United States
Environmental Protection
Agency
February 1979
Toxic Substances
The Toxic
Substances
Control Act
Questions and
Answers:
Proposed
Premanufacture
Notification
Regulations
-------
This booklet contains questions and answers
designed to assist members of the chemical
industry, and other interested persons, in
understanding the proposed premanufacture
notification regulations recently published
in the Federal Register.
PREPARED BY:
Industry Assistance Office
Office of Toxic Substances
U.S. Environmental Protection
Agency
-------
U.S. EPA / TcxLc Substances Control Act
PROPOSED PREMANUFACTURE NOTIFICATION
REGULATIONS"
-published in June 10, 1979 Federal Register-
(Vol. kk, pp.
QUESTIONS AND ANSWERS
(l) Q: WHAT IS THE SIGNIFICANCE OF THE PROPOSED PRE-
MANUFACTURE NOTIFICATION REGULATIONS RECENTLY PUBLISHED
IN THE JANUARY 10, 1979 FEDERAL REGISTER?
A: It is important for all members of the chemical
industry, and other interested groups, to understand
the concept and scope of EPA1s proposed premanufacture
notification requirements, for two reasons. First, the
requirements will be finalized, and become a reality in
1979— in other words, EPA is mandated under the Toxic
Substances Control Act (TSCA) to develop and put in
place a premanufacture notification procedure. This
procedure will change the way the chemical industry in-
troduces new chemicals for commercial purposes in the
United States. And second, now during the provided 75-
day comment period, which ends on March 26, 1979, is
your chance to critique the premanufacture notification
rules and notification forms, and influence their final
format.
(2) Q: PRECISELY, WHAT IS PREMANUFACTURE NOTIFICATION
AND WHAT IS ITS PURPOSE?
A: Premanufacture notification (PMN) is the term
applied to the process which will require U.S. manu-.
facturers and importers of new chemical substances to
notify the U.S. Environmental Protection Agency (EPA)
of their intentions, before introducing these substances
into. U.S. commerce. This procedure was authorized
under Section 5 of TSCA.
-------
The purpose of PMN is prevention. In other words, this
procedure will allow EPA to review new chemical sub-r
stances with respect to their potential harm to humans
or the environment before they are manufactured or
imported for commercial purposes — and to take action,
if necessary, to control them at that time.
(3) Q: HOW DO THE PREMANUFACTURE NOTIFICATION FROCK-
PURE REQUIREMENTS RELATE TO THE "CHEMICAL SUBSTANCE
INVENTORY?
A: TSCA gave EPA the responsibility of gathering
a list of all existing commercial chemical substances
manufactured in or imported into the U.S. Therefore,
regulations were published in December 1977, requiring
manufacturers and importers of chemical substances,
used for commercial purposes, to report them to the
Agency during a 120-day period (Janurary'l - May l) in
1978. The list of all the chemicals reported will be
entitled, "The Chemical Substance Inventory", and will
be published in the first half of 1979.
The Inventory's publication will enable EPA to
launch the premanufacture requirement under TSCA. Once
the Inventory is released, the world of chemicals —
produced for commercial purposed in the United States—
will be divided. There will be "existing" chemicals—
those listed on the Inventory; and there will be "new"
chemicals — those not listed on the Inventory.
All new chemicals will be subject to TSCA's pre-
manufacture notification requirements, once they are in
place. Beginning 30 days after the Inventory's publi-
cation, manufacturers and importers will be required to
notify EPA of their intent to make, or bring into the
U.S., a new chemical substance for a commercial pur-
pose. (As with reporting for the Inventory certain types
of chemical substances — including those used solely
in foods, drugs, Cosmetics or pesticides — will be ex-
cluded from this requirement.)
EPA will review the submitted premanufacture noti-
fication concerning the new chemical. If the Agency
does not take regulatory action within a specified
-------
period, manufacture or importation of the new chemical
may begin — and it will be added to the "Chemical Sub-
stance Inventory" of existing chemicals. If EPA de-
cides to regulate the new substance, the chemical can
be regulated under TSCA or other laws.
Thus in summary, only chemicals of an "existing"
status (that is, those on the Inventory) may be manu-
factured or imported for a commercial purpose — once
the premanufacture procedure begins.
Q: WHO MUST SUBMIT PREMANUFACTURE NOTICES?
A: Beginning 30 days after the Inventory's publi-
cation, in early 1979, you will have to submit a pre-
manufacture notice to EPA, if:
l) you intend to manufacture a new chemical
substance for commercial purposes in the U.S. — even
if you want to only export the substance;
2) if you intend to import a new chemical in
bulk form'for commercial purposes in this country —
that is, not as a mixture component or in an article;
3) or, if you have been manufacturing or im-
porting a chemical substance which was previously
exempt from premanufacture notification — perhaps, it
was being used only in small quantities for research
and development, or as a pesticide — but you now want
to manufacture or import the substance for a commercial
purpose.
(5) Q: WILL IMPORTERS OF MIXTURES CONTAINING NEW
CHEMICAL SUBSTANCES ALSO HAVE TO SUBMIT PREMANUFACTURE
NOTICES?
A: Eventually importers of mixtures containing
new chemical substances will also be subject to pre-
manufacture notification requirements, but not at the
same time as manufacturers and importers of new chemi-
cal substances (i.e., 30 days after the Inventory's
initial publication in early 1979). Subsequently, 30_
days after a revised version of the Inventory is pub-
lished in 1980 importers of mixtures also will have to
-------
submit premanufacture notices for all new chemicals
contained in the mixtures they import into the U.S.
The Revised Inventory will include; substances
appearing on the Initial Inventory; substances report-
ed by processors and certain importers, during the 210-
day reporting period beginning in April 1979; as well
as substances that have completed premanufacture re-
view and have begun to be manufactured or imported for
commercial purposes.
(6) Q: WILL IMPORTERS OR MANUFACTURERS OF EXISTING
CHEMICALS, ALREADY ON THE "CHEMICAL SUBSTANCE INVEN-
TORY". WHICH ARE USED FOR A "SIGNIFICANT NEW USE" BE
SUBJECT TO PREMANUFACTURE NOTIFICATION REQUIREMENTS?
A: In the future chemical substances which appear
on the Inventory, but which are manufactured or import-
ed for a "significant new use" 'may be subject to PMN.
A determination on significant new use policy has not
yet been made by EPA, but is expected by the time the
premanufacture notification regulations are finalized
in 1979.
(7) Q: WHO SHOULD NOT SUBMIT PREMANUFACTURE NOTICES?
A: You will not have to submit a premanufacture
notice, once the procedure begins, if you intend to im-
port an article containing a new substance. However,
in the future, EPA may designate categories of chemicals
in articles for which a premanufacture notice would be
necessary.
Also, if you intend only to process or use a new
chemical substance, you are not required to submit a
notice. In other words, there is no legal obligation
for processors and users to participate in PMN. How-
ever, they are encouraged to aid manufacturers and
importers if requested to do so. This aid would pro-
bably involve the completion of Processor and Consumer
Use Forms, which will be supplied by the manufacturer
or importer.
-------
(8) Q: ARE AMY CHEMICALS EXCLUDED FROM PREMANUFACTURE
NOTIFICATION?
A: There are some chemicals made or brought into
the U.S, which have limited or no commercial purpose.
The regulations propose that these be excluded from
premanufacture notification requirements. These chemi-
cals or chemical uses include:
l) those used only in small quantities for research
and development;
2) those used only for test marketing— however, a
written exemption from EPA must he obtained in these
cases;
3) chemical mixtures — however, the chemicals
which make up the mixtures are not excluded;
H) chemicals used only in pesticides, tobacco pro-
ducts nuclear materials guns and ammunition, foods,
food additives, drugs or cosmetics;
5) any co-product,if its only commercial purpose
is to be sold to municipal or private organizations
who burn it as a fuel, dispose of it as a waste, in-
cluding in a landfill or for enriching soil; or extract
component chemical substances — however, if the
extracted substances are themselves new chemical sub-
stances, they are subject to PMN;
6) any manufactured chemical substance which has
no commercial purpose separate from a substance, mix-
ture, or article of which it is a part — these include
impurities, byproducts, non-isolated intermediates, and
several others listed in Section 720.13_(e) of the pro-
posed regulation.
(9) Q: WHEN WOULD PREMANUFACTURE NOTICES HAVE TO BE
SUBMITTED?
A: Everyone required to submit a premanufacture
notice would do so at least 90 calender days before
beginning to manufacture or import the new chemical
substance for commercial purposes.
(10) Q: WHERE COULD YOU GET THE FORMS AND INSTRUCTIONS?
A: Both the premanufacture notice forms and in-
struction manual would be available from EPA. You
could have them sent to you by calling toll free:
BOQ-k2k-9065: in Washington, D.C.:
-------
(11) Q: WHEN WOULD THE 90-DAY PREMANUFACTURE NOTIFI-
CATION PERIOD "COUNT DOWN" BEGIN?
A: The day the EPA office (which would be indicated
on the form) receives the notice is the date on which
90-day premanufacture notification period would begin.
EPA would then immediately acknowledge by mail its
receipt of your notice.
(12) Q: WOULD EPA LET ANYONE KNOW ABOUT THE PRE-
MANUFACTURE NOTICES IT RECEIVES?
A: The law (TSCA) requires EPA to publish, in
the Federal Register, cer.tain information concerning
each premanufacture notice it receives. The Agency is
to submit this information to the Federal Register
Office for publication no later than 5 working days
after a premanufacture notice is received.
Under the proposed rules, the notice will include,
(subject to confidentiality claims) 3 things;
l) either the specific chemical identity, or — if
that is claimed confidential — the proposed generic
name; 2) the proposed uses of the substance, and esti-
mates of human exposure and environmental release; and
3) a summary and description of test data submitted on
the new substance.
(13) Q: WHAT TYPE OF INFORMATION WOULD BE REQUIRED ON
A PREMANUFACTURE NOTICE?
A: The following general types of information
would be requested on a premanufacture notice:
l) the specific chemical identity of the new
chemical substance;
2) the total estimated production volume;
3) a description of the manufacturing and pro-
cessing activities associated with the new chemical
substance;
k) proposed uses, including estimated production
volumes for each use;
5) methods of distribution and disposal, includ-
ing estimated volumes for each method;
6) a description of human exposure and environ-
mental release of the new substance;
-------
7) information concerning related chemical substances
and mixtures— including feedstocks, byproducts or
intermediates related to the manufacture or process-
ing of the new substance.
Q: WOULD MY ADDITIONAL INFORMATION, OTHER THAW
THAT ASKED FOR ON THE NOTICE FORM, HAVE TO BE SUB-
MITTED UNDER THE PREMANUFACTURE NOTIFICATION
REQUIREMENTS?
A: TSCA requires that you attach to the pre-
manufacture notice form any test data in your posses-
sion or control— as well as, descriptions or other
data you know about — concerning the environmental
and health effects of the new substance.
_EPA has proposed that studies, concerning the
new chemical substance, which are published in certain
periodicals (listed in the appendix of the proposed
PMN regulation) need only to be described with a stan-
dard literature citation.
In addition, health and environmental effects
data previously submitted to EPA or another government
agency would not have to be resubmitted with a pre-
manufacture notice. Instead, you could provide with
your notice: the Agency and the office or person the
information was given to, on what date, and, if appro-
priate, a standard literature citation.
(15) Q: WHAT IS THE PROPOSED FORMAT OF THE PREMANU-
FACTURE FORM?
A: The proposed premanufacture notice form has 3
parts. Part I and II are mandatory; the information
in these two portions of the notice must be provided
to the extend it is known or reasonably ascertainable.
Part III 4s optional; the information asked for in this
section may^or may not be provided.
\ Part I .would require information on the manu-
facturer's identification, the chemical's identity,
-------
certain marketing data, a schematic diagram of the
manufacturing and processing activities the sub-
mitter intends to conduct.
Part II would require information a"bout risk
assessment; actual information you have concerning
the chemical's properties, characteristics, and effects
data. This also asks for data on human exposure and
environmental release.
Part III of the proposed form is optional. It
concerns risk analysis and optional data about expo-
sure safegaurds, as well as, information on economic
factors and benefits of the chemical substance. In
other words, the Agency is asking you here to volun-
tarily provide information, such as what your company
has done, or plans to do, to protect against exposure
to the chemical.
(l6) Q: WOULD THE PROCESSORS. USERS (I.E.. CUSTOMERS)
AND FOREIGN SUPPLIERS/MANUFACTURERS (OF U.S. IMPORTERS)
BE ASKED TO COMPLETE ANY INFORMATION FOR THE DOMESTIC
PMN SUBMITTERS (MANUFACTURERS OR IMPORTERS)T
A: Domestic manufacturers and importers, in
addition to completing the required PMN notice form,
must send a separate "Processing and Consumer Use"
form to their customers. This form requests similar
information to that in part II of the PMN Notice Form.
Importers must also send a separate form to
their foreign manufacturers and suppliers. This form
requests information similar to that in Sections I and
II of the PMN Notice Form.
Completion of these forms (by the processor,
user, foreign supplier/manufacturer) is optional. They
may return the forms directly to EPA with the infor-
mation claimed confidential.
(IT) Q: COULD U.S. MANUFACTURERS AND IMPORTERS MAKE
CONFIDENTIALITY CLAIMS FOR THE INFORMATION SUBMITTED
WITH PREMANUFACTURE NOTICES?
-------
A: You may claim any information confidential,
in whole or in part, which you submit on or with a
premanufacture notice. Confidentiality claims must
be made at the same time the notice form is filled
out. On the proposed forms a. check mark is to be
put in the box provided, in the left-hand margin ad-
jacent to each information entry you want claimed
confidential.
In addition to putting check marks next to
•information claimed confidential, you will also
have to provide certain substantiation for some
types of claims including those for chemical ident-
ity and health and safety data.
(18) Q: HOW ARE CONFIDENTIALITY CLAIMS PROPOSED TO BE
MADE ON SEPARATE DOCUMENTS (E.G., HEALTH AND SAFETY
DATA) SUBMITTED WITH PREMANUFACTURE NOTICE FORMS?
A: Under the proposed rules, if you submit a
separate document with your premanufacture notice
form and you want to make confidentiality clai.ms for
data included in it, you must submit two copies of
the document to EPA.
One copy must be submitted with the information,
you want to be kept confidential, marked clearly with
a label — such as, "confidential", "proprietary", or
"trade secret". This is to be done for every appro-
priate page. On the second copy, the portions stamped
"confidential" on the first copy, are to be left blank;
all other information is to be included. EPA would
place the second copy in the public file.
(19) Q: COULD EPA ASK YOU TO CORRECT SOMETHING ON A
PREMANUFACTURE NOTICE FORM?
A: Under the proposed rules, the Agency could
notify you by certified mail, of minor deficiencies
on a notice form, which need to be corrected. The
minor deficiencies needing correction would include:
no date on the form; typographical errors which make
-------
information unclear or ambiguous; confusing responses;
or ansvers not conforming to the notice instructions.
EPA has proposed that the premanufacture notice
period will be suspended from the date the Agency sends
the letter requesting corrections, until the date
the Agency receives the corrections. If the corrections
are not received within 30 days, EPA may determine the
submitted notice invalid.
(20) Q: COULD EPA DECLARE A PREMANUFACTURE NOTICE
INVALID FOR AMY REASON?
A: According to the proposed regulations, the
Agency could determine a notice is invalid, at any
time during the notification period, based on one or
more of the following grounds:
l) failure to sign the form;
2) failure to comply with the procedure for
obtaining information from other people (for importers,
this includes foreign manufacturers or suppliers);
3) failure to provide information on the form,
which is known or reasonably ascertainable, and which
is not clearly indicated as optional (if you can't
answer something on the form, indicate that it is
"unknown" or "not applicable");
k) failure of a form being submitted by the
specific person, or their designated agent, intending
to manufacture or import the substance;
5) failure to describe or submit any known or
possessed test data concerning the chemical;
6) failure to include the specific chemical
identity;
T) failure to return form corrections, requested
by EPA, to the Agency within 30 days;
8) if EPA discovers (even after the 90-day
notification period has expfred) that someone
intentionally submitted false or misleading statements
on a notice form. (That notice will be declared
invalid from the time of its initial submission.
The person submitting the false information will
then be in violation of the law if he manufactures,
imports, processes, or distributes into commerce
the substance named in the notice from declared
invalid. )
10
-------
(21; y: COULD THE PREMANUFAGTURE NOTIFICATION PERIOD
EVER BEE LONGER THAN 90 DAYS?
A: Under the law (TSCA), EPA can extend for a
"good cause" the premanufacture notification review
period beyond 90 days. The proposed regulations include
these examples of "good cause" for extension:
l) after reviewing a submitted notice, the Agency
believes the substance should be regulated because it
may present an unreasonable risk, but additional time
is needed to take regulatory action: 2) after re-
veiwing a notice, EPA decides to obtain more infor-
mation on the chemicals; 3) based on priorities and
resources, within the Agency, the notice cannot be re-
viewed and processed in the initial 90-day time frame.
(22) Q: WHAT IS THE LONGEST LENGTH OF TIME A PREMANU-
FACTURE NOTIFICATION PERIOD COULD BE?
A: The initial extension may be 90-days or less.
If it is less, there may be additional extensions; but
the sum total of extension days allowed is 90. In other
words, the longest a notification review perios can possi-
bly be is l80 days(not counting supensions or time lost
for invalid notices")^
EPA must notify the submitter by certified mail of
the extension and the reasons for it. This informatioD
must also be published in the Federal Register.
(23) Q: HOW COULD YOU KEEP TRACK OF THE STATUS OF PRE-
MANUFACTURE NOTICES(NEW SUBMISSIONS, APPROVED SUBMISSIONS,
ETC.)?
A: EPA is required, under TSCA, to publish in the
Federal Register at the beginnning of each month, a status
report of premanufacture notices. The monthly report is to
include: l) each chemical for which a premanufacture notice
has been received, and for which the notification period
has not ended; 2) each chemical for which the notification
period has ended, since the preceeding month's Federal
Register report; 3) and, each chemical which has been add-
ed to the Inventory, since the last month's publication.
92k) Q: AFTER GOING THROUGH PREMANUFACTURE. WOULD YOU HAVE
TO DO ANYTHING ELSE BEFORE STARTING TO MANUFACTURE OR IMT
PORT THE NEW SUBSTANCE?~
A: One last thing, the-day you begin to manufacture or
import the chemical for commercial purposes, the proposed
-------
regulations require that you would submit to
EPA a "Notification of Commencement
df Manufacture or Import". This form would be
sent to you with your premanufacture form and
instructions.
The Notice would then alert the Agency to the
actual start of commercial manufacture or import
into the U.S. of the chemical substance. It would
include a reference to the relevant premanufacture
notification form, and you would also have to certify
on it that all confidential substantiations of the
chemical identity are still accurate.
(25) Q: WHERE ARE WRITTEN COMMENTS ON THE PROPOSED
PREMANUFACTURE NOTIFICATION REGULATIONS. PUBLISHED
IN THE JANUARY 10. 1979 FEDERAL REGISTER, TO BE
SUBMITTED?
A: Send written comments concerning these
proposed regulations and notice forms, postmarked
no later than March 26, 1979, to: Document Control
Officer (TS-793); Office of Toxic Substances, U.S.
EPA; kOI "M" St., S.W.; Washington, D.C. 20U60.
Also, all written comments should have the control
number. OTS-050002, on them.
(26) Q: IS EPA CONDUCTING ANY PUBLIC MEETINGS ON
THE PROPOSED PREMANUFACTURE NOTIFICATION REGULATIONS?
A: EPA has scheduled the following public
meetings on these proposed rules and forms during
the official comment period: January 31 - Atlanta,
Ga. (Sheraton Atlanta, 590 West Peachtree, N.W.);
February 1 - Dallas, Tex. (EPA Conference Room,
1st International Bldg., 1201 Elm St.); February 2 -
Los Angeles, Ca. (Wilshire Hyatt House, 3535 Wilshire
Blvd.); February 6 - Chicago. 111. (Hyatt Regency
Chicago, 151 East Wacker Dr.); February 7 - Cleveland,
Oh. (Stouffer's Somerset Inn, 3550 Northfield Rd.);
February 8 - Newark, N.J. (Hilton Gateway, 8lO
McCarter Highway); February 13 - Washington, D.C.
12
-------
(North Bldg. Auditorium, Dept. of Health, Education,
and Welfare, 330 Independence Ave. , S.W.); March 7..r
Washington, P.O. ..(same location as the February 13
meeting). Also on March 9 - New York City (Conference
Room 305C Federal Bldg. Worth & Broadway Street -,
26 Federal Plaza) EPA will hold a public meeting to
receive comment on international aspects of the pro-
posed rules and forms.
All meetings will begin at 9:00 a.m. and end at
U:30 p.m. The meetings will start with a short
summary by EPA of the proposed rules and notice forms,
to be followed by oral presentations from the floor.
Persons who wish to present oral comments at
any one of the meetings should contact EPA, no
later than H days before the meeting date, by
calling D.G. Banne.rman toll free at 800-^2k-9Q6^
(in Washington, D.C., call 55^-1^0^), or by writing
to: John B. Bitch, Jr., Director, Industry Assistance
Office, Office of Toxic Substances (TS-799), U.S.
EPA, U01 "M" St., S.W., Washington, B.C. 20n60.
(27) Q: IS THERE SOMEONE TO CONTACT FOR FURTHER
INFORMATION OR TO GET A
COPY OF THE PROPOSED
PREMANUFACTURE NOTIFICATION REGULATIONS?
rrr
rH
Ctf
P CU
G 0
0) -H
G 4-1
0 0
in
ef, G O
r- W G
^ CO i=C
0 (1)
«^> -P G
in (0 O
-P-H
< CO -P
fli O
CD -P
Q -P O
H--H in
I"O C P4
H £3
i— 1
0
}-l
-P
G
n
o
nces
F^ ,2 ^"^
= s -1 S Q 2
°- -i2 T5 S c §
^ w .S3 to 0 CM
t— oJ E S OICM"
ijj tf 5 ° "-c SI.
H^ "r~ i J;^
O a> Q! ^
> 2> o
Z Q-
ui ^
• o
O
------- |