Agriculture, Biopesticides, Industry News

Development and Management of Biopesticides in China

Development and Management of Biopesticides in China

Over the past five years, the number of biopesticides registered in China has enjoyed a 16% increase while growth of chemical products was just 3%. Currently, the global biopesticide industry is worth 3.2 billion USD annually. Over 60% of the market is dominated by the United State and European enterprises. As the largest chemical pesticide producer and exporter in the world, China wants a bigger piece of this emerging sector. China’s ambition is not limited to securing a market niche in the global biopesticide sector. The Chinese government is also eager to find safer alternatives to the chemicals currently used domestically. Food safety is a massive concern in China and the government has tried to drive substitution of hazardous chemicals domestically by subsidizing biopesticide users and offering favorable registration policies.


Overview

In China, biopesticide refers to biochemical, microbial pesticides, botanical pesticide, biochemical pesticide, natural enemy and pest-resistance GMO crops. Both the industry and the academic community believe that agricultural antibiotics should also be classified as biopesticides; however this product category is actually registered as a chemical pesticide a fact reflected in the registration statistics. Nevertheless, the numbers of active ingredient and biopesticide products have grown by 20% in the last couple of years. By the end of April 2014, the number of biopesticide active ingredients and products expressed as a percentage of total pesticides registered with ICAMA were 14.5% and 3.3% respectively.

Table 1. Number of Biopesticide active ingredient and products registered in China

Category Number of Registered Active Ingredient Number of Registered Product
Microbial pesticide 31 363
Botanical pesticide 23 256
Biochemical pesticide 38 373
Natural enemy 2 3
Agricultural antibiotics 17 2668
Total 111 (94) 3663 (995)
All pesticide 650 30,000
Percentage of Total registered pesticide 17.1% (14.5%) 12.2% (3.3%)

In the past biopesticide producers looked for governmental support in the form of policies that offered data exemptions and expedited the registration process. In response to this need, the authorities started to draw up a supplementary document for data requirement on biopesticide registration in 2010 and a revised draft of the Data Requirement on Pesticide Registration was released for public consultation the following year. However the consultation never progressed any further similar to its overarching regulation, the “Regulation on Pesticide Administration”. The revised draft of the “Regulation on Pesticide Administration” was released in 2011 for public consultation with ICAMA officials optimistically vowing that the new regulation would be promulgated by the end of 2012. The biggest obstacle facing China’s biopesticide registration policy remains the delay in the legislative process of this overarching regulation. The acceleration of efficacy testing which was set to change the standard field testing protocol which uses 4 sites for 2 years to 8 sites for one year will also not be achieved. However China’s biopesticide registration process is still faster than its global counterparts.

Table 2. Required times on efficacy test by regions.

Country/Region Requirements on Efficacy Test Time
United State No requirement at national level but differs from different State; 18 months
Europe 2 planting season At least 29 months
Brazil 1 planting season 18 to 36 months
India 2 planting season, 3 test sites 24 months
Argentina 1 planting season, 3 test sites 12 to 15 months
Japan 2 planting season, over 3 test sites 24 to 30 months
China 2 planting season, 4 to 5 test sites 3 months (temporary registration), 12 months (full registration)

During the National Biopesticide Development and Application Exchange Conference in Shandong, Mr. Yuan Shankui from the Efficacy Review Department of ICAMA outlined the most frequent data problems during the registration process and the different requirements for different biopesticide categories.

Table 3. Similarities and difference of registering biopesticide and chemical pesticides

Difference
Similarities
  •  Both of them require the chemical , efficacy, residue, toxicology and environmental data;
  • Share the same criterion during risk decisions and requirement on pesticide labeling;
  • The requirements on efficacy test are basically the same: 4 to 5 sites for 2 years;
  • Both the biopesticide and chemical pesticide should go through the same reviewing process;
 Difference
  • The number of test and cost on registering biopesticide are usually much lower;
  • Most of the active ingredient in biopesticide can be waived of residue, toxicology and environmental data requirements
  • The test method and measuring index of some biopesticides are distinct, such as biochemical pesticide and nature enemy;
  • Most of the biopesticide are reviewed “case-by-case”

During the National Biopesticide Development and Application Exchange Conference in Shandong, Mr. Yuan Shankui from the Efficacy Review Department of ICAMA outlined the most frequent data problems during the registration process and the different requirements for different biopesticide categories.


Microbial Pesticide

Microbial pesticide consists of fungi, bacterium, virus, protozoan and rickettsia-lick. Currently, there are 10 fungus, 10 bacteria and 11 viruses registered in China and the number of total microbial pesticide reached to 353.

Table 4. Active ingredients of microbial pesticide registered in China

Type Number of registered active ingredient/product Name of active ingredient
Fungicides 10/269 bacillus thuringiensis; bacillus thuringiensis H-14; bacillus sphaericus H5a5b; bacillus subtilis; bacillus cereus; pseudomonas fluorescens; paenibacillus polymyza; empedobacter brevis; bacillus licheniformis; sphaerotheca amyloliquefaciens
Bacterium 10/36 metarhizium anisopliae; beauveria bassiana; trichoderma harzianum; trichoderma SP; paecilomyces lilacinus; verticillium chlamydosporium ZK7; conidioblous thromboides; coniothyrium minitans; torula yeast
Virus 11/58 EONPV; Euproctis pseudoconspersa Nucleopolyhedogsis Virus; LeNPV; Mamestra brassicae multiple NPV; autographa californica NPV; dendrolimus punctatus cytoplasmic polyhedrosis virus; periplaneta fuliginosa densovirus (PfDNV); pierisrapae granulosis virus(PrGV); plutella xylostella granulosis virus (PXGV); spodopteralitura NPV; heliothis armigera NPV

Microbial strains are usually infectious and reproductive in their host and/or environmental media,. Mutations can cause unexpected adverse effects. Thus evidence outlining lack of pathogenicity to humans etc. of these microorganisms is required:

Table 5. Data requirements on Microbial pesticide

Data Category General Requirements
Chemical and biological data
  • General the same as chemical pesticide;
  • Inoculum(species of the microbe) identification is required;
  • The technical specification and shelf life on certain formulation types are different from chemical pesticide;
Efficacy
  • The same as chemical pesticide;
Toxicology
  • Supporting document that the microbe is non-pathogenic to humans and other mammal(usually a non-pathogenic report issued by MoA authorized microbial testing institute);
  • Basic toxicology data (acute oral, acute skin, acute inhalation, eye irritation, skin irritation and skin sensitization). Additional toxicology data is usually not needed if the microbial pesticide is not highly or extremely toxic in basic toxicology study;
Environmental Data
  • Acute toxicity test on fish, daphnia, algal, bee and silkworm;
  • The environmental fate test can usually be exempted;
Residue
  • Usually exemptible;
*During the 5th plenary session of the 8th national Expert Committee for Pesticide registration, the experts agreed that if the TC (TK) of the microbial pesticide is low or negligibly toxic, the residue data of TC/TK and formulated product registration can be exempted.

MoA has not yet officially designated testing labs for microbe species identification, Mr. Yuan revealed that the identification report issued by two institutes are generally acceptable for microbial pesticide registration. Another big issue for registering novel microbial pesticide is the nomenclature on the microbe. The applicant of novel microbe pesticide should obtain a letter of pesticide nomenclature from the Secretariat of National Technical Committee on Pesticides Standardization Administration and submit the letter alongside the registration dossier. Some common faults of the dossier were also pinpointed during Yuan’s speech:

  • The content of microbial pesticide should be normatively described in “CFU/g (mL)”or “IU/mg (mL)”and “PIB (OB)/mg (mL)”;
  • The control index of undesired microbes should be defined in the dossier. But this requirement is usually omitted or the applicant simply fills in with “less than 0.1%” without consideration. This application material would often be rejected by the reviewing body because ICAMA insists that controlling undesired microbes under 0.1% is unachievable and unrealistic.
  • All pesticide application materials should include quality specifications. If China has not yet established national or industrial quality standard for the pesticide, the applicant should establish the enterprise standard for the pesticide. If the applicant of microbial pesticide has no idea of how to formulate the quality standard, some recently released national quality standards on microbial pesticide can be referenced
  • Storage stability report( at least 12 months) should be included;

Botanical Pesticide

The registration of TC/TK of botanical pesticide cannot be exempted even if TC or TK is low or slightly toxic. But the residue data can be exempted for its corresponding formulated product.

Table 6. Active ingredients of botanical pesticide registered in China

Type Number of registered active ingredient/product Name of active ingredient
Insecticide 13/182 matrine; rotenone; azadirachtin; vertrine; pyrethrins; nicotine; celastrus angulatus; eucalyptol; camphor; d-camphor; oleum anisi stellate; neochamaejasmin;
Molluscacide 1/2 TDS
Regulator 2/50 brassinolide; propionyl brassinolide
Rodenticide 2/4 triptolide; curcumol
Fungicide 5/18 cnidiadin; eugenol; eugenol; physcion; berberine

If the active ingredient of the botanical pesticide was chemically synthesized, the pesticide should be registered as a chemical pesticide. If the formulated botanical pesticide product was mixed with a chemical pesticide data waiving is not applicable.

Table 7. Data requirements on Botanical pesticide

Data Category General Requirements
Chemical
  • General the same as new chemical pesticide;
  • If the full-component analysis is unachievable, the full-component report can be exempted, however a proof issued by MoA approved testing facility is required and the applicant should provide the identification report of at least one major active ingredient of the botanical pesticide;
Efficacy
  • The same as chemical pesticide;
Toxicology
  • Generally the same as full registration of new chemical pesticide;
  • If the pesticide was approved by the national authorities to be registered as food additive, dietary supplement and medicine etc., the reproductive, teratogenic, chronic and carcinogenicity toxic data can be waived;
Environmental Data
  • Acute toxicity test on fish, daphnia, algal, bee and silkworm;
  • Over 90% of the botanical pesticide can be waived of environmental fate data;

The registration of TC/TK of botanical pesticide cannot be exempted even if TC or TK is low or slightly toxic. But the residue data can be exempted for its corresponding formulated product.

If the active ingredient of the botanical pesticide was chemically synthesized, the pesticide should be registered as a chemical pesticide. If the formulated botanical pesticide product was mixed with a chemical pesticide data waiving is not applicable.


Biochemical Pesticide

Biochemical pesticides are often natural compound or have the same chemical structure as natural compound. Their most significant characteristic is that they have no direct toxic effect on their target. They usually include pheromone (ectohormone, allomone, kairomone and sex attractant, etc.), hormone, natural plant growth regulator/insect growth regulator and protein/ enzyme. There are 38 active ingredients and 373 products registered as biochemical pesticide in China.

Table 8. Active ingredients of Biochemical pesticide registered in China

Type Number of registered active ingredient/product Name of active ingredient
Regulator 18/258 gibberellic acid; 4-indol-3-ylbutyric acid; enadenine, oxyenadenine; 6-benzylamino-purine; triacontanol; (+)-abscisic acid; 1-methylcyclopropene(1-MCP); sodium nitrophenolate; sodium 2,4-dinitrophenolate; sodium 5-nitroguaiacolate; sodium para-nitrophenolate; sodium ortho-nitrophenol; potassium nitrophenolate; potassium ortho-nitrophenolate; potassium para-nitrophenolate; 1-naphthyl acetic acid; aspirin
Rodenticide 5/6 Cholecalciferol; 3-chloropropan-1,2-diol; difennuozhi; barium sulfate; vitamin C
Pheromone/ Attractant 5/6 muscalure; trimedlure; E-8-dodecen-1-yl acetate; Z-8-dodecen-1-ol; Z-8-dodecen-1-yl acetate
Repellent 1/27 ethyl butylacetylaminopropionate
Inductor 1/2 methiadinil
Protide 2/3 harpin protein; plant activator protein
Saccharide 5/68 oligosaccharins; fungous proteoglycan; chltosan; pujuxitang; oligosaccharides
Fatty acid 1/3 mixed aliphatic acid

If the biochemical pesticide has a low exposure risk (non-sex attractant), it is exempted from most data exemption requirements.

Table 9. Data requirements on Botanical pesticide

Data Category General Requirements
Chemical
  • General the same as new chemical pesticide;
Toxicology
  • Basic toxicology data (acute oral, acute skin, acute inhalation, eye irritation, skin irritation and skin sensitization);
  • The subchronic and mutagenic data are exemptible unless the biochemical pesticide is highly or extremely toxic during basic toxicology study;
Environmental Data
  • TC application need to submit acute toxicity test on fish, daphnia, algal, bee and silkworm;
  • The environmental fate data can generally be waived unless the biochemical pesticide is highly toxic to non-target organism ;
Other Data
  • Usually exemptible

Biochemical pesticides have distinct functional mechanism exposure pathways compared with other pesticide categories and are thus usually tested and evaluated using different criteria. For example, an applicant of a pheromone attractant usually needs to ask ICAMA’s local subordinates for suggestion on the measurement of efficacy. The other issue on this category is whether the biomimetic synthesized (chemical modified from natural biochemical) compound should be classified as biochemical pesticide and enjoys the data exemptible preference. The authority adopts a precautionary approach towards biomimetic compounds and deems azoxystrobin and diflubenzuron as chemically modified and thus subject to registration as a conventional chemical pesticide in China.


Agricultural Antibiotic

Though agricultural antibiotic has the greatest number of registrations compared with other biopesticides, the data requirement are more like chemical pesticides and the test data for medical registration cannot be utilized for pesticide registration.

Table 10. Active ingredients of Agricultural antibiotics registered in China

Type Number of registered active ingredient/product Name of active ingredient
Insecticide 5/2168 abamectin; spinosad; spinetoram; ivermectin; emamectin benzoate;
Rodenticide 2/5 Botulinum toxin D; Botulinum toxin C,
Fungicide 10/495 Jingangmycin A; kasugamycin; polyoxin; pyrimidine nucleoside; cytosinpeptidemycin; ningnanmycin; streptomycin sulfate; phenazino-1-carboxylic acid; zhongshengmycin; tetramycin

Future Trend

Mr. Yuan outlined that ICAMA is very cautiously reviewing each biopesticide registered for the first time in China and also standardizing its preference policy on biopesticide:

  • The active ingredient in the microbial pesticide will be registered in accordance with the strain instead of the microbial species;
  • For the biopesticide active ingredients already registered in China, ICAMA will formulate a “dynamic list” and the on-going pesticide based on the included active ingredient can be exempted of residue test;
  • Explosiveness test can be exempted on all categories of biopesticide;
  • MoA will publish the name of testing facilities capable of microbe identification test and biopesticide quality test;

If you want to see more regulatory news and ICAMA registration information about the above biopesticide, please visit ChemLinked Agro Portal and explore our CPAD database to access all the product and producer registered or licensed in China.

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