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
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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.
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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
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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
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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.
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PART A. FORMAL REGULATORY ACTIONS
1. SECTION 5(£) RULES
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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.
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PART A. FORMAL REGULATORY ACTIONS
2. Unilateral Section 5(e) Orders
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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.
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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.
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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.
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PART A. FORMAL REGULATORY ACTIONS
3. SECTION 5(e) CONSENT ORDERS
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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.
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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.
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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.
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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.
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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.
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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.
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PART A. FORMAL REGULATORY ACTIONS
4. MODIFICATIONS OF SECTION 5(e) ORDERS
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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.]
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PART B. INFORMAL REGULATORY ACTIONS
1. VOLUNTARY TESTING
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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.
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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-
-------
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-
-------
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-
-------
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-
-------
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.
-42-
-------
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-
-------
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."
-44-
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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-
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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-
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Part C. PMNS WITHDRAWN
1. Prior to Likely Section 5(e) Action
-49-
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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
-------
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-
-------
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-
-------
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-
-------
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 -
-------
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-
-------
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
-------
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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