FEDERAL FOOD, DRUG, AND COSMETIC ACT (Chemical Additives in Food) TUESDAY, JANUARY 31, 1956 HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH AND SCIENCE OF THE The subcommittee met at 10 a. m., pursuant to notice, in room 1334 of the House Office Building, Hon. J. Percy Priest (chairman) presiding. The CHAIRMAN. The Health and Science Subcommittee will come to order. This morning the subcommittee is beginning hearings on a number of bills designed to amend the Federal Food, Drug, and Cosmetic Act with regard to chemical additives in food. I wish, first, to say a few words about the origin of some of the 10 bills on which the hearings are being held. Some of these bills were introduced by my distinguished colleague from Minnesota and myself at the behest of different industry groups. It is my understanding that the two latest bills introduced by Mr. O'Hara and myself-H. R. 8271 and H. R. 8275-are the result of a substantial agreement reached with regard to this legislation by the food industries and the chemical manufacturers. I need not go into details concerning the differences between these two latest bills and earlier bills introduced by Mr. O'IIara and myself, because I am certain that the witnesses representing the chemical manufacturers and the food industries will elaborate on these differences at considerable length. The bill that Mr. Delaney introduced grew out of hearings which were held before a select committee of which he was chairman 3 years ago. Congressman Miller of Nebraska, has introduced a new bill, II. R. 8748, which supersedes an earlier one introduced by him under the number of H. R. 5927. Mr. Delaney and Mr. Miller will discuss the background and provisions of their bills as soon as I have completed a few additional remarks. The introduction of numerous bills on the same subject gives the appearance of basic disagreement. However, just the reverse is true. There is basic agreement among proponents of this legislation with regard to the need for additional legislation. The industries concerned those who manufacture the chemicals in question and those who use them in connection with food products-and the Government agencies are in agreement that an advance determination by the Government as to the acceptability of a chemical in connection with foods 1 2 FEDERAL FOOD, DRUG, AND COSMETIC ACT is desirable from the point of view both of the industries concerned, the Government, and the consumer. It has been my experience and others will have undoubtedly made the same observation-that parties who are in agreement on basic premises but disagree as to details, sometimes put up a better fight than persons who are in fundamental disagreement. As I indicated in my recent luncheon talk commemorating the passage of the first Federal food and drug laws in 1906: Our food and drug legislation today is no longer concerned with the basic principle of consumer protection, for this principle has been accepted. Instead, the writing of new food and drug legislation today is generally concerned with designing methods and procedures to deal with some new situation. I stated that the contribution of this committee with regard to many recent food and drug amendments has been "to prod" if I might use that word the representatives of industry and Government to compromise extreme positions and to find solutions which will accomplish the desired objectives without sacrificing principle or causing unnecessary hardship. I referred specifically to the chemical additive bills now before us and I stated that the issues raised by these bills are of the kind which require a cooperative approach in order to bring about legislation which will give the consumer the protection to which he is entitled without imposing unnecessary hardships on the producers of the food additives and the food processors who are using these additives. During the 83d Congress this committee worked hard to bring about final agreement among all parties concerned with regard to pesticide legislation. It is my sincere hope that the splendid example which was set by the industries concerned and the responsible Government officials will be emulated in the case of this legislation and that before any bill is reported by this committee to the floor of the House, the interested groups and officials who are already in agreement with regard to the basic principles underlying this legilsation will also reach complete agreement on the procedural details involved in these bills. I want to put into the record at this point the bills on which our hearings are held this morning and also the department reports, and then we shall hear from our colleagues, Mr. Miller and Mr. Delaney. (The bills and reports are as follows:) [H. R. 4475, 84th Cong., 1st sess.] A BILL To protect the public health by amending the Federal Food, Drug, and Cosmetic Aet so as to provide for the safety of chemical additives in food Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 201 of the Federal Food, Drug, and Cosmetic Act is amended by the addition of the following paragraph: "(s) The term 'chemical additive' means any substance (including products resulting from changes in such substance after use) which (1) is intended for use (A) as a food or (B) to preserve or alter any food or any characteristic of any food; or (C) for any other purpose in producing, processing packing, transporting, wrapping, or holding food if such use is likely to result in the contamination of food, but shall not include pesticide chemicals used in the production, storage, or transportation of raw agricultural commodities, as defined in section 201 (q) of this Act; and (2) is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of chemical additives, as having been adequately tested to show that it is not poisonous or deleterious, or is a poisonous or deleterious substance which is not generally rec FEDERAL FOOD, DRUG, AND COSMETIC ACT (Chemical Additives in Food) TUESDAY, JANUARY 31, 1956 HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH AND SCIENCE OF THE The subcommittee met at 10 a. m., pursuant to notice, in room 1334 of the House Office Building, Hon. J. Percy Priest (chairman) presiding. The CHAIRMAN. The Health and Science Subcommittee will come to order. This morning the subcommittee is beginning hearings on a number of bills designed to amend the Federal Food, Drug, and Cosmetic Act with regard to chemical additives in food. I wish, first, to say a few words about the origin of some of the 10 bills on which the hearings are being held. Some of these bills were introduced by my distinguished colleague from Minnesota and myself at the behest of different industry groups. It is my understanding that the two latest bills introduced by Mr. O'Hara and myself-H. R. 8271 and H. R. 8275-are the result of a substantial agreement reached with regard to this legislation by the food industries and the chemical manufacturers. I need not go into details concerning the differences between these two latest bills and earlier bills introduced by Mr. O'Hara and myself, because I am certain that the witnesses representing the chemical manufacturers and the food industries will elaborate on these differences at considerable length. The bill that Mr. Delaney introduced grew out of hearings which were held before a select committee of which he was chairman 3 years ago. Congressman Miller of Nebraska, has introduced a new bill, II. R. 8748, which supersedes an earlier one introduced by him under the number of H. R. 5927. Mr. Delaney and Mr. Miller will discuss the background and provisions of their bills as soon as I have completed a few additional remarks. The introduction of numerous bills on the same subject gives the appearance of basic disagreement. However, just the reverse is true. There is basic agreement among proponents of this legislation with regard to the need for additional legislation. The industries concerned those who manufacture the chemicals in question and those who use them in connection with food products-and the Government agencies are in agreement that an advance determination by the Government as to the acceptability of a chemical in connection with foods 1 2 FEDERAL FOOD, DRUG, AND COSMETIC ACT is desirable from the point of view both of the industries concerned, the Government, and the consumer. It has been my experience and others will have undoubtedly made the same observation-that parties who are in agreement on basic premises but disagree as to details, sometimes put up a better fight than persons who are in fundamental disagreement. As I indicated in my recent luncheon talk commemorating the passage of the first Federal food and drug laws in 1906: Our food and drug legislation today is no longer concerned with the basic principle of consumer protection, for this principle has been accepted. Instead, the writing of new food and drug legislation today is generally concerned with designing methods and procedures to deal with some new situation. I stated that the contribution of this committee with regard to many recent food and drug amendments has been "to pred" if I might use that word . the representatives of industry and Government to compromise extreme positions and to find solutions which will accomplish the desired objectives without sacrificing principle or causing unnecessary hardship. I referred specifically to the chemical additive bills now before us and I stated that the issues raised by these bills are of the kind which require a cooperative approach in order to bring about legislation which will give the consumer the protection to which he is entitled without imposing unnecessary hardships on the producers of the food additives and the food processors who are using these additives. During the 83d Congress this committee worked hard to bring about final agreement among all parties concerned with regard to pesticide legislation. It is my sincere hope that the splendid example which was set by the industries concerned and the responsible Government officials will be emulated in the case of this legislation and that before any bill is reported by this committee to the floor of the House, the interested groups and officials who are already in agreement with regard to the basic principles underlying this legilsation will also reach complete agreement on the procedural details involved in these bills. I want to put into the record at this point the bills on which our hearings are held this morning and also the department reports, and then we shall hear from our colleagues, Mr. Miller and Mr. Delaney. (The bills and reports are as follows:) [H. R. 4475, 84th Cong., 1st sess.] A BILL To protect the public health by amending the Federal Food, Drug, and Cosmetic Aet so as to provide for the safety of chemical additives in food Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 201 of the Federal Food, Drug, and Cosmetic Act is amended by the addition of the following paragraph: "(s) The term 'chemical additive' means any substance (including products resulting from changes in such substance after use) which (1) is intended for use (A) as a food or (B) to preserve or alter any food or any characteristic of any food; or (C) for any other purpose in producing, processing packing, transporting, wrapping, or holding food if such use is likely to result in the contamination of food, but shall not include pesticide chemicals used in the produc bon, storage, or transportation of raw agricultural commodities, as defined in section 201 (q) of this Act; and (2) is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of chemical additives, as having been adequately tested to show that it is not poisonous or deleterious, or is a poisonous or deleterious substance which is not generally rec FEDERAL FOOD, DRUG, AND COSMETIC ACT 3 ognized among such experts as having been adequately tested to show that it is safe for its intended use." SEC. 2 Section 301 of the Federal Food, Drug, and Cosmetic Act is amended by changing "404 or 505" in subsection (d) to "404, 409, or 505"; and “404, 505, 506, 307, or 704” in subsection (j) to “404, 409, 505, 506, 507, or 704". SEC. 3. Section 304 of such Act is amended by changing "404 or 505" in subsections (a) and (d) to “404, 409, or 505”. SEC. 4. Section 402 (a) of such Act is amended by changing the period at the end to a semicolon and adding: “or (7) if it is, or bears or contains a chemical additive, unless the use of such chemical additive has been approved pursuant to section 409." SEC. The following section shall be added to chapter IV of such Act: "CHEMICAL ADDITIVES "SEC. 409. (a) No person shall introduce or deliver for introduction into interstate commerce any chemical additive, unless the use of such chemical additive has been approved pursuant to this section. (b) Any person may file with the Secertary an application for the issuance of an order approving the use of a chemical additive. There shall be submitted to the Secretary with the application (1) a statement of the intended use of the chemical additive and demonstrating that such employment of the chemical additive will serve a purpose which will be useful to the consuming public; (2) reports of investigations which have been made to determine the acute and chronic toxicity and other potentiality for harni of the chemical additive; (3) a statement of the composition of the chemical additive; (4) a description of methods of analysis for the quantitative determination of the chemical additive, and its reduction products, in or on food; (5) such samples of the chemical additive as the Secretary may require; (6) all directions, recommendations and suggestions proposed for the use of the chemical additive; and (7) if the chemical additive is a poisonous or deleterious substance, reports of investigations which have been made to show the quantities of the chemical additive remaining in or on the food and that it is required for its intended use. (e) The Secretary shall issue an order approving the application within ninety days after the filing of the application if the Secretary finds that the reports submitted to him pursuant to subsection (b) demonstrate (1) that the chemical additive is not a poisonous or deleterious substance or if it is that it is safe and required for its intended use, and (2) that the intended use of the chemical additive will serve a purpose which will be useful to the consuming public; otherwise, except as provided in subsection (d), the Secretary shall issue an order within said ninety days refusing to approve the application. d) Within said ninety-day period specified in subsection (c), the Secretary, when he deems such action advisable or upon notification from the applicant, shall submit the application and other data before him to an advisory committee to be appointed pursuant to subsection (f). Within sixty days after such referral, or within an additional thirty days if the committee deems such additional time necessary, the committee, after independent study of the data submitted to it by the Secretary, shall certify to him a report and recommendations on the proposal in the application, together with all underlying data and a statement of the reasons for the recommendations. Within thirty days after such certification, the Secretary, after giving due consideration to all the material, including such report and recommendations, then before him, shall issue an order approving the application if he finds that the chemical additive is not a poisonous or deleterious substance or if it is that it is safe and required for its intended use, and that its intended use will serve a purpose which will be useful to the consuming public; otherwise the Secretary shall issue an order within said thirty days refusing to approve the application. In determining whether a chemical additive is safe under subsection (c) or (d), the Secretary shall take into account the other ways in which the consumer may be affected by the same substance or other substances. (e) Within thirty days after the issuance of an order under subsection (c) or (d), any person adversely affected may file objections thereto with the Secre tary specifying the reasons he deems the cider objectionable and requesting a public hearing upon such objections. After furnishing due notice, the Secretary shall thereupon hold a public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. Any report, |