"(2) there is in effect, and the use or intended use of such additive is in conformity with, a regulation issued under this section announcing the conditions (including any directions or other labeling or packaging requirements contained in such regulation) under which such additive may be safely used.

While such a regulation relating to a chemical additive is in effect, a food shall not, by reason of bearing or containing such an additive in accordance with the regulation, be considered adulterated within the meaning of clause (1) or (2) (C) of section 402 (a).

"PETITION TO ESTABLISH SAFETY

"(b) (1) Any interested person may, with respect to any intended use or uses of a chemical additive, file with the Secretary a petition proposing the issuance of a regulation announcing the conditions under which such additive may be safely used.

"(2) Such petition shall, in addition to setting forth the regulation proposed by the petitioner and stating reasonable grounds in support of the petition, contain or be accompanied by

"(A) the name and all pertinent information concerning such chemical additive, including where available its chemical identity and composition; “(B) (i) a statement of the conditions of the proposed use or uses of such additive, including all directions, recommendations, and suggestions proposed for the use of such additive, and including specimens of its proposed labeling; and (ii) all relevant data bearing on the functional value of such additive;

"(C) a full description of the methods used in, and 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 breakdown 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 used as components thereof, and of the food in or on which the additive is proposed to be used.

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

"ACTION ON THE PETITION

"(c) (1) As soon as practicable after the filing of the petition, and in no event later than the expiration of the applicable period specified in paragraph (2) of this subsection, the Secretary shall, in the absence of a prior referral or request for referral to an advisory committee made pursuant to this section—

"(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 (B) of this paragraph shall be issued within ninety days after the date of filing of the petition, except that the Secretary may (prior to such ninetieth day), by written notice to the petitioner, extend such ninety-day period to such time (not more than one hundred and eighty days after the date of filing of the petition) as the Secretary deems necessary to enable him to study and investigate the petition.

"(3) No such regulation shall issue unless the scientific data submitted or otherwise before the Secretary establish that the proposed use of the chemical additive, under the conditions of use to be specified in the regulation, will be

without hazard to the health of man or other animals consuming any food which is or may, directly or indirectly, be affected by such use, including any food that is yielded by or derived from an animal or plant into which a chemical additive has been introduced by feeding or otherwise, and that such proposed use has functional value; except that the Secretary shall not take functional value into account if he finds that such additive is not a poisonous or deleterious substance.

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

"(A) the probable consumption of the additive and of any food in or on which it is intended to be used as a component;

"(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 initiative or upon the request of any interested person, propose the issuance of a regulation announcing, with respect to any particular use or uses of a chemical additive, the conditions under which such additive may be safely used. After the expiration of thirty days after publication of such a proposal, the Secretary may by order establish a regulation based upon the proposal, unless within such thirty-day period a person who is entitled to file a petition under subsection (b) with respect to such additive requests that the proposal, or any question of fact raised thereby, be referred to an advisory committee appointed pursuant to this section.

"REFERENCE TO ADVISORY COMMITTEE

"(e) (1) Within the applicable time limit specified in subsection (c) for action by the Secretary upon a petition but in no event more than thirty days after publication of an order issued pursuant to such subsection, or within thirty days after publication of a proposal for issuance of a regulation pursuant to subsection (d), the petitioner (or, in the case of a proposal under subsection (d), any person entitled to file a petition with respect to the additive involved) may request that such petition or order thereon, or such proposal, or any question of fact raised by such petition, order, or proposal, be referred to an advisory committee. Upon 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 with and subject to the provisions of section 408 (g) and shall refer such petition, order, or proposal, or such question of fact, as the case may be, to such committee and furnish it with all the data before him: Provided, That the requirement of representation from land-grant colleges on the committee shall not apply and that in the event of the inability or refusal of the National Academy of Sciences to act the Secretary shall select the members of the committee. A person who has filed a petition or who has requested the referral of a proposal to an advisory committee, as well as representatives of the Department of Health, Education, and Welfare, shall have the right to consult with such advisory committee in connection with the matter referred to it.

"(2) Within sixty days after the date of such referral, or within an additional thirty days if the committee deems such additional time necessary, the committee shall, after independent study of the data furnished to it by the Secretary and other data before it, certify to the Secretary a report and recommendations, together with all underlying data and a statement of the reasons or basis for the recommendations. Within thirty days after such certification, and after giving due consideration to all data then before him, including such report, recommendations, underlying data, and statement, and to any prior order issued by him in connection with such matter, the Secretary shall confirm or modify any order theretofore issued or, if no such order has been issued, shall establish a regulation announcing, with respect to any particular use or uses

of the chemical additive involved, the conditions under which such additive may be safely used or refuse to establish a regulation.

"(3) The Secretary may by regulation condition referrals to advisory committees pursuant to this subsection upon the payment, by the person requesting the referral, of fees to defray the costs arising by reason of such referrals. Such regulations may provide for waiver or refund of fees in whole or in part when in the judgment of the Secretary such waiver or refund is equitable and not contrary to the purposes of this subsection. Such fees, including advance deposits to cover such fees, shall be available, until expended, for paying (directly or by way of reimbursement of the applicable appropriation) the expenses of advisory committees under this subsection and other expenses arising by reason of referrals to such committees, and for refunds pursuant to this paragraph.

"PUBLICATION AND EFFECTIVE DATE OF ORDERS

"(f) Any order, including any regulation established by such order, issued under subsection (c), (d), or (e) of this section, shall be published and shall be effective upon publication, but the Secretary may stay such effectiveness if after issuance of such order the petition or any question of fact raised thereby is referred to an advisory committee pursuant to subsection (e) or if a hearing is sought with respect to such order pursuant to subsection (g).

"OBJECTIONS AND PUBLIC HEARING

"(g) Within thirty days after publication, any person adversely affected by an order made pursuant to subsection (c), (d), or (e) of this section may file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating reasonable grounds therefor, and requesting a public hearing upon such objections: Provided, That if, after issuance of an order under subsection (c), the right of referral to an advisory committee is invoked, only the order thereafter issued pursuant to subsection (e) after receipt of the advisory committee's report shall be subject to such objections and public hearing. The Secretary shall thereupon, after due notice, hold such public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. Any report, recommendations, underlying data, and reasons certified to the Secretary by an advisory committee shall be made a part of the record of the hearing if relevant and material, subject to the provisions of section 7 (c) of the Administrative Procedure Act (5 U. S. C., sec. 1006 (c)). The advisory committee shall designate a member to appear and testify at any such hearing with respect to the report and recommendations of such committee upon request of the Secretary, the petitioner, or the officer conducting the hearing, but this shall not preclude any other member of the advisory committee from appearing and testifying at such hearing. As soon as practicable after completion of the hearing, the Secretary shall act upon such objections and shall by published order either confirm or modify the order to which objections have been filed. Such new order shall be based only on substantial evidence of record at such hearing, including any report, recommendations, underlying data, and reasons certified to the Secretary by an advisory committee, and shall set forth detailed findings of fact upon which the regulation is based. No such order shall 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.

"JUDICIAL REVIEW

"(h) In a case of actual controversy as to the validity of any order issued under subsection (g), including any order thereunder with respect to amendment or repeal of a regulation issued under this section, any person who will be adversely affected by such order may obtain judicial review thereof in accordance with, and subject to, the applicable provisions of section 408 (i).

"AMENDMENT OR REPEAL OF REGULATIONS

"(i) The Secretary shall by regulation prescribe the procedure by which regulations under the foregoing provisions of this section may be amended or repealed, and such procedure shall conform to the procedure provided in this

section for the promulgation of such regulations, including the appointment of advisory committees and the procedure for referring petitions or proposals to such committees.

"EXEMPTIONS FOR INVESTIGATIONAL OR OTHER USE

"(j) The Secretary (1) shall promulgate regulations providing for exempting from the requirements of this section any chemical additive, and any food bearing or containing such additive, intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety of such additive, and (2) may by regulation exempt any other chemical additive, or any food bearing or containing it, or both, when in his opinion such exemption is consistent with the public health."

SEC. 6. Section 301 (j) of such Act is amended by inserting "409" after "404,". SEC. 7. (a) Except as otherwise provided in this section this Act shall take effect on the one hundred and eightieth day (hereinafter referred to as the effective date of this Act) after the date of its enactment.

(b) Any interested person desiring to do so may at any time, after the date of enactment and prior to the effective date of this Act, file a petition as provided in subsection (b) of section 409 of the Federal Food, Drug and Cosmetic Act, as enacted by section 5 of this Act, in which event the provisions of such section 409, and of section 201 (s) and section 301 (j) of such Act as amended by this Act, shall become effective immediately as applied to such petition and to proceedings thereon; but nothing in this subsection shall be construed to accelerate the effective date of the remaining provisions of this Act.

(c) Where a chemical additive was in use for one or more purposes immediately prior to the date of enactment of this Act, the amendments to sections 402 (a) and 406 (a) of the Federal Food, Drug and Cosmetic Act made by section 4 of this Act shall not, as applied to such preexisting use or uses of such additive, become effective until

(1) the final establishment of a regulation or exemption relating to such use or uses pursuant to section 409 of such Act or the final denial of a petition for such regulation or exemption (without, in either case, further opportunity for referral to an advisory committee, for an administrative hearing, or for judicial review); or

(2), if earlier, the expiration of either (A) the one-year period beginning on the date following the effective date of this Act, or (B) such additional period (not extending beyond two years after the effective date of this Act) as the Secretary of Health, Education, and Welfare may prescribe on the basis of a finding that such extension involves no undue risk to the public health and that conditions exist which necessitate the prescribing of such additional period.

SEC. 8. There are hereby authorized to be appropriated, out of any money in the Treasury not otherwise appropriated, such sums as may be necessary for the administration of this Act.

SEC. 9. Nothing in this Act shall be construed to exempt any meat or meat food 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 and extended (21 U. S. C. 71 and the following).

[H. R. 7700, 85th Cong., 1st sess.]

A BILL To protect the public health by amending the Federal Food, Drug and Cosmetic Act so as to provide for the safety of chemical additives in food

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 201 of the Federal Food, Drug and Cosmetic Act is amended by the addition of the following paragraph:

"(s) The term 'chemical additive' means any substance (including products resulting from changes in such substance after use) which (1) is intended for use (A) as a food, or (B) to preserve or alter any food or any characteristic of any food; or (C) for any other purposes in producing, processing, packing, transporting, wrapping, or holding food if such use is likely to result in the contamination of food, but shall not include pesticide chemicals used in the production, storage, or transportation of raw agricultural commodities, as defined in section 201 (q) of this Act; and (2) is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of chemical additives,

as having been adequately tested to show that it is not poisonous or deleterious, or is a poisonous or deleterious substance which is not generally recognized among such experts as having been adequately tested to show that it is safe for its intended use."

SEC. 2. Section 301 of the Federal, Drug and Cosmetic Act is amended by changing "404 or 505" in subsection (d) to "404, 409, or 505"; and "404, 505, 506, 507, or 704" in subsection (j) to "404, 409, 505, 506, 507, or 704".

SEC. 3. Section 304 of such Act is amended by changing "404 or 505" in subsections (a) and (d) to “404, 409, or 505".

SEC. 4. Section 402 (a) of such Act is amended by changing the period at the end to a semicolon and adding: "or (7) if it is, or bears or contains, a chemical additive, unless the use of such chemical additive has been approved pursuant to section 409."

SEC. 5. The following section shall be added to chapter IV of such Act:

"CHEMICAL ADDITIVES

"SEC. 409. (a) No person shall introduce or deliver for introduction into interstate commerce any chemical additive, unless the use of such chemical additive has been approved pursuant to this section.

"(b) Any person may file with the Secretary an application for the issuance of an order approving the use of a chemical additive. There shall be submitted to the Secretary with the application (1) a statement of the intended use of the chemical additive and demonstrating that such employment of the chemical additive will serve a purpose which will be useful to the consuming public; (2) reports of investigations which have been made to determine the acute and chronic toxicity and other potentiality for harm of the chemical additive; (3) a statement of the composition of the chemical additive; (4) a description of methods of analysis for the quantitative determination of the chemical additive, and its reduction products, in or on food; (5) such samples of the chemical additive as the Secretary may require; (6) all directions, recommendations, and suggestions proposed for the use of the chemical additive; and (7) if the chemical additive is a poisonous or deleterious substance, reports of investigations which have been made to show the quantities of the chemical additive remaining in or on the food and that it is required for its intended use.

"(c) The Secretary shall issue an order approving the application within ninety days after the filing of the application if the Secretary finds that the reports submitted to him pursuant to subsection (b) demonstrate (1) that the chemical additive is not a poisonous or deleterious substance or if it is that it is safe and required for its intended use, and (2) that the intended use of the chemical additive will serve a purpose which will be useful to the consuming public; otherwise, except as provided in subsection (d), the Secretary shall issue an order within said ninety days refusing to approve the application.

"(d) Within said ninety-day period specified in subsection (c), the Secretary, when he deems such action advisable or upon notification from the applicant, shall submit the application and other data before him to an advisory committee to be appointed pursuant to subsection (f). Within sixty days after such referral, or within an additional thirty days if the committee deems such additional time necessary, the committee, after independent study of the data submitted to it by the Secretary, shall certify to him a report and recommendations on the proposal in the application, together with all underlying data and a statement of the reasons for the recommendations. Within thirty days after such certification, the Secretary, after giving due consideration to all the material, including such report and recommendations, then before him, shall issue an order approving the application if he finds that the chemical additive is not a poisonous or deleterious substance or if it is that it is safe and required for its intended use, and that its intended use will serve a purpose which will be useful to the consuming public; otherwise the Secretary shall issue an order within said thirty days refusing to approve the application. In determining whether a chemical additive is safe under subsection (c) or (d), the Secretary shall take into account the other ways in which the consumer may be affected by the same substance or other substances.

"(e) Within thirty days after the issuance of an order under subsection (c) or (d), any person adversely affected may file objections thereto with the Secretary specifying the reasons he deems the order objectionable and requesting a public hearing upon such objections. After furnishing due notice, the Secretary shall thereupon hold a public hearing for the purpose of receiving evidence