FDA and USDA Regulatory Updates: August 2023

Strategic Insights -

Recent updates from the FDA and USDA cover a wide range of topics, including the approval of new animal drugs, food additive petitions, and regulatory amendments. The updates are reflected in various Federal Register notices issued in August 2023.

Notably, the FDA has issued several notices announcing the approval of new animal drugs, including a final rule amending sections 558.76 and 558.515 to reflect the approval of a new animal drug application filed by Alpharma Inc. This approval allows for the use of bacitracin methylene disalicylate and robenidine hydrochloride in three-way combination Type C medicated broiler chicken feeds. Additionally, the FDA has approved a supplemental new animal drug application filed by Hoechst Roussel Vet, which provides for the use of an approved fenbendazole Type A medicated article to make Type B and Type C medicated feeds used for the removal and control of gastrointestinal worms.

The USDA has also issued several notices in August 2023, including a final rule amending regulations for importing poultry products to allow poultry carcasses, parts, and products (except eggs and egg products) that are not eligible for entry into the United States to move through the US via land ports from Mexican states that Mexico considers to be free of exotic Newcastle disease. This change is intended to relieve restrictions on trade while continuing to provide protection against the introduction of exotic Newcastle disease into the United States.

Furthermore, the USDA has announced a public meeting to discuss agenda items to be addressed at the First Session of the Codex Ad Hoc Intergovernmental Task Force on Fruit and Vegetable Juices, which will be held in Brasilia, Brazil. The meeting will take place on September 7 at FDA headquarters in Washington, DC, and will cover issues such as the proposed draft Codex general standard for fruit juices and nectars, revised Codex standard for vegetable juices, and proposed Codex guidelines for labeling mixed fruit juices and nectars.

Additionally, the USDA has added Denmark to the list of BSE nations, which means that the restrictions on the import of ruminants that have been in Denmark and meat, meat products, and certain other products of ruminants that have been in that nation will continue.

Lastly, the EPA has announced the filing of a pesticide petition proposing to establish tolerances for residues of a herbicide in various crops.

Key Takeaways:

  • FDA approved a new animal drug application for Alpharma Inc. to make three-way combination Type C medicated broiler chicken feeds using bacitracin methylene disalicylate and robenidine hydrochloride.
  • The FDA also approved a supplemental new animal drug application for Hoechst Roussel Vet to make Type B and Type C medicated feeds used for the removal and control of gastrointestinal worms.
  • The USDA amended regulations for importing poultry products to allow poultry carcasses, parts, and products (except eggs and egg products) that are not eligible for entry into the United States to move through the US via land ports from Mexican states that Mexico considers to be free of exotic Newcastle disease.
  • The USDA announced a public meeting to discuss agenda items for the Codex Ad Hoc Intergovernmental Task Force on Fruit and Vegetable Juices.
  • The USDA added Denmark to the list of BSE nations, subjecting imports from Denmark to restrictions on ruminants and meat products.
  • The EPA filed a pesticide petition proposing to establish tolerances for residues of a herbicide in various crops.

Statistics:

  • The FDA estimated an annual reporting burden of 18.5 hours for the Infant Formula Requirements information collection, based on 70 responses.
  • The agency also estimated an annual recordkeeping burden of 20 hours, based on 70 records.
  • The FDA estimated an annual reporting burden of 1,000 hours for the Food Safety Survey information collection, based on 2,000 responses.
  • The EPA proposed tolerances for residues of a herbicide in milk, meat of cattle, sheep, goats, and horses, fat of cattle, sheep, goats, and horses, and kidney of cattle, sheep, goats, and horses.

Sources:

  • Federal Register, August 18, 2023 (65 FR 50543)
  • Federal Register, August 18, 2023 (65 FR 50539)
  • Federal Register, August 23, 2023 (65 FR 51283)
  • Federal Register, August 24, 2023 (65 FR 51518)
  • Federal Register, August 24, 2023 (65 FR 51608)