Page images

ment, and the laboratory in Fairbanks, Alaska, with the health problems peculiar to Alaska. It is not possible to identify in a meaningful way the strictly environmental aspects of the activity.

Question 2. What are the fields of specialization of the scientific investigators in your laboratories? What advanced degrees do they hold!

Answer. FDA : In general, scientists in the FDA include specialists in various aspects of chemistry, medicine, physics, mathematics, and related sciences. With the exception of the National Center for Toxicological Research, the programs employing these scientists do not perform environmental research.

NIH: The scientific investigators listed below are all trained at the doctoral level and are engaged in laboratory research in NIEHS. These are in addition to scientists engaged in program planning, program direction, and management of extramural programs as well as engineers who do not possess doctoral degrees. Chemists

15 Biologists

6 Pharmacologists

8 Medical Officers_ Veterinarians Physical Scientists. Statisticians Physiologists

[ocr errors]


53 HSUHA: The fields of specialization cover medical science, sanitary engineering, industrial hygiene, psychology, and sanitary science.

Question 3. What is your present level of funding for environmental research! What is your present level of authorization for environmental research? For how many years?

Answer. FDA: The FDA has no present level of funding or authorization for funds for environmental research. We are administering the National Center for Toxicological Research on funds (1.4 million dollars) from the Environmental Protection Agency.

NIH: For FY 71 NIEHS appropriation, which is made for one year only, is approximately $20 million. There is no authorization limitation on the activities of the Institute. The Institute's functions are carried out under the broad authority contained in Section 301 of the PHS Act.

HSMHA : See comments under the answer to Question 1. Question 4. What kinds of prolems are you addressing under the category "environmentalresearchWhat proportion of this work would you consider basic" research, defined as research producing fundamental, theoretical knowledge which was not sought for immediate problem-solving purposes ? What proportion is devoted to technology development? To technology assessment?

Answer. FDA: The National Center for Toxicological Research will be engaged in the following problem areas: A. Evaluation of methods

Current methods of carcinogenesis, teratogenesis, and mutagenesis will require further evaluation, correlations, and modification as our sophistication increases in certain areas, to provide clearer understanding of dose-response interrelationships (i.e. mutagenesis, carcinogenesis, and teratogenesis). Also included will be comparisons on in vivo and in vitro metabolic-biochemical-toxicological response studies in animals and correlations with such studies in man. B. Application of methods

The credibility of current procedures in terms of adequate assessment of safety and/or toxicity will be studied. C. Development of methods

Newer biomethodological approaches will be explored to detect early warning signs of impending hazards. Comparative metabolism relevant to inter and intra species responses and development of preclinical sensors and biochemical profiles are envisioned as program components for emphasis. This phase of the program will also include development of suitable species and strains of animal and studies on experimental variants (diet and other interactants) which require standardization.

D. Exploitation of interrelationships between epidemiology projects (human

toxicology) and toxicology projects in animals systems From data banks on human disease incidence (cancer, metabolic disease, chromosomal and teratogenic effects, etc.) such information will be correlated where possible to observe effects in experimental animals to adapt certain approaches and guide the development of project protocols. Conversely, data elicited from animal experimentation will be examined and adapted to the development of epidemiological studies on human population laboratories by collaborative effort with other agencies or local and State health facilities or hospital groups which present such important resources. E. Specific approaches in towicology projects

Ancillary to and predicated on the development of standard biomethodological procedures, the Center will be responsible for assessment of the potential toxicity of a wide spectrum of environmental agents as previously described, which encompass the following testing:

1. Short term studies. To include acute and subacute evaluations. This will encompass LDso determination (if not reported elsewhere), determination of teratogenic and mutagenic response, reproductive performance and physiologic, biochemical and metabolic effects (effect of chemical on the test system or effect of test system on the chemical). Where indicated, studies on microbiologic aspects will be undertaken.

2. Long term studies.—To include acquisition of data on longevity, tumorigenic response and other chronic effects.

3. Supportive resources in methodological studies.-If chemically unidentified, the stress agents will be characterized either as parent substrates, metabolites (endogenous) or as exogenous agents environmentally produced (i.e. marine biotoxin, mycotoxin, etc.). Facilities will provide for essential instrumentation and laboratory equipment for chemical identification and analyses. Studies on metabolic fate will be conducted using radiolabeled compounds (radioisotope facility).

NIH: The program of the National Institute on Environmental Health Sciences is oriented primarily to the development of scientific information relevant to the identification, evaluation, and resolution of environmental health problems. The Institute program is directed to the identification of chemical, physical, and biological environmental factors which affect human health, determination of the mode of action of such factors, and development of a scientific basis for implementation of appropriate control measures. Of particular consequence are those human health problems attributable to environmental stressors acting in combination at low levels over long periods of time.

The emphasis in the program of NIEHS is on producing fundamental, theoretical knowledge on the health effects of exposure to environmental agents, but with consideration for its ultimate relevance to the solution of practical environmental problems. This is extended when necessary, in collaboration with the control agencies, into immediate problem-solving activities. None of the program is devoted to technology development or technology assessment.

HSMHA: All work is of an applied nature.

Question 5. List your current research projects on ecosystem structure and function, if any.

Answer. FDA: The Food and Drug Administration has no research in this area.

NIH: The scientific staff of NIEHS is engaged with the Environmental Protection Agency (EPA) in formulating a systematic survey of potential stressors and their distribution in the ecosystem.

HSMHA: None.

Question 6. How much of your environmental research is conducted at your own facilities? How much is done by contract to other institutions? Please indi. cate the proportion of contract work assigned to each of various types of institutions (university, independent research firm, industry, etc.).

Answer. FDA: The FDA will conduct environmental research only at the National Center for Toxicological Research. It is envisioned that special competence and resources in academic and consulting research laboratories will be utilized through contract supported research projects to augment the program of the Center. Special consideration will be given to the adaptation of such extramural resources for studies on non-human primates.

NIH: The programs of the NIEHS are carried out through grants to universities and institutions of higher learning; through contracts to institutions of higher learning, non-profit research firms and industry; and directly in its own laboratories in the Research Triangle Park, North Carolina.

The 1971 budget provides $20.0 million for the activities of the Institute. Of this amount approximately $16.0 million is committed to the conduct of research activities—$9.5 million through grants, $1.0 million through contracts, and $5.5 million in the Institute's laboratories in North Carolina .

The preponderance of the research conducted through grants and contracts is carried out through university research centers around the country.

HSMHA: No research contracts are awarded.

Question 7. What mechanism, if any, do you have for identifying and addressing large-scale environmental questions by interdisciplinary teams! What mechanism do you have for coordinating your activities with the Environmental Protection Agency? Please include copies of any memoranda or letters of agreement which detail your coordination mechanism.

Answer. NIH: Certain Chemical Biological Research facilities at Pine Bluff Arsenal, Pine Bluff, Arkansas, were formally turned over to the Department of Health, Education, and Welfare on April 1, 1971, for the purpose of setting up a National Center for Toxicological Research. FDA, DHEW, and EPA have entered into an agreement to coordinate their activities for the purpose of toxicological studies, and extending the use of the Center to other agencies as determined by a policy board. An interim policy board of six members has been established consisting of three FDA members and three EPA members. A permanent policy board will be established soon.

A copy of the interagency agreement for joint participation in this facility is attached to the end of this report.

NIH: NIEHS has several mechanisms for identifying and addressing large scale environmental questions. One of the successful mechanisms for the identification of research needs is the establishment of ad hoc task forces of experts such as the Task Force on Research Planning in Environmental Health Science which met in the summer of 1969 and published its recommendations in "Man's Health and the Environment-Some Research Needs,” U.S. Government Printing Office, 1970. In cooperation with the EPA and other agencies, steps are being taken to periodically bring this report up to date and to redefine research needs as progress is evaluated.

The University Environmental Health Centers developed by the extramural program of NIEHS are a valuable resource for addressing environmental prohlems by interdisciplinary teams. In each center there is a wide variety of disciplines and at the same time each center is a source of expertise that is unique to that specific center. Through regular conferences between the center directors and NEIHS staffs, this Institute and center directors are aware of programs, problem areas under study, and capabilities within each institution, thus facilitating the identification and evaluation of emerging problems.

Since the establishment of NIEHS it has had full-time staff charged with liaison with the many Federal agencies with environmental responsibilities including EPA and its predecessor agencies. This liaison has resulted in exchange of information and recognition of research needs with those agencies. Recently the Director of NIEHS met with the Assistant Administrator for Research and Monitoring, EPA, to establish mechanisms for coordinating the activities of the two agencies. Currently, formal memoranda of agreement are being prepared. In the meantime, NIEHS is continuing and ad hoc committees concerned with specific problems, for example, the Lead Liaison Committee and the Committee for Biologic Effects of Atmospheric Pollutants.

HSMHA: Not applicable to HSMHA.

Question 8. What important questions, if any, are you unable to research adequately within your esisting rescarch structure? What are the main hindrances to proceeding with such research?

Answer. FDA: An accelerated and extensive concern relevant to the potential health hazards of environmental chemicals has imposed an unprecedented re quirement on regulatory agencies for the assessment of safety and control of such compounds in man's environment. A wide array of such agents of chemical, microbial, or processing origin, to which man may be continuously or intermittently exposed, may either individually or additively impact on his health, General classes of compounds or potential toxic agents to which man may be exposed may be categorized as food additives, industrial and household chemicals, pesticides, natural toxins (plant, marine, and microbial), cosmetics, drugs, and others still uncharacterized.

Whereas some past assurance of safety has been established for some cases of chemicals used in the food supply, some of these have come under extensive review recently. Current approaches and resources are inadequate to provide an assessment and assurance of the degree of safety currently required. Of special concern is the valuation of potential hazards related to low dose exposures. Better understanding of low level dose-response relationships is needed to evaluate genetic abberations, birth defects, cancer or undifferentiated biochemical-metabolic deviations induced in animals and their relevance to human health.

On the basis of these pressing requirements, a National Center for Toxico logical Research will be established under the administration of the Food and Drug Administration. Program support in funding and participation by other agencies will provide a collaborative input in the resolution of the problem of safety evaluation in this important area of environmental health.

NIH: Because the National Institute of Environmental Health Sciences is a new organization, it has been necessary to establish priorities for its study of the health effects of environmental agents. Consequently, in some instances the study of problems of secondary priority has been postponed until more adequate resources were available. With new intramural research facilities that have just become available and modest increases in personnel and budget, many projects that have been delayed can be undertaken. With anticipated further increases in resources in intramural, collaborative and grants programs, NIEHS expects to be able to undertake adequate research to produce fundamental, theoretical knowledge on the health effects of environmental agents on man. Plans for the develop ment of additional laboratory facilities for the intramural research program on the permanent 509-acre site in North Carolina are in progress.

NSHMA: The recent reorganization has removed all research concerned with pesticides from HSMHA, and there is need for this competence in disease control activities. The limitation is funding. INTERAGENCY AGREEMENT BETWEEN THE DEPARTMENT OF HEALTH, EDUCATION,



On January 27, 1971, President Nixon announced the establishment of a National Center for Toxicological Research at Pine Bluff, Arkansas. The Food and Drug Administration will administer the facility in a manner that is responsive to the needs of the signatory agencies when programs require research and development suitable to the Center. In addition, other Federal agencies, universities, and industry groups will be invited to participate to the extent that their participaion appears feasible and desirable. Priority is to be given to those programs of concern to the participating agencies, particularly if these programs are jointly planned or supported. An effort will be made to maintain maximum flexibility in the operation and management of the facility to ensure responsive ness to the changing needs of participating agencies. Principles of Operation:

There will be a Director of the Center with overall authority to operate and manage the Center in accordance with policies and priorities established by a policy board. The Director will be appointed by the Commissioner of the Food and Drug Administration after consultation with and approval by the policy board.

The policy board will consist of government employees appointed by the Secre tary of Health, Education, and Welfare, and the Administrator of the Environmental Protection Agency, with provision for additional members as needed.

All members of the board must have an opportunity to express their opinions and vote on all major decisions.

The Director will be authorized to arrange for operations of all or any portion of the Center by contract with a suitable organization, if after consultation with the policy board, such contract operations seem desirable.

Fiscal and agency audit functions will be the responsibility of the Food and Drug Administration.



Functions of Director:

The Director will have full authority to operate the National Center for Toxicological Research within the guidelines established by the policy board.

The Director shall provide a full-time staff of one or more people acceptable to the policy board to serve as Secretariat to the policy board. The Director will provide managerial supervision and facilities to this staff, but will not interfere in any way with any instructions the Secretariat staff receives from the board. He will assure that such staff as well as the members of the board have full acess, with his knowledge, to all activities of the Center. Functions of Policy Board:

The policy board will meet at regular intervals, no less than six times per year primarily at the Center, to consider and develop policies, scientific priorities, and related program budgets and such other matters as may affect the scientific excellence of the Center and to assure its flexibility to serve the purposes for which it is established. An interim board is hereby established to serve not berond September 30, 1971, by which time the permanent policy board will be designated. The membership of the interim board will consist of three voting members appointed by the Secretary of Health, Education, and Welware, three voting members appointed by the Administrator of the Environmental Protection Agency, one observer from the Office of Science and Technology, and one observer from the Council on Environmental Quality. The six voting members shall elect a chairman from among themselves.

The interim board will proceed immediately to develop a charter and operating procedures to be approved by the Secretary (HEW) and the Administrator (EPA). The charter and operating procedures will specify: the structure and membership of the board, the procedure for appointing members (which procedure shall in any event provide for representation in equal numbers from HEW and EPA), a mechanisın for participation of other organizations that should participate in the policy and priority setting, a mechanism for obtaining scentific advice from consultants, the selection of the chairman, the frequency of meetings, the definition of a quorum, the procedures for convening special meetings, and a method of amending the charter and operating procedures.

Matters upon which the policy board will provide advice or guidelines to the Director include:

1. Organization of the Center.
2. Qualifications and selection of key personnel.
3. Overall budget requests and modifications.
4. General plans and overall protocols of major projects.
5. Major building construction and modification requirements.
6. Arrangements for contracts for major activities of the Center.

7. Contingencies which require experimentation and expenditures of contingency funds.

8. Such other matters as the Director or members of the board considers appropriate.

Protection of the scientific integrity of the laboratory is paramount. To this end it should be understood that no regulatory body will be obligated in any way to give any special weight to results of activities of the Center or interpretation of those results; by the same token, the board, rather than individual scientists, will be the source of any official interpretations of Center activities desired by regulatory agencies.

As soon as possible, the interim board will recommend contracts or other activities to the Commissioner of FDA that will facilitate and expedite the establishment of appropriate activities of the Center, making use of the funds being held in reserve for this purpose. Functions reserved to the Commissioner of FDA:

1. Appointment of the Director of the Center after consultation with an approval by the policy board.

2. Establishment of procedures to assure the legal and fiscal responsibilities of the Center. Effective date:

This plan of operation will become effective on the first day after it has been signed by both the Secretary of HEW and the Administrator of EPA.

« PreviousContinue »