Republic of Korea

by Su-Myeong Hong

Registration and management scheme in the Republic of Korea

Pesticide registration in the Republic of Korea

The Pesticide Management Act (PMA) has been revised and re-enforced several times since it was promulgated in 1957 for the first time in the Republic of Korea. Pesticides had been registered by Ministry of Agriculture and Forestry (MAF) till November 1996 under the legislation system of pesticide commodity permission and commodity notification. Upon adopting the notification system of pesticide formulation, everybody was able to register the notified pesticide by submitting the formulation recipe and supply certificate of the technical grade of active substances (TGAI). Thus, the Republic of Korea became a heart of generic pesticides all over the world because pesticide formulators were intensively importing low-priced TGAIs with less confidence of the quality. In consequence, the Government entirely revised the PMA with full registration scheme and pesticide registration was given to the Administrator of Rural Development Administration (RDA) which has an activity on research and extension services involving various disciplines of agriculture as well as expert resources related with crop protection since December 1996. Henceforth, there has been several enforcement of PMA to reduce pesticide risks including special reviews of distrustful pesticides in safety on dietary intake of residues or non-targeted environmental impact, introduction of re-registration every ten year cycle, a separate registration scheme for bio-pesticides, etc.

Before a pesticide is considered for registration in Korea, it must be reviewed to identify the potential risks to human health and the environment as well as demonstrate its biological efficacy to target pests. For documents on application for agrochemical registration which applied annually, it was made sure that safe agrochemical were registered through quick and accurate reviewing for each fields, based on agrochemical management act, article 9.

A total of 297 product items were applied for the registration in Korea during 2004. The data of each item including efficacy, phytotoxicity, toxicity and residue test were submitted for being reviewed by each expert. The reviewing results of them were that 259 items were registered while 24 items were rejected and 14 items were asked to submit additional data. 76 items for minor crops and 52 items by official authority were also reviewed for registration.

Toxicity category for each pesticide to be registered was classified and notified on the basis of its acute toxicity to mammals and fish. Eight formulations were classified into toxicity category III and 92 formulations were classified into toxicity category IV. Fish toxicity categories were assigned to I, IIs, II and III for 15, 1, 15 and 78 formulations, respectively.

It was shown that there were 35 incongruities for data supplement or holding of registration in the result for assessment of application requirements in 2004. The summary registration applications were as below; 127 formulations 219 applications in fungicide, 116 formulations 207 applications in insecticide, 57 formulations 67 applications in herbicide, 11 formulations 16 applications in growth regulator and etc.

Pesticide registration procedure in the Republic of Korea

PSAC: Pesticide safety Advisory Committee

Re-registration

In line with demands for ever more safety assurance being used on pesticides and increased international harmonization efforts, re-registration program had included in PMA as of December 1996 to ensure that older generation, but still widely used, products meet today's qualified environmental and safety standards. Thus a total of 244 products registered before December 1986, which had been informed to fulfil the data gap, were evaluated the data. Of the re-assessed products, 39 products were withdrawn from registration, 32 had target crops or pests cancelled, 31 were re-classified in their toxicity grade, 130 had their pre-harvest intervals (PHIs) changed, and 60 were amended with precautions for reduction of acute mammal or environmental exposure on December 6, 2001.

Registration of bio-pesticides to support biologically-based farming practices

A differentiated registration scheme for microbial pesticides was already in operation in order to promote and spread the environmentally sound ones in crop protection area since 2001. The principle of registration process basically was two tiered approaches on data requirements and assessment. Meanwhile, the share of products, amount and value of the bio-pesticides occupies still minor portion like other countries. RDA is conducting intensive work together with related agencies to extend the bio-pesticides to biochemical pesticides and natural enemies since 2004.

With modification/addition in test standards, methods, and application requirement, the application regulation for biopesticides was established and proposed, based on convenient Microbial Pesticide Application Regulations, in comparison with foreign registration systems for biochemical pesticide (which include pheromone and natural chemicals). And 6 incongruities were found in 54 formulations (111 items) of registration application samples, current pesticide samples, and petition samples for quality control for biopesticides. These incongruities were caused in 3 active ingredient absence/deficiencies, 3 physical inferiorities. The analysis method of new active ingredients for later quality assurance was established and notified as inspection method for pesticides.

Enforcing test guideline (TG)s and data assessment scheme of pesticide residue studies

TG for pesticide residue studies in/on crops and environment compartments has enforced to secure the food safety and to prevent environment deterioration by introduction of pesticides into agro-ecosystem. Crop residue data has been generated by dissipation study in/on target crop after application to the crop only; however, in recent post-harvest stability and metabolism studies in the target crop have emphasized to fulfill safety of post-harvest crops being exported and to clarify fate and their metabolites of the applied pesticides. TG for stability tests of post-harvest and metabolism studies in the target crop was established in harmonization with EU, OECD, and US/EPA/OPP guidelines. In addition, TG for pesticide adsorption/desorption study was also set up, which is suitable for local agricultural situation. Those TGs and data assessment schemes of pesticide residue were conveyed to the relevant steering subcommittee of Pesticide Management Committee for adopting the legal enforcement.

Risk assessment tools

Continued work was conducted to advance the science needed to understand and accurately assess the potential risks that pesticide can pose to human health. The advanced risk assessment schemes to be implemented by OECD countries such as USA and UK were investigated for setting up new risk assessment tools in Korea. Risk assessment tool for pesticide handlers was newly introduced through modification of EUROPOEM. Dietary risk assessment for consumer was established with two methods, namely MOE approach for non-carcinogen and Q1* approach for carcinogen pesticides.

Standards and methods for efficacy/phytotoxicity assessment and test of pesticides

In concern of efficacy/phytotoxicity assessment standards, the test method which was added "integrated test method with usage and nature of pesticide" was notified for test result requirements for growth regulators. In application test standards and methods, revision was made in the contrast agrochemicals for different pests and pathogens, major investigation items, minimal ratio of 'untreated pathogenicity.' In addition, new standards and methods for "storage improvement after harvest" were established and notified.

Special review

The pesticides having an argument with safety or banned in use in OECD countries have been reviewed in accordance with PMA process. Pesticides reviewed are given as follows:

Pesticide quality analysis

To revise the Korean pesticide test guidelines internationally harmonized, many guidelines were collected and reviewed from other countries including US/EPA, EU, OECD and Japan. The result of reviewing collections found that there were many guidelines to be amended, which are stability test and degradation test of active substance, storage stability test and so on. Draft test guideline for physico-chemical properties of pesticide active ingredients was made.

To evaluate pesticide product qualities, 100 pesticide technical grade, 923 products in circulation, 131 products for registration trials, 117 products for registration and 28 products on civil petition were analyzed. 14 products of those were declared inadequate, new official analytical methods of newly-registration of 11 items (Simeconazole etc.) were fixed and the provisional KOPAC methods of Etofenprox etc. were modified. This laboratory has participated in the CIPAC collaborative study on Prallethrin analysis and IAEA Coordinated Research Project on elaboration of multi-analytical method for quality control of Isoprothiolane and IBP.

Impurities in TGAIs

TGAIs being used for pesticide formulations contain known or unknown toxicants due to the purity, PMA announced the recognized toxic impurities which might contaminate in the final pesticide products. All the formulators have to inform RDA of the qualitative data on the impurity in case they manufacture the pesticide products. All the formulators have to inform RDA of the qualitative data on the impurity in case they manufacture the pesticides using relevant TGAIs. The announced impurities are as below.

Re-formulating pesticide products with expired shelf-life on the market

Pesticide products on the market with expired shelf-life are being collected by formulators voluntarily, transported to their factory, and re-formulated in accordance with the physicochemical parameters of their registration profiles. A remarkable reduction of obsolete pesticides on the market was achievable by adopting this system.

Pesticide use survey

Pesticide usage survey was made on leaf vegetables growers and pesticide sellers. Input amounts per unit on leaf vegetables was surveyed as 3.91 kg/ha on cabbage of field cultivation, 2.93 on cabbage of greenhouse, 0.76 on lettuce, 0.55 on spinach, 1.34 on perilla leaf, 4.89 on leek and 0.42 kg/ha (with active ingredient) on young radish, respectively.

Survey on pesticide use pattern is being performed in a four year cycle; rice, orchard fruits, leafy vegetables and fruit vegetables. Annual input of pesticide in arable paddy rice was surveyed in 1999 and 2003. Korea Crop Protection Association (KCPA) publishes pesticide year book which contains extensive information; list of registered pesticides, imported and exported amount, produced and consumed amounts at factory's gate, etc. The survey on rice over the last two cycle revealed that the statistics of KCPA on rice was able to represent visiting survey on end-user's level with more than 90 percent of fitness; 5.4 kg of TGAI/ha in 2003. Hereafter, the indicator on rice will be provided with the production statistics.

Compliance education on pesticide safe use

In order to promote compliance through education activities, Pesticide Safety Division of NIAST supported other related organizations to conduct education for farmers, pesticides dealer and public servants regarding agricultural industry. PSD staffs participated in many education programs as lecturers.

Pesticide residual monitoring

In Korea, several organizations are being involved in the mission of residue monitoring as far as agricultural produces are concerned; National Institute of Agricultural Science and Technology (NIAST) in the field, National Agricultural Products Quality Management Service (NAPQMS) under MAF at farmer's gate, and KFDA at basket level. Monitoring activities of pesticides residues in/on agricultural crops in the field at harvest have been concentrated on rice, fresh vegetables and fruits. The surveyed average residue data showed that no violation was recorded in rice, very small portion (less than 1 percent) of violation in fruits, and still small portion (around 1 percent) of violation in vegetables. The monitored data on pesticide residue have been fed back to the farmer so that they are able to reference pesticide use calendar to produce listed on food chain of wholesale markets or department stores is being done to provide healthy and safe food supply. In case the produce violated the MRLs, the farmer is unable to list his/her produce on the market for a certain period of time. This voluntary surveillance system devoted in a greater extent to reduce dietary exposure caused by pesticide residues.

Generation of temporal maximum residue limit (MRL) and pre-harvest interval (PHI) of pesticides for ensuring safe agro-products

A total of temporal 252 MRLs involving 96 active ingredients in 41 agricultural crops were transferred to the Korean Food and Drug Administration (KFDA). The MRLs were established from the local residue data in/on the target crops and chronic toxicity data submitted from the pesticide manufacturers. Most MRLs were re-assessed in the Food Safety Committee under KFDA, in which almost all the MRLs has established as national ones. At the same time, 122 PHIs in 38 crops were notified by Rural Development Administration (RDA), which were generated from the dissipation data of the residue in/on the crop and from their MRLs.

Comments

Korea government has set the goal to reduce pesticide use by 50 percent during past two decades. Even through many other intensives have been provided to achieve the goal including IPM, government-driven introduction of biological based pesticides or natural enemies, most commonly practiced crop protection is being done by chemical pesticides. Furthermore, top ten pesticides from the total pesticide sales seizes upon about 50 percent. However, they are still used all over the world.

Agicultural vetinary chemicals management is another vacant area in the Republic since RDA is responsible for pesticides used in agriculture only. The government had several meeting to designate the responsible agency taking care of biocides or agvet chemicals. For the time being, each chemical is being managed in relevant organization.

Crop strengtheners or environmentally friendly crop protection agents are illegally on Korean market without registration, which resulted in crop damages for farmers including poor protection activities and relatively high costs. Quality control and assurance methodologies have to be established to reduce the damages as well as unpredictable risk to worker and environmental compartments.

QUESTIONNAIRE SUMMARY

Republic of Korea

Selected Country Statistics:

GDP = Gross Domestic Product; GNI = Gross National Income; Hunger = Population below minimum energy requirement; FAOSTAT = latest data entry between 1998 and 2002

Institutional Profile

Industry Associations: Korea Crop Protection Assoc.

Non-Governmental Associations: Consumers Korea

Questionnaire responses: Yes = Yes; - = No;? = don't know; (blank) = no answer