2 AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT Amend the title so as to read: "A bill to amend section 402 (c) of the Federal Food, Drug, and Cosmetic Act, with respect to the coloring of oranges." PURPOSE OF THE BILL The purpose of the bill, as amended, is to permit the orange industry to continue for a maximum period of 3 years (until March 1, 1959) the long-established practice of artificially coloring with a coaltar color designated as FD&C Red 32 oranges which are ripe but whose skins do not have the characteristic orange color. The standards of maturity which such oranges must meet are established by the law of the States in which the oranges are grown. This practice has become an economic necessity for a major segment of the orange industry, since large quantities of oranges grown in Florida and Texas would meet with strong consumer resistance if they were not artificially colored. Oranges so colored are plainly stamped "color added" so that the buying public is fully apprised of this fact. The Food and Drug Administration does not object to the enactment of the bill as amended. The need for this legislation arises because the only coal-tar color suitable for coloring oranges (FD&C Red 32) has been stricken from the approved list by the Food and Drug Administration. The Administration, after public hearing, concluded that this particular coal-tar color was not harmless but was toxic, and that under present law the Administration could not list this color as "harmless and suitable for use in food" although the Administration testified before the committee that the scientific evidence so far available does not establish any likelihood of injury to man from use of this color on the exterior of oranges at the levels of use presently employed. The bill, as amended, provides that the authority to use this color terminates if prior to March 1, 1959, the Food and Drug Administration (pursuant to sec. 406 of the Food, Drug, and Cosmetic Act) places on the approved list another coal-tar color which is harmless and suitable for the coloring of oranges. The bill, as amended, further provides that the continued authority to use FD&C Red 32 is limited to oranges which are not intended for processing with the exception of oranges designated by the trade as "packinghouse elimination." The latter term is understood by the industry to mean oranges originally not intended for processing but which are sent to processing plants after thay have been colored because for some reason they are not considered suitable for sale as raw fruit. FD&C Red 32 was introduced for the purpose of coloring in the mid thirties. This color was first placed on the approved list early in 1939 and has been certified since that time for food use. Prior to certification, use of this color on oranges was permitted under a special proviso of section 402 (c) of the Federal Food, Drug, and Cosmetic Act. The order of the Secretary of Health, Education, and Welfare removing this color and two other coal-tar colors from the approved list was published on November 16, 1955. Under existing law (sec. 402 (c) of the Federal Food, Drug, and Cosmetic Act), a food bearing a coal-tar color is adulterated unless AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 3 the color is from a certified batch. The Department is authorized to list only those coal-tar colors "which are harmless and suitable for use in food," and to "provide for the certification of such [listed] colors with or without harmless diluents." The order of the Secretary was based on the Department's conclusion, reached after a public hearing and on the basis of a public record and detailed findings of fact, that FD&C Red 32 was not a harmless color, but a toxic one, and hence was not eligible for listing and certification under the law. The effect of this order is to ban as an adulterated food color-added oranges. The order of November 16, 1955, has been attacked in three Courts of Appeals: (1) The Certified Coal Tar Color Industry Committee petitioned for review of the entire order in the Second Circuit, and the case is scheduled for argument on May 14, 1956; (2) Eli Lilly & Co. petitioned for review in the Seventh Circuit seeking to set the order aside as it affects use of the colors in drug products; and (3) Florida and Texas orange growers petitioned for review in the Court of Appeals for the Fifth Circuit challenging the order insofar as it prevents use of Red 32 for coloring the skins of oranges. In this case the Government and the petitioners agreed to an order to maintain the status quo, the effect of which is to permit continued certification and use of Red 32 in coloring mature oranges for a temporary period until the case can be argued and decided. Since the color is an economic necessity and since, according to the testimony of the Food and Drug Administration, the evidence so far available does not establish any likelihood of injury to man from the minute amount of this coal-tar color which might find its way into man's diet from his use of colored oranges, the Committee believes that temporary legislation should be enacted to permit continued use of the color for coloring the skin of mature oranges generally not intended for processing. pre However, the committee concluded that this legislation should be limited to a maximum period of 3 years. This will allow time for the necessary scientific studies in the development of a harmless synthetic color. The committee received testimony that these studies are well under way and promise to yield good results. The bill, as amended, will also allow time for the further exploration of the toxicity of FD&C Red 32. Before a final conclusion about the cise toxicity of this color can be drawn, it is necessary to conduct comprehensive, scientific studies of chronic toxicity with laboratory animals over their life span. This will involve feeding tests at levels relating to the quantities of the color that might enter man's diet from his consumption of colored oranges. Such tests and studies will require approximately 3 years and the industry is expected to make these studies during this period. CHANGES IN EXISTING LAW In compliance with clause 3 of rule XIII of the Rules of the House of Representatives, changes in existing law made by the bill, as introduced, are shown as follows (new matter is printed in italics, existing law in which no change is proposed is shown in roman): 4 AMEND THE FEDERAL FOOD, drug, AND COSMETIC ACT SECTION 406 OF THE FEDERAL Food, Drug, AND COSMETIc Act, as AMENDED TOLERANCES FOR POISONOUS INGREDIENTS IN FOOD AND CERTIFICATION OF COAL-TAR COLORS FOR FOOD SEC. 406. (a) Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the application of clause (2) of section 402 (a); but when such substance is so required or cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of clause (2) of section 402 (a). While such a regulation is in effect limiting the quantity of any such substance in the case of any food, such food shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated within the meaning of clause (1) of section 402 (a). In determining the quantity of such added substance to be tolerated in or on different articles of food the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production 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 shall promulgate regulations providing for the listing of coal-tar colors which are harmless and suitable for use in food and for the certification of batches of such colors, with or without harmless diluents. SEC. 408. (c) The Secretary shall promulgate regulations providing for the lifting of coal-tar color for use in the coloring of the outside of oranges meeting the standards of maturity and grade of the United States of America and the respective States where used and which are safe in the manner in which used and suitable for such use, and for the certification of batches of such color, with or without diluents which are not unsafe in the manner in which used. The coal-tar color designated as FD&C Red No. 32 shall be included in the above category and shall continue to be listed until a color or colors which is or are more acceptable on the basis of standards set up by the Secretary may be listed and made available for use. CHANGES IN EXISTING LAW MADE BY THE COMMITTEE AMENDMENT TO THE BILL, AS REPORTED For the information of the Members of the House, changes in existing law made by the committee amendment to the bill, as reported, are shown as follows (new matter is shown in italics, existing law in which no change is proposed is shown in roman): AMEND THE FEDERAL FOOD, DRUG, AND COSMETIC ACT 5 SECTION 402 (c) OF THE FEDERAL Food, Drug, and Cosmetic Act, AS AMENDED ADULTERATED FOOD SEC. 402. A food shall be deemed to be adulterated—(a) (c) If it bears or contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 406: Provided, That this paragraph shall not apply to citrus fruit bearing or containing a coal-tar color if application for listing of such color has been made under this Act and such application has not been acted on by the Secretary, if such color was commonly used prior to the enactment of this Act for the purpose of coloring citrus fruit: Provided further, That this paragraph shall not apply to oranges meeting minimum maturity standards established by or under the laws of the States in which the oranges were grown and not intended for processing (other than oranges designated by the trade as "packinghouse elimination"), the skins of which have been colored at any time prior to March 1, 1959, with the coal-tar color certified prior to the enactment of this proviso as FD&C Red 32, or certified after such enactment as External D&C Red 14 in accordance with 21 Code of Federal Regulations, Part 9: And provided further, That the preceding prociso shall have no further effect if prior to March 1, 1959, another coal-tar color suitable for coloring oranges is listed under section 406. O 6368 CONGRE AUTHORIZING SALE OF CERTAIN The Clerk called the bill (H. R. 6084) to authorize the Secretary of the Interior to sell certain lands of the Agua Caliente Band of Mission Indians, California, to the Palm Springs Unified School District. There being no objection, the Clerk read the bill, as follows: Be it enacted, etc., That, with the consent of the tribal council of the Agua Caliente Band of Mission Indians, the Secretary of the Interior is authorized and directed to sell to the Palm Springs Unified School District of the State of California, in consideration of the payment by such school district of an amount agreed to by such tribal council, the Secretary of the Interior, and such school district all of the right, title, and interest of the United States and of the Agua Caliente Band of Mission Indians in and to that tract of land containing 10 acres, and more par ticularly described as follows: Southwest quarter northeast quarter southeast quarter, section 14, township 4 south, range 4 east, San Bernardino base and meridian. SEC. 2. The proceeds of such sale shall be deposited in the Treasury of the United States to the credit of the Agua Caliente Band of Mission Indians. With the following committee amendment: Page 2, line 7, strike the word "Indians." and insert in lieu thereof the words "Indians, and such proceeds, when distributed to individual members of said band, shall not be subject to Federal income tax." The committee amendment was agreed to. The bill was ordered to be engrossed and read a third time, was read the third time, and passed, and a motion to reconsider was laid on the table. AMENDING SECTION 406 OF THE The Clerk called the bill (H. R. 7732) to amend section 406 of the Federal Food, Drug, and Cosmetic Act (Public Law 717, 75th Cong.), as amended. There being no objection, the Clerk read the bill, as follows: Be it enacted, etc., That section 4C6 of the Federal Food, Drug, and Cosmetic Act (Publle Law 717, 75th Cong.) (52 Stat. 1049). as amended, be, and the same is hereby amended by adding after subsection (b) of section 406 a new subsection as follows: "SEC. 408. (c) The Secretary shall promulgate regulations providing for the lifting of coal tar color for use in the coloring of the outside of oranges meeting the standards of maturity and grade of the United States of America and the respective States where ured and which are safe in the manner in which used and suitable for such use, and for the certification of batches of such color, with or without diluents which are not unsafe in the manner in which used, "The coal tar color designated as FD & C Red No. 32 shall be included in the above category and shall continue to be listed until a color or colors which is or are more acceptable on the basis of standards set up by the Secretary may be listed and made available for use." April 16 Improvements thereon, at the option of the SEC. 2. The real property to be conveyed to the State of Wyoming is described as follows: All the northeast quarter of the southeast With the following committee amend- quarter of section 7, township 32 north, range 71 west, except seventy-four one-hundredths ment: acre in the southwest corner of said northeast quarter of the southeast quarter of section 7, such excepted portion being more particularly described as follows: Beginning at a point on the west line of said northeast quarter of the southeast quarter of section 7, bearing north 60 degrees 53 minutes east a distance of 1,504.2 feet; thence south 29 degrees 10 minutes east on present fence line a distance of 124 feet; thence south no degrees 21 minutes cast on present fence line to the scuth boundary of the northeast quarter of the southeast quarter of section 7; thence south 89 degrees 28 minutes west on present fence line a distance of 58.33 feet to a point on the west line of the northeast quarter of the southcast quarter of section 7; thence north no degrees 28 minutes west on sald west line of the northeast quarter of the southeast quarter of said section 7, a distance of 590 feet to the point of begin. ning; and containing in all thirty-nine and twenty-six one-hundredths acres, more or less, subject to aneasement granted to the town of Douglas, Converse County, Wyoming, for a pipeline for transportation of water, together with the right of ingress and egress, said pipeline running parallel with and distant 27 feet west of the centerline of the LePrele County Road. Strike out all after the enacting clause and insert the following: "That paragraph (c) of section 402 of the Federal Food, Drug, and Cosmetic Act, as amended, is amended by inserting immediately before the period at the end thereof a colon and the following: 'Provided further, That this paragraph shall not apply to oranges meeting minimum maturity standards established by or under the laws of the States in which the oranges were grown and not intended for processing (other than oranges designated by the trade as "packing house elimination"), the skins of which have been colored at any time prior to March 1, 1959, with the coal-tar color certified prior to the enactment of this proviso as FD&C Red 32, or certified after such enactment as External D&C Red 14 in accordance with 21 Code of Federal Regulations, part 9: And provided further, That the preceding proviso shall have no further effect if prior to March 1, 1959, another coal-tar color sultable for coloring oranges is Nsted under section 406"." The committee agreed to. amendment was The bill was ordered to be engrossed and read a third time, was read the third time, and passed. The title was amended so as to read: "A bill to amend section 402 (c) of the Federal Food, Drug, and Cosmetic Act, with respect to the coloring of oranges.' A motion to reconsider was laid on the table. CONVEYANCE OF A PORTION OF The Clerk called the bill (H. R. 8404) There being no objection, the Clerk read the bill, as follows: Be it enacted, etc., That the Administrator ming, by quitclaim deed, without monetary to convey the property to the State of Wyo (a) reserve to the United States all mineral rights including gas and oil; (b) reserve to the United States right of exclusive use without charge therefor of such property together with any improvements thereon during any period of national emergency; and (c) specify that said property shall be used for the training of the National Guard or for other military purposes, and in the event of nonuse for such purpose, shall, in its then existing condition together with any SEC. 3. The cost of any surveys necessary as an incident of the conveyance authorized herein shall be borne by the State of Wyoming. The bill was ordered to be engrossed and read a third time, was read the third time, and passed, and a motion to reconsider was laid on the table. AMENDING PUBLIC HEALTH The Clerk called the bill (S. 2587) to amend the Public Health Service Act to authorize the President to make the commissioned corps a military service in time of emergency involving the national defense, and to authorize payment of uniform allowances to officers of the corps in certain grades when required to wear the uniform, and for other purposes. There being no objection, the Clerk read the bill, as follows: Be it enacted, etc., That section 216 of the Public Health Service Act (42 U. S. C. 217) is amended to read as follows: "USE OF SERVICE IN TIME OF WAR OB EMERGENCY "SEC. 16. In time of war, or of emergency proclaimed by the President, he may utilize the Service to such extent and in such man. ner as shall in his judgment promote the public interest. In time of war, or of emer gency involving the national defense proclalined by the President, he may by Execu tive order declare the commissioned corps of the Service to be a military service. Upon such declaration, and during the period of such war or such emergency or such part thereof as the President shall prescribe, the commissioned corps (a) shall constitute a branch of the land and naval forces of the United States, (b) shall, to the extent preEcribed by regulations of the President, be subject to the Uniform Code of Military Justice, and (c) shall continue to operate as part of the Service except to the extent |