Transcript of Proceedings
U. S. ENVIRONMENTAL. PROTECTION AGENCY
DISCUSSIONS WITH THE
COMMISSION OF- THE EUROPEAN COMMUNITIES
Washingtonr D- C.
January 11, 1980
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1 U. S. ENVIRONMENTAL PROTECTION AGENCY
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3 DISCUSSIONS WITH THE COMMISSION
4 OF THE EUROPEAN COMMUNITIES
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9 Room 1103 - West Tower
Waterside Mall
10 Washington, D. C.
Friday, January 11, 1980
9:30 A.M.
12 "
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15 Guests
16 Michel Carpentier, General Director
Environment and Consumer Protection Service
17 . Commission of the European Communities
18 Goffredo Del Bino, Principal Administrator
Environment and Consumer Protection Service
19 Commission of the European Communities
20 Erwan Fouere, Administrator
Environment and Consumer Protection Service
21 Commission of the European Communities
22 Michael Goppel, Principal Administrator
Delegation of the European Communities to the U.S.
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Georges Mosselmans, Principal Administrator
24 Environment and Consumer Protection Service
Commission of theEuropean Communities
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EPA
Steven D. Jellinek, Assistant Administrator
Office of Pesticides and Toxic Substances
Environmental Protection Agency
Marilyn C. Bracken, Deputy Assistant Administrator
Office of Program Integration and Information
OPTS, EPA
John DeKany, Deputy Assistant Administrator
Office of Chemical Control, OPTS, EPA
Irving L. Fuller, Director
International Chemical Affairs, OPII, OPTS, EPA
Don Oakley, Acting Director
Office of International Activities, EPA
Herbert Page
Office of Testing & Evaluation, OPTS, EPA
Ron Outen
Office of Testing & Evaluation, OPTS, EPA
Richard Denney
Office of the General Counsel, EPA
Don Abelson
Office of U.S. Trade Representative
Joseph V. Rodricks, PDA
Ernest Brisson, FDA
William D'Aguanno, FDA
James Sartorius
Department of State - —
Jane Lewis
Department of Commerce
Orville E. Paynter
Department of Commerce -
Dr. Abraham Reich, OSHA
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INDEX
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TOPIC
Discussion of GOOD LABORATORY PRACTICES
RISK ASSESSMENT
LABELING
CONFIDENTIALITY
MS. BRACKEN'S ITEMS
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CHAIRMAN JELLINEX: Well, let's get started.
Michel, I would like to welcome you and your delegation back
again. It is a pleasure to have you here, and I look forward
to a day of useful and productive discussions.
6 As we have done in the past, why don't we take
7 a minute at the beginning for us at least to introduce our-
8 selves. Most of us know you and your delegation, but if you
9 want to do that, that would be fine too. Why don't we start
10 off by having the United States contingent introduce themselves
11 by name and affiliation.
12 I am Steve Jellinek, and I am Assistant Adminis-
13 trator of the Pesticide and Toxic Substances at EPA.
14 MS. BRACKEN: I am Marilyn Bracken, Deputy Assis-
15 tant Administrator for Program Integration and Information
16 Toxic Substances.
17 MR. FULLER: Irving Fuller, Director of Inter-
is national Chemical Activities.
19 MR. BRISSON: Ernest Brisson, Food and Drug Admin-
20 istration, and I would like to introduce Dr. Joe Rodricks from
21 Food and Drug Administration, who will participate in the
22 discussions.
23 . MR. SARTORIUS: James Sartorius, Department of
24 State.
25 MR. D'AGUANNO: William DTAguanno, Bureau of Drugs-
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1 Food and Drug Administration.
2 MR. PAYNTER: Orville E. Paynter, Department of
3 Commerce.
4 MR. OUTEN: Ron Outen, EPA.
5 MS. MILROY: Breck Milroy, International Chemical
6 Affairs.
7 -MS. CURRAN: Marcia Curran, Office of Program
8 Integration and Information, International Chemical Affairs.
9 MR. CARPIEN: Alan Carpien, EPA, Office of General
10 Counsel.
11 MS. BELL: Ruth. Bell, Office of General Counsel.
12 MR. PAGE: Norb Page, Office of Testing and
13 Evaluation, EPA.
14 MR. MORRIS: Carl Morris, Health Review Division,
15 Office of Pesticide and Toxic Substances.
16 MR. DENNEY: Dick Denney, Associate General Counsel
17 for Toxic Substances, EPA.
18 MS. LEWIS: Jane Lewis, Deputy Directory,
19 Environmental Affairs, Department of Commerce.
20 MR. HARTY: Jack Harty, FDA International_Field
21 Staff.
22 MS. MORSE: Leigh Morse, Department of State,
23 European Bureau.
24 MR. SIELEN: Alan Seilen, EPA, Office of Internation-
25 al Activities.
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1 MS. REISA: Diana Reisa, Pesticide Programs, EPA.
2 MR. ROSS: Ralph Ross, U. S. Department of Agri-
3 culture, Agricultural Research.
4 MR. CARPENTIER: We will do the same, I think.
5 Michel Carpentier, Environment and Consumer Protection Service
6 Commission of European Communities.
7 ' MR. MOSSELMANS: Georges Mosselmans, Environment
8 and Consumer Protection Services, Commission ofEuropean Com-
9 munities.
10 MR. DEL BINO: Environment and Consumer Protection
11 Service, Commission of European Communities.
12 MR. FOUERE: Erwan Fouere, Environment and Con-
13 sumer Protection Service, Commission of European Communities.
u MR. GOPPEL: Michael Goppel, Delegation of Europeaijx
15 Communities to the United States.
16 CHAIRMAN JELLINEK: Okay, why don't we get started
17 I don't have anything in the way of formal remarks. My formal
18 remarks have gotten shorter with each meeting. Just "Hello,
19 let's go!" ''
20 ( Laughter. ) .
21 MR. CARPENTIER: If I may, I should say we are
22 still in the time of the year when we can wish you Good Year.
23 MR. JELLINEK: Thank you.
24 MR. CARPENTIER: Happy New Year, and we hope this
25 year will see good progress in the work of the organization
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of views in the field of toxic substances.
Before we start, if I may, I would like just to
say a few words about what has happened since September, when
we last met. You have published in October 1979, the proposed
rules and forms for manufacturer's notification. We have
sent you some comments on this publication. We have expressed
our appreciation of the kind of mo.vement which has been made
in this country to a stepwise approach to the evaluation of a
chemical.
We have also noticed some progress in the OECD Pror-
gram, and I would like to mention in particular, the report
of the step-systems group establishing so-called MPD
(minimum premarket set of data) and what has been done to
define step-sequence scheme. We are not entirely satisfied
with this work. It is not finished, but we have noticed
some progress.
In fact, while agreement upon the MPD is important
and necessary for- steps towards international acceptance of
information about substances, we must at least say that a
minimum premarket set of data in itself does not provide the
harmonization in international trade. And we think that fur-
ther testing must take into consideration testing performed at
each level, the criteria for exclusions or substitutions,
criteria for inclusions or substitutions, and the enforceable
administrative criteria for initiating the different steps of
the sequence.
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1 Today, I think, will be very helpful to point
2 out some possibilities of organization of our approaches in
3 the field of new chemical substances and I think the agenda
4 which has been put forward by you is satisfactory. We think
5 it might have been more logical to start by talking about pre-
6 marketing or pre-manufacturing notification, but it is of not
so much importance, and we can start with good laboratory
8 practices.
9 Also, I think you have asked some people to talk
10 on this point. We can follow your scheme of work, and I agree
with you, the sooner the better.
12 CHAIRMAN JELLINEK: Well, I think the topics on
13 the agenda reflect our agreement in September and the concept
14 of premanufacture cuts through all of them and I suspect we
will be talking about Section 5 in a number of differenct
16 contexts. We have, of course, put labeling on the agenda
because we are very much interested in your experience with it
18 Why don't we start talking about good laboratory
19 practices, and I just want to note that the Food and Drug
20 Administration is with us today. They are usually with us,
21 but they are with us today in force because of the key role
22 they have played in the United States- in the development of
23 good laboratory practices, and also because of their history
24 of international discussions and agreements with other coun-
25 tries on good laboratory practices for Drugs.
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We are happy to have them with us. Ernie Brisson,
Joe Rodricks, and Bill D'Aguanno can all participate and jump
3 in at any time.
4 Why don't we get started.
5 MR. CARPENTIER: You have more experience than we
have, so maybe you could start the discussion on this point.
CHAIRMAN JELLINEK: Okay. Carl or Norbert -- I
guess Carl is the one person primarily involved with good
laboratory practices. It might be useful to give a very brief
10 summary of our approach to good laboratory practices in the
TSCA context. Perhaps we can ask Ernie, I guess, to talk
12 about the FDA context, and keep that as short as possible, and
13 then answer any questions or concerns that the Commission
14 people might have.
15 MR. MORRIS: Basically, I would like to give a quick
16 update on where we are with the GLP. FDA and EPA are at
17 different steps in the regulatory process. As you know,
18 under the authority of the Toxic Substances Control Act, we
19 published on May 9, 1979, in the Federal Register, our first
20 proposals on GLP's.
21 I might preface these comments by saying that
22 Ernie Brisson and his colleagues at FDA and myself and others
23 here at EPA had some rather intense discussions in trying to
24 harmonize within our own government these documents. Quite
25 frankly, we did plagiarize large sections of the FDA
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document.
These GLP's are directed primarily to health effects
testing facilities. The Office of Pesticides and Toxic
Substances is now expanding its efforts and will be
publishing, in the near future, a document related to ecologi-
cal effects and chemical fate, GLP's. That will be published
some 'time later this year. The Office of Pesticide Programs
under-FIFRA is now developing a similar companion document to
the TSCA proposal and FDA final rule. I believe it is
10 anticipated that this document will also appear in the
11 Federal Resister in the next few months.
12 We will be looking at the public comments from both
13 the FIFRA and TSCA documents shortly. We will have an
14 opportunity, I'm sure, to once again sit down with FDA under
15 all three regulatory authorities and attempt to harmonize our
16 thinking.
17 We have entered into an interagency agreement back
18 in 1978 with the Food and Drug Administration for the inspec-
19 tional aspects of GLP's. A year or so ago, that particular
20 interagency agreement was rewritten to also include., both the
21 FIFRA or pesticides inspections as well as those that would be
22 done eventually under TSCA. As you can see, we have a very
23 strong intergovernmental relationship in the inspection area.
24 it is anticipated that the inspections for ecologi-
25 cal effects and chemical fate parameters under TSCA will be
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done by the EPA Office of Enforcement personnel. In terras of
the international OECD-GLP activities, in which both Ernie
Brisson and myself participate as well as your Commission
staff, we have proceeded very well in the GLP area, as I may
have indicated to you earlier.
We have a document which we call the generic section
of our "OECD Principles of Good Laboratory Practice." This
general document, the generic part, will be forwarded to the
High Level Meeting of the OECD Chemicals Group for their
consideration in May of this year.
With that brief outline, I would like to call on
Ernie and see if he would like to put any more of these
aspects into perspective.
MR. BRISSON: I will be brief also. For your
information, the FDA finalized its GLP regulations in
December 1978, and we have been making inspections of our
domestic toxicological laboratories for about three years now,
We have also been making inspections of laboratories in
foreign countries, especially in Great Britain. We have been
to France, Italy, Belgium, and we have even been requested to
make inspections in some of the foreign laboratories who are
seeking an FDA blessing, if you will, so that they can have
some kind of documentation to give to American and European
clients who are asking whether or not they comply with GLP's.
We have negotiated a number of bilateral agreements
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in the GLP area with our neighbors the Canadians, and also with
Sweden. We are in the process now of negotiating similar
agreements with the Swiss, the Dutch Government has indicated
an interest, as has the Japanese, but nothing concrete has come
from the Netherlands or Japan as of yet.
OR. D'AGUANNO: Do you want to explain our policy
on international inspections?
MR. BRISSON: Dr. D'Aguanno has brought up a good
point. Even though we receive requests to make inspections
at foreign laboratories, we don't make those inspections as a
service to those laboratories. We will do it to accomodate
those requests if we happen to be in that country, inspecting
a laboratory that has submitted toxicological data to FDA to
support either a new drug application or food additive petition.
Our inspectional authority in foreign countries
is nonexistent. Our inspectional authority over some of the
laboratories in the United States is somewhat tenuous in that
we don't have any explicit statutory authority to inspect all
kinds of laboratories. So the Agency has adopted a policy of
refusing to accept any study from a laboratory that_refuses to
permit us to inspect its facility.
Thus far we have met with a lot of cooperation
from industry in foreign governments in terms of carrying out
those inspections and we have only met with four or five refvisa]
in our own Country to permit inspection of those laboratories
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1 and of those,four or five have since requested to be inspectec.
2 to compete with other laboratories. That's about all I have
3 in the way of background.
4 CHAIRMAN JELLINEK: I would like to ask a question
5 Ernie, if I may. What has been the reaction of foreign
6 countries or drug firms to your policy of refusing to accept
7 studies from laboratories that won't let you inspect them?
8 ' MR., BRISSON: Foreign firms have not given us any
9 trouble at all. The policy has not really been argued, it
10 has kind of been accepted. I don't know if that's because we
11 did a good job in selling it or whether the rationale for
12 that policy is clear to everyone. But we have not met with
13 any resistance to that policy.
u OR. D'AGUANNO: I would tend to agree with that
15 in that we have been greeted with open arms by pharmaceutical
16 firms that were inspected. We never made an inspection with-
17 out a data audit. In other words, there has been a study
18 submitted to support an application. If we were not allowed
19 to inspect it, we would not use the data to support the appli-
20 cation, so it's in the interest of the country for_us to go
21 over and rerctew the data. We've had no problem and we keep
22 getting requests for inspections from firms,and governments
23 have been fully cooperative.
24 The policy we have with European inspections is,
25 everyone was advised about a month before hand that we were
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1 going over to make these inspections, governments, companies,
2 and the U.S. affiliates.
3 MR. CARPENTIER: What is the content of the
4 bilateral agreements you mentioned with Canada, Sweden, and
5 i so on; could you tell me?
6 CHAIRMAN JELLINEK: The U.K., as well; isn't that
7 right?
8 MR. BRISSON: What we have now is a memorandum of
9 understanding, and all it is is a Statement of Intent by the
10 countries involved to first, develop good laboratory practice
11 standards, either as regulations or guidelines, and secondly,
12 to institute or establish an enforcement program or inspection
13 program to enforce those guidelines. It also provides for
14 exchange of information in terms of inspectional reports and
15 data audits.
16 It also set the stage for what might be called a
17 second-generation understanding which would provide for recip-
18 rocal recognition of each country's~inspection program.
19 MR. CARPENTIER: Does the memoradum of understanding
20 provide for inspection by FDA in the foreign country?
21 MR. BRISSON: Yes, these agreements provide for
22 joint inspections. All inspections are coordinated with the
23 local authorities, and they are given the opportunity to join
24 us or not to join us.
25 We have an informal understanding with the U.K.
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1 for example, whenever we plan to make an inspection in the
2 U. K., we advise the U. K. authorities and give them the oppor
3 tunity to come along with us. Thus far they have refused
4 because apparently they are a little embarrassed about making
5 some of those inspections. In some cases, some of the firms
6 would prefer that we inspect alone without the national author
7 ties .of the country.
8 DR. D'AGUANNO: You might want to talk about the
9 history of the good manufacturing practices that we set.
10 MR. BRISSON: The laboratory practices are similar
11 procedurally to conducting good manufacturing practices in-
12 spections of drug firms where we notify the local authorities
13 again. In some countries like Switzerland and Sweden, if you
n have anti-espionage laws, we have an arrangement with those
15 countries whereby we advise them which firms we would like to
16 inspect and they in turn invite us to participate with them
17 in one of their inspections.
18 MR. CARPENTIER: Have you developed common princi-
19 pies or standards with these countries first?
20 MR. BRISSON: No.
21 MR. CARPENTIER: You have to make inspections
22 according to certain criteria.
23 MR. BRISSON: We are making inspections based on
24 our GLP'-s until such time as they establish their own standard
25 The Canadians are in the process now of promulgating GLP
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guidelines very similar to our own. The Swiss and the Swedes
also. Many countries are waiting for the OECD document to
3 emerge.
4 MR. CARPENTIER: That's what I thought. I have
5 not too much comment on this point. As you know, there is not
6 much provided for in the 6th Amendment on GLP's except tests
7 must'be carried out according to principles related to GLP's.
8 The member states are not bound by any regulation as regards
9 GLP. Moreover, in most of the member states, there does not
10 exist specific GLP's.
11 I am surprised by what you said about the U.K.
12 because our information is not so detailed. As many countries
13 you mentioned, we are also waiting for the results of the
14 OECD work, the document you mentioned,' Mr. Morris.
15 I am not sure it will suffice as it will, in fact,
16 consist of a rather general document, but it is a first step
17 which will be very useful.
18 Later on, we have to look at the possibility to
19 think of more specific guidelines governing certain princi-
20 pies, then afterwards, to look at the different enforcement
21 systems that we can imagine. I imagine the inspection
22 by your department can — as you mentioned — you can think
23 of different steps. First, try to get information, then
24 supplementary information, and at the end, see whether or not
25 it is necessary to have inspections. Then you may have also
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1 ' National inspections, mutual recognition of National
2 inspections, and finally, the system you are applying.
3 I think it's a bit premature for us to say more
4 at this stage. We have to look first at the first results in
5 May of the work carried out by OECD.
6 I have been told there is another group — I don't
7 know ,if it is the same group — who is going to study the
8 implementation a little later in the year.
9 MR. MORRIS: Yes, maybe I can clarify that. The
10 particular GLP group initially had been given the charge to
11 develop the principles document. Then, perhaps, there would
12 be another activity relating to implementation issues. At the
13 OECD Management Committee meeting in December in Paris, the
14 decision was made that this particular group should be
15 expended with appropriate additional representation, and we
16 would be establishing a subcommittee dealing with the imple-
17 mentation issues.
18 I have informally asked Ernie Brisson of FDA to
19 serve as subcommittee chairman for that activity, and that
20 would all become more official in the next few weeks. Also,
21 as you have indicated, we will be establishing three addition-
22 al subcommittees to look at Part I test guidelines that OECD
23 has developed in the light of category-specific GLP issues,
24 and that will be the subject of our meeting in March in Paris.
25 MR. CARPENTIER: We understand that there is a
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1 certain necessity to ensure the quality and integrity of the
2 data for many reasons. On the other hand, we would not like
3 to accept standards which would unduly constrain study design
4 and increase the cost of the study in a disproportionate way.
5 There are some problems and you are also involved with bud-
6 getery problems in this Country, as we are. Our idea is to
7 try to find a good compromise between general guidelines and
8 specific guidelines, and find a good compromise in the way the
9 implementation will be made.
10 In any case, within the community, I don't imagine
11 there will be inspections from one country to another. At
12 least we don't see it that way for the time being. Certainly
13 we will move towards that kind of mutual recognition and if
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14 it is so, we will certainly have to consider all the aspects
15 of inspections made by American authorities. I don't think I
16 can add anything on that point.
17 DR. D'AGUANNO: I think you have to understand
18 there is always apprehension when there is talk of new regula-
19 tions and we had to go through an educational process in the
20 United States. The European countries, or at least the Chemical
21 industry now has the degree of apprehension that we had in thi 5
22 Country two or three years ago.
23 There is a developmental process and_an educationajl
94 process. Fortunately, you all had the foresight to start the
25 educational process, the December colloquium at Luxemburg was
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well attended and well received, and, as a matter of fact, the
comments I have received that they hoped there would be more
colloquia-of this type. I think both EPA and CEC should be
complimented on a fine colloquium.
. MR. CARPENTIER: Yes, with a small nuance. I don't
think the implementation was the main point.
DR. D-'AGUANNO: No, but it's a gradual building
process in terms of education.
CHAIRMAN JELLINEK: Will the community countries
be prepared to accept FDA inspection of European facilities?
MR. CARPENTIER: I don't know. Frankly, I cannot
answer this. I think we must go step-by-step. First, we will
see the kind of guidelines which you have promulgated and
there we see making a good job and we will fully participate.
Then, we will see what we do with the new guidelines. We have
to decide whether we will take it for ourselves.
Second, we have to see if more specific guidelines
are necessary or not. Third, what will be done about enforce-
ment. I think it is too premature to answer your questions
because I have no answers.
You are right. It is a matter — you said education,
I have some doubt about the word because it means that people
who are speaking are not educated, and I would not agree on
that.
DR. D'AGUANNO: I think; people have; looked at our
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l regs and said, "You should not need a regulation to have good
2 laboratory practices. You learn that when you first go into
3 the business of doing laboratory work."
4 We had to go to a regulation because there was
5 evidence that there were not, in fact, good laboratory prac-
6 tices. It is a few "bad apples" that create regulations.
7 , MR. CARPENTIER: I agree. Don't misunderstand me.
3 . DR. D'AGUANNO: The education is on the regulation
9 rather than the good laboratory practice.
10 MR. CARPENTIER: But then, you have enforcement, and
H I don't know if people have to be educated about enforcement.
12 They have to think of it, but this is where we stand now.
13 Would you like us to do something else?
14 CHAIRMAN JELLINEK: Not unless you want to get into
15 more detail. We would be happy to answer any more of your
16 questions. As Carl summarized it, at EPA, we are in a
17 transition stage between a proposal and a final regulation.
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18 We have received and reviewed your formal comments, and we
19 will take them very seriously into account.
20 We are working within the United States tp_ harmonize
2i between TSCA and FIFRA (our pesticide law) , between EPA and
22 FDA. And we still have not achieved that as well as we would
23 like to, to try to get as close as possilbe within the U.S.
24 and only have differences where they can be justified on the
25 basis of the statutory requirement.
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l We are continuing our discussion within EPA and
2 between EPA and FDA on that. We can move on if you wish to
3 move on. If you want to talk about more specifics, we can do
4 that as well.
5 MR. CARPENTIER: I think that after the OECD
6 meeting we have to wait for the results and at the end of this
7 year, the Commission will certainly organize one of several
8 meetings with member states.
9 CHAIRMAN JELLINEK: The next topic is Risk Assessment
10 Why don't I just make a couple of very quick comments,
11 and then throw it open to any questions you might have?
12 We have discovered in the past couple of years of
13 dealing with the scientific aspects of chemical regulation
14 that even the science of hazard assessment, of assessing the
15 toxicity of chemicals, is in many ways an art. When it comes
16 i to risk assessment, the way we in the United States deal with
17 i it is taking the science of toxicity, of what the hazard of
18 a chemical might be, and combining it with the opportunities
19 of exposure of that chemical to people and trying to predict
20 what the results of that toxicity and exposure will be in
21 terms of health effects. That is on even a more sublime plane
22 in our experience.
23 It is just a very complex and difficult and certainly
24 unsophisticated activity. It is one where we in the
25 United States are learning fast and trying to share our own
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experiences and philosophies with each other, once again,
among the various regulatory agencies and within EPA, but we
are at a very preliminary stage domestically in developing
anything that could be called a science, or system, or
procedure of risk assessment.
Frankly, most of our decision are ad hoc. We take
the facts available to us in any given situation and try to
put them together in a way that makes the most sense, and
make decisions on that basis. Very often, at the end of the
decision process, we are not dealing with objective matters
but subjective matters. The value systems of the individuals
making the decisions, the value systems of the particular
culture, society, and people with that society are as
important as any particular set of numbers.
With that kind of general conceptual opening, we will
try to hear your thoughts.
MR. CARPENTIER: We share your thoughts. You will
remember we are aware of the opinion that this subject might
be a good field for research and further exchange of views.
I do not say when, but, this or next year, a kind of
scientific seminar might be organized between us.
We agree with you that, in fact, risk assessment
inciludes two elements, one which we would call hazard assess-
ment which is depending on information and scientific criteria
but, as you say, also the exposure assessment which depends
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1 very much on social factors and others which cannot be
2 harmonized. We do not expect to have scientific methods to
3 define this type of assessment.
4 But we have two questions to put to you, one on the-
5 OECD definitions. I don't know if you agree on them. You
6 remember that the OECD says that three issues" must be
7 : considered for hazard assessment, the chemicals' predicted or
8 actual concentration, the fate of the chemical in the environ-
9 ment, and the distribution and density of population in the
10 environment.
11 We think the two'last points are more or less parts
12 of the exposure assessment in your approach and in our ap-
13 proach. Have you any concern about the OECD work? That is
14 the first question. Second, what do you think of the possibil
15 ity of the acceptance of yardsticks which may allow classifi-
16 cation of chemicals in broad categories and would avoid too
17 much variable criteria? Have you thought of this?
18 CHAIRMAN JELLINEK: Let me- start by trying to answer
19 the second question. We have definitely thought about trying
20 to identify categories of chemicals that we can make certain
21 — we can assume are low risks or we can assume are high
22 risks. We hope that is going to be possible eventually.
23 Frankly, as I said, until we have a lot more
24 experience on what kind of chemicals we are faced with, until
25 we know a lot more about exposure situations, it is going to
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1 be very difficult for us to develop criteria that we feel we
2 can stand behind. That is clearly our objective, and one of
3 the reasons we want to do it is to focus our limited resources
4 on the real problems. If we can conclude that some things
5 are not problems or not likely to be high priority
6 problems, then it will free us up to work on things that are
7 problems.
8 - We are looking at such things as polymers. I know
9 you have already dealt with that and we are looking at that
10 and expect to face that issue later this year.
n We are thinking,!in the very early stages, about
12 trying to identify specialty, specialized industries or
13 specialized chemicals that have specific uses that we can
14 categorize as being chemicals of probable low risk right up
15 front so the industry will know, and our friends in other
16 countries will know, how EPA will generally tend to come out
17 on chemicals that fall into that category.
18 I see it as a very fruitful field, but one that
19 we have not really developed. It is something we want to do
20 later this year because it will make our job easier..
21 MR. CARPERTIER: In that case, maybe you can think
22 of the suggestion you have somewhere next year that kind of
23 scientific seminar.
24 CHAIRMAN JELLINEK: I see the seminar dealing with
25 your first question. If I
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i interpret it correctly, the second question is, "Can we, at
2 the beginning, identify certain categories of chemicals that
3 are no problem, or certain chemicals that are probably always
4 going to be a problem," so that the industry and the public
5 can have some idea of where we are coming from when they send
6 in a chemical, what kinds of information they will want on the
7 high risk problems versus low risk or whatever. That will be
8 very helpful and make our operation a lot more efficient, and
9 give the industry and the public a lot more idea of what to
10 expect from regulatory review.
11 The first part of your question, I see though,
12 as being more directed toward the science of risk assessment
13 and- towards developing common criteria for dealing with a
u measurement of risk. Hazard on the one hand, and exposure on
15 the other. I think it is possible to develop criteria that
16 can be internationally accepted on how one measures exposure.
n Where it becomes very difficult is how one values
18 that measurement in terms of the importance of risk, the im-
19 portance of averting or not averting risk. The weight of the
20 economic benefits versus the weight of the particular risk,
21 that's been very difficult.
22 Right now in January, 1980, I think it will be
23 impossible to come to any kind of cut and dried standards on that
24 final decision making. It will still remain very subjective*.
25 and it will depend on values systems of individuals and
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societies and cultures. The scientific part of developing
criteria for measuring exposure and measuring risks, I think
there is hope for. And that is clearly the kind of thing we
ought to be dealing with in a symposium like you suggested.
I am not comfortable, frankly, Michel,- in reacting
to your definitions. It may be useful for me to ask
Ron Quten to summarize briefly our approach to risk assess-
ment and how we can go through the steps and our definitions.
Ron has done some work on that, and perhaps, we can get
together in the future.
MR. OUTEN: We are devoting a rather large amount of
resources in the Office of Pesticides and Toxic Substances to
the questions Steve Jellinek was discussing concerning the
scientific rationale and logic for risk assessment. We
definitely agree with you, Mr. Carpentier, that risk is a
function of toxicity or chemical effects, chemical properties,
and also, the potential for exposure. Certainly, the fate
analysis is the bridge that allows one to determine something
about exposure.
We are attempting4 to build a risk-assessment logic
for a number of reasons. One, of course, is that we have a
statutory responsibility to perform risk assessment. Both for
reasons of law and common sense and fairness, we need to do
that in a consistent fashion.
So we are attempting to build at least guiding
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1 principles on how we would react given certain kinds of data.
2 This may or may not get to the point of being some kind of
3 quantitative-assessment criteria, and even if it does, that
4 point will be a long way off.
5 We are beginning the logic of our risk-assessment
6 work with the assumption that a chemical is released in some
7 way, and then, pose basically chemical-fate questions. This is
8 especially the case if it is discharged to the environment in
9 which case we are concerned about environmental contamination
10 and indirect exposure to humans after transport through the
11 environment.
12 There we look immediately at questions involving
13 partitioning among environmental compartments, air or water,
14 or accumulation in the soil if it is a discharge to land.
15 This involves analysis of chemical properties and degradation
16 characteristics, followed by analysis of what we are calling
17 "transformation half-life," a term we have invented which is
18 a prediction of degradation rates as a result of different
19 forms of degradation in different media. Coupled with that is
20 an attempt to identify degradation products which might be
21 more dangerous than the parent chemical.
22 This constitutes an initial fate analysis. Based
23 upon this analysis, further transport analysis, if needed, and
24 initial consideration of toxicity characteristics, it becomes
25 possible to make preliminary conclusions concerning which
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life forms and toxic effects should be of most concern.
These conclusions are the basis for more detailed assessment,
determination of additional testing needs, et cetera.
This is the tack we are taking. Chemicals that
are persistent and tend to bioaccumulate are chemicals about
which we would tend to be more concerned in terms of an
indirect exposure route affecting humans. The assessment from
that point would proceed according to whatever medium we are
concerned about. Drinking water might be a problem or air.
As this logic scheme is being built, visually it
'looks like flow diagrams, with decision diamonds, and points
to acquire test data or acquire information that would
substitute for data in places where decisions need to be made,
as well as identification of the information that would go
into the decision.
Quite frankly, it looks a little grander at the
moment than it is. There is something reassuring about having
things drawn out, and we are not yet sure, in most cases, what
those decisions really turn upon. But that's the nature of
the attack, and it will serve the program in a number of
ways.
In addition to encouraging consistency in risk
assessments, the connection with testing logic is obvious,
and quite a lot of what we are learning will be, as we
develop it, offered to OECD in the form of step-sequence
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testing ideas through the Steps Systems Group of which
Dr. Page and I are delegates. We expect to be able to offer
information within this year that would be useful to the
Steps Systems Group.
MR. CARPENTIER: I just want to add, in the first
place, what you said is relatively familiar to us, especially
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in the field of water pollution. As you know, the Commission
has been in charge of putting forward to the Council Ministers
initial standards for discharging into water. We make this
kind of risk assessment and think of criteria and look at all
the criteria you mentioned, degradation, bioaccumulation and
6 set categories.
7 • I would say we are not entirely dealing with the
intellectual aspects in dealing with this problem. I have not
much to add. Maybe Mr. Del Bino would like to say something
10 about yardsticks.
11 MR. DEL BINO: Yes. First of all, I can recall
12 the system provides for some risk evaluation process, which
13 until now mainly was directed towards classification of chem-
•
14 icals. In fact we have criteria to classify chemical and
15 inside a class there is an embyro of categorization, a toxic
16 chemical, or is it a flammable, inside some class there is
17 already some categorization.
18 Then of course, there is a need to adopt thejcisk-
19 assessment process as the next step after notification. That
20 means annex 7 and annex 8 which is the testing program, which
21 is the MPD, need to be assessed later on by national authori-
22 ties first of all. This process is first of all in the hands
23 of the national authorities, but the Commission as you know,
24 has a role to harmonize procedure.
25 For that reason we intend to adopt guidelines for
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risk assessment. We need guidelines.
I would like, in fact, to come back a little bit
on the yardstick concept. We are now trying to develop a
program on yardstick, to define a mean, chemicals themselves
which could be used as yardsticks. It is not only a question
to define the concept, but also a question to work with, and,
in fact, we have defined some 60 chemicals that could be
screened through annex 7 and 8 of our system to finally see
from these 60 chemicals if we could select some definite
yardstick, and we hope to resolve this program in November of
this year.
At that moment, we can see there is some scientific
conference or seminar because, of course, it is very impor-
tant eventually to harmonize our approach on the concept it-
self, but it would be useless if we would not go further on
and harmonize the chemicals themselves. I suppose that it may
s
be a" medium term problem and it is enough to say what I say now
MR. RODRICKS: I wonder if the delegates are familiar
with the document developed by EPA, FDA, and other regulatory
agencies in this country on assessment of carcinogenic risk?
MR. CARPENTIER: Yes.
MR. RODRICKS: They are familiar with that. We
at FDA are using the elements of that document for some
classes of substances. We agree with everything Steve said
earlier about the limitations in the process, but for
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1 some classes of substances we regulate, we see no better
2 alternative. We are using risk assessment as a feature of
3 regulation, for example, of food contaminants like PCB's and
4 aflatoxins. We use quantification of risks as part of that
5 standard setting process. We are perhaps, overly cautious in
6 our approach to quantification but that is the result of the
7 great uncertainties in the data we have.
3 We use it for animal drugs that may leave residues
9 in edible animal tissues, and in that particular one we've
10 had to tackle the question of what is a tolerable risk where
11 a material is essentially unavoidable, how much risk can be
12 tolerated.
13 We had, in FDA, a public hearing on the very ques-
14 tion that we are developing in the record. I support your
15 suggestion on FDA's side about the idea of a conference on
16 this and other subjects of more direct interest to you all.
17 MR. CARPENTIER: At the time you have made your
18 studies and we have finished our studies, the right moment
19 might be at the beginning of next year.
20 X am glad you said that quantitation is among the
21 criteria. I think we are making some step forward in the step
22 sequence progress.
23 CHAIRMAN JELLINEK: I might add, Michel, that in
24 our regulation of pesticides, we are also using risk assess-
25 ment. When we talk about carcinogens, we use the assessment
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l document that Dr. Rodricks referred to, and we are using
2 quantification whenever we can with caution as well. So we
3 have some experience.
4 MS. BRACKEN: I was going to ask Dr. Del Bino to
5 elaborate a little more on the yardstick concept. "How are
6 you assessing, based on your experience in the dangerous
7 substance classification? Would you elaborate a little bit
8 more on how you are approaching the problem?
9 MR. DEL BINO: As I say, there is a program with 60
10 chemicals. Of course, 60 is too much. We tried 60 chemicals
n to select a very few. Out of this, while of course the
12 starting point is chemicals very well assessed already, and
13 no difference in assessment around the world, so it is clear
14 enough that such a chemical is very persistent, such a.
15 chemical is ver degradable.
16 MR. CARPENTIER: You could explain the concept.
17 MR. DELBINO: Well, as you know, the yardstick con-
18 cept is a question'to find'out reference compound, to assess
19 the environmental significance of a substance. There is a
20 point to. fix" yardstick for' one. particular property.. If .you.
21 consider'once again persistence, then you select a few chemi-
22 cals which are well known as very persistent'or the contrary.
23 NOW what is the interest of this? Of cojurse,. if you
24 compare a new chemical with such a yardstick, you don't care
25 about the systematic error you might have in your testing
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1 program or your assessment too.
2 Now what is certainly difficult, and that of
3 course is the main work to be done, to combine different yard-
4 sticks for different characteristics or properties to have a
5 global assessment of the environmental significance of a chem-
6 ical.
7 ' So there is certainly a lot of interest from our
3 side.•
9 CHAIRMAN JELLINEK: Would the object be that if
10 you can establish a yardstick for bioaccumulation, say PCB's
11 results, in X, then any new chemcial that is more bioaccumula-
12 tive than PCB's would definitely be a problem and the competent
13- authority of the member state would be expected to deal with
»
u it in some way. Is that what you are thinking about, setting
15 limits or standards of sorts by using yardstick chemicals to
16 measure new chemicals?
17 MR. DEL BINO: If you consider once again the
18 persistence case, which may be the best case, now, there is
19 a very well defined concept for a chemical but very difficult
20 to- define by testing. Certainly, systematic error-is very
21 big.
22 So what is important is to compare your new chemi-
23 cal with a reference chemical which is good, and_good means
24 it is available and well assessed for the characteristic you
25 are looking at. In that case, we find out that the polymer
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1 with particular weight of 800 or something like that, was
2 the right chemical to be used to test a new chemical for bio-
3 degradation, biodegradation.
4 MR. CARPENTIER: I would like to answer your ques-
5 tion more specifically. If, through this system, we can reallj
6 have a good scale, persistence, biodegradation, toxicity, it
7 gives you, in any case, a good idea of the priority- actions
8 which I have.
9 We should be very satisfied to have such a system
10 because as you know, if you manage to legislate on five sub-
11 stances a year it will take centuries to come to good regula-
12 tions. In any case, it would be good to have this reference
13 system to fix our priorities. Maybe in some cases fix limita-
*
u tions and certainly this might have some interest in classifi-
15 cation.
16 It will help, naturally, to make further studies
17 because that's the kind of—not suspicion, but as I said, a
18 priority list, and then it would be easier to devote more time
19 to this type of chemicals or substances or others.
20 You are in the same position we are, you have not
21 much staff and it costs money./ and we must certainly go to
22 priority substances and this is one way. It is still the field
23 of conceptual research.
24 DR. D'AGUANNO: I want to know if I am understanding
25 this correctly. In concept, these reference compounds would
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1 be run through a series of tests that the new compound would
2 be run through under the identical conditions. Is that what
3 you mean?
4 MR. CARPENTIER: Yes, if you know pretty well one
5 substance and you can say, "Well, this substance is really
6 this and this condition—"
7 ' DR. D'AGUANNOi Positive control, do you mean
8 incorporating a positive control into your experiment regardless
9 of what your experiment is?
10 MR. CARPENTIER: Yes.
11 DR. D'AGUANNO: Under certain conditions you are
12 really talking about increasing costs.
13 MR. CARPENTIER: We don't know yet, it's too soon
14 to say.
15 DR. D'AGUANNO: If you are going to include a
16 reference compound or positive control in every carcinogenicit^
17 study just to see how it compares—this is what I'm asking.
18 This is to incorporate a positive control for each new chemical
19 as you are performing the experiments on the new chemical.
20 MR. MOSSELMANS: Dr. D'Aguanno, if I.can make a
21 comparison. Say if we try to have a scale, a meter and to
22 say this compound has this persistence. Other compounds are
23 more persistent or less persistent. This is a type of scale,
24 and at this point we try to make a judgment, we say, small
25 persistence, less persistent than this well known compound.
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1 But the compound we study are submitted to the same test that
2 the new compound must pass to be put on the market.
3 DR. D'AGUANNO: You are talking about a literature
positive control type of thing rather than being one concomi-
tantly under conditions the new chemical is being tested.
MB. CARPENTIER: This means we have still work to
do. 'Anything else?
CHAIRMAN JELLINEK: No. I think frankly, since
we are moving along pretty well, why don't we turn now to the
10 Labeling discussion, and after the coffee break we can talk
11 about confidentiality and anything else you have on. PMN, be-
12 cause I know those two are wrapped together pretty closely.
13 i would like to begin by asking John DeKany to
14 bring us quickly up to date on where we stand on our labeling
15 activities, and answer any questions.
MR. DEKANY: We have had some discussions with
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Mr. Mosselmans, and he has a pretty good familiarity of what
we were planning to do several months ago, and I would like to
bring you up to date in terms of any changes we may have had
in our current strategy.
As you probably know, the Labeling Program will be
a joint effort between EPA and-our Occupational Safety and
Health Administration. Since we talked, Mr. Mosselmans, there
has been a re-direction in terms of the assignments given each
agency. Presently the issue of which, chemicals would be covered
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by the labeling regulation is something that OSHA is currently
trying to determine.
Our role in the labeling program at this point is
to come up with a system of labeling. Basically, establish
the ground rules for defining conditions under which a sub-
stance would be labeled, how it would be labeled, the symbols
that'would be used, the definition and advice on the labeling,
and so on.
At the present time, our strategy has been to
pay considerable attention to the American National Standards
Institute scheme for labeling, which is a voluntary system
of labeling in the United States. Mr. Mosselmans and I and
my staff have done considerable talking about the differences
between the ANSI approach and the European Community approach.
I happe'n to think that the differences are largely
technical and there is considerable room for harmonization of
label requirements • ~- . I personally feel that common
sense will dictate that we do harmonize labeling since there1
is such a great deal of trade world wide in chemicals, and I
think it would be very foolish for all the nations^- communi-
ties to impose different labeling requirements upon the industry,
I think the positive aspects that I see are the
very common;-starting points between the EC proposed labeling
system and the American National Standards Institute's system.
I would like to spend some time perhaps identifying
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i the differences between ANSI and the European Community, and
(
2 perhaps ask some questions in terms of why are these differ-
3 ences there.
4 I think the most significant difference pertains
5 to the actual numerical values used to determine the degree
6 of hazard. For instance, there are minor differences between
7 the rules for LDso's to determine oral toxicity, minor differ-
8 ences- in the selected standard for the dose response for
9 skin inhalation toxicity. I think that these kinds of differ-
10 ences are due to the fact that ANSI picked their values sev-
11 eral years ago, while the European Community has picked their
12 values recently. I don't think that is a great stumbling
13 block.
14 I think a scientist could agree on moving these
15 quantitative values back and forth to determine where the
16 trigger should be for oral.-toxicity labeling and so on.
17 I think we can then move into the issue that fpr
18 every effect the European Community has chosen to identify
19 three categories of hazard, whereas ANSI has two categories
20 of hazard, and I would like to ask you why is there a 3 tier
21 system of hazard classification, what are the advantages of
22 a 3 tier system, and so on. I thought, we could have some
23 dialogue here, rather than my doing the talking._
24 MR. MOSSELMANS: I appreciate very much what you
25 say, and I think we must try to harmonize, especially in the
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labeling field. I agree, with you it is ridiculous for commer-
cial exchange. We must change the label, and we must try to
make some progress in this field first.
To come to your question, "Why three categories?"
We have .worked from the '67 to '74, and in '74 we began a
study of the pesticide preparation, and we know from industry
that -there is some accident, and they ask to create this toxic
class-, with the same symbol but with different risk phrases,
what we call the risk phrases, indication of risks to be very
toxic by inhalation or very toxic by skin contact.
The proposal was practically what we find in the QMS
for pesticides, the value for LD — I'm sorry — WHO, 025
milligram LD and now we are using LD , 025, 2500, 2000. We
think we are most safe with the ANSI proposal.
If I remember, it is about 500 milligrams, we go to
a thousand. You speak, and I agree, to cooperation with OSHA
and so on. But the labeling in the European Community, the
labeling is made to advise the public, and when you see how
many substances, all dangerous substances must be labeled for
what we call physical hazards, say, flammability, explosibil-
ity, but all substances.
MR. DEKANY: The problem with the 3 versus 2 classes
is probably obvious. Namely, by establishing a third
class, our industry would be faced with the burden of perhaps,
additional testing. If nothing else, those who have already
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i adopted the ANSI system in the United States would of course
f
2 have the burden of re-classifying their prodducts.
3 I think this is something we ought to seriously
sit down and do some talking about. I think the demarcation
point between toxic and non-toxic is not as troublesome. That
can be shifted and adjusted, but when we bring in an additiona .
7 tier( we are concerned that that would produce an additional
8 burden on our industry, namely testing, or certainly, litera-
9 ture searching.
10 MR. MOSSELMANSr May I say something about this.
11 We speak now about existing substances. With this value, we
12 know LDso is a statistical value. We say 195 milligrams or
13 205 milligrams. Let's say our first value to go to I^g, "
14 and after this we say, "Of course, not only the acute. .•• > • -i
is effect, but the long term and chronic effects." The acute
16 effects are just to give an idea, and after this we refine
17 the first judgment with the chronic effect of the first point.
18 When you speak about testing, you speak about
19 existing chemicals. It is clear we can find a lot of infor-
20 mation for the label about acute toxicity. Sometimes also
21 about chronic toxicity, and I don't think the U. S. industry
22 will have to make a lot of testing. It's a question of— I
23 agree there may be some data that we find in the literature
24 is not up to date. Our data from 20 years may not be data
95 of good quality, but we have the choice of make the testing
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I or use this date with some doubt about the quality. After
2 a certain time, we can change our judgment.
3 MR. DEKANY: I would just simply like to point out
4 at this point where we find significant differences, how these
5 differences might affect us. I would like your comments in
6 terms of what are the ANSI limitations, what significance
7 would they have for the European Community.
3 Of course, you also have 14 hazard classes and ANSI
9 has 11. I think subtracting hazards might not be as much as
10 a stumbling block as the 3 versus 2 classification.
H We treat fire hazards, two classes of fire hazards
12 and you have three, and that could be a substantial stumbling
13 block with some of our other labeling regulations, the Depart-
•
14 ment of Transportation and so on. Again, when we have the
15 three versus two classes, we have the problem of reeducating
16 those people who use the label as to the significance of the
17 classes.
18 Finally, we have in ANSI a sensitizer class whereas
19 the Directive does not have a comparable class. That's the
20 main difference in the hazard class in the criteria.
21 MR. MOSSELMANS: What we have is risk phrases for
22 sensitization, R42 or 43, may cause sensitization, skin
23 sensitization, by skin contact or by inhalation.
24 About the sensitizer, in 95% of the cases, if you
25 have a sensitizer, it's an irritant. In this case, we label
it as irritant, and
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1 you put on the label the risk phrases, may cause sensitization
2 by skin contact.
3 We are in the same situation as ANSI except we
4 have two types of symbols, symbols for physical hazards and
5 health hazards.
6 MR. DE KANY: Maybe it would be more fruitful to
7 look•at the broader question of how would one obtain harmoni-
8 zation of labeling in the world. There isn't any doubt, all
9 of us agree that we need harmonization, but maybe it would be
10 more profitable at this meeting to do some thinking in terms
n of how do we pursue this issue of harmonization.
12 We have thought of perhaps of proposing in our
13 Federal Register, both systems for public comment, both the
14 European Community and ANSI system classification. I wonder
15 if this might be an appropriate topic to spend a few minutes
16 talking about. Certainly there are other possibilities of
17 bringing people together who are working on it.
is MR. CARPENTIER: You know there has been work in
19 the framework of the United Nations for years. I don't want
20 to—I can say it has been progressing very slowly. Your last
21 suggestion to put together some specialists from this Country
22 and other people in the community might lead to some good re-
23 SUltS.
24 We cannot now go into details because we have no
25 time, and we are not specialists here around the table. I'm
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l sure Mr. Mosselraans could accept to discuss with you the
2 procedure to have us move in this field. As you say, it is so
3 obvious, to go to Europe you have to change the labeling
4 system, or the other way, is too big.
5 The first resolution you made, you agree, it is not
6 so important. The second, I don't know, maybe this might
7 be looked at more in depth to see in reality if there is a
3 problem or not. If it is a problem of transition and educa-
9 tion at a cost which is acceptable, it would ease the situatio^.
10 MR. DE KANY: It was simply a personal opinion based
n on my experience that sometimes semantics become the most
12 difficult obstacles in international negotiations. That is
13 why I suspect maybe the words, the number of classes, become
14 very hard sometimes to work out.
15 MR. CARPENTIER: The second word is "cost benefit."
16 I'm sure there would be some cost, but it would be a tremen-d
17 dous benefit to industry to have this labeling system harmon-
18 ized. If the United States and the Community could make some
19 step forward, this would have some influence on the interna-
20 tional work in the UN.
21 MR. DE KANY: I might suggest for starters, to
22 start discussion, perhaps it might make sense to have a more
23 direct working relationship with Mr. Mosselmans and maybe map
24
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out a strategy of what do we do and how do we handls this prob-
lem of harmonization. More of a first get-together to do some
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1 thinking and planning in terms of how could we approach har-
2 monization, what are difficult areas, what is the United Nations I
3 doing, etc;.
4 MR. MOSSELMANS: May I suggest Article 7„ para-
5 graph 5, of the 6th Amendment. That, you solve the problem we
6 have used in the Community for '67. The first point is the
i*
7 first recommendation to the user.
8 - It is impossible to ever complete a total harmoni-
9 zation between labeling prepared for the user and labeling
10 prepared for the transport. Take benzene. Benzene is con-
11 sidered flammable liquid for transport, but considered as highly
12 toxic, flammable and highly toxic for the user. In this case,
13 what we have said, only for the labeling use for transport,
14 when you have big packaging, but the little package we send
15 to the user must be labeled differently, and that's a very
16 important thing.
i? CHAIRMAN JELLINEK: I think John's suggestion that
18 We get together is a very good one. We are very interested in
19 harmonizing efforts on this issue. There are some differences
20 but we are not quite even at the proposal stage. We will iden-
21 tify the Commission's system as one of the really live alter-
22 nates we are looking at.
23 MR. CARPENTIER: It has been working_for more than
24 20 years.
25 CHAIRMAN.JELLINEK: Why don't we take a very brief
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break, but before we do, let me introduce at least one person.
John came in, and you met him before, but someone you have not
met before is Don Abelson with the Office of U.S. Trade
representative. We welcome Don to these sessions for the
first time, and there are some people who came in afterwards
that I don't know, and I would like to be sure you know who
they are. Why don't you introduce yourselves?
MR. REICH: My name- is Abraham Reich from OSHA, and
I am taking Flo Rider's place.
MR. HOINKES: I am Dieter Hoinkes from Commerce
Department office.
MR. FLAMM: I am Scott Flamm, on John DeKany's
staff.
MR. NELSON: Jim Nelson, Office of General Counsel. '
MS. FRANE: Jean Frane, Office of Pesticides
Program.
MR. SEMENIUK: I am George Semeniuk, Office of
Pesticides.
CHAIRMAN JELLINEK: Let's take five minutes for
stretching and coffee.
CShort recess.)
CHAIRMAN JELLINEK: Can we get started again? I
would like to introduce a new entry, Bob Nicholas of the
President's Council on Environmental Quality, and Ed Cull of
Marilyn Bracken's office.
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l Why don't we get started on the discussion of
2 confidentiality, and on this one I would like to turn it over
3 to you or Goffredo and see what questions you have and what
4 we can do in the way of answering them.
5 MR. DEL BIND: Yes, let me briefly recall what is
6 the Community position on confidentiality. The 6th Amendment
7 defines a system for protection of confidential information
3 and data based on specifications first of all by the notifier
9 itself, but of course, is a decision of the national authority
10 which received the notification dossier, who is competent to
H decide if such information has to be considered confidential
12 or not.
13 The more interesting, issue for our-discussion here
14 is tha't at the same time, the 6th Amendment defines a certain
15 number of items which cannot be considered in any way as
16 confidential. As you know, Article 11 of the Directive
17 specifies the items which I will briefly recall.
18 You have the trade name, physical chemical data,
19 ways of rendering the substance harmless, recommended pre-
20 caution and interpretation of the tests. I would add to this
21 list, other items which are implied and which did not appear
22 very openly. So it is important for you to realize that the
23 identity of a notified chemical after three years has to be
24 made public. Before the three years' time, there is the possi
25 bility for the notifier to ask that the chemical be put on
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1 the list of notified chemicals in encoded form. Then, and -
2 it's an important point, the identity of a notified chemical
3 classified as dangerous must be published, that is to say,
4 put on the label.
5 This poinjt maybe does not come out very clearly from
6 I the Directive, and for that reason, I would like to underline.
7 In conclusion, in the case of a dangerous chemical, no code,
8 and the identity has • to be put on the label.
9 CHAIRMAN JELLINEK: The name as well as the warning.
10 MR. DEL BINO: As well as the name and address of the
11 producer on the label —
12 CHAIRMAN JELLINEK: Who decides, and how is it
13 decided that a chemical is dangerous?
14 MR-. DEL BINO: The Directive specifies certain
15 criteria, according to which a chemical is to be classified as
16 dangerous. So we appreciate that, in certain cases, there
17 will be some interpretation problems. But the Directive
18 provides for criteria which, of course, can be improved and
19 developed later on.
20 Our system provides that for a dangerous chemical,
21 there is no way to keep confidential the chemical name.
22 MS. BRACKEN: What about health and safety data
23 associated with that chemical submitted with the .notice that
24 is classified dangerous?
25 MR. DEL BINO: As I say, the Directive provides
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that only the interpretation of data, and the results of test-
ing, have to be public. But don't forget that the notifica-
tion dossier, as far as the testing would be concerned, would
be a very big one.
I see for the information needs of the public, they
should certainly know the results. But there is no problem
with the exchange of confidential data between nine national
authorities and the Commission. So one could say you have
two cases. One is that data cannot be considered confidential
and so disclosure of such data is possible. In the second
case, you have data or information which, upon the request of
the notifier and justification provided, it can be decided
is confidential, and in that case, you have no disclosure of
data, but you have exhange of information between the national
authority and the Commission.
There's no escaping the full exchange of information
between the nine authorities and the Commission, and thatfs im-
portant to point out. That's also'true, and that we have open
ly .to say the confidential information may also be brought to •
the attention'of persons directly involved in legal proceeding.
It precisely says that such proceedings are only
those undertaken for the purpose of controlling chemicals, no
other kind of procedure.
As far as the information of the public or
disclosure of information', the Directive does not provide
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autonomism. It does not provide a. mechanism for publication
of information for the public at large.
You have in TSCA five days after notification for pub
lication of data. As I say, there is not autonomism in the
6th Amendment unless in the labeling provision to publish the
data I mentioned, data which cannot be considered confiential.
I can- say roughly that our system, I feel, is not too far from
yours.
We have not maybe the problem you have on the confi-
dentiality of the chemical name related to the chemical prop-
erties. But, and it's an important point, we cannot forget
that our notification systems are different. So we cannot con
sider this confidential issue separate from the entire system
which is the notification in itself.
You know very well what the difference is. We have,
for instance, that the new chemical remains new forever, and
there is an obligation to notify by subsequent notifier. We
feel that confidentiality is a problem which we have to try to
harmonize in the contest of the notification system.
MR. CARPENTIER: Any questions? ,
CHAIRMAN JELLINEK: I would like to step aside and
make sure I understand a couple of things.
First of all, you said that after three_years, any
identities claimed confidential can be made public. So there
is a three-year period of confidentiality for any chemical
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1 whose identity is claimed confidential.
2 MR. DEL BINO: But that applies after the decision
3 of the national authority is received. In notification, the
4 national authority may decide it is not possible to answer
5 favorably to the request. Anyway, as I said before, if the
6 chemical is classified dangerous, then no question—
7 CHAIRMAN JELLINEK: Right from the beginning,
8 okay. Those are two interesting points that I did not fully
9 appreciate. It seems to me, whether our differences, are wide
10 or narrow will depend to some extent on how we resolve .the
n question of chemical identity and the release of chemical .
12 identity.
13 As you know, that is a major issue on our regula-
14 tion on premanufacturing notification. We will have to re-
15 solve that as we develop the regulations.
16 There is one area where I think our differences
n are not resolvable by discussion or regulation, and that is .
18 the disclosure of health and safety studies as opposed to
19 studies or summaries of studies or whatever. I think you- are
20 familiar enough now with our law that you know that that is
21 a requirement of the law, and it can--only be changed by
22 changing the law.
23 I guess I would like to ask. you, how-much of a
24 problem do you think that is going to be in terms of the
25 member states of the European Community. You can decline to
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1 speculate on that if you wish. Certainly, the companies
2 claim it will be a major problem.
3 I find it curious that American companies subject
4 to the same requirement have really not claimed it is a major
5 problem,' and I did not realize that industry was so different
6 from one side of the Atlantic to the other. If the European
7 Community thought it was a major problem, I would think
8 American industry would.
9 Maybe it's a matter of politics on each side of the
10 Atlantic as well, and you do not have to speculate on that if
11 you don't want to.
12 MR. DEL BINO: Yes, I see the reason may be very,
13 very open.
14 As you know, Section 5 does not allow you to ask for
15 testing. You have no testing requirement under Section 5
16 unless through Section 4 to Section 5. So a notifier will
17 give you the information he has.
18 If a chemical is produced in the community, the
19 notifier has to do all the testing programs which are in Annex
20 lr and then coming into the U.S. and notifying under Section 5
21 he is obliged to give you all the data because he has this
22 data, and so according to Section 5, he is obliged to give you
23 this data. But these data are not protected by ^TSCA because
24 it is only the first notifier who has such an obligation.
25 MR. CARPENTIER: In other words, two plus two makes
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i four.
2 MR. DEL BINO: That's right, that's the big prob-
3 lem.
4 CHAIRMAN JELLINEK: That's only true to the extent
5 that the American company doesn't do anything. To the extent
6 the Americans do testing, they have to provide it to us, and
7 that .information is available to the Europeans, the rest of
8 the world. So you are right, you can't add two and two imme-
9 diately, you have maybe to divide and multiply and take the
10 square root before you get to "four" in the United States,
11 because it is not clear under what conditions companies will
12 test or whether EPA will intervene for required testing in
13 certain circumstances where the companies would not choose
14 to test on their, own.
15 The principle is the same if the company does the
16 test. One of the reasons I raised the question is that,
17 frankly, until a company starts doing some of the expensive
18 tests, which means in your system, .they get over 50,000 pounds
19 ten ton and then 50 ton figures, and still they start reaching
20 those higher triggers, the tests they are required to do are
21 not very expensive with the exception of the 28 day sub chroniŁ
22 I frankly believe that will be—doing the 28 day
23 sub chronic on a chemical under ten tons would be the excep-
24 tion rather than the rule, but be that as it may, the future
25 will tell that.
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l Given the fact that you assume they are not going
2 to be spending tremendous sums of money, certainly on the
3 base set, I question the depth of the concern. Most of the
4 .other tests in the base set are tests that can be fairly
5 easily replicated for not much money. I don't think that
6 information is that valuable.
7 , The information produced by acute tests or Ames
8 tests', mutagenicity screens, is just not valuable information
9 in the marketplace, whereas if they are producing their chem-
10 icals in 50 tons or above and have to do a long-term chronic
11 bioassay or carcinogen bioassay, and you are talking about
12 hundreds of thousands of dollars, then it starts becoming
13 very valuable.
14 Well, we are continuing to look for ways to deal with
15 these issues and we have to make a decision on the confiden-
16 tiality of identity.
17 MR. CARPENTIER: If I may, if, as we hope, we come to
18 a certain agreement on the base set, I think a large part of
19 the problem may be solved.
20 CHAIRMAN JELLINEK: That's a good point, because our
21 objective is to work with the OECD'to come to such an agree-
22 ment. I have been pleased with the way things have been going
23 in the last few meeting with that group, and I think that
24 would solve a lot of the problem.
25 MR. CARPENTIER: I think, in that case., the differ-
ences would not be so important,. -.
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1 CHAIRMAN JELLINEK: Yes. Do you have any question:!
2 or would Bob Nicholas or Jim Nelson like to elaborate.Marilyn.
3 MS. BRACKEN: No.
4 ' CHAIRMAN JELLINEK: Did you have any general ques-
5 tions about the premanufacturing notification regulation or
6 the process, that you would like to raise.
7 ' MR. CARPENTIER: I think we could pursue that.
8 We have still to work together, but there may be good pros-
9 pects for approximation of views and procedures. I hope we
10 can have scientific cooperation. So far, as GLP'a are con-
11 cerned, I think we have good progress.
12 You are also in the process of internal harmoni-
13 zation of views and so on. You can expect us to have better
14 views of the European system at the end of this year.
15 On confidentiality, I think we have understood
16 that, after all, there will not be so many confidential data
17 that would hamper implementation of the objectives of the
is law. As I say, if we can come to harmonize to basic data
19 which must be put forward and given by the notifier, the
20 problems will be reduced, not to nothing, but very-much reduce^
21 CHAIRMAN JELLINEK: Before we close, we have gone
22 through the formal agenda, and Marilyn has a couple of late
23 entries she would like to talk to you about„
24 MS. BRACKEN: Before we move on to these two areas
25 I would like to ask a question wer raised the last time you
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i were here, and that is, if you've done any more thinking about
2 how other manufacturers from outside the European Commission
3 will be able to find out from the first notifier who he is,
4 what data is available, and how he would negotiate for some
5 reimbursement for the data if he wanted to do that.
6 Our domestic manufacturers have that concern, and
7 I wonder if you have given any more thought to implementation
8 of that concept.
9 MR. MOSSELMANS: We make an inventory quite differ-
10 ently from the U. S., an inventory who says the inventor must
11 stop at 81. The Commission will publish the list of notified
12 substances and the form, and the information you will find in
13 this list must be defined through the particular procedure.
14 At this time we've had no meeting about this, and we don't know
15 the substance of the code.
16 At this time the new manufacturer or the second
17 manufacturer, if the substance has been notified and what are
18 the information, maybe we will publish that the substance has
19 been notified to the Italian National competent authority.
20 CHAIRMAN JELLINEK: What if he doesn't.see his
21 substance on the list, and only sees some name of substances
22 in some code and he doesn't know, obviously, whether his sub-
23 stance is in the code.
24 MR. MOSSELMANS: That's the problem of confident!-
25 ality at this time.
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1 CHAIRMAN JELLINEK: Then he has to go through the
2 notification process.
3 MR. MOSSELMANS: To the national authority.
4 MR. CARPENTIER: If he cannot find it, and he
5 wants to be sure he has notified, in that case he can address
& the Commission.
7 ' " CHAIRMAN JELLINEK: You will tell him. That's
8 what we do.
9 MR. CARPENTIER: We would not like to do it in all
10 cases, but we hope the manufacturer will take the pains to
11 look himself, at the list, and not say each case is easy for
12 me to ask the Commission.
13 CHAIRMAN JELLINEK: Frankly, our experience has
u been that it will not work that way. They will have to ask
15 you because the list will not be up to date because in your
16 case there will be coded, and in our case confidential generic
17 names, and if it is a matter of spending a lot of money or not
18 spending a lot of money or a matter of doing his own test, or
19 trying to pay the first manufacturer for the test, he will
20 want to know, particularly if there is a lot of money involved
21 he will want to know whether he has to notify 6r hot.
22 If there is not a lot of money involved, maybe he
23 wants to keep it confidential too, he will just dp the test,
24 and his substance will be coded as well. There are a million
25 complications and we have been through at least 600,000 of
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l them so far in the first six months of trying to make the
2 inventory work.
3 MS. BRACKEN: Plus, it is our experience that before
4 a notification comes in, they go through what we call the
5 bona fide intent to manufacture. They call us up and say,
6 "Is this chemical on the list?" because the list, as you know,
7 is in the state of always being added to, and they will not
3 spend the money to fill out th'e forms if they don't have to,
9 so they do check.
10 Our question to you is, how does a company check with
11 nine member countries or the Commission? If you are planning
12 on having a Commission vehicle similar to ours, that's good
13 and we're glad to do that,.
14 MR. CARPENTIER: Yes. I'm not glad, but you are.
15 (Laughter.)
16 MS. BRACKEN: In light of our agreement to have no
17 surprises, I just wanted to mention to you that we have an up-
!8 coming Section 13 import rule which, is required by our law.
19 We have a legislative mandate which requires importers to
20 certify that imports are incompliance with TSCA. The imple-
2i mentation is to be by a U.S. Treasury Department rule. The
22 Custom Office (part"of the Treasury Department) will be
23 developing the rule in consultation with EPA.
24 Our plans are, as I said, that Customs will publish
25 the rule and the preamble. At the same time, EPA will publish
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i an interpretation and enforcement policy. We have had a numbe:
2 of informal meetings just recently in December, and we invited
3 members from the Washington Embassy Community. So we had quitŁ
4 a number of representation from the Commission Embassies here
5 as well as someone from the Commission staff itself.
6 We expect publication in Spring. That's estimated
7 publication, Spring, 1980, and we will have a 90 day comment
3 period. There was discussion at our meetings about whether
9 t;hat would be sufficient time, and we are looking at that.
10 We expect promulgation of the rule in late 1980.
11 Let me quickly review the key provisions of the
12 draft. Importers will be required to certify their compliance
13 with TSCA. We anticipate a statement of certification on
»
14 existing customs entry forms, and we are planning to modify
15 the custom forms so we don't have new paper work, because no-
16 one wants additional paper work.
17 We will be working on a definition of what is an
18 importer and we are planning to do that and use the customs
19 definition, if that satisfies the concerns of our mandate.
20 The immediate provision of course, would be that they would
21 have to indicate that they are in compliance with the inven-
22 tory. That's the major thing, they would have to say, in fact
,3 they are in compliance with the inventory, and after the re-
24 vised inventory is out, they would have to indicate that.
25 It would be immediately effective for all shipment
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of chemical substances in bulk. After the revised inventory
we are talking about requirements for chemical substances in
mixture and we are not talking about chemical substances in
articles, so the provision does not apply to articles.
There is a provision for a special chemical import
form in addition to the certification statement, and that
would be developed by EPA, as we see the..need, in conjunction
with special Section 6 regulations or Section 8 regulations.
This could apply to chemical substances in bulk, in mixtures,
or articles pertaining to a regulated chemical.
MR. CARPENTIER: Would you repeat the last point?
MS. BRACKEN: In the rule, there is a provision for
additional special chemical import report form, and that
would be done, in connection with a separate special 6 rule.
If we felt we needed additional information, we would add for
that on a separate report form. We don't anticipate there
are many of these, and we don't quite know how we w.ill be
using these in detail, but we have a provision to allow for
this.
Just a point about the entry, detention, bonding
procedures, we will check the certification statement at the
port of entry. Detention can be triggered by absence of cer-
tification. Customs can release the material on a bond. EPA
will be the ones determining compliance with TSCA regulations.
The potential is there for the importer to try to
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1 bring the shipment into compliance, and there are various
2 options to the importer, if they can't bring the shipment into
3 compliance, that is ,to export it, abandon it, but in any
4 case, EPA is the one who determines ultimate disposition of
5 abandoned shipments. In essence, those are the key provisions
6 of the rule.
7 • The major comment we receive is how does the im-
8 porter or manufacturer in a foreign country know whether or
9 not he is in compliance with the rule. These are some of the
10 concerns raised by representatives, and for purposes of just
11 helping people we would put out some kind of flyer that says
12 "Here is what you have to do to be in compliance with TSCA
13 today", and this would be continuously updated.
u The Embassy representatives thought that would be
15 quite helpful, and we will be working with customs in terms
16 of educating importers, using import trade associations 'and
17 so forth, to get the word out. That is essentially the
18 Section 13 import rule.
19 Briefly on another, and that is Section 12'export
20 notification rule, you are problably familiar with that, but
21 let me quickly review that. Our legislative mandate in this
22 area requires that exporters must notify EPA of an export or
23 the intent to export any chemical substance or mixture for ~
24 which there has been submission, where there is a Section 4
25 provision for submission of test data, or 5E, where there - is
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i a Section 5 or 6 rule suggested or promulgated or where action
2 is pending under Section 5 or 7. EPA must notify the Governr-
3 ments of importing countries of the EPA action. The status
4 of that rule is that, on October 12th, and it was effective
5 immediately for interim guidance for PCB's.
6 The comment period closed December 31st, and we
7 have•received twelve comments on that rule. Again, the key
8 provisions of that rule were that one notice would be required
9 each year for each regulated chemical and in each country for
10 which the person will be exporting. Notice would be submitted
11 to EPA no later than seven days after export, and the notice
12 would specify the name of the chemical, this is the notice to
13 EPA, the name and address of the exporter, the country of im-
14 port, the date of export or intended export, and the TSCA
15 action which is triggering this notice.
16 Then EPA will notify foreign governments to their
17. countries' embassy in Washington within seven days. The
is foreign government will receive a notice that summarizes the
19 TSCA action, identifies a person to contact in EPA for further
20 information, and it includes a copy of the Federal Register
21 notice that we have already put out. Essentially that is our
22 planning on Section 12 and we hope to finalize the rule after
23 we go through the comments.
94 MR- CARPENTIER: One remark on your last point,
95 it seems to us we should receive the notice you mentioned.
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1 We should be told exactly, as the states are.
(
2 MS. BRACKEN: The Commission itself, yes.
3 MR. CARPENTIER: They're very necessary to us.
4 MS. BRACKEN: We can notify Mike.
5 CHAIRMAN JELLINEK: One last thing before we close
6 I thought you might be interested in what our experience has
7 been 'over the past six months with premanufacturing notices,
8 and I have asked Scott Flamm, with John De Kany's office, to
9 give you a brief summary of what we have received and what
10 kind of information, without disclosing any confidential data.
11 MR. FLAMM: Thus far, as of this morning, we have
12 received about 36 premanufacturing notices. They have been
13 coming in at a much faster rate over the last couple of months
u We had a Christmas rush, where we received about 18 before the
15 holiday season.
16 Most of the submitters have been what I would con-
17 sider large companies, 50 million and on up in annual sales,
18 $50 million. The uses have varied and have been mostly poly-
19 mers. There have been coating, resins, plasticizers, flame
20 retardants. .
21 As far as the toxicity data we have received, it's
22 been rather sparse. We generally receive physical chemical
23 data. We receive acute toxicity'data on about a .third-of the
24 substances. Often what they will do is not submit an LDso for
25 a PMN substance, but submit LDso's on structually similar
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substances. If they are making sodium salt of a compound,
they will submit the potassium salt or ammonium salt LDso-
We have received no chronic sub-studies. We may have received
one chronic study on PMN study and one or two mutagenicity
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studies.
We have received no carcinogenicity studies. Very
often-, again, we receive all types of data on precursor sub-
stances because it's been generated already and there is no
additonal cost.
Finally we receive some analysis for impurities.
Generally they characterize what impurities they expect to be
present. To complement this, we have received more exposure
data. We generally receive a description of the number of
orders and duration of exposure.
If we do not receive a process flow diagram, which
is a source of contention with industry, we can often get a
description from the manufacturer about what is going on in
the process in subsequent phone conversations. They seem more
willing to discuss that, and we receive estimates of what they
expect to be released to water bodies, to the air,_and to land-
fills. - -
Finally, we do not receive .very good information on
consumer exposure. They are hesitant to give us estimates of
what they expect the consumer market to be, and there is a
state of the art on estimating the magnitude of exposure to
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i consumers in its infancy, and they usually do not hazard a
2 guess.
3 MR. CARPENTIER: Can we have an idea of the number
4 of people working for TSCA?
5 CHAIRMAN JELLINEK: In the United States as a whol4?
6 MR. CARPENTIER: At EPA.
7 ' CHAIRMAN JELLINEK: There are not as many in EPA
8 as there are in the United States as a whole. There are prob-
9 ably more lawyers working for industry on TSCA than everyone
10 in. EP.A-_;work±ng on TSCA.
11 MR. CARPENTIER: Not now, but to have an idea of
12 the way you have organized your work. For instance, when you
13 thought about Section 13, I asked myself, "Well, EPA is going
u to do a lot." In fact play some role of control and so on,
15 and what does that mean in terms of staff?
16 CHAIRMAN JELLINEK: In Washington, in my office
17 now, we have approximately 300 people and we are going up to
is around 500 this year. In addition, in Washington and the field,
19 there are one hundred and something, I can't remember the exad.
20 numbers, of enforcement officers, who will be doing enforce-
21 raent of the various regulations that we develop here in Wash-
22 ington.
23 '"'.- -.-_ -The,- number of people working_on new cheft-
24 icals is hard to calculate because a lot of people work on
25 more than one aspect of TSCA, particularly the scientists and
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people working on information questions. The people who work
for Marilyn, for example. But in John's office, he has a
staff of approximately 60 right now working on these notices
and on the regulations supporting these notices.
MR. DE KANY: I think you're optimistic. We have
about 45, but not all of those are working on those. They are
worki'ng on the procedure to develop the rules. I would say
24 might be involved directly in notices.
CHAIRMAN JELLINEK: Plus the people in Warren's
office, scientists, and the people in Marilyn's office, so,
it's a fairly good-sized operation.
MR. DEL BINO: I would like to raise a question to
Mr. Flamm. In fact, you mentioned PMN's. I would like to
get some statistics on EPA response. What is EPA action after
you receive PMN — statistically? I'm not interested in a
specific case, but I'm interested to know how much additional
information is requested by EPA.
MR. FLAMM: There has been" one extension of the
notice period. The last time I checked, five to ten have com-
pleted the 90-day review and most of them are still, going
through the process. One was extended, and I believe, on
the remaining, no regulatory action was taken.
We have, in some cases, notified the manufacturer
of concerns we had, but we were not taking action for one
reason or another.
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1 CHAIRMAN JELLINEK: We intend to
2 take follow-up action through a Significant: New Use rule on
3 one of the first ten chemicals, and we are preparing that
4 now.
5 MR. DEL BINO: I have another question. It is
6 very interesting to know that you are prepared to publish new
rules, but what happens about:' Section 5?
8 • CHAIRMAN JELLINEK: When will the final rule be
9 promulgated?
10 MR. DEL BINO: Yes, when.
11 CHAIRMAN JELLINEK: Well, I keep asking that ques-
12 tion myself. I would say the final promulgation will not be
13 until late spring or early summer. We may put out an interim
policy statement, which would, provide more details and guidanci
15 The chances are the actual final rule itself won't be out until
late spring or early summer. Is that reasonable?
17 MR. DE KANY: Yes. I think it is fair to say that
the main obstacle is that we must do a very comprehensive cost
benefit, and the economics has been the most difficult for us
20 we' ve had to - change the contractor in the middle, of the stream
21 because he did not know how to measure innovation and impacts
22 of Section 5 rules on innovation.
23 The critical path is our economic report, and
24 under our economic procedures we must have the economic report
25 before we can promulgate, and that is the key.
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1 CHAIRMAN JELLINEK: Okay, thank you once again.
2 It's been a good morning.
3 MR. CARPENTIER: We wish you good luck.
4 CHAIRMAN JELLINEK: Same to you.
5 (Whereupon/ at 12:20 o'clock p.m., the meeting
6 was concluded.)
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2
3 REPORTER'S CERTIFICATE
DOCKET NUMBER:
CASE TITLE:"Discussion with the Commission of the European
Communities
HEARING DATE: • -1/11/80
LOCATION: Washington, D.C.
9
10 I hereby certify that the proceedings and evidence
herein are contained fully and accurately in the notes
12 taJcen by me at the hearing in the above case before the
13 U.S. Environmental Protection Agency
and that this is a true and correct transcript of the same,
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Date: .January 21, 1980
Official Reporter
Acme Reporting Company, Inc.
23 1411 K Street, N.W.
Washington, D.Crr 20005
24 "
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