H.R. 4473 — To make persons who are nationals of countries that are members of the European Community ineligible to certify products produced outside the United States for compliance with standards and requirements established by the food and Drug Administration for medical devices, electronic products, infant formula, animal feeds and drugs, drugs intended for human use, food, and color additives until the Secretary of Commerce certifies that the European Community is setting product standards and requirements in an open and fair manner and has established equitable rules for testing and certifying products for compliance with product standards and requirements.

 
HR 4473 IH
101st CONGRESS
2d Session
 H. R. 4473
To make persons who are nationals of countries that are members of the
European Community ineligible to certify products produced outside the
United States for compliance with standards and requirements established by
the Food and Drug Administration for medical devices, electronic products,
infant formula, animal feeds and drugs, drugs intended for human use,
food, and color additives until the Secretary of Commerce certifies that
the European Community is setting product standards and requirements in an
open and fair manner and has established equitable rules for testing and
certifying products for compliance with product standards and requirements.
IN THE HOUSE OF REPRESENTATIVES
April 4, 1990
Mr. GEJDENSON (for himself and Mr. MILLER of Washington) introduced the
following bill; which was referred to the Committee on Energy and Commerce
A BILL
To make persons who are nationals of countries that are members of the
European Community ineligible to certify products produced outside the
United States for compliance with standards and requirements established by
the Food and Drug Administration for medical devices, electronic products,
infant formula, animal feeds and drugs, drugs intended for human use,
food, and color additives until the Secretary of Commerce certifies that
the European Community is setting product standards and requirements in an
open and fair manner and has established equitable rules for testing and
certifying products for compliance with product standards and requirements.
  Be it enacted by the Senate and House of Representatives of the United
  States of America in Congress assembled,
SECTION 1. PRODUCT STANDARDS AND REQUIREMENTS OF FOOD AND DRUG ADMINISTRATION.
  Until the certification required by section 2 is made, any person who is
  a national of a country that is a member of the European Community shall
  not be eligible to certify the compliance of any product produced outside
  the United States with--
  (1) any performance standard or requirement established under subpart 3
  of part F of title III of the Public Health Service Act (42 U.S.C. 263b
  and following) for electronic products;
  (2) any performance standard or requirement established under section 514
  of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d) for devices
  intended for human use;
  (3) any standard or requirement established under the Federal Food, Drug,
  and Cosmetic Act for an animal feed or new animal drug;
  (4) any standard or requirement established under section 412 of the
  Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a) for infant formula;
  (5) any standard or requirement established under the Federal Food, Drug,
  and Cosmetic Act for any drug intended for human use or for any food; or
  (6) any standard or requirement established under section 706 of the
  Federal Food, Drug, and Cosmetic Act for any color additive.
SEC. 2. CONDITIONS FOR LIFTING RESTRICTIONS.
  (a) CERTIFICATION BY SECRETARY OF COMMERCE- The restrictions set forth
  in section 1 shall remain effective until the Secretary of Commerce,
  in consultation with the United States Trade Representative, certifies
  to the Committee on Foreign Affairs of the House of Representatives and
  other appropriate committees in the Congress that the European Community
  is setting product standards and requirements in an open and fair manner
  and has established equitable rules for testing and certifying products
  for compliance with standards and requirements of the European Community
  by laboratories that are located in countries that are not members of
  the European Community. In making such certification, the Secretary
  shall examine the extent to which the European Commission, CEN/CENELEC,
  ETSI, and any regional standards organization composed of members of the
  European Community--
  (1) share drafts of product standard or requirement directives of the
  European Commission and product standards or requirements developed by
  CEN/CENELEC, ETSI, and any such regional standards organization with all
  interested persons who are nationals of countries that are not members
  of the European Community, including persons who are nationals of the
  United States, at all stages of the process to set product standards or
  requirements, particularly at the working group level;
  (2) allow individuals who are citizens of countries that are not members
  of the European Community to participate as observers in CEN/CENELEC,
  ETSI, and any such regional standards organization;
  (3) consistently utilize internationally developed and internationally
  recognized standards and requirements as the basis for their regional
  standards activities;
  (4) allow the continuation of existing mutual recognition agreements
  between entities in the United States and countries that are members of
  the European Community; and
  (5) establish a testing and certification policy which allows persons
  who are nationals of the United States to test and certify, in the United
  States, products made in the United States for compliance with standards
  and requirements of the European Community if the competence of the
  persons testing and certifying the products can be established pursuant
  to internationally recognized criteria.
  (b) NOTIFICATION OF SECRETARY OF HEALTH AND HUMAN SERVICES- The Secretary
  of Commerce shall notify the Secretary of Health and Human Services of
  any certification made under subsection (a).
SEC. 3. CONTINUATION OF BILATERAL AGREEMENTS.
  Nothing in this Act shall be construed to cause the cancellation or
  suspension of mutual recognition agreements between the United States and
  other countries.
SEC. 4. DEFINITIONS.
  For purposes of this Act--
  (1) a person is a `national' of a foreign country if that person--
  (A) is a citizen of that foreign country;
  (B) is located outside the United States and is organized under the laws
  of that foreign country or has its principal place of business in that
  foreign country; or
  (C) is located outside the United States and at least 50 percent of the
  securities or other evidences of ownership of which is owned or controlled
  by persons described in subparagraph (A) or (B);
  (2) a person is a `national' of the United States if that person--
  (A) is a citizen of the United States; or
  (B) is organized under the laws of the United States or has its principal
  place of business in the United States;
  (3) the term `United States' means the several States, the District of
  Columbia, and any territory or possession of the United States;
  (4) the term `CEN' means the Comite European de Normalisation of the
  European Community;
  (5) the term `CENELEC' means the Comite European de Normalisation
  Electronique of the European Community;
  (6) the term `ETSI' means the European Telecommunications Standards
  Institute of the European Community; and
  (7) the term `mutual recognition agreement' means an agreement between
  two parties of different countries, whether private or governmental, that
  provides for the recognition by each party, for purposes of compliance
  with the mandatory or voluntary standards and requirements of the country
  of that party, of facilities located in the country of the other party
  for the testing and certification of products.
Sponsors

Subjects

Summary

Full Text

Legislative Actions

Ask about this bill
