Description
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) (FSMA) enables the Food and Drug Administration (FDA or the Agency) 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 preventive control type regulations for juice (Title 21, Code of Federal Regulations (21 CFR) part 120, the Juice 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 juice HACCP regulation requires juice processors to identify food safety hazards that are reasonably likely to occur with the products they process [2] and to develop plans for the control of those hazards. In addition, the juice HACCP regulation requires importers of certain juice products to comply with requirements designed to help ensure that these imported products are processed in accordance with the juice HACCP regulation.
Scope & Applicability
Product Classes
2Product category subject to FDA HACCP regulations.
Product subject to HACCP and FSMA regulations
Stakeholders
6Entities required to identify food safety hazards and develop plans
persons affected by prior notice rules
Person qualified to prepare translations
Entity engaged in manufacturing, processing, packing, or holding juice; Entity subject to 21 CFR part 120
Must comply with registration if meeting facility/responsible person definitions
Entity growing produce that may be exempt from part 112
Regulatory Context
Attributes
1Condition determining if transportation regulation applies
Identified Hazards
Hazards
4chemical hazard under 21 CFR 117.130(b)(1)(ii)
Risks addressed by food defense systems
Risk associated with tattoo inks that can lead to infection.; Risk associated with insanitary conditions in tattoo ink preparation
Biological hazards reduced by commercial processing
Related CFR Sections (6)
- 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 →
- 21CFR117.4§ 117.4 Qualifications of individuals who manufacture, process, pack, or hold food.
(a) Applicability.Read full regulation →
- 21CFR120.13§ 120.13 Training.
(a) Only an individual who has met the requirements of paragraph (b) of this section shall be responsible for the following functions:Read full regulation →
- 21CFR120.7§ 120.7 Hazard analysis.
(a) Each processor shall develop, or have developed for it, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for each type of juice processed by that processor and to identify control measures that the processor can apply to control those hazaRead 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 →
- 21CFR112.2§ 112.2 What produce is not covered by this part?
(a) The following produce is not covered by this part:Read full regulation →
Related Warning Letters (10)
- 2025-11-11
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Compass Group USA
- 2025-10-28
Foreign Supplier Verification Program (FSVP)
V & L Produce, Inc.
- 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.
- 2025-07-15
Foreign Supplier Verification Program (FSVP)
A.D. Berries @ More LLC
- 2025-06-24
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Marin Baking LLC
See Also (8)
- Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (Status: Final)
- Guidance for Industry: Questions and Answers on Juice HACCP Regulation (Status: Final)
- Guidance for Industry: Exemptions from the Warning Label Requirement for Juice (Status: Final)
- Small Entity Compliance Guide: Juice HACCP (Status: Final)
- Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods (Status: Draft)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- 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)