12 1 and fresh vegetables and no standard of identity for fresh 2 citrus fruits, fresh apples and fresh pears: And provided 3 further, That in any regulation pertaining to fill of container 4 the Secretary shall give due consideration to the natural 5 shrinkage in storage and in transit of fresh natural food and 6 7 8 9 10 11 12 13 15 16 to need for the necessary packing and protective material. In the fixing and establishing of any standard of quality for any canned fruit or canned vegetable, consideration shall be given and due allowance made for the differing characteristics of the several varieties of such fruit or vegetable. TOLERANCES FOR POISONOUS INGREDIENTS IN FOOD AND CERTIFICATION OF COAL-TAR COLORS FOR FOOD SEC.. 304 305. (a) To safeguard the publie health, 14 no Any poisonous or deleterious substance shall be added to any food, except where such substance is required in the production thereof or cannot be avoided by good 17 manufacturing practice shall be deemed to be unsafe for 18 purposes of the application of section 301 (a); but when such substance is so required or cannot be so avoided, the 20 Secretary is authorized, for the protection of public health, to promulgate regulations, as provided by sections 701 and 22 703, limiting the quantity therein or thereon to such extent 19 21 23 as he finds necessary for the protection of public health. In 24 determining the quantity of such added substance to be toler 25 ated in or on different articles of food the Secretary shall 13 1 take into account the extent to which the use of such sùb stance is required or cannot be avoided in the production 2 3 4 5 6 of each such article, and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances. (b) The Secretary is hereby authorized to promulgate 7. regulations, as provided by sections 701 and 703, for the 8 certification of coal-tar colors which are harmless and suit 11 13 EMERGENCY PERMIT CONTROL SEC. 305 306. (a) Whenever the Secretary finds 12 after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with 14 micro-organisms during the manufacture, processing, or pack15 ing thereof in any locality, be injurious to health, and that 16 such injurious nature cannot be adequately determined after 17 such articles have entered interstate commerce, he is then, 18 and in such case only, authorized to promulgate regulations, as provided by sections 701 and 703, regulations providing 20 for the issuance, to manufacturers, processors, or packers of such class of food in such locality, of permits to which shall be 22 attached such conditions governing the conditions of manufac23 ture, processing, or packing of such class of food, for such 24 temporary periods period of time, as may be necessary to 25 protect the public health, and thereafter after the effective 19 21 14 1 date of such regulations, and during such temporary period, 2 no manufacturer, processor, or packer of such class of articles 3 person shall introduce into interstate commerce any such 4 food manufactured, processed, or packed by any such manu5 facturer, processor, or packer unless he such manufacturer, 6 processor, or packer holds an unsuspended, valid a permit 7 issued by the Secretary as provided by the such regulations. (b) The Secretary is authorized to issue such permits for such periods of time as he may by regulations prescribe and to make regulations governing the issuance and renewal 8 9 10 11 thereof. The Secretary is authorized to suspend immedi12 ately upon notice any permit issued under authority of this 13 section if it is found that any of the conditions of the permit 14 have been violated. The holder of a permit so suspended 15 shall be privileged at any time to apply for the reinstatement 16 of such permit, and the Secretary shall immediately after 17 prompt hearing and an inspection of the establishment, reinstate such permit if it is found that adequate measures have 19 been taken to comply with and maintain the conditions of the permit, as originally issued or as amended. 18 20 21 (c) Any officer or employee duly designated by the 22 Secretary shall have access to any factory or establishment, 23 the operator of which holds a permit from the Secretary, for 24 the the purpose of ascertaining whether or not the conditions of 25 the permit are being complied with, and denial of access for 15 1 such inspection shall be ground for suspension of the permit 2 until such access is freely given by the operator. 3 4 5 CHAPTER IV ADULTERATED DRUGS SECTION 401. A drug shall be deemed to be adul 6 terated 12 7 any filthy, 8 putrid, or decomposed substance; or (2) if it has been 9 prepared, packed, or held under insanitary conditions 10 whereby it may have been contaminated with filth, or 11 whereby it may have been rendered injurious to health; or (3) if its container is composed, in whole or in part, of any 13 poisonous or deleterious substance which may render it 14 injurious to health; or (4) if it contains, for purposes of 15 coloring only, a coal-tar color other than one from a batch 16 that has been certified in accordance with regulations as 17 provided by sections 103 section 404, 701, and 703. (a) (1) If it consists in whole or in part of 18 (b) If its name is recognized in an official com19 pendium, or if it purports to be a drug the name of which is 20 so recognized, and it differs from the standard of strength, 21 quality, or purity as determined by the tests or methods of 22 assay set forth therein; except that whenever tests or meth23 ods of assay have not been prescribed therein, or such tests or methods of assay as are prescribed are insufficient, for 25 determining whether or not such drug complies with such 24 16 1 standard, the Secretary is hereby authorized to bring such 2 fact to the attention of the appropriate body charged with 3 the revision of such compendium and if such body fails within 4 5 6 a reasonable time to prescribe tests or methods of assay which are sufficient, then the Secretary may by regulations prescribe for the purposes of this Act such tests or methods of assay 7 by regulations as provided by sections 701 and 703. No 8 drug shall be deemed to be adulterated under this paragraph 9 because it differs from the standards standard, of strength, 10 quality, or purity strength therefor set forth in an official 11 compendium, if its standard of strength, quality, or purity 12 strength be plainly stated on its label. Whenever a drug is 13 recognized in both the United States Pharmacopoeia and the 14 Homeopathic Pharmacopoeia of the United States it shall 15 be subject to the requirements of the United States Pharma16 coporia unless it is labeled and offered for sale as a homoco17 pathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia. 18 19 20 21 22 23 24 25 (c) If it is not subject to the provisions of paragraph (b) of this section and its identity or strength differs from, or its purity or quality falls below, that which it purports or is represented to possess. (d) If any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) sub26 stituted wholly or in part therefor. |