f/EPA
           United States
           Environmental Protection
           Agency
           Uttice ot
           Toxic Substances
           Washington DC 20460
June 1984
Volume 1
Number 1
Chemical Control
in the United States:

Accomplishments
under the
Premanufacture Notice
Management Program
             CH
         CH
             CH

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JUNE 1984
              CHEMICAL CONTROL IN THE  UNITED STATES)




                       ACCOMPLISHMENTS UNDER




                     THE PREMANUFACTURE NOTICE




                         MANAGEMENT PROGRAM
                     OFFICE OF TOXIC SUBSTANCES




               U.S.  ENVIRONMENTAL PROTECTION  AGENCY

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                   ACKNOWLEDGMENTS
Wendy Cleland-Hamnett



Rebecca Torchia



Alison Kerester



Jon Silberman



Breck Milroy



Carl Mazza



James Nelson



Richard Green



R. James Alwood



Rose Allison



Lynda Garland
Joseph Boyle



Stephanie Roan



Anna Coutlakis



Daniel Dickson



Mary Cushmac



Robert Jones



Paul Matthai



June Thompson



Melvin Quick



Jane Talarico



David Bottimore
Cover design by Paul Bickart, Ph.D., Office of Toxic Substances

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                        TABLE OF CONTENTS

                                                         Page

Introduction	 i

Preface 	 iii

Overview of PMN Program Action	 1

A.  Formal Regulatory Actions Under TSCA, Section 5

    1.  Section 5(f) Rules	 3
    2.  Unilateral Section 5(e) Orders	 7
    3.  Section 5(e) Consent Orders	 13
    4.  Modifications of Section 5(e) Orders	 21

B.  Informal Regulatory Actions Under TSCA, Section 5

    1.  Voluntary Testing	 25
    2.  Voluntary Controls	 37

C.  Withdrawal of PMNs

    1.  Prior to Likely Section 5(e) Action	 49
    2.  Prior to Likely Section 5(f) Action	 61
                          LIST OF TABLES

    1.  Annual Compilation of PMN Program Actions	67

    2.  Percentage of Commencement of Manufacture Notices
        Received	 68

    3.  Annual Compilation of PMN Program Activities
        FY 1980 - FY 1984	 69

    4.  Historical Compilation of Specific Concerns
        Underlying Formal and Informal Regulatory
        Actions Domestic U.S. Import Chemicals	74

    5.  Fiscal Year Graph of Valid PMNs Received	 75

    6.  Comparison of Domestic vs.
        Imported PMNs Received	 75

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                           INTRODUCTION



     In recent years, many nations have instituted programs to

review the hazards presented by chemical substances before they

are introduced into commerce.  Under these programs the hazards

of such chemicals can be controlled before harm to human health

or the environment occurs.

     These national programs have been assisted in their

development by the work of the Organization for Economic Co-

operation and Development  (OECD) which has conducted an active

program in promoting common approaches to chemical control within

member nations.  Among the objectives of the OECD Chemicals

Program is the exchange of information and experience gained in

the implementation of national programs.

     This report provides the first annual summary of actions

taken under the United States new chemical program which is

mandated by the Toxic Substances Control Act (TSCA).  EPA

believes that the dissemination of such information

internationally will assist in developing better understanding of

the U.S. new chemical program and may be of use to other nations

involved in similar programs.
                                         Don R. Clay,  Director
                                         Office of Toxic  Substances
                               -i-

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                             PREFACE

     In authorizing the Toxic Substances Control Act  (TSCA),  (15
USC 2601 et seq.), Congress recognized that health and
environmental considerations are more easily addressed before,
rather than after, a chemical is manufactured and introduced  into
commerce.  Section 5 of TSCA mandates the Environmental
Protection Agency (EPA) to review the potential effects of new
chemicals prior to manufacture or import.  For purposes of this
premanufacture review, any chemical not included in the TSCA
Inventory of Chemical Substances, is considered "new".  The
Inventory is regularly updated by the Agency to include newly
manufactured or imported chemicals.  In addition, TSCA authorizes
premanufacture review of "significant new uses" of existing
chemicals, as may be defined by rule at the discretion of the EPA
Administrator.

     In either instance, manufacturers and importers  are required
to submit to EPA 90-day advance notification of intent to
manufacture, process, or import a new chemical substance, or  an
existing chemical substance for a designated significant new
use.  The Administrator may, for good cause, extend the 90-day
premanufacture review period for an additional 90 days.

     In order to meet the statutory mandate of TSCA Section 5,
the Agency has developed the Premanufacture Notice (PMN) Review
Program.  The purpose of the Program is to determine, before  a
new chemical enters commerce, whether proposed uses of the PMN
substance may result in an unreasonable risk of injury to health
or the environment.  To enable EPA to conduct its review, PMN
submitters must include the following information:  the name  of
the chemical, its chemical identity, and molecular structure;
proposed categories of use; an estimate of the amount to be
manufactured; the by-products resulting from the manufacture,
processing, and disposal of the chemical; exposure and release
information; and any test data in the manufacturer's possession
related to health and environmental effects.

     In addition, if a rule requiring testing of the  chemical has
been promulgated under TSCA section 4, the manufacturer must
conduct the testing before submitting the notice and must submit
data developed from that testing.  With respect to chemicals
subject to such testing rules, the Administrator must either
initiate regulatory action under TSCA sections 5, 6, or 7, or
publish in the FEDERAL REGISTER a statement of reasons such
regulatory action is not being initiated.  The same requirement
applies to chemicals previously listed by the Administrator under
TSCA section 5(b)(4) as potentially presenting an unreasonable
risk,  and to any use that has been designated by rule under TSCA
section 5(a)(2) as a significant new use.
                              -111-

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     Since the beginning of its program, July 1979, EPA has
received and reviewed increasing numbers of PMNs each fiscal year
(FY) [NOTE:  A fiscal year begins on October 1st of the preceding
calendar year.]  In FY 1983, for example, 1301 PMNs were
received, as compared with 281 in FY 1980.  Most PMNs reviewed do
not warrant regulatory action.  In many cases however, the Agency
has taken measures to obtain additional data from submitters or
has acted to control exposure to substances which are suspected
of presenting  an undue hazard.  Some of these measures include
formal regulatory actions, such as TSCA section 5(e) orders;
other informal measures involve negotiations with PMN submitters
and include voluntary testing or controls.

     This report, the first of an ongoing series of annual PMN
program activity reports, represents a complete compilation of
major actions  taken by the Agency in response to PMN
submissions.   it provides an overview of completed actions, both
formal and informal, from the inception of  the PMN program
through June 30, 1984.  In addition, a tabular breakdown is
provided of particular toxicity concerns raised by PMN reviews,
with reference to the exposed populations of concern.  This
overview is supplemented by detailed information on  individual
PMNs.

     Questions or comments on this report should be directed to
Margaret Stasikowski, Director, Chemical Control Division  (TS-
794), Environmental Protection Agency,  401  M  Street,  S.W.,
Washington, D.C.  20460.  For additional copies of this report—

    Write:  TSCA Assistance Office
        Office of Toxic Substances
         (TS-799)
        U.S.  Environmental  Protection  Agency
        401 M  Street, S.W.
        Washington,  D.C.   20460

    Call:  Toll Free 800-424-9065
         In Washington,  D.C.   202-554-1404
                               -iv-

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              OVERVIEW OF PMN REVIEW PROGRAM ACTION

     In the event that potential health or environmental concerns
are identified during premanufacture review, EPA may find that
additional data are necessary to determine whether proposed uses
of a chemical will present an unreasonable risk of injury to
health or the environment.  In such cases, the Agency may
prohibit or limit manufacture of the chemical under TSCA §5(e)
pending development, by the submitter, of the necessary data.  In
some circumstances, the Agency may permit production with certain
conditions, such as the use of protective equipment and/or
engineering controls pending development of such test data, and
may negotiate such protective measures with the PMN submitter.
When serious health or ecological effects are indicated by
existing data, the Agency may simply prohibit the manufacture,
processing, or use of the substance or otherwise limit such
activities under the provisions of TSCA §5(f).  Alternatively,
the Agency may pursue informal courses of action through
negotiations with PMN submitters to obtain additional test data
or appropriate limitations on manufacture, processing,
distribution in commerce, use, or disposal.

     Sections A and B below briefly describe the various formal
and informal mechanisms by which EPA may address concerns raised
during premanufacture review.  Formal actions under TSCA are
discussed in order of decreasing regulatory stringency, beginning
with section 5(f) orders.  Section C discusses a third possible
outcome of concerns raised during premanufacture review:
withdrawal by the submitter of the PMN from the review process.

A.  Formal Section 5 Regulatory Actions

    1.  Section 5(f) Orders or Rules.  Under TSCA section 5(f),
        the Agency may issue a proposed order prohibiting the
        activities described in the PMN if it finds that there is
        a reasonable basis to conclude that the PMN substance
        will present an unreasonable risk of injury to human
        health or the environment.  Alternatively, EPA may, upon
        the same finding, issue a proposed rule limiting the
        activities described in the PMN.  Such a proposed rule is
        effective immediately upon its publication in the FEDERAL
        REGISTER.

    2.  Unilateral Section 5(e) Orders.  EPA may issue a proposed
        section 5(e) Order if the Agency determines that, 1)  the
        information available is insufficient to permit a
        reasoned evaluation of the health and environmental
        effects of the PMN substance, and 2)  in the absence of
        such information, the activities described in the PMN may
        present an unreasonable risk, or 3)  that the substance
        is or will be produced in substantial quantities, and
        either enters or may enter the environment in substantial
        quantities or may result in significant or substantial


                               —l —

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        human exposure.  The terms of the order can prohibit or
        limit the manufacture, processing, distribution in
        commerce, use, or disposal of the substance.

    3.  Section 5(e) Consent Orders.  Section 5(e) Consent Orders
        are mutuallyagreed upon by the PMN submitter and EPA,
        and require the same findings as those for a Unilateral
        Order described above.  They specify requirements to
        limit exposure or environmental release, and sometimes
        reflect negotiated testing.

B.  Informal Regulatory Actions Under Section 5

    1.  Voluntary Testing.  EPA frequently  identifies a potential
        unreasonable risk concern that can  be addressed through
        testing the substance.  In such cases, the submitter may
        request a suspension of the notice  review period and
        voluntarily test the PMN substance  using a mutually
        agreed upon protocol.  EPA then evaluates the test
        results to determine whether the data nullify or confirm
        the Agency's concern.  The significance of the risk would
        determine whether additional regulatory action is
        necessary.

    2.  Voluntary Controls.  Occasionally,  EPA identifies a
        potentially unreasonable risk with  respect to one or more
        of the activities described in the  PMN that can be
        readily addressed through some form of voluntary
        control.  Such controls may involve limiting the
        manufacture of the substance to one physical form,
        modifying the labeling or Material  Safety Data Sheet
        (MSDS) to inform potentially exposed persons of the
        concern, or other measures.  In these cases, the Agency
        and the PMN submitter may agree to  amend the original PMN
        so that controls are specified that resolve EPA's
        concerns.  EPA would then take no formal regulatory
        action against the substance under  TSCA section 5 for the
        activities described in the amended PMN.  EPA has
        restricted use of voluntary controls to certain
        situations where enforceable controls are not warranted.

C.  Withdrawal of PMNs
    A PMN submitter may withdraw  a  PMN  from  review  at any time.
    Certain PMN submitters have chosen  to do this when  EPA has
    identified potential unreasonable risks  with respect to the
    activities described in the PMN.  EPA would otherwise address
    such risk through either an informal or  formal  regulatory
    action.  Once a PMN is withdrawn, the manufacturer or
    importer must submit another  notice, which is subject to
    another 90-day review period, before manufacture or import
    can begin.
                               -2-

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PART A.  FORMAL  REGULATORY ACTIONS
      1.  SECTION 5(£)  RULES
                -3-

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                        SECTION 5(f)  RULES
P83-1005, 83-1062           IMPORT


Chemical Name:  P83-1005 - Polycarboxylic Acid, Alkanolamine Salt

Chemical Name:  P83-1062 - Polycarboxylic Acid

     Concerns were raised for potential carcinogenicity during
product use for workers from the addition of nitrites to the PMN
substance.  EPA issued a section 6(a) rule under TSCA, made
immediately effective under section 5(f) on January 23, 1984.
The action required notification to consumers and labeling to
prevent the addition of nitrites and/or other nitrosating agents
to the substance.


84-310                      IMPORT

Chemical Name:  Amine Salt of a Substituted Organic Acid

     A section 5(f) Rule was signed on June 7, 1984 by the EPA
Administrator.  The PMN substance raised concern for
carcinogenicity associated with exposure in the workplace and
during use.   The Rule included warnings to processors and users
in the forms  of letters and labels as well as instructions to
avoid the addition of nitrates or other nitrosating agents.
                               -5-

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PART A.  FORMAL REGULATORY ACTIONS
2.  Unilateral Section 5(e) Orders
                -7-

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                  UNILATERAL SECTION 5(e)  ORDERS
P79-21, 22, 23, 24, 25, 26  DOMESTIC

Chemical Name:  P79-21 - Polymer of Phthalic Anhydride, Ethylene
                  Glycol, Heptanol, and 2-Ethylhexanol

                P79-22 - Polymer of Phthalic Anhydride, 1,2-
                  Propylene Glycol, 1,4-Butanediol, 1-Octanol,
                  and 1-Decanol

                P79-23 - Polymer of Phthalic Anhydride, Ethylene
                  Glycol, Heptanol, 1-Octanol, and 1-Decanol

                P79-24 - Polymer of Phthalic Anhydride, 1,2-
                  Butanediol, and 2-Ethylhexanol

                P79-25 - Polymer of Phthalic Anhydride, 1,3-
                  Butylene Glycol, 1-Octanol, 1-Decanol

                P79-26 - Polymer of Phthalic Anhydride, 1,3-
                  Butylene Glycol, and 2-Ethylhexanol

     Additional information associated with these PMN substances
was required by the Agency to properly address potential
carcinogenicity concerns if workers are exposed during
manufacture and processing.  Aquatic toxicity was another concern
related to these chemicals.  Manufacture of the PMN substance was
prohibited on April 25, 1980 pending submission of additional
information to address these concerns.  These chemicals were
subsequently withdrawn with no further testing data submitted.
P80-35
DOMESTIC
Chemical Name:  Substituted Phenol, reactive products with
                  C22-30 Alkenes

     Concerns were raised for potential dermal sensitization if
workers are exposed during manufacture and processing, and if
consumers are exposed during use of the final product.  EPA
issued a Unilateral section 5(e) Order on September 5, 1980 which
prohibited manufacture of the PMN substance pending submission of
additional information to address the noted concerns.
                               -9-

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                 UNILATERAL  SECTION  5(e)  ORDERS
P80-356, 357                IMPORT

Chemical Name:  P80-356 - Benzole Acid, 2-[[2-Amino-5-Hydroxy-6-
                  [[4'-[[l-Hydroxy-8-[ [4-
                  Methylphenyl)Sulfonyl]Ami no]-3,6-Disulfo-2-
                  Naphthalenyl]  Azo]-3,3'-Dimethoxy[1,1'-
                  Biphenyl]-4-yl]Azo]-7-Sulfo-l-Naphthalenyl]
                  Azo-5-Nitro-,  Trisodium Salt

                P80-357 - Benzoic Acid, 2-[[2-Amino-6-[[4'-[2,5-
                  Disulfophenyl Azo]-l-Hydroxy-6-(Phenylamino)-3-
                  Sulfo-2-Naphthalenyl]Azo]-3,3'-Dimethoxy[1, 1'-
                  Biphenyl]-4-yl] Azo]-5-Hydroxy-7-Sulfo-l-
                  Naphthalenyl]-Azo]-5-Nitro-,Tetrasodium Salt

     A Unilateral section 5(e) Order was issued on October  9,
1981.  The action prohibited importation of the substances
pending submission of test data to address the Agency's
carcinogenicity concerns of  workers exposed during processing as
well as of the general public exposed by contaminated drinking
water.  The Company chose to withdraw the chemicals.
P82-678, 679                IMPORT

Chemical Name:  P82-678 - Chlorinated Aromatic Azo
                  Anthraquinone Pigment

                P82-679 - Chlorinated Aromatic Azo Pigment

     An in vitro test protocol submitted by the Company was found
to be inadequate by the Agency to address carcinogenicity
concerns.  Therefore a Unilateral section 5(e) Order was
issued.  The Order recommends in vivo metabolism or other
appropriate testing of these chemicals.  The Company declined to
conduct an in vivo test and withdrew the PMNs.
                              -10-

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                  UNILATERAL SECTION 5(e)  ORDERS
P83-401, 418                IMPORT

Chemical Name:  P83-401 - Naphthalene Trisulfonic Acid,
                  Chlorotriaziny1amino-MethoxymethyIphenylazo

                P83-418 - Benzene Disulfonic Acid,
                  Chlorotriazinylamino Dimethyl Phenylazo-
                  Sulfonaphthalene Azo

     This Unilateral section 5(e) Order was delivered to the
submitter; however, a suspension was granted during the comment
period so that the submitter could address carcinogenicity
concerns associated with exposure to workers and to the general
public via contaminated drinking water.
P83-663                     IMPORT

Chemical Name:  Alkyl-substituted Aromatic Amine

     EPA prohibited importation of the PMN substance pending
submission of additional information to address carcinogenicity
concerns.  The Unilateral section 5(e) Order was issued on
November 16, 1983 to protect workers exposed during processing
and use.  The PMN was subsequently withdrawn.
                               -11-

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PART A.  FORMAL REGULATORY ACTIONS
  3.   SECTION  5(e)  CONSENT ORDERS
               -13-

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                   SECTION 5(e) CONSENT ORDERS
P82-400, 409                DOMESTIC

Chemical Name:  P82-400 - Potassium N, N-bis  (Hydroxyethyl)
                  Cocoamine Oxide Phosphate

                P82-409 - Potassium N, N-bis  (Hydroxyethyl)
                  Tallow Amine Oxide Phosphate

     The Company and EPA signed a section 5(e) Consent Order
limiting production of the chemicals to non-consumer use.  This
Order prohibits the Company from processing and distributing the
PMN chemicals to consumer product formulators pending further
testing at concentrations in formulations which would be
representative of consumer products.  A Significant New Use Rule
(SNUR) is now being prepared which will require any person to
submit a new PMN to the Agency for any consumer use of these
chemicals.  For this particular case, as soon as the SNUR is
promulgated, the 5(e) Consent Order will be automatically
revoked.
P82-684                     DOMESTIC

Chemical Name:  Halogenated Hydrocarbon

     A section 5(e) Consent Order was negotiated with the Company
following concern for potentially significant carcinogenic risks
to workers during manufacture and processing of the PMN
substance.  The Order established controls during portions of
manufacture and processing of the chemical.
                               -15-

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                    SECTION  5(e)  CONSENT ORDERS




 P83-23,  24,  49,  75,  272      DOMESTIC

 Chemical Name:   P83-23 -  Substituted  Phenol

                 P83-24 -  Substituted  Pyridine

                 P83-49 -  Substituted  Pyridine
                                                        I
                 P83-75 -  Sodium  2-substituted  Propanoate

                 P83-272 - Substituted Pyridine

 This  section 5(e) Consent Order  of  March  9,  1983  requires  use  of
 dermal protection for all of the substances, and  positive
 pressure,  full facepiece  air-supplied respirators for  two  of the
 chemicals, pending  information sufficient  to assess  the risks
 posed.   Concerns arose for  liver and  kidney  toxicity,  and  central
 nervous  system depression if workers  are exposed  during
 manufacture  and processing.


 P83-129  through 235         DOMESTIC

 Chemical  Name:  Syncrude  (Full range  dewaxed dearsinated Shale
                  Oil)

     A section 5(e) Consent Order was drafted  to  address
 carcinogenicity concerns associated with these synfuels and their
 potentially  hazardous wastes.  It requires the Company to  use
 special worker protection equipment during the upgrading process,
 as well as placing stringent controls on hazardous solid
 wastes.   The Order went into effect on  May 25, 1983.


 P83-237                     DOMESTIC


 Chemical Name:  Substituted Pyridine

     On April 4,  1983, a section 5(e)  Consent  Order  was signed by
the Agency.  The  Order requires the use of safety equipment and
processing controls at manufacture  and  processing sites.   These
actions were taken because of concerns  for potential liver and
kidney effects to workers.
                               -16-

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                   SECTION 5(e) CONSENT ORDERS
P83-255                      IMPORT

Chemical Name:  Dicarboxylic Acid Monoester

     The Agency was concerned about worker exposure during
processing, the use of the PMN substance, and the substance's
potential teratogenicity and reproductive effects.  The section
5(e) Consent Order, requiring worker protective equipment and
labeling, was signed April 8, 1983.


P83-370                      IMPORT

Chemical Name:  8-Acetyl-3-Dodecyl-7,7,9,9-Tetramethyl-l,3,8-
                  Triazaspiro [4,5] Decane-2,4-Dione

     Based on test data submitted with the PMN, both the Agency
and the Company concluded that the PMN substance is a strong skin
sensitizer.  As a result, a section 5(e) Consent Order was
negotiated with the Company.  This Order prohibits domestic
manufacture of the substance and requires that workers at sites
controlled by the submitter use protective equipment during
processing activities.  It also requires that a precautionary
label be affixed to all containers of  the substance that are
distributed, and imposes certain recordkeeping requirements.


P83-394                     DOMESTIC

Chemical Name:  Polyglycidyl Amine

     Concerns were raised for potential carcinogenicity,
reproductive effects, liver and kidney effects, and skin and eye
irritation if workers are exposed during manufacture and
processing.  EPA issued a section 5(e) Consent Order requiring
protective equipment during manufacture and processing, and
labeling.


P83-434                     DOMESTIC

Chemical Name:  Unsaturated Aliphatic  Diether

     Concerns were raised for potential carcinogenicity if
workers are exposed during manufacture and processing.  EPA
issued a section 5(e) Consent Order requiring the use of gloves
and ventilated laboratory bench hoods  during manufacture and
processing.


                              -17-

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                   SECTION 5(6) CONSENT ORDERS
P83-603                     DOMESTIC

Chemical Name:  Substituted Nitrile

     This section 5(e) Consent Order places restrictions on
manufacture and release of the PMN substance pending development
of neurotoxicity and aquatic toxicity data.  The Company
submitted test data for aquatic toxicity and a 28-day
neurotoxicity study.  A modification of the Consent Order was
issued in May extending the production period through November
1984, pending evaluation of submitted data.  A further
modification has been recommended to permit releases of aqueous
waste under specified conditions.  [See also Part A.4.]


P83-769                     DOMESTIC
Chemical Name:  Disubstituted Heterocycle

     Protective dust masks were the requirements of the section
5(e) Consent Order which was promulgated to address
carcinogenicity concerns if workers are exposed via inhalation
during manufacture.  The Order went into effect on November 8,
1983.
P83-822                     DOMESTIC

Chemical Name:  Trisubstituted Aniline

     Concerns were raised for potential carcinogenicity to
workers who are exposed during manufacture and processing.   EPA
issued a section 5(e) Consent Order in February 1984 requiring
use of impervious gloves during manufacture and special packaging
and labeling for processing.  The substance is only allowed  to be
manufactured and processed for one specific use and cannot be
distributed outside the Company.
                               -18-

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                   SECTION 5(6) CONSENT ORDERS
P83-906, 908, 909, 910      DOMESTIC

Chemical Name:  P83-906 - Brominated Aryl Alkyl Ether

                P83-908 - Ethylated Amino Phenol

                P83-909 - Amino Phenol

                P83-910 - Anilino Ether

     Potential teratogenicity and carcinogenicity to workers who
are exposed during manufacture were the concerns which convinced
the Agency to enact a section 5(e) Consent Order for these
PMNs.  Long sleeved protective gloves were the requirement of the
Order, which took effect in November 1983.


P83-1023                    DOMESTIC
Chemical Name:  Alkyl Aryl Phosphine

     A section 5(e) Consent Order was issued in January 1984
which requires the use of air-supplied respirators and protective
clothing at both the manufacturing and customer processing sites,
pending development of test information to address neurotoxicity
concerns.  The Company is required to submit neurotoxicity test
data before or at the time a specified production volume  is
reached.
P83-1085                     IMPORT

Chemical Name:  Substituted  Phenylacetamide

     A section 5(e) Consent  Order requiring full-face shield and
long-sleeved protective gloves became effective on December 8,
1983.  These restrictions were required  in order to reduce worker
exposure to possible carcinogens.
                               -19-

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                   SECTION 5(6) CONSENT ORDERS
84-27                       DOMESTIC

Chemical Name:  Polyol Carboxylate Ester

     On April 9, 1984, a section 5(e) Consent Order was signed by
the Agency.  The Order, brought about by carcinogenicity
concerns, places certain restrictions on the manufacturing,
processing, distribution in commerce, use and disposal of the
substance, including a requirement that, as a condition of
distribution the Company must notify, in writing, each person to
whom it distributes the PMN substance, of the requirements of the
Order.  This written notification must also be accompanied by a
Material Safety Data Sheet (MSDS).   [See Also Part A.4.]


84-105,106,107              DOMESTIC

Chemical Name:  P84-105 Halogenated Alkene

                P84-106 Halogenated Alkane

                P84-107 Halogenated Alkane

     A section 5(e) Consent Order was signed by the Agency on
June 13, 1984 requiring the use of appropriate protective
equipment and adequate ventilation in the workplace.  Concerns
raised were for dermal and inhalation exposure to unprotected
workers.  The Order took effect June 19, 1984.
84-176, 180 through 184     DOMESTIC

Chemical Name:  P84-176 Aliphatic Triol Ester Methacrylate

                P84-180 Polyether Acrylate Ester

                P84-181 Aliphatic Acrylate Ester

                P84-182 Polyether Acrylate

                P84-183 Aliphatic Ester Methacrylate

                P84-184 Aliphatic Ester Methacrylate

     The submitter and EPA agreed to the terms of a section 5(e)
Consent Order.  The Order was signed in May 1984 and addressed
carcinogenicity concerns associated with workers if exposed
during manufacture, processing and use.  The restrictions became
effective in June 1984.
                              -20-

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   PART A.  FORMAL REGULATORY ACTIONS
4.  MODIFICATIONS OF SECTION 5(e)  ORDERS
                  -21-

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              SECTION 5(e)  ORDERS WITH MODIFICATIONS
83-603                      DOMESTIC

Chemical Name:  Substituted Nitrile

     Concern for health and environmental effects brought about a
section 5(e) Consent Order on this chemical.  The Order was
modified on May 25, 1984.  The modification prohibits manufacture
and processing of the PMN substance after November 30, 1984.  A
further modification addressing treatment and release will be
required on or before that date.   [See also Part A.3.]


84-27                       DOMESTIC
Chemical Name:  Polyol Carboxylate Ester

     On April 18, 1984, the Company petitioned EPA for
modification of the Material Safety Data Sheet (MSDS) because the
specific physical, chemical, and toxicity test results contained
in the MSDS may not be applicable to formulated products
containing the PMN substance that the Company distributes to its
customers.  They requested that the language in a portion of the
Consent Order be modified to require only that the Company
provide its customers with an MSDS which contains, at a minimum,
health hazard data and industrial hygiene information which were
modified in response to Agency concerns.  EPA concluded the
change was appropriate and consistent with the purpose of the
Consent Order.  [See also Part A.3.]
                               -23-

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PART B.  INFORMAL  REGULATORY ACTIONS
        1.  VOLUNTARY TESTING
                 -25-

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                        VOLUNTARY TESTING
P79-27                      DOMESTIC
Chemical Name:  Alkenyl-Trialkoxysilane

     The submitter agreed to perform an Ames Test on the PMN
substance.  The results were obtained after the 90-day notice
review period expired and found to be positive.  The Company
agreed to develop and adopt language for use on warning labels
which would alert workers to possible adverse health problems
associated with the use of this substance.
P79-34                      DOMESTIC

Chemical Name:  Amido-Amine

     Skin sensitization testing was performed by the submitter to
address concerns of exposure to consumers during use.  The
results mitigated the concerns and the PMN substance was dropped
from the review process.


P80-238                     DOMESTIC

Chemical Name:  Glycerine, 1-Alkanoate, 3-Substituted Alkanoate

     This substance went  into detailed review because of concern
for extreme eye irritation during use.  The submitter performed
tests showing the chemical would not cause eye irritation as used
in the proposed formulation.  Based on the submitted test
information, the chemical was dropped from review and put into
follow-up review for other possible uses.


P8 0-267                     DOMESTIC

Chemical Name:  Substituted Phenol, Reaction Products with Sulfur
                  Chloride

     This substituted phenol was submitted for use as a lubricant
additive in later 1980.  OTS review of an analog raised concerns
for potential skin sensitization.  OTS negotiated for and quickly
obtained "use level" skin sensitization testing on the PMN
substance which revealed that the substance would not present an
unreasonable risk.  The review period was allowed to expire.
                               -27-

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                        VOLUNTARY TESTING
 P81-58,  59                   DOMESTIC

 Chemical  Name:   Phenolic Novolak  Resin

     After  EPA raised concerns about  the  chemicals  being
 potential skin sensitizers,  the submitter agreed  to perform skin
 sensitization studies.  Neither a 5(c)  extension  nor a 5(e) order
 were issued, and  the submitter provided data  within 90 days after
 the close of the  period.   The submitter affixed precautionary
 labeling  to containers of  the PMN substances  during the testing
 period.   Our review of the data indicated no  significant concerns
 regarding sensitization and  the labeling  was  removed.


 P81-310,  318, 338, 339, 340  DOMESTIC

 Chemical  Name:  Modified Phenolic Novolak Resin

     These  chemicals raised  concern for skin  sensitization.  The
 chemicals were dropped from  further review because  the submitter
 agreed to label them as skin sensitizers,  indicating the
 precautions to be taken.   The chemicals were  placed in follow-up
 review for  other  possible  uses.   Subsequently, the  submitter
 performed tests indicating the chemicals  would not  cause skin
 sensitization, and the label requirement  was  dropped.


 P81-427                      DOMESTIC

 Chemical Name:  Epoxidized Glyceride, Ether with  Polyoxyethylene

     The PMN substance was intended for a use that  would involve
 dermal exposure to the general public.  EPA had concern about
 potential dermal  irritation  and sensitization effects,  and  the
 submitter voluntarily initiated dermal  testing.   Results of the
 test were negative, removing the  concerns, and the  PMN was
 dropped.


 P81-500                      DOMESTIC

 Chemical Name:   2-Dodecyl-thiozanthen-9-one

     A subchronic dermal toxicity  test  was conducted by the
submitter to address EPA's questions concerning discrepancies and
observations in the acute tests.   EPA had potential  concerns for
chronic toxicity based on structure activity.  The  submitter
agreed  to amend the MSDS to reflect potential concern  and to
recommend special protection where applicable.


                              -28-

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                        VOLUNTARY TESTING
P81-532
DOMESTIC
Chemical Name:  Tetrafunctional Secondary Aromatic Amine

     The chemical raised concern for skin irritation and
histamine release.  A possible metabolite caused concern for
carcinogenicity, acute autonomic nervous system effects, and
liver and kidney toxicity.  Exposure was expected to be low and
the submitter performed a test that indicated the metabolite will
not form; therefore, the case was dropped from further review.


P81-558, 660                IMPORT

Chemical Name:  P81-558 - 4-Hydroxy-3-(5-(2-Hydroxysulfonyloxy)
                  Ethylsulfonyl)-2-Methoxy-Phenylazo)-7-Succinyl
                  Amino-2-Naphthalene Sulfonic Acid Disodium Salt

                P81-660 - 4-Hydroxy-3-(2-Methoxy-5-Methyl-4-(2-
                  Hydroxysulfonyloxyethylsulfonyl)Phenylazo-l-
                  Naphthalene Sulfonic Acid Disodium Salt

     Micronucleus testing results were received on the PMN
substance and the "drinking water" derivative.  The results were
reviewed and EPA found that neither substance appeared to induce
micronuclei under the conditions of the assays.  The Agency
decided that this testing adequately addressed concerns for the
chemical and thus it was dropped from review.
82-387, 388
DOMESTIC
Chemical Name:  P82-387 Phosphorodithioic Acid, O,0' Secondary
                Butyl and Isooctyl Mixed Esters

                P82-388 Phosphorodithioic Acid, 0,0' Secondary
                Butyl and Isooctyl Mixed Esters, Zinc Salt

     The PMNs raised neurotoxicity, reproductive and mutagenicity
concerns and the Company submitted reproductive and mutagenic
test data.  The Agency still had concerns and, following
extensive meetings and negotiations, it was recommended that the
PMNs be dropped and referred to Existing Chemicals for Section  6
label requirement for motor oils.
                               -29-

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                        VOLUNTARY TESTING
P82-465                     DOMESTIC

Chemical Name:  Quaternary Ammonium Chloride

     The submitter provided acute bacterial toxicity testing  to
address concerns raised for ecotoxicity if bacteria in  a  publicly
owned water treatment plant are exposed via contaminated
wastewater.  The data indicated that there will be low  concern
for the use described in the PMN.  However, the case was  referred
for follow-up review because there are several other uses for the
chemical that may cause concern, and those data will be useful
for follow-up review of other quaternary ammonium compounds.


P82-535                     DOMESTIC
Chemical Name:  Modified Phenol Formaldehyde Substituted
                  Alkylamine

     After the Notice Manager explained Agency concerns that  the
PMN substance may be toxic to aquatic organisms, the submitter
agreed to test the water solubility of the new chemical.   The
results mitigated the Agency's concerns and the substance  dropped
from the review process.


P82-701                     IMPORT
Chemical Name:  Aromatic Disazo Dye

     The Agency received short-term mutagenicity data  from the
submitter to address the concerns for carcinogenicity, and the
substance was not found to be mutagenic under the conditions of
the test.  No further action was recommended on the PMN
substance.
P83-110                     DOMESTIC

Chemical Name:  Saturated Acid Diester

     The Company provided Aquatic toxicity testing  to  address
concerns raised for aquatic life which may be exposed  to
contaminated surface water.  After Agency review of  the data,  it
was concluded that the PMN posed no significant risks  and dropped
the substance from further review.
                               -30-

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                        VOLUNTARY TESTING
P83-115                     DOMESTIC

Chemical Name:  Naphthalene Disulfonic Acid, Disodium Salt,
                  ((2-((Sodium Sulfoxyethyl)Sulfonyl)Aryl)Azo),
                  and Monochlorotriazinylamino, Substituted,
                  Copper Complex

     The Agency raised  concerns for mutagenic effects to workers
who are exposed during  processing and use.  Test results for an
Ames assay were received initially with the PMN submission, but
additional data were required in order to properly address the
concerns.  The PMN was  suspended to allow the submitter to
perform additional short-term testing.  These results indicated
no adverse effects.
P83-298, 299, 300, 301,     DOMESTIC
302, 306, 307, 308, 309,
310

Chemical Name:  P83-298, 299 - Toluene Alkylate

                P83-300, 301 - Dialkyl Benzene

                P83-302 - Alkyl Benzene

                P83-306, 307, 308, 309 - Polyalkylbenzene Sulfonate

                P83-310 - Benzene Alkyl Sulfonate

     The submitter provided an Ames assay and other test data to
address concerns raised for mutagenicity if workers are exposed
during manufacture and use.  The test results were received and
found to be negative.  The PMNs were subsequently dropped from
review on April 14, 1983.


P83-335                     IM PO RT

Chemical Name:  ((Substituted phenyl)azo)naphthalene
                  sulfonic acid, sodium salt

     The submitter provided an Ames test to address concerns
raised for carcinogenicity if workers are exposed during
occupational use and if the general public is exposed to
contaminated drinking water.  The data indicated no adverse
effects.  EPA has taken no formal regulatory action on this
substance.
                               -31-

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                        VOLUNTARY TESTING
P83-341                     IMPORT

Chemical Name:  7-[4-[4-chloro-6-[3-2-(hydroxysulfonyloxy)
                  ethylsulfonylanilino]-!,3,5-triazin-2-ylamino]
                  -2-ureidophenylazo]-1,3,6-naphthalene
                  trisulfonic acid, tetrasodium salt

     Testing to address carcinogenicity concerns were provided by
the submitter.  The results indicated that no significant hazard
to workers or the general public existed during processing and
use and the PMN was dropped from review.


P83-454                     DOMESTIC

Chemical Name:  Acrylamide Copolymer

     The submitter agreed to conduct aquatic toxicity testing of
this PMN substance.  The data indicated a toxicity concern, but
the Company submitted further information on exposure which
mitigated EPA's concerns.  The PMN substance was dropped from
further review.
P83-479                     IMPORT

Chemical Name:  Monoazo Substituted Aromatic

     Ames assay test results were received on this chemical
following Agency concerns for worker exposure.  The review
indicated no adverse effects and no further action was taken,
P83-486                     DOMESTIC

Chemical Name:  Zirconium Propanoate, Substituted

     The submitter provided aquatic toxicity testing to address
concerns raised for aquatic life forms which may be exposed via
contaminated surface water.  The data indicated no significant
effects.  EPA has taken no formal action on this substance.
                               -32-

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                        VOLUNTARY TESTING
P83-518, 523                 DOMESTIC

Chemical Name:   P83-518  -1,1'  [Isopropylidene  Bis(6-Hydroxy-M-
                  Phenylene)]Bis(Tetrahydrothiophenium
                  Hydroxide)Bis(Inner  Salt)  Tetrahydrate

                 P83-523  -  1,1  [Isopropylidene Bis(6-Hydroxy-M-
                  Phenylene]Bis(Tetrahydrothiophenium Hydroxide)

     Testing was performed by  the  submitter  to  determine  the
chemical impurity level.   The  concern  for  the chemical impurity
was potential neurotoxicity.   The  results  indicated  that  the
chemical impurity was maintained  at safe levels therefore
removing Agency  concerns.


P83-543                      DOMESTIC

Chemical Name:   Polymer  of Diethylenetriamine and  Higher
                  Polyamine  with  Dibasic Esters; Reacted  with
                  Epichlorohydrin

     Voluntary aquatic toxicity  testing  (acute  fish  and algae  and
chronic daphnid) was completed in  May  1983.  Test  results were
received at EPA  on June  7, 1983.   The  PMN  substance  was found  to
be acutely toxic to fish,  daphnid  and  algae; however,  based on
further analysis it was  determined that  the  PMN substance would
not be released  in quantities  sufficient to  create a concern.
P83-578                      DOMESTIC

Chemical Name:  Alkoxymethyl polysilazanes

     The submitter provided  eye  and skin  irritation  testing  data
to address concerns raised for eye and skin  irritation  if workers
are exposed during manufacture,  processing,  and  use.  The results
indicated no toxicity concern.   No further action was taken  on
this PMN.
P83-601                      IMPORT

Chemical Name:  Halogenated Alkene Acid  Ester

     The Company provided acute dermal toxicity  testing  to
address concerns raised for dermal toxicity  if workers are
exposed during occupational use.  The results removed the
concerns and the PMN was dropped.
                               -33-

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                        VOLUNTARY TESTING
P83-680                     DOMESTIC

Chemical Name:  Hydroxyethylaminomethylated Tannin

     Ecotoxicity testing was performed on this chemical which
indicated it was non-toxic to aquatic organisms.  It was allowed
to be dropped from review.


P83-739                     DOMESTIC

Chemical Name:  Diamide of Polybutenyl Succinic Anhydride

     Eye irritation testing data were provided by the submitter
to address concerns raised by the Agency for severe and
irreversible damage to the eye if consumers are exposed during
use.  It was found not to cause any irreversible corneal opacity
and the PMN was dropped from review.


P83-757, 758, 759           DOMESTIC

Chemical Name:  Functionalized Acrylic Polymer

     The submitter agreed to voluntarily conduct aquatic toxicity
tests on these PMN substances.  The data did not indicate any
significant ecotoxicological concern.
P83-785                     DOMESTIC

Chemical Name:  Substituted Heteromonocycle Sulfonylphenyl Azo
                Substituted Naphthalene Sulfonic Acid, Salt

     The submitter agreed to voluntarily conduct an Ames test
using the Prival method.  The test results mitigated  EPA's
concerns for mutagenicity should workers be exposed during
manufacture, processing and use.


P83-808                     DOMESTIC

Chemical Name:  2-, 3-, and 4-Pinanol Mixture

     The submitter provided chemical analysis to identify certain
components of the substance to address concerns raised for
chronic toxicity if workers are exposed during manufacture and
use.  The data was evaluated and no significant concerns
remained.
                               -34-

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                        VOLUNTARY  TESTING
P83-824
DOMESTIC
Chemical Name:  Organofunctional Polydimethylsiloxane

     Eye irritation testing  (at low concentrations) was provided
by the Company to address concerns for eye  irritation  to
consumers.  The data indicated no adverse effects.  Previous eye
irritation testing  (at high  concentrations) raised concerns for
workers exposed during industrial use.  The submitter  agreed to
amend the Material  Safety Data Sheet  (MSDS) to reflect this
concern.
P83-1003
DOMESTIC
Chemical Name:  Propanoic Acid, 3-[(Dibutoxy Phosphinothioyl)
                Dithiol] Methyl Ester

     The PMN review raised concerns of potential delayed
neurotoxicity.  The submitter conducted two "Neurotoxic Esterase
Assays".  Each set of results was clearly negative.  Based on the
results, EPA has no further concern.
P83-1026
DOMESTIC
Chemical Name:  Disubstituted Sulfamoylcarbomonocycle Azo
                Substituted Naphthalene Sulfonic Acid, Sodium
                Salt

     The submitter provided an Ames test using the Prival method
to address concerns raised for mutagenicity if workers are
exposed during occupational use.  The data mitigated the EPA's
concerns.
P83-1042
DOMESTIC
Chemical Name:  Acridine, 9-Phenyl

     Concerns were raised for toxicity to workers exposed during
processing.  The submitter provided acute toxicity testing which
resulted in removing EPA's concerns.
                               -35-

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                        VOLUNTARY TESTING
P84-73                      DOMESTIC

Chemical Name:  Polyester Polycarboxylate Salt

     Acute toxicity testing was carried out by the Company to
relieve concerns raised for aquatic toxicity.  The test results
indicated no significant hazard and the PMN was dropped from the
review process.


84-259,326                  IMPORT

Chemical Name:  P84-259-Bis(Polyalkylaminetriphenyl)-
                Bis(Alkylamino) Benzene

                P84-326-Bis(Polyalkylaminetriphenyl)-
                Bis(Aminoalkyl)Benzene

     The Company agreed to voluntary testing to address
ecotoxicity concerns.  The tests included aquatic toxicity in
fish and daphnia and a biological elimination test.  The review
period for the PMN substance was suspended in order to provide
additional time for analysis of data and a final disposition.
The exposure estimates indicated that releases to water are below
toxicity levels to aquatic species and the PMN substances were
dropped.
                              -36-

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PART B.  INFORMAL REGULATORY ACTIONS
       2.  VOLUNTARY CONTROLS
                -37-

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                        VOLUNTARY CONTROLS
P79-12                      DOMESTIC

Chemical Name:  Dodecenyl  Succinic Acid, Mono Alkyl  Ester

     The Company agreed to label their container and alter their
Material Safety Data  Sheet (MSDS) to reflect the eye and skin
irritation concerns identified by EPA in the course of  its review
of the PMN substance.   The case was subsequently dropped from
further review.
P80-182                     DOMESTIC

Chemical Name:  Alkanedioic Acids Mixed Alkanolamines  Salt

     Concerns were raised for carcinogenicity to workers who are
exposed during occupational use and to consumers who are exposed
during product use.   The submitter agreed to address the concern
by reformulating the  final product.


P80-256                     DOMESTIC

Chemical Name:  Methylaziridinyl Carbonylimino Oleyl Trimido
                Diisophorone Poly(Propylene Glycol)

     Concerns were raised for carcinogenicity to workers who are
exposed during manufacture.  In an amendment to the original PMN,
at Agency request, the Company stated that the particular
feedstock of concern  would not be used in the manufacture of the
final PMN substance.  The Company also agreed to label the
containers "Not recommended for spray applications.  Inhalation
may be hazardous."


P81-36                      DOMESTIC

Generic Chemical Name:  Alkyl Acid Phosphorous Esters

     The PMN substance caused permanent eye damage  in  test
animals.  With EPA's  assistance, the submitter developed a
strongly worded warning label for containers of the new
substance.
                               -39-

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                       VOLUNTARY  CONTOOLS
P81-41                      IMPORT

Chemical Name:  5-Methyl-4H-l ,2 ,4-Triazole-3-Selenol 1,2-Dihydro-
                5-Methyl-3H-l,2,4-Triazole-3-Selone

     This substance for photographic use was the first received
under TSCA for use by home hobbyists.  EPA's review raised
concerns for possible dermal absorption.  The substance, packaged
in a photographic developing kit, was labeled with a warning to
the hobbyist to wear rubber gloves.


P81-54                      DOMESTIC
Chemical Name:  Disazo Dye

     Concerns were raised for dermal toxicity to workers who are
exposed during manufacture, processing, and use.  The submitter
agreed to address the concern by demonstrating that the substance
would not be used in such a way that dermal absorption would
occur and further agreeing to sell the PMN substance only to
customers using proper protective equipment.


P81-69, 125                 DOMESTIC

Chemical Name:  P81-69-Salt of Benzophenone Tetracarboxylic
                Dimethyl ester and Diamines

                P81-125-Benzophenone Tetracarboxylic
                Dianhydride Polyimide

     Carcinogenicity concerns were raised to workers who are
exposed during manufacture.  The submitter agreed to address the
concern by certifying that their enclosed system manufacturing
process would be used for all manufacture of the PMN chemicals.
Once processed into a final product, exposure to the PMN
chemicals was not of concern.
                              -40-

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                        VOLUNTARY CONTROLS




P81-223                     IMPORT

Chemical Name:  Butanitrile, 3-Hydroxy-2-Methylene

     The submitter voluntarily agreed to have workers wear
protective clothing and glasses  because the substance is a skin
and eye irritant.  The low production volume and these controls
mitigated the Agency's concerns  and the case was dropped.


P81-255                     DOMESTIC

Chemical Name:  Di{2-Propenyl) 3,4,5,6-Tetrabromo-l, 2-Benzene-
                Dicarboxylate

     The Agency was concerned that the PMN substance might cause
cancer in exposed employees during manufacture, processing and
use.  The review indicated that  exposure would be low due to the
use of ventilators and protective gear.  The Company also agreed
to label the chemical to warn against contact.


P81-261                     DOMESTIC

Chemical Name:  Amine Derivative

     Concerns were raised for irritation, sensitization, and
carcinogenicity to workers who are exposed during occupational
use and to the general population exposed through contaminated
drinking water.  The submitter agreed to address the concern by
amending the label and Material  Safety Data Sheet (MSDS) to
advise use of protective clothing, goggles, and respirators for
workers and to discourage outdoor use where unprotected persons
might be exposed.
                               -41-

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                       VOLUNTARY CONTROLS
P81-307                     DOMESTIC

Chemical Name:  Alkylphenol Formaldehyde Tackifying Resin

     Initially this PMN substance was suspected of being a strong
sensitizer on the basis of structurally-related chemicals
reported to be sensitizers.  An isomer of this chemical was under
testing for sensitization at the close of the review period.  We
asked the submitter if he would agree to a voluntary label for
potential sensitization should test data for a similar chemical
be positive.  The Company not only agreed to a voluntary label,
but also agreed to amend its draft Material Safety Data Sheet
(MSDS) if EPA had reason to believe the chemical was a
sensitizer.  The test for the structural analog was negative,
however, and the Company was informed that labeling was
unnecessary.


P81-311                     DOMESTIC

Chemical Name:  Maleic Acid, Monoisoocytyamide, Diethane Olamine
                Salt

     The PMN substance was to be used to clean machined metal
parts.  The PMN substance was intended to replace nitrite, but if
nitrite were inadvertently added to the cleaning vat with the
substance, nitrosamines could form, raising concerns for
carcinogenicity.  The submitter agreed to add to the Technical
Service Data Sheet (TSDS) explicit instructions not to add
nitrite to the new substance.


P81-317                     DOMESTIC

Chemical Name:  Copolymer of an Unsaturated Amide with Quaternary
                Ammonium Derivative of an Unsaturated Amide

     Concerns were raised for ecotoxicity if aquatic life forms
are exposed via contaminated surface water.  The submitter agreed
to address the concern by indicating that the substance is highly
toxic to aquatic organisms and that proper usage, as described in
the PMN, will result in minimal release of the chemical to the
environment.
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                        VOLUNTARY CONTROLS
P81-445                     IMPORT

Chemical Name:  4-Trifluoromethoxy Phenylisocyanate

     Concerns were raised for acute and chronic health effects
including carcinogenicity and mutagenicity to workers who are
exposed during processing and use.  The submitter agreed to
address the concern by providing  information pertaining to
actions that should be taken should the chemical be ingested.
The Company also explained the stringent standards for worker
safety by using protective equipment and clothing.


P81-496                     IMPORT

Chemical Name:  3-Hydroxy-l-propane Sulfonic Acid

     The Company agreed to change the Material Safety Data Sheet
(MSDS) because the substance was  contaminated with a possible
carcinogenic impurity.  The revised label includes precautionary
measures which must be taken when handling the substance and
procedures to follow should an accident occur.  These controls
removed the Agency's concern.
P81-531                     DOMESTIC

Chemical Names:  Dialkylated Polyalkene Polyamine

     A modified warning label instructing users and workers that
the substance is harmful if swallowed was added to this PMN.   The
concerns included skin and eye irritation as well as systemic
effects to the kidneys, liver and lungs during exposure.


P81-554                     DOMESTIC

Chemical Name:  Metal Alkyl Thiocarbonate

     Test data were received by  EPA for the PMN chemical near  the
end of the 90-day review period which indicated that the chemical
caused severe skin and eye irritation.  The Company was asked  to
revise its Material Safety Data  Sheet (MSDS) and label to  include
notice of these effects and proper precautionary statements.
This was accomplished with the resubmission of new labeling
before the end of the 90-day period.
                               -43-

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                        VOLUNTARY CONTROLS
P81-580                     DOMESTIC

Chemical Name:  Poly(Oxy-l,2-Ethanediyl), Alpha-(Carboxymethyl)-
                Oraega-(4-Nonylphenoxy)

     During the review of this chemical, serious health effects,
including myocardial necrosis, were found for analogues of the
chemical in which the average number of a certain repeating unit
was between 15-29.  The Company agreed not to manufacture its
chemical with the number of repeating units in this range.


P81-613                     DOMESTIC

Chemical Name:  Alkyl Glucoside

     Concerns were raised for eye and skin irritation if
consumers are exposed during product use.  The submitter agreed
to address the concern by indicating the irritation potential on
the Material Safety Data Sheet (MSDS) and recommending warning
label statements.
P81-625                     DOMESTIC

Chemical Name:  Blocked Isocyanate

     The submitter agreed to include a Material Safety Data  Sheet
(MSDS) recommending ventilation in compliance with Occupational
Safety and Health Administration (OSHA) standards as well as
protective gear for workers exposed during manufacture and
processing.  The potential concerns included carcinogenicity and
methemoglobinemia if inhaled or ingested.


P81-662                     DOMESTIC

Chemical Name:  Substituted Propionamide

     Test data submitted with the PMN indicated that the chemical
would cause blindness.  The Company was asked to use a stronger
precautionary statement in the Material Safety Data Sheet (MSDS)
than "causes severe eye irritation."  A newly submitted MSDS
carries the precautionary statement, "Corrosive - causes
permanent eye injury."
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                        VOLUNTARY CONTROLS
P81-672                     DOMESTIC

Chemical Name:  Phenyl Acetic Acid Hydrazide

     The PMN chemical was found to be a potential carcinogen by
analogue to other known carcinogens.  The Company agreed to place
a cancer warning on the Material  Safety Data  Sheet  (MSDS).  The
Company also submitted more information on the manufacturing
process which lowered the concern for worker  exposure.


P82-12                      DOMESTIC

Chemical Name:  Substituted Polyhydroxy Benzene Derivative

     The Company agreed to provide a Material Safety Data Sheet
(MSDS) and a "process specification booklet"  which  tells
customers, in "cookbook" fashion how to use the chemical.  A
warning against direct discharge will be placed on  the
environmental information page of the booklet.


P82-44                      DOMESTIC

Chemical Name:  Chloroheteropolycyclic, Hydrochloride Salt

     The Material Safety Data Sheet (MSDS) was amended by the
submitter to reflect EPA's concerns for potential adverse chronic
effects for this intermediate.  Amendments include  an exposure
limit and an effects statement.  If the exposure limit is adhered
to in the workplace, the PMN substance would  pose no significant
hazard to workers.
P82-70                      DOMESTIC

Chemical Name:  2[(1,3-Dioxolan-2-yl-methoxy)Imino] Benzene
                  Acetonitrile

     Concerns were raised for acute toxicity to workers who are
exposed during occupational use.  The submitter voluntarily
agreed to include on its product label and Material Safety Sheet
(MSDS), a statement prescribing the use of an approved respirator
to minimize inhalation exposure.  Copies of the label and
Material Safety Data Sheet were provided to EPA during the review
period.
                               -45-

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                        VOLUNTARY CONTROLS
P82-72                      DOMESTIC

Chemical Name:  Alkenoic Acid Ester of a Halogenated Alkylaryl
                  Ether

     Various health concerns were identified for the PMN chemical
during review based on analogues.  Among them were
hepatotoxicity, carcinogenicity, and teratogenicity.  The Company
was asked to either test its product or revise the label pointing
out these effects.  The Company submitted unpublished test data
on a metabolite of the PMN chemical and revised its label, thus
lessening EPA's concerns.


P82-129                     DOMESTIC

Chemical Name:  Esterified Copolymer of a Vinyl Compound and an
                  Unsaturated Carboxylic Acid

     Test data submitted with the PMN indicated that the chemical
is a strong skin irritant.  The Material Safety Data Sheet (MSDS)
only indicated the potential for irritation.  After consultation
with EPA's toxicologist, the Company agreed to change the MSDS to
indicate that irritation will occur on dermal contact.
P82-426                     DOMESTIC

Chemical Name:  Substituted Cyclopentadiene

     The submitter was made aware of the Agency's health concerns
(mutagenicity, liver and kidney damage) and offered to label the
material sold to its user-customer.  The PMN was dropped from
review due to low exposure based upon the chemical's low vapor
pressure and low dermal absorption.  Even so, workers are alerted
through the label to avoid all dermal contact with the product
and inhalation of its vapors.


P83-656                     DOMESTIC

Chemical Name:  Substituted Alkyl Carboxylic Acid, Carbomonocylic
                  Ester

     Concerns were raised for ecotoxicity if aguatic life forms
are exposed via contaminated surface water.  The submitter agreed
to address the concern by disposing wastes containing the PMN
substance in a manner which would not contaminate surface waters.
                               -46-

-------
                        VOLUNTARY CONTROLS
P83-683                     DOMESTIC

Chemical Name:  1-Ethylnyl-l-Cyclopentanol

     With significant exposure causing sedative effects in
workers during manufacture of the PMN substance, the submitter
agreed to warn workers of the effects and specify the proper
precautions that should appear on the Material Safety Data Sheet
(MSDS).  With these controls, EPA determined that formal
regulatory action against the PMN substance was not necessary.


P83-997,998                 IMPORT

Chemical Name:  83-997 - 6-Diethylamino-2-(Substituted)
                           Spiro(Xanthene-9,3' Phthalide)

                83-998 - 6-Dibutylamino-2-(Substituted)
                           Spiro(Xanthene-9,3' Phthalide)

     Informed of Agency concerns, the PMN submitter agreed to
import these substances only in paste form, which would
significantly lower worker exposure during use of these
substances.  Concern was for potential carcinogenicity,
especially to workers who use the substances in powder form.


P84-150                     DOMESTIC

Chemical Name:  Aminomethylene Phosphonic Acid

     Following the Agency's request on November 14, 1983, the
submitter voluntarily agreed to add a corrosiveness warning to
the Material Safety Data Sheet (MSDS).  On November 21, 1983, the
Agency received the submitter's MSDS with the warning included.
                              -47-

-------
        Part C.  PMNS WITHDRAWN
1.  Prior to Likely Section 5(e) Action
                  -49-

-------
        PMNS WITHDRAWN PRIOR  TO LIKELY  SECTION  5(e)  ACTION
P80-2                        DOMESTIC

Chemical Name:  Fatty  Acid,  Tall Oil, Epoxidized Mixed C7, C9
                   Alkylester

     Concerns were raised for potential mutagenicity to workers
who are exposed during manufacture and processing and to  the
general population exposed to contaminated drinking water.   This
PMN was to have been  EPA's first section 5(e) case based  solely
on significant production volume and substantial exposure and/or
release.  When the Company learned of Agency intent to require
testing through a  formal section 5(e) Order, it withdrew  the PMN.


P80-137, 138, 264            DOMESTIC

Chemical Name:  P80-137 - Benzamine, 4,4'-Methylene-Bis [N-(l-
                   Methylhexylidene)]

                P80-138 - Benzamine, 4,4'-Methylene-Bis [N-(l-
                   Methylbutylidene)]

                P80-264 - Benzenamine, [N-(1-Methylhexylidene)-
                   N1-(l-Methylbutylidene)-4,4'-Methylene-Bis-

     These PMNs were withdrawn by the submitter on June 21,
1983.  They had remained in suspension for over two years while
the Company decided whether to conduct testing.  The Agency was
concerned about hazardous products released during the
substance's breakdown.  The Company determined that testing would
be too costly and  withdrew the PMNs.


P80-171                      DOMESTIC

Chemical Name:  Polyester of Dicarboxylic Acids Alkylene  Diols
                   and  Octyl Alcohol

     'EPA raised concerns for carcinogenicity and mutagenicity to
exposed workers and aquatic toxicity to organisms that are
exposed to contaminated surface waters.  The submitter withdrew
the PMN from the review process immediately prior to issuance of
a section 5(e) order.
                                          Material belongs to:
                                          Office of Toxic Substances Library
                                          U.S. L7r.vironmenti;l Protection Agency
                                          40] M'f.;fcet,S.W.TS-793
                                          Washington, D.C. 20460
                               -51-       (202)382-3944

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        PMNS  WITHDRAWN PRIOR TO LIKELY SECTION 5(e)  ACTION
P81-561, 661                IMPORT

Chemical Name:  P81-561 - 4-[4-(2-(Hydroxysulfonyloxy)
                  Ethylsulfonyl)-5-Methyl-2-Methoxyphenylazo)
                  -3-Methyl-l-(3-Sulfophenyl-5-Pryazolone

                P81-661 - 4-Hydroxy-3-(2-Methoxy-5-Methyl-4-(2-
                  Hydroxysulfonyloxy) Ethylsulfonyl) Phenylazo-6-
                  (3-Sulfophenyl)amino-2-naphthalenesulfonic Acid
                  Trisodisum Salt

     The submitter withdrew the PMNs rather than perform short-
term mutagenicity testing as requested by the Agency to address
carcinogenicity and mutagenicity concerns.


P82-340                     IMPORT

Chemical Name:  Complex Quaternary Ammonium Chloride

     The Company previously had agreed to negotiate voluntary
testing to address some of the environmental effect concerns
raised during review of the PMN.  The Company later felt that the
market potential of the PMN substance did not justify the testing
expenditure, and thus withdrew the chemical.


P82-401                     DOMESTIC

Chemical Name:  Polyvinyl Starch

     This PMN, which entered detailed review in July 1982, was
withdrawn in September 1982, when the submitter decided against
manufacture of the chemical.  The concerns initially raised by
the Agency were for acute human effects from inhalation.


P82-506                     DOMESTIC

Chemical Name:  Alkoxy Ester of N-Methylacetamide

     Due to carcinogenicity and exposure concerns, this chemical
would have, under a section 5(e) Order, required labeling to warn
workers that dermal protection would be needed when handling this
substance.  During development of the Order, the submitter
withdrew the PMN, preferring to use resources in the development
of a safer product.
                               -52-

-------
        PMNs  WITHDRAWN PRIOR TO LIKELY SECTION 5(e)  ACTION




P82-586                     DOMESTIC

Chemical Name:  Ethylester of  Tertiary Butyl Carbomonocyclic Acid

     On November 16,  1982, the decision was made to pursue the
development of a proposed section 5(e) Order pending the
submission of 90-day  sub-chronic and possibly 2-year reproduction
studies.  The submitter withdrew the PMN in December 1982 in face
of this development.


P83-11                      DOMESTIC

Chemical Name:  Oxirane (Phenyl Methoxy) Methyl

     This PMN was withdrawn following detailed evaluation of
concerns for carcinogenicity, sensitization, and cross-
sensitization from exposure in the workplace.  The submitter
declined to voluntarily provide additional information that EPA
considered necessary  to address the noted effects.


P83-36, 37                  DOMESTIC


Chemical Name:  Acrylated Alkoxylated Aliphatic Glycol

     Review of this chemical indicated aquatic toxicity problems
not alleviated by voluntary testing results.  The Agency had
additional concerns for carcinogenicity and the PMN was
withdrawn.


P83-285                     DOMESTIC

Chemical Name:  Phosphate Ester

     This PMN was withdrawn by the submitter in February 1983
after neurotoxicity concerns to workers developed.  The Company
declined to voluntarily provide additional information that EPA
considered necessary  to address the neurotoxicity concerns.
                               -53-

-------
        PMNs WITHDRAWN  PRIOR TO LIKELY  SECTION  5(e)  ACTION
P83-389                     IMPORT

Chemical Name:  ((Substituted Heterocycle)Azo)
                  Substituted Aniline, Acid Salts

     Concerns were raised for potential teratogenicity to workers
who are exposed to the substance during processing and use.  The
submitter declined to voluntarily provide additional information
that EPA considered necessary to eliminate the concern.  This PMN
was withdrawn in the face of a section 5(e) Order that was under
development within the Agency.


P83-433                     IMPORT
Chemical Name:  Monoazo Aromatic Compound

     The submitter withdrew the PMN rather than perform
metabolism testing which would have addressed concern for the
formation of potential carcinogenic metabolites of the PMN
substance.
P83-525                     IMPORT

Chemical Name:  Substituted Benzindolium Salt

     The submitter performed some acute aquatic toxicity testing;
however, Agency concerns still existed for acute and chronic
aquatic toxicity.  In response, the submitter withdrew the PMN in
November 1983, rather than perform the additional testing.


P83-532                     DOMESTIC

Chemical Name:  Glyceryl Propoxy Diacrylate

     After the Agency raised concerns for potential skin
carcinogenicity to workers who are exposed during manufacture,
processing and use, the submitter withdrew the PMN in face of a
section 5(e) Order.  The Company is, however, continuing its
performance of a 2-year bioassay.
                               -54-

-------
        PMNS  WITHDRAWN PRIOR TO LIKELY SECTION 5(e)  ACTION




P83-606                     DOMESTIC

Chemical Name:  9,10-Anthracenedione, 2-Methyl-l-Nitro

     The submitter withdrew the PMN rather than perform dermal
absorption testing to determine whether there would be potential
significant exposure to the PMN substance, a tested animal
carcinogen.


P83-673, 674                IMPORT

Chemical Name:  P83-673 - l-((4-((Substituted Phenyl)Azo)
                  -1-Naphthalenyl) Amino)-3-Methoxy-2-Propanol

                P83-674 - l-( (4-( ( Substituted PhenyDAzo)
                  -1-Naphthalenyl) Amino)-3-Butoxy-2-Propanol

     EPA was concerned over possible carcinogenicity if workers
are exposed during processing and if the general population is
exposed to contaminated drinking water.  The submitter withdrew
the PMNs rather than perform a 2-year bioassay.


P83-676                     DOMESTIC

Chemical Name:  1-Naphthalene Sulfonic Acid, 6-Amino-5-hydroxy

     The submitter withdrew the PMN rather than perform an Ames
test to address carcinogenicity concerns raised by the Agency.
The section 5(e) Order would have banned the substance's
manufacture until test data had been submitted.


P-83-820, 821               DOMESTIC
Chemical Name:  P83-820 - Disubstituted heterocyclic azo
                  disubstituted benzene

                P83-821 - Trisubstituted phenyl azo disubstituted
                  heterocycle

     Concerns were raised for potential carcinogenicity to
workers who are exposed during manufacture and processing and to
the general population which may be exposed to contaminated
drinking water.  The submitter withdrew the PMN to prevent the
possible issuance of a formal section 5(e) Order prohibiting
manufacture pending the submission of additional information.
                               -55-

-------
       PMNS WITHDRAWN  PRIOR  TO  LIKELY  SECTION  5(e)  ACTION
83-845                      IMPORT


Chemical Name:  Tetrasodium Salt of Mu-(2-(2-Hydroxy-3-Nitro-5-
                Sulfophenylazo)-2'-(2-Hydroxy-5-Substituted-3-
                Sulfophenylazo)-3,3'-Disulfo-6,6'-Iminodi-l-
                Naphtholate-(0,0',0'',0''')(S-)Dicopper (II) Acid

     After EPA expressed concern for carcinogenicity of a
potential metabolite of the PMN substance,  the submitter made
research and development assessments and  decided to withdraw the
PMN in the face of a section 5(e) Order.
P-83-1048                   DOMESTIC

Chemical Name:  Polyether Polyurethane

     Potential carcinogenicity concerns were raised by the Agency
regarding this PMN substance.  The submitter declined to
voluntarily provide additional information to address the effects
of the chemical on workers exposed during manufacture, processing
and use.
P-83-1057                   DOMESTIC

Chemical Name:  1,1 Di (Aklylsubstituted)Hydrazine

     EPA raised carcinogenicity and teratogenicity concerns
relating to exposure to workers during manufacture.  The
submitter preferred to withdraw the chemical rather than enter
into a consent agreement for protective equipment.
                              -56-

-------
        PMNs WITHDRAWN PRIOR TO LIKELY SECTION 5(e) ACTION
P-83-1267, 1268, 1270
IMPORT
Chemical Name:  83-1267:  9H-Thioxanthen-9-one, 2,4-Diethyl

                83-1268:  9H-Thioxanthen-9-one, 2,4-Dimethyl

                83-1270:  9H-Thioxanthen-9-one, 4-chloro-

     Concerns were raised for potential hepatotoxicity if workers
are exposed during processing.   The submitter withdrew the PMN to
prevent issuance of a section 5(e) Order prohibiting importation
pending the submission of additional information.
P83-1281, 1283, 1284,
1286, 1287, 1288
IMPORT
Chemical Name:  P83-1281 - Premetallized Aromatic
                           Substituted Disazo

                P83-1283 - Substituted Aromatic Disazo

                P83-1286 - Aromatic  Substituted Triazo

                P83-1284, 1287, 1288 - Reaction Product
                           of Diazotized Aromatic Compounds
                           with Fustic Extract

     The submitter has voluntarily withdrawn these PMNs in the
face of a section 5(e) Order requiring a 2-year bioassay on each
PMN substance.  When the decision was made to require bioassay
and ecotox testing to address carcinogenicity and ecotox
concerns, the submitter withdrew the PMN due to the expense of
the tests.
P-84-66
IMPORT
Chemical Name:  Substituted Phenol-Formaldehyde Condensate

     Possible releases of the PMN chemical into surface waters,
which exhibited potential aquatic toxicity, were a significant
concern of EPA's.   The Company needed further information to
mitigate these concerns, but instead it decided to withdraw the
PMN from review.
                               -57-

-------
        PMNs WITHDRAWN  PRIOR TO LIKELY SECTION 5(e)  ACTION
P-84-69                     IMPORT

Chemical Name:  Substituted Anthraquinone Ammonium Salt

     Concerns were raised for potential aquatic toxicity to
aquatic organisms exposed to releases from processing.  The
submitter withdrew the PMN to prevent the possible issuance of a
section 5(e) Order prohibiting importation pending the submission
of additional information.
P-84-86                     IMPORT

Chemical Name:  Heterocyclic Azo Substituted Aromaric Compound

     The Agency expressed concerns for potential aquatic toxicity
if aquatic organisms are exposed to releases from processing, and
for carcinogenicity if workers are exposed to releases from
processing, and the general population if exposed to contaminated
drinking water.  The submitter withdrew the PMN rather than
perform the testing.


84-93                       DOMESTIC

Chemical Name:  Substituted-lH-Isoindol-1-One

     On June 12, 1984, the submitter withdrew the PMN in the face
of a section 5(e) Order, after a series of suspension periods
intended for further research and development on the PMN
substance.
P-84-161                    DOMESTIC

Chemical Name:  Reaction Product of Urea,
                  Diethylene triamine,
                  Cardura E and Allyl
                  Glycidyl Ether

     Rather than enter into a consent agreement, the Company
withdrew the chemical after the EPA had shown concerns for
potential carcinogenicity to workers who are exposed to the PMN
substance.
                               -58-

-------
        PMNs WITHDRAWN PRIOR TO LIKELY SECTION 5(e)  ACTION
P-84-253                    DOMESTIC

Chemical Name:  Blocked isocyanate modified epoxy resin

     The submitter withdrew this PMN in the face of a possible
section 5(e) Order which would have prohibited manufacture of the
substance pending further testing.  The concern was for worker
exposure to a potential carcinogen during manufacture, processing
and use.  Additional data was necessary to make an accurate
finding.


84-262                      DOMESTIC

Chemical Name:  Safflower Oil; 1,2 ,3-Propanetriol; 2,5-
                Furandione; 4,5,6,7,88-Hexachloro-3A,4,7,7A-
                Tetrahydro-4,7-Methanoisobenzofuran

     The levels of a potentially carcinogenic impurity in the PMN
substance was the source of concern which called for a 2-year
bioassay.   The PMN was withdrawn in the face of a section 5(e)
Order, with no further test results submitted.
84-304                      DOMESTIC

Chemical Name:  Benzyl Dialkyl Methyl Quaternary Ammonium
                  Chloride

     The submitter decided to withdraw the PMN from the review
process in face of a section 5(e) Order which would have required
controls pending the submission of information on aquatic
toxicity.  The submitter felt that the expense of the tests was
prohibitive.


84-305                      DOMESTIC

Chemical Name:  2-Propenoic Acid, 2-Methyl-, 2-
                (((((1,Methylpropylidene)Amino)Oxy)Carbonyl)
                Amino)Ethyl Ester

     Following concerns for carcinogenicity, a 5(e) Consent Order
was proposed by the Agency.  The section 5(e) Consent Order,
followed by a Significant New Use Rule ( SNUR) , would require air
supplied respirators as well as gloves.  The Company withdrew the
PMN in the face of the Order.
                               -59-

-------
        PMNS  WITHDRAWN PRIOR TO LIKELY SECTION 5(e)  ACTION
84-531                      IMPORT

Chemical Name:  Cyanoethylated Isophoronediamine

     The Agency expressed concerns for teratogenicity and
neurotoxicity.  An Ames assay was performed and the results were
found to be negative.  The teratogenic concerns still exist.   The
submitter withdrew the PMN in the face of a section 5(e)
Unilateral Order which would have required oral teratology
testing.
                              -60-

-------
        Part C.  PNNs WITHDRAWN
2.  Prior to Likely Section 5(£) Action
                  -61-

-------
        PMNS WITHDRAWN PRIOR TO LIKELY SECTION 5(f) ACTION
P82-251                     DOMESTIC

Chemical Name:  3,4-Dichlorophenol

     The Agency was developing its first proposed section 5(f)
Rule for this PMN (concerns identified were oncogenicity, eye
corrosivity, chloracne, fetotoxicity, reproductive effects and
ecotoxicity).  A section 5(c) notice extending the review period
was signed on June 25, 1982.  The submitter withdrew the PMN from
the review process on the same day, stating that it did not wish
to be the subject of EPA's first TSCA section 5(f) Order.


P83-350                     DOMESTIC

Chemical Name:  2-Propoxyethyl Acetate

     Ihis PMN was withdrawn because of a potential section 5(f)
Rule pending related Section 6 action on glycol ethers.  The
concerns were raised for teratogenicity to workers who are
exposed during handling, and consumers during product use.


P83-654                     DOMESTIC

Chemical Name:  Lauryl Sulfate Salt with 2-Amino-2-Methyl-l-
                  Propanol

     The submitter voluntarily performed eye irritation testing
on concentrations of the PMN substance used in consumer
products.  At such levels, the substance was found still to cause
irreversible corneal opacity.  Ihe submitter was given the option
of testing the compound at even lower concentrations.  If it were
found to cause "no effects," EPA would then consider proposing a
section 5(f) Rule that would prohibit use at higher
concentrations.  Ihe submitter decided to withdraw the PMN at
this time and perform further testing on the chemical.
                               -63-

-------
Tables of PMN Activities
          -65-

-------
                                      Table  1.   Annual Compilation of PMN Program  Actions


                                                     Through June 30, 1984

Valid PMN's Received
5 (e) Orders Issued
Consent 5{e)
Orders Issued
5 ( f ) Rules Issued
Informal Action -
Voluntary Testing
Informal Action
Voluntary Controls
PMNs Withdrawn
In Face of Likely
5(e) order
PMNs Withdrawn
In Face Of Likely
5 (f) Order
Total
FY'79
8
0
0
0
0
0
0
0
0
FY'80
281
2 (7 PMNs)
0
0
1
1
1
0
5
FY'81
580
0
0
0
10
13
1
0
24
FY'82
839
1 (2 PMNs)
1 (2 PMNs)
0
5
16
1
1
25
FY'83
1301
2 (4 PMNs)
8 (117 PMNs)
0
42
2
18
2
76
FY'84*
870
1 (1 PMN)
9 (19 PMNs)
2 (3 PMNs)
14
4
27
0
57
Total
3,880
6 (14 PMNs)
18 (138 PMNs)
2 (3 PMNs)
72
36
48
3
185
I
o\
-J
I
        * As of June 30, 1984

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Table 2:  Percentage of Commencement of Manufacture Notices Received
Valid

FY 79
FY 80
FY 81
FY 82
FY 83
FY 84
PMNs Received

8
281
580
839
1301
870
% of Notice of
Commencements Received
Number
6
165
359
471
503
125
%
66.7%
58.7%
61.9%
56.1%
38.6%
14.4%
                               -68-

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Table 3.  Annual Compilation of PMN Activities  by  Specific  Concern
                              FY 1980
Action Type

Toxlclty Concern
Carcl nogen 1 c 1 ty/Mutagen Ic 1 ty
Teratogen 1 c 1 ty /Fetotox 1 c 1 ty
Reproductive Effects
Acute Effects
Other Chronic Toxlclty
Ecotoxlclty
Exposed Populations
Workers
Consumers
Environment
Voluntary
Testing
Domestic
1
0
0
0
0
1
0
0
Import
0
0
0
0
0
0
0
0
Vo 1 untary
Controls

Domestic
0
0
2
0
0
1
0
0
Import
0
3
0
0
0
0
0
0
55 (e) Order

Domestic
6
0
1
0
6
7
1
6
Import
0
0
0
0
0
0
0
0
Withdrawn In
the face of a
55 (e) Order

Domestic
9
0
1
1
0
5
2
0
Import
0
0
0
0
0
0
0
0
                     -69-

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Table 4.  Annual Compilation of PMN Activities  by  Specific  Concern
                              FY 1981
Action Type

Toxlclty Concern
Care 1 nogen 1 c 1 ty/Mu tagen 1 c 1 ty
Teratogen 1 c 1 ty/Fetotox I c 1 ty
Reproductive Effects
Neurotoxlclty
Acute Effects
Ecotoxlclty
Exposed Populations
Workers
Consumers
Env 1 ronment
General Population
Voluntary
Test 1 ng
Domestic
0

0
10
0
8
2
0
0
Import
0

0
0
0
0
0
0
0
\foluntary
Controls

Domestic
6

1
7
1
8
1
1
1
Import
0

0
2
1
2
1
0
0
55 (e) Order

Domestic
0

0
0
0
0
0
0
0
Import
2

0
0
0
2
0
0
2
Withdrawn In
the face of a
$5(e) Order

Domestic
0

0
0
0
0
0
0
0
Import
0

0
0
0
0
0
0
0
                     -70-

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Table 5.  Annual Compilation of PMN Activities  by  Specific Concern
                              FY 1982
Action Type

Toxic tty Concern
Carcinogenic I ty/Mutagenlclty
Ter atogen 1 c 1 ty /Fetotox 1 c 1 ty
Reproductive Effects
LIverAldney
Neurotoxlclty
Acute Effects
Other Chronic Toxic Ity
Ecotoxlclty
Exposure Concerns
Worker
Consumer
Environment
General Population
Vo 1 untary
Test 1 ng
Domestic
1
0
2
1
4
0
1
2
0
1
1
Import
0
0
0
0
0
0
0
0
6
0
0
Voluntary
Contro 1 s

Domestic
6
0
5
0
9
3
1
11
3
1
0
Import
3
0
0
0
2
0
0
2
0
0
0
$5(e) Order

Domestic
0
0
0
0
4
0
0
0
2
0
0
Import
0
0
0
0
0
0
0
0
0
0
0
Withdrawn In
the face of a
J5(e) Order

Domestic
2
2
0
0
2
1
0
2
1
1
1
Import
2
0
0
0
0
0
0
2
2
1
2
                     -7 1 -

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Table 6.  Annual Compilation of PMN Activities by Specific Concern
                              FY 1983
Action Type

Toxlclty Concern
Care 1 nogen 1 c 1 ty/Mutagen 1 c 1 ty
Teratogen 1 c 1 ty /Fetotox 1 c 1 ty
Reproductive Effects
Liver/Kidney
Neurotoxlclty
Acute Effects
Ecotox 1 c 1 ty
Exposure Populations
Worker
Consumer
Environmental
General Population
Voluntary
Testing
Domestic
14
0
1
2
3
8
18
1
8
2
Import
5
0
0
0
1
0
5
0
0
1
Voluntary
Controls

Domestic
0
0
0
0
2
0
1
0
1
0
Import
0
0
0
0
0
0
0
0
0
0
55 (e) Order

Domest 1 c
8
1
12
1
2
2
8
0
2
0
Import
2
1
0
0
0
0
3
0
0
2
Withdrawn In
the face of a
§5(e) Order

Domestic
7
2
2
1
1
2
12
2
2
2
Import
5
3
0
0
0
1
7
0
1
0
                     -72-

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Table 7.  Annual Compilation of PMN Activities  by  Specific  Concern
                              FY 1984
Action Type

Toxic Ity Concern
Care 1 nogen 1 c 1 ty/Mutagen Ic 1 ty
Ter atogen 1 c 1 ty /Fetotox 1 c 1 ty
Reproductive Effects
Liver /Kidney
Neurotoxlclty
Acute Effects
Other Chronic Toxic Ity
Ecotoxlclty
Exposure Populations
Worker
Consumer
Environment
General Population
Voluntary
Testing
Domestic
2
2
0
3
1
0
0
3
2
0
0
Import
3
0
0
0
0
0
2
3
0
2
1
Voluntary
Controls

Domestic
0
0
0
0
1
0
0
1
0
0
0
Import
2
0
0
0
0
0
0
2
0
0
0
$5(e) Order

Domestic
16
7
3
0
1
3
0
20
0
0
0
Import
2
0
0
0
0
0
0
2
0
0
0
Withdrawn In
the face of a
55(e) Order

Domestic
2
1
0
0
0
0
0
3
0
0
0
Import
11
1
0
1
0
0
5
7
1
5
1
                     -73-

-------
                                        Table 8.  Historical Compilation of Specific Concerns Underlying
                                                      Formal and Informal Regulatory Action
                                                         Domestic U.S.  Import Chemicals

Toxic Ity Concern
Care i nogen 1 c 1 ty/Mutagen Ic i ty
Ter atogen 1 c 1 ty /Fetotox 1 c 1 ty
Reproductive Effects
Liver/Kidney
Neurotoxlclty
Acute Effects
Other Chronic Toxic Ity
Ecotoxlclty
Exposure Populations
Worker
Consumer
Environment
General Population
FY« 80

Domestic
16
3
0
0
4
1
6
14
3
6
0
Import
0
0
0
0
0
0
0
0
0
0
0
FY« 81

Domestic
6
0
0
1
17
0
1
16
3
1
1
Import
2
0
0
0
2
0
1
4
1
0
2
FY' 82

Domestic
9
2
7
1
19
4
2
15
6
3
2
Import
5
0
0
0
2
0
0
4
2
1
2
FY'83

Domestic
29
3
15
4
8
0
12
39
3
13
4
Import
12
4
0
0
1
0
1
15
0
1
3
FY»84

Domestic
20
10
3
3
3
3
0
27
2
0
0
Import
18
1
0
1
0
0
7
14
1
7
2
Totals
Domestic
80
18
25
9
51
5
21
111
17
23
7
Import
37
5
0
1
5
3
9
37
4
9
9
Through 6/30/84

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                    Rate  of  Growth for Valid PMNs Received
                         by EPA  since  Program Inception
1400
1200 -
1000
 800
 600
 400
 200
                1979
                     1980          1981          1982
                              (FY PMNs Received)
                                                      1983         1984*

                                                  * (Fiscal Year Projection)
                                Domestic/Import PMNs
1400
1200
1000
 800
 600
 400
 200
         Valid  PMNs  D
 1979
 1980
 1981
 1982
 1983
*1984
 8   8    0
281  273   8
580  502  78
839  701  138
1301 1071 230
1220 976  244

 - Valid  PMNs
 - Domestic

 - Import
          FY79
              FY80
                                    FY81          FY82
                                   (PMNs by Fiscal Year)

    TirU.8. GOVERNMENT PRINTING OFFICE:  198«t  i»5i»  513  19380
                                                FY83         FY84*

                                                   *  (Fiscal Year Projection)

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