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
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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
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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
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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
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affidavit in response to the court's decision? That really
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lays out a fairly detailed program in what is goxng to
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happen under Section 4 as the Agency proposes it.
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MR, CAIRNS; I have not seen it.
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MR, MOONEY: In the next four years.
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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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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
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Tape 2 10
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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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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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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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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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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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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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7
8
9
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11
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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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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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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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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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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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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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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
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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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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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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 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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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.
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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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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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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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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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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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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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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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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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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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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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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.
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Those are two concepts, .^and-.yet one could be
argued as being consistent with the other. Every 12 hours
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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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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
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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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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.
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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
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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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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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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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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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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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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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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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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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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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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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2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
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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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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11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
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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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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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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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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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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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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
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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.
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But when the proposed rules have hit the register
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and there have been open hearings during that review period,
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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
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analyze the cost of not regulating.
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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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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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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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