[切片] FDA OASIS Import Refusals — Filthy, Decomposed Substances & Foreign Matter (Animal Feed / Pet Food)

Topic Overview

Filthy, decomposed, or extraneous materials constitute one of the oldest and most common grounds for import refusal under Section 402(a)(3) of the FD&C Act. For animal feed and pet food — which often contain rendered proteins, dried fish, bone meal, and plant by-products — these charges reflect FDA's "appearance standard" under 21 U.S.C. § 381. A shipment can be refused based solely on how it looks, smells, or feels, without laboratory confirmation.

> ⚠️ Data Note: Built from official charge code taxonomy (ACT_SECTION_CHARGES.CSV). Live country-level refusal counts require Qlik Sense dashboard session. Charge code taxonomy is authoritative for violation types.

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1. The "Appearance Standard" Legal Basis

The FD&C Act's import refusal authority under 21 U.S.C. § 381 (Section 801) allows FDA to refuse admission to articles that appear to be adulterated, misbranded, or unapproved — before a laboratory confirms the violation. This "appearance standard" is critical for:

• Rapid border enforcement on visual/olfactory evidence
• Bulk commodities (feed ingredients, protein meals) where sampling every bag is impractical
• Products in transit that may degrade during shipping

Snippet from IRR portal (fda-irr-portal-20260721.html): > "The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions..."

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2. Core Charge Codes

FILTH — Filthy Substance (Cosmetic/Device/Food)

• Code: FILTH
• Basis: 501(a)(1) Adulteration
• Statement: "The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that the article contains a filthy, putrid, or decomposed substance."

FILTHY — Filthy Food (General)

• Code: FILTHY
• Basis: 402(a)(3), 801(a)(3); ADULTERATION
• Statement: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food."

OFF ODOR — Off-Odor Adulteration

• Code: OFF ODOR
• Basis: 402(a)(3), 801(a)(3); ADULTERATION
• Statement: "The article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food."

FOREIGN OB — Foreign Object

• Code: FOREIGN OB
• Basis: 402(a)(3), 801(a)(3); ADULTERATION
• Statement: "The article appears to consist in whole or in part of a filthy, putrid, or decomposed substance, or is otherwise unfit for food."

POSS N/STR — Potentially Filthy Substance

• Code: POSS N/STR
• Basis: 501(a)(1); 801(a)(3) ADULTERATION
• Statement: "The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially injurious substances."

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3. BSE-Context Charges

BSE FILTH — BSE-Context Filth

• Code: BSE FILTH
• Basis: 402(a)(3), 801(a)(3); ADULTERATION
• Statement: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be unfit for food."

BSE DRUGS — BSE-Context Drug/Feed

• Code: BSE DRUGS
• Basis: 501(a)(2)(A), 801(a)(1); ADULTERATION
• Statement: "The article is subject to refusal of admission pursuant to Section 801(a)(1) in that it appears to have been prepared, packed, or held under insanitary conditions..."

Note: BSE = Bovine Spongiform Encephalopathy. These codes specifically address feed/products from BSE-risk countries.

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4. Why These Charges Matter for Pet Food

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Source: ACT_SECTION_CHARGES-20260721.csv + imprefusals.htm