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Market Entry Requirement of Animals and Animal Products - United States (US)

 

Controlled and Prohibited Goods
Import Requirements
Certificates
Food Regulation and Standards

 

  1. Controlled and Prohibited Goods

The Centers for Disease Control and Prevention (CDC) restricts the importation of any animals or animal products into the United States that might pose a public health threat. Any animal or animal product can be restricted from entry if CDC has reasonable knowledge or suspicion that it poses a human health risk.

Endangered and threatened animals, migratory birds, marine mammals, certain dangerous wildlife, and products made from them, are subject to import restrictions, prohibitions, and permit and/or certificate requirements in US (Bringing Pets and Wildlife into the United States).

The regulations governing meat and meat products are stringent. You may not export fresh, dried or canned meats or meat products into the United States. Also, you may not export food products into US that have been prepared with meat (Prohibited and Restricted Items).

The importation into the United States of milk and cream is prohibited unless the person by whom such milk or cream is shipped or transported into the United States holds a valid permit from the Secretary of Health and Human Services (US Code, Title 21 - Food and Drugs, Chapter 4 - Animals, Meats, and Meat and Dairy Products Subchapter IV - Importation of Milk and Cream Sec. 141 - Prohibition of importation without permit).

In some cases, milk or cream shall be considered unfit for importation. The cases can be found here: Milk or cream when unfit for importation.

Whenever, it shall be necessary for the protection of animals in the United States against infectious or contagious diseases, US may suspend the importation of all or any class of animals for a limited time, and may change, modify, revoke, or renew such proclamation, as the public good may require; and during the time of such suspension the importation of any such animals shall be unlawful (US Code, Title 21-Food and Drugs, Chapter 4-Animals, Meats, and Meat And Dairy Products, Subchapter II-Importation of Cattle and Quarantine).

 

  1. Import Requirement

 

  1. Country level approval

The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS) regulates the importation of animals and animal-derived materials to ensure that exotic animal and poultry diseases are not introduced into the United States.

To locate Import regulations for a particular state, please select the appropriate State from the following link: State Regulations for Importing Animals.

If you want to export any animals or animal products to US, you must complete the Permitting Assistant to learn the admissibility requirements for your commodity(ies). You will only need to complete an application if a permit is required. You can know about the requirements of importing any animals or animal products into US by entering the name of the animal or animal products into Veterinary Services Permitting Assistant.

  1. Establishment-level approval

Any facility (domestic and foreign) engaged in manufacturing, processing, packing, or holding food for consumption in the United States must register with Food and Drug Authority (FDA) (Title 21, Chapter 9, Subchapter IV, Section 350d). The registration process with FDA can be found in the link: Food Facility Registration User Guide: Step-by-Step Instructions for Registration.

  1. Compliance with Food Safety Modernization Act (FSMA)

The FSVP rule requires importers to perform risk-based foreign supplier verification activities to verify that:

  1. Certificate

The importation of any birds, poultry, horses, ruminants, swine, dogs and other animals along with aquatic animal species are accompanied by a health certificate of a full-time salaried veterinary officer of the national government of the region of origin of exportation, according to the CFR, Title-9, Chapter-I, Subchapter-D, Part-93.

  1. Food Regulation and Standards
  1. Maximum Residual Levels (MRLs) of Pesticides

CFR, Title 40, Chapter I, Subchapter E, Part 180, Subpart C sets out tolerance limit for specific chemicals.

  1. Contaminants

Under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act; 21 U.S.C. 342(a)(4)), a food shall be deemed adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. Based on this section FDA publish several guidelines for their stuffs. The guidelines can be used as reference documents for guidance on certain contaminants in food. The guidelines can be found in the links:

1. Chapter 5 - Food, Colors, and Cosmetics - Sub Chapters 537 - 567

2. Chapter 5 - Food, Colors, and Cosmetics - Sub Chapters 570 - 590

Some specific guidelines relation to certain contaminants are below:

Aflatoxins: CPG Sec 555.400 Aflatoxins in Human Food.

Hard or Sharp Foreign Objects: CPG Sec 555.425 Foods, Adulteration Involving hard or Sharp Foreign.

Objects

Adulteration Involving Infestation and 1080 Rodenticide: CPG Sec 555.450 Foods - Adulteration Involving.

Infestation and 1080 Rodenticide

Polychlorinated biphenyls (PCB's): CFR 21, Sec. 109.30-Tolerances for polychlorinated biphenyls (PCB's).

  1. Microorganism

Some specific guidelines relation to certain microorganism are below:

1. Salmonella: CPG Sec 555.300 Foods, Except Dairy Products - Adulteration with Salmonella.

2. Listeria monocytogenes: CPG Sec 555.320 Listeria monocytogenes.

More information regarding microbial risk can be found in the link: Microbial Risk, Food Safety and Inspection Service.

  1. Food Additives

CFR Title 21, Chapter I, Subchapter B (Part 170-180) lays down the food additive regulation of USA.

  1. Product Standard

There are several standards stipulated in the Code of Federal Regulation (CFR). The products standards include:

Shell Eggs: 21 CFR, Part 115, Shell Eggs

Milk and Cream: 21 CFR, Part 131, Milk and Cream

Cheeses and Related Cheese Products: 21 CFR, Part 133, Cheeses and Related Cheese Products

Frozen Desserts: 21 CFR, Part 135, Frozen Desserts

Bakery Products: 21 CFR, Part 136, Bakery Products

Eggs and Egg Products: 21 CFR, Part 160, Eggs and Egg Products

Labelling Requirement

21 CFR Part 101 -- Food Labeling lay down the labelling requirements of USA. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) lays down labelling requirements food containing allergenic substances. According to the act eight major foods or food groups—milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans— account for 90 percent of food allergies.