China Accelerates Development of Testing and Assessment Guidelines for Pesticide Registration

On 22 Oct and 1 Nov 2018, China ICAMA opened 4 draft pesticide guidelines to public consultation:1). Livestock toxicokinetics assessment,2).Livestock pesticide residue test, 3.)Residential exposure tests, 4). Risk assessment on long-lasting insecticide-treated mosquito net.

China Accelerates Development of Testing and Assessment Guidelines for Pesticide RegistrationChina promulgated a new pesticide regulation last year which significantly increased the regulatory compliance obligations of stakeholders in regards to generation of efficacy and safety data. New requirements include the issuance of a positive list of labs accredited to generate required data, elevated technical criteria and the introduction of risk assessment. The 4 drafts below offer guidelines for undertaking various testing requirements for pesticides:

  • Guideline for the testing of pesticide metabolism in livestock
  • Guideline for the testing of pesticide residues in livestock
  • Guidance on health risk assessment of public health pesticides
  • Testing methods of public health pesticide residential exposure

Animal Metabolism and Residue Tests

Livestock toxicokinetic data will be required for the registration of new pesticide (using new active ingredients) used on feed-related crops including rice, wheat, maize, soybean, peanuts and other fodders (alfalfa, ryegrass and silage maize). By using radiolabeling method, the absorption, distribution, metabolism, and excretion in animal, the final residue in its edible part and lipid solubility will be determined. Although the data on final residue in livestock is not yet compulsorily required, the residue exposure will be considered during dietary risk assessment. The testing guideline can also facilitate the establishment of pesticide MRLs for animal-derived food.

Guidelines for Household Insecticides

At the end of 2017, China ICAMA released 3 official models supporting the preliminary health risk assessment for several household insecticides. A guideline for mosquito net assessment was compiled to complete the assessment system. The guideline specified the element, procedure, calculation approach, affecting population, scenarios, and routes to be considered.  At present, China ICAMA has released 6 official models supporting preliminary assessment supporting for only limited numbers of products and exposure scenario:

 

Risk

Scope, Scenario and Products Applicable

CoPrisk

Occupational health

RQ calculation for non-paddy crop manual application of  liquid preparation/formulation(DC, OD, SP, SG, ST,SL, WP,  EA*,EB, EC, WDG, AS, EW, CS,ME, SC and SE )

CML Model

Residential health

RQ calculation for coil, vaporizing mat and liquid vaporizer

Areole Model

RQ calculation for Areole

Repellent Model

RQ calculation for Repellent

China-PEARL

Environment exposure

PEC calculation for northern upland scenario

TOP-Rice

PEC calculation for southern region scenario

These official models should be utilized for risk assessment. For scenario and product type that do not have an established guideline or official model, other proven models or assessment methods developed by EU or US, or minor and reasonable adjustment based on existing models are also acceptable.

If the preliminary assessment indicates an unacceptable risk to target population or organism (RQ>1), higher-tier field or simulation tests will be required to substantiate actual exposure. The draft guideline details the condition, requirements on test site and participants, measuring apparatus and method, number and time interval of observation and measurement, data to be collected and reporting of the test.

Guidelines for Environmental Tests

During an internal meeting on 8 November 2018, ICAMA official said another 8 guidelines have been drafted, which will soon be sent for final assessment:

  1. Chemical pesticides-Guideline for Daphnia Magna reproduction test
  2. Guidance on environmental risk assessment for pesticide registration- Part 9: Assessment of Pesticide Mixtures;
  3. Chemical pesticides- Guideline for field trial on earthworm;
  4. Chemical pesticides-Guideline for avian reproduction test;
  5. Chemical pesticides- Guideline for fish early life stage test;
  6. Chemical pesticides-Guideline for amphibian metamorphosis development test;
  7. Chemical pesticides-Guideline for calculation of soil absorption using HPLC method;
  8. Guideline for earthworm acute toxicity of volatile pesticides;

 

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