In This Week’s Edition:
- Revised FSMA Preventive Controls Guidance
- Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List
- TTB to Hold Listening Sessions on Labeling of Wine, Distilled Spirits, and Malt Beverages With Alcohol Content, Nutritional Information, Major Food Allergens, and Ingredients
- FSIS Highlights 2023 Accomplishments in Protecting Public Health and Strengthening the Food Supply Chain
- Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
- Biden-Harris Administration Announces Investments to Strengthen U.S. Specialty Crops Sector
- Oranges, Grapefruit, Tangerines, and Pummelos Grown in Florida; Increased Assessment Rate
- USDA Food Safety and Inspection Service Foreign Audit Report: Vietnam
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters`
Revised FSMA Preventive Controls Guidance
FDA is announcing the availability of a revised draft Introduction, and a revised draft Appendix 1, within a multichapter guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food.” This multichapter draft guidance, when finalized, will explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” We revised the draft Introduction and draft Appendix 1: Known or Reasonably Foreseeable Hazards to address comments submitted on drafts that we made available in 2016. This draft guidance is not final nor is it in effect at this time.
Agricultural Bioterrorism Protection Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List
In accordance with the Agricultural Bioterrorism Protection Act of 2002, USDA is proposing to amend and republish the list of select agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products. This Act requires the biennial review and republication of the list of select agents and toxins and the revision of the list as necessary. This action would implement findings from the biennial review for the list. The biennial review was initiated within 2 years of the completion of the previous biennial review.
TTB to Hold Listening Sessions on Labeling of Wine, Distilled Spirits, and Malt Beverages With Alcohol Content, Nutritional Information, Major Food Allergens, and Ingredients
The Alcohol and Tobacco Tax and Trade Bureau (TTB) is announcing virtual listening sessions to receive input from the public on labeling of wine, distilled spirits, and malt beverages to disclose per-serving alcohol and nutritional information, major food allergens, and/or ingredients. The Department of the Treasury’s February 2022 report on “Competition in the Markets for Beer, Wine, and Spirits” recommended that TTB revive or initiate rulemaking in these areas. These listening sessions are intended to engage the public, including consumers, public health stakeholders, and industry members of all sizes, and facilitate the public’s ability to provide input to inform rulemaking. The virtual listening sessions will be held February 28, 2024, from 10 a.m. to 2 p.m., EST; and February 29, 2024, from 1 p.m. to 5 p.m., EST. Register here.
FSIS Highlights 2023 Accomplishments in Protecting Public Health and Strengthening the Food Supply Chain
USDA announced its key achievements in 2023 that protected public health through food safety and strengthened the food supply chain.
“USDA’s Food Safety and Inspection Service is focused on protecting the American public, and in 2023, we continued to advance initiatives toward this goal, including by empowering small establishments in producing safe food and meeting consumer expectations on labeling claims,” said USDA Under Secretary for Food Safety Emilio Esteban. “As we reflect on the accomplishments of the past year, we remain committed to preventing foodborne illness, ensuring the safety of the nation’s food supply, and strengthening the food supply chain.”
Read the full list of achievements here.
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
FDA is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate as a source of chromium in turkey feed. This action is in response to a food additive petition filed by Kemin Industries, Inc.
Biden-Harris Administration Announces Investments to Strengthen U.S. Specialty Crops Sector
Agriculture Secretary Tom Vilsack announced two USDA investments designed to support the U.S. specialty crops industry. The launch of the Assisting Specialty Crop Exports initiative will provide $65 million for projects that will help the specialty crop sector increase global exports and expand to new markets. Additionally, USDA is announcing $72.9 million in grant funding available to support the specialty crops industry through the Specialty Crop Block Grant Program. The Specialty Crop Block Grant Program will fund innovative projects designed to bolster the competitiveness of the expanding specialty crop sector. Specialty crop exports totaled $24.6 billion in FY2023, representing 13.8 percent of total U.S. agricultural exports.
Oranges, Grapefruit, Tangerines, and Pummelos Grown in Florida; Increased Assessment Rate
This proposed rule would implement a recommendation from the Citrus Administrative Committee to increase the assessment rate established for the 2023-2024 fiscal year and subsequent fiscal periods from $0.015 to $0.02 per 4/5-bushel carton or equivalent for Florida citrus handled under the marketing order. The proposed assessment rate would remain in effect indefinitely unless modified, suspended, or terminated.
USDA Food Safety and Inspection Service Foreign Audit Report: Vietnam
FSIS maintains a list of comprehensive audits of foreign country inspection systems to ensure compliance with certain regulatory requirements. Vietnam has been added to this list.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the outbreak of Listeria monocytogenes (ref #1214) in a not yet identified food, FDA has initiated traceback, an onsite inspection, and sample collection and analysis.
- For the outbreak of Listeria monocytogenes (ref #1205) in an unidentified food, the outbreak has ended, and FDA’s investigation has closed.
- For the investigation of elevated lead levels in cinnamon applesauce pouches (ref # 1198) the complaints/adverse event reports in the advisory were updated. Refer to the advisory for additional information. The advisory is also available en español (Spanish).
- For the outbreak of Listeria monocytogenes (ref #989) in peaches, plums and nectarines, the advisory was updated on 1/30/2024. The outbreak has ended, and FDA’s investigation has closed.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include raw agricultural products for pesticides, foreign processors not in compliance with seafood HACCP, and more.
FDA Warning Letters
Marion Mullet Farm |
New Animal Drug/Adulterated |
Sambrosa Care Inc. |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
Grace Supply Inc. |
Foreign Supplier Verification Program (FSVP) |
Mexpobaja Corporation |
Foreign Supplier Verification Program (FSVP) |
A True Move LLC |
Foreign Supplier Verification Program (FSVP) |
Martin Farm, Konrad Martin |
New Animal Drug/Adulterated |
JJR Global Inc. |
Foreign Supplier Verification Program (FSVP) |
Cavevi Naturals LLC |
Foreign Supplier Verification Program (FSVP) |
Mei Lan Thailand Co., Ltd. |
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Refused Inspection |
S & J International Enterprises Public Company Limited |
CGMP/Finished Pharmaceuticals/Adulterated |