TABLE OF CONTENTS

IFDA’s Guide to Effective and Efficient Product Recalls

IFDA Manual on the FDA Sanitary Transportation of Food Rule

IFDA Manual on Hazard Analysis and Preventative Controls for Human Food​

Food Safety Modernization Act (FSMA)

Sanitary Transportation
Hazard Analysis & Preventive Controls for Human Food
Foreign Supplier Verification 
Accreditation of Third Party Auditors
Intentional Adulteration
Produce Safety
Hazard Analysis & Preventive Controls for Animal Food 
Other FSMA Regulations


Other Food Safety

Sesame Allergen LabelingUpdated May, 2021
GMO Labeling
Menu Labeling
Traceability 

*IFDA’s food safety counsel is Covington & Burling LLP unless otherwise noted.
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Food Safety Technology
The Food and Drug Administration announced a  “Blueprint for a New Era of Smarter Food Safety.” The framework addresses several areas, including traceability, digital technologies and evolving food business models.

In June 2021, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) has published a list of priority guidance topics for the coming year. FDA intends to publish such lists at the beginning of each calendar year and update the list mid-year. Counsel summary is here.

Food Safety Modernization Act (FSMA)

FDA  FSMA Resource Page
This site includes background information, key facts, and a Q & A section.

Sanitary Transportation
FDA Fact Sheet & Final Rule
Counsel summary

Hazard Analysis & Preventive Controls
FDA Fact Sheet & Final Rule
Counsel summary

Foreign Supplier Verification
FDA Fact Sheet & Final Rule
Counsel summary

Accreditation of Third Party Auditors
FDA Fact Sheet & Final Rule
Counsel summary

Intentional Adulteration
FDA Fact Sheet & Final Rule 
Counsel summary 
Counsel Summary of Guidance
Food Defense Plan Builder 

Produce Safety
FDA Fact Sheet & Final Rule
Counsel summary

Hazard Analysis & Preventive Controls for Animal Food
FDA Fact Sheet & Final Rule
Counsel summary

Other FSMA
FSMA Whistleblower Final Rule Summary
 

Other Food Issues

Sesame Allergen Labeling
On April 23, 2021, President Joe Biden signed into law the Food Allergy Safety, Treatment, Education and Research, or FASTER, Act, S. 578, making sesame the ninth major food allergen under the Federal Food, Drug and Cosmetic Act. Effective Jan. 1, 2023, the FASTER Act requires food manufacturers to list sesame as an allergen on food labels. In addition to the labeling mandate, the listing of sesame as a major food allergen has implications for the hazard analysis and preventive controls plans for facilities that handle sesame, under the Food Safety Modernization Act. Counsel summary is here.

GMO Labeling
In December, 2018, the Department of Agriculture (USDA) issued final rules governing the labelling of genetically-modified foods. The National Bioengineered Food Disclosure Law, passed by Congress in 2016, directed USDA to establish a national mandatory standard for disclosing bioengineered foods. Companies have options to choose from including text, a symbol, and an electronic link. The compliance date is January  1, 2022. The standard will provide a uniform way for food manufacturers to disclose whether a food or its ingredients were bioengineered while preventing a patchwork of state or private labels. Counsel Summary 


Menu Labeling

The Food and Drug Administration has issued final rules on requirements for calorie information in restaurants and on vending machines. The rules were mandated in the Affordable Care Act and will apply to restaurants and retail food establishments with more than 20 locations and in vending locations when the owner or operator has more than 20 machines.

Menu and Vending Machines Labeling Requirements Overview

Traceability
 In September, 2020, the FDA issued a proposed rule that would impose additional traceability recordkeeping requirements for certain high-risk foods. This rulemaking is required by section 204 of FSMA, and is an additional action in FDA’s ongoing FSMA implementation. The rule as proposed is extremely onerous to distributors. Counsel summary is here. In January, 2021 the FDA issued an FAQ update as well as a memorandum clarifying to its “Food Traceability List” (FTL) that would enumerate certain foods the agency deems “high-risk"Counsel summary is here.

Resources for Traceability, Recall, and Food Safety