4. latest developments in pesticides, china...evaluation of residue fate of a pesticide and its...

Latest Developments in Pesticide Residue Standards in China

SONG Wencheng Ph. D

Residue Division, Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA)Secretariat of Codex Committee on Pesticide Residues (CCPR)

Tel:010-5919 4105, Fax:010-59194107Email: [email protected] 28, 2010

Contents

� Legal Basis for Establishing Pesticide Residue Standards

� Steps of Establishing Pesticide Residue Standards

� Technical Requirements for Establishing Pesticide Residue Standards

� Characteristics of Establishing Pesticide Residue Standards

� The Facts of Pesticide Residue Standards

� About ICAMA

Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA)

I. Legal Basis

�Food Safety LawPromulgated on February 28, 2009

�Law on Quality and Safety of Agricultural Products Promulgated on April 29, 2006

�Regulations on the Control of Agricultural Chemicals Promulgated in 1997, Revised in 2001

�Data Requirements for Pesticide RegistrationPromulgated in 1984 by MOA, Revised in 2007

Article 20 of Food Safety Law provides that “food safety standards shall specify pesticide residues”; Article 21 provides that “the health department and agricultural department authorized by the State Council shall be responsible for establishing pesticide residue limits and related inspection methods”.

On September 19, 2009, MOH and MOA issued a Joint Opinion on Administration of Standards for Pesticide and Veterinary Drug Residues in Food (No. [2009] 828). It was clearly stipulated that MOA is responsible for establishing standards on pesticide and veterinary drug residues.


I. Legal BasisLaw on Quality and Safety of Agricultural ProductsFood Safety Law

Regulations on the Control of Agricultural Chemicals

Pesticide Registration

Pesticide RegistrationLabelNumber of applications and PHI

Data requirements for Pesticide Registration (residues);Metabolic mechanism in plants and animals (depends)Analytical MethodsField trial, GAPStorage stabilityResearch of processing (depends)

Pesticide Residue Standards

Data requirements:ToxicologyResidue ChemistryNational dietary data

Issuance of standards on Residue Limits and Inspection Methods


II. Steps of Establishing Standards


Approval of standard project

Draft of standard Comments

ReviewInform WTO Review

Jointly issued by MOH and MOA,Standard Code assigned by Standardization Administration

Issuance

MOA Undertaking departments Undertaking departments

National Review Committee on Pesticide Residue Standards

Planning of standard project

MOA

Review Committee on National Food Safety Standards

MOA, AQSIQ and MOC

III. Technical Requirements for Establishing Standards

A. Technical basis� Guidance for Risk Assessment of Pesticide Residues in Food

� Guidance for Establishment of Maximum Residue Limits in Food

� Classification of Foods and Animal Feeds for Establishment of Maximum

Residue Limits

� Norm for Pesticide Residue Trials (NY/T 788-2004)

� Sampling for Pesticide Residue Analysis (NY/T 789-2004)

� Good laboratory practice for pesticide residue trials（ NY/T 1493-2007）� Etc.


Approved on April 12 by First session of CNPRSE, still under issuance procedure.

B. Guidance for Risk Assessment of Pesticide Residues in Food

Scientific assessment of the probability and extent of risks from dietary

intake of pesticide residues through toxicological and residue

chemistry analysis, based on national dietary pattern

Including 3 parts:

1. Toxicological Evaluation

2. Residue Chemistry Evaluation

3. Dietary Intake Evaluation



B. Guidance for Risk Assessment of Pesticide Residues in Food1. Toxicological Evaluation� Identification and description of pesticide hazards, and recommendation of ADI and/or ARfd based on results from toxicokinetics tests and toxicological tests.�Toxicokinetics Evaluation

Evaluation of pesticide absorption, distribution, biotransformation, excretion and accumulation data in test animals.�Toxicological Evaluation

Evaluation of acute toxicity, short-term toxicity, long-term toxicity, carcinogenicity, teratogenicity, genotoxicity, reproductive toxicity and epidemiological analysis of a pesticide and its toxic metabolites.�Recommendation of ADI or ARfD

Derivation of recommended ADI based on results from toxicokinetics tests and toxicological tests. Derivation of recommended ARfDfor pesticides with acute toxicity.




2. Residue Chemistry Evaluation

Evaluation of residue fate of a pesticide and its metabolites in food and the environment, and recommendation of STMR and HR based on evaluation of animal and plant metabolism tests, residue field trials, feeding test, processing tests and environmental fate tests.

�Evaluation of Animal and Plant Metabolism Tests and Residue Definition�Evaluation of Residue Behavior

� Analytic Methods for Residue

� Storage Stability of Sample

� Supervised Residue Trial

�Processing Evaluation

�Evaluation of Animal Feeding Tests




3. Dietary Intake Evaluation

Based on toxicological and residue chemistry evaluation, conduct quantitative risk assessments of pesticide residues to human health from dietary intake and recommend MRLs

�National Estimated Daily Intake

is the evaluation of long-term intake of pesticide residues. Its calculation is based on daily average food intake per individual and STMR, taking into account the residue change during food processing, dietary intake from other sources and transformation products of toxicological significance.

NEDI =∑［STMRi× Fi）］If: NEDI≤63·ADI, then it's safe to recommend HR as MRL

NEDI≥63·ADI, then recommending HR as MRL is risky



B. Guidance for Risk Assessment of Pesticide Residues in Food3. Dietary Intake Evaluation

�National Estimated Short-Term Intake（（（（NESTI））））is the evaluation of short-term intake of pesticide residues. Its calculation is based on daily

(per meal) average food intake per individual and HR, focusing on residues from edible parts of foods, and taking into account dietary intake from other sources and transformation products of toxicological significance.

Case 1: Weight per item is below 25gNESTI = LP x (HR or HR-P）

Case2: Weight per item is above 25g－ Weight of edible parts per item is below the high percentile consumption － Weight of edible parts per item is above the high percentile consumption

Case 3: Canned foods or mixed-processed foods



C. Guidance for Establishment of Maximum Residue Limits in Food

Recommend highest residue level on the basis of pesticide application

methods recommended by GAP and supervised residue trials; and based on

ADI and ARfD determined by toxicological tests, conduct dietary exposure

assessments and recommend MRLs.

Including 4 parts

1. Procedure of Establishing MRLs

2. Reevaluation3. Periodic Reevaluation4. Other Situations



C. Guidance for Establishment of Maximum Residue Limits in Food

1. Procedure of Establishing MRLs

� Determination of STMR and HR

� Determination of ADI and/or ARfD

� Recommendation of MRLs

� Calculaiton of NEDI

� Calculaiton of NESTI

� Dietary intake evaluation

� Extrapolation within the same product group



C. Guidance for Establishment of Maximum Residue Limits in Food2. Reevaluation

Established MRLs shall be reevaluated when any of the following occurs:� When approved GAP changes significantly;� When toxicological research proves existence of new potential risks;� When monitoring data shows new intake risks;

Reevaluation shall be conducted in compliance with the procedure for establishing MRLs.

3. 3. Periodic ReevaluationTo ensure the timeliness and effectiveness of MRL standards, a periodic reevaluation

system is implemented for established MRLs in China; the reevaluation period is 15 years, and for temporary MRLs and EMRLs, 5 years.



C. Guidance for Establishment of Maximum Residue Limits in Food 4. Other Situations�Temporary MRL standards

� When ADI is temporary;� When no complete or reliable dietary data is available;� When no monitoring and analytical methods for residue meets the requirements;� When a pesticide or pesticide/crop combination is not registered or when international trade

or import inspection necessitates;� In case of emergency, when a pesticide is approved to be used on unregistered crops, an

emergency MRL standard shall be established, and its scope and period of validity shall be defined;

� When other data do not meet the full requirements of evaluation procedure.Temporary MRLs shall be established in compliance with the procedure for establishment of MRLs.

When new test or monitoring data are available, revisions shall be made in a timely manner. �EMRLs�MRLs in Spices/Condiments�Exemption from the requirement of a MRL



D. Procedure for pesticide risk assessments and establishment of MRLs



Evaluation of pesticide toxicological data:toxicokinetics;toxicological tests

Recommendation of:

STMR and HR Food consumptionRecommendation of:ADI or ARfD

National Estimated Daily IntakeNational Estimated Short-Term Intake

Recommended MRL

Residue Chemistry Evaluation Toxicological Evaluation

Evaluation of residue fate of a pesticide and its metabolites in food and the environment; animal and

plant metabolism tests, GAP tests, feeding tests, processing tests and environmental fate tests

Dietary Intake Evaluation

E. Classification of Foods and Animal Feeds for Establishment of Maximum Residue Limits

1. PurposesStrengthening registration, use and control of pesticides, promoting foreign trade

coordination, and laying a scientific foundation for establishing MRLs in agricultural products.

2. MethodsBased on the CAC crop method and system of classification, taking morphology,

cultivation measures and scale as reference, and focusing on the pattern of pesticide residues in edible parts of food; crops with similar residue characteristics were put into the same group, and the ones with the highest residues and largest consumption are selected as representative crops of the group.



E. Classification of Foods and Animal Feeds for Establishment of Maximum Residue Limits

3. Classification1. Grains: rice, wheat and barley, upland crops, and minor crops - 18 crops in 4 groups;2. Oil Crops: small oilseeds, soya, peanut etc - 9 crops;3. Vegetables: bulb vegetables, brassicas, leafy vegetables etc - 83 crops in 11 groups;4. Fruits: citrus fruits, pome fruits, stone fruits etc - 56 crops in 6 groups;5. Nuts: large nuts and small nuts - 9 crops in 2 groups;6. Sugar crops: sugar cane and sugar beet - 2 crops;7. Beverage crops: tea, coffee, cocoa, hops, chrysanthemum, rose - 6 crops;8. Edible fungi: mushrooms and wood ear - 20 crops in 2 groups;9. Spices: leaves and others - 10 crops in 2 groups;10. Animal feeds: legumes, grains and others - 16 crops in 3 groups;11. Medicinal crops: roots, leaves and stems, flowers and fruits - 12 crops in 3 groups.Total: 241 crops



IV. Characteristics of Establishing Standards

�Based on science. After evaluation of pesticide risks based on risk assessment, MRLs are established;

�Applicability. Integrated with the actual situation of agricultural production and dietary pattern in China, protecting both the industry and consumer safety;

�Consistency. Relevant FAO, WHO, CAC and OECD guidelines are taken as reference;

�Non-zero risk as objective.


V. The Facts of Pesticide Residue Standards

A. Present situation of pesticide residue standardsAt present, pesticide MRLs in China are comprised of National Standards and Industry Standards.

� National Standards

�Before 2009: jointly issued by MOH and Standardization Administration. Including Maximum Residue Limits for Pesticides in Food (GB2763-2005) and Revision 1; GB2763-2005 contains 478 MRLs for 136 pesticides. Some food hygiene standards, such as Hygienic Standard for Grains (GB2715-2005).

�2010 and after: jointly issued by MOH and MOA; GB25193-2010 was recently issued, which contains 16 MRLs for 12 pesticides.

� Agricultural Industry Standards

Issued by MOA. Agricultural industry standards for Maximum Residue Limits in agricultural products (NY series); industry standards of 329 MRLs for 118 pesticides.



B. Areas for improvement

�Not enough standards, development of standards lagging;

�Unsound risk assessment system;

�Weak in basic research, insufficient fundamental information and data;

�Lack of technical personnel.



C. Latest Developments1. New supervising organizations (institutions) on food safety established�The State Council created the National Food Safety Committee; 2010.2.6�MOH created the Review Committee on National Food Safety Standards; 2010.1.19

After consultation with MOH and agreement reached, MOA is responsible for establishing national standards for pesticide residues.�MOA created the National Review Committee on Pesticide Residue Standards; 2010.3.12Secretariat of the Committee is located in ICAMA .



C. Latest Developments2.Milestone Achievements

� Guidance for Risk Assessment of Pesticide Residues in Food

� Guidance for Establishment of Maximum Residue Limits in Food

� Classification of Foods and Animal Feeds for Establishment of Maximum Residue Limits

� 134 MRLs for 134 pesticides were established, among which 16 MRLs for 12 pesticides consistent with CAC standards has been promulgated(GB25193-2010), other MRLs are being circulated to WTO member countries as per procedure

� 2010-2012 Plan for Establishment of MRLs

� A project of cleaning up national and industry MRLsestablished before 2009 has been launched, and monitoring work on actual residue of related pesticides in corresponding agricultural products is now completed. After the cleaning-up, there will no longer be any agricultural industry standards.



D. Goals of Future Work

� Continue work on establishment of MRLs;

� Improve the residue standards system;

� Promote consistency in MRL setting and pesticide registration;

� Increase transparency and participation in the MRL setting process;

� Intensify exchange and communication with other countries and international organizations.


VI. About ICAMA

�Responsibilities:

�Control of Pesticides

�Pesticide Registration

�After-Registration Control of Pesticides

�Objective:

To ensure safety in agriculture and safeguard quality of agricultural products


26

Deputy DG

General Office

Planning and Financial Division

Administration Division

Information Division

Registration Division

Supervision Division

Bioassay Division

Chemistry Division

Residue Division

Import and Export Division

Biotech and Environmental Center

Director General

Toxicity Division

CNPRSE Secretariat

CCPR Secretariat

ICAMA

Organization Chart


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