questionable products for Federal authorities. They have checked the hamburger, tested the scales, and recalculated price by weight on prepackaged goods; they have discovered and acted against new health hazards or deceptive innovations in trade practices in advance of and apart from Federal action.

The State and local agencies still do these things. The daily performance of them does not capture many headlines; they are not the big, dramatic, pioneering work that is sometimes by contrast associated with federal operations. But these tasks loom large in total effective consumer protection and often constitute the more difficult administrative jobs.

Though overshadowed by present Federal research, State and local agencies have made contributions to the total body of human knowledge in support of consumer protection. Their present limited research activity is perhaps less a result of lack of interest or of individual capabilities than of the pressure of daily tasks, limited resources, and the concept that research belongs in universities and industry but not in regulatory agencies. Finally, many State and local agencies have dedicated leaders, well-trained employees, serviceable, and in some cases extensive, facilities. They do conscientious jobs, think productively about how their operations may be improved, and manifest a strong willingness to contribute to cooperative relationship in food and drug work. To maintain and enhance their contributions in the future, the better State and local programs must continue their alertness to changing needs. The less effective programs must be built up materially by serious and early attention to the application of merit principles, higher selection standards for personnel. enlarged job content with training and salaries to match, and the acquisition of facilities suited to current needs.

These State actions must be carried out in an environment characterized at once by an expanding range of information on which program plans may be based, better use of available information in the deployment of personnel, more adequate guidelines for inspectional staffs, and a uniformity of terminology for recording and reporting what has been found, what has been done, and with what effects.

10. The realities of both the setting and the present conduct of these governmental programs point to the basic needs for: (a) a continuing evaluation of the total task; (b) basic uniformity of policy, practice, and approach; and (c) fully coordinated cooperation.

The satisfaction of these basic needs requires: (a) a balanced partnership of Federal and State governments; (b) the acceptance by both of a realistic formulation of the respective Federal and State roles; (c) sufficient authority at the Federal level to carry out the essential Federal role of leadership; and (d) improvements in the legal foundations and management of State programs and in the coordination of State and local efforts. Industry must join at certain points in seeking these improvements.

B. Summary of recommendations

1. The interdependency and community of purpose among Federal, State, and local agencies must be expanded and further coordinated, through a balanced State-Federal partnership.

The Federal position in food and drug work is already a leading one, and it must remain so because of the nature of the regulated activities, the superior Federal financial capabilities, the range and depth of Federal interests, and the great human resources of the Federal executive branch.

A fully beneficial partnership must be one in which the Federal position is matched by strength in State agencies. Such strength should be expected of each State in relation to its program requirements and a realistic appraisal of its abilities. It should also be expressed through States acting together outside rather than within the Federal administrative system.

Strength of a State program requires an effective legal basis, sound organization and management, and financial, human, and physical resources sufficient to the tasks at hand. Strength has a further dimension, perhaps its most important one, in the quality of administrative leadership. It is challenge, in the form of opportunities to plan, design, and influence the execution of programs of importance, that breeds good leadership. The existence of such challenge will, in the long run, determine the ability of the States individually to secure and retain the administrative leadership and technical support that are indispensable to good performance. If the ultimate role of the States is to be limited

to only the undemanding and repetitive tasks in consumer protection, the usefulness of State and local agencies even in those lesser tasks will diminish.

2. There must be a clearer delineation of the respective responsibilities of State and Federal Governments so as to reduce the risks of duplication of effort and even conflict that arise from the overlapping of Federal and State legal powers.

The achievement of a sound and workable definition of respective roles must be the product of understandings and agreements by the two levels of government. Such roles are sound and workable only when they are tailored to the characteristics of the functions to be performed and the special capabilities available for their accomplishment. Such understandings and agreements must then be supported and maintained through full performance by agencies at each governmental level in their areas of responsibility.

3. The States should assume a broader role and acquire a more meaningful and useful participation in consumer protection with respect to the production, processing, and distribution of food and feed.

Many States are already making significant contributions to health and economic protection of their own residents and those of other jurisdictions; these efforts involve many well trained and diligent workers and substantial facilities. But few if any States have such scanty populations, resources, and concentrations of food and feed activity that they cannot be expected to fulfill a broader role. In planning, coordinating, correlating, and issuing the findings of work performed, in order to broaden the range and depth and increase the currency of pertinent informaiton for consumer protection programs, the Federal responsibility should be the larger one. The States should increasingly participate in the broad process of amassing information and seeking, through survey and research, answers to manifold questions of importance in the field of food protection. The States have a proximity to the marketplace and the consumer, a readiness of access to establishments, a potential but largely untapped relationship to the State university, and present capabilities and interests that, if encouraged and properly used, will permit substantial contributions to this need.

The States should expand their inspectional role in relation to food and feeds. There is even now a considerable sharing by the States and some local governments of Federal responsibility for inspecting establishments producing for interstate distribution. This expanded role would not be identical from State to State, but should be related to State interests, capabilities, and needs. Expansion of the State role in analytical work should parallel this. As State abilities are enlarged in particular operational areas, Federal resources should be diverted to points where the Federal responsibility is exclusive or State and local capabilities limited. In compliance, State activity should place increasing emphasis upon a judicious selection of compliance measures as well as upon preventive compliance, through education, cooperation with industry, and exploitation of industry interest in maintaining sanitation and quality.

4. In regard to drugs, the Federal role should in practice be exclusive in determining standards of quality, purity, strength, efficacy, and safety; limitations on dispensing, manufacturing practice, labeling, and advertising. The Federal role should be effectively exclusive in enforcing standards of efficacy, safety, and manufacturing practice.

The States should participate more actively in helping to enforce standards of quality, purity, strength, dispensing, labeling, and advertising. At the point of retail distribution, State responsibility should be the greater. The States should actively supplement Federal efforts by discovering and reporting for Federal attention new manufacturing and other drug establishments. The States should use more fully their capabilities in regulating medicated feeds.

The exercise of the Federal responsibilities proposed here requires the best scientific talents the country has available and a broad and profound social perspective. These requirements go far beyond the capabilities of any one State and call for the wisest counsel of the Nation-from its industries, professional practitioners, universities, and government. The manufacturing processes of the drug industry are such that, by and large, they are likewise beyond the capacity of a single State to evaluate from the points of view of process and quality control.

In practice, the States have already discontinued many activities in the areas herein proposed for Federal responsibility. In the fields proposed for increased State action, activity is now uneven: some States maintain active and highly useful programs in these areas, but programs in other States are insufficient.

5. The Federal Government should in practice have exclusive responsibility for the safety and quality of all food and drug imports; this responsibility should extend to the establishment and enforcement of standards of manufacturing practice, identity, quality, and labeling.

In considering the respective Federal, State, and local roles in relation to imported products, weight must be given to the exclusive Federal control over relations with other nations and over foreign commerce, and the economic importance to this country of its exports of foodstuffs and other products. The Federal performance in respect to imports must be such that it not only safeguards consumer interests but also prevents either local economic protectionism or trifling conflicts of policy from weakening the Nation's export position or its dealings with other nations in broader terms.

6. In other relevant areas, the proposed division of work is as outlined below. The Federal-State division of responsibility for cosmetics should follow that proposed for drugs. With respect to hazardous household substances, the States should assure the proper labeling, in conformity with Federal standards, of products of local manufacture and distribution, and maintain continuing surveillance of retail channels in satisfying their own direct obligations and in complementing Federal surveillance efforts.

The local origins of medical and nutritional quackery emphasize that each State should be alert and aggressive in stopping such activity before it reaches interstate proportions.

Principal responsibility for control of illegal trafficking in narcotic and psychotoxic drugs should not be assigned to state or local agencies whose chief concern in the drug field is with processes, products, and transactions of legitimate industry. Responsibilities for protecting the consumer from health hazards and economic fraud in legitimate business operations call for laboratory analysts, research scientists, and persons who know the processes of industry. Work on illegal traffic in narcotic and psychotoxic drugs calls for the skills of criminal investigators; to impose the demand for such skills upon food and drug agencies would only divert them from the important tasks for which they are qualified. State and local health and food and drug agencies should, however, carry out more fully the duty of securing adherence to legal provisions and professional standards in the dispensing of drugs through legitimate channels. These agencies also have obligations in educating the public, in interpreting problems of narcotics and psychotoxic drugs to police agencies, and in cooperating with them. 7. The Federal Government should exercise a more productive leadership in the coordinated use of total public resources for consumer protection.

Special problems exist in giving full effect to desirable Federal leadership. Unities inhere in consumer health and economic protection, at least in relation to food and feeds; these unities are increasingly reflected in State administrative organization, with work on food often performed in the administrative company of work on drugs, devices, cosmetics, and hazardous substances. Unities of function and of state organization, where they appear, are confronted by a persistent fragmentation in responsibilities and in ways of meeting them at the federal level.

8. All divisions of the national executive with responsibilities in the food and drug field should diligently seek and maintain in their programs a balanced view that attempts always to determine the problems of greatest moment, where they lie, and how they may best be solved; this balanced view should then be communicated to the states without the narrowness that otherwise can stem from the limited interest of a particular agency that administers specific statutes and is oriented accordingly towards the programs of one type of State or local agency. The organization of the Federal executive is beyond the scope of the present study. The emphasis placed upon the need for a balanced view is not meant to suggest that Federal efforts at interagency coordination have been feeble or that little or nothing has been accomplished through them. The point is that a much broader interagency coordination is needed, and can be achieved only through a true cohesiveness of federal policy and administration.

Assuming the Federal executive attains this broader view, its communication to State and local governments should be through that Federal agency which best satisfies certain criteria. That agency should be: (a) the one having broadest jurisdiction in consumer food and drug protection and hence presumably most capable of maintaining and conveying the balanced Federal view; (b) the one most accustomed to dealing with State and local consumer protection agencies, whatever their names and wherever they are found in the State or local admin

istrative structure; and (c) the one whose responsibilities are shared to the greatest extent by State and local agencies.

As Federal responsibilities are now assigned, the Food and Drug Administration seems to meet these criteria best. It is therefore recommended that this Agency be designated as the one to communicate a unified Federal approach.

9. There should be an enlargement of Federal assistance to State and local regulatory agencies.

The justification for this recommendation rests principally on two considerations. First, the field is one of overlapping legal jurisdiction, and many State and local agencies have been and even now are making contributions to the more effective discharge of responsibilities that have been assumed as Federal duties. Second, such assistance could, if wisely used, aid materially in achieving a more balanced and better coordinated use of all governmental resources while elevating State and local capabilities.

Components of this assistance should serve the broad need of coordinated policy and administration. They should take account of the great differences from State to State in (a) need for facilities suited to the complex, presentday demands of effective consumer protection, (b) the present readiness of different agencies to make meaningful contributions to consumer protection and their potential for an expanding future role, and (c) the degree to which State and local agencies are now sharing the burden of protective measures of national scope and benefit.

10. An enlarged Federal assistance program should include: A variety of direct technical assistance elements that will complement State or local agencies' resources and help in upgrading their capabilities; financial support for special projects to be carried out by State or local agencies to provide more information for food and drug programs and to improve administrative and technical practices; and payments to agencies in recognition of their present contributions and in support of a more thoroughgoing Federal-State-local coordination. Direct and special project assistance should be extended through the Food and Drug Administration and should include authority and financing for: (a) Provision of specialist inspectional, analytical, or administrative services on an ad hoc or continuing basis.

(b) Expanded training support, with intensified training activity for inspectional personnel and introduction of programs for analytical and administrative personnel; integration of Federal and State training; grants for specialized training; and grants to institutions in furtherance of the development of new or the adaptation of existing curricula to the needs of food and drug work.

(c) Detailing of FDA personnel to State or local agencies, to aid in initiating new programs or implementing special projects, or to fill critical vacancies on an advisory basis.

(d) Furthering of collaboration in improvement efforts involving officials of several States.

(e) Assistance to special projects of individual State or local agencies, such as projects in methodological studies or in efforts at improving administrative practices.

(ƒ) Enlargement of information services to State and local agencies, ranging through research findings, equipment, product and process developments, and administrative practices.

The coordinating projects proposed, and the payments thereunder, would have the purposes of (a) accelerating the attainment of formalized coordination in programing and operations between and among the Federal agency and selected State, and occasionally, local agencies, and (b) recognizing in financial terms the increased contributions such agencies would thus be making to federally assumed responsibilities. Through such projects, the potential for Federal-Statelocal duplication would be reduced. FDA would thus be allowed to work more intensively on activities beyond State and local capabilities.

Such projects, calling for agreements between FDA and a State or local agency, would specify programing arrangements, delineate the respective areas of responsibility, and set forth interagency reporting and other measures deemed mutually desirable to assure each of the two parties of the adequacy and effectiveness of the other's performance. They should stipulate the amount, manner, and use of payments and the financial reporting required.

11. The authority for coordinating projects should be used selectively. First, the contracting agency should be one whose legal responsibilities significantly parallel those of FDA, and it should in each case be able to make a

useful contribution to coordinated programing and operations. In general, State agencies should be strongly preferred over local agencies. In certain States, however, a broad autonomy in consumer protection programs has been granted to very large local units. Moreover, a realistic view of present agency programs and performance emphasizes that in some local agencies there is a better base to build from than in certain State agencies. A preference, too, should be shown for agencies having some breadth of responsibility in terms of variety of products covered and range of responsibility from production to consumption. An existing agency that covers only feeds or drugs and devices but whose capabilities rank high should, however, be considered for a coordinating project agreement. Coordinating project agreements would usually be limited, then, to State agencies having broad food responsibilities and those conducting programs extending to foods and some combination of drugs, devices, cosmetics, and hazardous household substances. As a rule, only one or at most two agencies should be party to such an agreement in each State. Eligibility for a coordinating agreement should be determined by reference to criteria or standards requiring that the agency: (a) have legal responsibility in the regulatory field covered by the agreement; (b) possess legal authority to enter into such an agreement; (c) present a plan for the coordination of State and local programs, approved by the State's chief executive and the other State agencies principally involved; (d) offer evidence of suitable personnel resources and a personnel system effectively based upon merit principles, or a plan for improvements in these areas; (e) present evidence of adequate physical facilities for analytical work, or a plan for acquiring them; and (f) have adequate administrative practices, or a plan for instituting them.

In detailing these standards and applying them, FDA should attempt to avoid difficulties in intergovernmental relations that have tended to characterize some other Federal-aid programs and which could limit the resort by State agencies to coordinating projects. It is recommended, therefore, that the Commissioner of the Food and Drug Administration appoint a committee on administrative standards to provide advisory assistance in detailing the standards and in reviewing state disagreements with their application. Such a committee might well include representatives from State government, interested professions, industry, and consumer groups.

12. Payments under coordinating projects should vary, within limits, with the scope of the agency's authority in terms of product coverage and its range of responsibility from production to consumption.

Payments should be sufficiently large to be meaningful in relation to present levels of state and local agency spending and should have at least a general correspondence with such outlays. As these are consumer protection programs, a simple per capita basis seems appropriate, with payment determined by multiplying the number of inhabitants within the boundaries of the parent State or local jurisdiction by an amount per capita. Spending within the various States for State and local food and drug programs taken together, amounts to a figure ranging generally between 25 cents and $1 per capita. A meaningful range of project agreement payments thus might fall between 2.5 and 10 cents per capita. Payments to agencies of limited range and scope, such as those confined to drugs and devices, should probably never exceed the lower amount (2.5 cents). A coordinating agreement covering a major aspect of consumer food protection should bring at least the minimum payment, and an agreement with an agency having broad jurisdiction in products and processes could well approach the maximum. This latitude as to per capita amounts might also be employed as a partial inducement for more orderly arrangements in relationships between State agencies and in State-local divisions of responsibility.

Payments should not ordinarily be permitted to replace the State or local agency's revenues from other sources. In defining "replacement" it should be recognized that individual jurisdictions experience financial difficulties from time to time. Thus, the expenditures of the cooperating agency should ordinarily advance from year to year proportionately with operating expenditures for other functions of the jurisdiction. A lag of 10 percent or more behind this rate might be considered prima facie evidence that Federal funds are replacing State or local funds. Exceptions to this general rule should be made to take account of the possibility that, through improved administration, a better job can be done at less than former costs.

Under coordinating agreements, payments of Federal money should be available for strengthening the State or local agency's program capabilities in any