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An SAB Report: Guidelines for Cancer Risk Assessment - ABSTRACT

  d. An SAB Report: Guidelines for Cancer Risk Assessment
           EPA first issued cancer guidelines in 1986.  In April 1996, new
  draft Guidelines were release.  The Science Advisory Board*s (SAB)
  Environmental Health Committee (EHC) was asked to review the proposed
  revisions, and met on February 13-14, 1997, in Washington, DC.
          The Committee found the proposed Guidelines to be significant step
  forward in carcinogen risk assessment, and particularly commended the
  Agency for addressing the controversial aspects of the new Guidelines with
  a frank, unbiased approach.  The new Guidelines will cause risk assessors
  to place greater emphasis on the utilization of all the available
  scientific information in characterizing cancer risks.  However, the also
  Committee identified areas in which improvement was possible.  These are:
          a) problems with the proposed categorization (The Committee could
  not come to a consensus as to how this problem should be addressed.)
          b) most Members supported the Agency*s handling of the issues
  raised when departure from the defaults are contemplated.  A sizeable
  minority of the Committee believed that the burden of proof should rest on
  showing that the defaults are implausible.
          c) the Guidelines should be clarified to alleviate potential
  concerns by users about the impacts of changes on the degree to which the
  document remains *public health conservative.*
          d) the EHC generally endorsed the Guidelines' mode of action
  proposals, but suggested that the Guidelines contain specific criteria for
  judging that the data on mode of action are valid and adequate.
          e) some Members noted that  there may not be enough guidance on
  incorporating other types of biological data and information on mode of
  action into dose response assessment.
          f) the Agency*s definition of a biologically based model seems
  unnecessarily narrow.
          g) the EHC suggests that further guidance be given in the
  Guidelines on determine the point of departure.
          h) there should be an explicit statement that statistical
  significance should be a basic requirement for determining causality.
          I) The developing infant/child should be recognized as a population
  subgroup that is particularly sensitive to the carcinogenicity of a number
  of agents.
          j) The Committee endorses the procedure adopted by the National
  Toxicology program of combining some closely related tumor types for
  statistical analyses, but otherwise conducting separate tests for different
  tumor types.
          e. An SAB Report: Review of the National Risk Management Research
  Laboratory (NRMRL)
          At the request of the Office of Research and Development (ORD), the
  Environmental Engineering Committee (EEC) of the Science Advisory Board
  reviewed (on September 25-27, 1996)  the Agency's National Risk Management
  Research Laboratory*s (NRMRL) program.  NRMRL*s mission is to conduct
  research to reduce uncertainties and costs associated with making and
  implementing environmental risk management decisions.  The EEC*s charge was
  to address the following questions:
              1) Examining and critiquing the research programmatic
  directions such as whether NRMRL is pursuing the most appropriate research
  problem areas.
          2) Commenting on strategic directions, e.g. use of its core
  technical competencies, transition from primarily extramural to an
  intramural R&D organization, leveraging with other agencies and
          3) Reviewing and commenting on the effectiveness of NRMRL*s
  approach to science management, e.g. measures of success and science
  quality, soundness of peer review process.
          4) Examining and critiquing the relationship of NRMRL*s risk
  management research and its intended role in the risk assessment/risk
  management paradigm.
          5) Reviewing and commenting on the strategic balance for the next
  decade among pollution prevention, technology development, remediation, and
  risk management assessment activities.
          Key comments include:
  a) NRMRL has in place a well-understood and coherent intellectual framework
  for strategic research planning
  b) The twelve areas NRMRL has selected seem appropriate and NRMRL will need
  a decision process leading to the addition or subtraction of research
  elements as needed
  c) NRMRL has developed key science management which will need refinement as
  each element of the new laboratory paradigm takes effect
  d) The Committee commends NRMRL for identifying factors that determine the
  value of the Agency*s risk management goals and the extent to which NRMRL*s
  research can influence or be influenced by them.