1 11 son who has filed a petition or who has requested the referral 2 of a proposal to an advisory committee, as well as repre3 sentatives of the Department of Health, Education, and 4 Welfare, shall have the right to consult with such advisory 5 committee in connection with the matter referred to it. 6 7 "(2) Within sixty days after the date of such referral, or within an additional thirty days if the committee deems 8 such additional time necessary, the committee shall, after 9 independent study of the data furnished to it by the Sec10 retary and other data before it, certify to the Secretary a 11 report and recommendations, together with all underlying 12 data and a statement of the reasons or basis for the recom13 mendations. Within thirty days after such certification, 14 and after giving due consideration to all data then before 15 him, including such report, recommendations, underlying 16 data, and statement, and to any prior order issued by him 17 in connection with such matter, the Secretary shall confirm 18 or modify any order theretofore issued or, if no such order 19 has been issued, shall establish a regulation announcing, 20 with respect to any particular use or uses of the chemical 21 additive involved, the conditions under which such additive may be safely used or refuse to establish a regulation. 22 23 "(3) The Secretary may by regulation condition re24 ferrals to advisory committees pursuant to this subsection upon the payment, by the person requesting the referral, 25 12 1 of fees to defray the costs arising by reason of such referrals. 2 Such regulations may provide for waiver or refund of fees 3 in whole or in part when in the judgment of the Secretary 4 such waiver or refund is equitable and not contrary to the 5 purposes of this subsection. Such fees, including advance 6 deposits to cover such fees, shall be available, until ex7 pended, for paying (directly or by way of reimbursement 8 of the applicable appropriation) the expenses of advisory 9 committees under this subsection and other expenses arising 10 by reason of referrals to such committees, and for refunds 11 pursuant to this paragraph. 12 13 "PUBLICATION AND EFFECTIVE DATE OF ORDERS "(f) Any order, including any regulation established 14 by such order, issued under subsection (c), (d), or (e) of 15 this section, shall be published and shall be effective upon 16 publication, but the Secretary may stay such effectiveness 17 it after issuance of such order the petition or any ques18 tion of fact raised thereby is referred to an advisory com19 mittec pursuant to subsection (e) or if a hearing is sought 20 with respect to such order pursuant to subsection (g). 21 22 2 23 "OBJECTIONS AND PUBLIC HEARING “(g) Within thirty days after publication, any person 23 adversely affected by an order made pursuant to subsection 24 (c), (d), or (e) of this section may file objections thereto 25 with the Secretary, specifying with particularity the pro 13 1 visions of the order deemed objectionable, stating reasonable 2 grounds therefor, and requesting a public hearing upon such 3 objections: Provided, That if, after issuance of an order 4 under subsection (c), the right of referral to an advisory 5 committee is invoked, only the order thereafter issued pur6 suant to subsection (e) after receipt of the advisory com7 mittee's report shall be subject to such objections and public 8 hearing. The Secretary shall thereupon, after duc notice, 9 hold such public hearing for the purpose of receiving evi10 dence relevant and material to the issues raised by such ob11 jections. Any report, recommendations, underlying data, 12 and reasons certified to the Secretary by an advisory com13 mittee shall be made a part of the record of the hearing 14 if relevant and material, subject to the provisions of section 15 7 (c) of the Administrative Procedure Act (5 U. S. C., sec. 1006 (c)). The advisory committee shall designate a 17 member to appear and testify at any such hearing with 18 respect to the report and recommendations of such committee 19 upon request of the Secretary, the petitioner, or the officer 20 conducting the hearing, but this shall not preclude any other 21 member of the advisory committee from appearing and 22 testifying at such hearing. As soon as practicable after com23 pletion of the hearing, the Secretary shall act upon such 24 objections and shall by published order either confirm or 25 modify the order to which objections have been filed. Such 16 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 23 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). 19 220 66 "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, in25 cluding the appointment of advisory committees and the 13 1 visions of the order deemed objectionable, stating reasonable 2 grounds therefor, and requesting a public hearing upon such 3 objections: Provided, That if, after issuance of an order 4 under subsection (c), the right of referral to an advisory 5 committee is invoked, only the order thereafter issued pur6 suant to subsection (e) after receipt of the advisory com7 mittee's report shall be subject to such objections and public 8 hearing. The Secretary shall thereupon, after due notice, 9 hold such public hearing for the purpose of receiving evi10 dence relevant and material to the issues raised by such ob11 jections. Any report, recommendations, underlying data, 12 and reasons certified to the Secretary by an advisory com13 mittee shall be made a part of the record of the hearing 14 if relevant and material, subject to the provisions of section 15 7 (c) of the Administrative Procedure Act (5 U. S. C., 16 sec. 1006 (c)). The advisory committee shall designate a 17 member to appear and testify at any such hearing with 18 respect to the report and recommendations of such committee upon request of the Secretary, the petitioner, or the officer 20 conducting the hearing, but this shall not preclude any other 21 member of the advisory committee from appearing and 22 testifying at such hearing. As soon as practicable after com23 pletion of the hearing, the Secretary shall act upon such 24 objections and shall by published order either confirm or 25 modify the order to which objections have been filed. Such 19 |