2

1 if such use is likely to result in the contamination of food, but

2 shall not include pesticide chemicals used in the production,

3 storage, or transportation of raw agricultural commodities, as

.

4 defined in section 201 (q) of this Act; and (2) is not gen5 erally recognized, among experts qualified by scientific train6 ing and experience to evaluate the safety of chemical addi7 tives, as having been adequately tested to show that it is 8 not poisonous or deleterious, or is a poisonous or deleterious 9 substance which is not generally recognized among such 10 experts as having been adequately tested to show that it is 11 safe for its intended use."

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SEC. 2. Section 301 of the Federal Food, Drug, and 13 Cosmetic Act is amended by changing "404 or 505" in 14 subsection (d) to "404, 409, or 505"; and "404, 505, 506, 15 507, or 704" in subsection (j) to "404, 409, 505, 506, 16 507, or 704”.

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SEC. 3. Section 304 of such Act is amended by changing 18 "404 or 505" in subsections (a) and (d) to "404, 409, or 19 505".

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SEC. 4. Section 402 (a) of such Act is amended by 21 changing the period at the end to a semicolon and adding: 22 "or (7) if it is, or bears or contains, a chemical additive, 23 unless the use of such chemical additive has been approved 24 pursuant to section 409."

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2

3

4

3

SEO. 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

5 introduction into interstate commerce any chemical additive, 6 unless the use of such chemical additive has been approved 7 pursuant to this section.

8

"(b) Any person may file with the Secretary an appli9 cation for the issuance of an order approving the use of a 10 chemical additive. There shall be submitted to the Secretary 11 with the application (1) a statement of the intended use of 12 the chemical additive and demonstrating that such employ13 ment of the chemical additive will serve a purpose which will 14 be useful to the consuming public; (2) reports of investiga15 tions which have been made to determine the acute and 16 chronic toxicity and other potentiality for harm of the chemi17 cal additive; (3) a statement of the composition of the 18 chemical additive; (4) a description of methods of analysis 19 for the quantitative determination of the chemical additive, 20 and its reduction products, in or on food; (5) such samples 21 of the chemical additive as the Secretary may require; (6) 22 all directions, recommendations and suggestions proposed for 23 the use of the chemical additive; and (7) if the chemical 24 additive is a poisonous or deleterious substance, reports of

4

1 investigations which have been made to show the quantities 2 of the chemical additive remaining in or on the food and that 3 it is required for its intended use.

4

"(c) The Secretary shall issue an order approving the 5 application within ninety days after the filing of the applica6 tion if the Secretary finds that the reports submitted to him 7 pursuant to subsection (b) demonstrate (1) that the chemi8 cal additive is not a poisonous or deleterious substance or if 9 it is that it is safe and required for its intended use, and (2) 10 that the intended use of the chemical additive will serve a 11 purpose which will be useful to the consuming public; other12 wise, except as provided in subsection (d), the Secretary 13 shall issue an order within said ninety days refusing to approve the application.

14.

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"(d) Within said ninety-day period specified in sub16 section (c), the Secretary, when he deems such action ad17 visable or upon notification from the applicant, shall submit 18 the application and other data before him to an advisory com19 mittee to be appointed pursuant to subsection (f). Within 20 sixty days after such referral, or within an additional thirty 21 days if the committee deems such additional time necessary, 22 the committee, after independent study of the data submitted 23 to it by the Secretary, shall certify to him a report and 24 recommendations on the proposal in the application, together 25 with all underlying data and a statement of the reasons for

5

1 the recommendations. Within thirty days after such cer2 tification, the Secretary, after giving due consideration to all 3 the material, including such report and recommendations, 4 then before him, shall issue an order approving the applica

5 tion if he finds that the chemical additive is not a poisonous

6

or deleterious substance or if it is that it is safe and required 7 for its intended use, and that its intended use will serve a 8 purpose which will be useful to the consuming public; other9 wise the Secretary shall issue an order within said thirty 10 days refusing to approve the application. In determining 11 whether a chemical additive is safe under subsection (c) or 12 (d), the Secretary shall take into account the other ways in 13 which the consumer may be affected by the same substance 14 or other substances.

15

"(e) Within thirty days after the issuance of an order 16 under subsection (c) or (d), any person adversely affected 17 may file objections thereto with the Secretary specifying the 18 reasons he deems the order objectionable and requesting a 19 public hearing upon such objections. After furnishing due 20 notice, the Secretary shall thereupon hold a public hearing 21 for the purpose of receiving evidence relevant and material to the issues raised by such objections. Any report, recom23 mendations, underlying data and reasons certified to the 24 Secretary by an advisory committee shall be made a part

22

H. R. 4432-2

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1 of the record of the hearing. The advisory committee shall 2 designate one of its members to appear and testify at any 3 such hearing with respect to its report and recommendations 4 upon request of the officer conducting the hearing or any 5 person adversely affected: Provided, That this shall not pre6 clude any other member of the advisory committee from 7 appearing and testifying at such hearing. As soon as prac8 ticable after completion of the hearing, the Secretary shall 9 act upon such objections and issue an order. Such order 10 shall be based only on substantial evidence of record at such 11 hearing, including any report, recommendations. underlying 12 data, and reasons certified to the Secretary by an advisory 13 committee, and shall set forth detailed findings of fact upon 14 which the order is based. No such order shall take effect 15 prior to the ninetieth day of its publication, unless the 16 Secretary finds that emergency conditions exist necessitating 17 an earlier effective date, in which event he shall specify in 18 the order his findings as to such conditions.

19

"(f) Whenever an application is referred to an advisory 20 committee, the Secretary shall appoint a committee of com21 petent experts to review the application and to make a report 22 and recommendations thereon. Each such advisory com23 mittee shall be composed of experts qualified in the subject 24 matter of the application and of adequately diversified pro25 fessional background selected by the National Academy of