In the Administration's product safety bill we proposed additional mechanisms to insure increased consumer participation. These provisions have been adopted in Title III of S. 3419. A qualified consumer group would be able to participate in the establishment of product standards. Such a group could be designated responsibility for developing the standard. The bill also authorizes the Secretary to provide financial assistance to make it more feasible for a consumer group to assume this responsibility. Consumers dissatisfied with the Government or industry performance would be able to sue for the enforcement of standards or a ban. Consumers may also petition for the establishment of standards or for other product safety proceedings (this was not specifically provided in the Administration bill since this right is available under the Administrative Procedures Act).

FDA also monitors and responds to consumer complaints and experience reports. Hundreds of letters and inquiries are received each month, many of which provide the basis for investigation and action.

7. Would you comment on what steps are being taken to insure that Product Safety will receive the attention of FDA's field staffs, if FDA remains in HEW? First, it should be clear that in the last two years there has been a significant increase in field activity in the product safety area because of our new toy safety responsibilities and our stepped up program of flammable fabrics investigations. In Fiscal Year 1973, field resources devoted to product safety will be nearly tripled, increasing from 2.5 million dollars to 7.1 million dollars. In addition, the Administration has earmarked 14 million dollars for implementing the product safety legislation. A major portion of this sum will be needed for activities concerned with standard-setting, but additional funds will also be allocated for field activities.

FDA has also developed a comprehensive training program to insure that inspectors, including those provided for in the 1973 request, are aware of the importance of all FDA programs including inspection and investigations of toys, flammable fabrics, and other products which will be subject to the new product safety legislation. Additional training will also be provided as may be necessary to facilitate the inspection staff capability in specific aspects of product safety. 8. Could you provide a description of what activities will be carried out by the Administration-proposed Office of Drug Regulation, Office of Food Regulation, and office of Product Safety Regulation?

This is now under development. At this time, we believe the Office of Drug Regulation would administer all provisions of the Federal Food, Drug, and Cosmetic Act pertaining to drugs (including veterinary drugs) and the Biologics Control Act, the administration of which will be transferred to the Food and Drug Administration.

The Office of Food Regulation would administer provisions of the Federal Food, Drug, and Cosmetic Act applicable to foods. It would also administer the Import Milk Act, Filled Milk Act, Tea Importation Act, and sanitation and quarantine programs under the Public Health Service Act (food service sanitation, shellfish certification, milk sanitation, and the interstate carrier program). The Office of Product Safety Regulation would administer the Federal Hazardous Substances Act, the Poison Prevention Packaging Act, the Department's responsibility for investigations under the Flammable Fabrics Act, the Radiation Control for Health and Safety Act, and the new consumer product safety legislation.

The Office of Drug Regulation and the Office of Food Regulation would both administer the Fair Packaging and Labeling Act. We are still considering the assignment of responsibility for cosmetics, medical devices, and color additives. The Office would be supported by information gathering, field surveillance, and research capabilities. In addition, a National Center for Consumer Safety Statistics would be established to collect, analyze and disseminate information on injuries and their causes as associated with food, drugs, and consumer products.

10. In testimony before the Government Operations Committee you said that the problems concerning consumer product safety could not be compared to those which mandated the creation of the Environmental Protection Agency, and that the governmental response necessarily had to be different. Would you please detail the differences between the problems and why the governmental response should differ?

The major difference is that the Environmental Protection Agency (EPA) was needed to consolidate numerous related functions scattered throughout government at low levels. In this diffusion of effort there was no one agency which

could be described as the "core agency" for environmental protection programs. In the case of consumer safety more Federal programs (and practically all which would be affected by S. 3419) are already consolidated within the Department of Health, Education, and Welfare in the Food and Drug Administration. A virtually complete consolidation of consumer safety programs would be achieved upon enactment of the President's proposal for a Department of Human Resources. This proposal would transfer to the OHR the consumer-oriented food programs from the Department of Agriculture and flammable fabrics and refrigerator safety activities from the Department of Commerce.

It was apparent to the Administration in developing the proposals for reorganization of the Executive Branch that the environmental protection function was not so compellingly related to the other functions being placed in any one of the four proposed Departments as to require placement within a particular Department. Environmental protection crossed the program lines of natural resources, human resources, community development, and economic development. Had environmental protection been placed in the Department of Natural Resources (or its "core agency," the present Department of the Interior) there could even have been a potential for conflict between ecological concerns and land, water, and the other resource development programs.

Consumer safety, on the other hand, is closely related to health research and services. For example, to the extent that the preventive function of a consumer safety program is effective, the demands for treatment of injury will be reduced. Research into the causes and treatment of conditions of ill health and disease is also related to considerations of safety of food, drug, and product safety, and both look to the same end-the improvement of health.

EXHIBIT 13

U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,

HEW Secretary Elliot L. Richardson announced today that the Division of Biologics Standards, presently a component of the National Institutes of Health, will be transferred to the Food and Drug Administration effective July 1.

DBS conducts research on, tests and regulates the use of biologic materials such as vaccines.

Following is a statement by Secretary Richardson on the transfer action: "During the past decade there have been repeated examinations of the question of the best organizational locus for the regulatory function of the Division of Biologics Standards.

"On the one hand there is important advantage in having a close working relationship between research scientists and the administrators charged with enforcing Federal regulations related to biologic materials. On the other hand, there is the obvious advantage gained by consolidating the DBS regulatory function with similar activities carried out on a much broader range by the Food and Drug Administration.

"We have decided that it is timely to bring about a consolidation, and to do so in such a way as to maintain the advantages of close scientific collaboration that have well served the DBS.

"Several weeks ago I announced my decision to consolidate certain functions of the DBS with the Food and Drug Administration. Following that announcement the Director of the National Institutes of Health provided his analysis of the DBS operations and the change in organization to Dr. Merlin K. DuVal, Assistant Secretary for Health and Scientific Affairs. Dr. DuVal and Dr. Marston have recommended that the consolidation can best be implemented by continuing to maintain as a functioning unit the regulatory activity with the research that is related to regulation. Furthermore, only 10 percent of DBS's current activity is research extending beyond the development and testing of biologic products. Many DBS scientists are actively engaged in multiple functions within the Division. To divide the existing organization among functional categories would practically require Solomon-like division of the effort of individuals. In the light of this situation, Dr. Marston has recommended that DBS be transferred intact. I am making public his analysis and recommendation.

"My action in bringing about the consolidation rests solely on the advantages to be gained from such a step. Reports of recent studies of DBS initiated by the NIH and the GAO have been interpreted as critical of the operations of the Division. I wish to emphasize that each of the studies confirms that the public has been well served by DBS within the limits of the current state of knowledge. The studies themselves point out that most of the noted deficiencies had been corrected by 1968. The remaining problems have been successfully resolved through subsequent steps by the Department and the NIH.

"DBS and its predecessor agency have had a long and distinguished record of services to the American people. I have urged its dedicated scientists and administrators to continue this tradition in the new setting at FDA.

"Dr. DuVal, Dr. Charles Edwards, Commissioner of the Food and Drug Administration and Dr. Marston have assured me of their dedication to making the new arrangement maximally effective using the resources of both agencies for this purpose."

Hon. ABRAHAM RIBICOFF,

U.S. Senate,

Washington, D.C.

MAY 25, 1972.

DEAR SENATOR RIBICOFF: Thank you for your letter of May 8 concerning the transfer of activities of the Division of Biologics Standards from NIH to the Food and Drug Administration.

We have decided to transfer intact the entire function and resources of the Division of Biologics Standards, effective July 1, 1972. The research and regulatory activities of the Division are so interrelated as to make any separation of them extremely difficult and generally undesirable. However, some reversion of positions and funds-not to exceed ten percent of the current DBS total-may be made to NIH at a later date for the portion of the current DBS research that relates to the general NIH mission. With kindest regards.

Sincerely,

ELLIOT L. RICHARDSON, Secretary.

EXHIBIT 14

ASSISTANCE PROVIDED TO THE FOOD AND DRUG ADMINISTRATION BY THE NATIONAL BUREAU OF STANDARDS, 1970-1972

All projects of assistance to the Food and Drug Administration by the National Bureau of Standards have been carried out on a cost-reimburseable basis. Although NBS does not have manyear data for these agreements, the dollar figures do reflect the magnitude of the assistance received.

The Food and Drug Administration is not aware of any instances where the National Bureau of Standards has refused or turned out any request for assist

? Funds remaining from 1964 NBS/PHS contract used on a credit basis until exhausted in 1972.

EXHIBIT 15

EXCHANGE OF CORRESPONDENCE BETWEEN HEW AND THE DEPARTMENT OF

COMMERCE

[The Food and Drug Administration is, or course, appreciative of all assistance and cooperation it receives from other Federal agencies, including the National Bureau of Standards. The Department of Health, Education, and Welfare would have to defer to the Department of Commerce in terms of the feasibility of the NBS providing increased assistance to FDA within the context of other NBS priorities. A request was made to NBS in this regard. The exchange of correspondence follows:]

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
FOOD AND DRUG ADMINISTRATION,

May 1972.

Mr. LEWIS M. BRANSCOMB,

Director, National Bureau of Standards,
Gaithersburg, Md.

DEAR MR. BRANSCOMB: On May 2 Secretary Richardson testified before a Subcommittee of the Senate Committee on Government Operations concerning S. 3419, a bill which would establish an independent Consumer Safety Agency (a copy of the statement is enclosed).

During the question and answer period following the Secretary's statement, Senator Percy asked a series of questions concerning the possibility of NBS assisting the Consumer Safety Agency in testing and establishing standards for products. Enclosed is an excerpt from the transcript on this discussion.

1. Senator Percy asked what was the total manpower NBS has supplied to FDA over the past three years, broken down in the areas of food, drugs, and product safety (page 232, lines 17-20).

2. He also asked whether any FDA requests for use of Bureau test facilities or personnel had ever been turned down and, if so, what reasons were given (page 232, lines 20-25). We could not recall any such instances and indicated we would have to check.

3. Senator Percy also asked us to explore whether it would be reasonable and logical to earmark possibly as much as a third of NBS's efforts for health and safety (page 233, lines 14-–17).

We would certainly appreciate your providing us with information which would permit us to answer items 1 and 3 above and also information on any instances in which NBS refused any FDA requests for use of facilities or personnel.

Our deadline for submitting information requested at the hearing is May 8 and we would therefore appreciate your response by that date.

Sincerely yours,

GERALD F. MEYER, Director, Office of Legislative Services.

U.S. DEPARTMENT OF COMMERCE,
NATIONAL BUREAU OF STANDARDS,

Washington, D.C., May 12, 1972.

Mr. GERALD F. MEYER,

Director, Office of Legislative Services, Department of Health, Education, and Welfare, Food and Drug Administration, Rockville, Mả.

DEAR MR. MEYER: This is in reply to your letter of May 4, 1972, to Dr. Branscomb advising of Secretary Richardson's May 2 testimony on S. 3419 before a Subcommittee of the Senate Committee on Government Operations and requesting information which would permit HEW to respond to certain questions posed by Senator Percy during that hearing. Set out below are our answers to those questions.

1. What was the total manpower NBS has supplied to FDA over the past three years, broken down in the areas of foods, drugs, and product safety?

The assistance given to FDA by NBS has been primarily in the areas of product safety. NBS has not supplied manpower as such but has worked on various projects under FDA sponsorship. Within the Product Evaluation Technology Division, eight persons have been so engaged. Additionally, two persons have been involved in our Building Research Division, and one in our Mechanics Divi

sion. Most of this safety activity has been in the area of toys where work has been or is being carried out on the following:

2. Have any FDA requests for the use of Bureau test facilities or personnel been turned down and, if so, what reasons were given?

A brief description of the procedure concerning FDA requests to NBS would, it is felt, prove more meaningful in responding to this question as it cannot be answered in a simple yes or no fashion. Generally, preliminary discussions between FDA and NBS are held to determine the most suitable projects to carry out within the limitations of funds provided by FDA, namely, $323,000 in FY 1972 and $132,000 in FY 1971. Only those which through mutual agreement would provide the most urgently required information and which best fit the talents of the available NBS staff are selected. Therefore, at any given time, other projects must be held in abeyance until funds become available. The situation has also occurred where NBS staffing was not available (otherwise engaged) for a specific project, but a knowledgeable NBS scientist has assumed the responsibility of overseeing on behalf of FDA, the project subsequently assigned to a private laboratory.

3. Is it reasonable and logical to earmark possibly as much as a third of NBS's effort for health and safety?

A large portion, at least a third, of NBS effort already supports or relates directly to health and safety. A much larger portion underpins the measurement system essential to assure health and safety.

NBS has four major objectives:

To Provide Physical Measurement Services Needed to Develop and Utilize Science and Technology

To Provide Scientific and Technological Services for Industry and Government

To Provide the Technical Basis for Equity in Trade

To Provide Technical Services Which Promote Public Safety.

NBS services are usually based on "meaningful" measurements, i.e., the ability to measure what is wanted to the accuracy needed. The understanding and measurement know-how required usually has a wide range of applicability including health and safety. For example, NBS skill in analytical chemistry and in developing Standard Reference Materials for the industrial and academic communities is presently being used in a collaborative program with the health services community to provide the Nation's clinical laboratories the means for self calibration in areas of critical importance.

Similar relationships and opportunities for multiple use of NBS competences exist in other health and safety problem areas. These opportunities are being exploited in varying degrees depending on NBS's capability to manage within its relatively small budget and the spending pattern of other agencies. For example, we have programs essential to informed and enforceable pollution abatement and to the avoidance of failures in materials and structures either during normal use or when exposed to natural disasters.

NBS is engaged in generic measurements for consumer product safety in areas such as safety of kitchen range surfaces, safety test methods for artificial turf, snow blowers, vacuum cleaners, strength studies of children, and riot helmets and protective equipment for police officers. NBS has major efforts in fire research, including flammable fabrics and building safety. Voluntary standards are being developed for carbonated beverage bottles and playground equipment.