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.

(e) 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.

(f) 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

meaningful way, and thus they should be available for personnel, services, supplies, or equipment calculated to produce this result. The coordinating agreement should in each case indicate the acceptable uses of the funds, if for no other reason than to assure careful planning of their use.

It should be possible to finance a useful program along the lines proposed in this report within a reasonably modest budget. For several reasons, both initial and long-run costs are difficult to estimate. The element of the recommended program likely to prove most costly-compensated coordinating agreements-is not intended to be used indiscriminately, but rather on a selective basis. Undoubtedly a number of agencies that might wish to receive Federal funds will not qualify, at least for several years. Others that could establish eligibility may prefer to work towards coordinated operations on an uncompensated basis. The direct assistance phase of the program is also to be selective. Major, extended, and costly research projects should not be considered within the proposed program; these undertakings should continue to be performed by institutions having research as a principal purpose. Instead, special projects should typically involve rather small sums of money and should be directed at objectives within the competence and related to the needs of regulatory agencies. The components of the proposed program of Federal assistance have much in common with those found in other fields of Federal-State relations. They have not, however, been tied together as a conventional grant-in-aid system. The nature and requirements of the food and drug field call for an approach that is different in several respects. Typically, grants-in-aid have been used for public service programs (health, highways, welfare, and others) where the Federal Government has not had broad action responsibilities. The food and drug field is by contrast a regulatory one, with considerable overlapping and concurrent jurisdiction and action between Federal and State agencies.

Grant-in-aid plans usually find each State eligible to receive a portion of the appropriated funds. In food and drug work, the increasingly complex requirements of a comprehensive program of consumer protection are such that it is necessary to question whether it is wise, either from the national point of view or in terms of State interest, to encourage every State to develop capabilities qualitatively equal to those of every other State and different only in quantitative aspects. Problems exist in grant-in-aid programs too, in the organizational and administrative constraints on States that characterize some of them, in the tendency of matching grant plans to reduce opportunities for State and local appraisals of priorities, and in other limitations on the scope of State or local decisions on program content and administration.

13. The proposed program should be carefully examined in concept, operations, and effects, at regular intervals.

The program of Federal assistance proposed in this report is without broad precedent in Federal-State-local relationships in that it contemplates the introduction of formalized intergovernmental dealings in a field predominantly regulatory in nature. For this reason, especially, the proposed program should be periodically evaluated. It is suggested, therefore, that an evaluation of experience and results should be carried out at the conclusion of 5 years of program operations and each 5 five years thereafter, so as to provide an adequate basis for decisions concerning needed modifications and further continuation of the program.

14. The executive and administrative leadership in each State should promptly initiate a broad reappraisal of State and local food and drug programs with a view to finding opportunities for improvement.

Needs vary in scope and acuteness from State to State. They are, however, present in every State, and range through the areas of program content and balance, legal foundations, organizational and administrative relationships, practices in the use of staff, adequacy of financing, personnel development, physical facilities, and others. Opportunities for improvement are sufficiently broad in at least a majority of the States to warrant a reappraisal extending through the subject areas outlined in the recommendations that follow.

The scope of indicated changes is such in most if not all States as to require the sustained interest of top departmer+al officials as well as program chiefs, with participation from the State's principal staff agencies.

15. Each State should reexamine the content of its entire range of consumer protection activities, for breadth of coverage and for balance among the various elements of the total program.

This reexamination should extend to both health and economic aspects, and should assess the effectiveness with which the State and its local units are now performing those jobs that are within their proper roles in respect to the range of products and consumer risks covered in this report. It should evaluate contributions the various agencies are making, opportunities for joint planning and operation, and the degree to which these have been exploited, all in context of the special characteristics of the State.

16. In each State, the legal bases of food and drug work should be analyzed and evaluated with the purpose of securing laws and regulations which: (a) are geared to modern needs; (b) are uniform with those of other States in all important respects and basically correspond with Federal legislation; (c) are free of inconsistences, confusing provisions, outmoded and excessively detailed requirements, and trade barrier elements; (d) provide adequate administrative authority for effective inspectional and compliance work; and (e) establish fair and workable procedures for the development and publication of regulations and for the application of administrative sanctions.

There is a variety of problems in State food and drug programs that have their roots in deficiencies of State legal provisions. These include (among others) questionable and perhaps inefficient divisions of work between State and local units, blurred distinctions between legal responsibilities of different State agencies, inadequate powers of enforcement, penalties too light to effectively discourage violations, insufficient coverage of consumer hazards, specific requirements for frequency of inspection, often geared to licensing provisions, that hamper a program director's ability to base planning and execution of activities on realistic appraisals of need, and absence of adequate provisions for sound administrative procedures in adoption of regulations.

The thoroughgoing revision of State food and drug laws proposed here should cover all points enumerated above, while giving careful attention to special legal problems the State might have, as evidenced in difficulties experienced by the various program chiefs. Relevant model laws, necessarily including the Uniform State Food, Drug, and Cosmetic bill, should be studied with a view to adoption of all provisions, and retention of common language.

17. In each State there should be established a pattern of State-local relationships which assures basic conformity of laws and regulations in the food and drug field throughout the State, and provides for effective coordination of the forces of State and local agencies.

There are often unnecessary differences in the controlling legal provisions of different local governments, and differences between those at State and local levels. It is not suggested here that the authority of larger local units to deal effectively with their special problems should be impaired, but rather that local authority be adjusted to local capabilities. There must be an adequate legal basis as well as operational plans if a fully coordinated use of State and local personnel and facilities is to be achieved.

State evaluation and certification of local programs, authority for contracts between State and local agencies, and mandatory conformance by local units to State laws and regulations are measures that should be considered.

18. The assignments of food and drug functions within the State administrative structure and within individual departments should be so designed as to recognize the vital importance of broad program responsibilities for sound and balanced program planning, and for the effective use of all available resources in achieving program objectives.

The present characteristic dispersion of administrative responsibilities for food and drug work at State level should be replaced by arrangements that satisfy certain basic standards. First, functions should be allocated in a way that assures a unity of view with respect to health hazards, and a breadth of field in planning and operations to deal with them that extends from farm and feed lot through retail outlets to the consuming public. Second, allocations of responsibility should recognize the close operational interrelations of health and economic protection. Third, they should recognize the need of these programs for serious attention from top departmental leadership, and for proximity to that leadership in the administrative structure of the department. Fourth, they should recognize the need for a pattern of organizational and administrative relationships that reflect the close ties of inspectional and analytical work, so essential to present day food and drug programs. Finally, within a department, they should avoid fragmenting the total program and compartmentalizing its pieces, out of respect for tradition or professional sensibilities.

It is to be expected that a reexamination of functional assignments and department organization for food and drug programs will produce different results in different States. In some, it could result in a rise in the organizational standing and influence of food and drug work in departments of health; in others, the decision may be that certain health department responsibilities ought to be relinquished to departments of agriculture. There may be States in which departments of agriculture develop, as some already have, a greater unification of consumer protection programs within their structures, or a clearer identification as a department with broad public interest and responsibility. Some States may find the Connecticut Department of Consumer Protection a useful model in certain of these respects.

In the event that two or more State agencies continue to share responsibilities in consumer protection, with resulting possibilities of overlapping or conflict, formalized agreements should be developed that delineate functions and responsibilities, describe working relationships, and define arrangements for joint planning and exchange of information.

19. Each State should carefully review the adequacy of total financial support for consumer protection programs, and the distribution of that support among the various program subdivisions, and among the categories of personal services, transportation, equipment, and other physical facilities, for maximum effectiveness. An effort should be made to seek out and eliminate impediments to the most efficient us of all available program support, giving special attention to those obstacles that may have arisen from the use of dedicated funds.

The two fields of inquiry-sufficiency of total support and balance in the use of present resources-are closely related. Increase of the total budgetary allotment is ordinarily difficult to justify in the absence of a clear showing that present financial support is being used to best advantage. Improvements in the employment of present levels of financing can make more incisive the showing of need for larger overall support.

General budgetary guidelines will have to be drawn up if meaningful comparative appraisals of financial support for State and local programs are to be carried out. The guidelines should take account of such factors as: (a) the numbers, sizes, and kinds of establishments subject to agency supervision; (b) the frequency and time requirements of inspectional attention to the various categories; (c) the implications of kinds and volume of production and processing activity within States for the types and numbers of laboratory analyses required to support the total inspectional programs; and (d) the contributions that Federal agencies and industry itself are making in controlling health and economic hazards.

The common dependence of certain food and drug programs upon program revenues should be an important aspect of the reappraisal. Dedication of revenues can contribute to program imbalance, by directly limiting important activities to the levels dictated by program receipts or by rigidly channeling the proceeds of established sources of income to particular aspects of the total program.

It is clear that some States have so limited their spending for analytical equipment that they are making poor use of the time and training of skilled analysts. In other cases, the needed equipment may be on hand, but salary levels may be such that agencies are effectively prevented from getting analytical personnel capable of making full use of it. Budgetary allotments for transportation, inspectional equipment, and library facilities have in many cases been neglected.

20. A careful review should be made in each States of the personnel system in an attempt to acquire for food and drug personnel a coverage under an effectively operative merit system, broader and more challenging career opportunities, accelerated and enlarged training, and pay commensurate with their contributions.

Some of these needs, like those in other areas, can be satisfied only if sympathetic attention from the State's legislative and executive leadership is secured, whether through the efforts of department heads or others. Improvements in pay and career features, however, will often require a clear showing of the range and depth of responsibilities of employments in inspectional and analytical fields. This demonstration must be made by program directors on the basis of present facts, or must be justified by an enlargement of job responsibilities and an elevation of performance standards. First responsibility in either case rests with the program chief.