Transcript  of  Proceed!
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
In the Matter of:

ADMINISTRATOR'S TOXIC  SUBSTANCES
ADVISORY COMMITTEES
Volume  1
Washington, D.C,

March 19,  1980
                                    ompany
                     Official Reporters
                       1411 < Street, N.w
                     Washington. 0. C. 20005
                        (202) 628-4888

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CB/mll
                           U.  S.  ENVIRONMENTAL PROTECTION AGENCY
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In the Matte,:^ of:

ADMINISTRATOR'S  TOXIC SUBSTANCES
ADVISORY COMMITTEES
                                                       X
                                           X
                            March 19, 1980
                            9;45 a,m.

                            Waterside Hall
                            Room M-3906-3908
                            Washington, D. C.

          SELINA BENDIX,  CHAIRPERSON

          MARSHA D.  RAMSEY, EXECUTIVE SECRETARY

          MEMBERS ;

          PROF.  MICHAEL S.  BARAM

          DR.  THEODORE L.  CAIRNS

          DR.  MAX EISENBERG

          BECKY  F,  MOON

          THOMAS W.  MOONEY

          DR.  LOUIS  E. SLESIN

          DR.  WILLIAM L.  SUTTON
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 1                          CONTENTS
                                                          PAGE
 2     Discussion  of ATSAC Report on TSCA's First
      Three  Years,  and Recommendations                    .  9
 3
      Section  4 Test Rules                                 48
 4
      General  Discussion of Follow-up Rules               132
 5
      What are EPA's Plans for Chemical Hazard Warning
 6     Labeling in Industry, Commerce?                     100

 7     Information Gathering, Public Participation
      International Issues                                 72
 8
      What are the Statuses of B(d)  and B(e)  Reports
 9     and the  8(c)  Rule?                                  136

10     EPA Internal Procedures for Rulemaking              149

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 2             CHAIRPERSON BENDIX:  Good morning.  I am




 3   Dr. Selina Bendix.  J. A. Kinney, the Chairperson of this




 4   Committee, was unable to be with us today, and I am acting




    on her behalf.




 6             The first item on the agenda this morning is




 7   a discussion of preliminary draft of an ATSAC report on




    TSCA's first three years.




 9             And since we do not have a full complement yet




10   here this morning, I wanted to hear those members who are




11   here, if they would like to take a few minutes to read some




12   of what Michael Baram has compiled, and then if other people




13   have arrived, we can then proceed with discussion of this.




14             If you will look in your packet, you will see




15   there is a thick item from Michael, a Report to the




16   Administrator — labeled "A Report to the Administrator,EPA,"




    from the Advisory Committee on Toxic Substances, April 1980,




18   with an outline at the bottom.




19             MR. BARAM:  Let me add, Selina, this is a strict




20   cut and paste job.  There was no editing.  I simply took




21   comments that were submitted by four members — five members




22   and cut and paste, them together.




23             CHAIRPERSON BENDIX::  Later I will ask Michael to




24   give us a brief report on what he has done and the range of




25   the kinds of comments that he has received, but I would





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     like to defer that until more members  of  the  Committee  arrive

              MR. BARAM:   It was sent  in  last week  to Marsha,

 3   and it took  time  to  Xerox.  I should  add  that the comments

 4   came in from Ted  Cairns, myself, Jackie Warren,  Jane Kinney,

 5   and Dr. Eisenberg submitted no  comments because  he is a new

 6   members.

 7            So five people are accounted for in this draft.

 8             (Whereupon,  a brief recess  was  taken)

 9            CHAIRPERSON  BENDIX:   I would like to  call the

10   meeting back to order.  I would like  to discuss  the agenda

11   for the rest of the  morning briefly.

12            As of now, I cannot see  our breaking  up into

13   three committees. What I would like  to propose to the group

14   is that we drop the  Section 6   Subgroup Meeting this morning,

15   since we  have, in fact, had considerable  opportunity at past

16   meetings  to  discuss  the asbestos issue, that we ask

17   Warren Muir  if by any  chance he could find it possible to

18   arrange his  schedule to come here  before  11:00  so we could

19   start the Section 4  Test Rules  discussion early.

20            There are  some changes in schedule1 in the items

21    under the "Information Gathering,  Public  Participation,

22    International Issues."

23             The schedule had been rearranged to change Item 2,

24    the status of the public participation program,  to 1:30;

25    Item  3, the  status of  8(d).  and  (e)  reports and  the 8(c)
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 l   rule to 2:15,  and the OECD activity to 11;45.




 2             I would propose that we might meet as a whole




 3   to discuss the Section 4 test rules, and when Mr. Fuller




 4   arrives at 11:45, we would have the option of either breaking




 5   up into two groups or if we feel that we are prepared to




 6   switch from Section 4, that we might all meet with him on




 7   the OECP activities.




 8             May I have some reaction to that?




 9             MR.  MOONEY:  Yes.  Selina, I think it is very




10   likely that what Mr. Fuller would have to say about OECD




11   bears very directly on Section 4 testing.




12             I think, in terms of what I see as being most




13   active in OECD right now, it relates to the testing subjects.




14   So I am not sure they are really exclusive, and you might




15   want to keep the whole group together.




16             CHAIRPERSON BENDIX:  I must confess I would




17   personally be happier that way because I would like to hear




18   the discussion of the OECD activities.




19             I just don't want people who are interested in




20   the Section 4 test rules to feel that we are cutting off




21   discussions prematurely.




22             MR.  MOONEY:  I think there is a linkage.




23             CHAIRPERSON BENDIX:,  I agree, and I dislike




24   breaking a group of six people up into subgroups  if I




25   could avoid it,






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 1             Marsha, could I  ask you  to  call Warren Muir  and




 2    ask  if  it would be possible  for him to  come  earlier, and




 3    meanwhile we will go on the  record and  ask Michael  Baram




 4    to discuss briefly what he did and to talk a little bit




 5    about this draft report.




 6             MR. BARAM:  Beforewe get to the draft report,  I




 7    do have one question, and  that is  on  the first page of




 8    the  agenda, Selina, the only item  that  is being dropped  from




 9    the  first page of the agenda is asbestos in  schools. .




10             CHAIRPERSON BENDIX:  That is  correct.  And Marsha




11    will notify Mr. DeKany and Mr. Guimond.




12             MR. BARAM:  And  we will  endeavor to deal  with




13    everything else in sequence  as one single group.




14             CHAIRPERSON BENDIX:  That means also we are




15    dropping Item 1 under Information  Gathering, so




16    Mr,  Bruno Vasta should also  be notified—"What information




17    is currently available to  the public? How can it be used




18    by the  public?




19             Is there anyone  else?  Would  you be willing  to




20    go to that rather than going to Section 4 test rules,and




21    is there anybody else who  would join  Becky on that?




22             MS, MOON:  It may  be just having — I guess  you




23    just can't make these pieces of material available.




24             CHAIRPERSON BENDIX:  If  he  had any handouts  that




25    he was  planning to make -<-






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               MS.  RAMSEY:   He was  really  going to  talk  about

     access  to  the  computer  system  and  that sort of thing.

     Marilyn Bracken was  going to give  a more  general overview

 4   earlier.

 5             MR.  BARAM:  I think  that would  be quite interesting.

 6             MS.  MOON:  Yes.   We  have been talking about  that.

 7             CHAIRPERSON BENDIX:   Somewhere  we are going  to

     have to make  a decision because we can't  do all these

 9   things  simultaneously.

10             MS.  MOON:  I  wonder  if Mr.  Vasta could come  in

11   at 10:00 or 10:30.   Could he possibly? We were going  to

12   have Warren Muir  come in earlier,  weren't we?

13             CHAIRPERSON BENDIX:   I really don't  think we

14   are going  to deal with  Section 4 in 45 minutes.  I  would

15   rather  see —

16             MR.  BARAM:  What  are our priorities  on the first

17   page?  The first  page would be Section 4  test  rules.

18   Secondly,  I think very  important,  are EPA's plans for

19   hazard  warning labeling.

20             I think that  is something the Committee should

21    discuss,

22              CHAIRPERSON BENDIX:   That is in the  afternoon.

23              MR,  BARAM:  That  is  in the  afternoon.  What  other

24    priorities do we  have on the  first page?   What are  the

25    3 and 4 priorities?  Maybe  we  can  drop some of the  other


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 l   items.


 2             MR. MOONEY:  Well, Mr. Auerbach's concurrent meeting


 3   labeling that is taking place right now, will that be over


 4   by 1:30?  Mr. Auerbach has three days.


 5             MS. RAMSEY:  Mr. Auerbach will not be here.


 6   John DeKany was going to do this,  There was a change on


 7   that,


               MR. MOONEY:  Okay.


 9             CHAIRPERSON BENDIX:  I think we ought to deal with


10   the morning to start with.  If we start worrying about this


n   afternoon's schedule, we are going to get bogged down.


12             What I was proposing that the Section 4 test rules


13   and the OECD item were the two priorities for this morning,


14   and Becky has suggested that.


15             CHAIRPERSON BENDIX;  Becky, I offered a suggestion


16   and you made a counter suggestion about the agenda.  Is


17   there anyone else who joins  Becky in wanting to have an


18   opportunity to discuss with Marilyn Bracken and Bruno Vasta


19    and Mr. Kovalick <-- no, Kovalick is available in the


20    afternoon, sot that is not a problem.


21              MS, MOON:  Perhaps it would be better to postpone


22    that until the next meeting but be sure to pick it up again


23    because Jackie was very interested and Janie was very


24    interested in that.


25              So perhaps that is what we ought to do—get those



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     things on the agenda next time.




               CHAIRPERSON BENDIX:  I think we will have  an




     opportunity to raise some issues about public participation




     tomorrow with Mr. Jellinek.




               MS. MOON: Let's do that.




  6             MS. RAMSEY:  The only thing we are going to do




  7   this morning is Section 4 test rules.




  8             CHAIRPERSON BENDIX:  And OECD with Mr.  Fuller




     at 11:45.




 10             MS. RAMSEY:  Is 45 minutes long enough  for the  test




 11   rules?




 12             CHAIRPERSON BENDIX:  That is why we were asking




 13   you to call Warren Muir to see if he could come in.




               MS, RAMSEY:  If he cannot, I will see if Pep Fuller




 15   can come earlier.




 16             MR, BARAM:  Once again now, we can turn to the




 i7   draft compilation of a possible committee report.  At the




 18   last meeting we discussed the  advisability of this




 19   Committee after 3-1/2 yeans of sitting in meetings and trying




 20   to play a constructive role, the advisability of  this




 21   Committee putting together a consensus report which  would




 22   establish some overall guidance and constructive  criticism




 23   and praise, where justified, on the program.




24             Without reaching any agreement as to the overall




25   advisability, we decided to do it as a preliminary kind of
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 1    exercise.

 2              I agreed to cut and paste the comments that came

 3    to me.   Of the 16 or 18 Committee members, five Committee

 4    members responded.

 5              These include Dr. Auerbach — I am sorry;

 6    Dr. Eisenberg, who simply said "no comment" because he was

 7    such a new member of the Committee.  That was his first

 8    meeting, in fact.

 9              Then substantive comments came from Ted Cairns,

10    Jackie Warren, Jane Kinney, the Chairman of the Committee,

11    and myself.

12              What I have done is simply cut and paste these

13    comments and, as you can see, they are not too lengthy,

14    they are general in nature, they generally run to criticism

15    not on legal or technical grounds, but I would say criticism

16    on internal policy about perhaps going too slowly or perhaps

17    too painstakingly, although there are other comments which

18    reflect other attitudes.

19              But we decided to deal with eight major issues

20    which are stated on the first page; How OPTS was performing

21    on testing requirements; Number 2, the PMN Procedures;

22    Number 3, Regulation, Risk Assessment and Economics; the

23    fourth issue had to deal with information gathering; the

24    fifth issue, citizen participation; the sixth, cooperative

25    efforts with other agencies and international efforts;


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               The seventh was specific cases of  regulation


     as  to asbestos and PCBs; the eighth, overall management.


 3   Well, the comments, as you can see, deal most heavily with


 4   the first three or four items and sort  of  tailed  off after


     that.


               Since you have just gotten this  report  this


     morning, it would probably be most useful  at this  stage if


     you simply took the report with you, thought about it,


 9   decided whether you wanted to add any comments  or,  as I


10   have done in a few of the cases, simply endorse comments


11   made by other people by adding my name  next  to  what they


12   essentially submitted and go through yet another  iteration


13   of  this or recommend that the whole matter seems  to be  not


14   leading to any useful convergence and should be dropped.


15             But I think probably some further  thought should


16   be  given since only five people responded  and since very


17   few of the members are here today to discuss the  report.


18             I would be happy to try to interpret  some of


19   these comments for you or go over them  with  you now if  you


20   want to spend the time.


21              CHAIRPERSON BENDIX:  Does anyone on the Committee


22    have any comments, any desires, with respect to how we


23    should proceed this morning with regard to this matter


24    that they would like to express?


25              MR. CAIRNS:  All the comments are  quite brief.



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 1    There are also a lot of them, if you add them all up.   I


 2    don't think I have been able to digest them; I have only


 3    got to Page 5 since the report was handed out.


 4              MR. BARAM:  It was unintentional to be so late.   It


 5    is just that the comments kept coming in.


 6              MR. CAIRNS:  I think we would do better, in view


 7    of the small attendance, to ask the Committee to go back and


 8    take a nice quiet Saturday afternoon where there are no


 9    football games and see if they have comments on the comments.


10              CHAIRPERSON BENDIX:  In that case, we would ask


11    Marsha Ramsey to send copies of this material to the


12    members of the Committee who are not present today.


13              MR. BARAM:  I would also suggest that this be


14    kept within the Committee's confines because these all


15    represent preliminary deliberations and discussions; these


16    do not reflect any Committee consensus at all, so we should


17    just keep this here for the Committee.


18              MR. CAIRNS:  And of course it is so indicated.


19              MR. BARAM:  Yes,  Are there any other comments


20    on this draft report?  Dov/we all agree then with Ted's


21    suggestion?


22              MR, MOONEY:  I want to comment, and it is only an


23    inadvertent oversight on my part that I failed to notice


24    this was in the packet that was sent to me when I missed


25    the last meeting,



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1             I do want to comment these are very interesting

2   to read.  Some I agree with and strongly support.  Others I

3   think I take issue with, at least from my perspective,  so

4   I would like the opportunity to comment.

5             MR. BARAM:  Fine.

6             CHAIRPERSON BENDIX:  Marsha, I think  that we  would

7   like to be sure that this material be sent  to the  members.

8             MS. RAMSEY: • It already has been  done.

9             CHAIRPERSON BENDIX:  All right.

10             MR. BARAM;  Perhaps a follow-up reminder note at

11   some time.

12             CHAIRPERSON BENDIX:  I would presume,  then, we

13   also wish to drop  from tomorrow's agenda the  11:30 item

14   on discussion and  adopt  resolutions.

15             MR. BARAM:  Yes,  definitely.

16             MS, RAMSEY:  I didn't hear the discussion because

17   I was on the telephone.

!8             MR. BARAM:  We are going to take  this  report  back

19   with us, Marsha, and discuss it at the next meeting  to

20   see where we are at the  next meeting.

21             MR. MOONEY:  Are  we likely to have  a  different

22   attendance tomorrow?  Should we keep an entry on the  agenda

2^   to at least  recycle on what we have been kicking around

24   here?'

25             We don't know  where the people are.

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               MS. RAMSEY:  I don't know what happened with

     Janette Sherman, but Ted Radford should be here tomorrow.

               MR. BARAM:  That is still less than half the

 4    Committee.

 5              CHAIRPERSON BENDIX:  I don't think it is worth

 6    reopening the discussion for one additional person.

 7              MR. MOONEY:  Okay.

 8              MR. BARAM:  I am sure we will have time for

 9    questions.  We will probably have time tomorrow.

10              CHAIRPERSON BENDIX:  It appears that the various

     people who are due to come in at 11:00 and subsequently

12    have schedules such that they couldn't come in earlier, and

l3    unless somebody present has something they would like to

     propose for discussion, we will recess the meeting for

15    11:00.

16              Does anyone have anything they would like  to

     bring up?  If there is anybody in the public who would

     like to make comments to those of us who are here at this

19    time, we would be happy to take public comments, since we

20    are ahead of schedule on our agenda.

21              Seeing no expression of such interest —

22              MR. MOONEY:  Is there any meaningful expression

23    we can have on Section 4 test rules?

24              MS. RAMSEY:  Can you read the paper?

25              MR. MOONEY;  Couldn't we turn, for example, to


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 1    Lou to update us on significant activities his'organization




 2    has been involved with that bears on this?




 3              MS. MOON:  I would appreciate hearing that.




 4              MR. MOONEY:  Your suit is a significant suit and




 5    something feels funny to me about just adjourning until




 6    11 o'clock, and I have got to believe there is something




 7    constructive we can do in the absence of Warren Muir until




 8    then.




 9              DR. SLESIN:  The NRCC suit is progressing.  We




10    have just received the papers from EPA just last week, an




   I   affidavit from Mr, Jellinek, and the test package.




12               We are still looking at that.  There is really



13
      not much to say, other than we have a few weeks to respond




      to that and we are now in the process of reading those




      documents and preparing a response.




                MR. CAIRNS:  What was this: the same thing we




17     got last —




18               DR. SLESIN:  Yes, absolutely.




19               MR, MOONEY:  Have people seen Jellinek's



20
      affidavit in response to the court's decision?  That really



9l
      lays out a fairly detailed program in what is goxng to


99
      happen under Section 4 as the Agency proposes it.


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                MR, CAIRNS;  I have not seen it.


24
                MR, MOONEY:  In the next four years.


95

                DR. SLESIN:  I would not have anything official
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 1    to say at this time until we have had a chance to look at

 2    it.

 3              MR.  MOONEY:   It probably puts you in an awkward

 4    position.

 5              MR,  CAIRNS:   Madam Chairman, this affidavit from

 6    Jellinek must be a public document.  It isn't 50 pages

 7    long, is it?

 8              MR.  SLESIN:   Yes.

 9              MR.  MOONEY:   It is 50 pages long or so.  I have

10    a copy of it.

11              MR.  CAIRN'S:   I was thinking it might be distributed

12    but that is not practical.

13              MR.  SLESIN:   It is certainly worth reading.

14               MR,  CAIRNS:   It could be distributed later, but

15     not something you could hand out now.

16               MR.  MOONEY:   Lou, can you comment on the original

17     basis for this suit?  Do people understand on what issue

18     you took the Agency to court because it deals with much

19     of the comment that is in here about how fast the Agency

20     is or isn't progressing under Section 4  as addressed by

21     NRDC's view that they certainly didn't, and they backed it

22     up?

23               CHAIRPERSON BENDIX;  Does anybody have any

24     feelings about the need to have this on the record?

25               MS.  MOON:  I think it might be worthwhile  for
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     people  who weren't  here  to  hear what  this  court suit was

     all  about.

3             MR.  MOONEY:  I am simply bringing this up because

4    if Warren walks  in, it is  a terribly  critical part of the

     EPA's  critical activities  and what is going to happen over

     the  next two or  three  years and, consequently, if we are

     not  up  to speed  on  it, I don't think  we can discuss it

     very meaningfully.

9             MR.  SLESIN:  We  are all acquainted with the time

10    schedules in the Act  for compliance with the ITC recommen-

11    dations, or  should  I  start further back?

12             ITC had nine months to issue a list of priority

13    chemicals for testing.  EPA then had  one year to respond

14    to that list.

15             Since then,  there have been additional lists.

16    The  first list was  issued in October  1977.  EPA took the

17    Federal Register in October of 1978 and listed its response

18    as not being ready  to make the decision called for in

19    TSCA to either begin  testing or state reasons not to begin

20    testing.

21             Essentially, the reason was we have not done

22    the  necessary background work, and research is continuing.

23    Essentially, the same approach was taken on the second

24    ITC list in  the following year.

25             Very little has  happened in terms of initiating


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 1    testing under TSCA.  There are two issues here.  One is  ^




 2    the law that says what the deadlines should be.  That is,




 3    the one-year deadline for EPA and, beyond that, what was




 4    legally called for in that response by EPA,




 5              That is, was the response as is given in the




 6    Federal Register one year later — that is, we are not




 7    ready in accordance with the mandate of TSCA.




 8              We, NRDC, took this issue to court after notifying




 9    EPA 60 days ahead of time that we would be doing so under




10    the provisions of the Act,




11              And the basic point of the suit is to get EPA




12    to meet this TSCA deadline.  What comes out of that work




13    really is the idea that you have a tremendous problem with




14    a number of chemicals, the number of effects of each




15    chemical, and you have to start working on this as soon as




16    possible, that the 12-month deadline mandated by TSCA is




17    as much a policy directive as a legal or scientific




18    directive by Congress to the Agency.




19              By that, I mean you have a job to do in 12 months,




20    and you can't do a perfect job, perhaps, but the problem is




21    such that you have got to get started.




22              When EPA did not meet the deadline and it became




23    clear that it would be a considerable amount of time before




94    they would be able to initiate testing on these priority




25    chemicals, we decided that perhaps a little general pressure






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    might work wonders.


              MR. BARAM:  This is all pursuant to what section


 3  of the statute?


 4            DR. SLESIN: • 4(e).  EPA, as you have all seen the


    test rule package which numbers a great number of pages, and


    EPA has done a very precise job in putting together that


    information, and one could raise a question of how much work


 8  should have gone into putting together these test rules.


 9            One particular issue is how much literature and


 10  how many abstracts should EPA have gone through to determine


 11  the necessity of testing under Section 4 (a).


 12            I would say it is my feeling that there is a


 13  problem here of exact science, taking over the policy


 14  directive of Congress.  That is, Congress said we have a


 15  problem with toxic chemicals; we need to do something about


 16  it; but to make sure we do it in careful steps we will set


 17   up an Interagency Testing Committee to select those chemicals


 18   which are in most need of testing; i.e., in most need of


 19   getting some information about their potential harmful


20   effects.


21             Congress went further and said we don't want this


92   to get out of hand,  so we will limit the number of chemicals


23   that can be on this  priority list to 50.


24             So 50 is not, we believe, a very large number,


25   given the other statistics of, say, 50,000 chemicals on the
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 1    inventory  out  of  the  4  million-odd  that  have been  cataloguec



 2    by  CES.


 3              What I  am getting  to  is it  has been  a  long time



 4    since TSCA has passed and EPA has yet to initiate  testing



 5    on  a single chemical.



 6              And  if  one  looks at the affidavit, one can see



 7    that it  will be still quite  a while before  testing will  be


 8    initiated  on these  chemicals.


 9              And  if  you  look then  at the further  time horizon


10    that is, how long it  will be before those test results —



11    let me back up a  minute and  say EPA's current  proposal is--



12    for some of these chemicals  is  to go  the ANPRN route.



13              Some of them will  go  to proposal;  some of  them



14    will go  to advanced notice.   Then we  will go to  proposal,



15    and then we will  go to final, and then testing will  begin;



16    that is, if there is  no litigation  on some  of  these  rules,



17    which is always a high probability  event.


18              Then we have years of testing, and if  the  tests



19    show anything, we go  through another  possible  Section 6



20    regs,.


21              You  see,  we can go right  into the 1990's very



22    easily.  What  we  are  talking about  is the first  report on



23    toxic substances  came out in 1970.  There were five  or



24    six years  of debate on TSCA to  1976.



25              We are  now  getting to be  mid-19 80.   We have yet




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 l    to test a chemical.   If there are any bad actors  here,  you

 2    are into 1990 before you see effective regulation,  and  this

 3    is just not what we  believe Congress had in mind  when it

 4    set out this process.

 5              Now we are not saying at all that we believe  that

 6    EPA should be doing  half the job in terms of the  science,

 7    but we do think that there is very little in profit in

 8    EPA going through every abstract of every study done on

 9    a chemical because one of the guidelines is what  information

10    do I need to ascertain whether this chemical is a problem.

11              Perhaps legally you might ask what burden must I

12    fulfill for the "will present standard" in Section 6 if that

13    chemical turns out to be a problem,

14              And I would say, given the Agency's performance

15    under asbestos in schools, PCBs, it "ain't" going to start

16    regulating on a 1938 Czechoslovakian study with how well

17    it was controlled, I don't think even if it was positive.

18              That is the point.  If you look at the  nature

19    of the burden that EPA must meet to initiate rulemaking

20    or to make a judgment on a chemical, it needs some pretty

21    solid information, and I would consider this sort of a

22    five-study problem;   that is, you could call up many of the

23    leading researchers   in the field across the country and

24    say, what do we know about this chemical; are you satisfied

25    that we know enough  about its mutagenicity or carcinogenicity


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 1    et cetera,  and go  through  these  effects.

 2              Going much  beyond 1960 there  may  or may  not be

 3    some  good studies  out there beyond 1960,  but you could find

 4    that  out without an expensive  contract  to review every single

 5    piece of literature,  every abstract,  every  paper in the

 6    literature.

 7              So there is a perfect  science problem going on

 8    that  I think is worth the  Committee's attention to the

 9    extent — let me say  that   .  Steve Jellinek was in New York

10    on Monday speaking to the  New  York Academy  of Sciences on

11    problems of risk in carcinogens, and I  think he gave an

12    excellent speech to that audience which basically  said no

13    decision is a decision and we  should bear that in mind and

14    that  if you worry  too much about false  positives or false

15    negatives you are  trading  off  among these.

16              I would  say that EPA's record under Section 4,

17    Section 6 and Section 8 in many  ways shows  what happens

18    when  you don't make a decision.   That is, .you have made

19    a decision not to  move ahead,

20              And I would say  that from a policy point of view

2i    what  NRDC is trying to do  is to  get this  program moving,  not

22    wait  for every single piece of information to be in to

23    start some of this testing on the road as soon as  possible.

24              One other issue  in the suit which is much talked

25    about in the affidavit,  which is the whole issue of ANPRNs


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 1    as a regulatory mechanism for public participation and public

 2    input into the regulatory decisions-making.

 3              We think that the — when the ITC list comes down

 4    to EPA, that really is effectively a notice to all concerned

 5    parties that these chemicals will be the subject of intense

 6    scrutiny by the Agency under recommendation of the ITC.

 7              Going to ANPRN route, it seems to me there is

 8    another built-in problem in the sense that you don't need

 9    that extra stage.  Any comments could be listed when the

10    ITC Report comes out.

11              The proposal stage is, I think, adequate for

12    getting substantial dialogue going on it, and if there are

13    revisions, these can be made in the final rules.

14              But we don't see a definite reasons to go ANPRN

15    on every single chemical.  Sometimes maybe there will be

16    outstanding problems with a chemical.  That means that

17    certain policy issues will have to be resolved, but on the

18    whole, I mean, going proposal and final, I would say, is

19    quite sufficient, given you have the ITC Report on the

20    public record at the outset.

21              MR, 3ARAM:  Does the ANPRN usage stall or prevent

22    citizen suits under Section 20?  Because citizen suits

23    against the Administrator for failure to act are limited

24    after the Administrator is duly processing.

25              DR. SLESIN:  That is a legal question which I


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      don't have  the  answer  to.


               MR. BARAM:   Because  it  may have  that purpose  as


      well.


 4             DR. SLESIN:  EPA has certainly been breaking  new


 5    grounds with  the  use ANPRNs , and  I would suggest  this is


 6    an  indication of  the tentativeness of  the  Agency  in


 7    approaching some  of these  problems which other agencies


      have not  had  to turn to  as much.


 9             I think if the Agency makes  a commitment to -do


10    something about the problems of toxic  chemicals it will


11    start going a bit more forcefully into this  area.


12             MR. CAIRNS:  You were talking about precise


13    science or  perfect science or  something.   I  think I know


14    what is bothering you, and it  bothered me.


15             I read  very  carefully the one on methylchloride,


16    and I somehow just don't feel  that EPA has to write this


17    scientific  monograph as  background to  justify testimony.


18             On  the  other hand, you  also  can't  or could not


19    reasonably  require testing if  you had  not  read the


20    literature  to know whether or  not it had been tested.


21             Now there are  all  sorts of reference services -.


22    nowadays, and I would  that EPA could quite reliably go


93    through  those with a much  smaller amount of  effort and


24    conclude  that a compound that  has not  had  an adequate


25    evaluation  for  carcinogenicity or teratogenicity  simply




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 1    state the references to justify that and then require


 2    the rule.


 3              Now is that the sort of thinking?


 4              DR. SLESIN:  Absolutely.  It seems to me there


 5    is a whole timing issue on some of these rules, that you


 6    don't have to get all your ducks in water before you start


 7    moving them out.  So you can stop worrying about that and


 8    start worrying about epidemiology.


 9              MR. CAIRNS:  I was wondering if somewhere in the


10    back of your tone of voice there was a hint, perhaps, that


11    you were advocating ignorance.


12              DR. SLESIN:  A perfect science, but we cannot


13    afford sloppy science.


14              MR. MOONEY:  Just a couple of comments.  I think


15    there are some points of Lou's which I would be very much


16    in agreement on the perfect science, and we have been into


17    this at great length in the test standard proposals so far.


18              If you digest those and study what they are


19    doing, they are extremely detailed.  These are the generic


20    standards proposed back in May of last year and July of


21    last year, and we can look forward to environmental


22    effects and environmental chemistry, physical property


23    chemical standards, emerging in 1980.


24              We have had a serious concern about whether there


25    is a need to go that far.  So in that sense of the refining



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 1     of  these  things  right  down to  the  specification of feeding


 2     levels  in the  diet and many, many  details  regarding the


 3     conduct of tests,  I think  the  Agency has  used a lot of time


 4     that it would  not  have needed  to use, the  alternative


 5     being to rely  on the judgment  and  professional experience


 6     of  the  people  who  have to  do the work.


 7               I know they  have some counter arguments that they


 8     can't do that  either,  but  I would  point out that if there


 9     is  a problem,  you  can't ignore the statute nor the way the


10     statute has been constructed.


11               It does  not make a testing rule  an easy exercise


12     for the Agency,  and I  don't think  you can  presume that the


13     Congress didn't know what  it was doing in  putting the


14     statute together.


15               It is  too easy to read through it and see the


16     requirements that  have to  go into  a well-constructed


17     testing rule.   They are substantial.


18               And  the  Agency has to do its homework to put it


19     together,  I would agree I think too much  old data is


20     probably not productive to pull together as a factor into


21     this analysis.


22               i would  submit,  for  example, reaching back to


23     1950 in the Section 8(d) proposal  is a waste of energy—


24     going too far  into history for data that by contemporary


25     standards may  be too old.



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               But ITC did not have access — at the time it is


     developing its priority recommendation does not have access


 3    to all of the literature and,  in fact, some very important


 4    contemporary literature, testing is not reflected in the


 5    literature.


 6              Industrial research  that is going on concurrently


 7    right now is not part of the literature that ITC can readily


     access, and it would seem to me to be a substantial waste of


 9    resources for the Agency to be promulgating test rules


10    dealing with what are unquestionably going to be some very,


11    very expensive testing requirements, if indeed there is


12    work in progress that is fully satisfactory for purposes of


13    filling the data gaps that the Agency determines exists with


14    regard to a given chemical.


15              So that is the problem: finding the right middle


16    ground where I think the Agency's testing recommendations


     are indeed based on solid perspective on what is going on.


18              CHAIRPERSON BENDIX:     I was going to comment,


19    Lou, that I believe that when  the ITC Report is published


20    in the Federal Register and is published with a request


21    for public comments, I would expect that concerned industry


22    groups that are aware of testing in process would communicate


23    this fact,if they saw a compound they were working on on


24    the ITC list would say, hey, you know, we are doing this


25    stuff now; you don't need to promulgate a test rule on that



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 1    one.

 2              MR. MOONEY:  It was published early on and the

 3    comments filed voluntarily.  That was not a Section 8(d)

 4    type rule; that was just an opportunity for comment.

 5              And my recollection is that the extent of comment

 6    was pretty limited.  I think that is  a.: practice that will

 7    change.

 8              This is an evolving thing and the rules of the

 9    game are not altogether clear to everybody.  And I am sure

10    a company that perhaps had a study in progress , not to  a

11    point of having anything conclusive, might well conclude

12    that it wasn't appropriate or wasn't timely, and the Agency

13    would undoubtedly be coming forward under AD, as indeed it

14    did with the first ITC List, to get a full report of what

15    factor is going on that might bear on the question of

16    whether a testing rule is appropriate.

17              That process, I think, will change.  I hope it

18    will change.

19              CHAIRPERSON BENDIX:  Lou.

20              DR. SLESIN:  I think in your comments about

21    second-guessing what Congress has in mind in terms of what

22    there needs  to be in terms of a testing rule, I think one

23    shouldn't also second-guess the Congress at 12 months.

24              That is a policy statement by the Congress of the

25    United States, saying we see this as a problem and we want


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1    you to get moving on it.


2              I think the deadline has  to be taken seriously.


3              MR.  MOONEY:  That is the  basis of the whole suit:


4    Just what did the Congress intend to happen.   What event


5    is it looking to see happen within  the 12 months?


6              NRDC has advanced the position, and the court has


7    supported that position,  and until  something changes, this


8    is the way it comes out.


9              But there is, of course — the interesting thing


10    to me about the suit, there really  is no test of what


11    reason, no sufficiency of reasons spelled out.


12              Your contention is that they did indeed meet their


13    12-month requirement of publishing reasons.  You contend


14    that they weren't sufficient, and the court has ruled in


15    your favor.  And now we are looking to see what does


16    constitute sufficient action on the Agency's part within


17    that 12 months.


18              But it is very interesting that the Congress


19    picked 12 months, recognizing that the same Congress also


20    established the requirements for a Section 4 rule and


21    established the rulemaking requirements under Section 8.


22              From what we all know about rulemaking, it is not


23    a process that moves all that expeditiously.


24              DR, SLESIN:  We certainly hope once the wheels


25    have been greased that things will start moving, hopefully


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 l     there is a  learning curve here, and  that EPA will  move


 2     ahead more  quickly.


 3              Let me  follow  up with a  couple of other  things.


 4     in  terms of going back in the  literature,  I think  in  the


 5     affidavit,  for  instance, I think it  points out  before


 6     1960 some of these reports were not  retrievable by machine,


 7     through services  like Toxline  and  other computer data


 8     systems.


 9              And here again, I  think  that is  a good way  to


10     cut it off  in terms of if there are  important studies out


11     there before 1960 I think any  researcher in the field will


12     know or a team  of researchers, if  one could quiz by phone,


13     will tell you the one or two studies that  are worth looking


14     at  before then.


15              MR. CAIRNS:  Even  review articles of  textbooks


16     will pick up most of  these.


17              DR. SLESIN:  Exactly.  In  terms  of  the precision


18     of  the test rules, I  think we  are  talking  about slightly


19     different things, and let me make  one point of  clarification,


20     One is the  protocols  or  standards, which I think you  were


21     addressing, and I was talking  mainly about the  background


22     work to determine whether testing  is necessary.


23              I think the standards, it  is important they be


24     uniform and well-thought-out so there is not  a  problem


25     that when the results do come  in "x" years after the  rules



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     are promulgated that everybody will be working from a

     common base.

3              Now certainly some flexibility will be there,

4    but how much is a difficult issue, also.

5              MR. BARAM:  Are any of the substances currently

6    regulated by other agencies or EPA under other statutes,

7    such as FDA or OSHA regulating any of these substances now?

               MR. MOONEY:  On the ITC list?

9              MR. CAIRNS:  I don't think so.

10              CHAIRPERSON BENDIX:  I think that was part of

     the basis for selection.

12              MR. BARAM:  I see, that they not be dealt with.

13              DR. SLESIN:  Is that — a good book by EPA that

14    has all of the rules on all of the chemicals.  I don't have

15    that here.

16              MR. MOONEY;  What I can't say for certain is

     whether any of these chemicals find a place, for instance,

     in an approved new drug or anywhere—food additives, indirect

19    food additives--where they might be subject to regulation

20    or as pesticides.

21              Presumably they don't, but I don't know that.

22              MR. CAIRNS;  There are some regulated by TLVs

23    under OSHA.

24              MR, MOONEY:  I want to make one more point,

25    Selina.  On this business of getting your data base together,

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 1    you know,  I  am told it is  not always  the easiest thing.

 2    Ted, you may have better experience than I,  but I am told

 3    it is not always  the easiest thing to get published in

 4  .  reputable research literature negative data.

 5              MR.  CAIRNS:  That is right.

 6              MR.  MOONEY:  So  what else is new?   You tested

 7    it and it didn't produce anything.  That really doesn't

 8    seem like interesting new  science and, therefore, it

 9    doesn't get published.

10              I am sure there  are some tests that have not been

11    published for that reason.  There are other  tests that have

12    not been published just because a firm has concluded that

13    is proprietary information and it is  not going to.

14              So I am simply making the point that the literature

15              DR.  SLESIN:  I would agree  with you totally, but

16    I think EPA is not turning to industry enough in this

17    particular exercise in the sense that there  is good data

18    out there that shows no good effect.

19              I would ask the  industry to come forward with that

20    data, and if they are relying on the studies that are

21    inappropriate, say not to  test and, therefore, to push it

22    under regulation in Section 6 .

23              I also count on  industry to come forward with

24    a critique of those studies.  What we are saying is between

25    those two calls there is a large area that says go ahead


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        3

        4

        5

        6

Tape 1  7
Side B
        8

        9

       10

       n

       12

       13

       14

       15

       16

       17

       18

       19

       20

       21

       22

       23

       24

       25
and test  and as you begin this process, you will have to

resolve a great number of issues, but start the proposal

so the debate can get under way, and if the decision not

to test is because of studies believed to be there or

because we don't know about the negative data, I think

industry can then come in once the rules are proposed.

          MR, BARAM;  What was that book you cited?

          CHAIRPERSON BENDIX:  It was sent to us a couple

of months ago.  I think it has a white cover, and it lists

each chemical and what its status is with respect to

every agency.

          MR. BARAM:  Every agency.

          MR. CAIRNS:  Does anyone have a copy?  I can't

recall it,

          MR. BARAM:  I can't recall getting it either.

          DR. SLESIN:  It is down in Marilyn Bracken's

shop,

          MS. RAMSEY:  It is not the inventory.

          DR. SLESIN:  It is much smaller.

          MR, BARAM:  I don't recall getting it.

          MS, RAMSEY:  I will see if I can find it, but

it would help if anybody could remember a name.  It is a

list of chemicals and where they are in terms of regula-

tions ,

          DR. SLESIN:  In terms of which agency has


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 1    participated in any kind of regulatory process with respect


 2    to that chemical.


 3              MR. MOONEY:  I don't know how that could possibly


 4    be a complete list, though, because the chemicals that


 5    make up a new drug, subject to new drug application, are


 6    proprietary and part of the drug file, but not necessarily


 7    part of a public file, nor do I know that FDA has developed


 8    a listing of all such materials.


 9              DR. SLESIN:  I think you are expecting too much.


10              MR. MOONEY:  I don't think what Mike is thinking


11    this is is necessarily the full story.


12              DR. SLESIN:  I think any time an agency has


13    put out a proposed rule on a chemical, that will appear.


14    Like if it is under the Clean Air Act, 112.


15              MR. MOONEY;  Oh, if the agency has acted, okay.


16              DR, SLESIN:  I don't know if it can be proposed


     or not, but  certainly if there is a labeling requirement

10
     or whatever, but nothing as precise as decomposing a


     drug into its components.

9fl
               CHAIRPERSON BENDIX:  On the other hand, all

21
     the pesticides are going through the ARPR process.

99
               MR. MOONEY:  In  the drug area, I would submit


     those  are fact related chemicals because an agency has had

94
     a chance to  review that file and take action, if they  felt

95
     the need to, but there would not necessarily be a composite



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                                                           35
list of all the materials that had gone through that process.


          CHAIRPERSON BENDIX:  I would like to place this


discussion perhaps in a more general context.  That is,


first of all, I think we ought to start with the premise


that OPTS staff are just as frustrated as anybody else


about the slowness of getting the law implemented.


          And I think we ought to understand that they all


have a very genuine concern about making this work.  I


think one of the most constructive things that the members


of this Committee could do would be to focus on this


question of what could reasonably be left out and that one


of the things we ought to be looking at in each issue that


we discuss is can we make recommendations to staff about


things that we think they don't have to do that would speed


up the process and that if we can come up with some


constructive suggestions, that this would be helpful.


          I don't think that it is constructive to make very


general statements about, gee, why can't you get more


regulations done faster,


          I think the kind of thing that we have been


talking about in terms of how exhaustive does a literature


search have to be is moving more in the direction of being


specific enough to be helpful.


          I would also suggest that now that some of us


have received those specific Section 4 proposals — and I



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 1    gather from those of you who have read them that you think


 2    they are perhaps unnecessarily thorough — I wonder if it


 3    would be helpful if a number of people went through and


 4    did an editing job and sent it back to staff and said if


 5    I had been doing it, this is the amount of information I


 6    would have put in.


 7              It might be helpful to EPA staff to see if there


 8    is some consensus on a very specific case about what was


 9    necessary and what wasn't.


10              MR. MOONEY:  Selina, I would like to raise a


11    procedural point.


12              MR. CAIRNS:  Excuse me, Tom, on the same point.


13    I don't think I am going to volunteer to do the editing


14    job, but if I did, I would not use two pages on the physical


15    properties of methylchloride under the section that is


16    entitled "Identity."


17              I just see that as nothing to do with the testing


18    rules.  Everybody knows what methylchloride is.  Now they


19    should specify purity, which they did.


20              CHAIRPERSON BENDIX:  Mr. Mooney.


21              MR, MOONEY:  The question I am raising is whether -


22    where we make our contribution.  Now you get into these


23    testing rules in terms of the kinds of specifics that


24    was brought up or back in the protocol details, and it


25    seems to me we are getting into an area of science that



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 1    I read our charter to suggest as the province of the


 2    Science Advisory Board.


 3              So I am trying to figure out where we play a


 4    role.  Do we get into this thing from a procedural standpoint


 5    or is it our place to get into critiquing whether the


 6    protocols are really detailed or the literature appears to


 7    have been misinterpreted.


 8              MS. RAMSEY:  The Executive Secretary — Helene,


 9    are you here still?  I know Helene is the Executive Secretary


10    for the Science Advisory Board, and I know they have spent


11    a good bit of time on these test rules, and perhaps you


12    could give us a reading on how far the Science Advisory


13    Board has gotten and what role they are playing in these.


14    Helene.


15              MS. GUTTMAN:  Well, I can give you only a very


16    brief rendition.  First of all, the SAB Subcommittee on


17    Toxic Substances only received the test rule package about


18    a week ago,


19              Therefore, they have something like 10 days to


20    review the test rule package and to have their first meeting


21    on the topic this Friday.


22              Therefore, no one can expect every question to


23    be answered at this time, but many of the problems which


24    you brought up in terms of picking up the high points and


25    giving the distillation of the salient features of what



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 1    the scientific problems are to accomplish all these things


 2    which I think everybody wants to do to get something not


 3    only adequate, but good out that will give both the public


 4    an opportunity to respond to and give a feeling of both


     comfort in terms of scientific adequacy as well as protection


     where needed will be achieved.


               I can't tell you what will happen on Friday, but


     certainly everybody is welcome to come and hear it for the


 9    first time, as I will,on Friday morning when our committee


10    convenes,


11              I might add that we were bumped out of our meeting


12    room here in the mal}., so if anyone here wants to attend


13    that meeting, it will take place in HEW North, Room 4131  to


     37, starting at 9 o'clock on Friday.


15              MS, RAMSEY:  Will that be a full day meeting?


16              MS. GUTTMAN;  It will be a full day.  The main


     agenda item, with very few exceptions , for old business


18    and some scheduling for the new things will be the Section


19    4  rule package,


20              However, it is. quite clear, as you yourselves


     have already figured out, that the meeting will cover main


22    points


23              I am going to request that the committee study


24    further and submit any further written comments as well


25    as to members who are unable to attend the meeting on



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 1    Friday and are already preparing  to  submit written  comments



 2    to me,



 3              MS. RAMSEY:  Thank you.



 4              CHAIRMPERSON BENDIX:  Mr.  Slesin.



 5              DR. SLESIN:  We  got  a list the  other day  from



 6    you of all the new EPA committees, and noticeably absent



 7    was the membership of this particular subcommittee  of the



 8    SAB.



 9              CHAIRPERSON BENDIX:  It is in there.



10              MS. GUTTMAN:   It is  a subcommittee of the Executive



11    Committee, and Committee Management  chose only to list the



12    committees and not the subcommittees.



13              DR. SLESIN:  Could you  tell us  then who was on



14    that  committee or just notify  us  in  some  way of the



15    membership.



16              MS. GUTTMAN:   All that  material will be there on



17    Friday,   I don't want to take  away from your schedule.



18              MS. RAMSEY:  If  you  see that I  get a list, I



19    will  make sure everybody gets  it.



20              MS. GUTTMAN;   You probably got it  in the mail



21    along with the agenda.



22              MS. RAMSEY;  I don't think we got  an agenda



23    of the meeting.



24              DR. SLESIN:  Could we also get all the comments



25    of the SAB?




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 1              MS.  GUTTMAN:   The  comments  will  be oral.

 2              DR.  SLESIN:   Will  there  be  any reports  out of

 3    the SAB?

 4              MS.  GUTTMAN:   There will be a set of summary

 5    minutes,  as for every  advisory committee.   A more inclusive


 6    report is not  timely at this point because of the preliminary

 7    nature of the  Section  4 rules.

 8              Since it is  not a  final  EPA document, it has not

 9    gone through final EPA review.  One of the more closer to

10    final reviews  will not be held until  a week from Friday

11    and, therefore, the comments and suggestions that the Board

12    Subcommittee makes will be advisory only and will not be

13    reflected with what the Agency's final position will be.

14              No doubt the Committee will be — subcommittee

15    will be given a copy of the  final  approved Agency document

16    for their further review, but that will be the document

17    which will also go to the public for  comment.

i8              So there is  a little slippage in what we will

19    see as opposed to what the final thing will be, and it

20    might not be a perfect report because I would expect that

21    possibly as a result of your committee's work, our

22    committee's work, the deliberations of the steering committee

23    and other internal advisory  is that there  will be some

24    changes made between the documents that we see, which I

25    believe is something like a version of a month ago and what


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 2
 3
 4
 5
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      transmitted to you.
 8





 9





10





11





12




13





14





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16





17




18





19





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22





23




24





25
                                                                 41
will finally come out for public comment.




          So just as with your draft comments, to bring




that out at this time will not be reflective of what our




final thing will be and will serve more to confuse than
      elucidate.
                DR.  SLESIN:   If  you can get the minutes  officially
          MS, GUTTMAN:  The minutes are-always transmitted




to committee management, where they are available  to everybod




and the public.




          DR. SLESIN:  If we could get them to ATSAC.




          CHAIRPERSON BENDIX:  I would like to respond  to




Mr. Mooney's earlier point as to the difference between




the responsibilities of the Science Advisory Committee




and the ATSAC.




          There is no question in my mind but that the




Science Advisory Committee will be doing a much more in-




depth analysis of the report and looking at questions of




how data were evaluated and what was considered to be




valid and useful for decision-making purposes.




          I  think there is an important role for this




Committee, however.  We are supposed to be dealing with




overall policy, and the single most important problem that




OPTS and perhaps all of EPA has, as far as I am personally




concerned, is the question of how can these mandates in





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                                                                 42
 1    the  various  statutes  that are being implemented be


 2    implemented  in a more expeditious  fashion.


 3              Anything that this  Committee can do to suggest


 4    policy decisions which would  aid in implementing these


      tilings as  quickly as  possible I think is perfectly within


 6    the  purview  of the Committee  and appropriately a focus of


 7    our  attention,  Yes?


 8              MS.  MOON;  I took the opportunity to look at the


 9    affividat, and it is  an extremely concise summary and


 10    explanation.


 11               As I was reading it, I could remember Steve said


 12     something  about that  three meetings ago and we picked up


 13     something  four meetings ago,  and what is interesting is


 14     you  can read through  and the  bits and pieces are put into


 15     historical perspective and it is beginning to make sense.


 16               I  think it  might be very worthwhile to have a


 17     copy of this.   It is  45 pages long,  if we drop out some


 18     of the addendums that were added, but it is very little


 19     verb age,


 20               It gets right to the point in two or three


 21     sentences  and explains ,


 22               MR,  MOONEY:  It is  for a judge: it has to be


 23     simple,


24               CHAIRPERSON BENDIX:  Do you think that your


25     office problems will  resolve to the point that it might be



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10

11

12

13

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                                                           43
possible to get copies of Steve's affidavit in connection

with the NRDC suit for members of ATSAC?

          MS. RAMSEY:  For tomorrow, no.

          CHAIRPERSON BENDIX:  I don't mean for tomorrow.

That would be unreasonable.

          MS. RAMSEY:  In the introduction of the test

rules, it gives some explanation which may serve the same

purpose in the preamble to the test rules.

          You might want to take a look at that.

          MS. MOON:  That might be adequate for some people,

but I think this a really good compilation.  It is the best

I have seen and far better than the other summaries I have

seen coming out in terms of me being able to pick out why

something was or was not done in an easy fashion.

          It is laid out very clearly.

          CHAIRPERSON BENDIX:  I think we might take note

of the fact that there are some members of the ATSAC, such

as Mr. Mooney and, I presume, Mr. Slesin, who already have

copies of the affidavit.  I don't know.

          MR. MOONEY:  I have a copy.

          CHAIRPERSON BENDIX:  Maybe it is more difficult

for you to start making exceptions.

          DR. SLESIN:  I would like to emphasize something

you said, Selina, and that is, there are many other things

that we as a committee could do under our mandate to try

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                                                                44
 1    and expedite this process.

 2              I think one of the things that is very clear

 3    that should be done — in fact, EPA has proposed to do this

 4    already — is the AD Rule.

 5              That is, under the AD Rule, EPA has proposed to

 6    make submissions under AD generic for all ITC chemicals.

 7    That is, every time the ITC List comes out, EPA does not

 8    have to issue another AD Rule.  That simply says, okay,

 9    this triggers off — ^the ITC List triggers off AD and you

10    must start submitting any document you feel you should —

11    you feel appropriate or would bear on those chemicals.

12              So that would be a very easy way to make the

13    process one more quickly.

14              CHAIRPERSON BENDIX:  Does anyone have any further

15    comments?

16              MS. MOON:  I just want to say I am very glad

17    that you and Tom Mooney did give us their feelings about

18    this.

19              I had heard about this and, as you know, Arizona

20    tends  to out in the hinterland.  We knew it was there,

21    but not sure what the whole thing was about.

22              That is why I think it is valuable to come in

23    and hear not only what is going on, but your specific

24    perspectives as to why you think this is important is so

-5    important.

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 1              CHAIRPERSON BENDIX:  Unless there is any other


 2    point that somebody wishes to make, I would like to call


 3    for a 15-minute recess, and we will reconvene here as a


 4    group at 11 o'clock for a discussion of the Section 4


 5    test rules with Warren Muir.


 6              (Whereupon, a recess was taken)


 7              CHAIRPERSON BENDIX:  I would like to call the


 8    meeting back to order even though some people haven't come


 9    back from the break yet.


10              I would like to raise a question about how people


11    want to handle the afternoon session so that we can inform


12    staff who needs to be here.


13              As I see it, we have two possibilities.  In the


14    1:30 to 3:00 segment, we could ask a total group to discuss


15    the EPA plans for chemical hazard warning labeling in


16    industry and commerce and get a brief update on the


17    status of 8(d) , (e) and  (c) rules or we could split up


18    into two groups, the seven of us, meaning, presumably,


19    groups of three and four, which would give us an opportunity


20    also to find out about the status of the follow-up rules


21    8 (a) and SNURs .


22              Unless there is one person on the staff who


23    could briefly cover both of those, I am not sure how


24    productive this would be or if we handled it just as an


25    information item, perhaps it could be handled.



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                MR.  CAIRNS:   I  think we should really meet as


      a  committee.   Too few  to  split up.


 3               CHAIRPERSON  BENDIX:   Do people have any feeling


 4     about what they want to do about 8(a)  and SNURs and


      8(c), (d)  and (e)?


 6               I have the impression there is a general consensus


 7     that everybody wants to hear about the hazard warning


 8     labeling.


 9               DR.  SLESIN:   Given that there is a proposed rule


10     out about  8 (a) , it might be helpful to talk about that.


11               CHAIRPERSON  BENDIX:   Well, how do other people


12     fend?


13               MR,  MOONEY:   Is DeKany scheduled at 1:30 on


14     label?


15               MS.  RAMSEY:   Yes .


16               CHAIRPERSON  BENDIX;   DeKany is also going to


      replace Irv Auerbach.   DeKany was to replace Irv Auerbach


18     on the chemical hazard warning and he cculd also cover the


19     8 (a)  and SNURs, in which case the fact that both of these


20     items are  scheduled for 1:30 is not too much of a problem.


21               DR.  SLESIN:   Who is going to do 8 (a): DeKany?


22     i  don't think that is  his —


23               CHAIRPERSON  BENDIX:   We have both DeKany and


24     and Blake  listed.


25               MS.  RAMSEY:   Not 8 (a).



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 1               CHAIRPERSON  BENDIX:   As  the  agenda was  set up,



 2     it was  DeKany  and  Biles  to  cover 8(a)  and SNURs.



 3               MS.  RAMSEY:   It wasn't under,  necessarily, 8 (a) .



 4               MR.  MOONEY:   Can  we  have them at 2:15?   Why don't



 5     you  have  DeKany  at 1:30  on  the labeling question  and the



 .6     other come in  at 2:15?


 7               CHAIRPERSON  BENDIX:   That was my thought.   Whatever



 8     he can  cover.   I am assuming for the public participation



 9     item as Item 1 there as  being  postponed until the next



10     meeting,  with  1  and 2  under Information Gathering, are off



11     the  agenda.



12               MR.  MOONEY:   Okay.



13               CHAIRPERSON  BENDIX:   In that case, our  agenda,



14     unless  there is  any further discussion this afternoon, will



15     be at 1:30 we  will discuss  EPA plans for   chemical hazard



16     warning labeling in industry and commerce and at  2:15 or



17     shortly thereafter we  will  be  discussing various  subsections


18     8 and possibly the SNURs.



19               MS.  RAMSEY:   Should  I ask Mr, Kovalick  to.be


20     prepared to cover the  8 (a)  topic during that time?



21               CHAIRPERSON  BENDIX:   That would be helpful if


22     you  could do that.  At this time,  I would like to turn the



23     meeting over to  Dr. Warren  Muir and Mr. Steve Newburg-Rinn


24     to talk about  Section  4 test rules, and I am asking them



25     to  focus  their presentation, since we  have such  a short




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                                                                48
 1    time, not on trying to tell us what is in this long document,


 2    but to focus on the areas where decisions are yet to be


 3    made where public input is being sought.


 4              DR. MUIR:  Selina, does everyone have a copy of


 5    this or is this the stack to be distributed?


 6              CHAIRPERSON BENDIX:  That is the stack to be


 7    distributed to everybody who needs a copy.


 8              MR. BARAM:  I could use a copy.


 9              DR. MUIR:  Steve has a brief amendment here.


10              MR, NEWBURG-RINN;  A brief administrative matter


11    on that.  In the package that was sent out to you, we found


12    that there were four pages of Appendix B on exposure that


13    were inadvertently omitted.


14              I have replacement papers.  And, in addition, on


15    the support document for chlorinated benzene, Pages 40


16    through 42 — you do have a 42, but the wrong 42, and I


17    have the right one for you.


18              I hope that did not confuse you.  Our apologies


19    for that confusion.


20              DR. MUIR:  Well, just by way of brief overview


21    as to where we stand, this is the first of hopefully a


22    continuing series of test rules that we will be proposing


23    that is in the Agency's review process now and is at the


24    Agency steering committee and will be reviewed by them next


25    week.




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                                                                 49
 1              Hopefully, we will move on to proposals no later




 2    than May or June, with the remaining agency clearances




 3    and so forth.




 4              This particular test rule basically incorporates




 5    the various appropriate test standards that have been




 6    proposed previously in the health effects area and proposes




 7    that certain of those test standards be carried out on the




 8    particular chemicals in the individual rule.




 9              In this case, chloromethane and the chlorinated




10    benzenes: mono, di,  tri, tetra, pentachlorabenzene, that




11    the specified chemicals be tested by our proposed test




12    standards.




13              Also, this package contains a notice of a tentative




14    determination by the Agency not to go forward with a proposed




15    rule to test acrylamide based upon its known neurotoxicity,




16    which is well confirmed at quite low levels and our under-




17    standing of the nature of the testing that will be initiated




18    by Dow Chemical Company to look at chronic and carcinogenic!t




19    and other chronic effects.




20              This particular test rule references test




21    standards in the health effects area only.  We are in the




22    process and will be coining up with proposals in the very




23    near future and are about ready to start a whole stream of




24    test standards in the environmental fate and ecological




25    effects areas, and as soon as we have a number of those that





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                                                                50
1    can be referenced to proposed rules and we hope by the

2    time of the next rule we will be able to cover both health

3    and environmental effects in our proposed rulemaking.

4              The basic content of this particular package, for

5    those of you who have not had an opportunity to digest it

6    all completely, there is at the front a preamble which

7    addresses both the major generic issues that we see raised

8    by this proposal as well as the chemical specific ones

9    and discusses the basic approach we plan on taking with the

10    test rules of this type.

11              As an appendix, we have an appendix discussing

12    exposure, the way in which we view the various sources of

13    exposure information, how it factors into our analysis and

14    decision-making.

15              We have the proposed rules themselves, again

!6    addressing chloromethane and chlorinated benzenes.  We have

17    technical support documents for chloromethane, chlorinated

18    benzenes and acrylamide which basically lay out our evaluatio

19    and rationale for the various conclusions that we have come

2°    to,

21              There is a notice indicating our tenative

22    conclusion not to go forward with the proposed testing of

23    acrylamide, and there is a discussion of exemptions,

24    policies and procedures as a separate piece to this

25    package.  So those are basically the component parts.


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 1              In getting from the statute to this particular




 2    document, we have slogged through an enormous number of




 3   • issues, many of them generic rather than chemical-specific.




 4              We have slogged through a number of issues which




 5    are not contained in this particular document because they




 6    are n ot pertinent to the particular chemicals we have gotten




 7    to and because we really need to have some idea of where --




 8    what the downstream ramifications of any policy we might




 9    take now might be.




10              So we have had to take a look ahead.  We have




n    found this particular job to be far more complex than xve




12    would have ever imagined, just taking a look, first glance,




13    at the statute and thinking about going forward with testing




14    recommendations on high priority chemicals recommended by




15    the ITC.




16              Hopefully, that will be apparent from your reading




17    through.  You can see a lot of the very complex kinds of




18    interactions and so forth that we find once we start




19    scratching the surface of this whole thing,




20              Just by way of trying to focus a little bit




21    the discussion in the preamble, pages 99 through 118 are




22    a series of questions and issues that we particularly solicit




23    public comment on in the proposal.




24              I am not going to go through all of those.  Many




25    of those are chemical specific, but how they may apply to






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                                                                52
     chloromethane.  We are going to bump into some circumstances

     in the future and so forth.

 3              So there are a series of questions there and

 4    issues that we are particularly soliciting comments on and

     for which there has been a lot of comment and consideration


 6    within the Agency.

 7              Among the issues that I might call particular

 8    attention to that we see in this package, first and foremost,

 9    is the amount of detail and the amount of energy necessary

10    to develop such proposed rules.

               I will say that there are some offices and  so

12    forth in the Agency which suggest that perhaps we ought  to

13    do some more analysis and be somewhat more — provide somewha

14    more rationale for what it is — for the conclusions  that

15    we come to, provide more evaluation for studies that  were

16    cited and so forth.

17              There is, we recognize, a very great concern

18    when you take a look at the aggregate of the amount of work

     it has taken to get the whole thing out to begin with.

20              I might say that Steve Jellinek's affidavit to

21    the court in the NRDC lawsuit clearly pointed out our

22    overall concern and frustration of the amount of hard work

93    and the amount of energy and transaction cost there is on

24    the part of the Agency to go forward in ways with testing

95    requirements and in some instances approaching or maybe  even



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 1    exceeding  the  cost  to  the  Agency  of the  cost of the impact

 2    of  the  regulation upon the industry,  which to us is not very

 3    good public  policy.

 4              There  is  a question or  issue as to whether or not

 5    to  reduce  the  economic impact of  the regulation whether we

 6    ought to go  through sequential rulemaking requiring a first

 7   . level of tests first.

 8              Maybe  an  effect  which might be more likely to

 9    come out adverse or something first and then after having

10    the data and going  foward  with subsequent rules for

11    subsequent effects,

12              A  major issue which is  likely to come up in the

13    context of the public  discussion   on this particular rule

14    is  the  use of  categories,

15              There  has been much comment on the Agency testing

16    reports which  recommended  categories to the Agency.  There

17     was a lot  of concern,particularly on the part of a number

18     of  industry  commenters that categories were not appropriate

19     for the ITC  to recommend and they recommend the Agency

20     limit their  uses as much as possible.

21               In this rule, we propose — we are basically

22     making our findings on the .category of chlorinated benzenes ,

23     We  are proposing testing of chlorinated benzenes.

24               We expect when we get the information in to

25     have the data  on the group of chlorinated benzenes and


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 1    hopefully to be able to make some judgments about chlorinated



 2    benzenes.



 3              In this particular test rule, we feel that we



 4    would have the basis for making findings on every one of



 5    the chlorinated benzenes which exist in the group.



 6              There are 11 such chlorinated benzenes.  All of



 7    them are on the inventory, but we have chosen a sampling



 8    approach which would require testing of six chlorinated



 9    benzenes because we think that is a more official use of



10    the limited toxicological resource out there and the



11    financial resource of the industry, and we think the data



12    on the six will provide an ample basis for us at the end



13    of making ample conclusions on the group as a whole.



14              I think the various ways, the various aspects



15    of our approaching categories, making findings on cate-



16    gories,  sampling categories and so forth will be an important



17    issue that is contained in this proposal and will be one



^    that during the public comment period I am sure will be



19    focused  on considerably.



20              Another significant issue in here is the whole



21    concept  of driving effect.  We have discussed that briefly,


99
     and that raises the whole question if there is a particular



     effect which is of important concern, sufficient for



     regulatory purposes, should we be  going forward with a


95
     testing  rule to evaluate the other effects or should we
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                                                                55
 i    try to hone in on the effect either for testing or for

 2    regulatory purposes.

 3              That hasn't presented itself too squarely in

 4    this particular case.  It was one which was considered in

 5    the instance of acrylamide where we have in our opinion

 6    well-characterized neurotoxicity of acrylamide, but the

 7    Agency also had concern about carcinogenicity and other

 8    chronic effects for which ongoing testing is going on

 9    and that  is the basis for our not going forward with

10    testing recommendations.

11              But in considering acrylamides, we realize that

12    there is  an important issue of that type which we must be

13    facing; that is, do we go forward with testing on the

14    most important effect or if there is  a basis for some

15    regulation on a particular effect,do  we go forward with

16    testing at all on the basis of that.

17              Next is the question of who to test.  The statute

18    provides  that the Agency shall require manufacturers or

19    processors — they are supposed to carry out testing

20    depending on whether the chemical —  whether the concern

21    arises out of manufacturing, processing, distribution

22    use or some combination.

-3              And in the instance where use or processing

24    raises concerns, processors would be  subject to the rule

25    under the regular requirements of the section.


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                                                                 56

 1               And we had the question of the extent to which



 2     we should specifically define processors under Section 4



 3     or whether we should go forward with just the statutory



 4     definitions for the processors under Section 4.



 5               Another issue which we have encountered is the



 6     whole issue of study plans.   In part, this is a test



 7     standard issue that was raised in the context of our



 8     chronic test standards where we had requested that study



 9     plans be submitted to the Agency and be submitted 90 days



10     in advance of the carrying out of the study.



11               In this proposed rule, we recommend for the --



12     propose that for the other tests that study plans be



13     submitted to us no later than the initiation of the test.



14               We did not, until we got into the rule, realize



15     the importance of that, how important it would be to have



16     study plans for purposes of running the exemption process



17     and verifying that testing is going on.



18               And really, we have only — as a result of



19     this rule, have bumped into the whole study plan issue.


90
-u     It is an important one.  I assume it is an important feature


21
      for the purpose of the Agency being able to know what kind


99
      of testing is going on subject to the rule and to be able


no
      to monitor the compliance of the various people subject


94
      to the rule, too.


95
                Those are a series of issues that are contained.
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                                                                57


 1    There are many, many more.  You may very well have a whole




 2    series of issues that are not listed in the pages I have




 3    cited.




 4              We have a number that are contained here.  Why




 5    don't I leave it at that and field questions that you




 6    have.




 7              CHAIRPERSON BENDIX:  Thank you very much.  I




 8    appreciate what a difficult job it was to condense your




 9    presentation, and I think you did a good job of  it.




10              Would anyone  like to comment on some of these




11    issues that Warren has  raised?  I think one of particular




12    importance is this question of the handling of category




13    and  sampling within categories, if someone would like  to




14    comment on that.




15              I know Ted has.




16              DR. CAIRNS:   At every meeting I think  this




17    Committee has had, I worry a great deal about using  the



18
     results of two or three compounds in a category  to believe




     that the other members  of that category are safe.


9Q

               I think we are  just bound to fall into traps.



21
     I  think in the chlorobenzenes I feel better than I do



92
     about many others,



93
               But there are just so many examples of the next


94
     higher homologue, the next lower homologue, or an isomer




     being basically different than the rest of the category.
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                                                                5 8
 1              I am sorry; I have said this before, and I think



 2    Warren is fully aware of it.



 3              CHAIRPERSON BENDIX:  Lou.



 4              DR. SLESIN:  I think it might be useful to



 5    look at the decisions on the chlorinated benzenes and



 6    explain perhaps specifically how you came out with the ones



 7    you did—six out of — what is it — 11.



 8              For instance, I know that you picked also paradi-



 9    chlorobenzene, which one would expect to have similarities.



10    I  guess the reason it is here is that it is produced in



11    small quantities.



12              But I wonder if you could go through some of



13    the thinking that you went through in terms of this is



14    the first time such a selection has been made and would be



15    extremely valuable.



16              DR. MUIR:  There are a number of factors that



17    have to be weighed in the sampling.  One is when you go



18    forward with a category under sampling one is making the



19    presumption, in the end when you have the data in, the



20    data is going to fall together in such a fashion that you



21    are going to be able to make some kind of overall conclusion.



22              There is, of course, the possibility that data



23    when it actually comes in will end up in such a hodge-podge



24    fashion that it will be clear that the group, in terms of



25    the information you got in, didn't hold together very well,




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                                                                 59
 1     that  the  group  is  a  reasonable proposal  of  the  group,  but

 2     at the  end when you  have  the  data  in hand it  starts  to

 3     fall  apart.

 4              Because  there is  that  possibility,  we tried  to

 5     strike  the best compromise  or try  as much as  possible  to

 6     get high  exposure  to chemicals into the  group,  into  the

 7     sample, in the  event that we  cannot in the  end  make  a  more

 8     summary conclusion about  the  group so that  if we need  to

 9     take  the  chemicals one on one and  the end with  the data

10     on hand,  it  will be  the basis for  dealing with  the most

11     important public health environmental concerns.

12              So exposure factors are  important in  our sampling

13     approach.  In terms  of selecting this particular sample,

14     the metabolism people and the pharmacokinetisist,toxicolo-

15     gists in  the office  and so  forth very carefully looked at

16     the group and wanted to get what they considered a

17     representative sampling of  the various substructural

18     classes that exist there, also factoring in the whole

19     question  of  exposure, and come up  with a sample that they

20     thought,  with the  data in hand and presuming  that it comes

21     in in a consistent fashion, would  allow  them  to make

22     judgments across the group.

               Now in the instance of choosing the orthopara vs.

      meta  exposure factor into that,  there are constituents with

      metho,  in relationship to each other, and their feeling was
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 l     that with  the  combination of the sampling we have of the




 2     dyeing tetras  and these two particular dye chemicals,




 3     dichloro compounds,  we would have the basis for judging.




 4               CHAIRPERSON BENDIX:  Yes,  Mr.  Mooney.




 5               MR.  MOONEY:  Warren,  how do these dovetail with




 6     the test standards finalized?  These make reference to the




 7     proposals  in May and July.




 8               DR.  MUIR:   We are proposing in this rule that




 9     these chemicals be tested by the method in our proposed




10     test standards, except that there are certain test modifi-




11     cations that are proposed here  which are of a chemical




12     specific nature and this proposal solicits comments on any




13     other test modifications which  ought to occur as a result




U     of a particular aspect of the particular subject chemical.




15               So we are proposing those test methods be the




16     tests that will be performed here in terms of our generic




17     test standards and the schedule they are on. The comment




18     period closed in October.




19 .              Comments are being digested by both the Office




20     of Testing Evaluation and Office of Pesticide Programs




21     in an effort to come up with a  common proposed — common




22     methodology between the two offices in the health area.




23               We would expect to have those final probably, I




24     would estimate, not in one package, but probably it will




25     come out in two or three pieces, with the acutes and so forth






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         3


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                                                           61
coming a little faster than the others, and probably those


in the Federal Register this summer.


          I will say that it isn't the most pressing


priority from our programs perspective because it is not


on the critical path for getting testing done, and we feel


we need to get the test standards into place before we go


final with these test rules, but we are devoting our energies


to developing test rules rather than test standards where


there is a trade-off.


          MR. MOONEY:  Could I fairly presume then the


test standards, as proposed, are eventually what we are


going to see as finalized?


          DR, MUIR;  I think there will be some changes.


          MR. MOONEY:  These chemical-specific rules,


though, you anticipate will not have gotten off the ground.


There will be time to factor that in to any development of


testing plans.


          DR, MUIR:  The test standards will be final


prior to release of  final test rules.


          DR. SLESIN:  I have not had a chance to read


all the pages you gave us, but can you explain to me, like


in Table 1 of the chlorinated benzenes, 59(a) of the


proposed test rules  for chlorinated benzenes.


          DR. MUIR:  59(a) of the Technical Support


Document, I am not sure I understand the difference between



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                                                                62
1    capital "D" and dash as to positions as to proposed testing
2    deferred, not at this time.
3              DR. MUIR:  Let me explain that.  The "X,"
4    obviously, we are proposing the proposal as contained in
5    here, and the instance where there is a dash we are not
6    proposing testing at this time because of either ongoing
7    testing or preexisting testing.
8              The National Toxicology Program has got the
9    chemical under test and, presuming that is going to come
10    in with sound results, we basically made a determination
11    not to propose.
12              But for some reason should that ongoing study
13    fall through, presumably, we would reserve the right to go
14    forward in the future.
15              In the instance of neurotoxicity, metabolism, and
16    behavioral teratogenicity, those are effects for which we
17    do not have any test standards.
18              Therefore, there wasn't a basis for having a
19    test that we could propose in this particular proposal.
20    so that is what these refer to.  We are going to be working
21    on additional test standards in the health area in both
22    the neurotoxicity area and behavioral teratogenicity and
23    also for the metabolism area.
24              In the case of mutagenicity, what we are doing
25    there is, in order to be more expedient with respect to these

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                                                                 63
 1     chemicals,  there  are a number of short-term tests  which we

 2     think are  good to the bottom tier test in the mutagenicity

 3     area.  They are rapid  and inexpensive,  and rather than going

 4     through the whole rulemaking process on that, to come up

 5     with decisions and decision rules and everything with

 6     respect to any 'advance mutagenicity testing, we are going

 7     to go ahead and just do that testing.

 8               It is very inexpensive and rapid, and we can get

 9     the results in probably before we get this proposal out.

10     So we will defer a decision on that as to whether or not

11     we need to require the advance mutagenicity test.

12               DR.  SLESIN:  Does that mean that your office,

13     ORD, is going to do that?

14               DR.  MUIR:  Yes, we will do that in that instance.

15               DR,  SLESIN;  You won't subcontract that out?

16               DR.  MUIR:  We may.  We presumably will be.  Our

17     office doesn't have a laboratory, so-if our office ends up

18     doing it,  it will be under contract.

19               But probably is ORD would do it, it would be

20     one of their contractors, too.  There are a number of

21     contractors both of the offices have which could perform

22     such things.

23               DR,  SLESIN:  Who will pay for that?

24               DR.  MUIR:  We will.  It is cheaper for us to do

25     the studies than to go through rulemaking.


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                                                                 64
                DR.  SLESIN:   So  the  way  you define  it,  I  thought

     epidemiology  should be  a "D"  rather than a dash  since there

     is  no standard  there.

                DR.  MUIR:  The problem with epidemiology  is we

     haven't been  able  to identify a cohort that would  serve

 6    as  the basis  for writing a  requirement.

 7               That is an important area.   It has  turned out

 8    in  our efforts  to  try to develop epidemiological test

 9    standards and so forth  that there is really no easy  generic

10    way of doing  that, and  actually the real determinant in the

11    epidemiological area of any type of study is our ability

12    to  get suitable cohorts for study.

13               So we are looking into various ways in  which we

14    can use 8 (a)  authorities and so forth to get us  information

15    down to where epidemiological studies are most appropriate,

16    and then there  has to be a  decision as to whether  Section 4

17    is  the right  vehicle for carrying it out.

18               We might want to get the right information under

19    Section 8.  So  at  this  point in time, we are not proposing

20    to  go ahead with epidemiology.

21               MR.  BARAM:  I would like a perspective  because

22    i haven't read  your document or the affidavit, but how

23    many chemicals  now has  the  ITC come forth with?

24               DR.  MUIR:  Thirty-eight recommendations.

25    Approximately half are  groups and half individual  chemicals .


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                                                                 65
1              MR. BARAM:   This  represents  a  proposed rule on

2    6,

3              DR. MUIR:   No,  in terms  of the recommendations,

4    they have  recommended  acrylamide.   They have recommended

5    chloromethane, which they  had two  recommendations which

6    covered  chlorobenzene,  so  this  covers four of the ITC

7    recommendations.

8              That  leaves  34  to go,  and there is a report

9    coming up  in  April  which  undoubtedly will have a number of

10    more chemicals in groups  recommended to us.

11              Our affidavit would indicate that based upon

12    this amount of analysis and  allowing ourselves the ability

13    to  review  premanufacture  notices  and so forth in the office,

14    that it  will  basically take  us  until 1984 to get proposals

15    out on all of the 38 chemicals.

16              MR. BARAM:   I  see.

17              DR. MUIR:   It  is  1984  for proposal.

18              MR, NEWBURG-RINN:  It  may actually be 1985.

19              DR. MUIR:   The  point is it is  a long time and

20    there is more piling up,  and we are not getting to other

21    chemicals  which  may be important  under Section 4 as well.

22              MR. BARAM:   So  what action does the Agency

23    intend to  take?

24              DR. MUIR;   We  have indicated we are doing a

25    fundamental rethinking about how  to approach Section 4 both


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                                                                C. r
     from a chemical-specific point of view and from a generic


     one as well,


 3               The obvious conclusion is that it is taking  too


 4    much to get too little, and we just don't think it is good


     public policy.


 6               MR, BARAM:  So this may be the first and  last


 7    time that you have taken this particular approach then;


     is that right?


 9               DR. MUIR:  Maybe so, except that we have  got


10    a substantial investment in the next few.


11               MR. BARAM:  Can you tell us what directions  you


12    might take?


13               DR. MUIR:  We are considering — well, much  of


14    the analysis, much of the energy in this goes into the


15    analysis of the sort of finding that existing information


16    is inadequate and testing is necessary.


17               There is a lot of analysis and 50 years '  worth


18    of literature.  We will certainly look into ways through —


19    I don't even know exactly how, but the way in which  the


20    Agency can take on less of the burden of having to do all


21    of that evaluation.


22               Maybe we will lay out certain criteria.   Maybe


23    using such criteria, make certain presumed conclusions  and


24    so forth.


25               This represents about as much analysis as we




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                                                          67
feel we would need to do to regulate these chemicals were


they a hazard and, in fact, in many respects, it is more


than that because you only need to have one important effect


to regulate a chemical, and here we are looking at the multi-


plicity of effects.


           So I think we recognize — well, we are not


happy, the step-back overview of the whole thing.


           CHAIRPERSON BENDIX:  Mr. Mooney.


           MR. MOONEY:  Warren, a series of questions or


inquiries with regard to some material on Pages 12 and 13.


           DR. MUIR:  The Preamble.


           MR. MOONEY:  Yes.  Test standards under Section 4


will be consistent with internationally and nationally


redefined guidelines approved by, et cetera.  Kow do you


do that when you have everything moving at the same time?


           OECD is a long way from finalized.  IRLG has


yet to get out proposals on very many of these human effect


areas.


           You have got a few out as drafts and more to


come, but your test standards are way ahead of them.


           DR. MUIR:  Our test standards are way ahead of


them, but we are to review and revise them in some respects,


and we are to review and revise annually, per Section 4, and


to the extent that they are basically scientific conclusions


of IRLG, would cause us to reconsider a particular aspect/


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                                                               68
 i    that will be part of our review process and be part of



 2    our proposed revisions.



 3               So we pick them up the next year.


 4               MR. MOONEY:  Would you broaden that statement


 5    to reflect consistency with FIFRA guidelines as well.



 6               DR. MUIR:  I don't think that there is any —


 7    with the exception of —^


 8               MR, MOONEY;  I am just highlighting another.


 9               DR, MUIR:  With the exception of any particular


10    aspect of FIFRA testing or TSCA testing, which are really


11    statute and pesticide and so forth .specific, our two offices


12    will be fully consistent.


13               MR, MOONEY;  So those will also be consistent.


14    Let me explore what consistency means a little bit because


15    I have a perception that you don't consider inconsistent


16    when you say will be consistent; however, because of


17    statutory reasons, we may be more specific.  And you still


18    consider that to be —


19               DR. MUIR;  I still consider that to be consistent.


20    That is right.  And to meet your point head on, this has


21    been the number one issue associated with our test standard


22  !  has been the whole question of specificity and, to date,


23    because of the way in which our statute is structured, we


24    do not see how we can propose as a testing requirement


25    which is the specification of what people should do, a series




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                                                               69
 1    of guidelines and principles on testing as the requirement



 2    as to what people shall do.



 3               We do expect that our test standards should be



 4    consistent.  Where things say appropriate species or at



 5    least 60 days in duration or more than one or whatever,



 6    that any specification that we do specify be consistent



 7    with those and, therefore, any of our test standards should



 8    fully satisfy IRLG, OECD and pesticide guidelines.



 9               But, in our view, there may very well need to



10    be, with respect to certain aspects of the test, there



11    may need to be additional specification because it will be



12    laid out as the requirement as to what people should do.



13               Under the statute, they don't have to do anything



14    more than what we tell them they have to do,



15               DR. MUIR:  Most of the guidelines contain a



16    considerable amount of judgment which is to be employed



17    by the experimenter and the evaluator, and I emphasize both



18    the experimenter and the evaluator, and in the instance —



19    in our instance, both the experimenter and the evaluator



20    have no other standard to judge it by but the standard we



21    lay out, and that is why there needs to be some additional



22    specification.



23               So you can anticipate our test standards will



24    be more specific in certain instances than IRLG or OECD



25    and in some —




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                                                               70

 1               MR.  MOONEY:   Let's move to the middle of the



 2  :  paragraph where you do  indicate that you may choose to be



 3    more specific because of,  I gather, statutory considerations



 4               We have had  a lot of difficulty understanding



 5    where we are coming from in our differing views on an issue



 6    like that, and I would just like to know for, as an example



 7    and pick another one if there is another discussion'.point:.



 8    that helps to clarify it better — why, for example, in a



 9    GLP area, which really  is  part and parcel of all of this



10    as well, is it necessary for the Agency to require board-



11    eligible or board-certified pathologists when the Food and



12    Drug does not?



13               I don't understand the consistency of those



14    positions.  Now we could pick other areas, but I just single



15    that one out to illustrate what to me is a difference, and



16    yet the Agency continues to say it is being consistent
17
19
     with ILRG and OECD, and I don't grasp how that is a form
18    of consistency.
                DR, MUIR:  There are no IRLG  GLPs, number one.
90
     Number two is, with respect to OECD at this point in terms




21    of draft, the only thing that has developed so far is a


99

     draft which discusses very broad principles associated




23    with GLPs and not GLPs themselves to address the GLP issue.




                There are a number of instances where in our




     test standards there are some specifications there which




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                                                          71
bear upon qualifications or how records shall be kept and


so on and so forth, for which we have had a lot of comment,


and we are going to carefully review that comment and see


whether or not we think it is necessary to assure the quality


of the test.


           If it is, we will have to go forward.  And if it


isn't, we won't.


           CHAIRPERSON BENDIX;  I am sorry, Mr. Mooney, but


I think we really need to go on to the next item on the


agenda.


           DR. MUIR:  I will be happy to talk to you more


about it separately.


           MR. MOONEY:  I am sure we will, which is what —


           CHAIRPERSON BENDIX:  Marilyn Bracken is here


to talk to us about OECD and efforts to involve public


interest groups in these activities.


           Thank you very much, Dr, Muir.


           DR. SLESIN:  Warren, before you go, I would like


to raise an issue  for later discussion.  I am very interested


in your thinking about the sampling, what I started to


discuss about selecting out some of the compounds from the


larger category.


           How willing will your team and general counsel


be if you get a positive result for one of the sample com-


pounds?  Will you be willing to go ahead?  And if you issue



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                                                               72
 1    a Section 6 rule, will you be willing to go ahead and

 2    regulate or propose regulation on those that you didn't

 3    actually test?

 4               DR. MUIR:  Let me give you a simple answer.  It

 5    is our presumption that we  in a sample get a consistent

 6    set of results.
                And I say consistent-—they don't all have to
     come out the same.  There may be just a logical trend in
 9    the data that would indicate concern.  It is our presumption

10    that that would provide us data upon which to make Section  6

11    judgment,

12               If that were not the case, there would be no

13    basis for not testing the other chemicals that are not

14    contained in the sample.
15               CHAIRPERSON BENDIX:  I am not going to make

     any introduction, so we can proceed.

I7               DR. BRACKEN;  Okay,  My understanding is what

     you really wanted to hear was how we were going to involve
19    public interest groups in OECD and other international

20    activities,

21               So I will take, as a presumption, you generally

22    know what we are doing with respect to OECD and some other

23    organizations.

24               CHAIRPERSON BENDIX;  Let me ask, would you group

25    prefer to have a few minutes' review of what is being done

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 1    with OECD?




 2               I don't know how familiar the members of this




 3    group are with these activities.




 4               DR, BRACKEN:  Why don't I give a few minutes.  I




 5    think most of you know that several years ago there was a




 6    meeting in Stockholm of the administrators of various




 7    governments regarding the environment and the issue of




 8    chemicals and the idea that since we have so many new




 9    pieces of legislation being developed internationally, it




10    impacted on chemicals and particularly notification programs




11    with respect to new chemicals, that we had this unique  ;eriod




12    of time to begin to look at harmonizing the implementation




13    of our various statutes and that it would make sense, as




14    much as possible and as closely as we could, to work together




15    and develop consistent guidelines, consistent protocol




16    standards, and implementation aspects of our law.




17               There were several priority areas that were




18    recommended where we should begin.  At the time, TSCA had




19    passed and the Sixth Amendment to the European Commissions




20    was just about to be put before the Commission, and that




21    since has been passed, so we had :two major pieces of




22    legislation we were dealing with.




23               The Japanese already had some legislation,




24    as did the Swiss and some other countries, but we did feel




25    it was a unique period of time and that we were trying,





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 l    essentially, to avoid the development of non-barrier trade'**




 2    barriers, different approaches to implementing our laws.




 3               The first effort that we undertook, which in




 4    fact had already been started in the chemical group in




 5    the OECD, was to develop test guidance, and they were being




 6    developed in five areas,




 7               That is, short physical chemical properties,




 8    short and long-term toxicity, et cetera.  There was another




 9    group developed to look at step systems or the taking of the




10    various protocols and putting them into a tiared approach




11    for testing new chemicals,




12               There was a  two-year program set up to develop




13    the five guidelines, the reports from the expert groups on




14    the five guidelines.




15               Expert groups were created under a lead country




16    approach, and as a matter of fact, the groups were due




17    December 31, 1979.




18               We have now  received the guidelines from the




19    different groups.  They are not totally complete in all




20    cases in that that was  a major undertaking for these




2i    international groups, but we have got well over 200 guideline^,




22    when you take the fact  that physical chemicals, we had quite




23    a number of them in that particular area, but there has




24    been amazing and consensus on what should be involved in




95    these guidelines, and we had very good support by the






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 l    countries  and  on each  of  the expert  groups we  generally

 2    had a BIAC or  Business and  Industry  Member City.

 3               They will be received  in  the  U.. S., we  hope,

 4    and in fact I  have  several  already,  but  we will put  a

     notice in  the  Federal  Register indicating the  availability

 6    of the guidelines  as developed by the  expert  groups.

 7               And I expect that to be in  about two weeks.   We

 8    intend to  put  these guidelines in the  regional offices

 9    and in our own public  reading  room around the  cities  and

10    convenient places,  but I  call  your attention  to  the  fact

     that it is stack  like  this.

12               So  we won't be copying extensively  because it

13    is just too burdensome, so  we  are trying to put  them  around

     the country so people  can go in and  look at  them.

15               We  will take —  we  meaning  the OECD Chemicals

16    Group — will  take comments from countries  on these  guidelines

17    and since  they were developed  by  the best experts, we think,

     in the various countries, we  don't expect to  find extensive

     comments on them.

20               But comments will be coming — we,  EPA, will

21    handle the EPA comments,  and  they will be forwarded  from

     this country to an editing group  that  has been developed

23  i  by the Chemicals  Group, and that editing group has membership

24    by the six chairmen of the five expert groups.

                The editing group  is chaired by  Canada, and there


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                                                               76


 1    is a representative from EPA and from the European Commission



 2    and the Swiss are sitting on the editing group.



 3               This group will really just do that: edit.  They



 4    will not make substantive changes to the guidelines since



 5    they have already reached agreement within the expert



 6    groups.



 7               But if there are substantive changes that will



 8    be recommended, they will be given to an updating mechanism



 9    which we expect to create because we don't expect the



10    guidelines to exist forevermore.



11               We want to have an updating group that will



12    deal with the state of the art changes.  So we have an



13    editing group that will deal with editorial type comments



14    and a few areas developed in the guidelines and then



15    create an updating mechanism which we will put in place to



16    deal with changes to the guidelines in the future as the



17    state of the art changes.



18               So that is the story with respect to the guide-



19    lines,  The other area the OECD is working with is the



20    development of principles for laboratory practice, and we



21    now have, as Warren was mentioning, a document that is a


99
     very  generic document and addresses generic principles of



23    GLPs,



"4               We are working on some development  of some more


95                                          s
     specifics to that document, and then the second part of that




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                                                                77
     activity is to look at the means  for enforcing  those  GLPs
                                                  i

     internationally,


                The third  activity  is  the activity that  involves


     confidentiality or exchange  of confidential  information


     between countries involved in  regulatory  aspects  of


     chemical substances.


 7               That has just  gotten under way.   They  have


 8    had  two meetings to date.  It  is  again  an expert  group


 9    approach under the lead country of  France.


10               The U, S.  has  representation on that group


11    from the Department of Commerce,  EPA, CEQ, and  an industry


12    member.


13               And I will talk about  public interest  group


14    involvement in a minute.  Let  me  review the  other activities


15    We also have  an international  activity  under the  lead country


16    of the German Government  to  develop a glossary  of key terms.


17               We have been finding in  our  conversations  that


18    we use terms  differently, so this is the  idea of  developing.


19    We are starting primarily with legal terms;  that  is,  what


20    does a chemical substance mean under each statute,  how


21    do you define these kinds of terms.


22               So we will be  developing this  glossary initially


23    in two languages: the language of the OECD,  French and


24    English, but  then they will  be translated back  to languages


25    of other countries .



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                                                                7 8
  l               After we deal with the legal terms, those terms



  2    typically in the statute, we will deal with more scientific



  3    terms, and then we will be working closely with the OECD



  4    expert groups on the scientific terms.



  5               We have activities under way in economics in



  6    looking at the potential barriers and how different



  7    notification programs in different countries might impact



  8    economically on small business innovation and so forth.



  9               So that is another area of activity that is not



 10    a lead country approach.  That was a project handed to staff



 11    from the Secretary.



 12               And at this point, we have just developed a



 13    few documents that are being reviewed for the first time



 14    on impact and innovation,



 15               Those materials are available if people want to



 16    take a look at them.  I think I covered the major activities



 17    of the OECB.



 18               Let me just mention that we have made extremely



 19    good progress in these areas, and we plan to have a high



 20    level meeting in May, at which you will have the chemicals



 21    group meeting in what we call high level.



 22               They will be represented by, in our case, EPA



 23    or the U. S. will be represented by Doug Costle.  There will



24    be an equivalent level person from the other countries,



25    and they will come to discuss and possibly reach agreement




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 1                                                               79
 1     in certain areas,
 2                That will be the substance of the OECD test
 3     guidelines in principle.  Certain areas we will be looking
 4     for agreement in is the acceptance of the generic document.
                 Another area of agreement which has been
 6     generated as a result of the sub-systems group, and that is
 7     a minimum market base set, and this is countries would agree
      that this base set would be applicable to the testing of all
 9    • new chemical substances.
10                Now, of course, if EPA or the U. S., I should
      say, decides to take agreement in that area, that would, of
12     course, mean that we as an interim could say these would be
13     used as test guidance for all chemicals.
14                If we went any further than that, we would need
      a legislative change or something.  But what we are doing
16     at this point is this will be a discussion, and whether:.or
17     not there will be agreement reached, remains to be seen.
18                The other area there will be discussion and
l9     perhaps agreement on is what we call mutual acceptance
20     for test data.
21                What we are saying is that countries would agree
22     that if studies weren't conducted according to the OECD
23     test guidelines that data would be accepted for purposes
24     of risk assessment in one country and another country; that
25
      is, no country could:..claim —

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                                                                80
 1                So  that is  another area that we hope to reach


 2     agreement  on at  the high  level meeting.   There has been


 3     some  concern that we had  no mechanism for public interest


 4     groups  or  what we call NGOs,  Non-Government or Non-Industry


 5     kinds of organizations to participate in the activities of


 6     the  chemicals  groups and  the expert groups.


 7                The reason  that industry has been able to


 8     participate for  some time is that  there is what we call


 9     the  Business and Industry Advisory Committee, which is


10     a recognized committee of the OECD.


11                It  is an international  activity and there is a


12     USBIAC, and the  U. S.  and other countries as well have had


13     an industry member on  their expert delegations through


14     this  BIAC  committee.


15                There is no equivalent for environmental groups .


16     There is something called TUIC, which is the Trade Union


17     Advisory Committee, but this group has not been active in


18     chemicals.


19                In  order to bring in and to give the public


20     interest groups  and other organizations an opportunity to


21     be involved in our international activities, we have tried


22     to have briefing sessions as the first way of getting people


23     involved,  as  long as they understood what we were dealing


24     with, the  areas  we were working in.  That was the first
25     step.
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 l               We had a meeting at the State Department and


 2    invited a number of organizations and briefed them on where


 3    we were, what we were doing, and plans for the high level


 4    meeting.


 5               We suggested at the time — and since then a


 6    letter has gone out from me to all the participants at


 7    that meeting — that we would to, in the interim till they


 8    can get themselves some sort of equivalent organization


 9    with respect to OECD, like BIAC, that we at least get their


10    participation in expert groups through some coordinated


11    approach.


12               What we have suggested, and the Conservation


13    Foundation has agreed to organize the first meeting, we


14    feel we have a focal point for those groups to deal with.


15               It is much easier for us, so we have suggested


16    that these public interest groups get together, and under


17    the immediate direction of the Conservation Foundation--since


18    they have volunteered, they will call the first meeting—


19    they will organize themselves to provide a focal point for


20    us to talk and deal with and then we will try to get one


21    expert selected by that group to participate in the


22    individual expert groups.

90
                That is how we will deal with that.  We have


     also suggested that we form some sort of advisory panel of


     these groups to EPA that we can meet with on a regular



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                                                                82
 l    basis,  and we have  also  — we will  try  to  get  them involved


 2    in  this plan for  the  OECD updating  mechanism.


 3               We anticipate having  industry representation on


 4    that  group, and we  will  look  forward to having —  essentially


 5    we  have suggested several things.


 6               We will  continue to have these  meetings,  we have


 7    suggested  that they perhaps organize themselves into an


 8    advisory panel meeting on a regular basis.   They also


 9    created organizations somehow coordinated  at the moment


10    through the Conservation Foundation, and they  can select


11    their own  chairman  that  we can deal with,  and  perhaps through


12    some  funding grant  mechanism we  can provide for some repre-


13    sentation  at the  expert  group meetings.


14               So that  is our immediate plan.   We  have also


15    suggested  that the  labor union groups try  and  get the


16    trade union or the  TUIC  group revitalized  through the OECD.


17               That,  of course, will be up  to  Labor to try


18    to  get moving.  We  have  also  suggested  that they look into


19    getting themselves  something  like BIAC, but that is not as


20    simple as  it sounds because there are not  the  same kinds


21    of  organizations  in many other countries  like  we have in


22    this  country.


23               So it  probably will not  be quite so easy,


24    although  there has  been  offer made  by an environmental


25    group in  Germany  to take some — they have indicated some



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                                                                83
 1     interest  and  indicated  they  would work  for this  group and


 2     try  and see about  establishing some  kind of mechanism.


 3               That covers  it.   Pat,  do  you want to  add to


 4     it?   This is  "Pep"  Fuller,


 5               MR,  FULLER:   No,  I  think  you have summarized


 6     the  major features,  Marilyn,  I think we are quite open


 7     to  suggestions  as  to how environmental  groups can participate


 8     more actively,  and I think  the question of how they now


 9     play a role is  really up to  them at  this stage.


10               We put  forward a  number of suggestions and we


11     are going  to be  in  a listening  mode for  their response.


12               CHAIRPERSON  BENDIX:  Mr.  Slesin.


13               DR,  SLESIN:   If  I understand you correctly,


14     that means that you are now  willing  to  have environmental


15     and  public interest groups  on  these  expert committees .


16               It is just a matter of us getting our house in


17     order.


18               DR.  BRACKEN:  Yes,  to appoint a person.  And I  .


19     want to make  some  important caveats.  One is that the


20     membership on these groups  is  up to  the lead country


21     chairman.


22               Now  I have never had a lead country chairman


23     turn us down  on a  member in an expert group.  We make a


24     recommendation  when a BIAC  expert is suggested to us.


25               I  make  a recommendation to the chairman of



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                                                                84
 l    that particular group and suggest — describe the qualifi-


 2    cations because these are true expert groups, and when we


 3    have industry represented, we don't have industry from.


 4    Allied as an expert sitting on that committee, so we are


 5    looking for qualified experts.


 6               The chairman has always accepted  it, but the


 7    groups are kept very small, so we would keep the represen-


 8    tation to one person.


 9               We also need a commitment of continuity.  These


10    groups are usually in existence for about two years, and


11    it is very disruptive to keep changing the membership, so


12    we would need the continuity and commitment  from the person.


13               Also, it is important to point out that the


14    meetings are often held around the world, so there is  a


15    commitment of travel.


16               And in the case of industry, they have to pay


17    their own way, and of course the Government  pays their own


18    way,


19               And I know that is pretty much of a burden  on


20    the public interest groups.  We are looking  at some kind of


21    a grant mechanism, some kind of way we can try to help the


22    public interest groups cover that, but we are just starting


23    on that, and we have to work with this group.


24               DR. SLESIN;  One of the most important subgroups


25    is the Step Sequence Group, which I think is meeting at the



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                                                                85
 l     end of April  in New York.


 2               Do  you think with the Foundation's help that things


 3     will be arranged such that somebody can attend that?


 4               DR.  BRACKEN:  I  think the Chairman would be


 5     quite open to that, but it is up to the group to get


 6     themselves together to make recommendations to us.


 7               I think that will be able to be worked out, yes.


 8     And I also want to point out that some of the expert groups


 9     have finished their business.  So we will not be meeting


10     except on special call by  the chairman.


11               Some of the groups have a lot more to do.  For


12     example, the  toxicology group has a lot more to do in terms


13     of development of guidelines because that was way behind


14     to begin with.


15               There is not that much in that area in terms of


16     established guidelines.  Some of the long-term, short-term


17     group will only be meeting to address some issues they


18     haven't had a chance to address, like mutagencity and


19     neurotoxicity,


20               So they will only be having a few meetings.  We


•21     don't anticipate all of the groups to continue.  Step


22     systems, though, will be expanding, and we will be looking


23     at other areas as they go into the other tiers around.


24              - So that is a very good group to get involved


25     with,



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 l              MR. B&RAM:  Marilyn, I raised  this point  at  other

 2    meetings, and I always  find  this strange why  this  doesn't

 3    relate to the World Health Organization.

 4              I can understand OECD's  involvement on confiden-

 5    tiality and other business economic  related aspects of

 6    chemical regulations, but on the subject of the technical

 7    areas, WHO is all set up.

 8              I work with both organizations and  I find them

 9    miles apart,  and I find OECD probably the  poorest  forum

10    for  dealing with these  technical issues,

11              DR. BRACKEN:  I guess one  of  the major reasons tha
                                           '
12 I   we put the major emphasis on OECD  is that  they already  have

13    a chemical group, they  had a budget, there was a mechanism

14    to enhance that budget, they had the testing  program  well

15    under way, and WHO participates in the  experts group.

16              There is representation  by WHO in the chemicals

17     group, number one, and  on all the  expert groups, so they

18     are  in — the mechanism was  there.

19               Also, the WHO deals with longer  term problems.

20     They haven't  been able  to move  as  quickly  in  some  areas

21     as the chemicals group, so the  idea  of  the chemicals  group

22     might be able to turn something around  a little quicker.

23     For  example,  the general principles  of  the GOP area was

24     a concern.

25               This is a group that  has traditionally had  to


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                                                                87
 1     move  a little faster,  had the 24 major country participation,



 2     where WHO had been involved in risk assessment and longer



 3     term  activities.



 4               So we still  look to WHO to deal with that, and



 5     we have other activities involving them.



 6               MR, BARAM:   They are the only international



 7    organization thathas really come out with any documents is the



 8     WHO.



 9               I  guess the  question of philosophy of the organi-



10   zations, different philosophy, I think.



11               DR. BRACKEN:  We are looking to WHO to provide



12   a lot of guidance in risk assessment and individual chemical



13   assessment.



14               We are also  looking to getting WHO very actively



15   involved in the updating mechanism because we feel they can



16   make significant contributions in that area, the review



17   aspects of what are'.the  best test guidelines, but they have



18   been very much .involved' in the test areas...



19   v        '   CHAIRPERSON  BENDIX:  Any other comments?



20               DR. SUTTON:   At the moment, it seems that the



21   OECD test guidelines seem to leave a lot of room for flexi-



22   bility  in the  precise applications of test procedures,



23   whereas the test standards and rules that are-being proposed and



24   developed here are really quite specific, and it would seem



25   possible that  we would end up with a national focus here




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                                                                8 8
    which  is  very  specific  as  to  how  the  tests were  done  and




    international  ones,  that  leaves a lot more room  for flexi-




 3   bility,  and yet  you  are looking for some  mechanism by which




 4   each other will  accept  those  tests.



                What kind of  thinking have you done  about the




 6   import situation where  somebody is coming in with a set of




 7   materials,  tested it according to a flexible OECD guideline



    procedure and  quite  acceptable there  but  not matching any



    test rules that  we have?



10               DR.  BRACKEN:   First of all, when you really take




11   a look at the  OECD Test Guidelines,  they  aremore specific



12   than you would expect,




13               I  think  when  we have  done some  comparisons —



14   and I  think there are some others who could  speak to that —




15   when we have done comparisons of  our  test standards with the



16   OECD Test Guidelines, they are not that far  apart: they are



17   totally consistent.



18               They might  be, in some cases, more specific.



19   That is a problem we have to deal with because if our thinking



20   is, as far as  new chemicals and  for those chemicals where we




21   do not have a  Section 4 test rule, if a test is  conducted



22   along  with OECD  Test Guidelines,  they should be  well done




23   and they should  be acceptable for purposes  of risk assessment.



24               There may be  cases where  if we  have  a session



25   for test rule  out that  we will have to ask  for more specific





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                                                                89
 1   requirements,  for  the  reasons Warren stated before.

 2              But we are hoping to have  the  test  guidance


 3   specific enough in general  that we  can get very good  test

 4   results generated  from them.

 5.              But as I say, there may be cases where we have

 6   a  Section  4 test rule  that  we may have to  have  more specific

 7   in order to meet our own  requirements.

 8              Those  are  the areas we  have to look at carefully

 9   as we  review  the test  guidance.  We haven't seen the  whole

10   set of test guidance together as a  package.

11              Our expert group members have  seen  the individual

12   packages,  but as we get the whole set  together, we will  be

13   looking at carefully how  they do match.

14              We will be looking  to make that comparison to

15   see, in fact,  how  specific  they will be, how  they will meet

16   our requirements.

17              MR, FULLER:   If I can just add, the work  that

18   has gone  forward in the Step Systems Group, you mentioned,

19   has identified a minimum  set of data and that data, if it

20   is agreed  on  by member states, would really be  more compre-

21   hensive than  anything  we  are currently getting  now so that

22   when we talk  of new chemicals and we talk  of  importation of

23   those kinds of chemicals , we think  there is a real opportunity

24   there to have a very meaningful set of information that  would

25   be available  on imports and that would be  the same set that


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                                                            90
currently, as Marilyn aaid, it couldn't be mandatory under




existing law, but voluntary in the United States, and that




would be an addition to the knowledge base we have.




            CHAIRPERSON BENDIX:  Thank you very much.  Unless




people want to have less than an hour for lunch, I think we




are going to have to adjourn.




            I suspect our reporter might be much in need of




a break by now, too.




            $E. -.MOONEY:  Dr_ Bracken, I .hope one of the terms




your glossary group will work on will be guidance arid guideline




because it is frustrating and I think it is important we




do talk a common language.




            We talk guidelines under FIFRA which are in no




way guidelines to mandatory requirements.  We talk guidelines




under Section 5 of TSCA where it is voluntary concept just




because there is no statutory authority.




            So we have got to get those terms straight.




This consistency/ the picture you paint, when I look at what




has gone on within the U. S., with only four or five agencies




as parties to IRLG, with the differences that have emerged




within EPA with regard to testing effects standards under




FIFRA as opposed to TSCA, I would find it remarkable indeed




that these OECD groups could come out that close together.




            We haven't seen them so I can't deal substantively




with that issue, but I would find it very surprising that





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        1   there is  that level of uniformity.

        2               And this brings  me back to the point that I

        3   couldn't  tell when you had arrived behind me,  but it was the

        4   point I was belaboring with  Warren Muir.

        5               We have some strange concepts of conformity, of

        6   harmony,  and somehow there seems to be a  sense that two

        7   things are in harmony when one is general and the other is

        8   highly specific.

        9               And I don't understand that,  and I wonder from

       10   your perspective of having seen both what is emerging in

       11   that'big  stack from OECD and what is in existence on the

       12   books as  proposals under TSCA in this country whether that

       13   is what is at work here.

       14               A funny concept of consistency and conformity

       15   where somehow highly detailed is viewed as being in conformity

       16   with something that is rather general or  performance oriented,

       17   the GLP area for example.

       18               I would find it remarkable indeed if the OECD

       19   group could come up with something that matches EPA's current

       20   thinking  as reflected in the Human Health Proposals of last

       21   May.

Tape 222               DR. BRACKEN:  As I said, the  OECD has not a
Side 3
       23   specific  document at all.  The document as it exists now

       24   is "Principals and Management Practices."  It doesn't speak

       25   to specifics.


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                It will,  we hope,  in some areas speak to more




     specifics,  but in general at  this point it is a very general




     document.




                But when we say consistent,  I guess what we are




     talking about is in the case  of the Section 4 test rule we




     might — well, in the guidance, for example, it might say




     two species and it might identify the species, for example.




     That might be an example that we would say in the Section 4




 9   test guidance or test standards that two species are required




 10   and name the species ,




 11              I am not sure this is a good example, but it is




 12   the kind of thing we are talking about.  The specificity is




 13   more in terms of duration of  the test than numbers of




 14   species.  It is that level of detail rather than sort of




     general guidance you would tend to give a researcher.




 16              MR, FULLER:  I was going to add one thing.  I




 1?   think when we talk about consistency internationally, it is




 18   also useful to make a distinction between the large number




 19   of new chemicals that are going to be in international trade




 20   which we think we have so far evolved a rather good set of




 21    minimum packages of data for  those new chemicals to make a




 9~    distinction between that and  existing chemicals and to say




23    to our knowledge there are only three countries in the world




24    that are currently talking about dealing with existing




25    chemicals and testing.
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               The United States and the Japanese are already


    testing and the Germans have built into their law, which is


    not yet German law,  the fact that they plan to have the


    ability to test existing chemicals.


               So I think it is important to make that break


    because what you are talking to in specificity really goes


    to those existing chemicals and there is not a broad scale


    intent we have heard yet on the part of many nations to even


    test them at all.


10              So if you look at the new chemicals, what we


    think we have is a good package, that we think we will be


12   able to have agreement on and the 24 nations are saying


13   yes, this is a useful set of data for new chemicals that come


l4   in.  They are imported into our countries for us to use dn


15   making a risk assessment.


16              MR. MOOWEY:  Are you suggesting that the package


17   of requirements in the Sixth Amendment, with which I would


18   presume the German lav; and all others will need to conform


19   in the next year and a half or two years, are sufficient for


20   risk assessment purposes?


21              MR, FULLER:  I am not suggesting that; I am


22   suggesting that what is being evolved within OECD is a set
23
    that we hope all nations will feel form a reasonable basis
24  for making assessment on new chemicals.

nc
               They certainly represent much more than we have had


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                                                            94
 to date in the United States.   As I  say,  they wouldn't be

 mandatory in the States because we don't  have that authority.

            However,  the OECD document is  not a carbon copy

 of the Sixth Amendment, and the EC has indicated its intent,

 if international agreement is  reached, to take steps to

 modify the Sixth Amendment accordingly.

            DR. BRACKEN:  What we are suggesting as far as

 the new chemical is  concerned is that the recommended

 minimum base set that is coming out of the Step Systems

 Group is that:, a minimum base set that you would do for most

 chemicals, but that  does not preclude the country from asking

 for more test data if they feel it is necessary, depending

 on the chemical or,  in some cases, even less if it is a

 chemical for which there is some reason to believe we don't

 need to do the whole minimum.

            We are saying that is truly a minimum base set.

            MR. MOONEY:  This would suggest you are looking

down the road to modification of TSCA, Section 5, to

accommodate to something like this.

            DR. BRACKEN:  What we are saying, as an interim,

certainly, we could recommend the minimum base set as

guidance under TSCA,  and that is all we have the authority

to do at the moment under TSCA.

            But it does say that if we accept and reach

agreement that we will, in fact, require this for all new


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                                                                95
    chemicals  as mandatory, yes, we would  have  to  modify  TSCA



    in  some way.


               That  could be  modified  as  a  legislative



    amendment  or it could be modified through some sort of


    international  agreement where  you had  an international



    convention and countries reaching agreement, which would


 7   then  require Senate  ratification.


 8              Those could be two possible  ways.   You are right:


 9   if  we say  for  all new chemicals this is  a mandated base


10   set —


11              MR. MOONEY:  The Sixth  Amendment does have a



12   quantitative exclusion at  the  low end.  Would  this mean then


13   that  the Sixth Amendment countries  conforming  in this OECD


14   proposition would have to  reengineer their  own statute or


15   does  the OECD  Step Sequence Group take a position on  a


16   quantitative threshold?


17              DR. BRACKEN:   It doesn't,  to my recollection.


18   But it does have  some  language in there  that allows  for


19   flexibility.


20              So I  think that exemption  as it is now presented


21   in  the Sixth Amendment would probably  be allowable under the


22   wording that exists  in the Step Systems  Group.


23              But it may mean in time -~ as you  know,  the Sixth


24   Amendment  makes a recommendation  for additional testing as


25   you reach  certain production ranges.



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 I              That has not been a recommendation  that has  been



 2  accepted by the Step Systems Group yet, but  as  they proceed



 3  to make recommendations about higher  tiers of testing,  they



 4  may disagree with that trigger, and if  the Sixth Amendment



 5  countries subject to that  agree to that,  they would have to



 e  go back for some kind of change to the  Sixth Amendment,  too.



 7              So there is a  possibility there  will be changes



 8  in several countries,


 9              MR, MOONEY:  So sub-systems at this point hasn't



10  really progressed beyond the base set numbers.



11     .         DR. BRACKEN:   That  is right.  What  they have



12  said  is they anticipate a  constraint  behind  it, but they



13  haven't gotten that  far.



14              They have listed data elements involved in  the



15  base  set, and as they receive reports,  they  will  attach a



16  set to that and then they  will  be looking at higher tier



17  testing in the future.


18              MR, MOONEY:  Is there an  economic  component



19  to the Step Systems  Group? Is  anyone trying to put some cost



20  perspective on the package?



21              DR, BRACKEN:   Originally  that was  one  of  the



22  charges to the individual  expert  groups,  but in some  cases



23  the groups got to it and in some  cases  they  didn't, so  as


94  they  put  together these packages, the Step Systems will be



25  addressing cost,




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 1              DR. EISENBERG:  I, too, share some of the concerns



 2   Tom Mooney expressed about the use of the word "consistency."



 3   We talked about guidelines internationally because I had



 4   the same difficulty with some of the Federal agencies—



 5   with EPA and FDA.



 6              I think we might be better off if we use the



 7   term "they are not inconsistent with" rather than being



 8   .consistent with because what you are saying there is that



 9   when you are saying consistency you are giving the impression



 10   they are quite similar and they are dealing with the same



 11    subjects, where in some cases some might be very specific



 12    and others are quite flexible and general.



 13               If you call them consistent, I don't think that



 14    is really the case.  I think what the case is is that they



 15    are not inconsistent with each other.



 16               MR, MOONEY:  Let me illustrate my point.  The



 17    FDA's GLPs and EPA's GLPs have been represented as being



 18    consistent, and yet, as a case in point, EPA has taken the



 19    FDA GLP requirement to observe the animals twice a day



 20    and it has translated that into a requirement to observe



 21    the animals every 12 hours.


 99                     '
                Those are two concepts, .^and-.yet one could be



     argued as being consistent with the other.  Every 12 hours


94
     is, after all, twice a day, but the practical implications



     of the difference are tremendously important in terms of
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 1    research,  and it is that kind of thing that is troublesome,

 2    I think,  as these things evolve.

 3               On one hand,  one could easily look at these and

 4    conclude  these are consistent, and they indeed at a practical

 5    level are not.

 6               So we will view the stack with great interest.

 7               MR. 3ARAM:  I think we are talking about

 8    conceptual consistency.   It is just that each country has

 9    different needs. Legal requirements, technical findings

10    that have to be made here in the United States might require

11    more findings in other countries.

12               So we are talking conceptual consistencies,

13    economic  inconsistency,  and perhaps practice consistencies.

14               MR. MOONEY:  I agree, and yet we come down to the

15    literal language of the Agency's requirements, so at that
                                                         •^
16    point the conceptual aspect becomes less important to the

17    practitioner than the precise language that is down on

18    paper,

19               DR, BRACKEN:   Those are exactly the kinds of

20    comments  we would like to have because I think it is our

21    objective as we edit the OECD guidelines that we, in fact,

22    are not inconsistent, if that is better language.

23               MR, BARAM:  Would you ever get beyond conceptual

24    levels and agreement among the countries?  It is hard for

25    me to imagine that you would get down to practical
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 1   consistencies.



 2              MR. MOONEY:  I doubt if  the Europeans will  look



 3   kindly  at your pathology requirement  that  they  be  American



 4   board certified.



 5               (Laughter)



 6              DR. BRACKEN:  They haven't, to  be  perfectly honest,



 7   and  chances  are  —  I  don't  remember the wording; maybe


 8   Bob  can speak to that, he has been  one of  our experts  —



 9   that it would say something to the  effect  that  "or


10   equivalent."



11              So there will be some  equivalent to  that.   It



12   probably wouldn't get quite that  specific,  I don't even



13   know how the guidelines speak to  that, but it would be at



14   a  higher level in a hierarchy than  seeing  U.  S.  Board



15   Certified because clearly that couldn't be the  case if you



16   are  dealing with testing in another country.



17              MR, FULLER:  It  did get  their attention, though.



18               (Laughter)


19              CHAIRPERSON BENDIX:  Any further comments?   The



20   meeting is adjourned  until  1:30.



21               (Whereupon, at  12:45 p.m., the  meeting  was



22               recessed,  to reconvene at  1:40  p.m., this same



23               ^y,  March 19,  1980)



24


25




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 1                    AFTERNOON  S_ES_S_:iON



 2                                            1:40 p.m.



 3               CHAIRPERSON BENDIX:  If the members of the



 4    Committee who are scattered through the room would come up



 5    front, we would like to convene the meeting.



 6               I am going to be passing around the amended



 7    sheets for the Section 4 regs that were discussed this



 8    morning for those of you who don't already have them.



 9               Mr. DeKany is now going to talk to us about



10    EPA's plan for chemical hazard warning labeling in industry



11    and commerce.



12               MR. DE KANY:  Thank you.  I wonder if you would



13    refresh my memory.  Basically, the labeling program with



14    which we are involved is really a joint partnership between



15    EPA and OSHA, and basically what we have done is split the



16    responsibilities for the labeling program along these two



17     lines.



18               EPA has taken over the responsibility of



19    protocol labeling; namely, how do you label, what sort of



20    information you put on the label, label size, regulation



21    pertaining to which types of containers might be labeled



22    and so on.



23               OSHA has taken on the responsibility of



24    determining the scope of the labeling rule.  Basically,



25    which types of chemicals should be labeled, labeling in the




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                                                           101
workplace, any records keeping or information on chemicals


that relate to the workplace and so on.



           And I will be getting into the specifics of each



agency's responsibility.  Basically, let me start by giving



you a rather broad summary of the features of our proposal



at this point on the labeling of chemical hazards.



           We have broken up our rulemaking activity in two


basic parts, one dealing with the labeling of key hazards,



and the other dealing with chronic hazards, and both


activities fall in different pathways.



           Let me summarize how we propose to handle acute



warning.  Basically, we think the industry has done a great



deal of effort in this area. In particular, the American


National Standards Institute has devised an excellent labeling



system, and that becomes the framework upon which we are



building upon the procedures for labeling acute hazards.



           This system basically treats 13 categories of



health and safety hazards.  The health hazards include



things such as toxicity, corrosiveness of chemicals, those


that cause irritation to eyes, skin, and so on.



           The safety categories within the standard would



include such parameters like flammability, combustibility,



strong oxidizers, reactive materials,  compressed gases and



so on.



           MR. BARAM: These are all bounded by the workplace.




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           MR. DE KANY:  This is the classification,

basically the part of AN.CI,

           MR. BARAM:  It will apply only to the workplace.

           MR. DE KANY:  I will get to that in a minute.

Basically, what I am talking about now is what sort of

acute hazards does the "ANCI .standard,..address?


           Some are health related, some are safety related,

so we have, by and large, adopted that classification of

acute hazard.

           As far as the exclusions of the labeling

requirements  are concerned, we would, of course, exclude

those things  excluded by TSCA, including pesticides, food,

drugs, cosmetics, firearms, and so on.

           We would also at this stage propose to exclude

anything of the nature of articles because articles tend

to be complex mixtures of chemicals.  So this particular

phrase we would not propose that the labels apply to

articles.

           We would exempt from the label requirement

R&D chemicals because there are millions of them, and we

are, however, thinking in terms of a generic R&D label

which would be common to all R&D chemicals to be handled

by professional chemists or something like that, but would

not propose to have the ANCI system apply, to.,that.


           We would also exclude consumer products because,


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     in  this  case,  the  Consumer Product  Safety  Commission  has

     elected  to  do  that.

3               They  are  doing it  now, of  course.   I  am not going

4    down  the whole list,  but we will  also exclude  PCBs because

5    we  have  an  active  labeling requirement there,  so it doesn't

6    make  any sense to  include PCBs  in this.

7               Containers;  As far as  we are  concerned, EPA

8    labeling requirement would pertain  to barrels, drums, bottles,

9    boxes, basically the commercial containers for the commerce

10    and chemicals.

11               We  would  exclude  stationary stores, equipment

12    and reaction vessels.  Those kinds  of items are definitely

13    part  of  the workplace,  and of course  OSHA  is  currently

     investigating the  need  for labeling in that line.

15               We  would  also  exclude  large boat carriers , again

16    primarily because  these are  adequately and currently  regulated

     by  DOT.

18               We are  requiring  a manufacturer importer of a

19    chemical who is distributing in commerce to first of  all

20    determine  the  hazard of that chemical, and if the hazard

21    falls within the category as  defined by MCI to adopt basically

22    the provisions of  the ANCI label.

                And we  also  require that a recipient of a  --

24   commercial  recipient  of  a  labeled container must not remove

25   the  hazard warning  label from labeled containers unless the


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    item is repackaged or relabeled.


               And if you repackage or relabel it, he has  to


    at least carry forth the hazards and hazard warnings.   The


    reason for that, obviously, is that the prime thrust of our


    labeling program is directed toward commercial use.  Workers


    who are handling chemical  drums and so on are aware of the


    hazards contained in those drums.


 8              Of course those who are in the transport end of


 9   it also to be knowledgeable of the things they are getting


10   on board aircraft, trucks  and the like.


11              How does a manufacturer determine whether a


12   chemical is hazardous or not?  Well, we have done a consi-


13   derable amount of thinking about that.


14              We thought we would at first precisely identify


15   protocols for determining whether a chemical is  hazardous.


16   By protocols, I mean requiring, for example, a search  of,


17   let's say, chera tracks  or  something like  that.


18              Then we suddenly realize there are a  great  many


19   references in this area and,  frankly, if we have specified


20   specific sources of hazard information, we may limit the


21   liability of a manufacturer.


22              Therefore f we decided to provide flexibility and


23   make sure that he exercises his knowledge of the area.


24   in other words, we are  requiring that the manufacturer


25   make a reasonable effort to locate existing hazard data in



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     his own files and to take advantage of available literature

                This then, of course, puts a fair amount of

 3   responsibility on his shoulders because I think those of

 4   us in the chemical profession could easily agree upon the

     kinds of data that is available and what a reasonable

 6   manufacturer would do to investigate hazards.

 7              If the manufacturer produces a mixture of

     chemicals and he does not find any hazard information on

 9   the mixture itself, we would allow him to use his judgment

10   and determine what the hazard of the mixture would be from

11   consideration of the hazards of the individual components

12   in the chemical.

13              MR. BARAM:  Could you step back a little bit  on:

14   that liability provision?

15              MR. DE KANY:  I was simply saying that in a

16   situation, looking at the issue should we basically put

17   down a minimum requirement for research, that was one option.

18   We would identify what sources of literature—for instance

19   chem tracks or the journals.

20              The other approach would be to tell a manufacturer

21   you are responsible for determining hazards in chemicals ;

22   you take advantage of the literature.

23              If you take the former position, the kinds of

24   that one are >.if we spell out things you should look for,  then

25   it may relieve the manufacturer from the liability.


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 1              MR. BARAM:  You meant  responsibility.   It  could


 2   be  liability.

 3              MR. DE  KANY:   Sure,  because  he  said  I  searched

 4   all the  things EPA told  me to  search  and I  preferred  the

 5   minimum  — I  followed  the minimum requirements  of the regula-


 6   tion;  therefore, I am  not responsible for  missing something

 7   in  the journal.

 8              I  can see from the  faces I am getting  kind of

 9   boring,  but  if you want  me to  stop, you see,  what I am

*0   doing  is going through ANCI, and  many of you  may  be

11   familiar.

12              So if I am  covering areas  that  you feel you would

13   rather skip,  please tell me.   As  far  as the label, the

14   elements of  the  label  are concerned,  the ANCI system  provides

15   a single word something  like danger,  warning  or caution,

16   and this is  prescribed for each of the 13  hazard  categories,

17   and there are instructions or  triggers as  to  which term to

18   use, which single  one  to use—danger, warning or  caution.

19              There are three tiers, essentially,  of hazards

20   in each  of these categories.   It  also requires  a  statement

21   of the hazard:  for example, corrosive:  causes severe  burns

22   or highly toxic: may be  fatal  if  inhaled.

               These kinds of wordings or statements  of hazard

24   are in ANCI,  However, we would allow the  manufacturer to

25    change his words,  use  something equivalent if it  made more


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sense.

           There are also precautionary instructions required

on the ANCI label; that is, wear a respirator; do not expose

chemicals to open flames and other instructions such as

first aid, instructions in the event of fire, spill or

leak, storage handling instructions.

           These precuationary measures are discussed in the

ANCI standard in our regulations.  However, they are also

left up to the judgment of the manufacturer as to which of

these precautionary measures seem to be most appropriate.

           Also, the name and address of the manufacturer

and importer is required, and if it has been repackaged, the

name and address of the last repackager.

           This is important because often poison centers do

not know who to get ahold of.  Medical people can also write

for data sheets.  So that is the reason.

           MR. BARAM:  You won't have chemical composition

or name on the container of what the chemical is inside, but

would you have a coding requirement?  Because if you called

certain manufacturers, they wouldn't know what you were

talking about because there are so many different kinds of

chemicals out and containers that might be marked danger

or warning or caution.

           MR, DE KANY:  We certainly expect there will be

an identifying name on the label.  When I get to the OSHA


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    part of it, there will be certain requirements  for  revealing

    chemi cal i denti ty.

 3              We would  urge manufacturers  to  use the chemical

 4   identity.  If specific identity is confidential, a  generic

    identity would be desirable.

               We would  set the  use of guidelines as a  trademark.

    The date of the mixture, the date of  the chemical or  mixture

    preparation is also  required on the label,  and  the  reason for

 9   this is often particular trademark chemicals may from time

10   to time be changed in  formula,

11              They may  use one  solvent today  and have  to switch

i2   two and three months later.   So the date of the chemical

13   preparation is also  required,  and that  will enable  the

i4   manufacturer to pin  down the exact formula as to when it

i5   was manufactured.

16              Also,  a statement as to whether or not a material

17   safety data sheet is required or  available would be on the

18   label.

19              There  are things  like  display requirements, and

20   obviously we have regulatory language in there  that says it

21   must be written in English.   It should  be  durable,  visible,

22   et cetera,

23              These  are some  of the  administrative details

24   of the label itself,  I won't bore you  with all of  those.

25              MR, 3ARAM;  What  is a  Data Safety Sheet?


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                MR.  DE  KAHY:   That is  also a very common item in

     industry.   A Material Data Safety Sheet is  a summary of the

 3    information a manufacturer has regarding the health and

 4    safety considerations of his  chemical.

 5               It would give the  specific identity,  if it were

 6    not confidential.   Usually it is  given.  It would give

     important physical chemical properties.  It would give health

 8    and safety data.

 9               Many manufacturers even go so far as  to label

10    chronic data.  I  have seen many who say caution: this chemical

11    is found to be carcinogenic in animal tests.

12               That practice varies between manufacturers, but

13    a Material Safety Data Sheet  is a very, very important tool

14    to those in the chemical industry who are professionals,

15    who are using chemicals and handling chemicals at a stairway

     of learning about a chemical  and  its properties  from the

     manufacturer.

18               As far as the display  requirements are concerned,

19    the only thing of interest to you is we will not allow terms

20    such as nontoxic or safe to be used.

21               Basically, that would  be very difficult for

22    anybody to determine for sure whether a chemical is safe

23    or nontoxic, and I am sure you as consumers have seen

24    many, many labels on consumer products saying nontoxic.

                And that could be  very misleading, particularly if
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 1    the manufacturer is not  sophisticated  in  understanding what

 2    is toxic.

 3              As  far as  updating  labels,  we  will  require that

 4    a manufacturer update a  chemical  label whenever  he  learns

 5    of any new hazard data,  or  at  least  every three  years he

 6    should update  his label,  he should make an attempt  every

 7    three years.

 8              If  a chemical was judged  to be nonhazardous  solely

 9    because  there  was no  information  available,  the  manufacturer

1°    would have to  determine  annually, at least annually, make

11    an attempt to  search  the literature  again to make  sure  if

12    there is new literature  regarding hazards .

13              If  the manufacturer, in any event,  finds new

14    information on hazard, he would have to correct  and update

15    his  label within  180  days of finding new  information.

16              We  also  have  a fair amount  of  recording —  record

17    keeping  requirements. The  reason for  this is  a  study  that

18    the  regulation is enforceable.

19              If  a manufacturer puts out  a chemical without

20    a hazard warning  and  if  information  comes to our attention

21    that indeed this  chemical is hazardous, we would then  go

22    back to  the manufacturer and require him  to produce the

23    various  records that  might  be kept.

24              At  a minimum, he should be  able to  show us  he

25    has  made a good faith attempt to  research the  available


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 l    literature, and he would also have to make available to us


 2    the reasons for any judgments he might have made regarding


 3    the interpretation of that data.


 4               So the record-keeping part of it is a very


 5    important aspect of enforceability of the label provision.


 6               DR. SUTTON:  I have a question.  If the material


 7    is judged not to be hazardous, a label is still required?


 8               MR. DE XANY:  Would not be required.


 9               DR. SUTTON:  What is the signal word?  You can't


10    say it isn't hazardous.


11               MR. DE KANY:  We are talking about acute hazard,


12    13 categories.  If you find there are no data to suggest


13    that any of these 13 categories are not present, then you


14    don't have to label it.


15               ANCI, I think, is fairly definitive.  When you


16    are talking things about flammability, there are numerical


17    values.  If you talk about oral toxicity, ANCI has the


18    figures in terms of milligrams per kilogram of animal —


19               DR, SUTTON:  I am just trying to understand the


20    flow here.  The chemical is evaluated, you have good


21    experience with it, you have done appropriate toxicity


22    testing, and it does not fit any of the 13 hazardous


23    categories and, therefore, you don't put a precautionary


24    warning label on the product.


25               MR. DE KANY;  Bear in mind again I am still



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 1   talking about categories of acute hazard.


 2              DR. SUTTON:  That is what I am talking about.  I


 3   think that is what I am trying to talk about.  Then once



 4   a year are you supposed to do —


 5              MR, DE KANY:  Once a year there is a responsi-



 6   bility placed upon a manufacturer to at  least annually


 7   readdress the label.


 8              Let's take  a scenario where you are producing a


 9   new  chemical and you go to literature.   There is no data on


10   f lammability,


11              DR. SUTTON:  I asked you about a  situation where


12   there is data.  We have developed the data,  done the


13   testing for  acute hazard and have come to the conclusion


14   that there isn't.  Do  you once a year do a literature


15   search then?


16              MR. DE KANY;  Well, yes.  In  the  sense of


17   determining  whether or not there is new  evidence. What  I


18   am  talking about is a  case where there is no data.


19              If you have done all the testing, if you have


20   tested for f lammability, obviously  there is  no requirement


21   to  search  the  literature for  f lammability.



22              Let's take  oral toxicity.  You have searched the


23   literature and you found none, and  you have  not tested  your


24   chemical.  Therefore,  we can?t require you to post  an  oral


25   toxicity on  the  label, but you would then be obligated  at




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 1    least annually to search the literature for oral toxicity




 2    for things  like — frankly,  we would advise a manufacturer



 3    to do it annually, anyway,  in case of new hazards that may




 4    come up,



 5               DR, SUTTON:   I am not sure I yet understand all




 6    of the interfaces here,  but I think I see your problem.



 7    Clearly you are not requiring testing in order to label.



 8    In other words, you are  saying use the best data available



 9    and produce a label, and you don't want to provide testing



10    to do that,



11               So to make sure that that is reasonably updated,



12    you have asked for periodic reviews.



13               MR, DE KANY:   That is right,



14               DR, SUTTON:   Kow specific is that going to be?



15    Not very, I hope.  The point I am getting to —



16               MR, DE KAHY:   I know what you are getting to.



17    Let's suppose you have done all your testing, okay?  You



^    have found that your chemical does not fit into any of the



19    13 categories,




20               You are not then required to label.  Now whether



21    or not you are going to reexamine the literature is really


99
     your game,  your risk, because no one from EPA is going to



23    look over your shoulder,




                But let's suppose that someone else has tested




     your chemical and you found a negative, let's say, in a
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    test and they find a positive.

               EPA would then come back to you and say are you

    aware of the fact that there is new evidence to suggest that

    conflicts with your flammability data or oral toxicity data

    exist.

 6              We would then ask you why didn't you take

 7   cognizance of this new information or did you examine this

 8   new information.

 9              You would technically be in violation if you

10   say, no, I didn't search the labeling literature.  Frankly,

11   I think it is really a non-issue because  it is fairly

12   simple.

13              First of all, you wouldn't test your chemical

14   if there was literature available anyway.  The sequence of

15   events would flow as follows: you would probably search

16   literature first, then if there was missing data, test

17   yourself,

18              So when you were asked to reexamine the literature

19   every year, you wouldn't have to pour over the literature

20   already investigated; you would simply take 1981 literature

21   and review it,

52              So I don't think it is a real  issue.  I wouldn't

23   expect you to go back over the past literature once more.

24   It is just a current awareness kind of program.

25              CHAIRPERSON BENDIX:  Mr, DeKany, are there any


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 1    outstanding issues with  respect to  this  regulation,  any


 2    things  that are  not  yet  settled that the members of  this


 3    Committee  might  usefully —


 4               MR. MOONEY:   How  much time do you have, John?


 5               MR, DE KANY:   I will take off my coat.  It is


 6    getting warm here.


 7               CHAIRPERSON BEMDIX;   You have been presenting


 8    most of this as  pretty well  settled.  Where do you see the


 9    points  of  flexibility?


10               MR, DE KANY:   I  think as far  as the acute hazards


11    part of it, there really shouldn't  be any controversy


12    associated with  it,  at  least as far as industry is  concerned,


13    because basically we have adopted an industry developed


14    system,


15               It has been  developed and endorsed by most of the


16    leading chemical companies  in our industry.  The real con-


17    toversy is going to  come on  the next part, which we  refer


18    to as our  cancer hazard  warning label,


19               DR. SUTTON;   If you don't mind, I would just like


20    to pursue  my point  a little  bit.  I don't want to be


21    troublesome or cause a  lot  of difficulty, nor do I  think


22    this is the most important  issue, but it does illustrate


23    a troublesome kind  of feature.


24               Any time  you  go  from what amounts to a voluntary


25    and sensible kind of system, the one that is specified



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 1    precisely  in our regulation,  you get into difficulty,  and

 2    this  is  a  minor difficulty,  but it is one that is obviously

 3    going to face those people who have to comply with the

 4    regulation,  just as simple a one as the issue of reviewing

 5    the literature once every year.

 6              What literature are we talking about?  Where is

 7    it? Is it  worldwide? How do you really go about addressing

 8    worldwide  literature of everything that is written on 4,000

 9    chemicals  a  year?

10               it gets to be a significant issue for some people

11    that can't be tossed off lightly.  I don't want to try to

12    solve that issue right now,  but I want to make a point that

13    it is not  as simple as it may seem at first glance.

14               MR. DE KANY:  I would probably agree with you

15    to some degree.  However, frankly, what our attention is

16    to here is a simple one: you can't review in 1980 the

17    literature in 1981.

18               Basically, what we would expect a manufacturer

19    to do in 1981 is precisely what he did in 1980.  So the

20    review requirement is to make sure that you don't do this

21    in 1980 and  then not review it until 1999.

22              What we are talking about is simply reviev/ing the

23    current year's journals,  In fact, our position has been

24    somewhat simplified.

25              We feel you are the best judge, and by you I mean


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     the chemical industry,  of deciding which journals  are most



     relevant for your particular chemical.



 3               DR.  SUTTON:   If the reliability is missing data



 4    that is now available,  if it ds not relying on your infor-



     mation, reviewing every biological and toxicological article



 6    published worldwide,  that is another issue.



 7               And  you have converted one kind of liability of



 8    doing a good performance job into a specification  liability



 9    that you can monitor  once a year, and that is a very different



10    duty.



11               MR.  BARAM:  Are you going to specify one year



12    update?



13               MR.  DE KAMY:  For those who do not label, for
14
18
20
     those chemicals that bear no hazard warning label, nine times
15    out of 10 it is because the manufacturer has not tested itf



16    so he hasn't found anything in the literature and he hasn't



17    tested, so the chances are quite good that in a period of
     a year someone else may have investigated that chemical.
19              .Obviously,  a manufacturer who has done all the
     testing is obviously in very good shape.   We are not
21
     intending to hurt a person like that, but by and large,



92
     based on the notices we received to date, we are not getting


90

     acute hazard, let alone chronic hazard.


94
                MR.  BARAM:  Was that part of the ANCI STM


95
     requirement?
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 1               MR.  DE  KANY:   The  mechanism deals  with technica




 2    details  of  the  classification,  the  words  to use on a label.




 3    Obviously,  to adopt it in ANCI,  we  have had to put together




 4    administrative  rules,  and the kinds of things I am talking




 5    about are administrative rules.




 6               MR.  MOONEY:  John, I  have got three questions,




 7    before we get to the question of what are some of the issues.




 8    Let me post them for you.




 9               First,  as a general  comment, as a general issue,




10    why,  given  OSHA's  authority in  the  workplace and DOT'S




11    authority covering the shipment of  chemicals, what is the




12    rationale for EPA's involvement in  what is in the main




13    going to be largely a workplace and shipment oriented




14    labeling group?




15               MR,  DE  KANY;   This is directed to all the




16    industrial  users of chemicals.   There is no question in




17    my mind, based  upon, again, notice, review, experience in




18    Section  5,  that there are some  companies making new chemicals




19    who didn't  even know the feedstock  material.   They bought a




20    generic  compound and we had to  go back and find out what




21    that generic substance was that he  was using to make a




22    new chemical.




23               What we want to make sure is that all the




24    downstream processes are given  the  opportunity to at least




25    be aware of any knowledge requiring acute hazards and






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               .  .                                            119
     carcinogenicity,



               This  is what we  intend  to  do:  to  make  sure  the



 3    purchasing agent down  to  the  engineer who designs a process



 4    flow  sheet down  to the worker has  every  opportunity to



     understand that  this chemical causes  skin irritation.



 6              It is as  simple  as that,



 7              MR, MOONEY; The second question.   I am glad



 8    I  am  asking  simple questions.  The second one:  I don't find



 9    any discussion of the  concept of unreasonable risk in  your



10    preamble.  Perhaps I have missed it,  but you are  citing



11    Section 6 (a)  authority which  deals with  the  requirement



12    for finding  some unreasonable risk,  not  just hazard, but



13    some  unreasonable risk is going to be addressed by the



14    control mechanism that you  are proposing.



15              What  you  are  doing is dealing generically — so



16    I  guess I  am raising the  question of in  what way  have  you



     addressed  the unreasonableness in Section 6 (a)  terms.



18              MR.  DE KANY:   Of course,  our  regulation and our



     technical  support documents will express that.  The bottom



20    line  is we think any manufacturer who possesses information



21    on acute hazards would create an unreasonable risk if  he



22    didn't advise users  of that hazard.



23               Is it reasonable to expect a  fireman responding



24    to a  fire  at a plastics  company being faced  with  unmarked,



25    unlabeled  drums, not know whether one is generating




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 1    hydrocyanide gas,  not knowing whether he should make his

 2    men wear respirators, not knowing whether or not there is

 3    danger of an explosion from heat?

 4               I can  give you anecdote after anecdote;  namely,

 5    fire fighting.  The firemen have been killed and mutilated

 6    and hurt because  they didn't know what chemicals they were

 7    dealing with.

 8               DR.  CAIRNS:  I think Dr. Mooney has a point:

 9    everything you mentioned really dealt with unreasonable

10    risk.

11               There  are lots of hazards that I judge not to be

12    unreasonable.  I  think plain ordinary table salt, if you

13   just dissolve it and want to stick your finger in it for a

14   few hours, you are going to hava a let of irritation: it

15   dehydrates your finger,  I don't think that is unreasonable.

16               MR.  MOONEY:  I would pose a question on that

17   irritation.  The way this is worded I would question that

18   any chemical will  "pass" language.

19               So we  will end up labeling everything.

20               MR.  DE KANY:  Not really because we are adopting^

21   the criterion, the triggers for labeling that have been

--   generated by yourselves .

23               On one hand, you tell me don't label because we

24   have adopted ANCI  and every one of us religiously adheres,

25   and how you tell me it is unreasonable.


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 l               MR.  MOONEY:   I am sorry;  I am raising the


 2   question of unreasonable risk in purely legalistic TSCA


 3   terras, and you are saying there will  be support documents


 4   that address that and we will have to take a look at them.


 5               MR.  DE KANY:  We will weigh the cost of labeling.


 6               MR.  BARAM:  This will be  done for OSHA also.


 7               MR.  DE KANY;  Under this  regulation, we will


 8   have to balance the cost of labeling, the cost of searching


 9   the literature,  all the administrative requirements, against


10   the benefits of labeling and show that the risk of not


11   labeling offset the costs of labeling.


12               MR.  MOONEY:   Okay.  My final general question.


13               MR,  DE KANY:  We do have  a contract report being


14   generated which will address those kinds of issues.


15               MR.  BARAM:  Couldn't all  of this have been done


16   by OSHA itself, which wouldn't have to deal with the term


17   "unreasonable risk."


18               OSHA has other language in its statute and OSHA


19   could come up with the regs also.


20               MR.  DE KANY:  I don't know the answer because


21   I am not that familiar with the authorities.


22               MR. MOONEY:   I am raising the question in that


23   sense if OSHA has not taken action, doesn't that in fact


24   diminish your argument that an unreasonable risk is present?


25               MR. DE KANY:  No, because they felt TSCA was



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           a better vehicle  for requiring the  labeling.
                                                                    122
                       MR.  BARAM:   Your data base  is  much  broader than
           theirs.
        4

        5

        6

        7

        8

        9

        10

        11

        12

        13

Tape 3  14
Side A
        15

        16

        17

        18

        19

        20

        21

        22

        23

        24

        25
            MR. DE KAISJY:  This goes beyond just the workplace;

we are dealing with items in commerce.

            DR. EISENBERG:  If your concern were, to some

degree, the situations you described--firemen or emergency

personnel, a transportation accident or something like that--

I notice that what is specifically excluded is cargo

containers, shipping containers, anything other than barrels,

drums and things like that, so if someone were shipping it

in a tank car, it would be excluded from the labeling,

regardless.

          MR. DE KANY;  We are dealing with totally different

labeling needs.  We are dealing with large tank trucks.-  The

details like the size of the label, the information it

conveys, obviously you can't take a petroleum tanker and say

caution, benzene, breathing gasoline is dangerous to health.

          That is not the hazard of transportation.  You have

a great big flame symbol and basically contents flammable,

explosive.

          So there is a different need for hazard information

in large cargo carriers.  Tankers, even liquid chemical

tankers, are labeled.

          There are some very good, both domestically and

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 l   internationally developed, systems for handling hazards  123




 2   in transportatation.




 3             MR. MOONEY:  DOT goes considerably beyond tank




 4   cars. I see considerable potential for overlap.




 5             MR, DE KANY:  That is why we are saying we don't




 6   require it for shipment.  In other words, if the DOT label




 7   is on your container, it is not required to be duplicated.




 8             In other words, that is what the situation is with




 9   the  tanker.  You would not have to put an EPA label on a




10   tank truck or an outer shipping box.




n             Let's say you may have  100  jars of chemical substanc




12   within a  great big shipping carton.   The shipping carton would




13   bear the  DOT label, the individual labels themselves, just




14   the  way it is done now for those  that voluntarily label.




15             MR, MOONEY:  My last point  is there are deviations




16   from the  ANCI voluntary program in the standards or tests.




17   Does your support document address those as why you have




18   chosen to differ?




19             MR, DE KANY 5  Yes.  We  are  also at this point




20   proposing or will propose for comment the adoption of the




2i   European  labeling system which, in some respects, might be




22   more useful  than the ANCI labels.




03             They have developed a thorough system of symbol.




94   We have one  symbol, a skull and crossbones, but they have




95   a symbol  for flammability, a symbol for skin burns, and so






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                                                             124
    forth.

              Things  like  that will be  contained  in  our proposal.

    We have  asked  for public  comment, does  it make sense  for  us

    to adopt the European  community international symbol  language;

    should we adopt  the  language proposed by the  U.  N.

              Those  kinds  of  issues will be brought  up in the

    preamble in  the  proposed  regulation itself.   Obviously, the

    reasons  for  considering the European community is  for

    harmoni zation.

10             We will still be  faced with two systems  of  labeling

11   for  those who  import and  export.

l2             CHAIRPERSON  BENDIX:  Are  there any  other questions

13   on this  portion?

              MR,  BARAM:  John was going to talk  briefly  about

15   the  cancer labeling.

16             CHAIRPERSON  BENDIX:  That is  going  to  have  to be

    very brief because we  have  two more people  to hear from before

18   3 o'clock.

              MR.  DE KANY: We would propose that any  chemical

20   substance designated as a carcinogen would  be subjected.   By

21   that we mean the Administrator would put out  a published  list

22   of carcinogens .

23             This list  likely would be obtained  from  the Cancer

24   Assessment Group in  EPA,  from NCI Reports,  and  from OSHA  lists

25   but  there would be a very specific  list of  chemical substances

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                                                              125
     which, by tests, have been shown to be carcinogenic.

               In that event, that mixture for chemical substance

  3   would have to be labeled with a cancer warning, and this likely

  4   of course, would be very controversial.

  5             I have been asked to keep it short, but obviously

  6   no one would like to label their product with a cancer

  7   warning, for obvious reasons.

               Secondly, there may be great concerns and

  9   anxieties about how a chemical gets on the Administrator's

 10   list.

               These will be some very important issues.  The

 12   issue as to how do you handle a mixture when a carcinogen

 13   is present in a part per million level, our suggestion on

 14   that is there be a .01 threshold for a carcinogen unless a

 15   manufacturer deliberately added a carcinogen.

 16             In other words, if there was a carcinogen present

 17   as a by-product, we would not require it to be posted unless

 18   it is more than one percent.

 19             On the other hand, if it is something the manu-

 20   facturer deliberately adds —

 21             MR. BARAM;  There is no list — EPA list now, is

     there?

23             MR. DE KANY:  There is a NIOSH ACAG list.  We

24   will propose in a proposal we will present that list.  It

25   will be proposed the chemicals will be listed and the source


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                                                             126
    of  these  chemicals  through  GAG,  IRI, NCI  and  so  on.

              DR.  EISENBERG:  That  doesn't  seem to make  any  sense

 3   from a health  effects  standpoint at  all.  Why would  you  be

 4   concerned whether it  is  added intentionally or unintentionally,

 5             If the  tenth of one percent is  serious  or  something

 6   that one  should be  concerned about,  why is it relevant whether

 7   it  is intentional or  unintentional?

 8             MR.  DE  KANY:  Because we could  not  put a threshold

 9   if  it were not for the cost implications.  It is  probably

10   fairly arbitrary.

11             People  begin to argue about the .01 percent.

12             DR.  EISENBERG:  I am  not questioning the tenth of

13   one percent; I am arguing whether it is intentionally or

14   unintentionally.

15             MR,  DE  KANY:  There is no  analytical cost  if you

16   add it intentionally.  It is simply  to  lessen the burdens of

17   analytical costs.

18             DR.  CAIRNS:  Suppose  you did  the analysis  and  you

19   found it  was less than than the tenth of  one  percent.  You

20   wouldn't  have to  put  it  on  the  list  if  it was unintentional.

21             You should  drop the second part of  your proposed

22   rule because what you are telling us, I think, is that two

23   different things  can  come out,  two different  chemicals,  each

24   with the  same amount  of  carcinogen in them.

25             In one  case it would  be reported.   In  the  other


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 l  it wouldn't, and I don't think that makes sense.


 2            MR, DE KANY:  I am not happy.  I would rather remove


 3  the  .01 entirely.


 4            MR. MOONEY:  You will still have to  meet  the


    unreasonable risk test for carcinogenicity.


              DR. EISENBERG:  What happens if I do analyze and


    I do  determine it is  there but I am not adding it intentional!


    as a  product?


 9            In other words, I don't need it there.  It happens


10  to be a by-product of the process.  If I could avoid it,  I


11   would, but  for one reason or other I don't, and it happens


12  to be there incidentally.


13            MR. DE KANY:  Do you want an answer?


14             DR. EISENBERG:  Sure.


15             MR. DE KANY:  You should label it.


16             DR. CAIRNS:  But that is not what your proposed


17   rule  is,


18             MR. DE KANY:  I am sitting here as a person con-


19   cerned about public health, as a professional, and if you


20   know  there  is a carcinogen in there, you should disregard


21   what  EPA's  regulation is there,


22             DR, EISENBERG:  Why don't you say that in  the


23   regulation?


24             MR, DE KANY:  We will put it in the preamble, but


25   the point is the industry is coming in and arguing not about



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10


11


12


13


14


15


16


17


18


19


20


21


22


23


24


25
                                                         1 "I O
.01, but the industry is arguing vigorously it ought to


be one percent.


          DR. EISEWBERG:  Whatever level you determine, we


will still have the second question: whether, in fact, it


is intentional or unintentional.


          MR, DE KANY:   It certainly is something worthy to


think about,  If a manufacturer analyzes it and it is known


to him, he should post it.


          That would be one suggested part of the proposal.


But, strictly speaking, the .01 was put there to alleviate


the burden of extremely expensive analytical costs.


          It is very liberal:  a thousand parts per million.


It is very liberal.  But that is the main reason for it.


Now, frankly, I don't think I should have to sit here and


tell you what should I do if I know there is carcinogen in


there.


          You have to look at it as a responsible manufacturer.


          MR. MOONEY:  You shouldn't have to.  I think you


will have to meet the test of establishing a tenth or a


hundredth or one percent or whatever you are talking about


constitutes an unreasonable risk.


          MR. DE KANY:  Why do I have to do that?


          MR. MOONEY:  You are making the rule.


          MR, DE KANY:  We will do it for .01.  I feel


comfortable with that.



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                                                              125)
 1             DR. CAIRNS:  You have to demonstrate an unreasonable



 2   risk>! not just say that you think it is okay.



 3             MR. MOONEY:  .01 percent or any other level, per



 4   se, does not necessarily constitute an unreasonable risk  is



 5   all I am saying.



 6             MR. DE KANY:  On what basis do you make that



 7   statement?  Would you share with me a technical analysis  or



 8   is it simply your opinion against my opinion at this point?



 9             MR. MOONEY;  Probably the latter.



10             MR. DE KANY:  We would weigh the benefits.  I asked



11   you how much would the words "caution, suspect carcinogen1'



12   cost you.



13             Do you put a label on a product?  How much does a



14   multi-colored corporate logo cost you versus the cost of



15   three words saying, "caution, suspect carcinogen"?



16             MR. MOONEY:  I don't think the economics are



17   terribly important.



18             MR. DE KANY:  The buyer may avoid it like the



19   plague when he has got somebody else selling something that



20   is not a carcinogen.



21             We should be equitable, we should require all


99
    competitive comments are evaluated on -the same basis.



              CHAIRPERSON BSNDIX:  I am sorry; we are going to



•4   have to call it quits on this point because we have got



"5   other things we have to discuss.
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 l             I don't know how the rest of you feel, but I would


 2   like to make a request that on our agenda for the next


 3   meeting that we set some kind of a minimum time, like 45


 4   minutes or, better yet, an hour for each agenda item so we


 5   don't end up with this feeling of not being able to finish


 6   discussion.


 7             MR, BARAH:  Could John tell us where the status


 8   of this is right now, what is the next step, how is this


 9   going to proceed—just a time frame.


10             MR. DE KANY: I think this dialogue is helpful for


11   me.  The point is, we haven't even posted yet.  I think I


12   should point out that everyone in this room knows what we


13   are up to.  They have got copies of the drafts.  We will be


14   talking to manufacturers .


15             It is our aim to get a proposed notice out.  I


16   always eat my words on dates, but April, May, thereabouts.


17             MR. BARAM:  With OSHA.


18             MR, DE KANY:  Yes.  And then we will go over these


19   issues once again, and I think what I am hearing is that


20   the burden of unreasonable risk is upon our shoulders , and


21   I agree.


              MR. BARAM:  As long as you are going into it with

93
    OSHA, you have got OSHA's statutory authority,also.


24             MR. DE KANY:  Their part of it will be dealing

95
    with how to label process vessels, et cetera, fairly detailed
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                                                             131

    record-keeping requirements in the workplace:  names of


    specifically chemical substances manufactured in the workplace


 3   will have to be kept and posted in certain places in a work-


 4   place.


              They are basically aiming at providing workers


 6   with access to chemical identity and hazards at reasonable


 7   places in a company.


              MR. MOONEY:  When you talk about OSHA lists, are


 9   you talking about Category 1, Category 2 listings under their


10   new cancer policy?


11             MR. DE KANY:  The manufacturer will have to keep


12   the names of all chemical substances manufactured in a work-


13   place by identity and hazard and make it available to


14   workers, if they so desire.


15             The limitation on this will be, however, that it


    will only cover the chemical identities in our inventory


17   and in the registry of toxicological effects.


18             There are about 50,000 substances thereabouts in


19   our inventory and 33,000 in the register.  Roughly speaking,


20   it will cover maybe 60- to 70,000 chemicals.


              The requirement is there: is there access of

99
    chemical identity and hazard to the worker.


              MR. BARAM:  Do you see a need for other Section 6


~4   rules?  Do you think there will be less need to regulate on


25   Section 6 on a lot of these chemicals?
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                                                             132
 1             Is that one of the benefits that might come


 2   about?


 3             MR. DE KANY:  This won't, of course, relieve


 4   resource requirements to us to individually tag chemicals


 5   like we had to in the PCB case,


 6             We take advantage of what is an internationally


 7   recognized system.  It was developed by our industry.  The


 8   main issues are administrative rules of how to apply this


 9   system of labeling to the industry.


10             Obviously, there is some difference of opinion


11   there.


12             CHAIRPERSON BENDIX:  Thank you very much,


13   Mr. DeKany.  I believe Blake Biles is here and wants to


14   very briefly present something to the ATSAC.


15             MS. RAMSEY:  Is Mr. Robert Bohen here from 3M?


16             MR, BILES:  All I want to do is tell you what is


17   here, particularly because if you mail it, it will become


18   public document, and I wanted to get it in the hands of those


19   of you who are here, and I don't want to hear a week later


20   everybody saw it before we did.


21             What I have done is pull together a couple of


22   materials, with one exception that I will mention in a


23   second.


24             The cover memo that goes with it, you need to


25   make two or three edits on those.  There are some additions



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     that are not represented in the cover memo.


               What I have pulled together is listed in the cover


     memo.  As most of you are probably aware, we received a


     letter from Senator Muskie asking questions about:— enclosed is


     a copy of the memo in response to Senator Muskie.


               The caveat is that this still has not been signed


     by the Administrator, but I am going to provide it to the


     Committee in the hope that it does not change before it is


  9   signed,


 10             That is Attachment A, and that is there.  The


 11   second is listed on the cover memo; provision of a number


 12   of the 5D2 Federal Register Notices.  Those are not attached.


 13             You have those in your other larger packet.  Those


 14   are a big group of things, and they are not in the clip here.


 15   The third and fourth things listed on' the cover memo are


 16   attached: the test marketing exemption materials, and the


 17   other materials are some responses that we have sent to


 ^   companies who have submitted -- provided submittals to us


 19   that we deemed incomplete and therefore returned.


 20             And what we provided here are a couple of the


 21   letters that we sent back to the company specifying grounds


 22   that the submittals were incomplete,


 23             There are three or four other things that I just


     want to identify for you, and of course at a separate meeting


25    I will be glad to talk to you about it.
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                                                             134
 1             Most of these are in the public record.  First,



 2   we have attached two or three of the 5C extension review



 3   period notices, including one that is not Federal Register



 4   print, but that is basically typed like this.



 5             It is one that was signed last week, and it is in



 6   the Register or will be in this week.  It is extending the



 7   review period on one of the PMNs we have in the process.



 8             Second, towards the last, is a coalition of status



 9   of PMNs,  This is an update of one that is being sent to



10   Senator Muskie,



11             This is a more recent one: March 12th.  These are



12   some of the tables we have developed—over 80 by now—and



13   sort of the status of them, the types of information



14   received, basic indexing of types of information by company



15   size and so forth.



16             Those are the other materials , and the finally the



17   very last is an example or a copy of one of the 5D3 Notices,


18   which is-'.a section in the Act which requires us to publish



19   monthly.  That is all.  I am prepared to talk about anything,


20   of course, but that is all I felt the need, given your



21   time limits, to present, an explanation of what they were.



22             The one thing I mentioned in the cover memo that



23   is not here, as I have indicated previously, we would be


24   quite willing to meet and discuss with you.  It is just



25   that it is my judgment that we do not want to run off 30




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    copies of them.

              As I mentioned in the cover memo, this does not

3   include internal documents to be generated during our review


4   of notices, assessment reports and so forth.

              Any time in the  future we would be  glad to sit

    down with a committee of ATSAC, Section  5 Group, and provide

    you with some of those to  talk at as examples  of our assess-

    ment process,

9             I think it is inappropriate for us  to take them

10   as examples of company submittals, but  these  kinds  of

11   documents I gave you don't give you a total picture of  our

12   assessment because it doesn't represent  the internal docu-

13   ments.

14             We will be glad  to share some  of those with you

15   to the extent they don't contain confidential business

16   information,

17             My preference for doing that would  be to  do it

18   with meeting with the subcommittee and walk you through some

19   of the examples of the documents generated and not  focus  on

20   the specifics,

21             That is the thing that is missing,  and we would

22   be willing  to meet with you at any time  to talk about this.

23             CHAIRPERSON BENDIX:  Thank you very much. I  think

24   now Mr. Kovalick has been  waiting very  patiently, and I think

25   he has another meeting at  3 o'clock.  He now  gets his chance.


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              MR. KOVALICK:  Well, our adjusted agenda.  I


    was going to talk to you about two topics.  One was in work


    group format, public participation and Section 8 record-


    keeping and reporting rules,


              Marsha tells me that I should confine myself to


    Section 8 record-keeping reporting rules  and  the status


    report on where we are, primarily, on 8(c)f 8(a) and 8(d),


 8   if that is correct.


 9             CHAIRPERSON BENDIX:  I think that is a good deal


10   to cover in the next 20 minutes,


11             MR. KOVALICK:  All  right.


12             CHAIRPERSON BENDIX:  Particularly since  the


13   Committee will probably have  questions.


14             MR. KOVALICK:  I  am not going to give, you this


15   paper unless you want it, but I did  hand  out  two meetings


16   ago a chart that looks like this.


17             It has the status of our rules, and I won't give


18   you another one unless you  would like them.   It is the same


19   one.  It hasn't changed substantially.


20             At any rate, since  we last met, we  did publish


21   in the Federal Register on  February  29th  the  8(a)  Level A


22   rule that I think I briefly discussed.


23             This is the proposed basic information gathering


24   rule to gather preliminary  assessment information, and we


25   are now in the public comment period.


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              As is usually the case when we propose rules, we




    haven't gotten too many official comments because they




    usually come in the last day.




              We are planning at least one if not two public




    meetings, and we anticipate at least one of those not to be




    in Washington, which I am pleased to report.




              We are working with our Industry Assistance Office




    to make those arrangements.  So the comment period closes




    May 6th and both of those public meetings then would be held




10   before May 6th, before the end of the comment period.




11             That is the status of that, and we would anticipate




12   having comments come in in the early part of May.  That will




13   take us 60 to 90 days to wrestle with all of them and hopefull;




14   have a final rule ready to wind its way through EPA in June




15   or July, to be published by the end of the fiscal year, which




16   will be in September.




17             We are getting ready, then, to put into place our




18   first major rule that serves.ithe risk assessment process




19   which you have discussed at one time or another with




20   Warren Muir, and this is one of the primary uses of these,




21   and this information is to help that process.




22             I might add that the other levels, 8 (a), the levels,




23   more detailed levels of information, that would be more than a




24   12-question questionnaire are under way.




25             We have been meeting throughout EPA in the water





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                                                              138
 1   and air programs and been meeting with NIOSH, OSHA and



 2   other agencies to discuss their needs, and we are manifestly,



 3   therefore, intent upon building into Level B and C rules  the



 4   kind of information that they c an use in  the spirit  of  TSCA



 5   and not duplicating what others have gotten, but provide



 6   them access  to information  that we  alone  can gather.



 7             So we  are looking forward to having Level  B



 8   proposal  in  late summer, probably around  the same time  we



 9   finalize  Level A.



10             The 8(d), the submission  requirement  to submit



11   lists and copies of health  and safety studies,  was proposed



12   when you  met last December  31st,



13             The comment period for that rule closed February 29tji



14   and we have  recently published an extension of  the comment



15   period, primarily for two reasons,  one of which we have a



16   number of requests  from different individuals and companies



17   to extend the comment period for a  variety of reas.ons,



18   including a  number  of things for TSCA.  That is out  on  the



19   table now,



20             The second reason is that the public  record  for



21   8(d) was  not entirely in order and  everything wasn't in it



22   during the entire comment period.



23             So we  have rectified that and it is now in order,



24   and it is now available for anyone  who wishes to review it.



25   So that  30 days  didn't come on the  date we started,  so  it is





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    30  days  after the publication date,  which will lead us




    towards  the beginning of April for closing comments on



    Section  8(d), and we also have been  holding,  as the Federal




    Register Notice announced, a number, by request, of public



    meetings. Individual or trade associations or others can




    call up  and say we would like to  talk with people who  are




    working  on the rule,



              And we have scheduled two  or three days worth of



    those so far.  They are on the record, and the transcripts



10   appear in the public record.



11             That is for a more personal e xchange rather than



12   a more postured issuing of public statements.  The 8(c)



13   rule,which I believe I talked about a little bit and got into



14   some detail last time, was the requirement, the statutory



    requirement, for record-keeping of allegations, significant




16   adverse  effects to both workers and consumers, and a probable




    proposal for reporting of those allegations is now in



    Mr, Jellinek's office.



19             We have completed one of the major milestones in



20   doing that kind of rule.  It is called the Reports Impact



21   Analysis, the burden of those required to comply.


99
              And that was .an,...extensive, effort because in a




    thoughtful reading of TSCA you realize that the standard



24   industrial classification code, the SIC codes — we normally



25   think of when we think of TSCA those in chemicals and the




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 1   chemical portion of the Pharmaceuticals.


 2             SICs 2829 are far and  away not  the only  SIC  codes


 3   affected by this rule.  Anyone who manufactures  or processes


 4   chemicals — that means the applications  of chemicals  like


 5   paints and so forth.


 6             So the number of SIC codes starts back with


 7   mining and metallurgy  and almost comes  up into interstate


 8   wholesaling.


 9             We have to figure out  how many  processes there


10   are in that crowd.  It is a fairly heavy  effort, and we


11   have  to do some research in the  Bureau  of Labor  Statistics.


12             This is done now and so we begin our approximately


13   four  to six-week process to get  to the  Steering  Committee,—


14   Henry Beal is going to go through all this — the  process to


15   get it to the Administrator's desk, and then we  will have


16   a proposal again for comment coming out,  and I hope by the


17   end of April.


18             And this is  a rule that I am  particularly


19   interested in that we  have non-Washington pub.lic hearings


20   on,   If there is any useful input we can  get from  those  whom


21   we affect when writing a rule that affects consumers and


22   employees and their ability to make allegations, this  is it.


23             So we are most intent  about having a balance of


24   non-Washington as well as Washington-based public  meetings.


25   I have used about half my time,  and I will stop.



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              CHAIRPERSON BENDIX:   Thank you very much.   Any



    questions  or comments?



 3             MR.  BARAM:   A quick  question.   This 8(c)  rule you



 4   are talking about,  the allegations rule, those records are



    kept by the different manufacturers themselves?



              MR,  KOVALICK:  Yes.



              MR.  BARAM:   How did  OSHA's medical record contention



 8   of rulemaking come  out because that would be an important



 9   parallel development?



10             MR.  KOVALICK:  If we are talking about the same



11   thing, the last I knew, that was in their Solicitor's office.



12   I believe we are talking about a requirement to keep medical



13   records by the name of the individual.



14             We are talking about keeping an allegation by the



15   name of the chemical.



16             MR.  BARAM:   I see.



17             MR.  KOVALICK:  The problem we have, as you can



18   imagine, on first keeping the  records, when we say, do you



19   have any allegations, if you write a letter on cast number



20   so and so, it would mean looking through or having a



21   computerized set of employee medical records.



22       .      It is not fair to the vast majority because the



23   vast majority of people do not have that kind of system.  It



24   is not what you would call overlap and duplication.  We can't



25   make those mesh and still have undue burden.





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 1             I don't think that requirement is out, but I



 2   could be corrected,  I am sure.   Dr.  Sherman would know.



 3             DR,  CAIRNS:  I notice the  agenda mentioned also



 4   AD reports,  I am still interested.   Perhaps there is some



 5   in that package we got this morning.  Is there?



 6             What I was particularly in is what impact these



 7   have had, what action has been taken which resulted in



 8   improving health and safety.



 9             MR,  KOVALICK:  Yes.



10             DR.  CAIRNS:  Perhaps if that is in here, I will



11   read it.



12             MR.  KOVALICK:  I am not sure what is in there,



13   Marsha.



14             MS.  RAMSEY:  All that is in there is a compilation



15   of some of the AD notices that we have gotten after those



16   that were used for a compendium that is supposed to be coming



17   out next month.



18             MR.  KOVALICK:  We are going to be publishing a



19   compendium of all the status reports, a page or two-page



20   status report that they write up and an AE Notice is



21   submitted.  That is  going to be notices available in the



22   Federal Register.



23             What you have in your packet is a log listing of



24   notices received since the date they went to press.  In



25   other words, it is the more current issues.




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 1             Those two answers don't address your question,

 2   which is the fact that we have, if you look at the statistics

 3   of some 300 AE Notices, a number of them seem to be obvious

 4   to us---the Assessment Division, NIOSH or OSHA probably many

 5   of them, 120 or so, and we have been discussing whether we

 6   need to, as a matter of fact, last week, execute some kind

 7   of more formal agreement wi.th particularly NIOSH or OSHA

 8   and haven't reached a conclusion on that because — a couple

 9   of reasons.

10             One is we have an Assessment Division that keeps

11   an inventory or a stack of the forms NIOSH makes available

12   to any employee or employer where they can request a NIOSH

13   special survey, hazard survey, which they are required to

14   conduct, if requested.

15             If, as a matter of routine, we get a AE Notice

16   that seems to reflect occupational problems, we will send

17   the submitter a form so they know they have this right to

18   pursue their own follow-up.

19             The other reason that it may not seem obvious

20   is that we have a number of things we are asking other

21   agencies to do for us.

22             We are asking them to search their files for

23   &(a) and 8(d) information.  We are asking them to search

24   their files.  We are asking them to cooperate with us in

25   developing asbestos information, labeling information, so


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 1   when we go over with our men on .the side.,, they have to


 2   implement the Occupational Safety and Health Act or the


 3   Consumer Safety Act.


 4             So we do have to make a judgment about which of


 5   our major responsibilities are going to be the subject of


 6   formalized Memorandum of Understanding.


 7             I forgot the PMN Program.  That is up in the toss,


 8   and 8(e) has not come to that threshold yet.  So the NIOSH


 9   solution seems to be a pretty good one for about half of the


10   notices that seem to be occupationally related.


11             The Consumer Product Safety Commission also has


12   a hot  line, and they do log in and track consumer complaints


13   Those  that seem to be a consumer product have another avenue,


14             It is not immediately obvious that we need to


15   develop a bureaucratic and in the public administration


16   sense  arrangement where we get a report back from them every


17   month  on the ones they take in with their system and the


18   ones they don't.


19             DR, CAIRNS:  What I was really reaching for was


20   what has happened that is positively good as a result of


21   over 318 notices, not the mechanics but the actual results.


22             MR. MOONEY:  To say it another way, how many has.*


23   the Agency meet the 8 (a) test.  Unfortunately, I am not


24   the evaluator of the 8(e) Notices; I only look at the small


25   percentj the so-called emergencies, and I sign those letters



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 1    that  go back  to  the submitter  as  to whether they  are  a



 2    true  8(e) emergency.



 3             DR.  CAIRNS:  Have some  of them been  true  8(e)



 4    emergencies?



 5             MR.  KOVALICK:   They  were reportable.  They  should



 6    have  been reported as  a water  spill.   The  person  probably



 7    did that and  reported  it  to us and we  are  advising  them by



 8    error so much dye and  you should  have  called,  and they  usually



 9    do.



10             The ones I see, the  ones I evaluate, we haven't



11    seen  that many.  The ones — I can't think of  an  example,



12    but there are some odd ones, such as an explosion,  a  chemical



13    spewed all  over  the neighborhood, where the spill doesn't



14    obviously apply,



15             I can't think of one offhand, but the chemical



16    dissipates  in 15 minutes, and  so  the reporting mechanism we



17    have  means  you have to send in a  letter within 15 days.



18             So  it  is isn't  an emergency  response section  we



19    have  under  TSCA.  That is still vested in  the  emergency



20    response side of EPA.



2i             Emergency 8(e)'s, which are  10 or  12 out  of 300-



22    plus, are kind of a fish  out of water  relative to the ones



93    who  say, we  have completed a  rat study and it has  these



24    effects or  we have an  interim  result.



95             For example, the results on  formaldehyde  reported





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    by a firm.  Those you should have Joe Mirinda come in and

    discuss.

 3             Generically, I know they are funneled into leads

 4   for their assessment process to write the ship chemical

    hazard profile, and some become evidence to support a

 6   test rule where we already have information on a chemical.

 7             So there are those connections,

 8             MR. MOONEY:  Again, maybe what you are saying

 9   says that you are not the right person to address the

10   question to, but then have you drawn any conclusions about

11   what all this tells the Agency about 8(e) and its guidance?

12             MR. KOVALICK:  My conclusion on the vast majority

13   of them is  that they are finding them a valuable set of

14   leads for the risk assessment process and for knowledge

15   about additional chemicals that should enter that process.

16             We always have a cue of chemicals ready to go

17   into the risk assessment,When an 8(e) notice comes in that

    has serious information, it can cause a chemical to move

    to the top  of the cue which wouldn't ordinarily be there.

20             MR, MOONEY:  That is what I would anticipate. I

21   haven't seen anything come out at the end of that height

22   yet, but I  guess —

23             MR, KOVALICK:  That perhaps bears discussion of

24   how long that process takes.  I think you had a meeting

25   with Warren in a small attempt to look at the available


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      literature.

              It will be a three to five-month process to  look

    at the actual risk where they actually evaluate studies


    available.

              Given that 12- to 14-month horizon, it is not

 6   surprising you may not be able to see a whole slew of  8(e) 's

 7   coming out the other side.

 8             MR. MOONEY:  The 12- to 18-month horizon makes

 9   15 days seem rather precipitous, doesn't it, in terms  of

10   a company's reporting in the first place?

11             MR. KOVALICK:  Those are the emergency ones.

12             MR. MOONEY:  8(e) bears on the whole spectrum of

13   reports,  not just those that are just emergency,

14             MR. KOVALICK;  Yes .

15             MR. MOONEY:  The 15 days seems, at  odds to me with

16   the process, the response process, that  then takes  12  to  18

17   months.

18             MR. KOVALICK:  Oh.  Dr. Muir should probably talk

19   that  is the standard process.  The process,  for example,

20   making a  4(f) judgment.  We have to make a regulatory

21   decision  with 180 days, so each moment of that  time becomes

22   very  valuable.

23             If we get information that there is indication

24   of widespread injury or harm from a carcinogen, mutagen,

25   teratogen, we have to make a decision within 180 days, and  a


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Tape 3 25
Side B
half a year is not that long, given what you hear about a
                                                                    148
process
leave.
          MR. BEAL:  Is that my introduction?  I won't
          MR. KOVALICK;  Don't leave.
          CHAIRPERSON BENDIX:  Any more questions of

Mr. Kovalick?

          MR. MOONEY:  I don't know if you see where I am

headed with that line of questioning that 8(e) guidance

with its various ambiguities created a lot of uncertainty

within the industrial community, particularly immediate

response requirement in our  180 days, and now we see nothing

happening.

          MR. KOVALICK:  You have an ability to find out

what the process is, perhaps more than the average person,

so you may want to inquire about those 8(d)'s that have

entered the risk assessment, either the rapid one or the

slower one.

          But the fact that  the notice comes in quickly

doesn't make it any easier for us to conduct the work.

Well, I hope next time I will be able to report that we are

ready to start our discussion on 8(c), too,

          CHAIRPERSON BENDIX:  We hope so, too.  Thank you

very much.  We seem to have  lost a few of our Committee

members.  I suggest we take  advantage of a moment to stretch

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 l             ( thereupon, a recess was taken)

 2             CHAIRPERSON BENDIX:  I would like to reconvene  the

 3   meeting, please.  We will hear now from Mr. Henry Beal,

 4   Director of Standards and Regulations Evaluation Division,

 5   on EPA internal procedures  for rulemaking, and I would  like

 6   to point out to everybody,  in view of some of the points

 7   being made in our discussion this morning, that this  is the

 8   key question of where the time goes, and  anything that  we

 9   can learn from Mr. Beal about the internal procedures for

10   rulemaking should help us to deal with the question of  what

11   might be done to expedite the process.

12             MR. BEAL:  Thank  you very much.  I will try to

13   speak loud enough so the folks in the back can hear,  but

14   I would like to stand up here so I can use the chart  which

15   the folks at the table may  be able to read.

16             There is some fairly small printing on some of

17   the slides, but for those who can't read  it, I will be

18   talking to the points, anyway, so you will be able to pick

19   up the substance.

20             EPA's rulemaking  process is designed to help  its

21   senior managers make decisions in an environment of consi-

22   derable uncertainty and in  an organizational structure  that

23   is a highly complicated and in which we have to work  to

24   draw on a wide variety of disciplines to  help us solve

25   environmental problems.


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 1             The  process  that we  have designed to do that has


 2   been fairly  widely  regarded in the Government as  models of


 3   how one  ought  to  go about it.

 4             There are many questions left as  to how well we

 5   all work within these  processes,  but the designs  themselves


 6   have been regarded  rather well,

 7             Among those  who have regarded them well is  the

 8   White House, who used  EPA's process as the  basis  for  its

 9   Executive Order 12044  on improving Government regulations,

10   an order that  came  out a couple of years ago and  applied

11'   to the other executive agencies and asked them to set up

12   rulemaking processes that met  certain characteristics,

13   which characteristics  consist  in general of ensuring  that

14   senior managers in  each of the Government agencies exercise

15   effective oversight over the decisions.

16             Decisions are not made by junior staff  people

17   and then whirled through some  pro forma signature routing,

18   but in fact our senior managers focus in on what  is important

19   that we provide for meaningful public participation,  that we

20   ensure that we have identified the alternatives available to

21   us, and that we analyze those  alternatives  so we  know what

22   we are getting when we choose  one or the other of them.

23             Another feature is that we want a systematic

24   review of the  regulations that we have written and that we


25   do write, that we have some sort of an evaluation plan to ask


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 1   ourselves how are we doing after v/e have done it.

 2             And, finally, that we write these regulations

 3   clearly, that they be in plain English and understandable to

 4   the people who have to obey them.

 0             We do this in an environment of some considerable

 6   complexity.  EPA has 12 statutes that it administers.  That

    is more than any other of the regulatory agencies, and they
 Q
    are highly complex pieces of legislation often requiring
 a
    decisions, as you folks here are more familiar than me,of
    what science is able to tell us about both the nature of

    health problems and the risks they impose.and at  the edge
12
    of our technological capacity to solve them.
13
              EPA responded to Executive Order 12044, which
14
    asked us to develop this process largely by just  shaping

    up and improving on and hopefully making a little more
1 fi
    efficient and effective the process we already have, since

    it was the same process that 12044 enacted.
18
              What we have now in place as our system is a
19
    four-stage process for handling regulations that we regard
20
    as significant.Because there is such a substantial number
21
    of these significant regulations in the works at  any time,
22
    it really isn't reasonable to expect our senior managers
23
    to be able to deal with all of them to the same degree of
24
    attention.
25
              So one of the primary characteristics we wanted
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 l   to build into the system was some way of prioritizing what

 2   it was we were doing and then to manage the system in a

 3   way that reflected those priorities.   Yes,  sir?

 4       .      MR. BARAM:  Can you tell us what  significant means,

 5   how you measure significant?

 6             MR. SEAL:   I will be there  soon.   Finally, that we

 7   do improve our Outreach Program, that we find some way of

 8   bringing into the decision-making process people outside the

 9   Agency, both here and pay attention to their views more

10   successfully than we had been doing or indeed are doing now.

11             So those are the three features we were paying

12   particular attention to when we went  through a redesign in

13   regards to 12044.

14             We had a lot of significant regulations.  It seems

15   like a lot to me.  We have 190 in process right now, and

16   this little pie diart shows how they are broken up about

17   our various programs .

18             For those 'of you .who want a list  of these things,

19   they were just published.  We just published a list of them

20   in the Federal Register a week ago—either  last Friday or

21   the Friday before that.

22             It lists all the regulations, it  gives a brief

23   description of them, it tells their status  and contact points,

-4   if you want more information about them.  A useful document.

25             Briefly summarizing: 190 significant ones, a bulk of


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    them, no surprise,- in the water and air pollution. Toxic

    substances is not as large but growing, as you would expect.

 3             Some of these are a little misleading.  Believe it

 4   or not, solid waste shows three regs in the works.  Those

    are, however, parts of the RECRA, the Hazardous Waste

 6   Management Program, and they are truly a titanic effort.

 7             So this is numbers only.   We do classify those

    in a couple of ways.  First of all, and as we go through it

 9   in steps based on when we know enough to make judgments of

10   this sort, and the first judgment we want to make is, is it,

11   in fact, a significant regulation.

12             And the way we go about doing that ;is by the process

13   of exclusion.  We say what isn't significant,and what is left

14   over we call significant.

15             The effect of making this decision, this particular

16   decision, is chiefly a procedural effect.  If we say that our

17   regulation is significant, that means it goes through the

18   process I am about to describe.

19             If we say — the obvious alternative  to being

20   called significant, it should be insignificant, and people

21   had general objections nonsignificant to those kinds of

22   words,

23             So we decided not to do that and call it

24   specialized.  And actually that is a little bit more

25   accurate because what we mean by that is it goes through a


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 1   special development process.

 2             These regulations,  which number in the thousands,

    go through separate processes,  and some of them are very

    strange kinds of regulations.

              We would not normally think of them as regulations.

    They could change a tolerance level on a pesticide, for

    example, so the regulation consists of a number.

              We change the number from this to that.  It is

    generally regarded as a fairly minor kind of an action.  It

10   is a specialized process that goes through its own process

11             A state implementation plan, for example, which

12   must be approved by the Federal Government, published as a

13   Federal regulation, and goes through its own processes, and

14   it is labeled specialized.

15             So we have gone through the kinds of things that

16   we do here in the Agency that are of a rulemaking nature,

17   and we have separated out those that have their own set of

18   processes or that are unimportant for other reasons.

19             DR. EISENBERG:  What is your criteria for deter-

20   mining whether it is significant or specialized?

21             MR. SEAL:  By separate, a specialized regulation

    is one that has its own statutorily required review procedures

23   and, therefore, doesn't have to go through the process I am

24   about to describe or it is change that is mandated by statute

    and over which the Agency has no discretion whether to act

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    or not or to decide or not.



              A decision, for example, to set necessary mobile




 3   source emission reductions at 90 percent of the  1970  level.




 4   That  decision alone, if that was the entire regulatory



    decision, could be called a specialized decision because  we




 6   have  no  choice.



 7             It is not a matter that we have to debate.



 8             MR, BARAM:  But, Mr. Seal, in all candor, what  is




 9   the measure of significance?



10             MR. BEAL:  We don't measure significance.



11             MR. BARAM;  What does  the Executive  Order provide



12   as a  guidance?



13             MR. BEAL:  It simply says all significant regulation




14   must  go  through a process, and it leaves to each agency to



15   decide that,



16             We tried the more positive approach  first,  as you



    might expect: what would make a  regulation significant--



    it has a certain kind of health  impact, it has a certain



19   kind  of  cost, it affects certain critical industries, it



20   impacts  certain areas disproportionately to other  areas



21   and thus produces political problems, a whole  bunch of


OO      •
    things.




23             DR. EISENBERG:  If I can  get back to the example



24   you gave as an example: the one  you termed specialized was



25   one,  perhaps, where you changed  the tolerance  level of a





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 1   pesticide from one value to another value and you said




 2   it was only about three lines long.




 3             But the point is, a tolerance level could be very




 4   important from a health standpoint, from a cost standpoint




 5   could be very, very significant, but yet what basis does




 6   the Agency have to determine which kind of route they are




 7   going to go?




 8             MR. BEAL:  Because that kind of a decision has,




 9   as a matter of history, the statute under which it operates,




10   a separate decision-making process, which we said it does




11   not have to be subject to the same set of procedures as




12   these other decisions which lack that decision-making




13   process.




14             So that is what I am saying.  The specialized




15   does not mean unimportant; it means there is a special set




16   of procedures already in place that we determined were




17   adequate for ensuring that the decision was reviewed by the




18   right people and of acceptable quality.




19             MS. MOON:  Like the state implementation plans,




20   it is not that they are insignificant.




21             DR, EISENBERG:  I can appreciate when you are




22   talking about a tolerance for a pesticide, when you are




23   talking about kepone tolerances in fish or PCB tolerances in




24   fish.  If you are permitting a certain concentration in




25   fish right now and all of a sudden you come back and you






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 1   now  lower the tolerance to 50 percent of what  it was before,




 2   that action may be significant.




 3             You may be wiping out  the market.




 4             MR. SEAL:  What you are saying is  there  are  some




 5   specialized decisions.




 6-             DR. EISENBERG:  I am just taking the case you




 7   gave,




 8             MR. BEAL:  There are a couple of thousand tolerance




 9   actions per year on that order.  That is a tremendous  volume.




10   What I am about to describe—if  you tried to put that  volume




11   of decisions through the process, it would collapse it.




12             DR. EISENBERGs  Are you basically  saying it  is




13   a judgment value that  is placed  by EPA on an item  and  it  is




14   that judgment value that determines which course you  follow?




15             MR, BEAL:  That is right.  And the dividing  line




16   tends  to be whether or not — two sorts: either there  is




17   a procedure in place which we think can accommodate and




18   deal with those issues you raised already there or it  really




19   is a minor kind of thing over which we have  little discretion




20   and  has  little impact.




21             The next one is trickier, and from our point of




22   view has more effect,  at least on the way the  Agency manages




23   its  business, and that is, out of these significant regula-




24   tions, of which I said there were 190 in the works, we take




25   another  cut of them and the labels, we use for  dividing up






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     significant regulations  are  major and routine.            158




               These  labels don't particularly — the choice




     of the words doesn't mean anything,  but what we intend by




     the-se  labels is  to say that  there is a subset of our




     significant regulations  to which it  is clearly important




     that the senior  managers pay attention and we will put




     regulations into this category largely until we have absorbed




 8   the time that our senior managers can give to these things.




 9             If they could  spend all of their time working on




10   regulations, which they  cannot,  we might call all of them




11   major.  They cannot, so  we ^have  to start treating some




12   differently.




13             And the chief  difference is when they are major,




14   people who write them must give  more attention than otherwise




15   to keeping the senior managers informed of what they are




16   doing, what issues they  are  considering, and give them more




17   opportunities to influence the outcome.




18             MR, MOONEY: What  do you do if the schedule is




19   already full of  majors and along comes something that really




20   is major by any  criteria?  Do you —




21             MR, BEAL:   Bounce  something?




22             MR. MOONEY: Yes,  bounce something.




23             MR, BEAL:   There is nothing hard and fast about




24   the line.   I think the next  chart does show how it has been




25   divided so far,  and it ebbs  and  it flows.  If something






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                                                              159
 l    clearly  major  came  along, we would  definitely  add it to


 2    the  list.


 3              Whether something else  bounced out,  it is  not  black


 4    and  white  like that.   We would probably  leave  it in  except


 5    by attrition,  this  percentage.


 6              MR.  BARAM:   Do you have criteria for someone


 7    making the evaluation of whether  something is  major  or


 8    routine?


 9              MR.  BEAL:  There  are some marked criteria, but


10    for  the  most part,  the criteria remain subjective.   So we


11    are  talking about a relative  judgment here.


12              Out  of the 190, which are the  most important  to


13    the  Agency, and so  among  the hard criteria are cost  — will


14    it cost  a  hundred million dollars a year or more -—  we


15    chose that number because that number came from the  Executive


16    Order.


17              MR.  BARAM:   That  is  in the Executive Order, and


18    it is an important  criteria.


19              MR.  BEAL;  We use that to determine  whether a


20    regulation should be called major or not.  There are many


21    things we  call major that do not cost $100 million and


22    might not  have any  cost.


23              The  air cancer policy,  for example,  it is  a policy


24    statement,- it  has no economic, direct economic consequences.


25    The  decisions  we make later on as a result of  this policy



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 l   will  clearly have  cost, but we  don't  know what those  are



 2   yet.



 3             Nonetheless,  it  is  a  major  action.



 4             MR. BARAM:  What other  criteria are  there  that  you



 5   could reduce, like if we have $100  million  for cos.t,  you  have



 6   health criteria  like number of  risk,  risk exposures  reduced?



 7             MR. BEAL:  Impacts  :dn health!'.are  the first  of the



 8   criteria we will look at:  will  this action  have the  likeli-



 9   hood;  will it address a significant — a substantial  health



10   problem,



11             MR, BARAM:  You  see,  a  few  days ago  in the  New  York



12   Times Alfred Kahn  was quoted  as saying,  "We are grinding



13   down  on the health safety  environmental  regulations," and



14   to  many people  this  is  part of  that process of grinding down,



15             MR, BEAL:  Which is part  of it.



16             MR. BARAM:  This process  of segmentation of



17   regulations,  I  am just saying  to many people  that is the



18   major concern,  that there  seems to  be dual  criteria.



19             Congress has  established  the statutory framework



20   for the Agency  to  go out  and  deal with certain issues under



21   TSCA,  whereas the  President has a routing system under



22   Executive Order  12044 which is  supposed  to  grind down on



23   health safety environment  regulations.



24             So it  is this conflict  that is a  lot of concern



25   to  us between the  economic prioritization and  the health




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10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25
                                                         161
safety prioritization.

          MR. SEAL:  If you are saying people with evil

motives, wherever they are, might say, I want to spend my

time destroying only important regulations, you have to tell

me which are the important ones.

          MR. MOONEY:  You can't tell what the tread line

is there.  This may be an increase.

          KR. BEAL:  This is purely — as far as. EPA is

concerned, this is purely a management device.  I try to

keep this fairly constant, simply because v/hat I am trying

to do is find a way to feed information to our senior managers

at a pace and in a way that they can deal with it.

          I cannot treat 190 regulations as if they were

all equally important because if I do that, they will just

freak out.  They have no way of dealing with that.

          So I have to find some way of telling what is

important and what is not so important so they can budget

their time.

          That is the reason for this division.  Things happen

as a result of this choice other than purely management

nature;  that is, the obligations on the people who write

regulations as well as the people who make the final decisions

about them are affected by this choice, these particular

numbers,

          If you are interested in a particular program and

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                                                              162
 1   want  to know how many  regulations within each of our program


 2   areas have we put  this  label on,  feel  free  to come  up


 3   afterwards, but I  don't think we  will benefit by going


 4   through that right now.


 5             There is it.   All of  those regulations, whether


 6   major or  routine,  go through the  process I  am about to talk


 7   about, and I will  point out where they are  different, where


 8   major makes it different.


 9             I mentioned  a four-stage process.  What I am going


10   to do now is just  point out the four steps  and go into them


11   in a  little bit more detail in  the slides that follow.


12             Starting up,  that sounds simple enough, and of


13   course, starting,  you  didn't see  me make that a step.  But


14   we have bureaucrat!zed it.  Before you can  start up writing


15   a regulation here, the Assistant  Administrator who  wants  to


16   do that has to notify  the  other senior managers and has to


17   tell  them what he  is doing and  why he  has decided to do


18   this  and  has to invite them to  participate.


19             The  first  thing  these people who  participate do


20   is they write  a development plan  or work plan, and  I will


2i   tell  you  what  that is.   It just lays out what we are going


99   to do, when we are going to do  it, and how  fast.


23             That development plan gets reviewed by the senior


94   managers, and  it  does  make a difference whether it  is major


25   or routine.



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                                                              163



               Then  these  folks,  assuming  all  that  gets  approved,



 2    go  out  and write  the  regulation.  Writing a proposed  regula-



 3    tion  is  the  next  step.   It  goes out for public comment,  and



 4    here  you have the formal interactions with the public.



 5              Formal  is the  ones required by  laws.   That  takes



 6    place.   Here you  get  the comments back.   We respond to  them,



     we  work  on them,  and  the same group that  has been working on



 8    it  all  along puts together  the final  rule, which then goes



 9    through  a review  process.



               It is largely  in  these  review processes that  it



11    makes a difference, whether you call  them major or  signifi-



12    cant.



               MR. BARAM:   Are there significant time differences?



     If  you have  routed it through major or routine, what  is  the



     time  lag difference?


1 c

               MR. SEAL:   There  does not appear to  be any


17
     statistically significant difference,  depending on  the  label.


18
     Some  regulations  that are major do not have really  difficult


19
     technical problems.


20
               The  chief time lag in these regulations occurs


21
     right in here,  Base 2, between these  two  steps: between


22
     the development plan  and the proposed.  And that is because


23
     most of the  time  there you  are figuring out you have  got


24
     to get the health data or the environmental data, you have


25
     to analyze it,  you have  to  figure out what your solutions
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     are, you have to analyze them.



               Those activities are enormously time consuming  and



     expensive, and apparently from just examination of what in



  4   fact has happened, the regulations we call significant will



  5   face difficulties in assembling that data and analyzing it.



  6             That will end up taking them as long as the



  7   regulation that has major policy issues.



  8             DR. EISENBERG:  Can you explain to me the philosophy



  9   here in EPA whether in fact the intent is to have the best,



 10   to have as many of your ducks in line before you go to



 11   proposed rulemaking or to go with perhaps 89 percent into



 12   the proposed rulemaking and then to depend, to some extent,



 13   on comments of interested parties and other information



 14   gleaned from there before you go into the final rulemaking?



 15             MR. BEAL:  I would say in general we try to know



 ^   everything that is knowable and reasonable, expenditure



 17   and resources, before we start.



 18             DR. EISENBERG:  That may be one of the reasons



 19   why it takes so long to go to the final  rulemaking.  It



 20   might be more beneficial to go to the proposed 80 to 90



 21   percent than to rely, on some degree, to those who will



 22   be affected and other interested parties to bring forth



 23   information at that point.



 24             MR. BEAL:  I have two reactions to that.  One


95
     is that would tend to largely — one is  the timing and one
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    is kind of a politics thing.

              Let me talk about the politics one.  Maybe as part

    of involving a wider array of people in this decision-making

    process we should not go so far in our analysis and you

    would feel more confident that we had not made up our minds,

    really, and done everything we had to do if that were the

    case.

              That is one set of issues.  I would think that,

    though, is separate from the question of whether doing all

10   of that before we propose or after we propose will affect

11   how speedily we get to the final step.

12             I don't think it would make any significant

13   difference.If we did not do the analysis before we proposed

14   it, we would end up doing it after we proposed it.  We would

15   have to do it,

16             DR, EISENBERG:  The difference is in one case

17   you are relying upon your own resources to do the analysis,

18   and in the other case you would be also getting data from

19   other people, industry and outside sources.

20        '     MR. SEAL:  Certainly all that is true.

21             MS. MOON:  I am sorry; I didn't follow the latter

52   case.  Where are you saying you would be getting input from

23   outside sources?

24       •      DR. EISENBERG:  If EPA relies entirely upon their

    own — in other words, if they don't go to the proposed


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    rulemaking until they feel confident they have everything



    they need and all the data is there and everything has been



    generated by them before they go to the proposed rulemaking —



    in other words, before they come out with the proposed



    regs on the street, they want to know they have got every thing-



    there is to know.



              MS. MOON;  There is a lot, in my experience, going



    on between phase two and phase three.  That is the sort of



 9   thing you are talking about.



10             DR. EISENBERG:  Then only certain people are privy



11   to that.  It is not out on the street for everyone to take



12   a look at.



13             There may be some in-house work and private counsel



14   between friends in certain industry groups, but it is not



15   on the street.



16             MR, BARAM;  It would be helpful, Henry, if you



17   pointed out the nature of the consultation that goes on



18   between two and three and how it differs between three and



19   four.



20             CHAIRPERSON BENDIX:  Let me make one comment before



21   you  do that, and that is, one of the problems that I run



22   into, Max, is there is a certain amount of work you have to



23   do before you promulgate something; otherwise your agency



24   loses public credibility,



25             DR, EISENBERG:  I am not questioning that at all.




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 l    It is  just at which point.   It is  the  same  questions  we



 2    were having all along on the Section  4 portion.


 3              MR. SEAL:  The question  about how much you  have


 4    to know is the question that as a  general matter plagues  us


 5    in everything that we do,  and there are some obviously



 6    significant differences of  opinion outside  of EPA about how


 7    much that should be.


 8              MS. MOON:  At what point would EPA be going to

                                 1

 9    important Congressmen or to the President,  depending  on  the


10    impact of a significant reg, for input to see how they are


11    going?


12              For instance, the ozone  standard, We knew it was


13    going  to be a political baseball:  where did we start


14    broadening the game to include a lot of players; was  the


15    tie-up at the last management review;  was the tie-up  at  the


16    first  management review.


17              MR, BEAL:  It usually happens before—right in


18    herer--at least after a draft is read,  when  a draft of this


19    proposal is completed and organized and we  have some  pretty


20    good idea about what we want to publish.


21              At that point, as a general matter, we would let


22    people in other Government institutions, know what we were


23    going  to dot


24              Now there are a zillion  exceptions to that, and


25    it depends on how important it is.  If a regulation is going




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                                                            .  168
 1    to affect some other Government agency or if it deals with



 2    an issue that we knew the Congress was very much concerned



 3    about when it wrote the legislation,  we will be in touch



 4    with those other agencies and up in the Hill way earlier.



 5              MR, BARAM:  Can you tell us the fate of some of



 6    the TSCA proposed regs: where are they now?  If you could



 7    reference TSCA from time to time, it would help bring things


 8    to our major concern.



 9              MR. SEAL:  The  Section 4 rules, the first three


10    of them are coming to -- thank you for asking.  They are



11    coining to the Steering Committee process as a proposal a



12    week from this Friday, the 28th, which means that the



13    proposal is written, the supporting documents are written,



14    the documents that convey these to senior managers are



15    written, and it is ready to start through the Agency's review



16    process, which consists of three parts: the Steering Committee



17    which I chair, which is why I am invited here to talk about



18    it; the Steering Committee is composed of representatives



19    of the Assistant Administrators, and we have a couple of



20    functions, an issue resolution function when there are



21    issues in this package that have not been satisfied, and


22    a quality control function,



23              MR. BARAM:  Where does this all take place, vis-a-vijs


24    the earlier chart: the three levels of review?



25              MR, BEAL;  After each of these steps, there is a




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1   review.  Whatever it is that is being written has been




2   written, and now we need to get it out of the Agency.  We




3   need to get our senior managers to agree that this is what




4   they want to do, and they need some process to be sure that




5   what they are getting is a quality product.




6             As you might suspect, they do not, in fact, read




7   every page of this stuff.  The idea is can you get them to




8   pay attention to the important issues.




9             So at the TSCA 4 Regulation you are right here.




10   They have written a proposed rule.  They generally think it




11   is okay.  He wants to send it to the Administrator for




12   signature, and we start through this review process.




13  |           MS. MOON:  So that is where the political football




14   starts; between 3 and 4; it isn't after 4 where we start




15   having political decisions.




16             MR. SEAL:  It is right in here, that is right.




17             MR, BARAM:  Well, of course, the cases — you




18   said there were zillions of exceptions, and I think the




19   cases we read about in the paper are the exceptions and that




20   is where the political starts: between 2 and 3.




21             Between 3 and 4, you have an official notice of




22   comment period,  We are really talking about 2 and 3, the



9*}
    area of tremendous discretion and interagency pressures.




24             MR. BEAL:  This chart is a little funny looking,




25   so maybe it isn't right here.  The charts looks right, but it





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                                                              170
 1    is misleading because you have it wrong, you are on the



 2    wrong place on the chart, so I will have to fix that.


 3              We are in agreement on the substance — forget the


 4    chart — that the other players, other  players within the


 5    Government, can and are involved in our decisions before



 6    we publish the thing in the Federal Register as a proposal.


 7              And many of them we owe as a courtesy and the


 8    people on the Hill whose bill we are trying to implement


 9    we owe as a courtesy: here is what we are doing.


10              Other agencies who are going to be affected are


11    concerned about it.  Some of the White House staff is


12    concerned about it,


13              MR, BARAM;  Henry, most of the discussion of the



14    Committee before you came here today has been focused on


15    economic versus health trade-off,


16              Maybe you could confine your discussion to that.


17              MR, DEAL;  Let me hit this review process.  You


18    have the major nature of it.  This group of civil servants


19    looks at the stuff and does something about it, sends it


20    on to the senior managers ,


21              The senior managers in EPA consist of the


22    Assistant Administrators, and there are six, the Regional


23    Administrators, and there are 10, and a few Office Directors,


24    like the Director of the Office of Legislation, who is our


25    chief liaison to the Congress, and the General Counsel.




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                                                              171
               These folks get the package for their review,


 2   and at each of these stages the idea is we are trying to


 3   build a consensus about what it is we are doing.


 4             The reason for this multiple consensus building


 5   in all these different groups is the way SPA is organized—


 6   we have specialties all over the place.  We have to find


 7   some way of bringing them together and bringing attention


 8   to bear on the decision.


 9             Finally, it goes •— we can skip over this.  Here


10   are the main offices that write regulations—no surprise—


11   Air, Water, Toxics and Enforcement.


12             And here are the statutes that they administer.


13   The rest of the charts just go into more details of what


14   happens in each of these phases.


15             The starting up is purely internal.  Way early


16   when starts something starts up, you will know about it


17   because we print the agenda in the Federal regulations.


18             The development plan is actually a really


19   interesting part of this , and it is one that I would like to


20   see become a more public element of our rulemaking because


21    it is here that people are asking and are supposed to write


     down what alternatives are we going to examine and what are

90
     the issues we think are important.


24              The rest of it is like a normal work plate: how

9 =
     fast am I going to do it; am I going to do it by contract,
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1    in-house, blah, blah.

2       •       There is another feature I should skip over.  This

3    is the place where you identify who from outside the Agency

4    you are going to involve, what is your plan for involving

5    members of the public.  That is supposed to be in this

6    document.

7              Then there is a whole bunch of other things.

8              MS. MOON:  Where is economics?

9              MR. BEAL:  You have to say in here — the only

10    reason I am whipping along is to get to the part you

11    apparently really wanted to focus on.

12  i            We have to identify in here issues and alternatives

13    You also have to indicate what analyses are you going to

14    perform.

15              There is a lot of policies around some of them.

16    Say you have to have an urban community impact for certain

17    regulations and environmental impact analysis and economic

18    impact, a resources impact, and there is a couple of

19    others for which not all regulations do not need.  So you

20    have  to show which ones you need.  You don't do it here.

21              You just say you are going to do it.

22              DR. EISENBERG:  Kow widespread distribution-wise

23    is the development plan?

24              MR. BEAL:  Strictly in the Agency.  I think this

25    is a  good opportunity, a good kind of a thing, to circulate

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  1    around.



  2              A potential public analogue of this could be the




  3    Advanced Notice of Rulemaking.  There is a lot of it that




      is purely internal.



  5              CHAIRPERSON BENDIX:  Another potential analogue




  6    to this is the NEPA process.



  7              MR, BEAL:  I will take a look at it.



  8              MR. BARAM:  It is very similar—essentially going



  9    to the public and holding a few hearings to scope out



 10    what the impact statement should include.



 11              It is a useful analogue.



 12              MR. BEAL:  If you folks want to recommend -that



 13    to Steve Jellinek, if that is the limit of your concerns—




 14    if you want to direct it generally to the Agency—I



 15    personally would be very much supportive.


 1 fi
                This development plan goes through all this.



 17    This is just a summary of what is in the development plan,


 10
      and sometimes we publish an Advanced Notice of Proposed
19
      Rulemaking and sometimes we don't.
20
                I think what we want to do is build this up


91
      and make this a real part of the rulernaking process and


99
      then routine it as a way of making a commitment to do


90

      something and involve others.


94
                DR. SLESIW:  How many other agencies use the




25     ANPRM?
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 1              MR.  BEAL:   It is available as a tool, but how  174




 2    many actually  use it, I don't know.   I certainly know that




 3    they know it happens.  How often it happens, I don't know.




 4              DR.  SLESIN:  Does anyone use it to the degree




 5    this Agency does?




 6              MR.  BEAL:   I couldn't answer that.




 7              MR,  MOONEY;  There are certainly instances where




 8    agencies have  called informal rulemaking, so I couldn't use




 9    formal, but have certainly released draft documents.




 10              The  OSHA cancer:.policy certainly first appeared




 11     as a readily available document in draft form before it




 12     was formalized in the Register.




 13               I don't think • OSHA called it an ANPRM document




 14     or position.  It was that kind of a process, but it served




 15     the purpose of identifying issues.




 16               DR,  SLESIN:  That is certainly the exception.




 17               MR.  MOONEY:  It probably is.




 18               CHAIRPERSON BENDIX:  I think the answer —




 19               MR,  BARAM;  With regard to the ARPRN again, under




 20     TSCA and under the Clean Air Act and Water Act there is




 21     citizen provisisn that someone can sue the Administrator




 22     for failure to take action, unless the Administrator has




 93     launched some  sort of action.




24               Is an ANPRM some kind of a preclusion of citizen




25     suits, do you know?  If you publish an ANPRM, is that useful






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 i     as  a  defense  or  a motion  to  dismiss  a  citizen's  suit against

 2     the Administrator?

 3               MR. DEAL:   I wouldn't  make a legal  judgment about

 4     it  myself.  I guess  the General  Counsel has left,  so I

 5     have  nobody to rescue me.

 6               On  the substantive matter, it is  a  point of lav;

 7     that  somebody can figure  out,  I  guess,  but  does  this

 8     indicate  that we have started rulemaking and  then  we are

 9     committed.  We have  committed resources to  working on

10     something and then we are under  way  with something.   It

11     certainly does that.

12               Whether that precludes anything,  I  have  no idea.

13     It  means  that we are at work,  and that is what I know about

14     it.

15               How we are to the  part of  the process  that you

16     wanted to get to, and that is  writing  the proposed rule,

17     which we  call a  decision  package.

18               Now it consists of a bunch of things that go

19     around to the decision-makers.   Actually, we  have  been

20     through most  of  this already.

21               This is the thing  that has to contain all of the

22     analyses  that we were committed  to doing before.  It has

23     to  explicitly address the issues we  said we were going

24     to  address.

25               It  has to  show  alternatives  we examined.  It has


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 1     to explain why we chose what we chose.   If we are

 2     recommending something in several of our regulations, we

 3     will just identify alternatives or we will come to raally

 4     hard issues in one regulation and will say proposals saying

 5     we don't know what to do.

 6               But here are the things we looked at.  We would

 7     like comments,

                MR. BARAM:   I think we are particularly interested

 9     in the economic analysis that was on the preceding page.

10               MR, BEAL:  This is the stuff in the decision

11     package, and it is going to include supporting materials.

12     That is what the economic analysis will be in in the

13     supporting materials.

14  I             It has to be summarized here.

15  ;             MR. BARAM:   Is that done in-house or contracted

16     out?

17               MR, BEAL: Almost always contracted out.

18               MR. BARAM:   What do they usually cost, for

19     curiosity?

20               MR. BEAL:  The range is very considerable, from

21     something like $50,000 to a million or more.

22               MR. BARAM:   How do you handle this urban and

23     community impact analysis that is done in-house?

24               MR. BEAL;  We are struggling to do that ourselves,

25     largely because that is a new requirement and it is not clea:


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     what it  is.

 2               CHAIRPERSON BENDIX:  What was  the  cost:  $50,000

 3    to  $2 million?

                MR. BEAL:  Yes.   The other  analyses  are  also

     typically  contracted out,  and the  result of  these  different

 6    analyses is whan you combine together the idea is  that  you

 7    have some  conception of what you are  going to  get  for the

     various  alternatives and what the  cost on the  various

 9    actors will be, including  us.

10               One of the things that we really have to worry

11    about is can we do whatever it is  that we are  proposing

12    to  do; does the Agency have the resources to do it; do

13    the states have the resources to do it.

14               So with the states we are concerned  about

15    implementability as well as its theoretical  attractions.

16    And it is  in this stage that the various players outside

     of  the Agency at the senior levels have  typically  tried to

     influence  the decisions.   That was early on.

19               For the most part, we are trying to  bring some

20    rigor to that as well.  People who want  to influence the

21    regulation, that is perfectly all  right, and anybody who

22    wants to do that, in fact,  is why  we  are published.  If

23    you have a view, tell us about it.

24               What people object to when  they object to these

25    things is  that it is done  in secret and  that you don't  know


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 1    what Senator  "X" has said to the Administrator  or whether



 2    the President phoned in the night  and  told him  what  the



 3    decision was—any of those suspicions  that come to mind.



 4              And for the most part, I  think  everyone is  pretty


 5    well in agreement that these attempts  by  various people,



 6    whoever and wherever, to influence  the decision will  be made



 7    on the record,


 8              That  is certainly true about people like the



 9    Regulation Analysis Review Group and the  people who  staff


10    it or the Council of Wage and  Price Stability.  When  they



11    were first set  up the first few times, they  dealt very



12    informally.   They would develop their  position  and then  they



13    would phone over or come over  and  let  you know.



14              Now they still do that,  but  they also do that



15    on the record.



16              MR, BARAM:  Who doesn't  do it on the  record, just



17    out of curiousity?  I guess the Council of Economic  Advisors



18              MR. SEAL:  I can't say it doesn't  happen.



19              MR, BARAM;  I am just wondering is any of  this


20    hampering TSCA, in your opinion?



21              MR, BEAL:  No,



22              MR. BARAM:  Nothing  has  come out on the Section 6



23    in 3-1/2 years, and there seems to be  technical evidence  of


24    legal authority for a lot of actions,  and we are constantly



25    concerned about this constipation  in OT3 .




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 1              MR, BEAL:  It could be true,  I have no way of



 2    knowing who  called Steve Jellinek or Doug Costle.  They



 3    wouldn't tell me  if it happened, and I  don't  sit up  there



 4    and  listen.


 5              So tliat could happen, yes,  It probably does.



 6    Of course these people talk  to each other and express their



 7    views,  Is that improper or  unfair?  I  don't  think so.



 8    Communications have to happen.


 9              The Administrator, how/ever he reaches  a decision,


10    has  to have  a plausible rationale for it, and he has to



11    express it.



12              And in  regard to Section  6, I just  haven't heard



13    boo  about anybody outside of EPA trying to  prevent Section 6



14    action, and  I personally know  the people who  work on it.



15    I can't imagine that having  any influence.  What do  you


16    say  —


17              You can influence  it at the end.  You  can  say



18    about a package that got to  a  decision-maker, change the



19    number or something, but if  you are saying  don't do  it,



20    how  are you  going to stop — what does  Steve  Jellinek say:



21    well, I have these  200 people  down  here, I  have  somehow


22    got  to prevent them from writing this package they are


23    all  hired to write  and somehow do that  in a discreet way



24    so nobody knows that I have  done that.  That  is  impossible.



25              There are no signals going out to the people in




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 1    the Section 6 area saying don't produce, and make it go slow,


 2    and make sure that everything gummed up for as long as


 3    possible.


 4              We have problems with TSCA because of the nature


     of the issues these people are trying to solve.  And I have


 6    not seen any great bolts of wisdom from anybody about how


 7    to shoot through all of this and come out with great answers.


               Maybe here, maybe this is where it is coming from.


 9    That would be great.


10              MS. MOON:  Let me ask another question.  I am


11    still trying to get at the heart of something.  Where in this


12    long process do we begin to see the lack of enthusiasm on


13    EPA's part as an advocate?


14              What we see at the public hearing is EPA more or
15
      less  taking in  all of  the information  and  trying  to  sit
16    as  judge, evaluating whose  argument  is better  than whose


17    argument.


18              If  the public's argument is not  there  or the


19    public health or the public interest or  something or  other,

or\
     we  hear  these long  tales of woe:  oh, you have  to call out


     your  troops to balance  the  industrial side or  the union

99
     side  or whatever.

93
               I think the public perceives or  would  like  to

94
     perceive EPA  as being the advocate for the protection of

95
     public health in the environment, yet when it  comes to the
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     public hearing stage, we  seem  to  see  this  judge, who  is

     willing  to  commit himself, no  longer  advocating  and saying,

 3    all you  folks out there argue  amongst each other and  we

 4    will  put it in the political bag  and  come  out with a

 5    political decision,

 6              How long is EPA an advocate in this long process?

 7    At what  point is it  neutralized?  We  know  in the beginning

     when  you want a regulation, someone will say we  really need

 9    it, it is detrimental to  public health.

10              And going  from  that  to  the  point where we are

     so unemotional about the  whole thing, something  happens

12    between  the enthusiasm  and this very  lackadaisical let's

13    see how  many letters you  can turn out.

14              MR. BEAL:  I  don't think advocacy for  the objective

15    yes that there is not a problem with, and  I don't think you

16    can say  about the people  here  that their enthusiasm to reach

     the objective wanes.

18              Where we do —  so maybe it  does  happen sometimes ,

19    too,  but generally as-'.an  Agency I don't think that that is

20    true.

21              I think the people here, to a remarkable extent

22    up and down through  the Agency, are here because they have

23    a commitment to a set of  objectives,

24              It is very unlike other Government agencies.  It

25    is not universally true.   I think, to a very large extent,


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 1     that  is  true,  and  I  shouldn't  sell  it.   If you are looking


 2     for a job,  you can't have  a  job  now:  there is  a freeze.


 3     But this is a  terrific  place to  work,  for that reason.


 4               But  what happens when  you take that  commitment


 5     to an objective and  you say  and  now how do we  get from


 6     where we are to that place and what is  the best way of


 7     doing that,


 8               All  of a sudden  you  have  opened up a zillion


 9     decisions,   Now there is a highly complex series of things


10     that  have to happen  to  do  that.


11               In all of  those  steps  you have people you are


12     going to affect who  you have to  motivate in some way to


13     help  you reach that  objective—other Government .agencies ,


14     people who you..were'..going':.to_.regulate ,  politicians of all


15     sorts and. all. .levels ,.. citizens whose: continued support  is


16     absolutely critical  to  keeping an interest in  these


17     objectives out in  the public 'consciousness.


18               Balancing  all of those interests is  indeed a


19     concern  of ours,   We have  to be  sure that what we are


20     doing is going to  work, and that means  work in the short


21     term  and work  in the long  term and  work in the local


22     political processes  and the  state political processes


23     and the  national political processes.


24               And  if you are not sensitive  about what all is


25     happening there, in  the long run you are going to cause



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1    yourself a lot of trouble.



2              Yes, there is a balancing that goes on.  I don't



3    think we try to hide it.  We do want to balance these things,



4    We want to make balanced reasonable decisions,  and for what



     purpose?



6              And it is that purpose we are committed to, and



7    that is a clean environment in relation to TSCA and



     individual decisions.



9              MR. MOOWEY:   I would like to say something in



10    response.  I have been involved in a number of these TSCA
11
     rulemakings, and it is funny I have never felt that is the
12    way it is.




13              The picture you describe is not the way I  felt




     that it was in any of the meetings we had with the Agency.




15    At an early stage, in some instances, I think back to the




16    inventory, the PMN rules, where you were really in that




     stage in the evolution of the proposed rules, the issues


1 Q

     are being worked and the drafting is taking place.



19
               I have seen perhaps an agency openness or lack



20
     of defined position on an issue because it is learning




21    stage.



92
               But when the proposed rules have hit the register



93
     and there have been open hearings during that review period,


94
     I have felt that the Agency stands very fast behind what


95

     it has proposed and that it does, in fact, take an advocacy
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 1     position of what it has  put in that rule,  and it is  not

 2     saying if you people will all get together and figure out

 3     who has got the  most votes, that is the  way it will  come

 4     out.

 5               I really do sense a rather strong advocacy

 6     position on the  part of  the Agency on what they are  putting

 7     into that package.

 8               MR. BARAM;  I  think we would really find useful

 9     some more explicit discussion of the trade-off: what is

10     an acceptable trade-off,

11               Given  your experience at looking at economic and

12     health evaluations, what is it, why;-.does it come to  be the

13     appropriate kind of trade-off from your perspective?

14    '           MR. BEAL:  Do  you have a specific TSCA decision?

15               MR. BARAM;  We could take the ozone standard,

16     the ambient lead standard or another standard that is

17     analogous to a TSCA type of decision in some kinds of

18     respects.

19               MS.. MOON;  The ozone standard I think is not

20     less of a problem than a lot of the things we are facing

21     in TSCA, yet that whole  standard, it was so difficult.  It

22     was a political  football,  I don't know.  I just got fed

23     up with the whole process.

24               MR. BARAM:  Yes,  I think the early processes

25     discredited a lot of the results, unfortunately.

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 1               MS. MOON:  It was viewed by so many people as

 2     simply a political decision where we lost our advocate.

 3               MR. BARAM:  Let's say trade-offs had to be made.

 4     That is the way the statutes are written.  Every decision

 5     is a trade-off.  Can one spell out general rules as to how

 6     thse trade-offs are going to be made ahead of time or is

 7     the trade-off going to be made ad hoc in each case?

 8               MR. BEAL:  Well, there are different — there

 9     are different schools of thought about whether it is even

10     plausible thinking about developing a decision rule.

11               There is a formula in which you pluck the

12     variables and,'whammo, you know the answer.  From my point

13     of view, that would be wonderful.  It would save a lot of

14     wear and tear, but I don't think it is practical.

15               On the other hand, there are a variety of

16     analytic devices you can use to help you make an informed

17     decision.

18               Among those are the risk assessment methodologies.

19     How do you tell a decision-maker what the nature of a

20     health or environmental risk is from exposure to certain

21     things?

22               There is a lot of work that can be done to

23     prove how you tell people what is at stake.  In some areas,

24     the ozone standard was one.  We tried some fairly inventive

25     things, and they showed a great deal of promise, I think,


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 1    for the way we can make decisions in the future.

 2              There are a variety of economic things  for those

 3    regulations that are either required or allow you to consider

 4    economics.

 5              You can look at marginal costs and determine  as

 6    you move  from one degree of control to another what happens

 7    to the marginal costs of the firms that have to install  those

 8    controls.

 9              All it does is tell you certain things  about  how

10    that  cost pattern looks,  It doesn't tell you what cost is

11    acceptable.

12              On the other hand, there have evolved over time

13    some  basic perceptions in the economic community  on how to

14    interpret one of those curves,

15              You can compare costs and risks between decisions.

16    How much  cost were you willing to accept in the earlier

17    decisions you made?  What kinds of risks were enough to

18    motivate  you to act in earlier decisions?

19              MR, BARAM:  Is that information available?

20              MR, BEAL:  Sure.

21              MR, BARAM:  On what distributions of cost and

22    benefits  have been acceptable to the Agency?

23              MR. BEAL:  Have we ever compiled the whole thing?

24    No,   We have a project under way to do that, but  it is  not

25    done.


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 l              The  individual decisions  are  there.


 2              MR,  MOONEY:   I was  thinking the Agency  did  a


 3     study  on  the Section  5  that had  Arthur  D. Little.   Am I


 4     correct?


 5              MR,  BEAL:   Probably.


 6              MR.  MOONEY  I  got into  at  least one  estimated


 7     judgment  as  to what  it  was going to cost to put together


 8     a  PMN, what  the  impact  would  be  of  new  chemicals,  and we


 9     could  probably challenge every assumption, if you had a


10     mind to,  because it was a  judgment  call,


11              MR,  BARAM:  What is your  own  personal impression?


12     Are they  going to regularize  this or should we follow the


13     ad hoc approach?  The ad hoc  approach is where you can be


14     flexible.


15              At the same time, you  can abuse the whole process


16     of analysis.   Anything  cost benefit can be a  numbers  game,


17     So what do you think  is a better deal for the long run?


18              MR.  BEAL:   I  don't  think  a decision rule is


19     practical because of  the uncertainty in the individual


20     components that  make  it up,


21              But  what you  can do — pardon me — what we could


22     do and you could look at to help you judge whether we are


23     doing  anything sensible is to identify  the important


24     decisions in each of  our regulations, identify a  variety of


25     effects of various sorts, and array :  them so you can   .-.   . .




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 1    see what they were and what we looked at.



 2              And if we have enough data, we can identify the



 3    degree of certainty with which we know those things.  I



 4    think we should do definitely a lot more in that area.



               Our statistical work is a mixed bag, and our



     reliance on them to help us inform   decision-makers about



     how good these numbers are that we tell them about just



     hasn't been very effective.



 9              We can do a lot better there.  And just array



10    a bunch of things, but I would be interested in hearing



     from you what you think, what impacts you think ought to
12
     make  up the decision: should we look at costs and, if so,
13    what kinds of costs should we look at and the cost to




14    whom.




15              MR. MOONEY:  You have to look at cost.




               MR. BEAL:  In some cases we do, but not all.



17
               MR. MOONEY:  That is part of it, an unreasonable


1 Q

     risk determination.



19
               MS. MOON:  I can't resist being Janette Sherman,


9Q

     and how many times have we heard her say we are always




     analyzing the cost of regulating, but when are we going to


29
     analyze the cost of not regulating.


93

               Has this variable yet been pumped into the decision


24
     making?


25
               MR, BEAL:  There have been some efforts to do it.



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 1     While it is true the economic estimates are often highly

 2     uncertain, the efforts to quantify in economic terms the

 3     benefits of regulation or, alternatively, the cost of not

 4     regulating the methods are in a much more viable state of

      development.

 6               We have a major project under way right now

 7     spending $7 million to try to do that, but we are a long

      way,

 9               CHAIRPERSON BENDIX:  Can you tell us something

10     more about that?  What is that project and who is doing

      that?

12               MR. SEAL:  I am not — I would if I knew, but I

13     don't know, so I can't.  You should talk — get

      Franz to come to your next meeting.

l5               MS, RAMSEY;  I think tomorrow probably the

      panel discussion will throw some light on the issue.

17               DR. SUTTON:  I wDuld like to hear your views,

      Michael.  You spent a lot of time on this.  Not as long

19     as you could do, but as brief as you can do.

20               MR. BARAM;  Three things:  I did that study

21     at  the Administrative Conference years ago on how agencies

22     were using cost benefit analysis and how the White House

23     was doing their thing, and it came out with really three

24     findings.  First of all, the cost benefit analysis process

      is  a numbers game.

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 1             Most  of  analysts  I  spoke  to  in  the  agencies

 2    called  it pushing  the  numbers  to  justify  outcomes  that they

 3    felt  they had to justify.

 4             Maybe that isn't  the situation  in EPA now.

 5    Years ago or as of last year  that was  the situation,  that

 6    was the perception: people  were constantly scrambling  arouiid

 7    to  find the appropriate value  for human life, what should

 8    the discount be.

 9             I was at a meeting  yesterday where  someone was

10    asked the question, since industry  is  always  asking the

11    Agency  to do cost-benefit analysis,  tell  me,  do you use

12    cost-benefit analysis  in making your own  internal  company

13    decisions.

14             He said, no, we can't use the stuff,  it  is  too

15    indefinite.  It is not helpful.  The whole cost-benefit

16    approach has been  very arbitrary, somewhat abused, in  the

17    sense that it has  become a  numbers  game,  and  that  is why

18    a lot of my concern as a result of  that study focused  on

19    coming  onto general decision  rules.

20             If we are going to  make trade-offs,  let's break

21    the billet and  come out with  one  discount rate  or  one  value

22    of  human life,  if  we want-to  go that route.

23             The second point  is  that  there  are  procedural

24    violations.  Supposedly, the  President and the  economic

25    advisors, including the Council of  Economic Advisors,  their


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      Regulatory  Analysis  Review  Group  and  the OMB  fashioned



      the  legal argument  that these  treaties  to the Agency  should



 3     be channeled properly through  procedures, through the



 4     notice of comment period only,  not off  the record,  no


      ex parte communications, as have  been conducted in  the



 6     ozone case  and a number of  other  cases.



 7              So that was the second  big  finding, in a.  sense:


      that there  were lots of procedural abuses, violations of



 9     separation  of powers.


10              In other  words, on Mr,  Seal's  charts, these



11     communications between the  President's  office or some



12     officers and the President  and EPA should be  confined to



13     the  Notice  of Comment Period and, therefore,  part of  the



14     public record and,  therefore,  available  to everybody.



15              The third point was  that there were better  ways


16     to consider economics, that the cost-benefit  route  was



17     basically telling us how much  health  environmental  quality



18     we should have,  if the benefits  exceeded the costs,  the



19     number of lives to  be saved exceeded  the cost to industry,


20     or something of a crude nature like that.



21              It seemed to me under TSCA, under the Clean Air



22     Act  and other statutes, the Agency has  an affirmative duty



23     to stick out a health goal, get rid of  asbestos in  schools



24     or get rid  of asbestos exposure—a clear-cut  carcinogenic



25     hazard.  Stake out  that objective and then do a




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 1     cost-effectiveness  kind  of  approach,  do  the most cost-


 2     effective  way  to  get  the data.


 3               You  see,  there is a difference between the cost-


 4     benefit  and the cost-effectiveness  route.   The cost-benefit


 5     route  determines  what your  health goal is and then helps


 6     you adopt  the  means to achieving a  health goal,  whereas


 7     the cost-effectiveness rule, in my  opinion, is a limitation


 8     to the economic factors  to  choosing the  cheapest route to


 9     achieving  the  health  goal,which is  chosen on health grounds.


10               MR.  BEAL:  Why in your scheme, Mr. —


11               MR.  BARAM:   To answer your question, Bill, those


12     were the three findings, more or less.


13               DR,  SUTTON:  I listened very intently and with


14     considerable respect  because I know you spent a lot of


15     time and thought  on this, but I still got a little lost


16     because  you seem, on  the one hand,  to say, Michael, that


17     you really,;ean ' t  do by the  numbers  determination by a


18     formula  and come  out  with a good decision, and I don't


19     disagree with  that for a minute.


20               In fact,  I  agree  with that.  I don't think we


21     are anywhere near that stage where  you can plug these


22     decisions  into a  formula.


23               On the  other hand, I really can't imagine a


24     decision-making process  that doesn't in  some way try to


25     take into  account what is going to  be achieved in terms of


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                                                               193
      benefit for the achievement and what are the adverse

 2    impacts, whether they be economic or otherwise, and in the

 3    course of getting those achievements, and you couldn't

 4    construct some ridiculous situation, but the facts are

 5    there is a broad spectrum of those things.

 6              Not every health goal is curable.

 7              MR. BARAM:  I would expect the agencies wouldn't

      misuse their resources and choose health goals that have

      little benefit.

10              if you solve or achieve them, you would have' a

11    limited benefit.  Take a big one.  If you have the well-

12    established hazards like asbestos in places, in general,

13    there is no doubt about the technical evidence about the

14    causal exposure and harm, and the real question is cost

15    of the cheapest way to solve these particular problems.

                It seems to me the Agency should be able to

17    set those health goals on a health basis ; health impact

18    basis, and not on some balancing between health and

19    economics,

20              So, unquestionably, there are some of those.

21     There are also many that they must deal with which say

22     go regulate this, this and this, and you haven't — and

23     you don't have a mechanism of determining how much of

24     a health risk it is.

25               MR, BARAM;  That is an unfortunate lack.  It


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CB/mll
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would seem to me it would be a better use of EPA's money



instead of spending a million dollars to develop quantifi-



cation techniques, it would be a much better expenditure



of money if they came up with a health ranking scheme:



what are the,real health goals we should be focusing on



and the most cost effective way; are those health hazards



that are irreversible significant by any measure?



          In other words, where is the public health ranking



or index that should be used in helping the Agency select



their health goals, so then the cost-effective approach



could be taken.



          It seems to me that is the proper framework that



is needed here.



          CHAIRPERSON BENDIX:  We are pretty close to the



end of the time that had originally been allotted for this



meeting,



          I would like to suggest that since our reporter



is weary of reporting what we talk about, that we adjourn



the formal meeting.



          If people want to continue informally discussing



until our 5 o'clock meeting -•-



          (Whereupon, at 4:25 p.m., the meeting was



          recessed, to reconvene on March 20, 1980)
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                      REPORTER'S CERTIFICATE



    DOCKET NUMBER:

    CASE TITLE: Administrator's Toxic Substances Advisory Committee

    HEARING DATE: March 19, 1980

    LOCATION:  Washington, D.C.

9

10        I hereby certify that the proceedings  and evidence

    herein are contained fully and accurately in the  notes

12   taken by me at the hearing in the above case before  the

     United States Environmental. Protection Agency
13

14   and that this is a true and correct transcript of the same.

15

16

17

18                               .  Date:   March  31,  1980

19

20

21

22                                    " Official  Reporter
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                                      Washington, D.C.   20005
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