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CONSTRUCTION OF NEW BUILDING Senator HARKIN. Dr. Hoel, thank you very much.

For a number of years, the committee has been aware of your Institute's interest in constructing a new building to replace your north campus building in Research Triangle Park. I understand the lease on your existing building expires in May and that you are anticipating the costs of improvement for safety and air handling plus inflation will increase the rental costs by up to 50 percent at renewal time. So, this seems to make the option of building even more cost effective. Once again, however, there is no funding requested in the NIH buildings and facilities budget for construction costs of your building.

What would you expect the savings to be if we built a new building for the Institute as opposed to continuing rental expenses?

Dr. HOEL. I think if our rental costs did not go up-and, as I say, these are some old buildings that are

Senator HARKIN. If they do not go up. Dr. HOEL. If they do not go up, I understand that it would be about a 13-year payback on that lease. We do not know how much they are going to go up. If they go up 50 percent, of course, that 13-year estimate would be considerably less. So, it would both be the advantage of bringing our scientists together, plus, I think, it would be economical from the government's standpoint to construct this facility.

Senator HARKIN. Dr. Raub, what kind of priority do you place on this building?

Dr. RAUB. As we look at it over the longer term, it is clear that there are the advantages that Dr. Hoel indicates with respect to that facility. For the immediate future, we have been wrestling with the enormous problems of infrastructure on the NIH campus in Bethesda, and we have given a higher priority to those issues only because it literally means keeping the enterprise going as opposed to achieving some further improvements or some longer term cost savings.

We have identified the NIEHS needs in our professional judg. ments budgets and will continue to do that.

Senator HARKIN. I understand there is supposed to be two modules. One is a lab and one is an office module?

Dr. HOEL. Yes; that's correct.

Senator HARKIN. Which of the two would be the higher priority for the Institute?

Dr. HOEL. Well, sir, it would be the laboratory.
Senator HARKIN. Could we just proceed with one?
Dr. HOEL. Yes.

Senator HARKIN. One last question I have, Dr. Hoel, is last year the committee provided you and your Institute with an increase of $1.5 million to begin research on additional chemical compounds. The committee asked that you give the highest priority to research on those chemicals encountered by farmers, their families, and agricultural workers. I had asked that question earlier in a different vein.

But tell the committee what is underway now with regard to research into the health effects of agricultural chemicals.

Dr. HOEL. I think the most important thing we have started, which we had not done in the past, is to form a group of experts to concentrate on a particular area. We are starting with agricultural chemicals to see which ones they believe to be of the greatest importance from a public health standpoint with regard to toxicological testing-what types of tests and so on. They can advise us as to what the priorities should be.

Then the second issue would be what are we doing in terms of the toxicity testing. It is a long process in terms of nomination and going through preliminary research and testing. In 1991, among our subchronic tests we are beginning 21, of which 3 are agricultural chemicals, and of the chronic tests, we are beginning, 13, of which 1 is agricultural. In 1992, of our subchronics,

we will begin 14, of which 4 are agricultural, and of the chronics, 2 of the 12 are agricultural.

We have many competing issues here. For example, research on electromagnetic fields will begin. The retroviral vector that was mentioned relative to gene therapy will be tested. And so, there are quite a few other competing issues.

QUESTIONS SUBMITTED BY THE SUBCOMMITTEE Senator HARKIN. Thank you very much, Dr. Hoel. There will be some additional questions which will be submitted for your response in the record.

[The following questions were not asked at the hearing, but were submitted to the Institute for response subsequent to the hearing:)

QUESTIONS SUBMITTED BY THE SUBCOMMITTEE

THE CLEAN AIR ACT

Question. The Clean Air act Amendments which passed last October placed a number of requirements on your Institute to perform air pollution studies. More specifically, the studies are to identify the critical toxic elements in the air and the level at which they become health hazards. These additional responsibilities I understand would cost your Institute approximately $8 million.

Why is there no request for these funds?

Answer. When the Clean Air Act Amendments were signed into law on November 15, 1990, the process of preparation of the budget request for NIEHS for fiscal year 1992 was too far along to permit the major revisions and recalculations needed to justify additional funds to support a major expansion of research into the health effects of air toxics. However, our internal planning process tracked the progress of the Clean Air Act Amendments relating to health effects research over the summer of 1990 in anticipation of passage and enactment. We have completed a research plan which describes and sets priorities for additional studies authorized in the new law including biomedical, epidemiologic, and toxicologic studies intended to characterize the health risks of the air toxics cited in the 'reauthorization.

NON-ANIMAL METHODS

Question. Last year, the Committee raised a concern that your National Toxicology Program (NTP) has developed a number of non-animal-méthods, or tests, that could be used for examining the health effects of chemigal compounds but funding has been too short to validate these tests. In fact, the budget of the portion of the National Toxicology Program which validates nonanimal tests dropped from $5.7 million in 1984 to $2.8 million in 1990.

I see you are requesting $3.9 million for this program in 1992.

What can you tell the Committee about your efforts to validate these non-animal tests?

Answer. Since NTP's establishment, it has given high priority to development and validation of toxicologic assay methods which may reduce the use of whole animals and/or provide other non-animal models in toxicologic studies. One of our major efforts has been in the extensive validation of short-term mutagenicity studies. We have learned that a small battery of assays, including the bacterial Salmonella assay, identifies mutagenic activity and that a positive in-vitro mutagenicity result is a clear signal that a chemical is likely to be carcinogenic in animals. A negative mutagenicity result, however, is unclear regarding carcinogenicity. The demonstration that the existing short-term methods were severely limited for identifying carcinogens dictated that we explore methods that reduce our dependence on animals. New efforts will be directed to specific projects thať utilize computer-assisted chemical analysis and the latest methods of gene manipulation to develop non-animal models.

Question. To what extent will the validation of these tests help reduce the use of animals in your research?

Answer. One effort to reduce the use of animals in research is in the area of computer-assisted chemical analysis of the diverse chemical classes that have been assayed for cancer and other toxic endpoints. If such information proves diagnostic, it could be used to reduce the necessity to test additional chemicals within a given class, thereby reducing numbers of animal studies needed. Another major effort enables researchers to transfer and direct the expression of genes

into cells. As knowledge of molecular aspects of cancer improves, it becomes increasingly possible to introduce and activate metabolically important genes in cultured cells so that individual cells can assume many of the functions found in intact tissues in animals. Among the

advantages of these cells would be their ability to activate and detoxify chemical substances and their ability to exhibit easily measurable biochemical responses. While these efforts should reduce our dependence on animals, there is considerable scientific doubt about the prospects for total replacement of mammalian systems for toxicologic studies in the foreseeable future.

ELECTROMAGNETIC FIELDS

Question. Last year the Committee expressed concern about the health effects of constant exposure to low radiation emitting from such sources as electric blankets and power lines. Tell us the progress you are making on the research in this area and how it is coordinated with work funded by the Environmental Protection Agency.

Answer. The NIEHS has a number of activities which address the concerns raised about the health effects of low frequency electromagnetic fields (EMF) emitted by sources such as power lines. In September 1990, the Institute held a planning conference with participation by the Environmental Protection Agency (EPA), the National Institute of Child Health and Human Development, the National Institute for Neurologic Disorders and Stroke, the Electric Power Research Institute, and selected principal investigators. This meeting provided a direction for a program announcement planned for May 1991. The focus of this announcement is on the biological effects and basic mechanisms of low frequency EMF. In addition, this announcement encourages , investigators to develop improved exposure systems for EMF studies.

In February of this year, the NIEHS hosted a workshop entitled "Recent Developments on the Health Consequences and Clinical Applications of Low Frequency Electromagnetic Fields." This workshop helped to provide an awareness of the methodological problems encountered in conducting studies on EMF health effects, and provided an overview of the status of EMF research.

In FY 1991 the NIEHS funded three new grants on EMF health effects. Two of the grants are examining the effects of EMF at the cellular level, and the other grant is developing methodologies for precisely measuring exposures to low frequency radiation.

The NTP has been requested by the Department of Energy (DOE), the National Association of Regulatory Utility Commissioners, and the utilities Industries to evaluate the toxic and carcinogenic potential of EMF in laboratory animals. The nomination was approved by the NTP. Executive Committee which is comprised of nine Federal Agency Heads including the Administrator, EPA. The study design has been reviewed and approved by many expert scientists, including those from the EPA. No comparable studies have been planned by the EPA, DOE, or other Federal agencies. The first studies on the reproductive effects and possible carcinogenicity of 60 Hz magnetic fields will begin this year.

NEW NORTH CAMPUS BUILDING

Question. For a number of years the Committee has been aware of your Institute's interest in constructing a new building to replace your North Campus building in Research Triangle Park. I understand the lease on your existing building expires in May and that you are anticipating the costs of improvement for safety and air handling plus inflation will increase the rental costs by up to 50 percent at renewal time. This seems to make the option of building even more cost effective.

We have already paid for the architectural and engineering work of the new building, which I believe was finished last November. What is the shelf life of this work?

If we

Answer. The plans that we now have will be good until July 1992. haven't received a building permit by that time we would have to update the design to meet new building code requirements at a cost of approximately $1 million.

QUESTIONS SUBMITTTED BY SENATOR ARLEN SPECTER

HEALTH EFFECTS OF ELECTROMAGNETIC FIELDS

Question. Dr. Hoel, earlier today I raised a question with Dr. Broder regarding the health ffects of electromagnetic fields. As you may have heard, the residents of South Scranton are deeply concerned over the high voltage power lines which run through their community, and reports of an elevated incidence of cancer. Has the Institute supported studies on this matter?

Answer, Yes, the Institute began several projects in FY 1991 which address the concerns raised about the health effects of low frequency electromagnetic fields (EMF) emitted by sources such as power lines. Three new grants were funded which deal with the effects of EMF at the cellular level and with developing methodologies for precisely measuring exposures to low frequency radiation. NIEHS' National Toxicology Program (NTP) has begun studies on the reproductive effects and possible carcinogenicity of 60 Hz magnetic fields.

Question. Should a health effects study be done and what role could the National Institute of Environmental Health Sciences play in the matter?

Answer. Health effects studies should certainly be done. The Institute held a planning conference in September 1990 with participation by the Environmental Protection Agency, the National Institute of Child Health and Human Development, the National Institute for Neurologic Disorders and Stroke, the Electric Power Research Institute, and selected principal investigators. The focus of the conference was on the biological effects and basic mechanisms of low frequency EMF. Also, the Department of Energy, the National Association of Regulatory Utility Commissions, and the utilities industries have requested the NTP to evaluate the toxic and carcinogenic potential of EMF in laboratory animals.

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