{"topic_id":"fda_oasis_refusals_chemical_contaminants_mycotoxins_histamine_2026","category":"us-2026","context":"---\ntopic_id: fda_oasis_refusals_chemical_contaminants_mycotoxins_histamine_2026\ncategory: us-2026\ntitle: \"[切片] FDA OASIS Import Refusals — Chemical Contaminants: Mycotoxins, Histamine & Toxic Substances (Animal Feed / Pet Food)\"\nlang: en\nsource: >\n  Official Charges CSV (2026-07-21): pdf-raw/us-approvals/ACT_SECTION_CHARGES-20260721.csv\n  Dashboard: https://datadashboard.fda.gov/oii/cd/imprefusals.htm\ndate_parsed: 2026-07-21\ntokens_estimated: 1000\nverification:\n  method: substring_match\n  claims_detail:\n    - {text: \"HISTAMINE charge code — 402(a)(1); poisonous/deleterious substance\", passed: true, source: \"ACT_SECTION_CHARGES-20260721.csv\"}\n    - {text: \"AFLATOXIN charge code — 402(a)(1); mycotoxin poisoning\", passed: true, source: \"ACT_SECTION_CHARGES-20260721.csv\"}\n    - {text: \"MYCOTOXIN charge code — 402(a)(1); poisonous/deleterious substance\", passed: true, source: \"ACT_SECTION_CHARGES-20260721.csv\"}\n    - {text: \"EXCESS SUL — excessive sulfites, 402(a)(1)\", passed: true, source: \"ACT_SECTION_CHARGES-20260721.csv\"}\n    - {text: \"PB-FOOD — poisonous/deleterious substance, 402(a)(1)\", passed: true, source: \"ACT_SECTION_CHARGES-20260721.csv\"}\n    - {text: \"Section 402(a)(1) = poisonous/deleterious substance rendering article injurious\", passed: true, source: \"ACT_SECTION_CHARGES-20260721.csv\"}\n    - {text: \"Dashboard covers FY2016–Present; weekly update\", passed: true, source: \"imprefusals.htm\"}\n  claims_total: 7\n  claims_passed: 7\n  date: 2026-07-21\n---\n\n## Topic Overview\n\n**Chemical contaminants** — including **mycotoxins** (aflatoxin, fumonisin, vomitoxin), **histamine** (scombroid poisoning), and other poisonous/deleterious substances — are charged under Section 402(a)(1) of the FD&C Act. These are laboratory-confirmed violations, distinct from visual/appearance-based charges. For pet food ingredients (grains, dried fish, protein meals), chemical contamination is a persistent supply-chain risk.\n\n> ⚠️ **Data Note**: Built from official charge code taxonomy. Live refusal counts by country require Qlik Sense dashboard session.\n\n---\n\n## 1. Histamine (`HISTAMINE`)\n\n**Charge Code**: `HISTAMINE`\n**Legal Basis**: Section 402(a)(1), 801(a)(3); **ADULTERATION**\n**Charge Statement** (verbatim from CSV):\n\n> \"The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily render it injurious to health.\"\n\n**Why It Matters for Pet Food**:\n- Histamine poisoning (\"scombroid poisoning\") occurs in **dark-meat fish** — tuna, mahi-mahi, mackerel, sardines — commonly used in pet food and fish jerky treats\n- Fish not properly refrigerated after catch rapidly produce histamine via bacterial decarboxylation\n- Dogs are particularly susceptible to histamine toxicity from spoiled fish products\n- FDA has a ** histamine action level** of 50 ppm for fish; any detectable elevated level triggers refusal\n\n**Snippet from official CSV**:\n```\nCODE: HISTAMINE\nSECTION: 402(a)(1), 801(a)(3); Adulteration\nTEXT: The article appears to bear or contain histamine, a poisonous and\n      deleterious substance in such quantity as ordinarily render it\n      injurious to health.\n```\n\n---\n\n## 2. Aflatoxin (`AFLATOXIN`)\n\n**Charge Code**: `AFLATOXIN`\n**Legal Basis**: Section 402(a)(1), 801(a)(3); **ADULTERATION**\n**Charge Statement** (verbatim from CSV):\n\n> \"The article appears to contain a mycotoxin, a poisonous and deleterious substance which may render it injurious to health.\"\n\n**Why It Matters for Pet Food**:\n- **Aflatoxin B1** — produced by *Aspergillus flavus/parasiticus* — is one of the most potent natural carcinogens known\n- Common in **corn, peanuts, cottonseed meal** — staple ingredients in many pet food formulations\n- Dogs are extremely sensitive to aflatoxin (2007 Diamond Pet Foods recall: 76 deaths from aflatoxin-contaminated corn)\n- FDA has **strict action levels**: total aflatoxins ≤ 20 ppb for human food; pet food follows same threshold\n\n**Snippet from official CSV**:\n```\nCODE: AFLATOXIN\nSECTION: 402(a)(1), 801(a)(3); ADULTERATION\nTEXT: The article appears to contain a mycotoxin, a poisonous and\n      deleterious substance which may render it injurious to health.\n```\n\n---\n\n## 3. General Mycotoxin (`MYCOTOXIN`)\n\n**Charge Code**: `MYCOTOXIN`\n**Legal Basis**: Section 402(a)(1), 801(a)(3); **ADULTERATION**\n**Charge Statement** (verbatim from CSV):\n\n> \"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous and deleterious substance...\"\n\n**Why It Matters**:\n- Covers the full mycotoxin family: **aflatoxins, ochratoxin A, fumonisins, T-2 toxin, vomitoxin (DON)**\n- Corn, wheat, barley, and rice by-products used in pet food are all mycotoxin-susceptible\n- Import refusals for mycotoxins often involve **corn gluten meal, DDGS (distillers grains), rice bran** from China, India, Brazil\n\n---\n\n## 4. Other Chemical Contaminant Charges\n\n### `EXCESS SUL` — Excessive Sulfites\n- **Code**: `EXCESS SUL`\n- **Basis**: 402(a)(1), 801(a)(3); **ADULTERATION**\n- **Statement**: \"The article appears to contain excessive sulfites, a poisonous and deleterious substance which may render it injurious to health.\"\n- **Pet food relevance**: Sulfites used as preservatives in dried fruits, shrimp; banned in pet foods containing meat\n\n### `PB-FOOD` — Poisonous/Deleterious Substance\n- **Code**: `PB-FOOD`\n- **Basis**: 402(a)(1); 801(a)(3); **ADULTERATION**\n- **Statement**: \"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance...\"\n\n---\n\n## 5. Regulatory Thresholds\n\n| Contaminant | Product | FDA Action Level / Tolerance |\n|---|---|---|\n| Aflatoxin B1 | Human food & pet food | ≤ 20 ppb total |\n| Histamine | Scombroid fish | ≥ 50 ppm (concern level) |\n| Ochratoxin A | Wheat, barley, raisins | ≤ 20 ppb |\n| Fumonisin B1+B2 | Corn | ≤ 2–4 ppm (varies by use) |\n| Sulfites | Various | Not permitted in meat/fish |\n\n---\n\n**Source**: `ACT_SECTION_CHARGES-20260721.csv`\n","sources":[],"tokens_estimated":1000,"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."}