oEPA
              United St
              Environmental Protection
              Agency
 Office of
 Solid Waste and
               DIRECTIVE NUMBER:  9444.13(84)

               TITLE: Michigan Petition: Sb03 Listing
               APPROVAL DATE: 7-3

               EFFECTIVE DATE: 7-3

               ORIGINATING OFFICE:

               El FINAL
    Office of Solid Waste
               D DRAFT

                STATUS:
{  J
[  ]
               REFERENCE (other documents):
A- Pending OMB approval
B- Pending AA-OSWER approval
C- For review &/or comment
D- In development or circulating
         headquarters
  OSWER      OSWER      OSWER
VE   DIRECTIVE    DIRECTIVE   Dl

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PART 261  SUBPART D - LISTS
                                                              DOC:  9444.13(84)
    Words:    Listing, State Programs

Regulations:  40 CFR 261.33(f)

Subject:      Michigan Petition: SbC>3 Listing

Addressee:    'Michigan File

Originator:   Reva Rubenstein, Toxicologist , Studies and Methods Branch

Source Doc:   #9444.13(84)
Date:

Summary:
              7-30-84
     Sb03 will be listed at 40 CFR 261.33(f) as a hazardous waste based on the
findings in the Watt study that Sb03 is oncogenic in female rats.

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 Michigan PetiJtidhFTfcO3~ll»tlng                     -
 :--- --•— •••••--  - - -  --"-                    JUL
 leva Kubenstein, Toxicologlst -
 Studit* «  Methods Brmnch (WH-S62B)
                    ~ ~   ^  *   ^
 Michigan film

      Sb03  will  be Hated at  40 CF* 261.33f,  as a hazardous
 on  the basie o£ findings in  the Watt study that 8bO3  is onco^genic
 in  fenale  rats.                                               .
      In  the  Watt  inhalation  study female rats were tested at
 multiple dose  levels.  Increased incidence of neoplasms wer« noted
 at  dose  levels very close  to the occupational PEL (permissible
 exposure level).  Although the study was faulted because there
 was a lack of  adequate control of exposure,  the variability of
 exposure levels was quantified analytically.  OTS considers SbOj  -_-
 to  b« a  qualitative carcinogen with the full dose-response data
 still to be  measured.  There is a negotiated testing schedule  -
-with industry  to  determine toxicology data including oncogenlcity.

      Since the only currently available data is on a single sax,
 I would  rate the  weight of evidence, at best, as limited to
 inadequate depending on the  experimental quality of the Watt Study
 (well conducted?  proper number of aniaals? length of study? number
 of  controls? spontaneous tumors?)
                           •         •*_*         &


 ccs  David Friedman
      Alan Corson
      John Walker
      Laurence  Rosenstein

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