Description
This guidance is intended to provide recommendations for collecting a representative sample for testing when fish and fishery products are subject to detention without physical examination (DWPE) due to the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition. This guidance is also intended to help foreign manufacturers and other processors of fish and fishery products subject to DWPE under an import alert (IA) to introduce evidence to FDA to support a request to have products removed from DWPE. This guidance does not apply to seafood-related import alerts when sampling and testing is not relevant to securing release of individual shipments or removal from DWPE.
Scope & Applicability
Product Classes
5The primary product category covered by the sampling recommendations.; Products subject to detention without physical examination; Subject to detention without physical examination (DWPE)
Specific fishery product listed in Appendix B
Specific fishery product listed in Appendix B
Specific category of fish subject to higher confidence levels for decomposition
Category including catfish, tra, swai, and basa, which are excluded from this guidance.
Stakeholders
4Entity that may request removal from DWPE.; Entity requesting removal from DWPE
The party receiving the imported goods, responsible for submitting evidence.
Laboratories accredited under the Laboratory Accreditation for Analyses of Foods program.
The individual or entity responsible for collecting the sample units.
Regulatory Context
Attributes
5A characteristic of sampling required to ensure statistical confidence.
Level of confidence for decomposition in non-scombrotoxin-forming products
Methods that provide a level of confidence such as a 95% confidence of detecting L. monocytogenes.
Recommended weight of product per sample unit
Identifier used to group products with the same history of exposures.
Identified Hazards
Hazards
6Adulteration link that triggers DWPE.
Basis for sampling recommendations to detect adulteration
Microbiological hazard causing adulteration; Sampling recommendations for detecting contamination
Adulteration link that triggers DWPE.
Also known as histamine; a hazard in fish products.; Safety hazard in fishery products; Histamine contamination in fishery products
A condition leading to the appearance of adulteration.
Related CFR Sections (5)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR1.94§ 1.94 Hearing on refusal of admission or destruction.
(a) If it appears that the article may be subject to refusal of admission or that the article is a drug or device that may be subject to destruction under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the division director shall give the owner or consignee a written or electronic noticRead full regulation →
- 21CFR1.1107§ 1.1107 When must food testing be conducted under this subpart?
(a) Food testing must be conducted under this subpart whenever such testing is conducted by or on behalf of an owner or consignee:Read full regulation →
- 21CFR1.1149§ 1.1149 What oversight standards apply to sampling?
(a) Documents. Before analyzing a sample, the LAAF-accredited laboratory must develop (if it collected the sample) or obtain (if another firm collected the sample) the following information to be submitted with test results (see § 1.1152(c) ):Read full regulation →
- 21CFR1.1152§ 1.1152 What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA?
(a) General requirements.Read full regulation →
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (Status: Final)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (Status: Final)
- CPG Sec. 400.900 Class I Recalls of Prescription Drugs (Status: Final)
- CPG Sec. 454.100 OTC Ear Drop Preparations (Status: Final)
- CPG Sec. 430.300 Labeling Shipping Containers of Drugs (Status: Final)
- CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims (Status: Final)