ENVIRONMENTAL PROTECTION AGENCY
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PUBLIC MEETING OF:
THE ADMINISTRATOR'S TOXIC SUBSTANCES
ADVISORY COMMITTEE
West Tower, Room 3906
401 M Street, S.W.
Washington, D.C.
Friday, February 16, 1979
9:17 a.m.
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ATTENDEES
Dr. Peter W. Preuss
Chairman
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Susan Vogt
4 Executive Secretary
Warren Muir
Deputy Assistant Administrator
6 Office of Testing and Evaluation
7 Paul White
Assistant to the Chairman
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MEMBERS:
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Dr. Selina Bendix
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Dr. Leonard H. Billups
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Mr. Paul Danels
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Mr. David W. Gleeson
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Mr. Robert T. Hayden
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Dr. Janette B. Sherman
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Ms. Jacqueline M. Warren
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MR. JELLINEK: If other agencies who are well aware
of what we are doing on controversial chemical positions,
3 whether it be pesticides or others, know what is going on and
4 are not sharing their information with us, it is a problem. I
do not know that was the case but I know that we did first
6 hear about it from someone from OSKA. As far as I can tell
7 right now, it was still after the decision was made. That is
a problem.
9 When we find out what the facts are in that situatior
if there was a problem involved, I will talk to you about it.
n MS. WARREN: Okay. That's all.
12 CHAIRMAN PREUSS: Anyone else?
„ (No response.)
CHAIRMAN PREUSS: Thank you very much, Steve, we
15 appreciate it. The next part of the agenda deals with the
16 premanufacture notice requirements. You have all just been
17 handed a draft that has been prepared and I would ask Jackie
18 to take over the chair at this point and describe what and
19 where and how.
9Q AGENDA ITEM: ATSAC COMMENTS,PROPOSED
91 PREMANUFACTURE NOTICE REQUIREMENTS, BY
99 JACQUELINE WARREN, CHAIRMAN,. PREMANUFACTURE
93 WORK GROUP
94 MS. WARREN: The document that you all have been
95 given is a very rough draft of the work group, the Premanufacture
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1 Work Group's efforts to try to develop ATSAC comments on the
9 Section 5 regulations because some critical members were not
3 able to be at the whole work group meeting or be there at all,
4 there are still a few issues which we have to resolve amongst
ourselves before we can really even put those to the committee
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6 that they can consider adopting it.
7 What I want to raise, all of the things we talked
8 about and get committee opinon on them, but we are going to
9 be having one more meeting, probably next week, to try to
10 resolve the last ones. Then we will circulate the finished
n document for the Full Committee, but I would like to be able
12 to incorporate committee opinion that is expressed here in
13 that at the same time and I will just go through these.
14 I have to apologize for the typing and hand scrawlincjrs
15 all over them. We tried to divide our consideration of the
16 proposed regulations amongst issues that ATSAC had already
17 discussed, achieve consensus on it and make recommendations
18 to EPA about as to those things which are put in the section
19 for regulation simply by saying that we have had resolutions
90 on these in the past and we support the approach that is
21 being taken.
22 Then there is another which we also think warrants
23 support, the third group that we thought really needed to
94 have substantial modification to them and then just a section
95 on additional comments. I would like to go through those in
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l that order.
First of all, with respect to the premanufacture
3 notification guidelines, the work group's conclusion was that
4 was a part of the agency's decision to issue Section 5 testing
. guidelines and that they be published as soon as possible.
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6 The problem that arises in the absence of the
7 guidelines, first of all, the manufacturers do not know what
is being expected of them and they have to operateit with a
9 degree of uncertainty, that makes it very difficult to know
10 whether their notices are going to be the subject of a Section
n 5 (e) action for further information.
In general, it is more appropriate for a company to
1Q have some idea of what EPA expects of them. In this connection
lo
I wanted to restate that ATSAC had resolved,in the past — I
will get the resolution and read it to the committee.
Lo
In September 1978, with respect to the guidance
ID
for premanufaetured testing, the committee resolved, "That
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EPA should indicate that certain tested designs to evaluate
the full range of effects which are identified in the guidance
20 document as effects of the most important concern are expected
21 for all compounds unless the person submitting the Section 5
22 notice demonstrates, in a brief statement, that the test is
93 scientifically inappropriate for the chemical or the exposure
94 of humans in the environment, to the chemical, considering
95 both routine and non-routine situations, would be so small
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that the test is unnecessary or other tests provide at
9 least a sensitive evaluation of the effect in question as the
3 base set test."
4 The work group, in considering the premanufacture
proposal, felt again that this should be reiterated because,
6 as I just stated, specification of the nature and circumstances
7 for the conduct of minimum tests to assessment of environmental
8 risks would encourage more complete notices and thereby
9 expedite EPA review and at the same time, the uncertainty and
10 concern about whether commercial production is going to be
n delayed because of insufficient information will be reduced.
12 I think after each of these, I would like to ask if
13 there is any comment from anybody on the committee. I would
14 like to hear it instead of waiting until it is all over.
15 MR.HAYDEN: Just to make it easier to follow, you
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are talking about Roman Numeral II.A?
MS. WARREN: Right. The second point is implementation
18 of significant new usefuls. The support document to the pro-
posal states that the agency recognizes the importance of
9Q coming out with significant new usefuls and intends to get
started on it at some time in 1979 and recognizes the impor-
22 tance and significance of the end usefuls both for existing
93 chemicals and as a followup tool in conjunction with the
94 agency's initial review of chemicals.
95 | Again, as the advisory committee recommended at its
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i last meeting, some form of interim followup on significant
2 changes in the production volume, extended for exposure two
3 or category of use of new chemicals described in the initial
4 premanufacture notice"is necessary to protect the environment
5 and human health before significant new use rules for those
6 chemicals are so promulgated.
7 It was our feeling on the work group that such
8 coverage could be either added to the proposal in the provisior
9 that deals with the coverage of Section 5 to chemicals which
10 are presently under a testing exemption or some sort of other
n exemption where a significant change from that exemption
12 takes place or it could also just be directly required under
13 the reporting authority of Section 8(a).
14 Is there any question with respect to that?
15 CHAIRMAN PREUSS: If I understand, you are reiterat-
16 ing the resolution that was passed basically; you are rein-
17 forcing that?
18 MS. WARREN: We are committing the agency to recognize
19 the importance of getting out significant new use rules but
9Q at the same time, they have not dealt with the followup
91 problem so we are reiterating again our recommendation that
99 some form of followup be promulgated in the same time frame
93 as these regulations and suggesting that kind of followup
94 requirement could be directly added to the provisions requir-
95 ing that Section 5 reporting of uses of chemicals inconsistent
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1 with the terms of exception that are provided even for test
9 marketing or otherwise or it could be entered in as a form
3 of supplemental reporting under Section 8(a).
4 CHAIRMAN PREUSS: Right.
5 MR. HAYDEN: Just to further clarify in my own mind,
6 Jackie, in the preamble to the regs, EPA does say, "Therefore,
7 EPA will followup certain new substances after their intro-
8 duction to commerce." It goes on and says, "TOSCA provides
' EPA two basic tools"and it lists 8(a) and the significant new
10 use, but no where in the regulations does it do anything even
n with Section 8(a).
12 MS. WARREN: That_is_right.
13 MR. HAYDEN: I just wanted to make sure I did not
14 miss that. I could not find it either.
._ MS. WARREN: Going on to Roman Numeral III on this,
lo
16 which are other provisions that the work group felt warranted
17 support by the Full Committee. The first of these deals with
18 the solicitation of information from other persons than the
ig submitter of a premanufacturing notice.
9Q The language that we more or less agreed on here was
91 that ATSAC supports the provisions. It was difficult without
99 full representation on the subcommittee. ATSAC supports the
93 proposed provisions of the PMN regulations which require
94 manufacturers and importers to contact foreign manufacturers,
95 processors and users for information essential to assessing
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T the potential risk proposed by new chemicals.
2 The provisions relieving the submission of a pre-
3 manufacturing notice from responsibility for obtaining the
4 information after the persons have been contacted and authoriz-
5 ing direct submission of the requested information to EPA
6 under the same confidentiality projections of premanufacturing
7 notice information represents a reasonable accommodation of
8 the agency needs for information and the premanufacturing
9 notice submitters ability to obtain such information directly.
10 Any comments?
(No response.)
MS. WARREN: Then with respect to the supplemental
13 information reporting requirements which will be required in
14 certain circumstances, when either the optional information
appears to be of significance to EPA and they want more in-
16 formation about it or they want them finished in the first
17 place, we concluded there was a part of the procedure proposed
18 by EPA to facilitate the development of supplemental infor-
19 mation essential to assessing the potential risk of new
90 chemicals.
91 Such information must be available to the agency
99 on an expedited basis and a proposed approach will accomplish
93 that result.
24 CHAIRMAN PREUSS: I do not understand that.
MS. WARREN: We are just supporting the approach that
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! tha agency took on that, not suggesting any change to it or
9 any modification.
3 CHAIRMAN PREUSS: I am sorry; I am just not familiar
4 with that section of the regs, so I am not exactly sure what
5 it is that you are supporting.
6 MS. WARREN: The proposed — (Inaudible) — by the
7 means of using either authority under Section 5 or through
8 8(a) letters to either persons who have been listed as being
9 persons having information that EPA needs to make a risk
10 assessment or optional information which was not provided but
u which the agency feels that they do need in order to be able to
19 make the judgment about the unreasonable risk of a chemical.
13 They will then out, without formal separate rule-
14 making, to get that information and go directly out under
15 Section 8(a) and are, in effect, conducting that right now. We
16 are just supporting that provision.
17 Then with respect to provisions that we thought
18 require clarification or substantial revision, there are
19 several listed here. We have further agreement that needs to
90 be reached with respect to B which deals with the treatment
21 of byproducts in the regulations and also with the importation
22 of articles. I would like to go through all of those and
93 particular to get any committee comment on the ones where we
94 have not been able to reach agreement.
95 The first has to do with the procedure set forth for
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dealing with invalid notices. Our statement was that the work
2 group generally supports the establishment of procedures for
3 invalidating notices in cases where a manufacturer has to
4 comply procedurally with the notification regulations.
However, we believe that the circumstances under
which, a notice may be declared invalid are ambiguous in the
proposal and therefore, urge EPA to clarify the circumstances,
if any, in which the notice may be declared invalid because
9 the manufacturer failed to submit substantive information
10 requested on the notice forms, in particular the distinction
n between notices which are invalid for procedural reasons and
12 notices which contain insufficient information to permit a
13 risk assessment should really be made explicit.
14 The latter situation is something which Section 5 (a)
15 of the statute addresses directly and should be handled in
16 Section 5 rather than simply as a basis for invalidating the
17 notice.
g Secondly —
19 MR. HAYDEN: Before you get to that, I do have a
comment on it. On the one hand, under Roman Numeral II,
91 Paragraph A, we are saying that the guidelines for EPA ought
to make explicit that for practically all substances, a
23 certain amount of base set testing ought to be expected?
24 MS. WARREN: That's right.
25 MR. HAYDEN: If the notice is submitted without that
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exposure base set of information, shouldn't that just be
considered invalid rather than relying on Section 5(e)?
3 MS. WARREN: I think the fact that the information
4 is not there means that there is insufficient information to
make a judgment on the chemicals that the agencies more
properly should proceed under 5(e) rather than simply reject-
ing the notice as invalid.
8 Is there anybody here from the agency who can com-
9 ment on how they entered into that section?
10 CHAIRMAN PREUSS: I don't think so.
n MS. WARREN: On the invalidity of notices, this is
12 with respect to whether there is simply insufficient informaticjn
13 to evaluate the chemical?
14 MR. DENNY: I am Richard Denny, Associate General
15 Counsel for Toxic Substances. Basically, our position is
16 that with respect to the invalidity, that you are required by
17 the statute independently of even any rules we have to comply
18 with the requirements in Section 5, as to the information that
19 has to be provided and that it supports specifically in Sectior
90 5 with reference to Section 8(a).
91 If someone doesn't do that, the submission is, from
22 the beginning, invalid. The question of test guidelines that
we are dealing with now and if the agency hasn't decided how
94 it wants to deal with that, the theory that we would put out
25 — one of the theories that we might apply test guideline use -f-
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use to put out test guidelines would be that we are required
2 to take action under 5(e) if there may be an unreasonable
, risk and we lack information and this would give an indication
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4 of when we lack information.
The failure to comply with any test guidelines
6 that we put out would not in any event be the basis for in-
7 validating the notice because there is no specific requirement
in Section 5 for any tests, so there would be different
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theories all together.
In order to invalidate something under — strike
that. In order to determine that we would take action in a
situation where we felt there might be an unreasonable risk
because some tests that we felt should be taken were not
taken, we would have to do that, notify and comply with the
statutory requirements of Section 5(e), that is, showing
there might be an unreasonable risk and that we lack infor-
mation we do need and so on. That is the basis for the dis-
tinction between the two.
CHAIRMAN PREUSS: What would be a substantive ex-
ample of something that would invalidate a notice?
MR. DENNY: Something for instance, where we lack
99 information with respect to workers,exposure information
as you required, the requirement set forth in Section 8(a).
I do not have it in front of me but those specific requirement:
95 that is going to be an issue that still has to be worked out
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L as to just what we do whan somebody doesn't comply with the
2 specific Section that we required in the forms where we
3 say "Fill in this information." I presume it would be our
4 position that if somebody does not do that, since our notice
5 requirements have intended to reflect the requirements of
6 Section 5 and Section 8(a), that would probably be the basis
7 for invalidating the notice.
8 The answer to the question may be I do not know which
9 would be fine but that would not be a basis for invalidating
10 but somebody that refused to even answer one of the mandatory
n parts of the questionnaire, we would like to consider that as
12 a basis for determining the notice is invalid.
13 ' That is based upon the belief that they haven't
u complied with the requirements of Section 5, reading 3(a)
15 into it as we have interpreted those sections.
16 CHAIRMAN PREUSS: Right. Any questions on that?
17 (No response.)
18 CHAIRMAN PREUSS: Thank you, by the way.
19 MS. WARREN: The second aspect here —
90 . MR. HAYDEN: Let's clarify too, just what the con-
9! sequence of invalidation is, as Leonard just points out. That
99 means roughly that manufacturing cannot commence until a
93 valid notification is submitted.
94 MR. DENNY: That is correct. That would be exactly
95 right. That would be invalid as though no notice had been
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1 submitted. I would presume the consequences would be if
2 submitting a notice that we determine invalid, if an when the
3 person proceeded to manufacture that chemical, we would
4 probably bring an enforcement action against them. We would,
of course, notify him that we considered it invalid. I do
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6 not mean it would land in the agency and we just wouldn't say
7 anything until he did it.
8 Once we notify him, he can either resubmit his
9 notice or say, I disagree with you and go ahead and manufacture
10 We would bring an enforcement action and it is conceivable that
n the courts would agree with him that it was a valid notice
12 but nevertheless that is the way I think that issue would
13 come up.
14 We would not bring an independent action against
15 him for failure to submit a valid notice. We would wait until
1C he manufactured.
ID
17 MR. HAYDEN: Jackie, I would just suggest for
lg clarification of that language — I forget where we are, 3(a)
19 or 4(a> —
9Q CHAIRMAN PREUSS: 4 (a).
91 MR.HAYDEN: That rather than characterize where
92 invalid notices would apply, rather than calling that procedure
23 matters rather statutorily required information.
94 MS. WARREN: Fails to supply statutorily required
25 information?
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l MR. HAYDEN: Something to that affect. It seems to
2 me when you use the term "valid", it is almost like the person
3 has already done something wrong; he has violated something.
4 That is the impression I got, just the terminology it is
5 invalid versus insufficient information or unacceptable
6 procedures or something of that nature.
7 CHAIRMAN PREUSS: It is invalid. I assume in the
8 sense that he has supplied something that is incorrect and
9 doesn't meet the requirements. Is that the terminology that
10 the agency is assuming?
u MR. DENNY: That is correct. We have been using the
12 term "invalid". It is true that nothing would happen right
13 when he sends that in. We would send him a letter and say
14 we regard it as invalid. We would not try to bring any type
15 of action against him but it would be invalid for purposes of
16 Section 5, and therefore, giving notice even 90 days prior to
17 manufacture.
18 CHAIRMAN PREUSS: So that the 90 day clock does not
19 start running.
90 MR. DENNY: Exactly.
21 CHAIRMAN PREUSS: And it is the option of the
22 person submitting the notice?
23 MR. DENNY: Yes.
24 CHAIRMAN PREUSS: Whether or not to resubmit with
25 the material the agency deems has been required. If he does so,
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the agency accepts it as valid, let us say. At that point,
2 the 90 day clock starts running?
3 MR. DENNY: That is correct.
4 CHAIRMAN PREUSS: His other option would be to
proceed to manufacture and take the chances of an enforcement
6 action for failure to notify and argue in court with you
7 whether or not the notice was in fact valid?
8 MR. DENNY: Right. I think maybe the best way to
9 respond to that gentleman's concern is the notice would be
10 invalid but it is not illegal to submit an invalid notice; it
is just illegal to manufacture without having previously sub-
mitted a valid notice.
13 MR. GLEESON: I have two questions. One, can you
14 distinguish between maybe what is insufficient versus what is
15 invalid? Then, if I understood you correctly, a PMN notice
16 with regard to the 90 day response period — in other words,
17 that 90 day response period does not.. start until the agency
18 has determined that the notification is valid. Is that correct?
19
MR. DENNY: No, that is not correct. The 90 days
9Q would start when the notice — I do not have the statute;
91 I think it is when the notice is received. What we might do
99 now is, and if the notice is valid, then that starts the clock,
93 What we might do or what might happen is we would look at it
94 at some point, hopefully soon after receiving it, but at
95 some point and say this is not valid. In other words, what you
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1 sent in was not valid as a notice and so that wipes out,
2 basically says you have to start over again but the beginning
3 point of the 90 day clock is when you would get the thing.
4 MR. DANELS: Does that invite litigation, to do it
5 that way without having another step in between for invalid
Q notices? In other words, if there is a notice which is received
7 and the clock starts everything on January 1, let us say, and
8 you have 90 days prior to manufacture and you get around to
9 March 1, let us say February 15 is when you decide that it is
10 invalid, you notify them and they get a notice on February
u 21 that the notice is invalid. Doesn't that really create a
12 very difficult situation if the clock has already started
13 running?
14 MR. DENNY: It does. I will have to say that I do
15 not know if the regs deal with that, whether or not we impose
16 a deadline on ourselves or not but there is no question at
17 all that if we wait until the day before the 89th and then
18 submit it, you know your notice is invalid, that we are
19 certainly — it is. going to make everybody's job harder and
90 it certainly makes our position a lot tougher to sustain. We
21 wouldnot get a sympathetic court in that case.
99 MR. GLEESON: Again, the first part of what I
23 had asked, can you comment on insufficient information versus
24 an invalid PMN?
25 MR. DENNY: It is hard. Is this a term you are using
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l or is this a term you get out of our regulations? I am not
2 sure what:you mean.
3 MS. WARREN: Would you look at that? If you arenot
4 finding that word in some specific context, then I suppose
5 the answer would be if you provide us insufficient information,
6 then as defined by the statute and our regs interpreting the
7 statute, then you would have an invalid notice.
8 It is possible that even perhaps in our own preamble,
9 regs or other may be using insufficient information in some
10 other way, perhaps referring to the type of information we
ii seek and not receive under some sort of Section 5 guidelines.
12 I am not sure that there is any particular usage of that word
13 yet, so I would say it is conforming.
14 MS. WARREN: Insufficient is used under 5(e).
15 CHAIRMAN PREUSS: I think that is the problem we
16 have exactly. There do seem to be various uses of the words
17 "insufficient" and "invalid" and that is the point the work
18 group is making here, that whole piece needs to be clarified,
19 under what circumstances the agency would consider something
90 insufficient for purposes of 5(e) and what it would consider
21 invalid and what combination of semantics could one could?
22 MR. DENNY: If these are unclear in the preamble of
23 the regulation, as I say, I do not have it before me and I
24 have not been able to memorize it quite yet, it is brief and
25 plain English and all as it is, but if it is the case, then
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certainly it should be clarified.
MS. WARREN: Dick, I think I would say to you that
3 among four — (Inaudible) — there were four different inter-
4 pretations of what it meant.
MR. DENNY: Fine, then that leaves us lots of room,
6 Jackie. That wasn't meant seriously. I agree, in that case,
7 it should be clarified.
8 MS. WARREN: The second point on grounds for declaring
9 a notice invalid or deficient and both terms are used in the
10 regulations, there is a blanket prohibition excepting notices
from processors. The regulation simply'states that processors
12 are ineligible submitters of Section 5 notices.
13 The work group questions whether there might not be
14 circumstances for notification by processor might be appropri-
15 ate. The two examples which came to mind were one, where a
16 manufacturer of a chemical is producing for an exempt use and
17 does not submit a premanufacture notice on it although one of
18 his customers might use it for a non-exempt purpose and
19 there is no mechanism right now for that chemical to come into
20 the Section 5 process.
21 The second type of situation was where a processor
22 really wants the product to be manufactured for him but has
23 all of the information which would go into the premanufactur-
24 ing notice and where the manufacturer would have little, if
25 any of that information and to require the processor to rely 01
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the manufacturer in that situation because he is ineligible
himself to report, seems to be an inefficient way to go about
3
4 We would recommend that the agency reconsider the
circumstances under which a processor might be permitted to
6 submit the Section 5 notice.
7 CHAIRMAN PREUSS : Jackie, just for information,
are you saying that your recommendation is that under some
g circumstances, the agency might be willing to accept or is
the recommendation that in certain circumstances, processors
should be required to submit?
MS. WARREN: No. I think the agency should be
13
willing to exempt the statute that requires the manufacturer
14 to report. That does not preclude a processor from reporting,
15 the agency's interpretation of this is that a processor can not
16 report under any conditions.
17 What we are saying is that they should reconsider
18 that because there are circumstances in which a report by a
19 processor would be appropriate and they should allow for that,
9Q not require them but to allow for it. Is that clear?
91 CHAIRMAN PREUSS: Yes. It is clear. I am just
99 wondering why some work group did not take that extra step
93 and say that the agency consider requiring it under certain
94 circumstances.
95 MS. WARREN: I am not sure that they can require it.
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l The statute requires it of manufacturers. It is not clear
2 whether the agency can require it of a processor, directly
3 under Section 5(a).
4 MR. GLEESON: The option should be opened up to
5 processors, in a couple of distinct cases.
Q CHAIRMAN PREUSS: I agree with you too. There were a
7 clear set of gaps there that all out defies.
8 MR.HAYDEN: Jackie, you are saying that the agency
9 ought to allow the processor to submit the PMN if he wishes,
10 in some cases?
n MS. WARREN: Yes.
12 MR. HAYDEN: What would be the incentive of a pro-
13 cessor to do so?
14 MS. WARREN: The types of examples that came up
15 would be where the processor-really just contracts for the
16 manufacturer to make something for him but he really is, in
17 effect, developer of the product and doesn't want to share
!8 any of the information with the manufacturer and it is
!9 required of the manufacturer to submit the PMN the way the
20 regulations are proposed. It would just be to make it a little
21 bit more flexible than it is.
22 I do not think the product could be manufactured
23 under that circumstance. Somebody has to do the — (Inaudible)
94 MR. HAYDEN: The other example you gave was where
25 the manufacturer is manufacturing an exempted substance but
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the processor is turning it into a covered substance, convert-
ing it, doing whatever, doing reprocessing?
3 MS. WARREN: Right.
4 MR. HAYDEN: Why would somebody in the latter cate-
gory have the incentive to go through Section 5, TOSCA? It
seems to me that we just prefer to let it slip through in
the cracks.
8 MS. WARREN: Maybe it would not achieve the objectives
9 of the law to do that.
10 MR. HAYDEN: I agree. I would like to have someone
— (Inaudible) — I am not sure that permitting the processor
12 to do it will achieve anything there. Perhaps it ought to be
13 undertaken to sea if in that case, EPA could require notifi-
14 cation.
15 MS. WARBEN: You would probably need either a sig-
16 nificant new use rule on that.
17 MR. DENNY: Bob, there is an answer. It is a prohibit?
18 actual use for commercial uses, a chemical substance or
19 mixture which the person knew or had reason to know was
20 manufactured in violation of Section 5 so the processor would
21 be violating the law if he used something that he knew was
99 in the substance and had not cleared the premanufacture notice
93 or had reason to know.
24 MR. GLEESONi_""We are not really talking about a new
substance, at least not in my mind. We were talking about —
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1 what actually came up was what if you had, as a scenario, a
2 material that was exempt under the fact that it might be used
3 as a pharmaceutical or an Adchem or something of that nature,
4 and a processor found a way to use it,for example, as an
5 intermediate for codeine application.
6 If he proceeds along that line, if I understand the
7 Act, he is in violation. In my thinking, I cannot foresee
8 someone who is going to get into that situation running the
9 risk of doing that.
10 I think I would much prefer to say, okay, granted
n that is the law of the land, we might not like it but we will
12 have to back up and file a PMN. That being the case right
13 now, they cannot do that, they are locked out from doing it.
14 MR. KAYDEN: Your feeling is, they would be required
15 under Section 5?
16 MR. GLEESON: Yes.
17 MR. HAYDEN: And notice a significant new use?
18 MR. GLEESON: That's correct.
19 MS. WARREN: As you know, in the — (Inaudible) —
90 it is a pesticide or a track — it is not on the inventory
21 technically.
99 MR. GLEESON: It is technically in the material.
23 MR. EENNY: That is right.
94 MR. HAYDEN: Could it not be stated then, in that
25 case, the processor — it should be made clear that in that
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case, the processor has the same requirements as the producer.
MR. GLEESON: I think you get awfully hung up
3 though in talking about exempt uses versus non-exempt use.
4 I think it is fairly clear, as it is right now, a processor
cannot file a PMN and I can foresee at least two examples
"
where that totally prohibits a product coming on the market;
whether it would be acceptable or not is not germane. There jusjt
is no legal way to do it.
What I am saying is that if that is the case, then
10 EPA ought to allow a processor to submit a PMN. There may
n also be other examples that we have not thought about.
19 MS. WARREN: Did you want to say something more?
13 CHAIRMAN PREUSS: That's fine
14 MS. WARREN: The next subject area has to do with
15 byproducts. We have not reached agreement ourselves on this
16 but I just wanted to discuss a little bit of it. The thing
17 that prompted the statements that are in the report of the
18 work group, the treatment of byproducts in the proposed regu-
19 lation, appears to be inadequate to us and also inconsistent
9Q in some ways.
91 Some members of thework group believe that EPA
99 should get information on all types of products. The statute
93 says, in Section 8(a), I believe 3(a)(1)(d), that the premanu-
94 facturing notice should include a description of byproducts
95 that result from the manufacture, use, distribution in commerce
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disposal and processing.
The forms only require information on byproducts
3 from the manufacturer because the use used in consumer form
4 does not include a request for that kind of information from
anybody else further down the chain.
There also are some statements that deal with
not having to report byproducts which are on the inventory.
8 When I say byproducts, I am talking about byproducts, co-
9 products and other of the chemicals that are listed there.
10 So the only description that is going to come in
n of them is the one that results from the production of a new
12 chemical. Even then, it is not going to be clear to the person
13 filling out this form whether:they should report a byproduct
14 that is in the inventory or not because elsewhere in the
15 preamble it says, the products that don't have to be reported
16 are those that are on the inventory. So we thought that ought
17 to be clarified.
18 Then I would like to get some opinion from other
19 people in the committee also. We felt regardless of being in
20 the inventory or anything else, if there are byproducts, co-
21 products or other intermediates produced in tha manufacture,
22 processing or elsewhere in the chain, that ara of toxicologica]
significance, EPA should know about that and that any infor-
mation on those should be required to be reported by the
25 manufacturer and solicited from anyone else in tha chain who
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1 has information about it.
2 This is not to say that they have to tast them or
3 do anything but just simply ask for them for the quantities
4 that, would be produced, the anticipated worker exposure and
r the environmental release. Some of that information is now
0
6 requested on the forms for some compounds but it is not re-
7 quested anywhere beyond the manufacture.
8 The health and environmental effects stated in
9 the manufacturer's position and any risk or assessments that
IQ might have been conducted, are mentioned.
n Is there anyone else on the committee who would
12 like to comment on whether they think that information should
13 or should not be included? I know that David will probably
14 want to say something about that?
15 MR. GLEESON: If I comment, I will — (Inaudible).
16 DR. SHERMAN: My experience, of course, has been
17 with the workers who use the secondary product, that is
18 shipped by the manufacturer and used in plants. I think it
19 would certainly help the whole health and safety of all of the
20 country to know what the byproducts are and what is going on.
21 CHAIRMAN PREUSS: I would add to that, not asking
22 for it strikes me as opening up a rather substantial loophole
93 in the information network that is being set up under TOSCA.
24 I can see a number of instances where new products, new sub-
25 stances might be formed but which the agency would never find
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l out simply because they were byproducts or co-products. That
9 could potentially be extremely toxic.
3 One just has to look at some of the present problems
4 that we are dealing with at the moment where the main issue
5 is the byproduct and if that substance were being manufactured
6 or processed for the first time, we would simply not be getting
7 that kind of information. I think it is extremely important.
g I do not know what difficulty it imposes. I frankly
9 have no idea what kind of an additional burden it places on
10 an industrial manufacturer or processor to provide this kind
n of information, particularly the processor perhaps who may not
12 have the mechanism in place for these kinds of determinations.
13 It may create a whole new need for testing if the processor
14 just has nothing like that in place.
15 I assume he would want a processor to look at the
16 question or whether or not such byproducts are formed but
17 the wording here —
18 MS. WARREN: Yes. I do not know what kind of an
19 additional burden it would produce there but it would seem to
90 me also that it would create a great gap in information that
91 is really needed if you are trying to assess the exposure
22 resulting from the production of a new chemical. That exposure
i
23 involves the byproducts, co-products and all of these other
94 things that are produced all the way down the line.
25 If you are going to draw the line at the manufacturei
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l and then go on to say or at least imply that this product and
co-product are in the inventory, that nothing need be submitted
about them, I am not sura that is what EPA really wants but
o
4 that is the way the preamble reads and it is not clear. It
seemed to me to be a great shortcoming to draw the line at the
D
6 manufacturer and only ask processors and users about exposure
7 to the main compound.
g We will be drawing up a final report on comments and
g submitting them to the committee. I will ask if there are
dissenting views, to just band them and we can attach them
n when the document is submitted to the Administrator.
I would like to question dealing with byproducts,
13 impurities and non-isolated intermediates involves the agency's
apparent decision to exclude these compounds from the inventory
.. and from the premanufacturing requirements of Section 5 because
lO
16 it is the same question again, if they are not on the inventory
17 but they are not new chemicals, because we are excluding them
18 from Section 5 also, conceivably very large quantities of
19 toxicological significant compounds can be produced and
9Q exposure — (Inaudible) — has no record of it and no notice
91 to EPA at any point.
99 We also thought that the advisory committee should
\
93 recommend to the agency that they address that problem and
94 either consider applying Section 5 to them or otherwise put
95 out some significant new use for them, but in any event,
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1 a signficant use role that does not appear in the inventory
9 is a contradiction in terms. In any event, it is a problem
3 that is not being addressed by the agency but in effect, they
4 are defining the problem out of existence while it in fact
5 may exist.
6 The next topic deals with the R&D exemption. This
7 is the exemption for small quantities which are produced for
8 research and development. There is a requirement in the Act
9 that manufacturers of research and development chemicals notify
10 users of the chemicals and certain other persons of the risk
11 that may be involved from exposure to them.
12 We recommend that ATSAC endorse the agency's in-
13 elusion of this proposal in the regulations. At the same time,
14 there seemed to be some questions raised here which are not
15 answered because the agency's description of research and
16 development chemicals leaves the big question of what is the
17 research and development question? What is the research and
18 development chemical? The question of whether a commercial
19 producer of research and development chemicals could apply
90 for or not even apply for, but just read their regulation as
21 giving them an exemption from Section 5 seems to be a real
22 possibility.
t
93 It was our recommendation that the agency look again
94 at that part of the proposal and define what they are talking
25 about with respect to research and development chemicals.
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1 The next section deals with the importation of ar-
9 ticles containing new chemical substances. These are simply
3 excluded from the coverage of Section 5, even though Section
4 13, the section of the statute that deals with importation
. specifically refers to articles.
0
6 We foresaw two serious problems with the blanket
7 exemption of chemicals containing new chemicals. The first
8 of these is that toxic substances coming in in articles and
9 new chemical substances in the articles could have work spread
10 exposure and those articles could not be manufactured domesti-
'n cally without the manufacturer putting through a premarket
12 notification on the new substance.
13 It seems discrimination against domestic manufacturers
14 to allow, and it is advantage to the U.S. population besides,
15 to allow the substances to come in without any notice at all,
16 and not having any requirement to find out what the substance
17 was and get information on what was involved with exposure to
^g them.
19 How you go about doing that is very complicated but
90 I think the agency'needs to, again, not define it out of
21 existence but address it directly.
22 The second problem is that the disadvantage to U.S.
>
93 manufacturers and the fact that their competitors or they
94 will simply relocate abroad, manufacture the substance abroad,
25 thereby avoiding the requirement of Section 5, premanufacturinc
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notice and then import them back into this country for sale
and simply avoid Section 5 altogether to avoid proof of
hazards posed by those kinds of things coming in from foreign
manufacturers or the relocation of industry abroad.
We felt that the substances in those articles should
be subject to Section 5 or the articles should be prohibited
from importation entirely. Is there any comment on that?
CHAIRMAN PREUSS: Yes. For clarification, if someone
in the United States wants to produce an article using a
substance which would be subject to premanufacture notificatio
but that substance is entirely self-contained, entirely con-
tained but never gets out, could he produce that article witho
going through PMN at all?
The way the regulations are written —
MS. WARREN: Produce it in the United States?
CHAIRMAN PREUSS: Yes.
MR. DENNY: The answer is no.
MS. WARREN: I don't think so. It is a new chem-
ical.
MR. DENNY: He could not, if he manufactures that
in the United States, whoever manufactures it, the guy who
makes the article, or the fellow that sells the substance to
him, it has to go through premanufacturing notice.
The person who makes the article, and assuming he
doesn't also make the substance, would be liable if he knew or
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1 had reason to know that the substance had not gona through
2 premanufacturing notice, so the answer is no. The only way
3 — the only situation where somebody would be able to do this
4 is if a person possessed the material that he had no reason to
5 know and did not know it hadn't gone through premanufacturing
6 notice but basically the answer is yes, he has to go through,
T the manufacturer has to go through PMN within the United States
8 MS. WARREN: But if he manufactures abroad and it
9 just comes in, there just is a loophole in the regulation.
10 MR. DENNY: It is not really a loophole. It is one
n of the most difficult problems we have had to deal with. If
12 somebody imports, say a car, he does not know everything that
13 went in that and whether he should or not and we are still
14 trying to work this out. I am seeking comments on it but it
15 is very, very difficult to find out all of the things that we
16 into the car. He buys his seats from somebody else who buys
17 seats from somebody else who buys raw materials from somebody
is else.
19 It was.the agency's concern it would be literally
20 impossible to do in many cases. Whether or not you agree to
21 that, it is up to the committee to make recommendations on
92 it. That is a problem we have to deal with that many times a
23 guy simply ships in an article that may have hundreds of
94 thousands of chemical substances in it. Unless he found
25 out what all of those are —
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L CHAIRMAN PREUSS: That is exactly the same argument
2 applied to the domestic manufacturer.
3 MR. DENNY: No, the domestic manufacturer, you
4 have two situations there. Whoever makes the material is to
. get the PMN. He should be doing that.
6 Second, if a guy makes an article, assuming that
7 someone in the United States has not given notice, let us
8 say of how ha makes the car. It may be that there is a sub-
9 stance in there that was made in the U.S. that did not go
10 through, PMN.
n If a guy makes a car and he had no reason to know
12 that and had no way to know that, ha is not violating any
13 law. It is just if he had reason to know but the guy who
14 manufactured the material in the first place would be, but
15 in that respect, it is an analogous situation. General
16 Motors does not have to know all of the substances about
17 everything in its cars have gone through pramanufacturing
18 notice.
19 Of course it is in their interest to avoid getting
20 into sticky situations and make sure that thair processors
21 in fact give such notice. I shouldn't say processors; the
22 people that sell to them givs such notice but it is a diffi-
23 cult situation.
24 You have hit two reasons in your talk, Jackie, for
25 why a notice should be given when they import it but I hope
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you will deal with tha problems of just how we would maka this
work without bringing importation of articles to a halt.
DR. SHERMAN: Theoretically couldn't somebody import
TRIS-coated fabric?
MR. DENNY: Somebody could do it, would not have to
get premanufacture. First off,TRIS is already made in the
United States so it would not get premanufacturing notice
anyhow. One of the things I would like to make clear is
that we do have authority to restrict the importation of an
article containing anything and that would be our answer. We
would say something containing TRIS must go through premanu-
facturing notice or strike premanufacturing notice.
CHAIRMAN PREUSS: You would never know, that is
the point. Let us say there was an analog of TRIS that was
manufactured abroad of which you had no knowledge here in
the agency that was incorporated into materials and imported
as an article. The agency would have no way of knowing,
unless it deliberately went out to test or some other procedure
that in fact there was a known potentially toxic substance
incorporated into that fabric.
You would not have any measure — any way of en-
forcing .
MR. DENNY: I agree with that. As I said, try
to look at the other side and hope you will address it
because frankly if you don't address it, it does not help us
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as much. You can imagine the situation, someone brings in
clcth and a chain of suppliers of dyes and substances and
the dyes may go three, four,five chains back and they may
come from different countries and there may be more or less
honesty. That is the issue. That is what we have wrestled
with at EPA. I hope you hit that side when you discuss it.
CHAIRMAN PREUSS: Yes, Selina?
DR. BENDIX: I am glad your committee brought this
issue up because I think that this problem of imported articles
and what was and was not covered is one that has come up
repeatedly at ATSAC meetings. I think perhaps this is the
12
11
first time it has been made clear to us that the reason cer-
13 tain things are not being covered is that they cannot figure
14 out how to write a rule to do that.
,, It seems to me that it might be worthwhile for
1O
16 us at each meeting to perhaps schedule some time to just sit
17 and discuss ways and means of arriving at control that would
18 be reasonable.
19 MR. HAYDEN: I would like to ask a question related
9Q to this. I don't recall, does the statute address this matter
91 at all, importation of articles?
MR. DENNY: No.
MS. WARREN: The statute just says, "define manu-
facturers as including the importation of any chemical sub-
stance. "
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Presumably somebody that brings in an article has
brought in all of the substances, Congress just plain didn't
3 focus on the'issue, but if you read the statute, I think you
4 can see that somebody who does bring in an article, does
bring in all of the substances. That raises difficult
6 questions there.
7 Should we be requiring premanufacturing notice
8 anyhow just on the basis? If you make that interpretation,
9 I think we definitely want — I think it is a reasonable in-
10 terpretation and for the purposes of Section 6, that we
can regulate any part of a substance — any part of an article
12 brought into the country, say if somebody is importing TRIS-
13 treated nightwear, we can say that you can't bring that in or
14 you are not about to bring such nightwear in; you ara not
15 allowed to bring the TRIS part of it in
16 On the other hand, if you say, let us follow the
17 logic of that and then any substance that is brought in should
18
ba subject to premanufacturing notice, since it is "manufacture
19 when it is imported, then you have this other problem that
20 I mentioned. That is a statutory authority for definition
21 of manufacture.
22 MR. HAYDEN: Since Marilyn Bracken made a timely
23 entrance here, may I address a question to her concerning
94 this? Has there been any discussion of this problem in any
.75 of the international forums?
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l ' MS. BRACKEN: There has been a great deal of dis-
9 cussion, a great deal of discussion about this issue of
3 internationality. It has been raised at our meetings with
4 the European communities and it has been raised by various
5 importers,importing groups and they tend to point out-— the
6 internation community tends to point out the difficulty that
7 thsy have, the manufacturer, the importer, identifying all of
g the substances that are in an article, whether it is for
9 purposes — they have difficulty in just knowing or getting
10 the information from their sources as to just what is in that
n article.
12 So they have just kind of talked about the issues
13 that Dick has raised, just the difficulty in obtaining that
14 kind of information.
15 MR. HAYDEN: Has there bean any work to try to come
16 up with some kind of international program on how to deal with
17 it?
18 MS. BRACKEN: Not yet. It has been raised at some
19 issue and we have talked about how we will deal with the
9Q problem and.what we have talked off and on in different meetinc
91 about, .what we had proposed in our Section 5 regulations,, but
22 there has been no international project started yet on that.
93 MR. HAYDEN : The European community proposal deals
94 with a premarket notification?
25 MS. BARCKEN: That is right.
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MR. HAYDEN: How do they address this type of
problem? There.'is a lot of importation into European Common
3 Market of articles containing chemicals?
4 MS. BRACKEN: Yes. I am not certain how they are
5 addressing that yet. We do not have any details. It is done
6 firmly without their planning to address it. As you know,
their directive is still in the drafting stage. I am not cer-
8 tain how they are planning to deal with it.
9 MR. HAYDEN: Thank you.
10 CHAIRMAN PREUSS: It would certainly be a good
n timing for the recruitment of international aspects of TOSCA.
12 MR. HAYDEN: Yes, boss.
13 CHAIRMAN PREUSS: All right.
14 MS. WARREN: I would like to add one point. I do
15 not think the agency needs to solve the whole problem before
16 they take any action as to whatever aspects of it they can.
17 Your example was a car. The example we had when we talked
ig about it in the work group was just a pen, like Peter is
19 holding right now. It might have in it a new chemical
20 substance which would get in peoples' fingers, cause exposure
21 and that sort of thing.
22 I think the problem could be broken down into more
93 manageable aspects of it and those aspects dealt with rather
24 than solving the universe of the problem before you do any-
95 thing about it at all.
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8 i MR. HAYDEN: A point of information. It is March
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I would like to add, along those lines, that I
understand there will be a meeting in New York on premanu-
facturing notification for importers in March, on the 9th.
For those interested in following up this question, I am
hearing some of the other things. I am sure anyone who is
interested can get information directly from Blake Byles'
shop about that.
7.
MS. WARREN: I am sorry. That's Washington, and
it's March 9.
CHAIRMAN PREUSS: March 9. Is that it, Bob?
MR. HAYDEN: Yes.
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CHAIRMAN PREUSS: I believe you were up to Roman
numeral V.
MS. WARREN: I am up to Roman numeral V, which is
entitled, "Other Recommendations." These are three points
which the work group felt that the members of the Committee
should consider recommending to EPA for their attention.
The first one deals with the low-volume chemicals small-
business question which EPA raised in the Preamble asking for
comment on how the premanufactured program should be
implemented in relation to small businesses and low-volume
products.
In this connection I wanted to remind the people
at this meeting that ATSAC has a resolution dealing with the ,
question of small businesses. I would like to read it now
just to remind you of it.
We stated that, "EPA should fully investigate the
possibility of making assistance available in cases where it
can be shown clearly that assistance is needed to achieve
the needed testing and that such assistance bfe supplied as
soon as possible to be coordinated with the implementation, of
the premanufacturing requirements.
"The preface to that recommendation was that we
recognized that small-chemical manufacturers may face par-
ticular financial, manpower and/or technical burdens in
complying with testing requirements, including the
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premanufacturing test guidelines; and also, that adequate
testing for health and environmental effects should not be
sacrificed by such burdens on some companies."
Apart from having made the recommendations to EPA,
we have not really seen any evidence of a program or legis-
lative proposal or anything else which would accommodate that
problem. But the Agency has asked for comments on how to
apply the program to producers in those two categories.
I think they are really separate questions, and the
Preamble really recognizes that the source of the commodity
or the volume of the chemical are not necessarily synonymous
with the degree of risk which might be posed by that chemical.
For this reason we agreed that we should state that the risk
posed by a chemical is a function of the particular char-
acteristics of the chemical, the anticipated use and
resulting exposure, and for this reason the work group proposes
thai; the Advisory Committee recommend that EPA devise
criteria which reflect the above factors which are, as I
said, the particular characteristics of the chemical, the
anticipated use and resulting exposure.
In order to determine the conditions under which
lesser requirements for testing and information submitted
would be acceptable to the Agency for purposes of Section V
review, and that requirements consistent with such conditions
should,therefore, be incorporated in the Section V guidelines
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that would make the conditions synonymous with presumble low-
risk rather than small business or simply low-volume
production. Is there any comment on that?
CHAIRMAN PREUSS: Is this one in which the work
group did or did not achieve consensus?
MS. WARREN: We did not get to discussing it
because our business representative had to leave, but we will
8 be discussing it and we will submit and circulate to the
9 Committee any revised language that reflects an agreement on
10 it.
11 CHAIRMAN PREUSS: Any comments?
12 MR. HAYDEN: I do think David expressed general
13 agreement on it — did he not? I do not want to commit him
14 but I thought he had.
15 MS. WARREN: He expressed general agreement,with the
16 statement that this was a function of exposure, volume and
17 particular characteristics of the chemical. So I think he is
18 likely to agree with it. He wanted more time to talk about it
19 and: think about it.
20 The next one of the recommendations concerns the
21 question of confidentiality of chemical identity. The Agency1
22 position as stated in the proposed regulations presents a
23 compromise between the requirements of confidentiality and
24 also the public interest and access to health and safety
95 information.
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1 During and after the premanufacture period, in the
2 view of the work group that compromise as it applies to the
3 premanufacture-notice period, does not really accommodate the
4 interest which is protected by Section 14 (g) as far as the
5 premanufacture-period.notice is concerned.
6 Section 14 B(l)(a)2, provides that the public shall
7 have full access, in effect, to health and safety studies
8 during the premanufacture period as well as after manufacture
9 commences with the exception of process and proportions
10 information.
11 The Agency admits that chemical identity is part of
12 the health and safety study. They say it about four or five
13 times in that Preamble. Nevertheless, they are going to
14 withhold that identity when a claim of confidentiality is
15 made during the premanufacturing period.
16 For this reason we felt that the Advisory Committee
17 should urge EPA to develop and implement a mechanism that
18 would permit the stiaring of chemical-identity information
19 with bona fide public-interest groups and other independent
20 scientists under conditions which would prevent the disclosure
21 of such information to the competitors of the person submitting
22 the premanufacture notice. Is there any comment on that?
93 CHAIRMAN PREUSS: I know that this has been
24 suggested in the past, and discussed in the past with the
25 Agency. I'm not asking you to speak now for the Agency, but
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i as far as you know is there any reason why this was not done?
2 Or what were the resons why this was excluded?
3 MS. WARREN: As far as I know, it has only been
4 discussed. At least, in any public meeting I have ever been
5 in it has only been discussed in a very tangential way,
6 thought about in this manner but never any specific proposal.
7 In the EDF role, I have expressed some reservations about
8 signing a confidentiality agreement that might leave us open
9 to harrassment and having to defend liability suits and that
10 sort of thing.
11 However/ I would like to see a specific proposal,
12 for example, where we would have an independent scientist
13 come on as a nominal consultant to the Agency bound by the
14 confidentiality requirements. But in some way that might
15 eliminate a liability. I would like to. see some sort of a
16 proposal and I do not know how much attention the Agency has
17 given to that.
is As I said, I think their compromise really inhibits
19 any sort of effective public review during this premanufacture
20 period, and that the statute should provide for that. I would
21 like to see a more serious effort towards developing some
22 sort of mechanism.
23 CHAIRMAN PREUSS: Dick, did you want to say
24 something?
25 MR. DENNYj I just want to suggest that here one
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of the biggest problems is in the implementation. Frankly,
a recommendation that we implement something along that line
would not be nearly as helpful as how. You have two main
problems: One is how to determine whether some one is a
bona fide public-interest group or is a bona fide independent
scientist. What do you use — did he come from a good
family? It is a very tough thing to do.
Who sits there and says, "I don't think he is
bona fide but I think you are." And on what basis do you
review that decision. Secondly, what happens if you get in
there and look at the data and it indicates that every man,
woman and child in the United States is going to die and you
are not allowed to tell anybody about it?
MS. WARREN: You could use the generic name. You
have the data any. The only thing you don't have is the
chemical identity. If you are bound to keep from disclosing
the chemical identity but referred to that chemical — if
you made an announcement to the newspaper of the technical
name it is not going to mean anything to anybody but maybe to
the competitor, the generic name would serve just as well.
It is the problem of trying to-review the data with using the
generic name that is so difficult.
MR. DENNY:' But I would think you would have a
problem. The main purpose of gaining acess would be gain
additional information, and if that additional information
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1 did indicate a greater risk than the mere data itself
2 indicated and you were not allowed to tell, what do you do in
3 that situation?
4 CHAIRMAN PREUSS: It's not that you are not allowed
5 to tell. First of all, you are allowed to tell the Agency.
6 MR. DENNY: You are allowed to tell the Agency.
7 CHAIRMAN PREUSS: That's an important step forward
8 right there.
9 MR. DENNY: It would be. But still
10 CHAIRMAN PREUSS: I think as Jackie said, that
11 would be the least of the problems. If there were an
12 independent scientist who discovered a substantial risk that
13 would be involved, I'm not sure that would be the problem.
14 I can understand your first problem of trying to define who
15 was able to receive such information and who was not.
16 Again, I was pushing for that part of the discussion
17 in the work group. I think the feeling was that in some of
is the things we have been discussing, the Agency has to come
19 forward with recommendations for proposals, with ideas, so
20 that they can be put on the table and discussed and not say
21 they do not exist by ignoring them. I think that is the
22 problem we have in several of these instances. That more
23 than anything else is what we would like to have.
24 Let's see — we have Bob Hayden, and Jeanette and
25 then there is this unidentified individual in the audience.
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i Robert?
2 MR. HAYDEN: I have a problem with the Agency
3 "compromise" and the approach that we have up to now taken in
4 the Committee and that is that both of them in really in
5 violation of the statute. The statute simply says that this
6 information is to remain available. It may very well be true
7 that there is a real problem in making it available in that
8 Congress did not think out that problem.
9 However, I think a very strong case could be made
10 that either way we approach it is in violation of the act.
11 I think we ought to at least consider the Committee recom-
12 mending that EPA go to Congress and rectify that problem
is without suggesting what that solution is. I will relinguish
14 the microphone.
15 CHAIRMAN PREUSS: Jan?
16 MS. SHERMAN: I have a question. I'm wondering
17 that since the company that claims confidentiality is claiming
is it for an economic advantage, would there be a possibility of
19 requiring an affidavit or requiring assurance that because
20 they are claiming confidentiality that the validity of their
21 health and safety data does indeed rule out any imminent risk
22 or severe hazard from their product; and in exchange-for
23 receiving confidentiality they assume both personal and
24 corporate responsibility for any damage.
25 They clearly ought to have to give us something if
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they want something, and confidentiality is for economic
reasons — if they are so sure the data is good and there is
really no harm to the buyer's fear in any way, let them take
the responsibility for both corporate and personal risk as
corporate managers.
CHAIRMAN PREUSS: And now for the gentleman in the
audience. Yes, sir?
MR. BILES: My name is Lloyd Biles, Premanufacturin<
Review Division. The only comment I want to make is that on
the general issue of whether we considered this alternative,
we considered it along with seven others that were built into
this support document. My only point is that we picked one
position and did not pick the position being proposed.
However, there is no doubt that this is one of
several things that we considered quite a bit, arid we discussed
it with many people-outside of the Agency r. ,We continue to
be open on how to resolve it, but there are eight different
alternatives as to how we will handle it and they are
spelled out in the support document.
The only thing I am concerned about is that people
understand this is something we have seriously considered at
this time. We did not propose it. Just be aware of that.
CHAIRMAN PREUSS: All right.
MS. WARREN: I would like to respond to that. My
position speaking from EDF is not necessarily the same one
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i the Advisory Committee is going to want to take; but it seems
2 to me that the Agency takes kind of an all-or-nothing
3 approach. You have said you disagree that the statute provide
4 for complete public access to identity at all times.
5 As an attorney for EDF, I think it does. Our
6 position also is that the Agency will not concede that that
7 position being taken or advocated in the proposal that we
8 made was illegal. I have not seen anything that spells out
9 a mechanism. I have not heard anything in any public meeting
10 that in fact was a concrete proposal of how it might be done.
11 I have heard in every general discussion ideas as
12 to: We could always disclose it, we could never disclose it,
13 we could disclose it through a panel — all discussions were
14 quite general. I concede that they : are there but they are
15 not specific enough to rise to the level of being a specific
16 proposal on how it may be done. At least, I have not been
17 privy to any Agency discussion on that, or any articulation
18 of it on paper.
19 MR. BILES: On the first issue, on the legality, as
20 I said in every public meeting to date we have great legal
21 briefs on both sides of the issue: Marshall Cleveland from
22 NRTC, Jim Moraley, from Proctor and Gamble in the industry
23 side. I just maintain that on the legal side you can argue
94 both sides, and we will be in litigation on it, frankly,
25 whatever we do.
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On the pragmatic side of what we do, admittedly in
spelling out the alternatives, we have gone through most of
the detail on the alternatives selected. We do not consider
it was necessary to go into all of the detail of what we con-
sidered in the support document — every alternative.
Basically, we thought it was our position to lay
out why we did what we did, identify the other things we
considered and solicited comments on how these other approaches
might be taken. That is what we have done. I can guarantee
you this support document would be two or three times as--.long
as it is already, which it was in earlier drafts when we had
these kinds of things in it.
Part of our interest was in getting the thing down
to a manageable length so people could get all the way
through it, so we cut out a lot of the very specific
considerations on all of the alternatives on every issue in
here. That is how it came about.
CHAIRMAN PREUSS: Right. Yes, Salina?
DR. BENDIX: It seems to me that if there is
material that had been worked up and eliminated for what I
think is a very good reason of creating a document of
manageable size, then if that information is of sufficient
interest to the work group it might be helpful if it could
be made available to the work group*
MS. WARREN: The last subject is with with
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substantial risk information on new chemicals. The Section
8(e) of the statute deals only with the chemicals that are in
commercial production that are on the inventory or added to
the inventory.
The forms keep information that could indicate a
substantial risk really too optional to be submitted just at
the option of the person making up the notice, and that person
is not under an Section 8(e) obligation until the chemical
goes into production.
For that reason we stated first, our concern that
information indicating the possibility of substantial risk
from the new:;chemical is not required to be submitted under
the new proposed rules. And the example we gave would be
information indicating a structure activity relationship to a
known hazardous compound.
We felt this was a shortcoming in the regulations
and suggested that a general requirement possibly modeled on
this -Section 8(e) regulations now in effect for submission of
any information indicative of any substantial risk should be
included in the final Section 5 regulation as mandatory. Are
there any comments on that?
CHAIRMAN PREUSS: This is just an informational
question, Jackie. What is now required in terms of infor-
mation that is available to a manufacturer — testing
information or other information that he has in his possession!
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1 MS. WARREN: The Agency's definition of test data,
2 in my reading of it/ would not include structure activity
3 information. And the reason I included that is because that
4 type of information is specifically addressed in the optional
5 part of the form, which would lead somebody filling out the
6 form to conclude that that information did not have to be
7 submitted.
8 CHAIRMAN PREUSSS: There is no penalty, and no
9 problems, whether or not this kind of information had to be
10 supplied, whether or not there were problems or penalties
11 with simply not supplying it?
12 MS. WARREN: The only section that would, con-
13 ceivably, be applicable would be Section 8(e), and that only
14 applies to commercial chemicals; and a Section 5 chemical by
15 definition is not in commercial production.
16 CHAIRMAN PREUSS: Right. But when it does go into
17 commercial production it would be subject to 8(e)?
18 MS. WARREN: Yes.
19 CHAIRMAN PREUSS: So the concern of the work group
20 is at what part of the process? I am not sure?
21 MS. WARREN: During the premanufacturing-notice
22 period. The point of the premanufacturing notice is to
93 prescreen and conceivably prevent the chemical, if it is
24 hazardous, from going into commercial production. But if
95 that kind of information is not required to be submitted, you
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i are waiting until possibly, some exposure that might take
2 place before you submit it.
3 CHAIRMAN PREUSS: Any other comments on this?
4 Okay. In that case, let me thank you, Jackie, and the other
5 members of the work group who helped work on this, as well
6 as members of the staff and others who helped put this
7 together. I just want to make sure that we all understand
'
8 the process,, but I think what happens now is, since there is
9 an element of timeliness involved, we will be receiving a
10 firmer draft based on some additional conversations, for our
li review.
12 The comments should go back to Jackie immediately.
13 There has to be a very fast turn-around on this to see if
14 there any major objections or difficulties, and then a final
15 document will be prepared which we will submit formally on
16 behalf of the Committee. Yes, Lloyd?
17 MR. BILES: ' We would like to have a transcript of
18 this made a part of the public hearing, if it has been
19 raised. This would be helpful to us because it is akin to a
20 public hearing in terms of the discussions. It is being
21 transcribed so I do not think it is a problem.
22 CHAIRMAN PREUSS: Clearly, the transcriptions are
23 part of the public record anyway, so there is no problem.
24 MR. BILES: In terms of soliciting comments, they
25 are certain welcome to any representative of the Committee,
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on behalf of the Committee; and to also present a Committee
viewpoint at our public meeting on the 7th and 8th. In
addition to written comments, we are having 2 days of meeting
in the District on the 7th and 8th, and certainly on behalf
of the Committee if somebody wants to make a presentation,
we- are having meetings.
MS. WARREN: That's 2 days on Section 5? I thought
it was only 1 day.
f
MR. BILES: We already have enough people signed
up so it is going to go into the second day.
DR. SHERMAN: Tell us your specific address in case
anybody wishes to send —
MR. HAYDEN: Are you still going to New York on
the 9th?
CHAIRMAN; PREUSS: Is this still the final meeting
on PMN, the one in the District on the 7th and 8th?
MR. BILES: On the 9th we have an international.
MR. HAYDEN: I would like to raise one more point
that has been a concern of the Committee. At least, I
remember it being discussed a number of times but I do not
think there was ever any resolution. Still, a number of
people raised the question that chemicals for export ought
to be covered to the maximum extent.
The proposed regulations to require chemicals that
are going to be manufactured strictly for export do require
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1 them to submit premarket manufacturing notification. I
2 would recommend that we support that provision in the
3 regulations.
4 CHAIRMAN PREUSS: All right. Will you just make
5 sure that that is in the draft?
6 MR. HAYDEN: I'll work with Jackie — yes.
7 CHAIRMAN PREUSS: Are there any other comments on
8 the PMN draft that we have had before us? If not, then I
9 will stress the importance of doing this in a timely fashion
10 and I thank the members of the work group.
11 We'll go now to the next item on the Agenda, which
12 is in some ways similar to the PMN discussion. It certainly
13 has been around for a while. As you know, Vivien Paigen
14 was a chair of this work group until her recent resignation
15 from this Committee because of family health problems.
16 As a result, I have asked Leonard Billups to help
17 guide the discussion today on the guidelines. I will call
18 on him now to go forth with that. Len, in case you have need
19 for EPA staff people, there is a gentleman on my right who
20 might be able to answer a question.
.
21 DR. BILLUPS: The testing work group, of course,
22 was charged with going through the premanufacture-testing
23 guidelines. We found that .the draft of December 20th, 1978
24 was being redrafted, and apparently a final will be
95 available next week.
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i others under others.
2 If people do not fall into that trap, I don't
3 think it ought not to be too intimidating/ at least at this
4 stage.
5 CHAIRMAN PREUSS: Okay. Thank you. We have two
6 things that remain on our Agenda. Again, thank you, Warren,
7 for stopping by again. The things we have on the Agenda .
8 are, one; to make certain that we are clear as to the next
9 meeting date, which is April 23rd and 24th, that we had
10 discussed last time.
11 The second item is: What should be covered at
12 that meeting? Since a number of people who attended the
13 meeting have had to leave earlier today, I propose that I
14 get some suggestions in the mail to you for response. With
is bo response from you, I will take that to mean that you
16 concur with the suggestions.
17 Finally, we have time left at the end of today for
18 public comment about the various issues that are on the
19 Agenda. We have had a request for some time, and I will
20 invite Mr. Miller up here, and anyone else who wishes to
21 make a comment or make a statement may feel free to do so at
22 that time. Mr. Miller, will you please join us? You may
23 come up here if you like.
24 MR. MILLER: I'm Marshall Miller, a lawyer with
95 Colby, Miller and Haines. I am really not speaking today on
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behalf of my client, but I would like to take about 5 minutes
to raise an issue with you that I hope that Jackie or someone
in the group can do something about at the meetings of
Tuesday on PMN.
One of my clients is a company named, Cerac, which
is a small company making very highly-specialized scientific
products. I would almost call them "R&D products" but they
are not. They are in gram amounts: 10, 20, 50-and 100-gram
amounts.
They- were concerned because all of the things in
this catalogue — approximately 2500 of them — are all
things that they make, would be subject to the premarket
notification. This would not have been a problem, as I
understand, under the act as I read it. It would simply
identify the chemical name and a few details in it.
However, in the Section 5 proceedings as they have
been written, bringing parts of Section 4 and Section 8 into
them, the estimated costs now could run — I believe the
estimates are 2500, 41,000 just for PMN and not including any
testing. They obviously have a great deal of trouble with
chemicals which in themselves, the total value does not
exceed a couple of hundred dollars.
Yet, these small chemicals can be very important
in the electronics industry. For example, it only takes a
few grams of a doping compound to completely transform the
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electronics products of the process of matter. Catalysts and
others require only small amounts, so these are very
important.
The examples that he gave in the hearings were the
light-imaging diodes and calculators, each of which of course
6 takes an infinitesimal .amount of zinc corsynide. And it is
7 the only source in the United States for this. It is the
8 same with whatever compounds are used in the night-vision
9 scopes for the military. It is also the only source in the
10 United States
u Therefore, I would like to raise that question here.
12 It is not only him; and by the way, I will pass out copies of
13 that testimony because if you have a chance to look at page 3
14 on,you will see what those effects on. By the way, he tends
15 to specialize in things like gydelium, erbium, radium — all
16 things you may never have heard of.
17 There has been a suggestion that there be a
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definition of diminimus, an automatic assumption that something
be R&D if it is under a thousand pounds or if it is under
a thousand kilos, or something of this sort. This, of course,
would take care of this situation.
Another suggestion would be that we preserve the
sanctity of the process by the Government helping out a little
bit in terms of testing, and what not. The company would be
delighted if on a product costing a couple of hundred dollars
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the Government would kick in a couple of hundred-thousand
dollars in tests. But as a taxpayer, I'm not sure that is the
best solution.
What I would like to do today rather than try to
give suggestions to you as to what processes it would take
or what cutoffs there should be, or whether we are talking
about small-business exemptions of $5 million or $10 million
or small amounts, or small volume of those in kilos, is to
suggest the following to Jackie:
As an adjunct to your committee report, there might
be a desirability for having a special form. I noticed that
it was Paul Danels suggesting this morning something about a
special form on this particular question of small business
overlapping research and development, overlapping small
volume. I say this because Blake is going to be inundated
with questions of confidentiality and validation — all of
which are going to take a lot of time in the short time that
he has left.
I am concerned that this very important question
involving the many, many small companies that are notoriously
very poor at taking care of themselves will somehow be
"swept under the rug." It wouldn't be done deliberately
but just in that process of "let's see what happens."
I suggest that there might be an occasion perhaps
for a special meeting on the record in any way that anybody
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1 wants to have it, at which there would be an attempt to look
2 at the various ways of making distinctions, the various
3 approaches to this problem, having participants of small
4 businesses, the EPA and environmentalists, and anybody who
5 wants to go with this.
6 This is because if you think about it, the goal of
? the act as I see it is really to protect society from the
8 things that helped get the act sponsored in the first
9 place — like Kepone, which was producing over a million
10 pounds per year, vinyl chloride and the abestos problems;
11 PCB's, DDT and other such things, with none of them being in
12 the kinds of quantities that we are talking about.
13 These are in the hundreds^ofr-billions-rbf^pounds
14 range; and I think of the burden that would be inflicted;on
15 these small companies, most of whom simply would not do it.
16 You are not going to run tens of millions of dollars worth of
17 tests on those products that you make a couple of hundred
18 bucks out of. They will simply get out of the market and we
19 will all be the losers for it.
20 The: best' way of dealing with these companies that
21 produce only a tiny fraction of all of the chemicals used in
22 the United States, and which are very significant to our
23 economy and very significant in the work force, would be that
24 this problem should be approached in some way a little bit
25 more thorough and -workmanlike than we are likely to have in
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the present situations just in the public hearing. I would
welcome any comments and suggestions you have on this. I
feel this is an area that merits some attention.
CHAIRMAN PREUSS: Mr. Miller, I'd like to ask you
one question: Why do you and your client assume auto-
matically that they would not qualify as a research
chemical?
MR. MILLER: Because we have quite a number of
them that have been 10, 25 and 50-gram amounts, that are made
for commercial purposes. They are not made for R&D. They
are used, as an example, for making the light-emitting
diodes. You take the tiniest amounts, put it into the
doping or impurity agent and it completely changes the
properties. That is not R&D.
CHAIRMAN PREUSS: That's true. Is it true for the
general list of 2500?
MR. MILLER: He's safe from the 2500 because these
are going into inventory. But it is a significantly high
proportion of the work each year — yes.
DR. SHERMAN: May I ask what the yearly sales of
the Cerae Company is?
MR. MILLER: Approximately $2 million, only.
DR. SHERMAN: That is not terribly small.
MR. MILLER: But a small business in the chemical
industry is probably somewhere between $50 million and
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$100 million. Remember this is an $135-billion tc
$140-billion industry in which the larger companies are in
the multibillion-dollar range, a company in the million-
dollar range even if it employs 35 employees for example —
DR. SHERMAN: That's a pretty good return.
MR. MILLER: When you are dealing with gydelium,
erbium and radium, it is your development costs which are
important — not your —
DR. SHERMAN: I understand your problem, but I
wonder what would happen if you were doing just small
amounts, if you were manufacturing just small amounts of
dioxin, what would happen to your people?
MR. MILLER: It's an interesting point that
everytime you raise this question — and I raise the same
question dealing with them. I ask them: "What would happen
if you are manufacturing only a small amount of dioxin,
but of course nobody manufactures dioxin on purpose.
If you are looking over where the problems have
been in terms of chemical pollution, I am at a loss to come
up with any significant examples of this. I do not think
this society will be greatly improved — if at all — by
having these little things removed from production. And yet,
I think the cost will be quite significant.
If there were really significant hazards — like
this where people often think of Kepone as being of small
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volume. Well, it wasn't. It was a million pounds a year.
DR. SHERMAN: But it started out as small volume.
MR. MILLER: Everything starts out as small
volume.
DR. SHERMAN: That's exactly my point. They all
start out —
MR. MILLER: The legislative history suggests a
way of dealing with this. Magnuson, on the Senate floor,
suggested using significant new uses in dealing-: with
something that goes over low; volume. If it goes!:over: a
certain "trigger" or "threshhold" to require a significant
new use, then you can invoke all of the procedures that you
want to.
CHAIRMAN PREUSSt I'm not sure we want to get into
a lengthy discussion on this issue as there are other points
of clarification. I think the points you are making are
quite clear.
MR. MILLER: I want a formura for this rather than
trying to discuss the substance right here.
CHAIRMAN PREUSS: I understand. Are there other
questions?
MR. BILES: I am aware that SOCMA is preparing
comments on this. You may want to get together with them.
MR. MILLER: We do not really agree with SOCMA1s
comments on this.
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MR. BILES: Okay.
1
2 CHAIRMAN PREUSS: Jackie?
3 MS. WARREN: I just wanted to say that in the
4 general discussion we had on the proposed regulations, we couL
5 suggest to EPA that they establish some criteria for deter-
6 mining under what conditions this information should be
7 required, and if they did that they might come up with
8 something that would solve these kinds of problems.
9 The difficulty I have is with regard to exemptions,
10 with quantity. You really don't know how to get the toxic
11 ones when they are there. You just take the chance. There
12 is some question about notifying people even when they are
13 into chemicals — notifying people that they are going to be
14 exposed to it-that they are. There has to be some way to
15 determine that they are hazardous and at least tell those
16 people.
17 One should draw the line — just make the assumption
18 they are diminimus — just assuming a diminimus risk when it
19 might not be the case. There has to be some way of dis-
20 tinguishing out the hazardous ones from the non-hazardous.
21 MR. MILLER: We would be agreeable to doing
22 anything that was reasonable in terms of looking at this
23 problem.
24 MS. WARREN: Does your client do any of the LD 50's
25 on the chemicals?
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1 MR. MILLER: No. It does not try to do any of its
2 own testing at all.
3 MS. WARREN: Do they just not do any testing?
4 MR. MILLER: They use the standard chemical package
5 for these — standard literature on the subject. That is
6 about the extent of that. You see, you are dealing with such
7 expensive ones. They are dealing with such refined matters,
8 the chemicals are so expensive per unit that great care is
9 taken in how you handle them — even apart from the toxicity,
10 the use of "glove boxes" and everything of the sort. So the
n toxicity problem in that case is not really serious.
12 MS. WARREN: I could certainly understand what the
13 standard there would be on new chemicals, or are you people
14 not dealing with new chemicals?
15 MR. MILLER: They are dealing with chemicals that
16 would not be on the inventory, in which they would be taking
17 and making them into an extra degree of purity or special
18 sizings, or maybe putting a compound together that has not
19 been put together before — but with standard properties-,- a
20 new type of ferrous oxide, or something; something of new
21 properties.
22 CHAIRMAN PREUSS: I think the problem you are
23 raising here is not one of toxicology or health, or
24 whatever. It is a problem that we have discussed in the
25 past — the economic burden imposed on a small manufacturer,
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or a manufacturer of a small-volume chemical — either way
you want to define it.
MR. MILLER: That's right.
CHAIRMAN PREUSS: Thank you very much.
MR. MILLER: Thank you.
CHAIRMAN PREUSS: Is there another question or
comment from the audience?
(No response)
DR. SHERMAN: Peter, I don't know if it is
appropriate or not, but my last suggestion that if a company
is going to have relief in an economic matter they ought to
be able to affirm that they will be responsible for any health
or safety effects, both corporately and privately, as
corporate managers. This is one consideration which I think
ought to be taken up.
CHAIRMAN PREUSS: We have in the past made a recom-
mendation as a Committee about the problem of small businesses
That is point number one. Point number two is that you will
receive a draft from Jackie concerning the comments on PMN.
I think it would be entirely appropriate if you felt you
wanted to include that as part of your comments. Please do so
This is by way of suggestion. All right. I thank you all
very much, and the meeting is closed.
(Whereupon, at 4:18 p.m., the hearing was
adjourned.)
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