(c) Each request for an extension should be addressed to the Commissioner of Food and Drugs and should give: (1) The name and chemical composition of the pesticide chemical for which extension is requested. (2) A list of uses for which extension is requested and evidence that these uses were registered under the Federal Insecticide, Fungicide, and Rodenticide Act prior to May 1, 1955. (3) Information about the amounts of residues that are expected to remain on raw agricultural commodities from these uses. (4) Available information which indicates that these residues will not jeopardize the public health. (5) A statement of the reason(s) a tolerance or exemption from the requirement of a tolerance has not been requested. (d) In order that decisions on requests for extensions may be published before July 22, 1955, requests and supporting data should be received by June 27, 1955. (e) Use during the 1955 growing season of a pesticide chemical for which extension is granted may yield a raw agricultural commodity which bears residues of the chemical. In such case, the raw agricultural commodity will not be considered adulterated within the meaning of the act even though it is marketed after the growing season, provided the commodity bearing such residues would have been legal in interstate commerce during the 1955 growing season. (f) The Department believes that extensions beyond October 31, 1955, would lead to confusion in 1956. It recommends that States prepare spray schedules for the 1956 growing season which direct (1) pesticide uses that leave no residues at time of harvest or (2) the use only of pesticides for which tolerances have been established or exemptions granted under the Federal Food, Drug, and Cosmetic Act. § 3.41 Pesticide chemicals; extended dates on which statute shall become fully effective. (a) The amendment in clause (2) of section 402 (a) of the Federal Food, Drug, and Cosmetic Act shall become effective on the dates specified for the following pesticide chemicals: (1) The effective date for Aramite (2(p-tert-butylphenoxy) isopropyl-2-chloroethyl sulfite) shall be September 30, Onions (including leeks, shallots, and garlic). Parsley and watercress. Peas and cowpeas (including forage). Grains (including oats, rye, barley, wheat, Nuts (including pecans, almonds, hazel- Grass crops (pasture and range grass, timothy, grass hay). Mint, spearmint, and peppermint. (b) The extensions prescribed in paragraph (a) of this section apply only to the extent that tolerances or exemptions under section 408 of the Federal Food, Drug, and Cosmetic Act shall not have been established prior to the effective dates as extended. § 3.42 Pesticide chemicals; additional extended dates on which statute shall become fully effective; denial of requests for extensions. (a) Conditions exist which necessitate the following extensions. The amendment in clause (2) of section 402 (a) of the Federal Food, Drug, and Cosmetic Act shall become effective on the dates specified for the following pesticide chemicals: (1) Effective date October 31, 1955: Alkyl dimethyl benzyl ammonium chloride: On apples. Allethrin: On livestock. Chloro IPC: Preemergence use on spinach. Dimite: On fruits and vegetables. Ethylene dichloride: On citrus and strawberries. Ethylene oxide: On spices. Piperonyl butoxide: On apples, citrus, live stock, pears, tomatoes. Pyrethrins: On apples, citrus, grains (stored), livestock, pears, tomatoes. the extent that tolerances or exemptions under section 408 of the Federal Food, Drug, and Cosmetic Act shall not have been established prior to the effective dates as extended. (Sec. 402, 52 Stat. 1046, as amended, sec. 408, 68 Stat. 511; 21 U. S. C. 342, 346a) §3.43 Labeling of drug preparations containing salicylates. (a) Because salicylate preparations enjoy widespread use as analgesics and such articles are ordinarily not toxic in the amounts required for producing an analgesic action, they are frequently regarded by the public as harmless. Actually, salicylates are capable of causing injury and even death when consumed in excessive quantities. Salicylate preparations have caused a number of deaths through accidental misuse by both adults and children, which might have been avoided had the users been aware of their potential hazards. (b) On the basis of a study and conclusions by the Medical Advisory Panel on the Accidental Ingestion and Misuse of Salicylate Preparations by Children, under date of February 14, 1955, and in the interest of protecting the public health, the following recommendations are made concerning the labeling that should be employed for salicylate preparations to meet the requirements of section 502 (f) (1) and (2) of the Federal Food, Drug, and Cosmetic Act. (1) The labels of all packages of salicylate preparations that are labeled with directions for use should bear, clearly visible and in bold-face type, some such statement as one of the following: (i) "Warning-Keep out of the reach of children"; or (ii) "Warning-Keep this and all medications out of the reach of children." (2) In lieu of specific dosage recommendations for children under three years of age, the labeling of salicylate preparations for oral use should bear a statement such as: "For children under 3 years of age, consult your physician." (c) The labeling recommendations in paragraph (b) of this section are applicable to preparations containing aspirin, salicylamide, salicylic acid and its salts, and other salicylic acid derivatives used as analgesics, except as provided in paragraph (d) of this section. (d) To the extent shown in this paragraph, the labeling recommendations of paragraph (b) of this section do not apply to the following preparations. (1) Paragraph (b) (1) of this section does not apply to wintergreen oil subject to § 3.35. (2) Paragraph (b) (1) of this section does not apply to effervescent salicylate preparations since such preparations do not lend themselves to accidental use or overdosage. (3) Paragraph (b) (1) and (2) of this section does not apply to preparations of para-aminosalicylic acid and its salts, which are not labeled with directions for use as analgesics. (e) This statement in no way exempts salicylate preparations from complying in all other respects with the requirements of the Federal Food, Drug, and Cosmetic Act. (f) Copies of the recommendations adopted by the Medical Advisory Panel on the Accidental Ingestion and Misuse of Salicylate Preparations by Children, which convened on February 14, 1955, may be obtained from the Department of Health, Education, and Welfare, Food and Drug Administration, upon request. (g) Six months will be allowed for modification of existing labeling to comply with this statement. (Sec. 502, 52 Stat. 1050, as amended; 21 U. S. C. 352) § 3.44 Pesticide chemicals; further extended dates on which statute shall become fully effective. The amendments in clause (2) of section 402 (a) of the Federal Food, Drug, and Cosmetic Act shall become fully effective on the dates specified for the pesticide chemicals named in this section. The extensions prescribed in this section apply only to the extent that tolerances or exemptions from tolerances under section 408 of the act shall not have been established prior to the effective dates as extended. This section supersedes any extended effective dates for the same pesticide chemicals for use on the same raw agricultural commodities previously published in §§ 3.41 and 3.42. All further changes in extended effective dates on the same or other pesticide chemicals will be published as amendments to this section. (a) (1) Effective date January 22, 1956: Aldrin: For use on berries of the bramble type, blueberries, dates, pineapples, strawberries, beans (including black-eyed peas |