On February 24, 2010, a bill was introduced in the U.S. House of Representatives that would require foreign manufacturers of certain products imported into the United States to establish registered agents in this country who are authorized to accept service of process against such manufacturers. Of particular importance is the provision of the bill establishing that by registering an agent, the foreign manufacturer would thereby consent to personal jurisdiction of the state and federal courts in the state where the agent is located. This consent would be for the purposes of any civil or regulatory proceeding.

H.R. 4678, the Foreign Manufacturers Legal Accountability Act of 2010, would apply to a wide variety of, but not all, manufactured products. “Covered products” under the bill include drugs, devices and cosmetics as defined in Section 201 of the Federal Food, Drug and Cosmetic Act; biological products as defined in Section 351(i) of the Public Health Service Act; consumer products as defined in Section 3(a) of the Consumer Products Safety Act; chemical substances as defined in Section 3 of the Toxic Substances Control Act; and pesticides as defined in Section 2 of the Federal Insecticide, Fungicide, and Rodenticide Act. Noticeably absent from the list of covered products are automotive products, such as cars, tires and component automotive products.

U.S. Agency Responsibilities

Under the legislation, the heads of the Food and Drug Administration, the Consumer Product Safety Commission and the Environmental Protection Agency would be charged with requiring foreign manufacturers or producers to establish the registered agents in a state with a “substantial connection” to the importation, distribution or sale of their products. The bill does not define or provide guidance as to just what constitutes a substantial connection to a state where a product is imported, distributed or sold.

Also under H.R. 4678, the Secretary of Commerce would (in cooperation with the head of each of the three agencies) establish a registry of agents. The registry would be made available to the public through the Internet website of the Department of Commerce.

Beginning 180 days after enactment of applicable regulations, the importation to the United States of a covered product by a manufacturer or producer who does not have a registered agent would be prohibited. The Secretary of Homeland Security would be charged with prescribing regulations to enforce the import prohibition. The bill also contemplates expanding the registered agent requirements to foreign producers of food distributed in the United States. The Secretary of Agriculture and the Commissioner of Food and Drugs would be required to submit a joint report to Congress within a year of enactment commenting on the feasibility and advisability of applying the requirements of this bill to foreign producers of food.

A similar bill was introduced in the U.S. Senate on August 6, 2009. Senate Bill 1606, the Foreign Manufacturers Legal Accountability Act of 2009, is in committee pending further action.