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the facilities and controls used for, the production of

such additive;

"(D) a description of practicable methods for quantitative determination of such additive, and its break

down or reaction products, in or on food referred to in the petition; and

"(E) full reports of investigations made with respect to the toxicity or other potentiality for harm of such additive, including full information as to the methods and controls used in conducting such investigations.

"(3) Upon request of the Secretary, the petitioner shall furnish samples of the chemical additive involved, or articles 14 used as components thereof, and of the food in or on which 15 the additive is proposed to be used.

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"(4) Notice of the regulation proposed by the petitioner 17 shall be published in general terms by the Secretary within 18 thirty days after filing.

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"ACTION ON THE PETITION

"(c) (1) As soon as practicable after the filing of the 21 petition, and in no event later than the expiration of the 22 applicable period specified in paragraph (2) of this subsec23 tion, the Secretary shall, in the absence of a prior referral or

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1 request for referral to an advisory committee made pursuant

2 to this section

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"(A) by order established a regulation (whether or not in accord with that proposed by the petitioner) announcing, with respect to one or more proposed uses

of the chemical additive involved, the conditions under which such additive may be safely used (including, but

not limited to, specifications as to the particular food or classes of food in or on which such additive may be used, the maximum quantity which may be used or permitted to remain in or on such food, the manner in which such additive may be added to or used in or on such food, and any directions or other labeling or packaging requirements for such additive deemed necessary by him

to assure the safety of such use or uses), and shall notify the petitioner of such order; or

"(B) by order deny the petition, and shall notify the petitioner of such order and of the reasons for such action.

"(2) The order required by paragraph (1) (A) or 21 (B) of this paragraph shall be issued within ninety days 22 after the date of filing of the petition, except that the 23 Secretary may (prior to such ninetieth day), by written

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1 notice to the petitioner, extend such ninety-day period to 2 such time (not more than one hundred and eighty days after 3 the date of filing of the petition) as the Secretary deems 4 nccessary to enable him to study and investigate the 5 petition.

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"(3) No such regulation shall issue unless the scientific 7 data submitted or otherwise before the Secretary establish 8 that the proposed use of the chemical additive, under the 9 conditions of use to be specified in the regulation, will be 10 without hazard to the health of man or other animals con11 suming any food which is or may, directly or indirectly, 12 be affected by such use, including any food that is yielded 13 by or derived from an animal or plant into which a chemical 14 additive has been introduced by feeding or otherwise, and 15 that such proposed use has functional value; except that 16 the Secretary shall not take functional value into account if 17 he finds that such additive is not a poisonous or deleterious 18 substance.

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"(4) In determining, for the purposes of this section, 20 whether a proposed use of a chemical additive is safe, the 21 Secretary shall consider among other relevant factors—

"(A) the probable consumption of the additive

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as a component;

and of any food in or on which it is intended to be used

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"(B) the cumulative effect of such additive in the diet of man or other animals concerned, taking into account any chemically or pharmacologically related substance or substances in such diet where relevant because of their use in or on foods; and

"(C) appropriate safety factors for transposing animal experimentation data to practical use in appraising the hazard to man or to other animals expected to consume food that will or may be affected by such chemical additive.

“REGULATION ISSUED ON SECRETARY'S INITIATIVE

OR UPON REQUEST

"(d) The Secretary may at any time, upon his own 14 initiative or upon the request of any interested person, pro15 pose the issuance of a regulation announcing, with respect 16 to any particular use or uses of a chemical additive, the 17 conditions under which such additive may be safely used. 18 After the expiration of thirty days after publication of such a proposal, the Secretary may by order establish a regula20 tion based upon the proposal, unless within such thirty-day 21 period a person who is entitled to file a petition under sub22 section (b) with respect to such additive requests that the

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H. R. 6747-2

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1 proposal, or any question of fact raised thereby, be referred

2 to an advisory committee appointed pursuant to this section.

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"REFERENCE TO ADVISORY COMMITTEE

"(e) (1) Within the applicable time limit specified in 5 subsection (c) for action by the Secretary upon a petition

6 but in no event more than thirty days after publication of

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an order issued pursuant to such subsection, or within thirty 8 days after publication of a proposal for issuance of a regula

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9 tion pursuant to subsection (d), the petitioner (or, in the 10 case of a proposal under subsection (d), any person en11 titled to file a petition with respect to the additive involved) 12 may request that such petition or order thereon, or such pro13 posal, or any question of fact raised by such petition, order, or proposal, be referred to an advisory committee. Upon 15 such request, or if the Secretary within such time deems such a referral necessary, the Secretary shall forthwith appoint an advisory committee of competent experts in accordance 18 with and subject to the provisions of section 408 (g) and 19 shall refer such petition, order, or proposal, or such question 20 of fact, as the case may be, to such committee and furnish 21 it with all the data before him: Provided, That the require22 ment of representation from land-grant colleges on the com23 mittee shall not apply and that in the event of the inability 24 or refusal of the National Academy of Sciences to act the 25 Secretary shall select the members of the committee. A

per