[Congressional Record Volume 144, Number 72 (Friday, June 5, 1998)]
[Extensions of Remarks]
[Pages E1047-E1049]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




            H.R. 3946--THE ICCVAM AUTHORIZATION ACT OF 1998

                                 ______
                                 

                            HON. TOM LANTOS

                             of california

                    in the house of representatives

                          Friday, June 5, 1998

  Mr. LANTOS. Mr. Speaker, recently I introduced legislation to promote 
better business, protect consumers, increase the efficiency of the 
federal government, contribute to scientific progress, and protect 
animals. H.R. 3946--The ICCVAM Authorization Act of 1998--is a non-
partisan, non-controversial bill that emphasizes the protection of 
human health as well as animal health by facilitating the acceptance of 
alternative testing methods.
  Mr. Speaker, there has never been such an impressive marriage of 
diverse interests working together to supply the same legislation. I am 
honored and delighted that H.R. 3946 is supported by the Procter & 
Gamble Company, the Gillette Company, the Colgate-Palmolive Company, 
the American Humane Association, the Humane Society of the United 
States, the Massachusetts Society for the Prevention of Cruelty to 
Animals, the Doris Day Animal League, and over 6.5 million Americans 
who have demanded viable alternatives to animal testing whenever 
possible.
  Animal tests have been used for over fifty years by federal 
regulators to test for product safety. In the last decade, however, 
biotechnology companies have researched, developed, and manufactured 
alternative testing procedures that are just as effective as outdated 
animal testing, but these newer technologies currently have no 
established avenue for receiving approval by federal agencies. By 
continuing to promote antiquated, although generally accepted, animal 
tests, federal agencies have put up an unnecessary roadblock to 
scientific and technological progress and innovation.
  Mr. Speaker, in an effort to eliminate duplicative efforts and to 
increase communication in cross-cutting levels of different Federal 
regulatory agencies, the ground-work for the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM) under the 
National Institutes of Environmental Health Sciences (NIEHS) was laid 
by the National Institutes of Health (NIH) Revitalization Act of 1993. 
The ICCVAM has functioned solely on an ad-hoc basis since that time and 
was the first body to establish criteria for the validation and 
acceptance of alternative methods.
  This important committee has functioned well and recently completed a 
final report receiving acknowledgment from federal agencies. Under the 
NIEHS Applied Toxicological Research and Testing Program, ICCVAM 
Contracts were listed in the Federal Register: $666,950 (year one), 
$691,308 (year two), $717,167 (year three), with two additional option 
years. In contrast, the NIEHS budget for FY1998 was over $300 million. 
The ICCVAM is a body that more than pays for itself in terms of its 
worth to the Federal agencies and its contribution to industry and the 
public.
  H.R. 3946 will raise the ICCVAM to standing committee status and thus 
we can continue to move forward into the next century recognizing and 
supporting scientific progress. For years, the regulated industries and 
the bio-tech companies that engineer alternative testing methods have 
endured a frustrating, confusing Federal process for test method review 
and approval. Despite the fact that many companies have committed 
themselves to ensuring human safety while decreasing the usage of 
unnecessary animal tests, the federal government has remained 
unresponsive to their concerns. Mr. Speaker, these businesses have 
petitioned Congress to authorize the ICCVAM, thus simplifying the 
process for evaluating new tests.
  I have introduced legislation that, for the first time, provides for 
gathering information in a single body for agencies, companies, animal 
protection advocates, and the consumer. H.R. 3946 requires that 
agencies be accountable for providing the appropriate information 
regarding all regulations, requirements, and recommendations on the 
animal tests under their respective jurisdictions. Federal agencies 
with jurisdiction over toxicity tests would be required to review and 
identify all regulations that require animal use for toxicity tests and 
forward the list to the ICCVAM.
  Mr. Speaker, by adopting this legislation, the Congress will 
demonstrate a commitment to increasing the health and environmental 
safety of Americans. H.R. 3946 will open the doors to more 
technologically-advanced methods of research that will more closely 
replicate the reactions of the human body than does the current 
research that is done on animals. When a method meets a specific 
endpoint for specific agencies, or needs multiple agency acceptance, 
the ICCVAM can encourage agencies to modify their recommendations and/
or requirements to reflect the best new scientific methods.
  H.R. 3946 requires that agencies notify the ICCVAM within 180 days of 
receiving the ICCVAM's recommendations. The ICCVAM does not mandate the 
acceptance of any alternative testing method; it requires that federal 
agencies consider the ICCVAM's recommendations on new test methods and 
provides strict criteria under which the federal agencies can reject 
the alternative testing method. Under the Federal Advisory Committee 
Act, each agency under current federal

[[Page E1048]]

statute has the ultimate authority to accept or reject recommendations 
in any situation under its regulatory jurisdiction.
  Importantly, H.R. 3946 will end the incentive for companies to prefer 
status quo animal tests by giving the ICCVAM the authority to make an 
otherwise fragmented regulatory process coherent, cost-efficient, and 
accessible so that industry can more readily market its products.
  Mr. Speaker, when the NIEHS worked towards the goal of establishing 
the ad-hoc ICCVAM as a single review body for the entire federal 
government, the objective was to end the usage of inappropriate tests 
from as far back as the 1940's before we stepped into the 21st century. 
Without the ICCVAM, we will fall short of maximizing health and human 
safety protections for all consumers. H.R. 3946 prioritizes high human 
health standards.
  Mr. Speaker, to ensure that there is no confusion in its objectives 
and jurisdictions, H.R. 3946 also contains a specific exemption for 
regulations, guidelines, or recommendations related to medical 
research, expressly written into the bill. In effect, Mr. Speaker, 
medical research is not directly regulated by the federal agencies in 
the same manner as product testing.
  Mr. Speaker, I am delighted to introduce the ICCVAM Authorization Act 
of 1998. I believe that H.R. 3946 streamlines the federal bureaucracy 
while increasing human safety and progress while refining, reducing, 
and replacing animal testing. We in Congress must ensure that as we 
step into the next century, the federal government works efficiently to 
demonstrate leadership in scientific advancement while emphasizing 
human health and animal health. With these goals in mind, Mr. Speaker, 
I urge my colleagues to join me by supporting this bill.
  Recently, Mr. Speaker, I held a briefing on H.R. 3946. This 
legislation was broadly supported by the public and by all those who 
would be affected by this legislation. Mr. Speaker, I would like to 
defer at this time to the comments of the industry experts, scientists, 
and animal protection advocates, and federal agency representatives who 
have been integral in the creation of this legislation. Mr. Speaker, 
several of these distinguished professionals attended a briefing which 
I chaired and spoke out in support of H.R. 3946 and the merits of the 
ICCVAM. I ask that the full text of their testimonies be placed in the 
Record.

  Text of Presentation by Dr. Katherine Stitzel, The Procter & Gamble 
                                Company

       The Procter & Gamble Company is pleased to be here today to 
     support the ICCVAM Authorization Act of 1998. P&G is one of 
     the largest consumer products companies in the world. Our 
     products our under the sink and in the bathroom medicine 
     cabinet in nearly every home in America and used by billions 
     of people around the world. We have an obligation to ensure 
     our many products are safe not only when they are used as 
     intended, but also when they are accidentally ingested by 
     children, splashed into your eye, or used in other ways which 
     were not intended.
       We believe the ICCVAM Authorization Act of 1998 is a very 
     important step in industry's efforts to reduce the use of 
     animals while ensuring product safety. As science has 
     progressed over the years industrial toxicologists have been 
     constantly researching new ways to assess the effects of new 
     products and ingredients. In the last fifteen years we have 
     concentrated on developing and gaining regulatory acceptance 
     of alternative methods, that is methods that reduce the 
     number of animals necessary or the stress caused to the 
     animals or that replace animals with an in-vitro or non-
     animal method. We have spent over $64MM dollars on this 
     effort and reduced our animal use for non food/non drug 
     testing by over 85% since 1984 even though the Company is 
     more than three times larger than it was in 1984.
       While we cannot predict every possible toxicological effect 
     with an alternative test, there are many effects, such as the 
     ability of a material to penetrate the skin, where we still 
     find ourselves having to resort to what we believe is 
     unnecessary animal testing. this is because the process for 
     getting regulatory agencies to accept improved toxicological 
     methods is time consuming, difficult and very rarely 
     successful. Each new test must be submitted for evaluation 
     and approval to each agency--sometimes to several different 
     divisions within one agency. As the agencies are very busy, 
     most do not have the time to carefully evaluate new test 
     methods and therefore they opt to continue to use their 
     current methods. Think about it, we are about to begin the 
     21st century using many toxicology methods that were 
     originally developed in the 1940's. I can think of few other 
     fields where acceptance of scientific progress has been so 
     effectively blocked.
       Recognizing this problem in the early 1990's P&G joined 
     other companies and animal welfare organizations to support 
     inclusion of language in the NIH Revitalization Act of 1993 
     which directed National Institute of Environmental Health 
     Sciences to ``establish criteria for validation and 
     regulatory acceptance of alternative testing and recommend a 
     process through which scientifically validated methods can be 
     accepted for regulatory use''. NIEHS worked with 15 
     government agencies and with the public to develop what we 
     believe will be an effective solution--to create a single 
     review body for the entire federal government. This 
     organization, ICCVAM, is comprised of representatives from 
     the various federal agencies that use animal testing. It will 
     encourage the development of improved testing methods, 
     particularly alternative tests, and evaluate these new 
     methods for the entire government. This simplified process 
     will be much more efficient. It will also be more effective 
     because ICCVAM scientists will be expert in evaluating new 
     test methods. We are very supportive of the proposal, and 
     feel it is important to make ICCVAM a permanent part of the 
     NIEHS.
       We in industry applaud the efforts of Doris Day Animal 
     League, the American Humane Association, the Humane Society 
     of the United States, and the Massachusetts Society for the 
     Prevention of Cruelty to Animals for working with us to help 
     establish ICCVAM as the organization that will help ensure we 
     are using the most efficient and effective safety tests and 
     reduce animal use as far as scientifically possible
                                  ____


   Comments by Neil L. Wilcox, D.V.M., M.P.H., Senior Science Policy 
   Officer, Office of Science, Food and Drug Administration for the 
Congressional Briefing on the ``Inter-Agency Coordinating Committee for 
  the Validation of Alternative Methods (ICCVAM) Authorization Act of 
                                 1998''

       Congressman Lantos and distinguished guests, thank you for 
     the opportunity to participate in this briefing. I am here to 
     describe the current and potential relationship between the 
     Food and Drug Administration and the Inter-Agency 
     Coordinating Committee for the Validation of Alternative 
     Methods, or ICCVAM, listen to your comments, and attempt to 
     answer your questions.
       For the record, I may not take a position in favor of, or 
     in opposition to, this or any other proposed bill intended 
     for Congress. I am here to inform this audience as to how FDA 
     has participated on the inter-agency committee known as 
     ICCVAM and what affect it may have on the FDA in the future.
       The FDA has a sincere and dedicated interest in emerging 
     scientific technologies, including alternative methods 
     intended to reduce, refine, or replace the use of animals, 
     and that provide the agency with the best scientific answers 
     to accomplish our public health mission. In particular, we 
     are interested in test methods that provide specific answers 
     for safety and efficacy testing of FDA-regulated products. To 
     this end, the FDA supports the notion of the 3-R's in 
     research and testing where scientifically feasible.
       The FDA has been a participant of the ICCVAM ad hoc 
     committee since it was chartered in 1994 and continues to be 
     actively involved now that it is a standing committee. The 
     Office of Science has the lead for the agency and has formed 
     a committee with representatives from all FDA Centers and the 
     Office of Regulatory Affairs.
       You should understand that there is currently no formal 
     process for a new testing method to be reviewed by the FDA 
     for validation or regulatory acceptance. New methods are 
     incorporated into the review of product applications in FDA, 
     but it is on a case-by-case basis with no internal structure 
     in place to facilitate such action. The ICCVAM model proposes 
     to review new testing methods on behalf of federal agencies, 
     which would provide a service not currently available.
       ICCVAM, with its representatives from 15 federal agencies, 
     provides many benefits. This forum benefits not only the 
     agencies involved but also those who wish to introduce a 
     novel test method to a regulatory agency such as FDA. ICCVAM 
     will only review methods that have application to more than 
     one agency. If the method is such that it will be used only 
     by one agency, the sponsor of the method will be encouraged 
     to take the method straight to that agency. For a method with 
     potential use in several federal agencies, an early step in 
     the ICCVAM process will be to establish an expert working 
     group consisting of individuals from each of the agencies 
     where the method may have application. This expert working 
     group will then work with the sponsor of the method to make 
     sure that adequate data are available to have the method 
     thoroughly evaluated.
       Any method used by the FDA must be validated for its 
     intended use. Once the ICCVAM working group has determined 
     that the method is ready to be reviewed for validation, a 
     group of experts from outside the government would be 
     convened as a Federal Advisory Committee. Through this 
     external peer review process, the committee would make a 
     recommendation to ICCVAM as to whether or not the proposed 
     method meets the criteria for validation as put forth in an 
     ICCVAM document, Validation and Regulatory Acceptance of 
     Toxicological Test Methods, published in March 1997. The 
     expert peer review panel's recommendation would then be 
     conveyed to the relevant federal agencies by ICCVAM. Finally, 
     each agency would distribute the recommendation to its 
     appropriate organizational components.
       FDA has five product Centers, on research Center, and the 
     Office of Regulatory Affairs to which the ICCVAM 
     recommendation would be distributed. It is clear that 
     considering the many offices within the FDA to which such 
     information must be distributed, the ICCVAM proposal would 
     stream-line the

[[Page E1049]]

     process. Without ICCVAM, no one would know exactly which 
     office should review a particular test. Moreover, even if one 
     did know the appropriate offices to which a new method should 
     be introduced, there would be no consistent review criteria 
     for validation or regulatory acceptance across the agency. 
     The individual review offices are simply not equipped or 
     staffed to work with a method's sponsor for a process as 
     resource intensive as validation.
       Through an exhaustive and comprehensive three year process, 
     ICCVAM has worked with U.S. federal agencies, as well as 
     academia, industry and governments world-wide, to reach 
     consensus on criteria for validation and regulatory 
     acceptance. Due to the vast differences in regulatory 
     requirements between U.S. regulatory agencies, not to mention 
     other governments, the final acceptance and use of an ICCVAM-
     reviewed method remains the prerogative of each regulatory 
     agency. However, ICCVAM assures that, to the extent feasible, 
     adequate data for the proposed method have been reviewed by 
     external peer review for their validity. ICCVAM provides a 
     vehicle for a new method to be introduced to each agency 
     through scientists responsible for its internal use.
       With such intimate involvement of agency experts from 
     within the appropriate scientific field, the method and its 
     potential uses will be well understood by participating 
     agencies. Furthermore, by the time a method has reached 
     recommendation status to the agencies, it will more likely 
     gain regulatory acceptance. Since the ICCVAM process has been 
     endorsed by experts across the U.S. and throughout the world, 
     international harmonization on ICCVAM-reviewed methods will 
     be encouraged. Finally, the incorporation of methods that 
     promote the reduction, refinement, and replacement of whole-
     animal tests into regulatory decision-making clearly supports 
     the responsible use of animals in product testing.
       In summary, from an FDA perspective, the ICCVAM facilitates 
     the scientific review by experts, in both the public and 
     private sectors, to establish the scientific validation of 
     new testing methods that may have application in determining 
     the safety of FDA-regulated products. It should be 
     emphasized, however, that there may be occasions when a 
     sponsor of a particular method would prefer submitting its 
     data on a new method directly to the FDA, or any other 
     agency, and this remains an important option. The ability to 
     employ new technology in the regulatory decision-making 
     process and facilitate the acceptance of new methods for 
     safety testing is clearly enhanced with the added dimension 
     of the ICCVAM process.
       I would welcome questions relating to the current 
     activities between ICCVAM and FDA, as well as our vision of 
     this relationship in the future. Again, thank you for the 
     opportunity to discuss this important issue in a public 
     forum.
                                  ____


  Statement of Holly E. Hazard, Executive Director, Doris Day Animal 
                                 League

       We are proud to join with industry and animal protection 
     organizations in support of the ``ICCVAM Authorization Act of 
     1998.''
       The bill, sponsored by Representative Tom Lantos, will 
     raise to standing status, an interagency coordinating 
     committee that will review alternative methods for risk 
     assessment and safety substantiation for humans and the 
     environment. ICCVAM will make recommendations to agencies to 
     adopt procedures for implementing these recommendations. The 
     committee will be comprised of representatives from each of 
     the agencies with jurisdiction over products that require or 
     recommend some form of animal testing. There are over 15 such 
     agencies in the federal government. The committee will also 
     establish a scientific advisory committee that will allow 
     interested outside scientists and other stakeholders to 
     comment on newly-developed alternatives as they become 
     available.
       This committee will facilitate the acceptance of the use of 
     alternatives that will significantly decrease the numbers of 
     animals used in toxicity testing, while not only ensuring 
     that the health and safety of Americans and the environment 
     remain at the highest level, but hopefully increasing that 
     level of safety as more technologically-advanced methods of 
     research more closely mimic what may happen in the human 
     body.
       The bill is an outgrowth of the former Consumer Products 
     Safe Testing Act. It builds on the mandate given to the 
     National Institute of Environmental health Sciences in the 
     NIH Revitalization Act of 1993 to develop criteria for the 
     validation and acceptance of alternative methods. It also 
     consolidates the requirements for an evaluation of 
     alternatives that have interagency implication to one central 
     committee, rather than agency by agency.
       We've received many staff calls on how this bill affects 
     medical research. The bill has a specific exemption for 
     research. However, because the government does not regulate 
     industry protocols for medical research, the entire issue is 
     outside the scope of the legislation.
       The Doris Day Animal League is working with a number of 
     leaders in industry, and within the animal protection 
     movement, to bring about changes in the uses of animals for 
     toxicity testing. These individuals include: Dr. Martin 
     Stephens and Dr. Andrew Rowan of the Humane Society of the 
     United States; Dr. Dan Bagley of Colgate-Palmolive; Dr. 
     Wallace Hayes and Dr. Louis DiPasquale of Gillette; Dr. Kathy 
     Stitizel of Procter & Gamble; Ms. Adele Douglass of the 
     American Humane Association; and Dr. Peter Theran and Elaine 
     Birkholz of the Massachusetts Society for the Prevention of 
     Cruelty to Animals.
       One of the significant frustrations of the humane community 
     has been the lack of acceptance by the federal government of 
     technologically-advanced alternatives to animal testing. Many 
     in industry have met with a brick wall when they have 
     attempted to move alternative methods of testing through the 
     government bureaucracy to get their products on the market. 
     The fact is that the easiest thing for any company is to 
     simply maintain the status quo and do the animal tests to get 
     on with marketing their products.
       The Doris Day Animal League, along with a number of other 
     organizations, successfully lobbied the Department of 
     Transportation for the acceptance of the first federally-
     approved alternative to animal testing. This was an 
     alternative to the use of rabbits for the testing of highly 
     corrosive chemicals to determine the correct packaging 
     material for transportation. In the animal test, the product 
     would literally eat away the skin of a rabbit while 
     researchers tested how long this took; it could take anywhere 
     from hours to days. While this alternative was accepted at 
     one agency, the company had to petition others for multiple 
     agency acceptance and, as of yet, has been unsuccessful in 
     securing full federal approval for the continued acceptance 
     by the government of this alternative.
       This bill is desperately needed to push this issue forward 
     significantly in this country, and because of this country's 
     stature in this area, throughout the world. We believe that 
     many companies are standing ready to invest the resources 
     that they need to develop alternatives. And now regulators 
     have taken the first step. Many in the federal bureaucracy 
     are extremely comfortable with old methodologies that have 
     established protocols and a history of success from a 
     regulatory perspective. Congress needs to push these agencies 
     to look ahead, not behind, in terms of the most efficient, 
     effective and humane scientific judgment that should be 
     expected from the agencies called upon to protect the 
     consumers of this country.
       I urge your strong support of the ICCVAM Authorization Act 
     and invite questions for the League or for our industry 
     supporters.

     

                          ____________________