Source: https://www.federalregister.gov/documents/2018/10/22/2018-23005/guide-to-minimize-food-safety-hazards-of-fresh-cut-produce-draft-guidance-for-industry-availability?utm_source=October+Updates+from+the+PSA&utm_campaign=PSA+August+2018+Updates&utm_medium=email
Timestamp: 2020-04-08 13:25:37
Document Index: 512326649

Matched Legal Cases: ['art 1', 'art 110', 'art 117', 'art 117', 'art 117', 'art 117', 'art 117']

Federal Register :: Guide To Minimize Food Safety Hazards of Fresh-Cut Produce: Draft Guidance for Industry; Availability
Guide To Minimize Food Safety Hazards of Fresh-Cut Produce: Draft Guidance for Industry; Availability
83 FR 53197
53197-53199 (3 pages)
Docket No. FDA-2018-D-3583
https://www.federalregister.gov/d/2018-23005 https://www.federalregister.gov/d/2018-23005
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled “Guide to Minimize Food Safety Hazards of Fresh-cut Produce.” The draft guidance, when finalized, will supersede a previous guidance, entitled “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,” that we issued in 2008. The draft guidance is intended to explain our current thinking on how to comply with recently modernized requirements for current good manufacturing practice (CGMP) and with new requirements for hazard analysis and risk-based preventive controls under our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” during the production of fresh-cut produce.
Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that Start Printed Page 53198identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
Instructions: All submissions received must include the Docket No. FDA-2018-D-3583 for “Guide to Minimize Food Safety Hazards of Fresh-cut Produce: Draft Guidance for Industry.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Submit written requests for single copies of the draft guidance to the Office of Food Safety, Division of Produce Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance.
Insook Son, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1648.
We are announcing the availability of a draft guidance for industry entitled “Guide to Minimize Food Safety Hazards of Fresh-cut Produce.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA 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 alternate approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public health by helping to ensure the safety and security of the food supply. FSMA enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production. Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act), by adding section 418 (21 U.S.C. 350g) with requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities under our regulations in 21 CFR part 1, subpart H, in accordance with section 415 of the FD&C Act (21 U.S.C. 350d).
In 2008, we issued a guidance for industry entitled “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables.” Fresh-cut fruits and vegetables mean any fresh fruit or vegetable or combination thereof that has been physically altered from its whole state after being harvested from the field (e.g., by chopping, dicing, peeling, ricing, shredding, slicing, spiralizing, or tearing) without additional processing (such as blanching or cooking). That guidance was intended for all fresh-cut produce processing firms to enhance the safety of fresh-cut produce by minimizing the microbial food safety hazards. It explained our thinking on how to comply with CGMP requirements that then were established in a regulation entitled “Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food” (21 CFR part 110).
In the Federal Register of September 17, 2015 (80 FR 55908), we published a final rule that, among other things, modernized the CGMP requirements and established them in new 21 CFR part 117 (part 117), entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” Part 117 also includes new requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities. The draft guidance that we are making available for public comment is intended to explain our current thinking on how all food establishments that produce fresh-cut produce can comply with the modernized CGMP requirements in part 117. The draft guidance also is intended to explain our current thinking on how fresh-cut produce food facilities that are subject to the new requirements for hazard analysis and risk-based preventive controls can comply with those requirements.
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Start Printed Page 53199Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 117 have been approved under OMB control number 0910-0751.