What do seeds imported for planting, chicken broth in an imported soup, or vitamins and minerals derived from animal origin materials intended for use in a dietary supplement have in common, you ask?
They may all be jointly regulated by USDA and FDA!
USDA (US Department of Agriculture) and FDA (Food and Drug Administration) regulations can be a complex terrain to navigate, especially when it comes to determining if and when USDA permits are required for FDA-regulated products. Failing to understand the joint compliance requirements, and securing the necessary permits in place prior to import, can result in excessive costs including storage fees, product delays, and re-export or destruction costs. Whether you’re dealing with animal products, animal byproducts, plants, or plant products, in FDA-regulated goods including conventional food, cosmetics, supplements, or biologics, understanding when a USDA permit is necessary is crucial for compliance and smooth operations. We’ll take a look here at the ultimate tag-team match and what triggers both FDA and USDA regulation!
The USDA and FDA: Who Does What?
Before diving into the specifics of permits, it’s important to understand FDA’s and USDA’s distinct role:
- USDA: primarily responsible for the safety of agricultural products, including meat, poultry, and certain egg products. They also oversee the health of plants and animals, working to prevent the spread of diseases and pests through regulatory programs.
- FDA: In contrast, FDA regulates most food products not covered by the USDA, including dairy, seafood, fruits, vegetables, and other processed foods. They also oversee animal drugs, animal feed, and veterinary biologics, ensuring these products are safe for animals and, indirectly, for the people who consume them.
Permit Patrol: USDA Permits for Animal Products and Byproducts
When dealing with animal products and byproducts, USDA permits are typically required in the following situations:
- Importation of Meat, Poultry, and Egg Products
While the FDA regulates many animal-derived food products, the USDA’s Food Safety and Inspection Service (FSIS) is responsible for the regulation of meat, poultry, and certain egg products. Importing these products into the United States requires a USDA import permit to ensure they meet FSIS standards for safety, quality, and labeling. This is critical for preventing the entry of contaminated or misbranded products.
- Importation of Animal Byproducts
Animal byproducts (such as hides, skins, bones, and fats) can pose risks related to animal diseases like BSE (Bovine Spongiform Encephalopathy) or foot-and-mouth disease. A USDA Animal and Plant Health Inspection Service (APHIS) Veterinary Services (VS) permit is required for importing animal byproducts. This ensures that these materials are safe and will not introduce foreign animal diseases into the U.S.
- Veterinary Biologics
Veterinary biologics, including vaccines and diagnostic kits, are regulated by USDA APHIS. A VS permit may be required for the importation, production, or distribution of veterinary biologics. Again this type of permit supports in assuring these products are safe, pure, potent, and effective, aligning with FDA regulations for animal health products.
- Transport of Animal Products Across State Lines
Interstate movement of animal products can also require USDA oversight, especially for products that may be subject to state-specific restrictions or quarantine regulations. Depending on the product and its origin, a USDA permit may be needed for interstate transport to prevent the spread of diseases or pests.
When your Kale Needs Clearance: USDA Permits for Plant and Plant Products
For plants and plant products, USDA permits are generally required in these scenarios:
- Importation of Plants, Seeds, and Plant Products
The USDA’s APHIS Plant Protection and Quarantine (PPQ) program regulates the importation of plants, seeds, and plant products to prevent the introduction of harmful pests and diseases. A PPQ permit is required for importing live plants, seeds, fruits, vegetables, and other plant products. This is essential for preventing invasive species and diseases that could harm U.S. agriculture.
- Movement of Regulated Plant Products Within the U.S.
Certain plant products are subject to interstate movement restrictions to prevent the spread of pests like the gypsy moth or diseases like citrus canker. A USDA permit is necessary for moving regulated plant products across state lines. The permit ensures that the movement adheres to federal and state quarantine regulations.
- Genetically Engineered Organisms (GEOs)
The USDA, through APHIS, also regulates the importation, movement, and field testing of genetically engineered organisms, including plants. If you’re working with GEOs, you’ll likely need a USDA permit to ensure these organisms are safe for the environment and agriculture. This permit complements FDA oversight of genetically engineered food products.
- Importation of Plant-Derived Food Products
While the FDA regulates food safety, the USDA plays a role in ensuring that plant-derived food products imported into the U.S. are free from pests and diseases. A PPQ permit may be required for certain plant-derived food products, especially those that could carry pests or diseases, such as fresh produce or raw grains.
When USDA and FDA Regulations Intersect
The below examples further clarify when USDA and FDA regulations overlap, and when you may need to get a USDA permission slip for your imports:
- Animal-Derived Food Products: While the FDA may regulate the safety and labeling of animal-derived food products like dairy, USDA may require permits for the importation of the animals themselves or their byproducts.
- Plant-Based Foods: The FDA oversees the safety of plant-based foods, but the USDA may require permits for importing the raw materials, like seeds or fruits, to ensure they are free from pests.
As you can see, navigating the requirements for USDA permits in the context of FDA-regulated products can be complex, but understanding when these permits are needed is crucial for compliance, and avoiding added costs as a result of holds, product refusals, Emergency Action Notices (EAN) and other enforcement measures, and fundamentally, to protect public and agricultural health.
And we must say, the permit shuffle can be a fun dance move too!
For more information on USDA and FDA regulation of FDA-regulated goods, EANs, or other regulatory compliance and enforcement, please email info@garg-law.com.
