A Comparative Analysis of China’s New and Old Pesticide Regulation

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China New Pesticide RegulationsOn February 8nd 2017, the State Council passed the draft of revised Regulation on Pesticide Administration. We forecast the new Regulation on Pesticide Administration will be issued in April or May, 2017.

New management measures will come into effect, including Pesticide Production License, Pesticide Registration, Permission of Pesticide Experiment Institutions and Pesticide Distribution Permit. In order to ensure traceability throughout the entire pesticide supply chain, the Ministry of Agriculture will take full responsibility for pesticide production, registration, distribution and application.

Our predictions for the new regulation are as follows:

Old Regulation

Prediction of New Regulation

Chapter I General Provisions

Article 2

Words like “destroying or wipe out” used in the context of pesticide efficacy were deleted in the new regulation. The aim of pesticide is to prevent or control diseases, pests etc. Pesticide with the ability of destroying or wiping out disease, pests etc. may pose unnecessarily high risk to the environment and human health. The supervision of highly toxic pesticides will be more stringent.

Article 2.2

To prevent, wipe out or control storage diseases, pests, rodents and other harmful organisms.

To prevent or control storage and processing places diseases, pests, rodents and other harmful organisms.

Article 2.6

To prevent, wipe out or control organisms harmful to dikes and dams, railroads, airports, buildings and other facilities.

To prevent or control organisms harmful to dikes and dams, railroads, dock, airports, buildings and other facilities.

Chapter II Registration of Pesticide

Article 7

The pesticide production (including technical material and formulated product production and subpackage) and imported pesticide shall be registered in China.

The pesticide production and imported pesticide shall be registered in China. The applicant and owner of certificate is a manufacturer based in China or overseas. In addition, the new pesticide developer can also apply pesticide registration and own the certificate based on this regulation.

The pesticide registration applicant can transfer data to anyone. But the registration certificate cannot be transferred. If the manufacturer wants to transfer the data, they only can transfer it to manufacturer who can produce the same product.

Article 7

Pesticide registration shall be conducted in three stages, including field test stage, temporary registration stage and formal registration stage.

Temporary registration will be cancelled in the new regulation. For applications from domestic manufactures, they should obtain the primary review comments from provincial department of agriculture first and then submit to Ministry of Agriculture for further evaluation. However, for the applications from foreign manufactures, they can submit the applications to Ministry of Agriculture directly.

In the last several decades, staged pesticide registration was suitable for generic pesticides, which in the past have accounted for a significant proportion of pesticides in China. Temporary registration allows for expedited market access for generic pesticides through simplified processes and data requirements.

However, more new pesticide products are being created due to increased government funding and incentives for R&D. Temporary registration is no longer appropriate. All new pesticides should apply for full formal registration.

 

The field tests application of domestic pesticide registration should be reviewed by provincial department of agriculture firstly, and then reviewed by Ministry of Agriculture. The field tests application of imported pesticide can be reviewed by Ministry of Agriculture directly.

Field testing of new pesticide shall be reviewed by Ministry of Agriculture directly. For other pesticide, like generic pesticide, field tests application can be put on record in provincial department of agriculture. New pesticide is regulated strictly because of unknown risk, while generic pesticide is regulated in a less stringent manner.

Not mentioned.

For pesticide which has the same composition, same application scope and method, the data requirement for residue and environment impact parts can be waived except for that the data is in 6 years protection period. This measure will make the same product registration easier and save time and money.

Chapter III Production of Pesticide

Article 13

The establishment of a pesticide manufacture shall be reviewed and approved by the departments for licensing administration of industrial products and then be reported for approval to the administrative department of chemical industry of the State Council.

The pesticide production approval will be cancelled. Instead a Permit of Pesticide Production issued by Ministry of Agriculture will come into effect.

Pesticide Production License and the approval document for pesticide production will be cancelled.

The Ministry of Agriculture will be the sole regulatory authority and will be tasked with complete control of both pesticide production and management, which is convenient and simplified for management.

Article 14

When producing pesticides for which national standards or trade standards are available, an application for a Pesticide Production License shall be submitted to the department of licensing administration of industrial products of the State Council. The production of pesticides for which national or trade standards are not yet available but enterprise standards are available shall, upon the examination and approval by the departments for licensing administration of industrial products of provinces, autonomous regions and municipalities directly under the Central Government, be reported to the administrative department of chemical industry of the State Council for approval, and be issued with the approval document for pesticide production.

Article 15

Pesticide producing enterprises shall carry out the production in accordance with the product quality standards and technological processes for pesticide production, and the production records must be complete and accurate.

Complete pesticide production management system, including procurement system of conformity and purchase records system for raw materials, inspection system of delivery and sales record for pesticide product.

The manufacturer shall purchase qualified raw materials attached production certificate of conformity, relevant licenses. The source of raw material should be recorded for 2 years.

Article 17

Before leaving the factory, pesticide products shall go through quality inspection and bear a qualification certificate of product quality. Products that are not up to the product quality standards shall not be allowed to leave the factory.

Before leaving the factory, pesticide products shall go through quality inspection and bear a qualification certificate of product quality. Products that are not up to the product quality standards shall not be allowed to leave the factory.

The sale volume and clients should be recorded for 2 years.

Chapter IV Distribution of Pesticide

Article 18

The following units may market pesticides:

  1. marketing units of agricultural production means of the supply and marketing cooperatives;
  2. plant protection stations;
  3. soil & fertilizer stations;
  4. popularization setups of agricultural and forestry technology;
  5. setups of preventing and controlling forest disease and insect pests;
  6. pesticide producing enterprises;
  7. other marketing units prescribed by the State Council.

If the pesticides to be marketed are classified as dangerous chemicals, a license for market shall be acquired in accordance with relevant provisions of the State.

Fixed point distribution of pesticide will be replaced by pesticide distribution license (except for public health pesticide), which is managed by Ministry of Agriculture.

The agents who meet the requirement of distribution pesticide and permitted by the authority can distribute pesticide.

Article 20

When purchasing pesticides, the marketing units shall check the products against the labels or directions for use and the qualification certificates of product quality, and shall inspect their quality.

When purchasing pesticides, the distributors shall check the products against the labels, directions for use and the qualification certificates of product quality, the permit of pesticide production.

The distributors shall record the source of the products for 2 years.

Article 22

The marketing units shall make sure that the marketed pesticides are of good quality and that pesticides are checked against the labels or directions for use and the qualification certificates of product quality.

The marketing units shall give correct instructions to units and individuals using pesticides about the use, method of use, dosage, first-aid measures in case of poisoning and matters needing attention.

Distributors shall make sure products are fully compliant when checking the products against labels, qualification certificates of product quality.

They have the responsibility for guide the user how to use the pesticide scientifically. According to different diseases and pests, distributer should provide the user adequate direction for pesticide application.

Pesticide products shall be separate from other product in stores.

The sold products shall be recorded the place to go for 2 years.

Chapter V Use of Pesticide

Article 24

The competent administrative departments of agriculture of the people's governments at or above county level shall, in accordance with the plant protection principle of "prevention first, comprehensive prevention and control", organize popularization of safe and highly effective pesticides, carry out training activities to improve farmers' application techniques of pesticide and do a good job in disease and pest prediction and forecast.

Country level government is responsible for the usage reduction plan of pesticides. They encourage and support actions such as voluntary reduction the application amount of pesticide voluntarily.

Department of Agriculture is responsible for completing pesticide safety and reasonable usage system. Besides, they are in charge of pesticide promotion of pesticide scientific usage.

Department of forestry, food and health are responsible for technical guide on pesticide usage in forestry, grain storage and public health area.

Department of environment protection is responsible for technical guide on environment protection and prevention.

Town-level government serves as an assistant in pesticide usage guide.

Article 25

The competent administrative departments of agriculture of the people's governments at or above the county level shall enhance guidance in safe and rational use of pesticides, work programs for alternating pesticides in light of local incidence of agricultural diseases, pests, weeds and rodents. Use pesticides in a planned way in order to reduce the resistance of diseases, pests, weeds and rodents to pesticide and improve the effectiveness of pest control measures.

Article 29

The administrative departments of forestry, grains and public health shall strengthen their guidance in safe and rational use of pesticides for forestry, grain storage and sanitation.

Not mentioned.

Add pesticide use record system. The relevant units or individuals shall record the pesticide application information for 2 years, including the application time and site, target object, pesticide species, dosage, the manufacturer, etc.

Chapter VI Supervision and Administration

Chapter title

Other Provisions

Supervision and Administration

Article 31

Pesticides listed below are considered fake pesticide:

(1) a non-pesticide substance passed off as a pesticide or one pesticide passed off as another;
(2) a pesticide whose category and name of effective ingredients does not tally with that described on the label or in the directions for use.

Complete definition of fake pesticide:

  1. a non-pesticide substance passed off as a pesticide or one pesticide passed off as another;
  2. a pesticide whose category of effective ingredients does not correspond with that described on the label or in the directions for use.

The pesticides listed below will be treated as fake pesticide:

  1. prohibited pesticide;
  2. manufactured or imported pesticide which has not been registered in China according to the regulation;
  3. Pesticide which has no label attached.

Article 32

Pesticide listed below are considered pesticides of inferior quality:

  1. failing to meet the quality standards of pesticide product;
  2. losing utilization efficiency;
  3. mixing with harmful ingredients that may cause hazards.

Pesticides listed below are considered pesticides of inferior quality:

  1. failing to meet the quality standards of pesticide product
  2. mixing with harmful ingredients that may cause hazards;

Besides, the pesticides out of the expiration date will be treated as pesticide of inferior quality.

Not mentioned.

Establish pesticide waste recycling system. The manufacturers and distributors bear full responsibility for waste recycling of all pesticide.

Not mentioned.

Establish pesticide recall system. If the pesticide has high risk or hazard to agriculture, forestry, human and animal safety, quality and safety of agricultural products and ecological environment, it should be recalled and recorded immediately.

Not mentioned.

Establish pesticide credit archive system. Country agricultural departments or above provincial level government bodies should establish a pesticide credit archive system for pesticide production, distribution and issue all information to the public. Suspected crimes/violations involving pesticides will be investigated and punished.

Not mentioned.

Establish a disposal system for fake pesticide, sub-standard pesticide and pesticide waste. The institutes which have the qualifications for hazardous wastes disposal will be responsible for disposal of fake or recalled pesticide.

Chapter VII Legal Liability

Chapter title

Penalty Provisions

Legal Liability

Not mentioned.

If the certificate of pesticide registration is cancelled by the license-issuing authority because of suspected crime, the authority will not review further pesticide registration applications for 5 years.

Not mentioned.

For some serious crime, like production or distribution of pesticides without authorities’ permission, registration certificate or licenses cancelled by authority, the main personnel will not be engaged in pesticide production or distribution for 10 years in China.

Chapter VIII Supplementary Provisions

 

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