112(o) - National Academy of Sciences Study on Risk Assessment

(o) National Academy of Sciences Study: Requires the EPA and the National Academy of Sciences to conduct a review of the EPA's risk assessment methodology and to report to Congress concerning the findings of the study. The study must address both cancer and non-cancer risks. The contact for this NAS report is Dennis Pagano (pagano.dennis@epa.gov).

The full text of CAA Section 112(o) follows:

(o) National Academy of Sciences Study.-  
     (1) Request of the academy.-  Within 3 months of the date of
  enactment of the Clean Air Act Amendments of 1990, the Adminis-
  trator  shall  enter  into  appropriate  arrangements with  the
  National Academy of Sciences to conduct a review of - 
          (A) risk assessment methodology used by the Environmen-
       tal Protection  Agency to determine the  carcinogenic risk
       associated  with exposure to hazardous air pollutants from
       source  categories  and   subcategories  subject  to   the
       requirements of this section; and 
          (B) improvements in such methodology. 
     (2) Elements to  be studied.- In conducting such review, the
  National  Academy  of  Sciences  should consider,  but  not  be
  limited to, the following -  
          (A) the techniques  used for estimating  and describing
       the  carcinogenic  potency  to  humans  of  hazardous  air
       pollutants; and 
          (B) the  techniques  used for  estimating  exposure  to
       hazardous  air  pollutants  (for hypothetical  and  actual
       maximally  exposed individuals  as  well as  other exposed
       individuals). 
     (3)  Other  health  effects   of  concern.-  To  the  extent
  practicable,  the  Academy shall  evaluate  and  report on  the
  methodology  for assessing  the  risk of  adverse human  health
  effects other than cancer for which safe thresholds of exposure
  may  not  exist, including,  but  not  limited to,  inheritable
  genetic    mutations,    birth   defects,    and   reproductive
  dysfunctions.     (4) Report.- A report  on the results of such
  review  shall   be  submitted   to  the  Senate   Committee  on
  Environment and Public Works, the House Committee on Energy and
  Commerce,  the  Risk   Assessment  and  Management   Commission
  established by section 303  of the Clean Air Act  Amendments of
  1990 and the Administrator  not later than 30 months  after the
  date of enactment of the Clean Air Act Amendments of 1990. 
     (5)  Assistance.- The Administrator shall assist the Academy
  in  gathering any  information the  Academy deems  necessary to
  carry  out  this  subsection.  The Administrator  may  use  any
  authority under this Act to obtain information from any person,
  and  to require any person  to conduct tests,  keep and produce
  records, and make reports  respecting research or other activi-
  ties  conducted by such person  as necessary to  carry out this
  subsection. 
     (6)   Authorization.-   Of  the   funds  authorized   to  be
  appropriated to  the Administrator by this Act, such amounts as
  are required shall be available to carry out this subsection. 
     (7)   Guidelines  for  carcinogenic  risk  assessment.-  The
  Administrator shall consider, but need not adopt, the recommen-
  dations  contained in  the report  of  the National  Academy of
  Sciences prepared pursuant  to this subsection and the views of
  the Science Advisory Board, with  respect to such report. Prior
  to the promulgation of any  standard under subsection (f),  and
  after notice  and  opportunity for  comment, the  Administrator
  shall publish revised Guidelines  for Carcinogenic Risk Assess-
  ment  or  a  detailed  explanation  of  the  reasons  that  any
  recommendations contained in the report of the National Academy
  of Sciences  will not be  implemented. The publication  of such
  revised  Guidelines shall be a final Agency action for purposes
  of section 307.

112(o) - National Academy of Sciences Study on Risk Assessment

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