Scope & Applicability
Product Classes
10Fish species prone to histamine development
Foods that consumers eat without cooking; fresh-cut produce is typically considered ready-to-eat; RTE foods that do not require further processing for safety
Shorthand description for thermally processed low-acid foods packaged in hermetically sealed containers.
Not covered by the NSSP but covered by LACF regulations
Food product subject to standard of identity revisions
Subject to both HACCP and LACF regulations; Subject to HACCP for hazards other than Clostridium botulinum.; LACF reference in index
Included in the regulatory definition of fish
Products requiring strict temperature control during transport
The primary product category covered by the sampling recommendations.; Products subject to detention without physical examination; Subject to detention without physical examination (DWPE)
Subject to special requirements under 123.20 and 123.28; Specific product category for targeted training; Existing MOUs for these products fulfill HACCP requirements.; Subject to specific controls under 21 CFR 123.20 and 123.28; Specific category with unique regulatory requirements; Testing frequency for molluscan shellfish
Stakeholders
10An establishment that performs processing steps on ACTPs.
Temporary storage by fisherman
entity that may remove tags during processing
entity subject to sanitary transportation regulation
Entity being verified by the importer; entity whose HACCP program is reviewed for inadequacies; Non-domestic entity required to have a HACCP plan
Not subject to HACCP regulations unless they meet the definition of importer.
Person qualified to perform hazard analysis and record review
entity receiving product from a primary processor
entity responsible for controlling sulfite hazards
Subject to regulation if they process seafood
Regulatory Context
Attributes
3determines if a product is subject to seafood HACCP
Criteria for smoked, vacuum packed product
Critical limit for fully cooked products
Identified Hazards
Hazards
10Hazard requiring control in scombroid species; Hazard in scombroid species resulting from temperature abuse; Hazard resulting from time/temperature abuse; Chemical hazard associated with scombrotoxic fish
Hazard control for scombrotoxic fish
Paralytic Shellfish Poisoning hazard in lobster and shellfish
Controls for Clostridium botulinum in vacuum packed raw fish
focus of inspection to prevent occurrence
pathogens that must be eliminated by heat treatment
Environmental hazard in imported products
Toxin production in products held at room temperature; Pathogen capable of toxin formation; Enterotoxigenicity of strains isolated from ready-to-eat foods.; Production of extracellular compounds and behavior in foods; Predictive modeling of growth of Staphylococcus aureus
Chemical hazard to be considered in shrimp hazard analysis
Toxin hazard in certain produce like mushrooms
Related CFR Sections (10)
- 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 →
- 21CFR123.12§ 123.12 Special requirements for imported products.
This section sets forth specific requirements for imported fish and fishery products.Read full regulation →
- 21CFR123.10§ 123.10 Training.
At a minimum, the following functions shall be performed by an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing at least equivalent to that received under standardized curriculum recognized as adequate by the U.S. Food aRead full regulation →
- 21CFR123.8§ 123.8 Verification.
(a) Overall verification. Every processor shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, and that the plan is being effectively implemented. Verification shall include, at a minimum:Read full regulation →
- 21CFR123.9§ 123.9 Records.
(a) General requirements. All records required by this part shall include:Read full regulation →
- 21CFR123.7§ 123.7 Corrective actions.
(a) Whenever a deviation from a critical limit occurs, a processor shall take corrective action either by: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 →
- 21CFR123.5§ 123.5 Current good manufacturing practice.
(a) Except as provided by § 117.5(b) , parts 110 and 117 of this chapter apply in determining whether the facilities, methods, practices, and controls used to process fish and fishery products are safe, and whether these products have been processed under sanitary conditions.Read full regulation →
- 21CFR123.6§ 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.
(a) Hazard analysis. Every processor shall conduct, or have conducted for it, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product processed by that processor and to identify the preventive measures that thRead full regulation →
- 21CFR123.11§ 123.11 Sanitation control procedures.
(a) Sanitation SOP. Each processor should have and implement a written sanitation standard operating procedure (herein referred to as SSOP) or similar document that is specific to each location where fish and fishery products are produced. The SSOP should specify how the processor will meet those saRead full regulation →
Related Warning Letters (10)
- 2025-12-16
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Harbor Marine Product Inc.
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-08-19
Seafood HACCP/CGMP for Foods/Adulterated
Chaohu Daxin Foodstuffs Co., Ltd.
- 2025-06-24
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Yongdae Hwangtae Union Corp Daeryung
- 2025-06-03
Low Acid Canned Food Regulation/Adulterated
United King Foods Private Limited
- 2025-05-27
Seafood HACCP/CGMP for Foods/Adulterated
Rey de los Camarones S. A.
- 2025-05-27
Seafood HACCP/CGMP for Foods/Adulterated
Reunipeche SAS
- 2025-05-21
Low Acid Canned Food Regulation/Adulterated
Baldwin Richardson Foods Pennsauken, LLC
- 2025-05-20
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Yeshua Bendito, C.A.
- 2025-05-20
Low Acid Canned Food Regulation/Adulterated
Chongqing Tianrun Food Development Co., Ltd
See Also (8)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods (Status: Draft)
- Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling (Edition 5) (Status: Final)
- CPG Sec 540.525 Scombrotoxin (Histamine)-forming Fish and Fishery Products – Decomposition and Histamine (CPG 7108.24) (Status: Final)
- Small Entity Compliance Guide: Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation (Status: Final)
- CPG Sec 555.250 DRAFT: Major Food Allergen Labeling and Cross-contact (Status: Draft)
- FDA Oversight of Food Covered by Systems Recognition Arrangements (Status: Final)
- Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization Act (Status: Final)