All 68 Stat. 517. Education, and Welfare with any certification of usefulness under this subsection an opinion, based on the data before him, whether the tolerance or exemption proposed by the petitioner reasonably reflects the amount of residue likely to result when the pesticide chemical is used in the manner proposed for the purpose for which the certification is made. The Secretary of Agriculture, after due notice and opportunity Regulations, eto. for public hearing, is authorized to promulgate rules and regulations for carrying out the provisions of this subsection. "(m) The Secretary of Health, Education, and Welfare shall pre- HEW procedure scribe by regulations the procedure by which regulations under this for regulation section may be amended or repealed, and such procedure shall con- amendment. form to the procedure provided in this section for the promulgation of regulations establishing tolerances, including the appointment of advisory committees and the procedure for referring petitions to such committees. "(n) The provisions of section 303 (c) of the Federal Food, Drug, Guaranties. and Cosmetic Act with respect to the furnishing of guaranties shall be 21 USC 333. applicable to raw agricultural commodities covered by this section. (o) The Secretary of Health, Education, and Welfare shall by Payment of regulation require the payment of such fees as will in the aggregate, fees. in the judgment of the Secretary, be sufficient over a reasonable term to provide, equip, and maintain an adequate service for the performance of the Secretary's functions under this section. Under such regulations, the performance of the Secretary's services or other functions pursuant to this section, including any one or more of the following, may be conditioned upon the payment of such fees: (1) The acceptance of filing of a petition submitted under subsection (d); (2) the promulgation of a regulation establishing a tolerance, or an exemption from the necessity of a tolerance, under this section, or the amendment or repeal of such a regulation; (3) the referral of a petition or proposal under this section to an advisory committee; (4) the acceptance for filing of objections under subsection (d) (5); or (5) the certification and filing in court of a transcript of the proceedings and the record under subsection (i) (2). Such regulations may further pro-Waiver or vide for waiver or refund of fees in whole or in part when in the refund. judgment of the Secretary such waiver or refund is equitable and not contrary to the purposes of this subsection." SEC. 4. There are hereby authorized to be appropriated, out of any Appropriation. moneys in the Treasury not otherwise appropriated, such sums as may be necessary for the purpose and administration of this Act. SEC. 5. This Act shall take effect upon the date of its enactment, Effective except that with respect to pesticide chemicals for which tolerances or dates. exemptions have not been established under section 408 of the Federal Ante, p. Food, Drug, and Cosmetic Act, the amendment to section 402 (a) 21 USC 342. of such Act made by section 2 of this Act shall not be effective (1) for the period of one year following the date of the enactment of this Act; or (2) for such additional period following such period of one year, but not extending beyond two years after the date of the enactment of this Act, as the Secretary of Health, Education, and Welfare may prescribe on the basis of a finding that conditions exist which necessitate the prescribing of such additional period. Approved July 22, 1954. To amend section 402 (c) of the Federal Food, Drug, and Cosmetic Act, with respect to the coloring of oranges. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That paragraph (c) Oranges. of section 402 of the Federal Food, Drug, and Cosmetic Act, as 52 Stat. 1046. amended, is amended by inserting immediately before the period at 21 USC 342. the end thereof a colon and the following: "Provided further, That this paragraph shall not apply to oranges meeting minimum maturity standards established by or under the laws of the States in which the oranges were grown and not intended for processing (other than 70 Stat. 512. oranges designated by the trade as 'packing house elimination'), the 70 Stat. 513. skins of which have been colored at any time prior to March 1, 1959, with the coal-tar color certified prior to the enactment of this proviso as F. D. & C. Red 32, or certified after such enactment as External D. & C. Red 14 in accordance with section 21, Code of Federal Regula- 21 CFR Part 9. tions, part 9: And provided further, That the preceding proviso shall have no further effect if prior to March 1, 1959, another coal-tar color suitable for coloring oranges is listed under section 406". Approved July 9, 1956. (58) 21 USC 346. 84th Congress Chapter 861 - 2d Session To amend sections 401 and 701 (e) of the Federal Food, Drug, and Cosmetic Act so as to simplify the procedures governing the prescribing of regulations under certain provisions of such Act, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 401 of Federal Food, the Federal Food, Drug, and Cosmetic Act (21 U. S. C., sec. 341) is Drug, and amended by striking out "(a)" where it appears after "SEC. 401.", and subsection (b) of such section is repealed. "Cosmetio Aot, SEC. 2. Section 701 (e) of such Act (21 U. S. C., sec. 371 (e)) is amended to read as follows: "(e) (1) Any action for the issuance, amendment, or repeal of any Regulations. regulation under section 401, 403 (j), 404 (a), 406 (a) or (ɓ),501 (b), 502 (d) or (h), 504, or 604, of this Act shall be begun by a proposal 21 USC 343, 344 made (A) by the Secretary on his own initiative, or (B) by petition 346, 351, 352, of any interested person, showing reasonable grounds therefor, filed 354, 364. with the Secretary. The Secretary shall publish such proposal and shall afford all interested persons an opportunity to present their views thereon, orally or in writing. As soon as practicable thereafter, the Secretary shall by order act upon such proposal and shall make such order public. Except as provided in paragraph (2), the order shall become effective at such time as may be specified therein, but not prior to the day following the last day on which objections may be filed under such paragraph. "(2) On or before the thirtieth day after the date on which an order Hearings. entered under paragraph (1) is made public, any person who will be adversely affected by such order if placed in effect may file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating the grounds therefor, and requesting a public hearing upon such objections. Until final action upon such objections is taken by the Secretary under paragraph (3), the filing of such objections shall operate to stay the effectiveness of those provisions of the order to which the objections are made. As Notice in Fedsoon as practicable after the time for filing objections has expired the eral Register. Secretary shall publish a notice in the Federal Register specifying those parts of the order which have been stayed by the filing of objections and, if no objections have been filed, stating that fact. (3) As soon as practicable after such request for a public hearing, the Secretary, after due notice, shall hold such a public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. At the hearing, any interested person may be heard in person or by representative. As soon as practicable after Issuance of completion of the hearing, the Secretary shall by order act upon such order by objections and make such order public. Such order shall be based Secretary. only on substantial evidence of record at such hearing and shall set forth, as part of the order, detailed findings of fact on which the order is based. The Secretary shall specify in the order the date on which it shall take effect, except that it shall not be made to take effect prior to the ninetieth day after its publication unless the Secretary finds that emergency conditions exist necessitating an earlier effective date, in which event the Secretary shall specify in the order his findings as to such conditions." Prior hear SEC. 3. In any case in which, prior to the enactment of this Act, a public hearing has been begun in accordance with section 401 of the ings. Federal Food, Drug, and Cosmetic Act upon a proposal to issue, amend, or repeal any regulation contemplated by such section, or has All 70. Stat. 920. been begun in accordance with section 701 (e) of such Act upon a proposal to issue, amend, or repeal any regulation contemplated by section 403 (j), 404 (a), 406 (a) or (b), 501 (b), 502 (d), 502 (h), 504, or 604 of such Act, the provisions of such section 401 or 701 (e), as the case may be, as in force immediately prior to the date of the enactment of this Act, shall be applicable as though this Act had not been enacted. Approved August 1, 1956. Public Law 85-250 85th Congress, H. R. 6456 August 31, 1957 AN ACT 71 Stat. 567. To amend section 304 (d) of the Federal Food, Drug, and Cosmetic Act, with respect to the disposition of certain imported articles which have been seized and condemned. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That subsection (d) Reexportation of section 304 of the Federal Food, Drug, and Cosmetic Act, as of articles. amended (21 U. S. Ç. 334 (d)), is hereby amended by inserting imme- 52 Stat. 1044. diately before the last sentence thereof a new sentence as follows: "If the article was imported into the United States and the person seeking its release establishes (1) that the adulteration, misbranding, or violation did not occur after the article was imported, and (2) that he had no cause for believing that it was adulterated, misbranded, or in violation before it was released from customs custody, the court may permit the article to be delivered to the owner for exportation in lieu of destruction upon a showing by the owner that all of the conditions of section 801 (d) can and will be met: Provided, however, 52 Stat. 1058. That the provisions of this sentence shall not apply where condemna- 21 USC 381. tion is based upon violation of section 402 (a) (1), (2), or (6), sec tion 501 (a) (3), section 502 (j), or section 601 (a) or (d): And pro- 52 Stat. 1046,1049 rided further, That where such exportation is made to the original 1050, 1054. foreign supplier, then clauses (1) and (2) of section 801 (d) and the 21 USC 342,351, foregoing proviso shall not be applicable; and in all cases of exporta- 352,361. tion the bond shall be conditioned that the article shall not be sold or disposed of until the applicable conditions of section 801 (d) have been met." |