July 2006
Volume 2, Number 4
Table of Contents

U.S. Resources In International Food Law

By Lynne R. Ostfeld

July, 2006

During the 100th anniversary celebration of the creation of the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS), it is appropriate to point out sources of authority over what we put into our stomachs, particularly when we are referring to imported food. 

To help understand how we got to where we are today, know that Upton Sinclair came to Chicago to research and write his novel The Jungle, with the intent of proselytizing readers to supporting socialism and better conditions for workers.  Teddy Roosevelt, the then U. S. President and a prolific reader, read the book, was horrified at what he thought was going on in the slaughterhouses, and put in motion the creation of the FSIS.  Sinclair was disappointed because he intended to hit us in the heart and he hit us in the stomach instead.  To our benefit, he was the catalyst for the passage of the Federal Meat Inspection Act (FMIA).

To quote information put out by FSIS about the significance of what occurred,

“Today, more than 7,600 FSIS inspection program personnel are assigned to about 6,000 federally inspected meat, poultry and egg products facilities in the United States to ensure products are safe, wholesome and accurately labeled. FSIS also inspects each shipment of imported meat and poultry from qualified countries to ensure U.S. food safety requirements are met.

FSIS incorporates the results of more than 90,000 microbiological tests annually for E. coli O157:H7, Salmonella and Listeria monocytogenes to further the goal of preventing contamination and protecting public health. The Centers for Disease Control and Prevention has attributed significant declines in rates of illness from foodborne pathogens to the implementation of FSIS food safety regulations.”

I. Government Agencies Involved With The Regulation Of The Importation Of Food Products Into The U.S.

A. U.S. Food and Drug Administration (FDA) ( www.fda.gov/)

The FDA is part of the U.S. Department of Health and Human Services. With the exception of most meat and poultry, which are regulated by the U.S. Department of Agriculture, all food, drugs, cosmetics, medical devices, and electronic products that emit radiation are subject to examination by FDA when they arrive in the United States. Through its district offices and resident posts, or in coordination with the Customs Service, the FDA is directly or indirectly involved in surveillance of the import of food products at each of the approximately 500 U.S. Customs Service points of entry in the country.

By law, all of these products must meet the same standards as domestic goods. Imported foods must be pure, wholesome, safe to eat, and produced under sanitary conditions; drugs and devices must be safe and effective; cosmetics must be safe and made from approved ingredients; and all labelling and packaging must be informative and truthful.

To import regulated food products, the importer or agent files entry documents with the U.S. Customs Service within five working days of the date of arrival of a shipment at a port of entry.  The FDA is notified of the entry through duplicate copies of Customs Entry Documents (CF 3461, CF 3461 ALT, CF 7501 or alternative).  Further information can be obtained from:

Food and Drug Administration
Division of Import
Operations and Policy
15800 Crabbs Branch Way
Rockville, Maryland 20855
Tel : 301-443-6553

See, also, information published by the Center for Disease Control ( www.FoodSafety.gov) and www.FoodSafety.gov

B. Alcohol and Tobacco Tax and Trade Bureau (TTB) ( www.ttb.gov/alcohol/index.htm)

The TTB is part of the Department of the Treasury.  It collects excise taxes on aalcohol, tobacco, firearms and ammunition, and ensures that these products are labelled, advertised and marketed in accordance with the law.

Information on the requirements to import wine, beer and distilled spirits from various countries is available on www.ttb.gov/alcohol/info/interre1.htm. These requirements may include licensing, labelling and taxation considerations.  A general listing of requirements (including licenses, label approvals, etc.) to import alcohol products (malt beverages, wine, and distilled spirits) into the U.S. is available on www.ttb.gov/international_trade/importing_alcohol.html.  Individual states may also have regulations governing the sale of alcohol and tobacco.  Their individual regulations should be consulted before importing any of these products.

C. Animal and Plant Health Inspection Service (APHIS) ( www.aphis.usda.gov/ )

The Animal and Plant Health inspection Service (APHIS), part of the U.S. Department of Agriculture (USDA), is responsible for protecting and promoting U.S. agricultural health, administering the Animal Welfare Act, and carrying out wildlife damage management activities.

1. APHIS Plant and Protection Quarantine (PPQ)

PPQ concerns the successful flow of healthy commodities into and out of the United States in order to protect agricultural and natural resources from risks associated with the entry, establishment or spread of animal and plant pests and noxious weeds. PPQ does this by regulating the importation of agricultural products with obligatory phytosanitary (plant health) certificates, importation rules, and inspections. A phytosanitary certificate is a document issued by an exporting country, which certifies that the phytosanitary status of the shipment meets the phytosanitary regulations of the United States. PPQ employees can advise importers on phytosanitary restrictions and provide information (including regulations, policies and procedures) on bringing agricultural commodities into the United States.

Importers may obtain information or import permits by looking at the International Services ( www.aphis.usda.gov/is/) or by contacting:

Permit Unit
4700 River Road, Unit 136
Riverdale, MD 20737
Telephone : (877) 770-5990
Fax : (301) 734-5786

2. National Center for Import and Export (NCIE) Veterinary Services Import/Export ( www.aphis.usda.gov/vs/ncie/)

The APHIS Veterinary Services (VS) unit regulates the import and export of live animals, animal products, and biologics. VS monitors the health of these commodities, at the border, in case they are infected with foreign animal diseases, such as avian influenza or foot-and-mouth disease, that could threaten U.S. livestock populations.

Additional information regarding permit applications and information about import requirements and user fees related to importing animals, birds and animal products, can be obtained from:

National Center for Import/Export
4700 River Road, unit 40
Riverdale, MD 20737-1231
Telephone : (301) 734-3277/8364
Fax : (301) 734-4704/8226

D.  U.S. Customs and Border Protection ( www.customs.gov/)

Customs and Border Protection assists the FDA in the execution of the prior notice requirements in 21 U.S.C. § 381(m) and its implementing regulations.  It collects samples of products upon FDA request and forwards these samples to the FDA.

E. U.S. Department of Agriculture ( www.usda.gov/wps/portal/usdahome)

1.  Foreign Agriculture Service ( http://www.fas.usda.gov/)

The Foreign Agricultural Service (FAS) is a part of the U.S. Department of Agriculture (USDA).  It works to improve foreign market access for U.S. products, build new markets, improve the competitive position of U.S. agriculture in the global marketplace, and provide food aid and technical assistance to foreign countries.  Staff are readily available to provide assistance to exporters of food products. 

2.  Food Safety and Inspection Service ( www.fsis.usda.gov/)

As stated above, the FSIS is involved in the inspection of food that is produced both domestically and in other countries.  Information about regulations can be obtained at www.fsis.usda.gov/Regulations_&_Policies/index.asp.  Additional assistance can be obtained by contacting:

International Policy Division
Food and Safety Inspection Service
U.S. Department of Agriculture
Washington, D.C. 20250
Telephone : 202-720-3473

F.  National Marine Fisheries ( www.nmfs.noaa.gov/)

NOAA's National Marine Fisheries Service, a division of the Department of Commerce, is the federal agency responsible for the management, conservation and protection of living marine resources within the United States' Exclusive Economic Zone (water three to 200 mile offshore).  Receiving its charge and funding under a variety of federal laws, it protects endangered species, collects data relative to environmental studies, and acts to prohibit transactions which violate state, federal, native American tribal, or foreign laws. 

G. U.S. Fish and Wildlife Service ( www.fws.gov/)

All imported wildlife products are inspected by the U.S. Fish and Wildlife Service upon entry into the United States.  Importers must obtain export permits from the country of origin and U.S. import permits to import the wildlife.  Oftentimes, samples will be analyzed by NOAA before full scale importing is allowed.  In this case, the importer will have to follow strict procedures in order to ensure that samples arrive safely and legally at NOAA laboratories.

H. Environmental Protection Agency ( EPA) : Pesticide Residue Limits on Food ( www.epa.gov/pesticides/food/viewtols.htm)

EPA sets limits on how much of a pesticide residue can remain on food. These pesticide residue limits are known as tolerances. Inspectors from the Food and Drug Administration and the United States Department of Agriculture monitor food in interstate commerce to ensure that these limits are not exceeded.  The tolerance information is found in 40 Code of Federal Regulations (CFR) 180 “Tolerances and Exemptions from Tolerances for Pesticide Chemicals in Food”.

II. Treaties Touching On International Commerce Of Agricultural Products And Food

A.  World Trade Organization (WTO) (www.wto.org/english/thewto_e/whatis_e/tif_e/agrm3_e.htm)

One of the major treaties with which the U.S. is involved, and one frequently in the news, is the World Trade Organization.  This successor to the General Agreement on Tariffs and Trade (GATT) has been charged with reducing the restrictions on trade among the member countries.  Although not the only issue in dispute, it is struggling with a liberalization of member countries’ support of their agricultural industries and the balancing of the needs and goals of first world and third world countries.

B.  Agreement on Application of Sanitary and Phytosanitary Measures (SPS Agreement)


The SPS Agreement recognizes the fundamental right of countries to protect the health and life of their consumers, animals, and plants against pests, diseases, and other threats to health.

C. Agreement on Technical Barriers to Trade (TBT Agreement)

The TBT Agreement, which applies to agricultural products, helps to ensure that technical regulations and product standards do not create obstacles to trade.  It permits technical regulations designed to meet legitimate national objectives, including protection of human health, safety, animal or plant life or health, or the environment. Regulations must not be more trade-restrictive than necessary to fulfil a legitimate objective. When international standards exist, WTO Members should use those standards as the basis for their technical regulations (Arts. 1, 2). The TBT Agreement does not apply to measures governed by the Agreement on the Application of Sanitary and Phytosanitary Measures, which applies to issues of food safety, as well as animal and plant health (Art. 1)

D. The Cartagena Protocol on Biosafety to the Convention on Biological Diversity (Montreal 2000) (www.biodiv.org/doc/legal/cartagena-protocol-en.pdf)

This Protocol treats the “transfer, handling and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on the conversation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.”

The Protocol provides for adoption of a process for development of international rules governing liability and redress for damage from transboundary movements of LMOs.

Further resources relative to international free trade agreements between the U. S. and other countries are available on www.customs.gov/xp/cgov/import/international_agreements/free_

Special Trade Programs are available on www.customs.gov/xp/cgov/import/international_agreements/special_



Back to Top