USDA Permit Compliance

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Background on USDA Import Permits

The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), and Plant Protection Quarantine (PPQ), require companies to have a USDA-issued permit to import products containing plant or animal origin ingredients, that may present a threat of spreading animal diseases or pests depending on the health situation in the region of origin. Such permits are intended to verify the safety of imported products at the port of entry. USDA permit requirements will differ depending on the origin of the plant or animal material, the finished product, and any treatment or processing of the specific imported product. Importers looking to import USDA-regulated product or joint FDA and USDA- regulated products to the US, must determine whether they will need a USDA import permit.

Determining whether a permit is required, and obtaining that permit prior to import, can potentially save thousands of dollars in storage fees, product delays, and re-export or destruction costs. Additionally, product compliance helps cement productive sales relationships between supply chain parties and customers, and establishes positive regulatory standing with USDA.

Specifically, APHIS regulates the import, or transport of live organisms, embryos, vectors, cell cultures, animal products and animal by-products into the U.S. APHIS Veterinary Services (VS) requires importing entities to submit and obtain USDA permits for animal products and/or animal-derived materials to prevent the introduction of exotic and poultry disease into the U.S. Generally, a USDA VS permit is required for animal-derived materials, or for materials exposed to animal-source materials, including animal tissues, blood, cells or cell lines of livestock, or poultry origin, as well as microorganisms including bacteria, viruses, protozoa and fungi. Additionally, APHIS VS permits are also based on Food Safety and Inspection Service (FSIS) compliance, wherein animal products must be derived from FSIS-approved establishments.

Plant Protection Quarantine (PPQ) safeguards agriculture and natural resources against the entry, establishment and spread of economically and environmentally significant pests, while facilitating the safe trade of agricultural products. PPQ permits are required for the importation into and transit through the U.S. of specific plants and plant products for consumption or propagation, including seeds, fruits, vegetables and protected plant species such as orchids.

Import Alerts can affect manufacturers, shippers, growers, importers, or an entire geographic area of a specific country.

How Garg Law Can Help:

Whether you are a company importing FDA- and USDA- jointly regulated products (e.g. dietary supplements containing an animal-origin ingredient such as fish oil, cosmetic shampoos containing orchid, or soup products containing chicken bone broth) or USDA-regulated products alone (e.g. seeds for planting, animal products), obtaining your USDA or PPQ permit is critical.

With our expertise in FDA, USDA, and CBP compliance, Garg Law can assist you in filing and obtaining VS permits with USDA APHIS, and addressing USDA EAN and On-Hold Shipment Notification matters. This includes:

• Assessing a company’s business operations and products to determine with a USDA permit filing is required

• Preparing and filing permit applications through the e-filing portal

• Managing, maintaining and renewing permits

Imports of food products that require a VS or PPQ permit must present the USDA import permit to U.S. Customs and Border Protection (CBP) for the shipment to be permitted U.S. entry. Failure to have the proper permit at importation can result in USDA issuing an Emergency Action Notice (EAN) and On-Hold Shipment Notification where the goods will be held or refused entry until such compliance concerns are resolved.