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(A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and
(B) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto;
except that such term does not include any material which the Secretary, by regulation, determines is used (or intended to be used) solely for a purpose or purposes other than coloring.
(2) The term "color" includes black, white, and intermediate grays.
(3) Nothing in subparagraph (1) of this paragraph shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological processes of produce of the soil and thereby affecting its color, whether before or after harvest.
(u) The term "safe," as used in paragraph (s) of this section and in sections 409, 512, and 706, has reference to the health of man or animal.
w) The term "new animal drug" means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed—
V 1 **
(1) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; except that such a drug not so recognized shall not be deemed to be a "new animal drug" if at any time prior to June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use;
(2) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions; or
(3) which drug is composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, or any deriva
1 Repealed by sec. 701 of P.L. 91–513,
tive thereof, except when there is in effect a published order of the Secretary declaring such drug not to be a new animal drug on the grounds that (A) the requirement of certification of batches of such drug, as provided for in section 512(n), is not necessary to insure that the objectives specified in paragraph (3) thereof are achieved and (B) that neither subparagraph (1) nor (2) of this paragraph (w) applies to such drug.
(x) The term "animal feed", as used in paragraph (w) of this section, in section 512, and in provisions of this Act referring to such paragraph or section, means an article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal.
(y) The term "informal hearing" means a hearing which is not subject to section 554, 556, or 557 of title 5 of the United States Code and which provides for the following:
(1) The presiding officer in the hearing shall be designated by the Secretary from officers and employees of the Department of Health, Education, and Welfare who have not participated in any action of the Secretary which is the subject of the hearing and who are not directly responsible to an officer or employee of the Department who has participated in any such action.
(2) Each party to the hearing shall have the right at all times to be advised and accompanied by an attorney.
(3) Before the hearing, each party to the hearing shall be given reasonable notice of the matters to be considered at the hearing, including a comprehensive statement of the basis for the action taken or proposed by the Secretary which is the subject of the hearing and a general summary of the information which will be presented by the Secretary at the hearing in support of such action.
(4) At the hearing the parties to the hearing shall have the right to hear a full and complete statement of the action of the Secretary which is the subject of the hearing together with the information and reasons supporting such action, to conduct reasonable questioning, and to present any oral or writ ten information relevant to such action.
(5) The presiding officer in such hearing shal! prepare a written report of the hearing to which shall be attached all written material presented at the hearing. The participants in the hearing shall be given the opportunity to review and correct or supplement the presiding officer's report of the hearing.
(6) The Secretary may require the hearing to be transcribed. A party to the hearing shall have the
right to have the hearing transcribed at his expense. Any transcription of a hearing shall be included in the presiding officer's report of the hearing. (z) The term "saccharin" includes calcium saccharin, sodium saccharin, and ammonium saccharin.
CHAPTER III-PROHIBITED ACTS AND
SEC. 301 . The following acts and the causing thereof are hereby prohibited:
(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.
(b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.
(c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
(d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 404 or 505.
(e) The refusal to permit access to or copying of any record as required by section 703; or the failure to establish or maintain any record, or make any report, required under section 505 (i) or (j), 507 (d) or (g), 512(j), (1) or (m), 515 (f), or 519 or the refusal to permit access to or verification or copying of any such required record.
(f) The refusal to permit entry or inspection as authorized by section 704.
(g) The manufacture within any Territory of any food, drug, device, or cosmetic that is adulterated or misbranded.
(h) The giving of a guaranty or undertaking referred to in section 303 (c) (2), which guaranty or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the food, drug, device, or cosmetic that is adulterated or anty or undertaking referred to in section 303 (c) (3), which guaranty or undertaking is false.
(i) (1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification device authorized or required by regulations promulgated under the provisions of section 404, 506, 507, or 706.
(2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other thing designed to print, imprint, or reproduce the trademark, trade
Appendix: Administrative procedure provisions_.
VOLUME III-ENVIRONMENT LAW
The Clean Air Act..
Title I-Air Pollution Prevention and Control..
Part C-Prevention of significant deterioration of air quality.
Part A-Motor Vehicle Emission and Fuel Standards.
Appendix: Provisions of the Clean Air Act Amendments of 1977 which did not amend the Clean Air Act_.
Solid Waste Disposal Act.
Title II-Solid Waste Disposal..
Title I-Grants for the Detection and Treatment of Lead-Based
Title II-Grants for the Elimination of Lead-Based Paint Poisoning-
Title IV-Prohibition Against Future Use of Lead-Based Paint.
Occupational Safety and Health Act..
Public Health Service Act:
Title XIV-Safety of Public Water Systems..
Part B-Public Water Systems....
Part C-Protection of Underground Sources of Drinking Water-
Part E-General Provisions_
National Environmental Policy Act..
Appendix: Administrative procedure provisions_
VOLUME IV-CONSUMER PROTECTION LAW
Title I-Consumer Product Warranties.
Title II-Federal Trade Commission Improvements_ Federal Trade Commission Act....
Motor Vehicle Information and Cost Savings Act.
Federal Hazardous Substances Act...
Fair Packaging and Labeling Act..
Magnuson-Moss Warranty-Federal Trade Commission Improvement
Title I-Bumper Standards.
Title II-Automobile Consumer Information Study-
Title V-Improving Automotive Efficiency.
National Traffic and Motor Vehicle Safety Act of 1966
Title I-Motor Vehicle Safety Standards.
Title III-Research and Test Facilities.
Appendix: Administrative precedure provisions__.