Food Industry Regulatory Update April 22, 2022

In This Week’s Edition:

Changes to World Agricultural Supply and Demand Estimates starting in May
FDA Takes New Steps Regarding Evaluating Public Health Importance of Additional Food Allergens
FDA and USDA Scientists Research Seasonal Effects Linked to E.coli Outbreaks in Bagged Romaine
Standards for Birds Not Bred for Use in Research Under the Animal Welfare Act
FDA Policy Regarding N-acetyl-L-cysteine: Draft Guidance for Industry
Petition Submitted by Northern Goose Processors Ltd. to FSIS to Change the Definition of Ready-to-Cook Poultry
FDA Releases Final Rule for Added Fluoride Levels in Bottled Water
New Slaughter Subclasses for Young and Adult Goats in the Public Health Information System
USDA Announces Key Staff Appointments
FDA CORE Outbreak Investigation Status Update
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
FDA Warning Letters

Changes to World Agricultural Supply and Demand Estimate Reports starting in May

Starting with the May 12, 2022 release, the following changes will be made to the World Agricultural Supply and Demand Estimates report:

The sugar WASDE table (page 16) will have a separate line listing under “Imports” for High-tier tariff imports. The new line will appear directly below the line for imports from Mexico. Footnote 5 which once referenced imports from Mexico; and high-tier tariff sugar and syrups not otherwise specified will be eliminated.
The U.S. Dairy Supply and Use table (page 33): The table will remove CCC Donations as a separate category and include all donations as part of domestic use. As such, stocks, imports, exports, and use will reflect total rather than commercial use and the headings will be adjusted accordingly.

Sample tables are available here.

FDA Takes New Steps Regarding Evaluating Public Health Importance of Additional Food Allergens

FDA issued a draft guidance that, when finalized, will outline the agency’s approach to evaluating the public health importance of food allergens that are not one of the major nine food allergens identified by law in the U.S.

FDA and USDA Scientists Research Seasonal Effects Linked to E.coli Outbreaks in Bagged Romaine

Scientists from the FDA CFSAN and the USDA ARS have been working collaboratively to understand the seasonal effects and other factors that may be contributing to outbreaks of E.coli O157:H7 linked to bagged romaine lettuce. Leafy greens, including bagged romaine lettuce, have been implicated in outbreaks of foodborne illness caused by Shiga toxin-producing E. coli, the most common of which is E. coli O157:H7.

Standards for Birds Not Bred for Use in Research Under the Animal Welfare Act

USDA is extending the comment period for their proposed rule that would revise the regulations to establish standards governing the humane handling, care, treatment, and transportation of birds, excluding birds bred for use in research, covered under the Animal Welfare Act.

Policy Regarding N-acetyl-L-cysteine: Draft Guidance for Industry

FDA is announcing the availability of a draft guidance for industry entitled “Policy Regarding N-acetyl-L-cysteine: Draft Guidance for Industry.” The draft guidance, when finalized, will explain FDA’s intent to exercise enforcement discretion with respect to the sale and distribution of certain products that contain N-acetyl-L-cysteine and are labeled as dietary supplements.

Petition Submitted by Northern Goose Processors Ltd. to FSIS to Change the Definition of Ready-to-Cook Poultry

The petition requests that FSIS amend 9 CFR 381.1 to change the Ready to Cook Poultry definition to include partial dressing of a carcass as authorized by the Secretary if the producer shows that there is a market for the product and that the carcass can pass a post-mortem inspection.

FDA Releases Final Rule for Added Fluoride Levels in Bottled Water

FDA issued its final rule for added fluoride levels in bottled water titled Beverages: Bottled Water. This final rule amends the allowable level for fluoride in domestically packaged and imported bottled water to which fluoride is added to 0.7 milligrams per liter (mg/L).

New Slaughter Subclasses for Young and Adult Goats in the Public Health Information System

This notice informs inspection program personnel (IPP) of the new slaughter subclasses for goats (i.e., young and adult goats) in the animal disposition reporting section of the Public Health Information System. It also instructs IPP to discuss this change with establishment management at goat slaughter establishments.

USDA Announces Key Staff Appointments

USDA announced the names of individuals who will hold senior staff positions in Washington, D.C.

Scott Marlow was named Deputy Administrator for Farm Programs in the Farm Service Agency
Tim Gannon was named Chief of Staff for Farm Production and Conservation
Andrea Delgado was named Chief of Staff for Natural Resources and Environment
Sara Bleich, PhD was named Director of Nutrition Security and Health Equity for the Food and Nutrition Service

FDA CORE Outbreak Investigation Status Update

This week’s updates are:

For adverse event report investigations, FDA will indicate a product category and not publicly name a specific product until there is sufficient evidence to implicate that product as a cause of illnesses or adverse events.
For the new adverse events investigation (reference #1064), FDA is following up on a series of unconfirmed adverse event reports that may be associated with dry cereal. Although FDA has not determined that this cereal is linked to these adverse event reports, FDA is conducting an investigation to determine the potential causality of these complaints. The total number of adverse events reported includes the number of adverse events that have been self-reported by consumers to FDA consumer complaint coordinators and the CFSAN Adverse Event Reporting System (CAERS), which could include duplicate reports.
For adverse event investigation (reference #1060), a product category has been added and the number of adverse events has been adjusted to only include consumer reports to FDA consumer complaint coordinators and CAERS.

CORE Investigation Table