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Chapter 350 - 1st Session

H. R. 5740

AN ACT

To amend the Federal Food, Drug, and Cosmetic Act, so as to protect the public health and welfare by providing certain authority for factory inspection, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 704 of Federal Food, the Federal Food, Drug, and Cosmetic Act, as amended (21 U. S. C., Drug, and Cossec. 374) is amended to read as follows:

"FACTORY INSPECTION

metio Aot,
amendments.
52 Stat. 1057.

"SEC. 704. (a) For purposes of enforcement of this Act, officers or 67 Stat. 476. employees duly designated by the Secretary, upon presenting appro- 67 Stat. 477. priate credentials and a written notice to the owner, operator, or agent in charge, are authorized (1) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or are held after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics in interstate commerce; and (2) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness.

"(b) Upon completion of any such inspection of a factory, warehouse, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgment, indicate that any food, drug, device, or cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance, or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary.

"(c) If the officer or employee making any such inspection of a factory, warehouse, or other establishment has obtained any sample in the course of the inspection, upon completion of the inspection and prior to leaving the premises he shall give to the owner, operator, or agent in charge a receipt describing the samples obtained.

"(d) Whenever in the course of any such inspection of a factory or other establishment where food is manufactured, processed, or packed, the officer or employee making the inspection obtains a sample of any such food, and an analysis is made of such sample for the purpose of ascertaining whether such food consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise unfit for food, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in charge."

SEC. 2. Section 301 of such Act (21 U. S. C., sec. 331) is amended by 52 Stat. 1042. adding at the end thereof the following new paragraph:

"(n) The using, in labeling, advertising or other sales promotion of use of reports any reference to any report or analysis furnished in compliance with or analysis. section 704."

SEC. 3. Section 304 (c) of such Act (21 U. S. C., sec. 334) is amended 52 Stat. 1045. to read as follows:

All 67 Stat. 477.
Seized goods.
Sample.

(c) The court at any time after seizure up to a reasonable time before trial shall by order allow any party to a condemnation proceeding, his attorney or agent, to obtain a representative sample of the article seized and a true copy of the analysis, if any, on which the proceeding is based and the identifying marks or numbers, if any, of the packages from which the samples analyzed were obtained."

Approved August 7, 1953.

Chapter 143

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H. R. 6434

AN ACT

To amend sections 401 and 701 of the Federal Food, Drug, and Cosmetic Act so as to simplify the 'procedures governing the establishment of food standards.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 401 of Food standards the Federal Food, Drug, and Cosmetic Act (21 U. S. C., sec. 341), is regulations. amended by inserting "(a)" after "SEC. 401." and by adding at the end 52 Stat. 1046. of such section the following new subsection:

"(b) (1) Any action under subsection (a) for the issuance, amend- Initiation of ment, or repeal of any regulation shall be begun by a proposal made action. (A) by the Secretary of his own initiative, or (B) by petition of any interested person, showing reasonable grounds therefor, filed with the Secretary. The Secretary shall publish such proposal and shall afford all interested persons an opportunity to present their views thereon, orally or in writing. As soon as practicable thereafter, the Secretary shall by order act upon such proposal and shall make such order public. Except as provided in paragraph (2), the order shall become effective at such time as may be specified therein, but not prior to the day following the last day on which objections may be filed under such paragraph.

"(2) At any time prior to the thirtieth day after the date on which Filing of an order entered under paragraph (1) is made public, any person objections. who will be adversely affected by such order if placed in effect may

file objections thereto with the Secretary, specifying with particularity

the provisions of the order deemed objectionable, stating the grounds 68 Stat. 54. therefor, and requesting a public hearing upon such objections. Until 68 Stat. 55. final action upon such objections is taken by the Secretary under paragraph (3), the filing of such objections shall operate to stay the effectiveness of those provisions of the order to which the objections are made. As soon as practicable after the time for filing objections has expired the Secretary shall publish a notice in the Federal Register specifying those parts of the order which have been stayed by the filing of objections and, if no objections have been filed, stating that fact.

"(3) As soon as practicable after such request for a public hearing, Public hearing. the Secretary, after due notice, shall hold such a public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. At the hearing, any interested person may be heard in person or by representative. As soon as practicable after completion of the hearing, the Secretary shall by order act upon such objections and make such order public. Such order shall be based only on substantial evidence of record at such hearing and shall set forth, as part of the order, detailed findings of fact on which the order is based. The Secretary shall specify in the order the date on which it shall take effect, except that it shall not be made to 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. Such order shall be subject to the provisions of section 701 (f) and (g)."

SEC. 2. Section 701 (e) of the Federal Food, Drug, and Cosmetic Act is amended by striking out "401,".

21 USC 371.

SEC. 3. In any case in which, prior to the date of the enactment of Hearings pendthis Act, a public hearing has been begun, in accordance with section ing.

701 (e) of the Federal Food, Drug, and Cosmetic Act, upon a proposal

to issue, amend, or repeal any regulation contemplated by section 401

All 68 Stat. 55.

of such Act, the provisions of such Act, as in force immediately prior to the date of the enactment of this Act, shall be applicable as though this Act had not been enacted.

Approved April 15, 1954.

Chapter 559 2d Session
H. R. 7125

AN ACT

AT1 68 Stat. 511.

To amend the Federal Food, Drug, and Cosmetic Act with respect to residues of pesticide chemicals in or on raw agricultural commodities.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 201 of Pesticide chemthe Federal Food, Drug, and Cosmetic Act is amended by adding at ical residues. the end thereof the following new paragraphs:

52 Stat. 1041.

Definitions.

"(q) The term 'pesticide chemical' means any substance which, 21 USC 321. alone, in chemical combination or in formulation with one or more other substances, is an 'economic poison' within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U. S. C., secs. 135-135k) as now in force or as hereafter amended, and which is used 61 Stat. 163. in the production, storage, or transportation of raw agricultural commodities.

"(r) The term 'raw agricultural commodity' means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing."

21 USC 342.

SEC. 2. Clause (2) of section 402 (a) of the Federal Food, Drug, and Adulterated Cosmetic Act is amended to read as follows: "(2) if it bears or con- food. tains any added poisonous or added deleterious substance, except a pesticide chemical in or on a raw agricultural commodity, which is unsafe within the meaning of section 406, or if it is a raw agricultural 21 USC 346. commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of section 408 (a) ;”.

SEC. 3. Chapter IV of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end thereof the following new section: "TOLERANCES FOR PESTICIDE CHEMICALS IN OR ON RAW AGRICULTURAL

COMMODITIES

"SEC. 408. (a) Any poisonous or deleterious pesticide chemical, or any pesticide chemical which is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of pesticide chemicals, as safe for use, added to a raw agricultural commodity, shall be deemed unsafe for the purposes of the application of clause (2) of section 402 (a) unless

"(1) a tolerance for such pesticide chemical in or on the raw agricultural commodity has been prescribed by the Secretary of Health, Education, and Welfare under this section and the quantity of such pesticide chemical in or on the raw agricultural commodity is within the limits of the tolerance so prescribed; or

"(2) with respect to use in or on such raw agricultural commodity, the pesticide chemical has been exempted from the requirement of a tolerance by the Secretary under this section. While a tolerance or exemption from tolerance is in effect for a pesticide chemical with respect to any raw agricultural commodity, such raw agricultural commodity shall not, by reason of bearing or containing any added amount of such pesticide chemical, be considered to be adulterated within the meaning of clause (1) of section 402 (a).

21 USC 342.

"(b) The Secretary shall promulgate regulations establishing toler- Establishment of ances with respect to the use in or on raw agricultural commodities tolerances. of poisonous or deleterious pesticide chemicals and of pesticide chemicals which are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of pesticide chemicals, as safe for use, to the extent necessary to protect the public health. In establishing any such regulation, the Secretary shall give appropriate consideration, among other relevant factors, (1) to the

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