1 2 3 4 5 6 7 the recommendations. Within thirty days after such certification, the Secretary, after giving due consideration to all the material, including such report and recommendations, then before him, shall issue an order approving the applica tion if he finds that the chemical additive is not a poisonous or deleterious substance or if it is that it is safe and required for its intended use, and that its intended use will serve a 8 purpose which will be useful to the consuming public; other 9 11 wise the Secretary shall issue an order within said thirty 10 days refusing to approve the application. In determining whether a chemical additive is safe under subsection (c) or 12 (d), the Secretary shall take into account the other ways in which the consumer may be affected by the same substance or other substances. 13 14 15 "(e) Within thirty days after the issuance of an order 16 under subsection (c) or (d), any person adversely affected 17 may file objections thereto with the Secretary specifying the 18 reasons he deems the order objectionable and requesting a 19 public hearing upon such objections. After furnishing due 20 notice, the Secretary shall thereupon hold a public hearing 21 for the purpose of receiving evidence relevant and material to the issues raised by such objections. Any report, recom23 mendations, underlying data and reasons certified to the 24 Secretary by an advisory committee shall be made a part 22 H. R. 4014-2 6 1 of the record of the hearing. The advisory committee shall 2 designate one of its members to appear and testify at any 3 such hearing with respect to its report and recommendations 4 upon request of the officer conducting the hearing or any 5 person adversely affected: Provided, That this shall not pre6 clude any other member of the advisory committee from 7 appearing and testifying at such hearing. As soon as prac8 ticable after completion of the hearing, the Secretary shall 9 act upon such objections and issue an order. Such order 10 shall be based only on substantial evidence of record at such 11 hearing, including any report, recommendations, underlying 12 data, and reasons certified to the Secretary by an advisory 13 committee, and shall set forth detailed findings of fact upon 14 which the order is based. No such order shall take effect 15 prior to the ninetieth day of its publication, unless the 16 Secretary finds that emergency conditions exist necessitating an earlier effective date, in which event he shall specify in 18 the order his findings as to such conditions. 17 19 "(f) Whenever an application is referred to an advisory 20 committee, the Secretary shall appoint a committee of com21 petent experts to review the application and to make a report 22 and recommendations thereon. Each such advisory com23 mittee shall be composed of experts qualified in the subject 24 matter of the application and of adequately diversified pro25 fessional background selected by the National Academy of 7 1 Sciences: Provided, That in the event of disability or refusal 2 of the National Academy of Sciences to act, the Secretary 3 shall select such a committee. The size of the committee 4 shall be determined by the Secretary. Members of an 5 advisory committee shall receive as compensation for their 6 services a reasonable per diem, which the Secretary shall 7 by rules and regulations prescribe, for time actually spent 8 in the work of the committee, and shall in addition be 9 reimbursed for their necessary traveling and subsistence ex10 penses while so serving away from their places of residence. 11 The members shall not be subject to any other provisions 12 of law regarding the appointment and compensation of em13 ployees of the United States. The Secretary shall furnish 14 the committee with adequate clerical and other assistance. "(g) Any person adversely affected, and representa16 tives of the Department of Health, Education, and Welfare, 17 shall have the right to consult with any advisory commit18 tee provided for in subsection (f) in connection with the 19 application. 15 225 20 "(h) Orders issued under this section, and orders 21 amending or repealing such orders, may be appealed by 22 any person adversely affected in accordance with the pro23 visions of section 505 (h): Provided, That the findings of 24 the Secretary shall be sustained if supported by substantial 25 evidence when considered on the record as a whole. 1 8 "(i) The Secretary shall promulgate regulations es2 tablishing the procedure by which orders issued under this 3 section may be amended or repealed, and such procedure 4 shall conform to the procedure provided in this section for 5 the promulgation of regulations, including the appointment 6 of advisory committees and the procedure for referring 7 applications to such committees. 8 "(j) The Secretary shall promulgate regulations ex9 empting from the operation of this section chemical additives 10 intended solely for investigational use by experts qualified 11 by scientific training and experience to investigate the safety 12 of such chemical additives." 13 SEC. 6. The Secretary of Health, Education, and Wel14 fare, by regulation, shall require the payment of such fees 15 for the performance of the Secretary's functions under this 16 statute as will in the aggregate, in the judgment of the 17 Secretary, be sufficient over a reasonable term to provide, 18 equip, and maintain an adequate service for such function. 19 SEC. 7. This statute shall take effect six months after 20 the date of its enactment. |