Contains Nonbinding Recommendations 
 
 
The FDA Food Safety Modernization Act; 
Extension and Clarification of 
Compliance Dates for Certain Provisions 
of Four Implementing Rules: What You 
Need to Know About the FDA 
Regulation:  
Guidance for Industry  
 
Small Entity Compliance Guide  
 
 
Additional copies are available from: 
Office of Foods and Veterinary Medicine 
Food and Drug Administration 
10903 New Hampshire Avenue 
Silver Spring, MD  20993 
(Tel) 301-796-4500 
http://www.fda.gov/Food/Guidances 
 
You may submit either electronic or written comments regarding this guidance at any time.  
Submit electronic comments to https://www.regulations.gov.   Submit written comments on the 
guidance to the Dockets Management Staff (HFA-305), Food and Drug Administration,  5630 
Fishers Lane, rm. 1061, Rockville,  MD 20852.  All comments should be identified  with the 
docket number FDA-2018-D-1378  listed in the notice of availability  that publishes in the 
Federal Register.   
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition  
Center for Veterinary Medicine 
 
May, 2018 
   
  Contains Nonbinding Recommendations 
The FDA Food Safety Modernization 
Act; Extension and Clarification of 
Compliance Dates for Certain 
Provisions of Four Implementing Rules: 
What You Need to Know About the 
FDA Regulation:  
1
Guidance for Industry   
 
Small Entity Compliance Guide  
 
 
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 the FDA staff responsible 
for this guidance as listed on the title page. 
 
 
 
On August 24, 2016, FDA published  in the Federal Register a final rule that extended the dates 
for compliance with certain provisions  in four final rules:   
  Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Human Food (21 CFR part 117);  
  Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Food for Animals (21 CFR part 507);  
  Standards for Growing,  Harvesting, Packing, or Holding  of Produce for Human 
Consumption  (21 CFR Part 112); and  
  Foreign Supplier  Verification Programs for Importers of Food for Humans and Animals 
(21 CFR Part 1, Subpart L). 
 
                                              
1 This guidance has been prepared by the Office of Food and Veterinary Medicine at the U.S. Food and Drug 
Administration.  
 
  2  Contains Nonbinding Recommendations 
FDA extended the compliance dates of these four rules to address concerns about the practicality 
of compliance with certain provisions,  consider changes to the regulatory text, and better align 
compliance dates across the rules. The final rule became effective on August 24, 2016.  
 
On January 5, 2018, FDA issued a guidance document 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. This guidance 
document states the intent of FDA not to enforce certain regulatory requirements as they 
currently apply to certain entities and/or activities.  
 
The January 2018 guidance document covers essentially all of the regulatory provisions 
addressed in the August 2016 final rule:   
  Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Human Food (21 CFR part 117);  
  Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Food for Animals (21 CFR part 507);  
  Standards for Growing,  Harvesting, Packing, or Holding  of Produce for Human 
Consumption  (21 CFR Part 112); and  
  Foreign Supplier  Verification Programs for Importers of Food for Humans and Animals 
(21 CFR Part 1, Subpart L). 
 
Entities seeking additional  detail  on FDAs policy regarding its intent not to enforce the 
regulatory provisions  discussed in the August 2016 final rule should consult the January 2018 
final guidance 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. 
(https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/uc
m590646.htm) 
 
We have prepared this Small Entity Compliance  Guide in accordance with section 212 of the 
Small Business Regulatory Enforcement Fairness Act (Public Law 104-121,  as amended by 
Public Law 110-28).  This guidance document is intended to assist small entities in complying 
with the final rule entitled The Food and Drug Administration  Food Safety Modernization  Act; 
Extension and Clarification  of Compliance Dates for Certain Provisions of Four Implementing 
Rules (81 FR 52284). The rule is binding  and has the full force and effect of law. 
 
FDA's guidance documents, including  this guidance, do not establish legally  enforceable 
responsibilities.   Instead, guidances describe our current thinking  on a topic and should be 
viewed only as recommendations,  unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required.  
 
 
 
 
 
  3