Source: https://www.federalregister.gov/documents/2018/01/05/2018-00050/policy-regarding-certain-entities-subject-to-the-current-good-manufacturing-practice-and-preventive
Timestamp: 2019-10-17 21:12:52
Document Index: 544753795

Matched Legal Cases: ['§\u200910', 'art 117', 'art 507', 'art 112', 'art 117', 'art 507', 'art 117', 'art 507', 'art 117', 'art 507', 'art 1', 'art 112']

Federal Register :: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs; Guidance for Industry; Availability
Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs; Guidance for Industry; Availability
A Rule by the Food and Drug Administration on 01/05/2018
598-600 (3 pages)
FDA-2017-N-6908
Reference 4 Comment from Northwest Food Processors Association...
Reference 3 Comment from Midwest Food Processors Association...
Refrence 2 Comment from American Frozen Food Institute to...
https://www.federalregister.gov/d/2018-00050 https://www.federalregister.gov/d/2018-00050
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 identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. Start Printed Page 599
Instructions: All submissions received must include the Docket No. FDA-2017-N-6908 for “Enforcement Policy for Certain Entities Subject to Requirements in the CGMP and Preventive Controls Regulations, the Produce Safety Regulation, and the Foreign Supplier Verification Programs Regulation.” 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 guidance to Office of Food Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-300), 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 guidance.
For questions relating to Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Rebecca Buckner, Office of Foods and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4576.
For questions relating to Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Samir Assar, Center for Food Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1636.
We are announcing the availability of a guidance for industry entitled “Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry.” We are issuing the guidance consistent with our good guidance practices regulation (21 CFR 10.115). In accordance with § 10.115(g)(2), we are implementing the guidance immediately because we have determined that prior public participation is not feasible or appropriate. Although the guidance document is immediately in effect, FDA will accept comments at any time. The guidance is not subject to Executive Order 12866.
This guidance document concerns four of the seven foundational rules that we have established in Title 21 of the Code of Federal Regulations (21 CFR) as part of our implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353). The four final rules are entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (published in the Federal Register of September 17, 2015, 80 FR 55908) (https://www.fda.gov/​food/​guidanceregulation/​fsma/​ucm334115.htm) (part 117); “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (published in the Federal Register of September 17, 2015, 80 FR 51670) (https://www.fda.gov/​food/​guidanceregulation/​fsma/​ucm366510.htm) (part 507); “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (published in the Federal Register of November 27, 2015, 80 FR 74226) (https://www.fda.gov/​food/​guidanceregulation/​fsma/​ucm361902.htm) (FSVP regulation); and “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (published in the Federal Register of November 27, 2015, 80 FR 74354) (https://www.fda.gov/​food/​guidanceregulation/​fsma/​ucm334114.htm) (produce safety regulation or part 112).
In the guidance, we state compliance policy for certain entities and/or activities under these four rules:
Specific facilities subject to part 117 and/or part 507:
○ Certain facilities that would qualify as secondary activities farms except for the ownership of the facility (e.g., certain produce packinghouses and warehouses, egg packinghouses, grain elevators, cotton ginners);
○ Facilities that would qualify as farms if they did not color RACs;Start Printed Page 600
○ Facilities that would qualify as secondary activities farms except that they pack, package, label, and/or hold processed food that consists only of RACs that have been dried/dehydrated to create a distinct commodity (e.g., dried beans);
○ Farm mixed-type facilities making silage food for animals;
Written assurances under the “customer provisions” in part 117 and related rules;
Importation of food contact substances under the FSVP regulation; and
Certain human food by-products for use as animal food, with regard to certain requirements under part 507.
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management 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. The collections of information in part 507 have been approved under OMB control number 0910-0789. The collections of information in 21 CFR part 1, subpart L have been approved under OMB control number 0910-0752. The collections of information in part 112 have been approved under OMB control number 0910-0816.
[FR Doc. 2018-00050 Filed 1-4-18; 8:45 am]