Description
This guidance is intended to clarify steps that owners of fish and fishery products, or their representatives, can take to segregate non-violative products from products adulterated with pathogens, unlawful animal drugs, scombrotoxin (histamine), and decomposition, to demonstrate compliance with the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Specifically, this document provides guidance for reconditioning by:
Scope & Applicability
Product Classes
1The primary product category covered by the sampling recommendations.; Products subject to detention without physical examination; Subject to detention without physical examination (DWPE)
Stakeholders
3Person whose actions may cause a product to be deemed adulterated
An establishment that performs processing steps on ACTPs.
FDA official handling seizures or import notices
Regulatory Context
Attributes
2Attribute used to identify and segregate portions of an article
Statistical parameter for detecting health risk adulterants
Identified Hazards
Hazards
4Microbiological hazard causing adulteration; Sampling recommendations for detecting contamination
Adulterant mentioned as a cause for reconditioning.
A condition leading to the appearance of adulteration.
Also known as histamine; a hazard in fish products.; Safety hazard in fishery products; Histamine contamination in fishery products
Related CFR Sections (3)
- 21CFR1.95§ 1.95 Application for authorization to relabel and recondition.
Application for authorization to relabel or perform other action to bring the article into compliance with the Federal Food, Drug, and Cosmetic Act or to render it other than a food, drug, device, or cosmetic may be filed only by the owner or consignee, and shall:Read full regulation →
- 21CFR1.96§ 1.96 Granting of authorization to relabel and recondition.
(a) When authorization of a proposal under § 1.95 is granted by the division director, the applicant shall be notified of authorization, in writing, which may include:Read full regulation →
- 21CFR123.3§ 123.3 Definitions.
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) and in parts 110 and 117 of this chapter are applicable to such terms when used in this part, except that the definitions and terms in parts 110 and 117 do not govern such terms where suRead full regulation →
See Also (4)
- Pre-Launch Activities Importation Requests (PLAIR): Guidance for Industry (Status: Final)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Guidance for Industry: Questions and Answers on HACCP Regulation for Fish and Fishery Products (Status: Final)
- Guidance for Industry: Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products (Status: Final)