AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT 15

ing of regulations under certain provisions of such act, and for other purposes. This bill would extend the procedural simplification provisions of Public Law 335, 83d Congress, 2d session, by removing the requirements of formal rulemaking-public hearing, and establishment of a record of testimony and exhibits on which to base a decision-with respect to certain regulations in cases where the regulation, or amendment or repeal of the regulation, is noncontroversial. The regulations concerned are those dealing with labeling for special dietary foods (sec. 403 (j)), emergency permit control (sec. 404), tolerances for necessary and unavoidable poisonous and deleterious substances in foods (sec. 406 (a)), listing of coal-tar colors which may be certified for use in food, drugs, and cos metics (secs. 406 (b), 504, and 604), modification of tests and assays prescribed in official compendia or prescribing tests for official drugs where the compendia have not prescribed tests (sec. 501 (b)), listing of chemical derivatives of habitforming drugs (sec: 502 (d)), and packaging requirements and labeling precautions for drugs liable to deterioration (sec. 502 (h)).

The bill would greatly facilitate the establishment of regulations insofar as they are noncontroversial. It would also simplify hearings on regulations containing both controversial and noncontroversial issues by separating and eliminating the noncontroversial. On the narrow issues about which there is controversy, any interested person affected by a proposed regulation could, by filing a petition, initiate the formal procedure, including a public hearing, establishment of the public record on which our action would be based, and review of our action in the United States Courts of Appeals. Thus, no substantial rights of any person would be relieved of protection, while Government, the public, and industry are relieved of the costs and expenditure of time in holding hearings on points about which all agree.

Experience with Public Law 335, which was limited to regulations establishing standards of identity, quality, and fill of container for food products, has shown that it provides an effective procedure for establishing regulations with a mini. mum of cost and wasted effort, while at the same time protecting the rights of interested persons.

Your committee's report on II. R. 6434 (which became Public Law 335) stated in regard to the proposal to simplify the procedure for food standards issued under section 401 of the act:

All of the communications received by the committee, including many not a part of the record, and both of the witnesses appearing before the committee, favored the proposed legislation and urged its early enactment. There is no known opposition.

The consensus of opinion as expressed in these communications and by witnesses appearing before the committee may be fairly stated to be that (a) the procedural requirements of the present law are unnecessarily burdensome in that they require formal hearings and all that this implies, whether a proposed regulation is controversial or not, with the resultant useless expenditure of time and money by both the Government and the interested industry, even when all are in agreement as to the proposed regulation; and (b) the proposed legislation is favored by them because it should provide the needed relief from these unnecessary burdens by eliminating the requirement for formal hearings except in instances where such a hearing is desired for the purpose of providing a basis for the judicial review as now provided in the act, should the objecting party find the ultimate regulation still objectionable (H. Rept. 934, 83d Cong., 1st sess.).

We believe that the amendment of section 701 (e) contained in the bill, which makes the simplification effected by Public Law 335 applicable to the procedure for the other regulations governed by section 701 (e), will prove as noncontroversial in its extension to other regulations as was the prior amendment affecting only the food standards procedure.

The existing law is unnecessarily burdensome, and the proposed bill would afford the required relief. We recommend that it be considered favorably by your committee.

We have also prepared and submitted to the President of the Senate an identical draft bill, with a request that it be considered by the appropriate committee of the Senate. A copy of our letter of transmittal of the draft bill is enclosed for your convenience.

The Bureau of the Budget advises that it perceives no objection to the submission of this report to your committee.

Sincerely yours,

M. B. FOLSOM, Secretary.

16 AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,

Hon. RICHARD M. NIXON,

The President of the Senate.

June 6, 1956.

DEAR MR. PRESIDENT: We are enclosing a draft of a bill to amend section 701 of the Federal Food, Drug, and Cosmetic Act so as to simplify the procedures governing the prescribing of regulations under certain provisions of such act, and for other purposes. This bill is identical with H. R. 9547, introduced in the House of Representatives by Congressman Robert Hale.

This bill would extend the procedural simplification provisions of Public Law 335, 83d Congress, 2d session, by removing the requirements of formal rulemaking-public bearing, and establishment of a record of testimony and exhibits on which to base a decision-with respect to certain regulations in cases where the regulation, or amendment or repeal of the regulation, is noncontroversial. The regulations concerned are those dealing with labeling for special dietary foods (sec. 403 (j)), emergency permit control (sec. 404), tolerances for necessary and unavoidable poisonous and deleterious substances in foods (sec. 406 (a)), listing of coal-tar colors which may be certified for use in food, drugs, and cosmetics (secs. 406 (b), 504, and 604), modification of tests and assays prescribed in official compendia or prescribing tests for official drugs where the compendia have not prescribed tests (sec. 501 (b)), listing of chemical derivatiives of habit-forming drugs (sec. 502 (d)), and packaging requirements and labeling precautions for drugs liable to deterioration (sec. 502 (h)).

The bill would greatly facilitate the establishment of regulations insofar as they are noncontroversial. It would also simplify hearings on regulations containing both controversial and noncontroversial issues by separating and eliminating the noncontroversial. On the narrow issues about which there is controversy, any interested person affected by a proposed regulation could, by filing a petition, initiate the formal procedure, including a public hearing, establishment of the public record on which our action would be based, and review, of our action in the United States Courts of Appeals. Thus, no substantial rights of any person would be relieved of protection, while Government, the public, and industry are relieved of the costs and expenditure of time in holding hearings on points about which all agree.

Experience with Public Law 335, which was limited to regulations establishing standards of identity, quality, and fill of container of food products, has shown that it provides an effective procedure for establishing regulations with a minimum of cost and wasted effort, while at the same time protecting the rights of interested persons.

The report of the Senate Committee on Labor and Public Welfare on H. R 6434 (which became Public Law 335) stated in regard to the proposal to simplify the procedure for food standards issued under section 401 of the act:

.

The consensus of opinion among all the leading food producers, as well as Food and Drug Administration, officials, is that the existing standard-making procedures are slow and cumbersome. The procedural requirements of the present Jaw are unnecessarily burdensome in that they require formal hearings and all that this implies, whether a proposed regulation is controversial or not, with the resultant useless expenditure of time and money by both the Government and the interested industry, even when all are in agreement as to the proposed regulation. Enactment of this bill would provide needed relief from these unnecessary burdens by eliminating the requirement for formal hearings except in instances where such a hearing is desired for the purpose of providing a basis for the judicial review as now provided in the act, should the objecting party find the ultimate regulation still objectionable.

The Commissioner of Food and Drugs, together with counsel representing the interest of leading food producers, appeared before members of the Subcommittee on Health of this committee and strongly urged the early enactment of this legislation. All communications received by the committee concerning this measure have been unanimous in favor of the bill's enactment and the committee knows of no opposition thereto (S. Rept. 1000, 83d Cong., 2d sess.).

We believe that the amendment of section 701 (e) contained in the bill, which makes the simplification effected by Public Law 335 applicable to the procedure for the other regulations governed by section 701 (e), will prove as noncontroversial in its extenison to other regulations as was the prior amendment affecting only the food standards procedure.

AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT 15

ing of regulations under certain provisions of such act, and for other purposes. This bill would extend the procedural simplification provisions of Public Law 335, 83d Congress, 2d session, by removing the requirements of formal rulemaking-public hearing, and establishment of a record of testimony and exhibits on which to base a decision—with respect to certain regulations in cases where the regulation, or amendment or repeal of the regulation, is noncontroversial. The regulations concerned are those dealing with labeling for special dietary foods (sec. 403 (1)), emergency permit control (sec. 404), tolerances for necessary and unavoidable poisonous and deleterious substances in foods (sec. 406 (a)), listing of coal-tar colors which may be certified for use in food, drugs, and cosmetics (secs. 406 (b), 504, and 604), modification of tests and assays prescribed in official compendia or prescribing tests for official drugs where the compendia have not prescribed tests (sec. 501 (b)), listing of chemical derivatives of habitforming drugs (sec: 502 (d)), and packaging requirements and labeling precautions for drugs liable to deterioration (sec. 502 (h)).

The bill would greatly facilitate the establishment of regulations insofar as they are noncontroversial. It would also simplify hearings on regulations containing both controversial and noncontroversial issues by separating and eliminating the noncontroversial. On the narrow issues about which there is controversy, any interested person affected by a proposed regulation could, by filing a petition, initiate the formal procedure, including a public hearing, establishment of the public record on which our action would be based, and review of our action in the United States Courts of Appeals. Thus, no substantial rights of any person would be relieved of protection, while Government, the public, and industry are relieved of the costs and expenditure of time in holding hearings on points about which all agree.

Experience with Public Law 335, which was limited to regulations establishing standards of identity, quality, and fill of container for food products, has shown that it provides an effective procedure for establishing regulations with a minis mum of cost and wasted effort, while at the same time protecting the rights of interested persons.

Your committee's report on II. R. 6434 (which became Public Law 335) stated in regard to the proposal to simplify the procedure for food standards issued under section 401 of the act:

All of the communications received by the committee, including many not a part of the record, and both of the witnesses appearing before the committee, favored the proposed legislation and urged its early enactment. There is no known opposition.

The consensus of opinion as expressed in these communications and by wit nesses appearing before the committee may be fairly stated to be that (a) the procedural requirements of the present law are unnecessarily burdensome in that they require formal hearings and all that this implies, whether a proposed regulation is controversial or not, with the resultant useless expenditure of time and money by both the Government and the interested industry, even when all are in agreement as to the proposed regulation; and (b) the proposed legislation is favored by them because it should provide the needed relief from these unnecessary burdens by eliminating the requirement for formal hearings except in instances where such a hearing is desired for the purpose of providing a basis for the judicial review as now provided in the act, should the objecting party find the ultimate regulation still objectionable (H. Rept. 934, 83d Coug., 1st sess.).

We believe that the amendment of section 701 (e) contained in the bill, which makes the simplification effected by Public Law 335 applicable to the procedure for the other regulations governed by section 701 (e), will prove as noncontroversial in its extension to other regulations as was the prior amendment affecting only the food standards procedure.

The existing law is unnecessarily burdensome, and the proposed bill would afford the required relief. We recommend that it be considered favorably by your committee.

We have also prepared and submitted to the President of the Senate an identical draft bill, with a request that it be considered by the appropriate committee of the Senate. A copy of our letter of transmittal of the draft bill is enclosed for your convenience.

The Bureau of the Budget advises that it perceives no objection to the submission of this report to your committee.

Sincerely yours,

M. B. FOLSOM, Secretary.

16 AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,

Hon. RICHARD M. NIXON,

The President of the Senate.

June 6, 1956.

DEAR MR. PRESIDENT: We are enclosing a draft of a bill to amend section 701 of the Federal Food, Drug, and Cosmetic Act so as to simplify the procedures governing the prescribing of regulations under certain provisions of such act, and for other purposes. This bill is identical with H. R. 9547, introduced in the House of Representatives by Congressman Robert Hale.

This bill would extend the procedural simplification provisions of Public Law 335, 83d Congress, 2d session, by removing the requirements of formal rulemaking-public hearing, and establishment of a record of testimony and exhibits on which to base a decision-with respect to certain regulations in cases where the regulation, or amendment or repeal of the regulation, is noncontroversial. The regulations concerned are those dealing with labeling for special dietary foods (sec. 403 (j)), emergency permit control (sec. 404), tolerances for necessary and unavoidable poisonous and deleterious substances in foods (sec. 406 (a)), listing of coal-tar colors which may be certified for use in food, drugs, and cosmetics (secs. 406 (b), 504, and 604), modification of tests and assays prescribed in official compendia or prescribing tests for official drugs where the compendia have not prescribed tests (sec. 501 (b)), listing of chemical derivatiives of habit-forming drugs (sec. 502 (d)), and packaging requirements and labeling precautions for drugs liable to deterioration (sec. 502 (h)).

The bill would greatly facilitate the establishment of regulations insofar as they are noncontroversial. It would also simplify hearings on regulations containing both controversial and noncontroversial issues by separating and eliminating the noncontroversial. On the narrow issues about which there is controversy, any interested person affected by a proposed regulation could, by filing a petition, initiate the formal procedure, including a public hearing, establishment of the public record on which our action would be based, and review of our action in the United States Courts of Appeals. Thus, no substantial rights of any person would be relieved of protection, while Government, the public, and industry are relieved of the costs and expenditure of time in holding hearings on points about which all agree.

Experience with Public Law 335, which was limited to regulations establishing standards of identity, quality, and fill of container of food products, has shown that it provides an effective procedure for establishing regulations with a minimum of cost and wasted effort, while at the same time protecting the rights of interested persons.

The report of the Senate Committee on Labor and Public Welfare on H. R. 6434 (which became Public Law 335) stated in regard to the proposal to simplify the procedure for food standards issued under section 401 of the act:

The consensus of opinion among all the leading food producers, as well as Food and Drug Administration, officials, is that the existing standard-making procedures are slow and cumbersome. The procedural requirements of the present Jaw are unnecessarily burdensome in that they require formal hearings and all that this implies, whether a proposed regulation is controversial or not, with the resultant useless expenditure of time and money by both the Government and the interested industry, even when all are in agreement as to the proposed regulation. Enactment of this bill would provide needed relief from these unnecessary burdens by eliminating the requirement for formal hearings except in instances where such a hearing is desired for the purpose of providing a basis for the judicial review as now provided in the act, should the objecting party find the ultimate regulation still objectionable.

The Commissioner of Food and Drugs, together with counsel representing the interest of leading food producers, appeared before members of the Subcommittee on Health of this committee and strongly urged the early enactment of this legislation. All communications received by the committee concerning this measure have been unanimous in favor of the bill's enactment and the committee knows of no opposition thereto (S. Rept. 1060, 83d Cong., 2d sess.).

We believe that the amendment of section 701 (e) contained in the bill, which makes the simplification effected by Public Law 335 applicable to the procedure for the other regulations governed by section 701 (e), will prove as noncontroversial in its extenison to other regulations as was the prior amendment affecting only the food standards procedure.

AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT 17

The existing law is unnecessarily burdensome, and the proposed blil would afford the required relief. We recommend that it be referred to the proper committee of the Senate for consideration.

The Bureau of the Budget advises that it perceives no objection to the submission of this proposed legislation to the Congress for its consideration.

Sincerely yours,

M. B. FOLSOM, Secretary.

A BILL To amend section 701 of the Federal Food, Drug, and Cosmetic Act so as to simplify the procedures governing the prescribing of regulations under certain provisions of such Act, and for other purposes

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 401 of the Federal Food, Drug, and Cosmetic Act (21 U. S. C., sec. 341) is amended by striking out “(a)" where it appears after "Sec. 401.”, and subsection (b) of such section is repealed. SEC. 2. Section 701 (e) of such Act (21 U. &. C., sec. 371 (e)) is amended to read as follows:

"(e) (1) Any action for the issuance, amendment, or repeal of any regulation under section 401, 403 (j), 404 (a), 406 (a) or (b), 501 (b), 502 (d) or (h), 504, or 604, of this Act shall be begun by a proposal made (A) by the Secretary on his own initiative, or (B) by petition of any interested person, showing reasonable grounds therefor, filed with the Secretary. The Secretary shall publish such proposal and shall afford all interested persons an opportunity to present their views thereon, orally or in writing. As soon as practicable thereafter, the Secretary shall by order act upon such proposal and shall make such order public. Except as provided in paragraph (2), the order shall become effective at such time as may be specified therein, but not prior to the day following the last day on which objections may be filed under such paragraph.

(2) On or before the thirtieth day after the date on which an order entered under paragraph (1) is made public, any person who will be adversely affected by such order if placed in effect may file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating the grounds therefor, and requesting a public hearing upon such objections. Until final action upon such objections is taken by the Secretary under paragraph (3), the filing of such objections shall operate to stay the effectiveness of those provisions of the order to which the objections are made. As soon as practicable after the time for filing objections has expired the Secretary shall publish a notice in the Federal Register specifying those parts of the order which have been stayed by the filing of objections and, if no objections have been filed, stating that fact.

"(3) As soon as practicable after such request for a public hearing, the Secretary, after due notice, shall hold such a public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. At the hearing, any interested person may be heard in person or by representative. As soon as practicable after completion of the hearing, the Secretary shall by order act upon such objections and make such order public. Such order shall be based only on substantial evidence of record at such hearing and shall set forth, as part of the order, detailed findings of fact on which the order is based. The Secretary shall specify in the order the date on which it shall take effect, except that it shall not be made to take effect prior to the ninetieth day after its publication unless the Secretary finds that emergency conditions exist necessi tating an earlier effective date, in which event the Secretary shall specify in the order his findings as to such conditions."

SEC. 3. In any case in which, prior to the enactinent of this Act, a public hearing has been begun in accordance with section 401 of the Federal Food, Drug, and Cosmetic Act upon a proposal to issue, amend, or repeal any regulation contemplated by such section, or has been begun in accordance with section 701 (e) of such Act upon a proposal to issue, amend, or repeal any regulation contemplated by section 403 (J), 404 (a), 406 (a) or (b), 501 (b), 502 (d), 502 (h), 504, or 604 of such Act, the provisions of such section 401 or 701 (e), as the case may be, as in force immediately prior to the date of the enactment of this Act, shall be applicable as though this Act had not been enacted.