FEDERAL FOOD, DRUG, AND COSMETIC ACT 21 SEC. 6. There are hereby authorized to be appropriated, out of any moneys in the Treasury not otherwise appropriated, such sums as may be necessary for the purpose and administration of this Act. SEC. 7. This Act shall take effect upon the date of its enactment. Hon. J. PERCY PRIEST, UNITED STATES Department of JUSTICE, -Chairman, Committec on Interstate and Foreign Commerce, House of Representatives, Washington, D. C. DEAR MR. CHAIRMAN: This is in response to your request for the views of the Department of Justice concerning the bill (H. R. 7605) to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to prohibit the use in food of new food additives which have not been adequatley tested to establish their safety. The bill would amend the Federal Food, Drug, and Cosmetic Act so as to prevent the use in foods of any harmfu! new food additive. The term "new food additive" would be defined as any substance used or intended for use to preserve or alter any food or for any other purpose in manufacturing, processing, packing, transporting or holding food, which is not generally recognized among experts as having been adequately shown, through prolonged use in or on food or through scientific procedures, to be safe when used in a specified manner and quantity. The bill would designate a new food additive as unsafe unless a regulation is issued by the Secretary of Health, Education, and Welfare that the additive is safe when used in or on a food in the manner and quantity specified in the regulation. The bill would provide a method whereby an interested party may apply for a regulation and would also make provision for public hearings and judicial review in the event of adverse action by the Secretary. Whether the bill should be enacted involves a question of policy concerning which this Department prefers to make no recommendation. The Bureau of the Budget has advised that there is no objection to the submission of this report. Sincerely, Hon. J. PERCY PRIEST, WILLIAM P. ROGERS, Deputy Attorney General. THE SECRETARY OF COMMERCE, Washington, D. C., February 1, 1956. Chairman, Committee on Interstate and Foreign Commerce, DEAR MR. CHAIRMAN: This letter is in reply to your request of January 12, 1956, for the views of this Department with respect to H. R. S271 and H. R. $275, identical bills: "To amend the Federal Food, Drug, and Cosmetic Act for the protection of the public health, by prohibiting new food additives which have not been adequately pretested to establish their safe use under the conditions of their intended use.' "9 H. R. 8271 and H. R. 8275 would provide for regulation of the use of new additives in foods. At present the use of such additives in foods is not subject to regulation unless the Secretary of Health, Education, and Welfare can show that the additive is poisonous or deleterious, in which event the law generally forbids its use in food. The proposed legislation would require a person proposing to use an additive in food to establish that the additive as proposed to be used will be safe. Subject to your consideration of the comments set forth below, this Department recommends enactment of H. R. $271 or II. R. $275 in preference to the other bills for the same general purpose now pending before your committee (H. R. 4099, H. R. 4100, H. R. 4475. ÎH. R. 5927, H. R. 760.5). It is clear that the public interest and the public health require that the use of a particular new additive in food be demonstrated to be safe before the public is exposed to it. Although the commercial value of a new additive is rather quickly determinable, the determination of the effects of its prolonged use upon the consumer 22 FEDERAL FOOD, DRUG, AND COSMETIC ACT requires exhaustive scientific and biological research over a period of many months or years. It has been established that repeated small dosages of some substances may have toxic, carcinogenic, or other harmful effects which would be completely unsuspected in the absence of such tests. For these reasons we endorse enactment by the Congress of legislation for this purpose. H. R. 8271 and H. R. 8275 provide that "with respect to a particular food, or class of foods, any substance to the extent to which, prior to January 1, 1956, its use in the United States in or on such food or class of foods was authorized or approved by any governmental agency or official pursuant to any law of the United States or any regulation promulgated thereunder; or any substance approved for use in or on a food by or under this act" would be exempted from coverage thereunder. It is our understanding there are now being used in foods some 100 chemical additives, the safety of which has not been established. We suggest the language quoted above be modified to provide that chemical additives now in use may continue to be used pending completion within a suitable period of the procedures prscribed in the proposed new section 409. Such an amendment would insure that present manufacturing processes would not be affected needlessly, while at the same time insuring prompt determination of the effect of continued use on the health of the public. We wish to endorse specifically section 2 of these bills which provides safeguards against unauthorized disclosures of trade secrets of manufacturers. It is noted that H. R. 8271 and H. R. S275 would provide for use of the Declaratory Judgments Act in the enforcement of its provisions. This Department has no preference between this enforcement procedure and the other procedures which have been suggested in bills now pending before the committee. We recommend, Lowever, that your committee adopt that enforcement procedure which public hearings develop as being the method best calculated to provide maximum protection to the public with the most expeditious procedural handling. Consideration should also be given to including within the coverage of the bills irradiation or treatment with radioactive substances. Subject to your consideration of these comments, this Department recommends enactment of H. R. 8271 or H. R. 8275. We have been advised by the Bureau of the Budget that it would interpose no objection to the submission of this report to your committee. Sincerely yours, SINCLAIR WEEKS, Secretary of Commerce. EXECUTIVE OFFICE OF THE PRESIDENT, BUREAU OF THE BUDGET, Washington D. C., February 6, 1956. Hon. J. PERCY PRIEST, Chairman, Committee on Interstate and Foreign Commerce, House of Representatives, Washington 25, D. C. MY DEAR MR. CHAIRMAN: This is in response to your request for reports on H. R. 7605, H. R. 8748, É. R. 4475, H. R. 8275, H. R. 8271, and H. R. 7607. These bills all have the purpose of protecting the public health by amending the Federal Food, Drug, and Cosmetic Act to prohibit the use in food of additives which have not been adequately tested to establish their safety. We have also been asked to comment on II. R. 4099 and H. R. 4100, which we understand have been superseded by H. R. 7605 and H. R. 7606. It is possible to group all of these bills under three general heads depending upon the distinctive procedural techniques which they propose: Administrative procedure approach, H. R. 4475, H. R. 7605, H. R 7606, and II. R. 8748; declaratory judgment approach, H. R. 8275 and H. R. $271; injunction approach, H. R. 7607 and H. R. 7764. In the report of the Department of Health, Education, and Welfare, and in its accompanying staff study, extensive criticisms are made of the declaratory judg ment and injunction type approaches. The Department suggests a number of amendments, which, if adopted, would make the provisions of II. R. 7605, H. R. 7606 or H. R. 8748 acceptable to the Department as the agency now charged with the major responsibility for administration and enforcement of the food and drug laws. While the Bureau is not technically equipped to pass on the details of these proposed amendments, we are firmly convinced that the principles underlying them are sound. FEDERAL FOOD, DRUG, AND COSMETIC ACT 21 SEC. 6. There are hereby authorized to be appropriated, out of any moneys in the Treasury not otherwise appropriated, such sums as may be necessary for the purpose and administration of this Act. SEC. 7. This Act shall take effect upon the date of its enactment. Hon. J. PERCY PRIEST, UNITED STATES DEPARTMENT OF JUSTICE, -Chairman, Committec on Interstate and Foreign Commerce, House of Representatives, Washington, D. C. DEAR MR. CHAIRMAN: This is in response to your request for the views of the Department of Justice concerning the bill (H. R. 7605) to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to prohibit the use in food of new food additives which have not been adequatley tested to establish their safety. The bill would amend the Federal Food, Drug, and Cosmetic Act so as to prevent the use in foods of any harmful new food additive. The term "new food additive" would be defined as any substance used or intended for use to preserve or alter any food or for any other purpose in manufacturing, processing, packing, transporting or holding food, which is not generally recognized among experts as having been adequately shown, through prolonged use in or on food or through scientific procedures, to be safe when used in a specified manner and quantity. The bill would designate a new food additive as unsafe unless a regulation is issued by the Secretary of Health, Education, and Welfare that the additive is safe when used in or on a food in the manner and quantity specified in the regulation. The bill would provide a method whereby an interested party may apply for a regulation and would also make provision for public hearings and judicial review in the event of adverse action by the Secretary. Whether the bill should be enacted involves a question of policy concerning which this Department prefers to make no recommendation. The Bureau of the Budget has advised that there is no objection to the submission of this report. Sincerely, Hon. J. PERCY PRIEST, WILLIAM P. ROGERS, Deputy Attorney General. THE SECRETARY OF COMMERCE, Chairman, Committee on Interstate and Foreign Commerce, DEAR MR. CHAIRMAN: This letter is in reply to your request of January 12, 1956, for the views of this Department with respect to H. R. $271 and H. R. S275, identical bills: "To amend the Federal Food, Drug, and Cosmetic Act for the protection of the public health, by prohibiting new food additives which have not been adequately pretested to establish their safe use under the conditions of their intended use." H. R. 8271 and H. R. 8275 would provide for regulation of the use of new additives in foods. At present the use of such additives in foods is not subject to regulation unless the Secretary of Health, Education, and Welfare can show that the additive is poisonous or deleterious, in which event the law generally forbids its use in food. The proposed legislation would require a person proposing to use an additive in food to establish that the additive as proposed to be used will be safe. Subject to your consideration of the comments set forth below, this Department recommends enactment of H. R. $271 or II. R. $275 in preference to the other bills for the same general purpose now pending before your committee (H. R. 4099, H. R. 4100, H. R. 4475. H. R. 5927, H. R. 7005). It is clear that the public interest and the public health require that the use of a particular new additive in food be demonstrated to be safe before the public is exposed to it. Although the commercial value of a new additive is rather quickly determinable, the determination of the effects of its prolonged use upon the consumer 22 FEDERAL FOOD, DRUG, AND COSMETIC ACT requires exhaustive scientific and biological research over a period of many months or years. It has been established that repeated small dosages of some substances may have toxic, carcinogenic, or other harmful effects which would be completely unsuspected in the absence of such tests. For these reasons we endorse enactment by the Congress of legislation for this purpose. H. R. 8271 and H. R. 8275 provide that "with respect to a particular food, or class of foods, any substance to the extent to which, prior to January 1, 1956, its use in the United States in or on such food or class of foods was authorized or approved by any governmental agency or official pursuant to any law of the United States or any regulation promulgated thereunder; or any substance approved for use in or on a food by or under this act" would be exempted from coverage thereunder. It is our understanding there are now being used in foods some 100 chemical additives, the safety of which has not been established. We suggest the langunge quoted above be modified to provide that chemical additives now in use may continue to be used pending completion within a suitable period of the procedures prscribed in the proposed new section 409. Such an amendment would insure that present manufacturing processes would not be affected needlessly, while at the same time insuring prompt determination of the effect of continued use on the health of the public. We wish to endorse specifically section 2 of these bills which provides safeguards against unauthorized disclosures of trade secrets of manufacturers. It is noted that H. R. 8271 and H. R. S275 would provide for use of the Declaratory Judgments Act in the enforcement of its provisions. This Department has no preference between this enforcement procedure and the other procedures which have been suggested in bills now pending before the committee. We recommend, however, that your committee adopt that enforcement procedure which public hearings develop as being the method best calculated to provide maximum protec tion to the public with the most expeditious procedural handling. Consideration should also be given to including within the coverage of the bills irradiation or treatment with radioactive substances. Subject to your consideration of these comments, this Department recommends enactment of H. R. 8271 or H. R. 8275. We have been advised by the Bureau of the Budget that it would interpose no objection to the submission of this report to your conìmittee. Sincerely yours, SINCLAIR WEEKS, Secretary of Commerce. EXECUTIVE OFFICE OF THE PRESIDENT, BUREAU OF THE BUDGET, Washington D. C., February 6, 1956. Hon. J. PERCY PRIEST, Chairman, Committee on Interstate and Foreign Commerce, House of Representatives, Washington 25, D. C. MY DEAR MR. CHAIRMAN: This is in response to your request for reports on H. R. 7605, H. R. 8748, É. R. 4475, H. R. 8275, H. R. 8271, and H. R. 7607. These bills all have the purpose of protecting the public health by amending the Federal Food, Drug, and Cosmetic Act to prohibit the use in food of additives which have not been adequately tested to establish their safety. We have also been asked to comment on II. R. 4099 and H. R. 4100, which we understand have been superseded by H. R. 7605 and H. R. 7606. It is possible to group all of these bills under three general heads depending upon the distinctive procedural techniques which they propose: Administrative procedure approach, H. R. 4475, H. R. 7605, H. R 7606, and H. R. 8748; declaratory judgment approach, H. R. $275 and H. R. $271; injunction approach, H. R. 7607 and H. R. 7764. In the report of the Department of Health, Education, and Welfare, and in its accompanying staff study, extensive criticisms are made of the declaratory judgment and injunction type approaches. The Department suggests a number of amendments, which, if adopted, would make the provisions of II. R. 7605, H. R. 7606 or H. R. 8748 acceptable to the Department as the agency now charged with the major responsibility for administration and enforcement of the food and drug laws. While the Bureau is not technically equipped to pass on the details of these proposed amendments, we are firmly convinced that the principles underlying them are sound. FEDERAL FOOD, DRUG, AND COSMETIC ACT 23 We support the enactment of legislation which would: (a) Require the submission to the Department of Health, Education, and Welfare of pretesting data adequate to establish the safety of an additive, (b) give the Department clear powers to compel adherence to its scientific determinations on tolerances and safety, (c) provide for judicial review in which the findings of the Secretary with respect to questions of fact shall be sustained if supported by substantial evidence when considered on the record as a whole, (d) provide that the burden of obtaining judicial review of the administering agency's final decision shall be on the person seeking to set aside that decision, (e) provide for collection of fees to defray the costs of administering the legislation and (f) give adequate time for the Federal Government and the industries affected to establish procedures for administration of the legislation before it comes into effect. DEAR CONGRESSMAN PRIEST: This is in reply to your request of July 29, 1955, for a report on H. R. 7605, a bill to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to prohibit the use in food of new food additives which have not been adequately tested to establish their safety. The Department has no objection to the enactment of this bill. H. R. 7605 defines "new food additive" as any substance used, or intended to be used, to preserve or alter any food for any purpose in manufacturing, producing, processing, packing, wrapping, transporting, or holding food that is not generally recognized among experts qualified by scientific training and experi ence to evaluate the safety of such substauce as having been adequately shown, through use in food or scientific procedures, to be safe when used in or on a food in a specified manner and quantity. However, the term does not include pesticide chemicals in or on raw agricultural commodities. Any new food additive shall be deemed unsafe for the purpose unless a regulation has been issued by the Secretary of Health, Education, and Welfare, pursuant to this section, announcing that said additive is safe when used in food as specified in the regulation. Any interested person shall have the right to file with the Secretary an application containing pertinent data for the purpose of establishing that a new food additive is safe when used in a specified manner and quantity. Within a specified period of time after the filing of the application, the Secretary is required to issue a regulation announcing that the new food additive is safe or notify the applicant that no such regulation will be issued. Scientific and judicial reviews are provided for in the event the application is denied. The bill authorizes the appropriation of such sums as may be necessary for the purpose and administration of the legislation out of any moneys in the Treasury not otherwise appropriated. The legislation is to take effect upon the date of its enactment. It is suggested that on page 4, line 14, the word "reduction" be changed to "degradation." "Degradation" is the more acceptable terminology. The Bureau of the Budget advises that there is no objection to the submission of this report. DEAR CONGRESSMAN PRIEST: This is in reply to your request of March 3. 1955, for a report on H. R. 4475, a bill to provide for the safety of chemical additives in food. The Department has no objection to the enactment of II. R. 4475, if amended as indicated herein. |