Source: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm569727.htm
Timestamp: 2017-09-23 02:18:02
Document Index: 267893407

Matched Legal Cases: ['art 120', '§ 103', '§ 418', '§ 350', 'art 113', 'art 113', 'art 120', 'art 112']

Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act
Download the Guidance (PDF: 139KB)
Guidance for Industry: The Juice HACCP Regulation - Questions and Answers
Submit electronic comments on http://www.regulations.gov to docket number FDA-2017-D-3176.
All comments should be identified with the docket number FDA-2017-D-3176.
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 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.
Importantly, several of the regulations that FDA has issued under FSMA provide exemptions that are related to the juice HACCP regulation. This guidance addresses those exemptions, and also provides information about the juice HACCP regulation in connection with the FSMA regulations.
Though not the subject of this guidance, we also note that some juice products are also subject to 21 CFR part 113 (Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers). Certain FSMA regulations provide additional exemptions related to part 113.
This guidance summarizes how the following FSMA regulations affect processors and importers covered under 21 CFR part 120, the Juice HACCP regulation:
21 CFR part 112, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (the Produce Safety Regulation)
21 CFR 1, subpart O, Sanitary Transportation of Human and Animal Food (the ST Regulation).
Chapter 2: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Chapter 4: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
Chapter 5: Mitigation Strategies to Protect Food Against Intentional Adulteration
Chapter 6: Sanitary Transportation of Human and Animal Food
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact FDA’s Technical Assistance Network by submitting the form available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm459719.htm.