By the authority vested in me as President by the Constitution of the United States of America, and in order to further the foreign policy interests of the United States and to provide for effective and responsible implementation of the Export Administration Act of 1979 (50 U.S.C. App. 2401 et. seq.) and other statutes insofar as they relate to the export of banned or significantly restricted substances, it is hereby ordered as follows:
1 - 1. Scope of the Order
1 - 101. For the purposes of this Order, the term "banned or significantly restricted substance" means:
(a) a food or class of food which
(1) is adulterated, as defined by rules or orders issued under Sec. 402 (a) or (c) (21 U.s.c. 342 (a) or (c)), or
(2) is in violation of emergency permit controls issued under Sec. 404 (21 U.S.C. 344) of the Federal Food, Drug, and Cosmetic Act;
(b) a drug which is
(1) adulterated, as defined by rules or orders issued under Sec. 501 (a), (b), (c), or (d) (21 U.S.C. 351 (a), (b), (c), or (d)),
(2) misbranded, as defined by rules or orders issued under Sec. 502(j) (21 U.S.C. 352(j)) or
(3) a new drug or new animal drug for which an approval is not in effect under
Sec. 505 (21 U.S.C. 355) or Sec. 512 (21 U.S.C. 360), respectively, of the Federal Food, Drug, and Cosmetic Act;
(c) an antibiotic drug which has not been certified under Sec. 507 (21 U.S.C. 357) of the Federal Food, Drug, and Cosmetic Act;
(d) a drug containing insulin which has not been certified under Sec. 506 (21 U.S.C. 356) of the Federal Food, Drug, and Cosmetic Act;
(e) a device which
(1) is adulterated, as defined by rules or orders issued under Sec. 501(a) (21 U.S.C. 351(a)),
(2) is misbranded, as defined by rules or orders issued under Sec. 502(j) (21 U.S.C. 352(j)),
(3) does not conform with a performance standard issued under Sec. 514 (21 U.S.C. 360d),
(4) has not received premarket approval under Sec. 515 (21 U.S.C. 360e),or
(5) is banned under Sec. 516 (21 U.S.C. 360f) of the Federal Food, Drug, and Cosmetic Act;
(f) a cosmetic which is adulterated, as defined by rules or orders issued under Sec. 601 (21 U.S.C. 361) of the Federal Food, Drug, and Cosmetic Act;
(g) a food additive or color additive which is deemed unsafe within the meaning of Sec. 409 (21 U.S.C. 348) or Sec. 706 (21 U.S.C. 376), respectively, of the Federal Food, Drug, and Cosmetic Act;
(h) a biological product which has been propagated or manufactured and prepared at an establishment which does not hold a license as required by Sec. 351 (42 U.S.C. 262) of the Public Health Service Act;
(i) an electronic product which does not comply with a performance standard issued under Sec. 358 (42 U.S.C. 263f) of the Public Health Service Act;
(j) a consumer product which
(1) does not comply with a consumer product safety standard adopted under Secs. 7 and 9 (15 U.S.C. 2056 and 2058) other than one relating solely to labeling,
(2) has been declared to be a banned hazardous product under Secs. 8 and 9 (15 U.S.C. and 2058),
(3) presents a substantial product hazard under Sec. 15 (15 U.S.C. 2064), or
(4) is an imminently hazardous consumer product under Sec. 12 (15 U.S.C. 2061) of the Consumer Product Safety Act;
(k) a fabric, related material, or product which does not comply with a flammability standard (other than one relating to labeling) adopted under Sec. 4 (15 U.S.C. 1193) of the Flammable Fabrics Act;
(l) a product which is a banned hazardous substance (including a children's article) under Secs. 2 and 3 (15 U.S.C. 1261 and 1262) of the Federal Hazardous Substances Act;
(m)(1) a pesticide which, on the basis of potential risks to human health or safety or to the environment,
(A) has been denied registration for all or most significant uses under Sec. 3(c)(6) (7 U.S.C. 136a(c)(6)),
(B) has been classified for restricted use under Sec. 3(d)(1)(C) (7 U.S.C. 136a(d)(1)(C)),
(C) has had its registration cancelled or suspended for all or most significant uses under Sec. 6 (7 U.S.C. 136d),
(D) has been proceeded against and seized under Sec. 13(b)(3) (7 U.S.C. 136k), or
(E) has not had its registration cancelled, but requires an acknowledgement statement under Sec. 17(a)(2) (7 U.S.C. 136o(a)(2)) of the Federal Insecticide, Fungicide, and Rodenticide Act, or
(2) a pesticide chemical for which a tolerance has been denied or repealed under Sec. 408 (21 U.S.C. 346(a)) of the Federal Food, Drug, and Cosmetic Act; and
(n) a chemical substance or mixture
(1) which is subject to an order or injunction issued under Sec. 5(f)(3) (15 U.S.C. 2604(f)(3)),