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Progress and Barriers to Incorporating Alternative Toxicological Methods in the US
A Workshop

November 17 & 18, 2005
Marriott Waterfront Hotel
(800) 468-3571
700 Aliceanna Street, Baltimore, MD 21202
 

Workshop Highlights

The International Society of Regulatory Toxicology and Pharmacology hosted a workshop in November 2005 that explored progress to date in implementing new, revised and alternative toxicological test methods across regulatory evaluation frameworks and decision-making programs in the US; identified barriers to progress; and explored potential bridges to facilitate overcoming such barriers.

The final workshop session was a roundtable discussion facilitated by Leon Bruner (Gillette) that included representatives from academia (Alan Goldberg, John Hopkins University), government (William Stokes, NIEHS/NICEATM), animal welfare (Andrew Rowan, HSUS), industry (William Stott, Dow Chemicals), and private contract research (Rodger Curren, Institute of In Vitro Sciences). This session aimed to identify the critical barriers to the implementation of new, revised alternative toxicological test methods by regulatory agencies in the U.S. and the actions that will overcome these barriers. The main barriers identified fit into the following categories:

• Funding / Resources: Research on alternative methods is not a priority for government funding.
  
  Recommendation: Individuals need to keep pressure on agencies to fund focused research on validating and implementing alternative test methods.
   

• Scientific: Data housed in industry libraries may be abundant, although not uniform, but it is proprietary. Outside of a government mandate to make data available and compensate companies for releasing data, not much can be done to force data sharing. Additionally, data published in the peer-reviewed literature does not provide the individual animal data that is needed to run statistical models for predictive toxicology. Basic research providing reference data and proof-of-concept need to be generated.
  
  Recommendation: Focus research on elucidating mechanism of action, identifying biomarkers, validating new methods, and translating methods into an applied risk assessment use. All data needs to be cataloged in publicly accessible databases.
   

• Education: There is a low level of comfort with alternative assays in the regulatory community.
  
  Recommendation: All interested parties need to keep pressure on the toxicology community to provide forums for all stakeholders to participate and educate on the use of alternative methods.
   

• Coordination / Leadership / Regulatory Change: The number of submissions or nominations to ICCVAM for method validation has been less than expected. Additionally, awareness is low that the Animal Welfare Act (7 USC 2131-2159) states that investigators should consider alternatives to animal testing and use them when appropriate, however awareness of regulatory requirements is low.
  
  Recommendation: The NTP could serve as a coordinating agency within the federal government to encourage development and use of alternative methods.
   

• Clarity of Objectives:
  
  Recommendation: Need to identify short- and long-term objectives.

Panelists and audience members focused the discussion on the following questions and formulated a general consensus for each.

• Does the community have a collective understanding of the research now in progress? Is research focused in the correct areas?
  
  No, individuals do not have a wide breadth of understanding. There needs to be national coordination to gather data and present it.
   

• The agencies have implemented many programs aimed at the development of new methods – Is it clear what agency strategies in this area are? Is there a need for an overarching federal strategy for prioritizing this research?
  
  A few agencies (EPA, FDA, NTP) have begun to implement alternative methods programs. There is a need for an overarching strategy that could be provided through NTP’s Roadmap. Short and long term goals need to be clarified.
   

• Is funding of research directed to the right targets? Does the funding ensure transfer of new methods from the bench to practical use in a regulatory framework?
  
  Funding sources for this area are unclear and there is a need for a guiding agency to focus and allocate funding.
   

• Are current regulatory frameworks too rigid for the substitution of validated methods? Should regulatory frameworks be changed in a way that makes them more flexible with regard to the adoption of new methods?
  
  Yes, current frameworks are too rigid to allow the substitution of validated alternative methods. The rigidity is provided by current law and guidelines, and furthered by the fact that regulators are uncomfortable in changing the structured framework. Some flexibility is starting to appear, i.e. OECD acceptance of in vitro eye/skin corrosivity testing.
   

• Is the federal decision making approach designed in a way that facilitates the incorporation and use of valid test methods? Can the acceptance process be improved? If so, how?
  
  There has not been much progress in this area as the details of the federal decision making approach are unclear. The workshop did not generate an answer to these questions.
   

• What are the barriers to removing animal testing methods from federal guidance once a validated replacement method becomes available – method preference, historical data, legal barriers, inertia?
  
   A clear answer to this question was not generated. Discussion focused on where methods have been deleted, i.e. OECD removed animal tests for skin/eye corrosivity and therefore, member countries were forced to remove their requirement; OPPT is also removing the chronic dog assay.

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