Food Industry Regulatory Update June 28, 2024
In This Week’s Edition:
- FSMA Section 204 Updated Resources
- APHIS Publishes Data on Enforcement Statistics for FY2023
- FSMA Produce Safety Rule Water Requirements; Webinar Recording
- USDA and Cornell University Break Ground on National Grape Improvement Center
- APHIS Establishes a Host List for Regulated Articles for the Queensland Fruit Fly
- APHIS Phases Out ePermit Program: Reminds Stakeholders to Submit an eFile Application
- U.S. Grade Standards for Pecans Updated
- FDA Issues Warning Letter to Bimbo Bakeries Over Food Allergen Labeling Concerns
- FSIS Revises Guideline for Residue Prevention
- USDA and Reinvestment Fund Launch New Program to Increase Access to Healthy Foods in Underserved Communities
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
FSMA Section 204 Updated Resources
FDA has published additional resources to its website to help industry comply with the Food Traceability Rule. These include:
- A downloadable, electronic sortable spreadsheet template;
- Minor revisions to the Food Traceability List clarifying the status of previously frozen foods on the list, as well as a new FAQ summarizing the changes;
- A chart summarizing exemptions relevant to produce farms for both the Produce Safety Rule and the Food Traceability Rule;
- A supply chain example for sprouts; and
- New translated material about the Traceability Lot Code and the Traceability Plan.
APHIS Publishes Data on Enforcement Statistics for FY2023
The enforcement statistics may be found here.
FSMA Produce Safety Rule Water Requirements; Webinar Recording
The FDA hosted a webinar on the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water on May 20. The recording is available here.
USDA and Cornell University Break Ground on National Grape Improvement Center
USDA’s Agricultural Research Service (ARS) and Cornell University’s College of Agriculture and Life Sciences hosted a groundbreaking ceremony for a new state-of-the-art USDA grape research facility on the Cornell AgriTech campus.
The over 70,000 square foot facility will be named the National Grape Improvement Center and will house the ARS Grape Genetics Research Unit and ARS Plant Genetic Resources Unit. In addition, four Cornell grapevine research projects will move into the research facility.
APHIS Establishes a Host List for Regulated Articles for the Queensland Fruit Fly
APHIS has established a host list for regulated articles for the Queensland fruit fly (QFF), Bactrocera tryoni. The berries, fruits, nuts, or vegetables of these hosts are regulated articles. QFF is a destructive fruit fly that is native to Australia and is not endemic to the United States. QFF attacks more than 120 plant species, including numerous commercial varieties of fruits and vegetables. This action is necessary due to the ongoing QFF quarantine in California, described in DA-2023-21, the first for this species in the Western Hemisphere.
APHIS Phases Out ePermit Program: Reminds Stakeholders to Submit an eFile Application
If your permit was issued in ePermits, you must apply and establish an account in APHIS eFile to continue working with regulated materials.
U.S. Grade Standards for Pecans Updated
AMS is revising the U.S. Standards for Grades of Pecans in the Shell and the U.S. Standards for Grades of Shelled Pecans by replacing the current grades with U.S. Extra Fancy, U.S. Fancy, U.S. Choice, and U.S. Standard grades. In addition, AMS is updating terminology, definitions, and defect scoring guides.
FDA Issues Warning Letter to Bimbo Bakeries Over Food Allergen Labeling Concerns
FDA issued a warning letter to Bimbo Bakeries USA, Inc. because, during two inspections in late 2023, FDA found that some of the company’s bakery products included ingredients that are or contain major food allergens on their labels, but those ingredients were not included in the product formulations. Food products must bear truthful and non-misleading labeling; otherwise, they are misbranded under the Federal Food, Drug, and Cosmetic Act.
FSIS Revises Guideline for Residue Prevention
The updated guideline explains how industry can meet FSIS requirements regarding violative residue prevention.
USDA and Reinvestment Fund Launch New Program to Increase Access to Healthy Foods in Underserved Communities
At the National Rural Grocer’s Summit, U.S. Agriculture Secretary Tom Vilsack announced that USDA and Reinvestment Fund are launching a new program under the Healthy Food Financing Initiative to increase access to healthy foods in communities underserved by grocery stores. Funding for the new Food Access and Retail Expansion Fund is made possible by President Biden’s American Rescue Plan Act.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the outbreak of Salmonella Typhimurium illnesses (ref #1234) linked to a not yet identified product, the case count has increased from 47 to 53. FDA has initiated traceback.
- For the investigation of illnesses (ref #1233) linked to Diamond Shruumz-brand Chocolate Bars, Cones, and Gummies, the advisory has been updated to include additional illnesses and investigation updates.
- For the outbreak of Listeria monocytogenes illnesses (ref #1232) linked to a not yet identified product, FDA has initiated an inspection and sample collection.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include imported food products that appear to be misbranded, food products that appear to be adulterated for economic gain, and more.
FDA Warning Letters
K2 Distro LLC, d/b/a K2 Distribution |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Bimbo Bakeries USA, Inc. |
Food Labeling/Misbranded/False and Misleading |
Sani-Care Salon Products, Inc. |
CGMP/Finished Pharmaceuticals/Adulterated |
Trippyvapors LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Indiana Lions Eye Bank, Inc. dba VisionFirst Indiana Lions Eye Bank |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
Magma Holding Inc. d/b/a EightVape |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Vape Royalty |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Buy Pods Now |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |