74 STAT. 405. (b) Subject to the other provisions of this section 21 USC 346, (1) any color additive which, on the day preceding the enactment date, was listed and certifiable for any use or uses under section 406(b), 504, or 604, or under the third proviso of section 52 Stat. 1049, 402 (c), of the basic Act, and of which a batch or batches had 1052, 1055, been certified for such use or uses prior to the enactment date, and 1047. (2) any color additive which was commercially used or sold prior to the enactment date for any use or uses in or on any food, 342. drug, or cosmetic, and which either, (A), on the day preceding the enactment date, was not a material within the purview of any of the provisions of the basic Act enumerated in paragraph (1) of this subsection, or (B) is the color additive known as synthetic beta-carotene, shall, beginning on the enactment date, be deemed to be provisionally listed under this section as a color additive for such use or uses. (c) Upon request of any person, the Secretary, by regulations issued under subsection (d), shall without delay, if on the basis of the data before him he deems such action consistent with the protection of the public health, provisionally list a material as a color additive for any use for which it was listed, and for which a batch or batches of such material had been certified, under section 406(b), 504, or 604 of the basic Act prior to the enactment date, although such color was no longer listed and certifiable for such use under such sections on the day preceding the enactment date. Such provisional listing shall take effect on the date of publication. (d) (1) The Secretary shall, by regulations issued or amended from time to time under this section (A) insofar as practicable promulgate and keep current a list or lists of the color additives, and of the particular uses thereof, which he finds are deemed provisionally listed under subsection (b), and the presence of a color additive on such a list with respect to a particular use shall, in any proceeding under the basic Act, be conclusive evidence that such provisional listing is in effect; (B) provide for the provisional listing of the color additives and particular uses thereof specified in subsection (c); (C) provide, with respect to particular uses for which color additives are or are deemed to be provisionally listed, such temporary tolerance limitations (including such limitations at zero level) and other conditions of use and labeling or packaging requirements, if any, as in his judgment are necessary to protect the public health pending listing under section 706 of the basic 52 Stat. 1058. Act; (D) provide for the certification of batches of such color additives (with or without diluents) for the uses for which they are so listed or deemed to be listed under this section, except that such an additive which is a color additive deemed provisionally listed under subsection (b) (2) of this section shall be deemed exempt from the requirement of such certification while not subject to a tolerance limitation; and (E) provide for the termination of a provisional listing (or deemed provisional listing) of a color additive or particular use thereof forthwith whenever in his judgment such action is necessary to protect the public health. (2) (A) Except as provided in subparagraph (C) of this paragraph, regulations under this section shall, from time to time, be issued, amended, or repealed by the Secretary without regard to the requirements of the basic Act, but for the purposes of the application of section 706 (e) of the basic Act (relating to fees) and of determining the availability of appropriations of fees (and of advance deposits 21 USC 376. 2 3 74 STAT. 406. to cover fees), proceedings, regulations, and certifications under this (B) If the Secretary, by regulation (i) has terminated a provisional listing (or deemed provisional listing) of a color additive or particular use thereof pursuant to paragraph (1) (E) of this subsection; or (ii) has, pursuant to paragraph (1)(C) or paragraph (3) of any person adversely affected by such action may, prior to the expira- (C) Any person adversely affected by an order entered under subparagraph (B) of this paragraph may, within thirty days after its publication, file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds for such objections, and requesting a public hearing upon such objections. The Secretary shall hold a public hearing on such objections and shall, on the basis of the evidence adduced at such hearing, act on such objections by published order. Such order may reinstate a terminated provisional listing, or increase or dispense with a previously established temporary tolerance limitation, or make less restrictive any other limitation established by him under paragraph (1) or (3) of this subsection, only if in his judgment the evidence so adduced shows that such action will be consistent with the protection of the public health. An order entered under this subparagraph shall be subject to judicial review in accord| 52 Stat. 1055. ance with section 701 (f) of the basic Act except that the findings and order of the Secretary shall be sustained only if based upon a fair evaluation of the entire record at such hearing. No stay or suspension of such order shall be ordered by the court pending conclusion of such judicial review. 21 USC 371. (D) On and after the enactment date, regulations, provisional listings, and certifications (or exemptions from certification) in effect. under this section shall, for the purpose of determining whether an article is adulterated or misbranded within the meaning of the basic Act by reason of its being, bearing, or containing a color additive, have the same effect as would regulations, listings, and certifications (or exemptions from certification) under section 706 of the basic Act. 74 STAT. 407. A regulation, provisional listing or termination thereof, tolerance imitation, or certification or exemption therefrom, under this section shall not be the basis for any presumption or inference in any proceeding under section 706 (b) or (c) of the basic Act. (3) For the purpose of enabling the Secretary to carry out his functions under paragraphs (1) (A) and (C) of this subsection with respect to color additives deemed provisionally listed, he shall, as soon as practicable after enactment of this Act, afford by public notice a reasonable opportunity to interested persons to submit data relevant thereto. If the data so submitted or otherwise before him do not, in his judgment, establish a reliable basis for including such a color additive or particular use or uses thereof in a list or lists promulgated under paragraph (1)(A), or for determining the prevailing level or levels of use thereof prior to the enactment date with a view to prescribing a temporary tolerance or tolerances for such use or uses under paragraph (1)(C), the Secretary shall establish a temporary tolerance limitation at zero level for such use or uses until such time as he finds that it would not be inconsistent with the protection of the public health to increase or dispense with such temporary tolerance limitation. EFFECT ON MEAT INSPECTION AND POULTRY PRODUCTS INSPECTION ACTS SEC. 204. Nothing in this Act shall be construed to exempt any meat or meat food product, poultry or poultry product, or any person from any requirement imposed by or pursuant to the Meat Inspection Act of March 4, 1907, 34 Stat. 1260, as amended or extended (21 U.S.C. 71 and the following), or the Poultry Products Inspection Act (21 71 Stat. 441. U.S.C. 451 and the following). Approved July 12, 1960. 4 Absolute criminal liability, §3.14.2(1) [citations are to sections] Addressees, difference in, as principle to distinguish Adjudication, substantial evidence upon judicial review Administrative complexity, §3.5, §5.3 Administrative Procedure Act, generally, §3.15 exercise in drafting, §3.13 Advance appropriations, $3.6 Advance payments, authority for, with respect to do- Aid to Families with Dependent Children, §3.6, §3.8, Allotments to states formula for, with respect to domestic violence pro- See also App. B Ambiguity in drafting, §1.5, §5.1, §5.2, §5.4 Amendatory bill, ch. 4, passim See also specific topic Amendatory legislation, similarity to free-standing bill, Amending amendments, $4.7.3 Amendments, in general amendatory techniques, ch. 4, passim amendments to, §4.7.3 checklist, use of drafting outline as, §4.2 "cut and bite", §4.6.2 grouping by subject, §4.3 implication, amendment by, $4.7.2 restatement, amendment by, $4.6.2 Amendments to domestic violence proposal, see Do- American Samoa, inclusion in definition of "State", "And", convention in use of, $5.9 Anticipating all cases, $3.5 Northern Marianas Complexity of administration, $3.5 Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of Comprehensive definitions, $3.4.2 Comptroller General, access to records, $3.8 Conforming amendments, $4.6.3, §4.6.1 Congress, relation of authorizing committee to ap- propriating committee, $3.6 Congressional Budget Act of 1974, $3.6 Consistency of expression, $5.2 Consumer Product Safety Act. P.L. 92-573, §3.12 Contract, liquidation of, $3.6 "Contract", meaning affected by Fed. Grant & Coop. Agr'm't Act, $3.4.1 Contract Work Hours Standards Act, $3.8 Cooperative agreement, $3.4.3 Corporation included in the term "person", $3.4.1(5) Criminal intent. $3.14.2 Criminal liability, $3.14.2(1) Criminal penalties, see Penalty provisions Cross reference style in draft bill, $2.10 draft bill, App. M draft bill making amendments to, App. R specifications for amendments to, App. N territories, inclusion of, §1.5(1) unordered sections, App. F Draft bills, generally administrative provisions, $2.6 appropriations authorizations, $3.6 Early involvement of the draftsman, §1.2 Egg Products Inspection Act, §2.2, §2.3, §2.6, App. E Evaluating specifications, §1.2, §1.3 administrative provisions, App. M (sec. 9) conceptual distinctiveness of sections, §2.2 conforming amendment, §4.6.3 "cut and bite" amendments, $4.6.2 draft bill, free-standing, App. M |