Laws of the People's Republic of China

Ministry of Agriculture

Order of the Ministry of Agriculture of People's Republic of China

No. 59

The Measures of the Examination and Approval for Agricultural Genetically Modified Organisms Processing, which were adopted at the 3rd executive meeting of the Ministry of Agriculture on January 16, 2006 upon deliberation, are hereby promulgated and shall be implemented as of July 1, 2006.

Minister of Ministry of Agriculture, Du Qinglin

January 27, 2006

Measures of the Examination and Approval for Agricultural Genetically Modified Organisms Processing

Article 1

In order to strengthen the administration of examination and approval for agricultural genetically modified organisms processing, the present Measures are formulated in accordance with the relevant provisions of the Regulation on the Security Administration of Agricultural genetically modified organisms.

Article 2

The term "agricultural genetically modified organisms processing" as mentioned in the present Measures refers to an activity of producing the relevant products of agricultural genetically modified organisms by making use of active agricultural genetically modified organisms as the raw materials.

The term "products of agricultural genetically modified organisms" as mentioned in the preceding paragraph refers to genetically modified animals and plants, microorganism products and the directly processed products from genetically modified agricultural products as prescribed in items (2) and (3) of article 3 in the Regulations on the Security Administration of Agricultural Genetically Modified Organisms.

Article 3

An entity or individual that engaged in the processing of agricultural genetically modified organisms within the territory of the People's Republic of China shall acquire a License for Agricultural Genetically Modified Organisms Processing as issued by the competent department of agriculture administrative of the local people's government at the provincial level at the locality of processing (hereinafter referred to as the Processing License).

Article 4

An entity or individual that engaged in the processing of agricultural genetically modified organisms shall not only accord with the conditions for establishment as prescribed by the relevant laws and regulations but also accord with the conditions as follows:

(1)

Having the relevant special production line and closed storage facilities applicable to the processing of agricultural genetically modified organisms;

(2)

Having the relevant equipment and facilities for disposal of processing wastes and inactivation;

(3)

Having the relevant controlling measures for pollution disposal in the processing and transforming between agricultural genetically modified organisms and non-genetically modified organisms that function as raw materials; and

(4)

Having perfect safety management system on agricultural genetically modified organisms processing by the follows means:

a)

Setting up an archive for the management of purchase of raw materials, transportation, storage, processing and sale;

b)

Setting up a system of post responsibility;

c)

Setting up the relevant emergency preliminary schemes for such emergencies as spread of agricultural genetically modified organisms; and

d)

Setting up a group in charge of the safety administration of agricultural genetically modified organisms, consists of the relevant management personnel and technicians who have the relevant knowledge on the safety of agricultural genetically modified organisms;

Article 5

An entity that submits an application for a Processing License shall submit the application to the competent department of agriculture administrative of the people's government at the provincial level and come up with the following materials:

(1)

An Application Form for Processing License (See Attachment);

(2)

A text of the safety administration system for agricultural genetically modified organisms processing;

(3)

The name list, professional knowledge and educational certificates and credentials of the members of the group in charge of the safety administration of agricultural genetically modified organisms;

(4)

Records on the training of the relevant regulations on the security of agricultural genetically modified organisms and the relevant knowledge of processing security;

(5)

The specimens of the labels of agricultural genetically modified organisms products; and

(6)

The photocopy of the Security Certificate of Agricultural Genetically modified Organisms for the raw materials in processing.

Article 6

The competent department of agriculture administrative of the people's government at the provincial level shall accomplish the examination within 20 workdays as of accepting an application. Where the application accords with the relevant requirements, a Processing License shall be issued, which shall be reported to the Ministry of Agriculture for archival filing. Where any application fails to accord with the relevant requirements, a written notice shall be issued to the relevant applicant, wherein an explanation shall be given.

As required, the competent department of agriculture administrative of the people's government at the provincial level may organize an expert group to carry out an appraisal on the application materials. An expert group may carry out an on-site inspection and submit a report on inspection within the prescribed time limit as prescribed by the competent department of agriculture administrative.

Article 7

The validity term of a Processing License is 3 years. Where any entity or individual wants to continue its/his processing business after the expiration of the License, it/he shall submit an application for a Processing License again 6 months before the original License expires.

Article 8

Where an entity or individual that engaged in the processing of agricultural genetically modified organisms processing alters its/his name, it/he shall submit an application for changing its/his Processing License.

Where an entity or individual that engaged in the processing of agricultural genetically modified organisms processing is under any of the circumstance as follows, it/he shall submit an application for a new Processing License:

(1)

Where the relevant business goes beyond the confine of the processing scope as prescribed in the original Processing License; or

(2)

Where the production location is altered, including such cases as production in different places and setting up branches.

Article 9

An entity or individual that violates the provisions of the present Measures shall be subject to the punishment in accordance with the relevant provisions of the Regulation on the Security Administration of Agricultural Genetically modified Organisms.

Article 10

The Processing Licenses shall be uniformly printed by the Ministry of Agriculture.

Article 11

The present Measures shall be implemented as of July 1, 2006.

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Attachment:

Application Form for Processing License

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