Draft Guidance

The FDA recently released a draft guidance on the Food Safety Modernization Act (FSMA) Produce Safety Rule, and they are looking to industry to provide comments. The videos below summarize each chapter and highlight certain aspects of the draft guidance that differ from what has already been published.

Public comment is being accepted until April 22, 2019. To submit comments online, go to www.regulations.gov/ and search for Docket No. FDA-2018-D-3631. You can also fax comments to the FDA at 301-827-6870, or mail comments to:

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

When submitting comments either by post or email, include the Docket No. FDA-2018-D-3631.

Chapter 1: General Provision (Subpart A)

Chapter 2: Personnel Qualifications and Training (Subpart C)

Chapter 3: Health and Hygiene (Subpart D)

Chapter 4: Biological Soil Amendments of Animal Origin and Human Waste (Subpart F)

Chapter 5: Domesticated and Wild Animals (Subpart I)

Chapter 6: Growing, Harvesting, Packing, and Holding Activities (Subpart K)

Chapter 7 Part 1: Equipment, Tools, Buildings, and Sanitation (Subpart L)

Chapter 7 Part 2: Equipment, Tools, Buildings, and Sanitation (Subpart L)

Chapter 8: Records (Subpart O)

Funding for this website was made possible in part by the Food and Drug Administration through grant PAR-16-137. The views expressed in the posted materials do not necessarily reflect the official policies of the Department of Health and Human Services, nor does any mention of trade names, commercial practices or organization imply endorsement by the United States Government.

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