fied experts when in his opinion such exemption is consistent with the public health.

NOTE.-Section 201 of the Labor-Federal Security Appropriation Act, 1944 (21 U.S.C. 377), provides that the Secretary in carrying into effect this Act "is authorized to cooperate with associations and scientific societies in the revision of the United States Pharmacopeia and in the development of methods of analysis and mechanical and physical tests necessary to carry out the work of the Food and Drug Administration."

Effective date of Sec. 706. The Color Additive Amendments to the Federal Food, Drug, and Cosmetic Act took effect on the date of enactment, July 12, 1960, subject to the provisions of sec. 203, title II, of P.L. 86-618 which follows:

[Provisional Listings of Commercially Established Colors

[(a)(1) The purpose of this section is to make possible, on an interim basis for a reasonable period, through provisional listings, the use of commercially established color additives to the extent consistent with the public health, pending the completion of the scientific investigations needed as a basis for making determinations as to listing of such additives under the basic Act [the Federal Food, Drug, and Cosmetic Act] as amended by this Act. A provisional listing (including a deemed provisional listing) of a color additive under this section for any use shall, unless sooner terminated or expiring under the provisions of this section, expire (A) on the closing date (as defined in paragraph (2) of this subsection) or (B) on the effective date of a listing of such additive for such use under section 706 of the basic Act, whichever date first occurs.

[(2) For the purposes of this section, the term "closing date" means (A) the last day of the two and one-half year period beginning on the enactment date or (B), with respect to a particular provisional listing (or deemed provisional listing) of a color additive or use thereof, such later closing date as the Secretary may from time to time establish pursuant to the authority of this paragraph. The Secretary may by regulation, upon application of an interested person or on his own initiative, from time to time postpone the original closing date with respect to a provisional listing (or deemed provisional listing) under this section of a specified color additive, or of a specific use or uses of such additive, for such period or periods as he finds necessary to carry out the purpose of this section, if in the Secretary's judgment such action is consistent with the objective of carrying to completion in good faith, as soon as reasonably practicable, the scientific investigations necessary for making a determination as to listing such additive, or such specified use or uses thereof, under section 706 of the basic Act. The Secretary may terminate a postponement of the closing date at any time if he finds that such postponement should not have been granted, or that by reason of a change in circumstances the basis for such postponement no longer exists, or that there has been a failure to comply with a requirement for submission of progress reports or with other conditions attached to such postponement. [(b) Subject to the other provisions of this section

[(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 402(c), of the basic Act, and of which a batch or batches had been certified for such use or uses prior to the enactment date, and

[(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, 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 betacarotene,

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 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 to cover fees), proceedings, regulations, and certifications under this section shall be deemed to be proceedings, regulations, and certifications under such section 706. Regulations providing for fees (and advance deposits to cover fees), which on the day preceding the enactment date were in effect pursuant to section 706 of the basic Act, shall be deemed to be regulations under such section 706 as amended by this Act, and appropriations of fees (and advance deposits) available for the purposes specified in such section 706 as in effect prior to the enactment date shall be available for the purposes specified in such section 706 as so amended.

[(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 this subsection, initially established or rendered more restrictive a tolerance limitation or other restriction or requirement with respect to a provisional listing (or deemed provisional listing) which listing had become effective prior to such action, any person adversely affected by such action may, prior to the expiration of the period specified in clause (A) of subsection (a)(2) of this section, file with the Secretary a petition for amendment of such regulation so as to revoke or modify such action of the Secretary, but the filing of such petition shall not operate to stay or suspend the effectiveness of such action. Such petition shall, in accordance with regulations, set forth the proposed amendment and shall contain data (or refer to data which are before the Secretary or of which he will take official notice), which show that the revocation or modification proposed is consistent with the protection of the public health. The Secretary shall, after publishing such proposal and affording all interested persons an opportunity to present their views thereon orally or in writing, act upon such proposal by published order.

[(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 actions will be consistent with the protection of the public health. An order entered under this subparagraph shall be subject to judicial review in accordance 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.

[(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. A regulation, provisional listing or termination thereof, tolerance, limitation, 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.]

ADVERTISING OF CERTAIN FOODS

SEC. 707. [378] (a)(1) Except as provided in subsection (c), before the Secretary may initiate any action under chapter III—

(A) with respect to any food which the Secretary determines is misbranded under section 403(a)(2) because of its advertising,

or

(B) with respect to a food's advertising which the Secretary determines causes the food to be so misbranded,

the Secretary shall, in accordance with paragraph (2), notify in writing the Federal Trade Commission of the action the Secretary proposes to take respecting such food or advertising.

(2) The notice required by paragraph (1) shall—

(A) contain (i) a description of the action the Secretary proposes to take and of the advertising which the Secretary has determined causes a food to be misbranded, (ii) a statement of

the reasons for the Secretary's determination that such advertising has caused such food to be misbranded, and

(B) be accompanied by the records, documents, and other written materials which the Secretary determines supports his determination that such food is misbranded because of such advertising.

(b)(1) If the Secretary notifies the Federal Trade Commission under subsection (a) of action proposed to be taken under chapter III with respect to a food or food advertising and the Commission notifies the Secretary in writing, within the 30-day period beginning on the date of the receipt of such notice, that

(A) it has initiated under the Federal Trade Commission Act an investigation of such advertising to determine if it is prohibited by such Act or any order or rule under such Act,

(B) it has commenced (or intends to commence) a civil action under section 5, 13, or 19 with respect to such advertising or the Attorney General has commenced (or intends to commence) a civil action under section 5 with respect to such advertising,

(C) it has issued and served (or intends to issue and serve) a complaint under section 5(b) of such Act respecting such advertising, or

(D) pursuant to section 16(b) of such Act it has made a certification to the Attorney General respecting such advertising, the Secretary may not, except as provided by paragraph (2), initiate the action described in the Secretary's notice to the Federal Trade Commission.

(2) If, before the expiration of the 60-day period beginning on the date the Secretary receives a notice described in paragraph (1) from the Federal Trade Commission in response to a notice of the Secretary under subsection (a)—

(A) the Commission or the Attorney General does not commence a civil action described in subparagraph (B) of paragraph (1) of this subsection respecting the advertising described in the Secretary's notice,

(B) the Commission does not issue and serve a complaint described in subparagraph (C) of such paragraph respecting such advertising, or

(C) the Commission does not (as described in subparagraph (D) of such paragraph) make a certification to the Attorney General respecting such advertising, or, if the Commission does make such a certification to the Attorney General respecting such advertising, the Attorney General, before the expiration of such period, does not cause appropriate criminal proceedings to be brought against such advertising,

the Secretary may, after the expiration of such period, initiate the action described in the notice to the Commission pursuant to subsection (a). The Commission shall promptly notify the Secretary of the commencement by the Commission of such a civil action, the issuance and service by it of such a complaint, or the causing by the Attorney General of criminal proceedings to be brought against such advertising.