Description
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables the FDA to better protect public health by helping to ensure the safety and security of the food supply. It requires FDA to promulgate food safety rules that focus on preventing food safety issues rather than relying on detecting issues and reacting to them after they occur. FSMA recognizes that FDA has previously established a preventive control type regulation for fish and fishery products (Title 21, Code of Federal Regulations (21 CFR) part 123, the seafood HACCP regulation) based on the Hazard Analysis and Critical Control Point (HACCP) concept. See FSMA §§ 103(a), 103(f), 105(d), and 301 (§§ 418(j) and 805(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 350g(j), 350g note, 350h note, and 384a(e))). The seafood HACCP regulation requires seafood processors to identify food safety hazards that are reasonably likely to occur and to develop plans for the control of those hazards.
Scope & Applicability
Product Classes
3Product category subject to FDA HACCP regulations.; Presence, detection and growth of Listeria monocytogenes.
Sprouts in their raw or natural state
Subject to specific HACCP and FSVP exemptions.
Stakeholders
6Entities required to identify food safety hazards and develop control plans
IA regulation does not apply to a very small business
Entities required to comply with requirements for imported seafood products
Entity responsible for implementing HACCP and complying with part 117.
Person qualified to prepare translations
Must comply with registration if meeting facility/responsible person definitions
Identified Hazards
Hazards
3Risks addressed by food defense systems
Explicit regulatory text in Subpart B of part 117 addresses this
A type of chemical hazard that must be considered in hazard analysis.
Related CFR Sections (8)
- 21CFR123.12§ 123.12 Special requirements for imported products.
This section sets forth specific requirements for imported fish and fishery products.Read full regulation →
- 21CFR117.3§ 117.3 Definitions.
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this part. The following definitions also apply: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 →
- 21CFR117.4§ 117.4 Qualifications of individuals who manufacture, process, pack, or hold food.
(a) Applicability.Read 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 →
- 21CFR117.5§ 117.5 Exemptions.
(a) Except as provided by subpart E of this part , subparts C and G of this part do not apply to a qualified facility. Qualified facilities are subject to the modified requirements in § 117.201 .Read full regulation →
- 21CFR1.500§ 1.500 What definitions apply to this subpart?
The following definitions apply to words and phrases as they are used in this subpart. Other definitions of these terms may apply when they are used in other subparts of this part .Read full regulation →
- 21CFR1.501§ 1.501 To what foods do the requirements in this subpart apply?
(a) General. Except as specified otherwise in this section, the requirements in this subpart apply to all food imported or offered for import into the United States and to the importers of such food.Read full regulation →
Related Warning Letters (10)
- 2025-12-16
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Harbor Marine Product Inc.
- 2025-11-11
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Compass Group USA
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Gracie's Kitchens, Inc.
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Tan Nam Corporation
- 2025-09-09
Foreign Supplier Verification Program (FSVP)
Jalisco Fresh Produce, Inc.
- 2025-08-26
Foreign Supplier Verification Program (FSVP)
Eurobread Inc. dba First Harvest
- 2025-08-19
Seafood HACCP/CGMP for Foods/Adulterated
Chaohu Daxin Foodstuffs Co., Ltd.
- 2025-06-24
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Marin Baking LLC
- 2025-06-24
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Yongdae Hwangtae Union Corp Daeryung
See Also (8)
- CVM GFI #246 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program (Status: Draft)
- Guidance for Industry and FDA Staff: Model Accreditation Standards for Third-Party Certification Body Accreditation for Food Safety Audits (Status: Final)
- Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements Due to COVID-19 : Guidance for Industry (Status: Final)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Guidance for Industry: Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food Rule (Status: Final)
- CVM GFI #235 Current Good Manufacturing Practice Requirements for Food for Animals (Status: Final)
- Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-cut Produce (Status: Draft)