[切片] FDA OASIS Import Refusals — Chemical Contaminants: Mycotoxins, Histamine & Toxic Substances (Animal Feed / Pet Food)

Topic Overview

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.

> ⚠️ Data Note: Built from official charge code taxonomy. Live refusal counts by country require Qlik Sense dashboard session.

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1. Histamine (HISTAMINE)

Charge Code: HISTAMINE Legal Basis: Section 402(a)(1), 801(a)(3); ADULTERATION Charge Statement (verbatim from CSV):

> "The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily render it injurious to health."

Why It Matters for Pet Food:

• Histamine poisoning ("scombroid poisoning") occurs in dark-meat fish — tuna, mahi-mahi, mackerel, sardines — commonly used in pet food and fish jerky treats
• Fish not properly refrigerated after catch rapidly produce histamine via bacterial decarboxylation
• Dogs are particularly susceptible to histamine toxicity from spoiled fish products
• FDA has a histamine action level of 50 ppm for fish; any detectable elevated level triggers refusal

Snippet from official CSV: `` CODE: HISTAMINE SECTION: 402(a)(1), 801(a)(3); Adulteration TEXT: The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily render it injurious to health. ``

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2. Aflatoxin (AFLATOXIN)

Charge Code: AFLATOXIN Legal Basis: Section 402(a)(1), 801(a)(3); ADULTERATION Charge Statement (verbatim from CSV):

> "The article appears to contain a mycotoxin, a poisonous and deleterious substance which may render it injurious to health."

Why It Matters for Pet Food:

• Aflatoxin B1 — produced by *Aspergillus flavus/parasiticus* — is one of the most potent natural carcinogens known
• Common in corn, peanuts, cottonseed meal — staple ingredients in many pet food formulations
• Dogs are extremely sensitive to aflatoxin (2007 Diamond Pet Foods recall: 76 deaths from aflatoxin-contaminated corn)
• FDA has strict action levels: total aflatoxins ≤ 20 ppb for human food; pet food follows same threshold

Snippet from official CSV: `` CODE: AFLATOXIN SECTION: 402(a)(1), 801(a)(3); ADULTERATION TEXT: The article appears to contain a mycotoxin, a poisonous and deleterious substance which may render it injurious to health. ``

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3. General Mycotoxin (MYCOTOXIN)

Charge Code: MYCOTOXIN Legal Basis: Section 402(a)(1), 801(a)(3); ADULTERATION Charge Statement (verbatim from CSV):

> "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..."

Why It Matters:

• Covers the full mycotoxin family: aflatoxins, ochratoxin A, fumonisins, T-2 toxin, vomitoxin (DON)
• Corn, wheat, barley, and rice by-products used in pet food are all mycotoxin-susceptible
• Import refusals for mycotoxins often involve corn gluten meal, DDGS (distillers grains), rice bran from China, India, Brazil

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4. Other Chemical Contaminant Charges

EXCESS SUL — Excessive Sulfites

• Code: EXCESS SUL
• Basis: 402(a)(1), 801(a)(3); ADULTERATION
• Statement: "The article appears to contain excessive sulfites, a poisonous and deleterious substance which may render it injurious to health."
• Pet food relevance: Sulfites used as preservatives in dried fruits, shrimp; banned in pet foods containing meat

PB-FOOD — Poisonous/Deleterious Substance

• Code: PB-FOOD
• Basis: 402(a)(1); 801(a)(3); ADULTERATION
• 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..."

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5. Regulatory Thresholds

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Source: ACT_SECTION_CHARGES-20260721.csv