14 1 new order shall be based only on substantial evidence of 2 record at such hearing, including any report, recommenda3 tions, underlying data, and reasons certified to the Secretary 4 by an advisory committee, and shall set forth detailed find5 ings of fact upon which the regulation is based. No such 6 order shall take effect prior to the ninetieth day after its 7 publication, unless the Secretary finds that emergency con8 ditions exist necessitating an earlier effective date, in which 9 event the Secretary shall specify in the order his findings as 10 to such conditions. 11 12 "JUDICIAL REVIEW "(h) In a case of actual controversy as to the validity 13 of any order issued under subsection (g), including any 14 order thereunder with respect to amendment or repeal of 15 a regulation issued under this section, any person who will 16 be adversely affected by such order may obtain judicial 17 review thereof in accordance with, and subject to, the 18 applicable provisions of section 408 (i). 19 20 225 "AMENDMENT OR REPEAL OF REGULATIONS "(i) The Secretary shall by regulation prescribe the 21 procedure by which regulations under the foregoing pro22 visions of this section may be amended or repealed, and 23 such procedure shall conform to the procedure provided 24 in this section for the promulgation of such regulations, in 25 cluding the appointment of advisory committees and the 15 1 procedure for referring petitions or proposals to such com 2 3 mittees. "EXEMPTIONS FOR INVESTIGATIONAL OR OTHER USE 4 "(j) The Secretary (1) shall promulgate regulations 5 providing for exempting froin the requirements of this sec6 tion any chemical additive, and any food bearing or con7 taining such additive, intended solely for investigational use 8 by experts qualified by scientific training and experience 9 to investigate the safety of such additive, and (2) may by 10 regulation exempt any other chemical additive, or any food 11 bearing or containing it, or both, when in his opinion such 12 exemption is consistent with the public health." 13 SEC. 6. Section 301 (j) of such Act is amended by 14 inserting "409" after "404,". 15 SEC. 7. (a) Except as otherwise provided in this sec16 tion, this Act shall take effect on the one hundred and 17 cightieth day (hereinafter referred to as the effective date of 18 this Act) after the date of its enactment. 19 (b) Any interested person desiring to do so may at any 20 time, after the date of enactment and prior to the effective 21 date of this Act, file a petition as provided in subsection (b) 22 of section 409 of the Federal Food, Drug, and Cosmetic 23 Act, as enacted by section 5 of this Act, in which event 24 the provisions of such section 409, and of section 201 (8) 25 and section 301 (j) of such Act as amended by this Act, 16 1 2 3 4 5 shall become effective immediately as applied to such peti tion and to proceedings thereon; but nothing in this subsec tion shall be construed to accelerate the effective date of the remaining provisions of this Act. (c) Where a chemical additive was in use for one or 6 more purposes immediately prior to the date of enactment of this Act, the amendments to sections 402 (a) and 406 (a) 7 8 of the Federal Food, Drug, and Cosmetic Act made by 9 section 4 of this Act shall not, as applied to such preexisting 10 use or uses of such additive, become effective until (1) the final establishment of a regulation or exemption relating to such use or uses pursuant to section 409 of such Act or the final denial of a petition for such regulation or exemption (without, in either case, further opportunity for referral to an advisory committee, for an administrative hearing, or for judicial review); or (2), if earlier, the expiration of either (A) the one-year period beginning on the date following the effective date of this Act, or (B) such additional period (not extending beyond two years after the effective date of this Act) as the Secretary of Health, Education, and Welfare may prescribe on the basis of a finding that such extension involves no undue risk to the public 17 1 health and that conditions exist which necessitate the 2 prescribing of such additional period. 3 SEC. 8. There are hereby authorized to be appropriated, 4 out of any money in the Treasury not otherwise appropri 5 ated, such sums as may be necessary for the administration 6 7 of this Act. SEC. 9. Nothing in this Act shall be construed to ex8 empt any meat or meat food product or any person from 9 any requirement imposed by or pursuant to the Meat Inspec10 tion Act of March 4, 1907, 34 Stat. 1260, as amended and 11 extended (21 U. S. C. 71 and the following). |