Senator INOUYE. Thank you very much, doctor. What is the primary reason or cause of the disproportionately high incidence of kidney disease among American Indians, Afro-Americans, and Native Hawaiians?

Dr. TISHER. Well, in addition to their overall general poor level of medical care, hypertension and diabetes are very common. In certain Native Indians, such as Puma Indians, over 70 to 80 percent of this population has diabetes, and diabetes leads to kidney failure in many cases. This is also true of Hawaiian Americans.

Senator INOUYE. So the primary cause is improper diet?

Dr. TISHER. This is a genetically inherited disease. It certainly can be modified by diet and by level of medical care.

Senator INOUYE. Well, I am with you, because one of the bullets that flew toward me nicked my right kidney. So I had better take good care of it.

Dr. TISHER. Yes, sir.

Senator INOUYE. Thank you very much, doctor, for your contribution today. If you could provide us with a more expanded testimony on how the reduction in funds has caused, as you said, the loss of one whole generation of investigators.

Dr. TISHER. We will be very happy to provide that information to the subcommittee.

Senator INOUYE. That would be most helpful, sir.

Dr. TISHER. Thank you.

Senator INOUYE. Thank you very much.

STATEMENT OF MARTIN L. STEPHENS, M.D., VICE PRESIDENT FOR LABORATORY ANIMALS, THE HUMANE SOCIETY OF THE UNITED STATES

ACCOMPANIED BY MARTHA ARMSTRONG, MASSACHUSETTS SOCIETY FOR THE PREVENTION OF CRUELTY TO ANIMALS

Senator INOUYE. Our next witness is the vice president for Laboratory Animals of the Humane Society of the United States, Dr. Martin Stephens. Dr. Stephens, welcome, sir.

Dr. STEPHENS. Mr. Chairman, members of the committee: Thank you for this opportunity to speak with you.

My name is Dr. Martin Stephens. I am vice president for laboratory animals at the Humane Society of the United States, and I am speaking on behalf of the SUS and the Massachusetts Society for the Prevention of Cruelty to Animals. I am joined by Martha Armstrong from the MSPCA.

Over the last 5 years, the HSUS and the MSPCA, with the help of former Senator Paul Tsongas, have been meeting with representatives of industry, Federal agencies, and Congress to expedite progress being made in the development of alternatives to the use of animals in toxicity testing. We began our work in 1986 when the congressional Office of Technology Assessment issued its landmark report entitled "Alternatives to Animal Use in Research, Testing, and Education."

The OTA reported that the use of tissue cultures, microorganisms, computer models, chemical assays, and other nonanimal methods can be faster, cheaper, and more sensitive than conventional animal methods. These practical advantages of nonanimal methods are of considerable importance when one considers that

tens of thousands of potentially toxic substances have never been adequately tested, and this is in large part because current animalbased toxicity tests tend to be costly and time-consuming.

During our efforts, we identified the national toxicology program as critical to the advancement of alternative testing methods. As you know, the NTP is an interagency program that specializes in toxicity testing. Its participating agencies include the NIH's National Institute of Environmental Health Sciences, the CDC's National Institute for Occupational Safety and Health, and the FDA's National Center for Toxicological Research.

The NTP not only develops tests, but it evaluates them. Without this so-called validation, promising new tests would language. The HSUS, MCPCA, industry, and others have identified validation as the main bottleneck to advancing these alternative technologies.

The NTP itself has identified over 100 promising alternative tests that have yet to be validated. It is currently validating only about five of these tests. Part of the problem is that during the last 6 years, as the NTP's total budget increased, it cut its validation budget in half. Consequently, last year we lobbied for additional funds for NTP's validation efforts, and we were grateful that the Senate responded positively to our request.

Unfortunately, the final report omitted a specific designation to the NTP's validation program. Nonetheless, the NTP increased its validation budget from $2.8 million last year to $3.6 million for fiscal year 1991.

PREPARED STATEMENT

This year the HSUS and MCPCA request that the Senate Appropriations Committee allocate an additional $5 million to the NTP and in report language urge that the funds be used specifically to validate new nonanimal tests.

Thank you for this opportunity to testify in support of greater Federal involvement in the search for better and more humane methods of testing potentially dangerous chemicals.

[The statement follows:]

STATEMENT OF DR. MARTIN L. STEPHENS

Mr. Chairman, members of the Subcommittee, thank you for the opportunity to speak to you today. My name is Dr. Martin Stephens. I am vice president for laboratory animals at The Humane Society of the United States (HSUS). I am speaking on behalf of The HSUS and the Massachusetts Society for the Prevention of Cruelty to Animals (MSPCA), two of the nation's largest animal protection organizations. We are seeking an additional $5 million appropriation for the validation activities of the National Toxicology Program.

Both the HSUS and MSPCA recognize that one of the pressing public health challenges facing the United States today is how to rapidly and effectively assess the potential danger posed by the chemicals and chemical-based products to which humans are exposed. Tens of thousands of potentially toxic chemicals are already on the market, yet have never been adequately tested. This problem is compounded by the addition of hundreds of new chemicals to the marketplace each year. Clearing out this backlog would take decades and billions of dollars using conventional animal tests. For example, the standard animal test for carcinogenicity takes two years to complete and costs between one and two million dollars. Many conventional animal tests also tend to be scientifically unsophisticated and of uncertain relevance to human experience, to say nothing of their humaneness. In September, for example, an editorial in Science magazine characterized the standard rodent test for detecting carcinogenicity as "an obsolescent relic of the ignorance of past decades." This is not to say that the use of animals has played an unimportant role in safety assessment in the past and that toxicologists are not continuing to rely on animal testing to a significant extent. However, the limitations of animal testing are also becoming increasingly apparent.

Fortunately, new tests are being developed. The ISUS and MSPCA are excited about these developments because many of these new procedures are alternatives to animal tests that involve either no animal use or minimal use. To greater or lesser degrees, industry, regulatory agencies, the scientific community, as well 3s animal protection organizations, are fostering the development of alternative methods, because these procedures tend to be less expensive, less time-consuming, more sophisticated, and more humane, than conventional animal tests.

During the last five years, The HSUS and SPCA have met with a number of industry and government leaders to identify ways to expedite progress in the development of alternative methods. We and others now believe that a major impediment to progress on alternatives is not developing more, novel procedures, but validating the ones that have already been developed, that is, making sure that promising new tests work properly in a variety of laboratories and on a variety of chemicals to be assessed.

We and others also believe that one federal program is in a unique position to help break the validation logjam. That program is the interagency collaboration called the National Toxicology Program (NTP). The HSUS and MSPCA request that the Senate Appropriations Committee allocate an additional $5 million to the NTP and, in report language, urge that the funds be used specifically for the validation of alternatives. We are gratified that the Senate responded positively to our similar request last year. However, the final report omitted a specific designation to the NTP's validation program. Therefore, the need still exists.

The NTP specializes in toxicity testing. Its participating agencies include the National Institutes of Health's National Institute of Environmental Health Sciences (NIH/NIEHS), the Center for Disease Control's National Institute for Occupational Safety and Health (CDC/NIOSH), and the Food and Drug Administration's National Center for Toxicological Research (FDA/NCTR).

The NTP is perhaps the focal point for research on the development and validation of non-animal testing methods in the federal government. "A central function of the [NTP]" is the development of toxicity tests that are "faster, more reliable, and more predictive of adverse health effects..." (NTP's Review of Current DHHS. DOE, and EPA Research Related to Toxicology. Fiscal Year 1989, hereafter Review, 1989).

NTP agencies are currently validating only 10 tests according to the NTP's Review, 1990. Of these, only about five can be considered alternative methods. This figure is disturbing when one considers that the NTP Annual Report for FY90 states: "There are well in excess of one hundred assays that have been proposed as potential substitutes for predicting or studying toxicological effects in whole animals. These short-term systems can be useful as rapid and inexpensive means of obtaining data on potential toxicity, but for many, their value has not been fully established" (p. 29). Clearly, newly developed tests should be validated so they can be put on line sooner rather than later. Therefore, the NTP's budget priorities should continue to shift accordingly.

The NTP's budget consists of voluntary allocations from the participating agencies (NIEHS, NIOSH, NCTR), the amounts of which are specified after yearly appropriations are known. From FY84 through FY90, the funding level of the methods development program has grown from $13.5 million to $18.6 million. However, during the same period, the allocation for methods validation has dropped from $5.7 million to $2.8 million. (The attached charts depict this drop in the validation budget during the same time span that the NIEHS and NTP budgets have increased.) NTP's 1991 budget is $83.6 million, provided principally (95%) by the NIEHS. Roughly $3.6 million is allocated for the validation of new methods. These new methods can be either non-animal or animal-based, so the agency is spending some fraction of $3.6 million on validating new alternatives.

We are pleased that the NTP is increasing its validation budget from $2.8 million in FY90 to $3.6 million in FY91. However, with the current backlog of 100 tests and the increasing number of potential toxic substances which must be tested, we believe our requested $5 million increase to the FY92 validation budget is essential to make alternativebased technology available for industry's use.

There is a second and complementary step that Congress can take. We request that the NTP be specifically charged with coordinating the development and validation of new alternatives throughout the government. The NTP is the logical administrative unit to play such a role. Its Executive Committee already consists of representatives from all of the relevent health research and regulatory agencies (e.g., NIH, FDA, and EPA).

By taking these small but significant steps, Congress would be heeding the policy implications of the Office of Technology Assessment's (OTA) 1986 landmark report entitled Alternatives to Animal Use in Research, Testing, and Education. The OTA reported that alternatives in the area of toxicity testing hold great promise, particularly the nonanimal methods, as they tend to be faster, less expensive and in some cases more reliable than conventional testing on animals.

The OTA report stated: "There has been a small but significant shift away from whole-animal testing to in vitro and non-animal techniques in recent years.... Many new methods are being developed for commonly used tests. Most of these are not yet validated, but they have potential uses for screening substances for the animal testing they may eventually replace" (p. 190).

Since the 1986 OTA report, research on the development of alternative testing methods has progressed. Such research is being conducted in order to develop tests that are better for scientific as well as humane reasons. Many of the regulatory agencies now include in their annual reports specific references to alternatives. For instance, the NTP devotes a special section of its annual reports to the research on alternative testing methods conducted by its contributing agencies. NTP's 1990 Annual Plan reports that these agencies are developing a total of 24 sets of alternative methods. Similar progress is being made in the private sector. Companies such as Procter & Gamble and many others have established internal programs on alternatives development as well as participated in industry-wide forums to advance the use of nonanimal testing methods.

The pace at which all this effort comes to fruition will depend on the emphasis placed on validation, and the NTP is the ideal program to accomplish this purpose.