USDA VS Permits

Imported orchid extract in shampoos, chicken broth in pre-packaged soup, fish oil in supplements, seeds for planting, seeds for research use only, and vitamins and minerals derived from bovine and ovine origin surprisingly have a common thread. These products all trigger potential regulation by U.S. Department of Agriculture (USDA). Materials derived from animals, produced with animal-origin ingredients, or that are derived or produced with plant or plant materials are potentially subject to both FDA and USDA regulation, and must be cleared by Department of Homeland Security (DHS) Customs and Border Protection (CBP) at the port of arrival before U.S. entry is authorized.

Too often, businesses that import products with animal-origin or plant-derived materials are unaware that USDA regulates their product and are faced with what is called an Agriculture Hold at the time of entry. These companies may receive an Emergency Action Notice (EAN) that will advise of the alleged violation, mandate a response within 48-hours and request the product be exported or destroyed unless the product can be shown to be compliant. Receiving an EAN inevitably triggers shipment delays, unexpected storage fees, and frustration and disruption with trade flow which can be overwhelming. However, the USDA also offers a process to effectively respond to an EAN and receive expedited review of documents and records to demonstrate compliance. This can potentially salvage the product and save on export or destruction costs.

The good news is that companies that import products with plant-derived materials or animal-origin ingredients can prevent delays at the time of import by proactive compliance. This involves determining whether USDA regulates the imported product and assessing regulatory requirements. Oftentimes, a USDA Veterinary Service (VS) Permit or Plant Protection Quarantine (PPQ) Permit is required. If a USDA permit is not required or if a particular product is exempt, we recommend having a regulatory rationale to file as part of a company’s due diligence. Generally, USDA Permits are required to be renewed annually, and can be renewed up to 3 months before the permit expiry. To avoid regulatory enforcement issues at the time of import and to ensure timely receipt of the new (or amended) permit, we recommend filing at least 8 weeks before permit expiry.

For animal products or animal byproducts, both USDA’s Animal and Plant Health Inspection Service (APHIS) and the Food Safety and Inspection Service (FSIS) may have oversight. Products may need to originate from FSIS-approved establishments, and from countries eligible to export to the U.S. for instance. During the permit process, APHIS and FSIS may jointly review the application to determine eligibility for export of the product under the particular circumstances (country of origin, country of export, processing methods, terms of import, intended use of product and more). USDA will also stipulate the permit terms, which can include the requirements for a Veterinary Health Certificate from a licensed veterinarian of the foreign government.

Permits are also required for plants and plant products intended for consumption or propagation. Plant and plant product permits include plants for planting (such as nursery stock, and small lots of seed), plant products such as fruits and vegetables, cotton and cut flowers, and protected plants and plant products such as orchids and threatened endangered plant species.

USDA also provides some exemptions and modifications of regulatory requirements for products intended for research use only, products that do not present a public health risk, or other carve outs based on materials and intended use.