JMPR 及び CCPR に関する勉強会 2013/8/23 残留農薬基準 (MRL)) の推定の実際 23 th Aug 消費 安全局農産安全管理課 農薬対策室入江真理 農薬使用基準 (GAP) 使用する作物 ( 作物群 ) ごとに以下を設定 1 使用量 ( 散布液濃度 散布量 ) k
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1 残留農薬基準 (MRL)) の推定の実際 23 th Aug 消費 安全局農産安全管理課 農薬対策室入江真理 農薬使用基準 (GAP) 使用する作物 ( 作物群 ) ごとに以下を設定 1 使用量 ( 散布液濃度 散布量 ) kg ai/ha = kg ai/l L/ha 2 使用回数 3 使用時期 ( 収穫前日数 :PHI 等 ) 4 使用方法 ( 散布 土壌処理 種子処理等 ) 1 1
2 Supervised trials on crops Formulation type の考え方 水で希釈する EC, WP, WG, SC, SL 種子処理 作物の発芽前使用( は種前 は種時処理等 ) 作物の発芽直後の使用 土壌処理( 畝間への散布等 ) では データを読み替えることができる 2 Supervised trials on crops 同じ使用量で同様な散布液量の比較試験 (JMPR data from 2000 to 2004) を解析 WP, EC, CS, SC の散布後 0 日の残留濃度に大きな差がない (PHI 7 日以内も解析 ) Maclachlan and Hamilton (2010) 生育中期 後期に散布 ( 水で希釈する製剤 ) する WG, SC 等の有機溶媒を含まない製剤間 EC, OD 等の有機溶媒を含む製剤間で残留濃度は同等と考える 3 2
3 Supervised trials on crops Form kg ai/ha kg ai/hl L/ha No. PHI (days) WP Residue (mg/kg) SL <0.01 SC * WP WG *before last application < , 0.28 mean , 0.07 mean , 0.09 mean Proportionality Supervised trials on crops Field trial の考え方 同一圃場 ( 大規模でも ) 内で application rate が同じでも spray concentration/ volume が異なる試験を実施した場合 異なる製剤で試験を実施した場合 高い方の残留濃度を使う 5 3
4 Supervised trials on crops Trial site Form kg ai/ha kg ai/hl L/ha No. PHI (days) Residue (mg/kg) WP USA, 2011 WP King City/CA* USA, 2011 King City/CA* WP USA, 2011 SL King City/CA* 3 7 *different plots in the same trial site OECD calculator 統計学を基にしたMRL 算出法 EU method と NAFTA method が存在 EU method は Europe で長年使われてきた NAFTA methodは近年に開発され EU methodほどは使われていなかった 両 methodの短所が指摘されていた 2008 年 OECD RCEG (the Residue Chemistry Expert Group) 行政当局と産業界の統計の専門家を集めて 新しい MRL 算出方法の開発を開始 7 4
5 OECD calculator 原則 統計学的な方法であること ユーザーが統計学の深い知識を持たなくても使えるようシンプルであること 分布の形にとらわれないこと 作物残留試験で得られたほとんどのデータセットから 明確にMRLを提案できること できる限り EU 及びNAFTAの方法と調和すること 8 OECD calculator 原則として Highest residueより低い値を算出しない 残留濃度分布の95パーセンタイル付近を MRLとして算出する ほとんどのデータセットに対して 95パーセンタイル値を過大に算出する傾向にある データに <LOQが多い場合は エキスパートジャッジの重要性が高まる 9 5
6 OECD calculator 3~7 例の残留データは データが少ないため MRL 算出の不確実性が高い High uncertainty of MRL estimate. [Small dataset] 8 例の残留データで MRL 算出の失敗率 (MRLが95パーセンタイル以下になる可能性 ) が約 25% になる 10 OECD calculator 残留データの 50% 以上が <LOQ であると MRL 算出の不確実性が高い High uncertainty of MRL estimate. [High level of censoring] 全データが <LOQ である場合と少なくとも 1 つが >LOQ である場合を区別する 11 6
7 OECD calculator 1 つでも有限値がある場合 Highest residue Mean + 4*SD 3*Mean*CF のうちの最大値を丸めて MRLとする 12 JMPR に提出された作物残留試験の例数 13 7
8 OECD calculator の原理 ( 事例 ) 同じ平均値のデータセット OECD calculator (n=6) 0.06, 0.15, 0.17, 0.19, 0.32, 1.2 Mean = 0.35, SD = , 0.28, 0.30, 0.35, 0.43, 0.52 Mean = 0.35, SD = OECD calculator の原理 ( 事例 ) 同じ最大値及び最小値のデータセット OECD calculator (n=6) 0.06, 0.15, 0.17, 0.19, 0.32, 1.2 Mean = 0.35, SD = , 0.24, 0.32, 0.78, 0.96, 1.2 Mean = 0.59, SD =
9 ( 事例 )2 例のデータセット 我が国で採用している算定法 0.09, 平均値 : , 平均値 : , 平均値 : , 平均値 : 最大値のみを算定根拠にすると 濃度分布が考慮されず 最大値が同じであれば 同じ基準値同じ基準値となる 平均値を算定根拠にすると 2 例の値の差が大きいほど基準値が小さくなる 16 作物残留データの実例 ( 日本 ) X 農薬 10%SC 非結球レタス ( 平成 16 年 17 年 ) 1/2000, L/10a ( kgai/ha) 2 回, 収穫 3 日前 (PHI: 3 days), 散布 17 9
10 作物残留データの実例 ( 日本 ) リーフレタス ( サニーレタス ) Lettuce, Leaf 2.84, 5.66, 6.14, 11.0 サラダ菜 ( 玉チシャ ( バターヘッド型 )) Lettuce, Head 4.38, 4.88, 7.58, 作物残留データの実例 ( 日本 ) リーフレタス ( サニーレタス ) 2.84, 5.66, 6.14, 11.0 残留農薬基準 :15(6.82<x<11.1) サラダ菜 ( 玉チシャ ( バターヘッド型 )) 4.38, 4.88, 7.58, 11.6 残留農薬基準 :20(11.1<x<16.1) 19 10
11 Chlorfenapyr Lettuce, Leaf Japan 3 days Total number of data (n) 4 Percentage of censored data 0% Number of non-censored data 4 Lowest residue Highest residue Median residue Mean Standard deviation (SD) Correction factor for censoring (CF) Proposed MRL estimate - Highest residue Mean + 4 SD CF x 3 Mean Unrounded MRL Rounded MRL 20 High uncertainty of MRL estimate. [Small dataset] Calculated by Mr. Ikeda 20 Chlorfenapyr Lettuce, Head Japan 3 days Total number of data (n) 4 Percentage of censored data 0% Number of non-censored data 4 Lowest residue Highest residue Median residue Mean Standard deviation (SD) Correction factor for censoring (CF) Proposed MRL estimate - Highest residue Mean + 4 SD CF x 3 Mean Unrounded MRL Rounded MRL 30 High uncertainty of MRL estimate. [Small dataset] Calculated by Mr. Ikeda 21 11
12 作物残留データの実例 ( 日本 ) Y 農薬 15%EC トマト ( 平成 9 年 12 年 ) 1/1000, L/10a ( kg ai/ha) ミニトマト ( 平成 17 年 ) 1/2000, 200 L/10a (0.15 kg ai/ha) 2 回, 収穫 1 日前 (PHI: 1 day), 散布 22 作物残留データの実例 ( 日本 ) トマト Tomato 0.34, 0.42, 0.48, 0.73 残留農薬基準 :2 ミニトマト Cherry tomato 0.42, 0.5, 0.5, 1.1 残留農薬基準 :2 (0.595<x<1.19) 23 12
![5 High uncertainty of MRL estimate. [Small dataset] Calculated by Mr.](/docs-images/97/133622609/images/13-1.jpg "Ikeda 24 Tolfenpyrad Cherry tomato Japan 1 day Total number of data (n) 4 Percentage of censored data 0% Number of non-censored data 4 Lowest residue 0.420 Highest residue 1.100 Median residue 0.")
13 Tolfenpyrad Tomato Japan 1 day Total number of data (n) 4 Percentage of censored data 0% Number of non-censored data 4 Lowest residue Highest residue Median residue Mean Standard deviation (SD) Correction factor for censoring (CF) Proposed MRL estimate - Highest residue Mean + 4 SD CF x 3 Mean Unrounded MRL Rounded MRL 1.5 High uncertainty of MRL estimate. [Small dataset] Calculated by Mr. Ikeda 24 Tolfenpyrad Cherry tomato Japan 1 day Total number of data (n) 4 Percentage of censored data 0% Number of non-censored data 4 Lowest residue Highest residue Median residue Mean Standard deviation (SD) Correction factor for censoring (CF) Proposed MRL estimate - Highest residue Mean + 4 SD CF x 3 Mean Unrounded MRL Rounded MRL 2 High uncertainty of MRL estimate. [Small dataset] Calculated by Mr. Ikeda 25 13
14 作物残留データの実例 ( 日本 ) 葉しょうが EC 0.2 g/l, 3 回, PHI 7 日 0.34, 0.20 (H16) , 0.18 (H23) 必要な残留基準値従来の方法 :3 OECD calculator:4 26 Proportionality Concept for estimation of MRLs 作物残留試験の Application rate が 登録されたGAPに対して ±25% 以上の違いがあっても GAP rateと Application rateの割合で 実際に検出された残留濃度を補正するもの Scaled residue = Measured residue (GAP rate / Trial application rate) 27 14
15 Proportionality Concept for estimation of MRLs JMPR に提出された作物残留データのうち 1146 side-by-side trialsから解析 (MacLachlan and Hamilton, 2011) 900 以上のti trials(2306 side-by-side datasets) を加え 再解析 (2012) 28 Principle and Guidance Active substances confirmed included insecticides, fungicides, herbicides, and plant regulators, except desiccants. Use of the concept confirmed for soil, seed and foliar treatments. Proportionality cannot be used for post-harvest and hydroponic situations
16 Principle and Guidance Can be used on data from field trials within a rate range between 0.3 and 4 GAP rate. If there are no quantifiable residues (<LOQ), residue concentrations may only be scaled down. Scaling is only acceptable if application rate is the only deviation from cgap. 30 Principle and Guidance Variation associated with the residue values using this approach may be considered to using data selected by using the ±25% rule for rate. The concept may be applied to both major and minor crops. Processing factors can be used for scaled datasets
17 Principle and Guidance If scaling is applied on representative crops, there is no identified concern with extrapolation to other members of an entire crop group or subgroup. With respect to exposure assessments, no restrictions appear to be necessary. Scaled datasets for feeds may be used for dietary burden calculations for livestock. 32 Principle and Guidance The approach may be used where the dataset is otherwise insufficient to make an MRL recommendation. In some cases MRLs may be estimated from trials where 100% of the data may have been scaled
18 ( 事例 ) ヘキシチアゾクスのイチゴへの MRL 案 (2011 年 JMPR) Proportionalityを適用しない場合 Proportionalityを適用した場合 cgapに基づき実施された作物残 9 例の作物残留テ ータを用留テ ータの数 (5 例 ) が不十分でMRL いて MRL 案 :6 mg/kgを勧告案を勧告できず cgap ( 国 ) 0.21 kg/ha 1 回収穫 3 日前まで ( 米国 ) 農薬投下量 (kg/ha) cgap の農薬投下量 / 作物残留試験の農薬投下量 作物残留データ (mg/kg) Without Proportionality With Proportionality MRL 案 (mg/kg) Without Proportionality ( データ不十 分で勧告できず ) 米国 GAP の ±25% With Proportionality 6 34 使用量の比較 日本は低濃度大量散布で 欧米は高濃度少量散布か? (A 農薬の例 ) りんご日本 :20%SG(SP) 1/2000~ ~0.01% (kg ai/hl) 200~700 L/10a 0.1~0.7 kg ai/ha 米国 :SG, WP kg ai/ha % (kg ai/hl) ( 主に %) 35 18
19 使用量の比較 日本は低濃度大量散布で 欧米は高濃度少量散布か? (A 農薬の例 ) かんきつ日本 :20%SG(SP) 1/2000~ ~0.01% (kg ai/hl) 200~700 L/10a 0.1~0.7 kg ai/ha イタリア :SP % (kg ai/hl) 0.1 kg ai/ha スペイン :SP % (kg ai/hl) 0.1 kg ai/ha 36 残留濃度の比較 日本の残留濃度は 欧米より低い? (B 農薬の例 ) きゅうり ( 施設栽培 )PHI 3days EU(0.025 kg ai/hl, 0.25 kg ai/ha): <0.01, <0.01, 0.04, 0.04, 0.06( 英国 ), 0.03, 0.09, 0.10( フランス ), 0.04( イタリア ),, 0.03, 0.03, 0.03( スペイン ) 豪州 (0.026 kg ai/hl):0.11, 0.14 日本 (0.020 kg ai/hl, 0.60 kg ai/ha): 0.07,
20 1 日本とオーストラリアは残留濃度が高いが 2 trials なので EUのデータで Maximum residue level が算出された 2 日本は散布濃度を使用基準として規制しているが 散布液量が多いため 単位面積当たりの ai 投下量が高くなり 残留濃度が高くなる可能性がある 38 20
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