{"topic_id":"cn_gb_ade_crossref_enrofloxacin","category":"cn-vet-drug-ade-crossref","context":"---\ntopic_id: cn_gb_ade_crossref_enrofloxacin\ncategory: cn-vet-drug-ade-crossref\ntitle: \"GB 31650-2019 MRL × FDA ADE：恩诺沙星（Enrofloxacin）\"\nlang: en\nsource: \"GB 31650-2019 食品安全国家标准 食品中兽药最大残留限量 (first-hand national standard text, landed) + openFDA animalandveterinary/event.json (FDA CVM ADE)\"\nsource_file: pdf-parsed/cn_gb31650_ade_2026-08-16.json\ndate_parsed: 2026-08-16\ntokens_estimated: 360\nverification:\n  method: derived_from_dataset\n  claims: 20\n  note: \"GB 31650-2019 MRL / zero-tolerance facts (drug name, table reference where asserted, and each tissue-value pair) are verbatim (whitespace-normalized) substrings of the landed source text (pdf-raw/vet-drug-mrl/cn_gb31650.txt). The OpenFDA ADE report count(s) are report-level aggregates from the cited openFDA JSON; not verbatim substring, not additive, not causation. Active-ingredient→OpenFDA term mapping is editorial.\"\n  date: 2026-08-16\ncitation:\n  authority: \"SAMR/MOA GB 31650-2019 (PRC national food-safety standard) + US FDA CVM (openFDA)\"\n  title: \"GB 31650-2019 MRL × FDA ADE：恩诺沙星（Enrofloxacin）\"\n  url: \"\"\n  retrieved: \"2026-08-16\"\n  ref: \"pdf-raw/vet-drug-mrl/cn_gb31650.txt\"\n  doc_type: \"government regulation (national standard) + open dataset (JSON API)\"\n  needs_review: true\nauthority_tier: T1\nauthority_tier_basis: \"T1:gov+cn\"\nauthority_tier_date: 2026-08-16\n---\n\n# GB 31650-2019 MRL × FDA ADE：恩诺沙星（Enrofloxacin）\n\nCross-reference between China's veterinary-drug residue limit standard (GB 31650-2019, 食品中兽药最大残留限量) and the US FDA CVM adverse-event (ADE) report database (openFDA `animalandveterinary/event.json`). This is a **structural link, not a clinical assertion**.\n\n## MRL entry (GB 31650-2019, first-hand national standard text)\n\n- **恩诺沙星（Enrofloxacin）** — 兽药分类: 喹诺酮类合成抗菌药\n- MRL table: 表41（应符合表41的规定）\n- Residue limits (靶组织 残留限量, μg/kg), verbatim from source:\n  - 脂肪100\n  - 肝300\n  - 肾200\n  - 奶100\n  - 肌肉100\n  - 脂肪100\n  - 肝200\n  - 肾300\n  - 肌肉100\n  - 皮＋脂100\n  - 肝200\n  - 肾300\n  - 肌肉100\n  - 脂肪100\n  - 肝200\n  - 肾200\n  - 皮+肉100\n- *The drug name and each (tissue, value) pair are verbatim (whitespace-normalized) substrings of the landed GB 31650-2019 source text `pdf-raw/vet-drug-mrl/cn_gb31650.txt`; the table reference above is likewise verbatim.*\n\n## OpenFDA ADE cross-reference\n\n- OpenFDA ADE 报告数（enrofloxacin）：**8828**（截至 2026-08-16，openFDA animalandveterinary/event.json 中以“enrofloxacin”为活性成分检出的不良事件报告总数，报告级聚合）。\n\n对应站内 FDA ADE topic：\n  - [enrofloxacin → ade_enrofloxacin_adverse_events](../../ade/ade_enrofloxacin_adverse_events/01_enrofloxacin.md)\n\n## Honest scope note\n\nGB 31650-2019 is a **food** (residue-limit) standard, not a feed-additive standard — it governs residues in animal-derived *food* (meat, liver, kidney, fat, milk, egg). Its pet-food relevance is indirect: animal-origin pet-food ingredients (meat meal, poultry by-product, fish, egg, dairy) must comply. The ADE count reflects US spontaneous-reporting volume, not incidence or per-animal risk, and may not include China-specific products or trade names. Active-ingredient→OpenFDA term mapping is editorial; a `0` or low count may reflect openFDA ingredient naming rather than true absence of reports. Source: GB 31650-2019 source text `cn_gb31650.txt` + openFDA slice `cn_gb31650_ade_2026-08-16.json` (both pulled 2026-08-16).\n","sources":["cn-vet-drug-ade-crossref — GB 31650-2019 MRL × FDA ADE：恩诺沙星（Enrofloxacin） (retrieved 2026-08-16)"],"source":{"authority":"cn-vet-drug-ade-crossref","title":"GB 31650-2019 MRL × FDA ADE：恩诺沙星（Enrofloxacin）","url":"","retrieved":"2026-08-16","ref":"","doc_type":"open dataset (JSON API)","source_document":"","verification_file":"pdf-parsed/cn_gb31650_ade_2026-08-16.json"},"source_document":"","source_file":"pdf-parsed/cn_gb31650_ade_2026-08-16.json","trust":{"authority_tier":"T1","fidelity":"verbatim","license":null,"display_grade":"A"},"tokens_estimated":360,"generated_at":null,"tip":"Use /api/v1/topics to discover more topics. /api/v1/nutrient for precise single-point queries. /api/v1/cross_compare for 2-3 standard comparisons."}