humans and Domestic Animals	V	V	V	V
Residue Chemistry	V	V
Data from Studies that Determine Hazard to Nontarget Organisms	V	V		V
Environmental Fate	V	V
Product Performance		V	V	V
Applicator/User Exposure		V
Studies
Advertisements		V	V

According the table above, we suggest that Taiwan’s lawmakers need to be aware of the regulation of “Residue Chemistry” and “advertisement” since there are more than two countries in the world take seriously about these parts.

Let’s search further in law and regulation from those three countries and Union!

US Regulations

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What are Biological pesticides(Biopesticides)?

Biological pesticides co are certain types of pesticides derived from such natural materials as animals, plants, bacteria, and certain mineral

Requirements

New pesticide application needs to pass the “pre-registration meeting” first. The applicant also need to hand in the required data. Then the next step is the assessment.

Reference

Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)

Federal Food, Drug, and Cosmetic Act (FFDCA)

40 CFR 158.2120: (1) Product Chemistry (2) Specifications

40 CFR 158.2130: Residue Chemistry

40 CFR 158.2140: Data from Studies that Determine Hazard to Humans and Domestic Animals

40 CFR 158.2150: Data from Studies that Determine Hazard to Nontarget Organisms and Environmental Fate

European Union Regulations

---

What are Biological pesticides(Biopesticides)?

None. They use “active substances” to classify the pesticide. According to Regulation 1107/2009, there are “chemical substance” and “microbial” two classes.

Requirements

First, new pesticide should pass the active substances test. Then hand in to the European Food Safety Authority(EFSA). Next, they will hand in to European Commission(EC). After pass all the tests, they will give the EU members to do the product check and then launch the product in their country.

Reference

Commission Regulation No. 544/2011

Commission Regulation No. 545/2011

Commission Regulation No. 396/2005

http://ec.europa.eu/food/plant/pesticides/index_en.htm

China Regulations

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What are Biological pesticides(Biopesticides)?

Microbial including bacteria, fungi, virus, and genetically modified microbial.

Requirements

Product Chemistry and data of Hazard to Humans and Domestic Animals are required. Others like the data of the pesticide efficiency and residue chemistry in other countries is also required. The special requirement of microbial is to provide the characteristic of the microbial.

Reference

农药管理条例

http://www.moa.gov.cn/ztzl/zjyqwgz/zcfg/201007/t20100717_1601261.htm

农药登记资料要求

http://www.moa.gov.cn/zwllm/zcfg/qtbmgz/200601/t20060123_540594.htm