xvEPA
United States
Environmental Protection
Agency
Office of
Toxic Substances
Washington DC 20460
EPA 560/3-86-001
June 1985
Chemical Control
in the United States:
Accomplishments Under the
New Chemical Program
CH3
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CHEMICAL CONTROL IN THE UNITED STATES:
\\
ACCOMPLISHMENTS UNDER
THE NEW CHEMICAL
PROGRAM
OFFICE OF TOXIC SUBSTANCES
U.S. ENVIRONMENTAL PROTECTION AGENCY
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Acknowledgments
Wendy Cleland-Hamnett
Jane Talarico
Rebecca Torchia
Anna Coutlakis
Jon Silberman
Daniel Dickson
Rose Allison
Candace Brassard
Stephanie Roan
Robert Jones
David Bottimore
Paul Matthai
Pam Vercellone
Eileen Gibson
Robert Flanagan
Melvin Quick
R. James Alwood
Charlotte White
Cover design by Paul Bickart, Ph.D.,
Office of Toxic Substances
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TABLE OF CONTENTS
Introduction[[[ i
Page
Pret ac e. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i i i
Overview ot PMN Program Action.......................................l
A.
B.
C.
Formal Regulatory Actions Under TSCA, Section 5
l.
2.
3.
Section 5(f) Hules - Manutactured Domestically...............3
Section 5(e) Consent Orders - Manufactured Domestically. .....7
Section 5(e) Consent Orders - With Testing Trigger-
Manufactured Domestically. ................................17
Section 5(e) Consent Orders-Imported........................23
4.
Informal Regulatory Actions Under TSCA, Section 5
1.
2.
Voluntary Testing - Manufactured Domestically.............. .27
Voluntary Testing - Imported................................3l
Withdrawal of PMN's
1.
Prior to Likely Section 5(e) Action - Manufactured
Dames tic a 11 y. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 7
Prior to Likely Section 5(e) Action - Imported..............43
Prior to Likely Section 5(f) Action - Manutactured
Dome s tic a 11 y. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 7
Prior to Likely Section 5(f) Action - Imported..............51
2.
3.
4.
LIST OF TABLES
1.
Annual Compilation of
PMN Program Actions. ..................55
2.
Percentage ot Commencement ot Manufacture Notices
Rece i ved. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .56
3.
Annual Compilation ot PMN Program Activities
FY 1984 - FY 1985...........................................57
4.
Historical Compilation ot Specitic Concerns
Underlying formal and Informal Regulatory
Actions tor Manufactured Domestically and Imported
C he m i c a 1 s. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 9
5.
Chemical Class it ication ot Actions Taken.................... 6 0
6.
Rate of Growth for Valid PMN's .............................61
7.
Comparison of PMN's Received with Those Manufactured
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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 ot the Organization for Economic Co-
operation and Development (OECD) which has conducted an active
program in promoting cammon 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 second 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.
Do~l~~. Die;&;
Office of Toxic Substances
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PREFACE
In authorizing the Toxic Substances Control Act (TSCA), (15
USC 2601 et ~.), Congress recognized that health and
environmental risks are more easily addressed before, rather than
after, a chemical is manufactured and introduced into commerce.
Section 5 of TSCA authorizes the Environmental Protection Aqency
(EPA) to review new chemicals prior to manufacture or import for
potential human health and environmental effects and, if
necessary, regulate the chemicals to limit any unreasonable risks
which they may present.
The premanufacture review program, developed by EPA to
implement section 5 of TSCA, is commonly referred to as the New
Chemical Program. Any chemical not included in the TSCA
Inventory of Chemical Substances is considered a "new"
chemical. The Inventory covers chemicals in commercial
production between the years of 1975 and 1979, and 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, a manufacturer or importer (submitter)
is required to submit to EPA advance notification of intent to
manufacture or import a new chemical substance, or manufacture,
import, or process an existing chemical substance for a
designated significant new use. The submitter is required to
complete a premanufacture notification (PMN) form which includes
the substance identity, proposed uses, estimated production
volume, and exposure data, including information on disposal.
Although toxicological data need not be developed solely for the
PMN's, it must be submitted to the extent that they are known or
reasonably ascertainable by the submitter. However, as discussed
below, EPA has broad authority to obtain such data when it is
needed for evaluation of potential risks.
In addition, if a rule requiring testing of the chemical has
been promulgated under TSCA section 4, the manufacturer 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 why
such regulatory action is not beinq 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 proposed chemical use
that has been designated by rule under TSCA section 5(a) (2) as a
significant new use.
EPA has 90 days to review the information in the PMN,
determine whether regulatory action is required, and take one of
the actions discussed in the following overview. For good cause
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EPA may extend the review period for an additional 90 days.
is most often done to allow EPA to take regulatory action.
Companies are encouraged to agree to voluntarily suspend the
review time if they are preparinq additional information.
This
Each notice proceeds through a screening process to
determine whether more detailed review is required and to
identify candidates for regulatory action. Thus, EPA focuses on
the relatively few new chemicals of qreatest concern - those
which are structurally related to known toxic chemicals, and
those about which little is known. EPA undertakes an in-depth
review of these chemicals in order to determine whether the
chemicals may present unreasonable risks. The review includes
analyses of available test data on the chemical and/or
structurally analogous chemicals, potential human and
environmental exposures, additional uses which could
significantly alter exposure, the benefits of the chemical, and
the relative risks posed by substitutes.
Since the inception of the New Chemical Proqram in July
1979, EPA has received and reviewed increasing numbers of PMN's
each fiscal year (FY) [NOTE: A fiscal year beqins on October 1st
of the preceding calendar year.] In FY 1983, for example, 1,301
PMN's were received, as compared with 281 in FY 1980. Most PMN's
reviewed do not warrant regulatory action. In a number of cases,
however, the Agency has acted to obtain additional data from
submitters or to control exposures to substances which are
suspected of presenting unreasonable risks. These actions
include formal regulatory actions, such as TSCA section 5(e)
orders, and informal measures, such as negotiations with PMN
submitters to obtain voluntary testing or controls.
This report, the second of an ongoinq series of annual New
Chemical Program activity reports, represents a complete
compilation of major actions taken by the Aqency in response to
PMN submissions. It provides an overview of completed actions,
both formal and informal, from July 1, 1984 through June 30,
1985. Volume I provides information on actions from the
inception of the New Chemical Proqram throuqh June 30, 1984.
Please direct questions or comments on this report to
Margaret Stasikowski, Director, Chemical Control Division (TS-
794), Environmental Protection Agency, 401 M Street, S.W.,
washington, D.C. 20460.
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For additional copies of this report, or Volume I.
Write:
Call:
TSCA Assistance Office
Office of Toxic Substances
(TS-799)
u.S. Environmental Protection
401 M Street, S.W.
Washington, D.C. 20460
Agency
Toll Free 800-424-9065
In Washington, D.C. 202-554-1404
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OVERVIEW OF PMN PROGRAM ACTIONS
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 health or
environmental risk. In such cases, the Aqency may prohibit or
limit manufacture of the chemical under TSCA S5(e) pending
development of the necessary data. Alternatively, the Aqency may
pursue informal courses of action through negotiations with PMN
submitters to obtain additional test data or other information.
Section 5(e) orders may also be issued when the data are
insufficient to permit a reasoned evaluation of the potential
effects of the substance, and the substance will be produced in
substantial volume and result in significant exposure.
When unreasonable health or ecological effects are indicated
by existing data, the Agency may prohibit or limit the
manufacture, processing, or use of the substance under the
provisions of TSCA ~5(f). Under this section, EPA may issue an
administrative order or an immediately effective rule.
Sections A and B below describe briefly 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 possihle
outcome of the 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 which prohibits 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. To date, the Aqency has issued three rules,
and no orders, under section 5(f).
2.
Unilateral Section 5(e) Orders. EPA may issue a proposed
section 5(e) Unilateral 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 of injury to
health or the environment, or 3) the substance will be
produced in substantial quantities, and either enters or
may enter the environment in substantial quantities or
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B.
C.
may result in significant or substantial human
exposure. All of the unilateral orders issued to date
have prohibited the manufacture, processing, distribution
in commerce, use, or disposal of the substance pending
the submission and evaluation of test data addressing the
health or environmental concern.
3.
Section 5(e) Consent Orders. A section 5(e) Consent
Order, mutually agreed to by the PMN submitter and EPA,
requires the same findings as those for a Unilateral
Order. Most section 5(e) consent orders specify
requirements to control exposures to the substances and
insure that persons who may be exposed are properly
notified. These requirements may include protective
equipment such as impervious gloves, safety gogqles, or
respirators, worker training programs, warning labels,
customer notification letters, and disposal
limitations. In addition, some section 5(e) orders
include "testing trigqers". These triqqers provide that
upon reaching a specified production volume, the
submitter must cease production of the PMN substance
unless it submits the results of a specified test which
permits a reasoned evaluation of the effects of exposure.
Informal Regulatory Actions Under Section 5 - Voluntary
Testing
EPA frequently identifies a potential unreasonable risk
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 usinq a
mutually agreed upon protocol. EPA then evaluates the test
results to determine whether the data confirm or refute the
Agency's concerns. The significance of the risk would
determine whether additional regulatory action is necessary.
Withdrawal of PMN's
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(f) RULES
MANUFACTURED DOMESTICALLY
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SECTION 5(f) RULES
MANUFACTURED DOMESTICALLY
84-529
Chemical Name:
Mixed Mono- and Oiamides of an Organic Acid
The Agency raised concerns for this chemical upon learninq
that the addition of nitrites to the PMN substance during product
use could result in the formation of nitrosamines, which are known
carcinogens. By issuing a section 6(a) rule under TSCA, which
became immediately effective under section 5(f), the Aqency
required customer notification and labeling to prevent the
addition of nitrites and other nitrosating aqents to the
substance.
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PART A.
FORMAL REGULATORY ACTIONS
2.
SECTION See) CONSENT ORDERS
MANTJFACTURED DOMESTICALLY
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SECTION 5(e) CONSENT ORDERS
MANUFACTURED DOMESTICALLY
83-1157,-1222,-1227,-1228,-1229
Chemical Name: 83-1157 Substituted Oxirane
83-1222 Substituted Alkyl Halide
83-1227 Perhalo Alkoxy Ether
83-1228 perhalo Alkoxy Ether
83-1229 perhalo Alkoxy Ether
During the review of this chemical, the Agency raised
concerns for carcinogenicity and pulmonary edema. A section 5(e)
Consent Order was developed pending a two-year rodent bioassay and
a 90-day subchronic inhalation study. The Order requires workers
to use appropriate protective equipment, including air-supplied,
positive pressure respirators, impervious full-body covering,
safety goggles and impervious gloves. In addition, the Company is
required to inform workers of the potential risk and of the terms
of the Order.
83-1162
Chemical Name:
Substituted Pyridine
EPA negotiated an Order requiring use of protective equipment
pending a two-year rodent bioassay. The equipment includes
impervious gloves and suits, goggles and cartridge respirators
approved for organic vapor. Concerns are for liver and kidney
toxicity effects and carcinogenicity.
83-1163
Chemical Name:
Substituted Pyridine
Liver and kidney toxicity concerns brought about negotiations
for a section 5(e) Consent Order for this chemical. The Order
remains in effect pending a 90-day subchronic inhalation study.
Workers are also required to use protective equipment.
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SECTION 5(e) CONSENT ORDERS
MANUFACTURED DOMESTICALLY
84-111, -112, -113, -114, -115, -116, -117
Chemical Name:
Substituted Aromatic Polymer
Concern for cancer and male reproductive effects brought
about this section 5(e) Consent Order. Under the terms of the
Order protective equipment during manufacture, pending the receipt
of data developed in a two-year rodent bioassay is required. The
protective equipment includes face shields, gloves and protective
clothing. Also, the Company is required to provide warninq
information to its employees exposed to the substance.
84-274
Chemical Name:
Poly(oxy-l,4-butanediyl)-alpha-(1-oxo-2-propenyl)-
omega-[(l-oxo-2-propenyl)oxy]
Because of concern for carcinogenicity, EPA developed a
section 5(e) Consent Order which requires workers to wear
protective equipment pending a two-year bioassay. The protective
equipment includes impervious gloves, safety goggles and
protective clothing during manufacturing, processing, and use
operations. Distribution of the chemical is limited to customers
who will both process and use the dhemical, and the Company is
required to notify customers of EPA findinqs and restrictions
placed on the chemical. In addition, the Company is required to
notify employees of the proper safety precautions. The containers
of the PMN substance are to be clearly labeled, and specific
recordkeeping requirements are to be met.
84-358
Chemical Name:
Polyaromatic Urethane Poly(unsaturated)ester
EPA raised concerns for carcinogenicity durinq review of
chemical. Pending a two-year rodent bioassay, EPA and the
submitter negotiated a section 5(e) Consent Order requiring
appropriate protective equipment, notification letters, and
labeling. Distribution of the PMN substance is also limited.
this
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SECTION 5(e) CONSENT ORDERS
MANUFACTURED DOMESTICALLY
84-491, 84-492
Chemical Name:
84-491
Substituted Aliphatic Acid Halide
84-492
Substituted Hydroxylamine
EPA raised carcinogenicity concerns for unprotected workers
exposed to the PMN substances. Pending a two-year bioassay, the
section 5(e) Consent Order requires the use of impervious gloves
and protective clothing by workers when handling either substance,
as well as the use of respirators when workers are exposed to
vapors of 84-491. Wastes resulting from production of 84-4ql must
be incinerated. Wastes resulting from production of 84-492 must
be treated so that the 84-492 content is less than 10 ppm prior to
discharge.
84-527, 84-537
Chemical Name:
84-527
Unsaturated Amino Alkyl Ester Salt
84-537
Unsaturated Amino Ester Salt
Potential carcinogenicity concerns and possible significant
dermal exposure during manufacture, processing and use were a
reason for a section 5(e) Consent Order on these substances. The
Consent Order requires the Company to inform workers of the
hazard, and provide labeling. The Order requires workers to wear
protective clothing, gloves and goggles, pending a two-year rodent
bioassay. In addition, controls on use, commercial distribution,
and discharge of waste will be implemented.
84-558
Chemical Name:
Carboxylated Alkane Diol
Dermal and inhalation exposure for workers during
manufacture, processing and use were grounds for a section 5(e)
Consent Order. Pending a two-year rodent bioassay, the Order
requires personal protective equipment to be worn to prevent
exposure to the potential carcinogen.
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SECTION 5(e) CONSENT ORDERS
MANUFACTURED DOMESTICALLY
84-814
Chemical Name:
Polysubstituted Polyol
This section 5(e) Consent Order was the first requiring
processors to become co-signers of the Order and subject to its
terms. This measure allows EPA to exercise greater control over
use of the PMN substance pending the development of a two-year
bioassay. The Order was prepared as a result of Agency concerns
for carcinogenicity and mutagenicity.
84-839
Chemical Name:
Polyfunctional Aziridine
Carcinogenicity and mutagenicity concerns brought about this
section 5(e) Consent Order. Under the terms of the Order,
protective equipment in the form of impervious gloves, goggles,
protective clothing and respirators is required for workers,
pending a two-year rodent bioassay.
84-860
Chemical Name:
Disubstituted Nitrobenzene
EPA raised carcinogenicity concerns during review of this PMN
substance. A section 5(e) Consent Order was developed pending a
two-year rodent bioassay. The Order requires workers to wear
protective equipment in the form of impervious gloves, goggles and
protective clothing when handling this substance.
84-902
Chemical Name:
Brominated Aryl Amine
Concerns for workers exposed to this chemical include
carcinogenicity, chronic effects, and mutagenicity. A section
5(e) Consent Order resulting from these concerns requires
protective equipment for potentially exposed workers, pending a
two-year bioassay and a 90-day subchronic study. In addition, the
Order restricts the physical form in which the PMN substance may
be distributed.
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SECTION 5(e) CONSENT ORDERS
MANUFACTURED DOMESTICALLY
84-913
Chemical Name:
N-N'-Bis(2-(2-(3-Alkyl)vinyl)-1,4-phenylene
diamine Double Salt - -
Extreme acute effects and possibly death were the concerns
raised during the assessment of the PMN. Pending acute toxicity
testing for this PMN substance, the conditions of the section 5(e)
Consent Order require the use of personal protective equipment
(goggles, gloves, chemical respirators) as well as labeling, a
notification letter with disposal and first aid procedures, and
certain restrictions on manufacture and distribution of the
chemical.
84-951
Chemical Name:
Substituted Aminobenzoic Acid Ester
During review of this chemical, EPA raised carcinogenicity
concerns for unprotected workers. The section 5(e) Consent Order
requires protective equipment such as impervious qloves, goggles,
and protective clothing, pending testing in the form of a two-year
rodent bioassay.
84-963
Chemical Name:
6-Nitro-2(3H)-benzoxazolone
EPA developed section 5(e) Consent Order when carcinoqenicity
concerns arose during review. The Order requires workers to wear
protective equipment in the form of impervious gloves, pending a
two-year rodent bioassay.
84-1007
Chemical Name:
3-Alkyl-2-(2-anilino) Vinyl Thiazoliniurn Salt
Extreme acute effects and possibly death were the concerns
raised during the assessment of the PMN. Pending acute toxicity
testing for this PMN substance, the section 5(e) Consent Order
requires the use of personal protective equipment in the form of
safety gogqles, impervious gloves, and chemical respirators. The
Order also requires labeling, a notification letter with disposal
and first aid procedures, and certain restrictions on manufacture
and distribution of the chemical.
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SECTION 5(e) CONSENT ORDERS
MANUFACTURED DOMESTICALLY
84-1042
Chemical Name:
Methylammonium N-methyldithiocarbamate
The Agency raised concerns for carcinogenicity, mutagenicity,
teratogenicity and neurotoxicity. EPA developed a section 5(e)
Consent Order requiring protective equipment pending the receipt
of the following data: a two-year bioassay, a two-generation
reproductive assay, a two-species teratology study, neuropathy
testing with correlative functional observation and acute exposure
neurotoxicity testing.
84-1062
Chemical Name:
Methyl Vinyl Sulfone
Concerns for carcinogenicity and mutagenicity for workers
exposed during manufacture and use of this substance were the
basis for a section 5(e) Consent Order. The Order requires
protective equipment for workers in the form of impervious gloves,
safety goggles, and protective clothing, pending the development
of a two-year rodent bioassay.
84-1068
Chemical Name:
N-Dimethylthiocarbamylthio-~'-phenyl Urea
EPA developed this section 5(e) Consent Order when concerns
for cancer, developmental toxicity, and neurotoxic effects
surfaced in review. The Order requires workers to wear gloves,
protective clothing, and chemical safety goggles, pending a
two-year bioassay, a developmental toxicity study and
neurotoxicity testing.
84-1074
Chemical Name:
Polyurethane Polymer
The Agency decided to develop a section 5(e) Consent Order
because of a concern for carcinogenicity of low molecular weight
species. The Order requires dermal protection, warninq labels,
and a letter and Material Safety Data Sheet (MSDS) notifying users
of the requirements of the Order and the hazard concerns,
pending a two-year rodent bioassay. The Company plans to perform
an analytical study on the PMN substance to determine if the
amount of low molecular weight species can be controlled.
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SECTION 5(e) CONSENT ORDERS
MANUFACTURED DOMESTICALLY
84-1079
Chemical Name:
Alkylated Diphenyl Oxide
EPA identified possible developmental and reproductive
toxicity effects for this PMN during review. The Agency developed
a section 5(e) Consent Order which requires chemical satety
goggles, impervious gloves and protective clothing to control
worker exposure, pending a developmental toxicity screening test.
84-1167
Chemical Name:
Epoxy Ester
Information obtained during review led to a concern for the
carcinogenicity ot this substance. The section 5(e) Consent Order
requires impervious gloves, protective clothing and chemical
safety goggles for workers, pending a two-year rodent bioassay.
84-1184
Chemical Name:
Polychlorofluoro Aromatic Alkylated Hydrocarbon
Carcinogenicity concerns brought about the development of
this section 5(e) Consent Order. The requirements of the Order
include the use of impervious gloves, a Material Safety Data Sheet
(MSDS) and a label that warns of potential effects pending a two-
year rodent bioassay.
85-118
Chemical Name:
polyurethane
Potential carcinogenicity was the basis of this section 5(e)
Consent Order. Pending a two-year bioassay, the Order limits
worker exposure and requires impervious gloves, safety goggles,
protective clothing and respirators.
85-301
Chemical Name:
Urethane Acrylate
A section 5(e) Consent Order was negotiated to address
carcinogenicity concerns that arose during review. The Order
requires the use ot protective equipment in the form ot impervious
gloves, safety goggles and protective clothing pending a two-year
rodent bioassay.
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PART A.
FORMAL REGULATORY ACTIONS
3.
SECTION 5(e) CONSENT ORDERS
W/TESTING TRIGGER
MANUFACTURED DOMESTICALLY
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SECTION 5(e) CONSENT ORDERS
W/TESTING TRIGGER
MANUFACTURED DOMESTICALLY
83-1033
Chemical Name:
C6-8 Carboxylic Acid
The section 5(e) Consent
production volume trigger, at
developmental toxicity data.
notification letters, labels,
(MSDS).
Order for this
which time the
The Order also
and a Material
PMN includes a
Company must submit
requires gloves,
Safety Data Sheet
84-393
Chemical Name:
2-Chloro-N-methyl-N-substituted acetamide
Concerns arising during review of this chemical are potential
kidney and liver effects in humans, and toxicity to aquatic
organisms. The section 5(e) Consent Order requires use of gloves
and respirators by workers. The Order also requires that aquatic
toxicity testing and a 90-day oral subchronic toxicity study he
conducted when specified production volumes are reached.
84-417
Chemical Name:
Substituted Phenol
EPA developed this section 5(e) Consent Order to address
concerns for liver, kidney and respiratory effects. The Order
requires workers to wear impervious gloves. Also, once the
production volume reaches a certain volume, production must cease
until the Company submits the results of a 28-day subchronic
dermal study.
84-464
Chemical Name:
Halogenated Aromatic Ether
This section 5(e) Consent Order requires gloves, protective
clothing, chemical safety goggles, and respirators as a result of
Agency concerns for liver, kidney and thyroid effects. Once the
production volume reaches a certain volume, production must cease
until the Company submits results of a 90-day subchronic oral
toxicity test.
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SECTION 5(e) CONSENT ORDERS
W/TESTING TRIGGER
MANUFACTURED DOMESTICALLY
84-482
Chemical Name:
Urea, condensate with POly[oxy(methyl-l,2-
ethanediyl)]-alpha-2-(2-aminomethylethyl)-omega-
(2-aminomethylethoxy)
EPA found that insufticient information was available to
evaluate this substance, and that it would be produced in
substantial volume and that exposure could be significant. Under
the terms of the Order, 28-day subchronic testing is required when
a specified production volume is reached.
84-660, 84-704
Chemical Name:
84-660
Substituted Aryl Olefin
84-704
Substituted Alkyl Arene
Chronic liver and kidney effects, neurotoxic, reproductive
and teratogenic effects are the concerns leading to this section
5(e) Consent Order. The Order restricts the PMN substance to a
maximum production volume pending 90-day subchronic testing to
address the health effects. The Order requires workers to wear
chemical satety goggles, impervious gloves, respirators and
protective clothing while handling this PMN substance.
84-824
Chemical Name:
Brominated Aromatic
Concerns for workers exposed to this chemical include
carcinogenicity, pulmonary effects, chronic effects and
mutagenicity. A section 5(e) Consent Order requires protective
equipment for potentially exposed workers. The Order also
includes a testing trigger requiring a 90-day subchronic study,
and restricts the physical form in which the PMN substance will be
distributed.
84-901
Chemical Name:
Brominated Aryl Carbonate
Concerns tor workers exposed to this chemical include chronic
effects and developmental effects. A section 5(e) Consent Order
resulting trom these concerns requires protective equipment for
potentially exposed workers. The Order includes a testing trigger
requiring a 90-day subchronic study and a second generation
reproductive study.
-20-
-------
SECTION 5(e) CONSENT ORDERS
W/TESTING TRIGGER
MANUFACTURED DOMESTICALLY
84-903
Chemical Name:
Brominated Aryl Amine
Concerns for workers exposed to this chemical include
carcinogenicity, chronic effects and mutagenicity. A section 5(e)
Consent Order resulting from these concerns requires protective
equipment for potentially exposed workers. The Order includes a
testing trigger requiring a 90-day subchronic study. In addition,
the physical form in which the PMN substance will be distributed
is restricted.
84-968
Chemical Name:
Alkyl Ester
The Agency raised concerns for developmental effects during
the initial review of the chemical. When the Company declined to
perform testing, and further concerns for worker and consumer
exposure were raised, a unilateral section 5(e) Order was
issued. When the Company submitted new exposure data which
explained the limitation of the chemical's use, the consumer
exposure concerns were eliminated. The concerns for unprotected
workers exposed dermally and via inhalation were the grounds for a
section 5(e) Consent Order. This Order included a testing trigger
for developmental toxicity testing.
84-1145
Chemical Name:
Alkyltrialkoxysilane
EPA negotiated a section 5(e) Consent Order to address the
Agency's concern for chronic toxicity of this PMN substance. The
Order requires chemical safety goqqles, impervious qloves,
respirators, protective clothing and includes a testing trigger
for a 28-day repeated dose inhalation study.
-21-
-------
PART A.
4.
FORMAL REGULATORY ACTIONS
SECTION 5(e) CONSENT ORDERS
IMPORTED
-23-
-------
SECTION 5(e) CONSENT ORDERS
84-7
Chemical Name:
IMPORTED
~,~,~',~'-Tetraglycidyl-l,3-bisaminomethyl
cyclohexane
Concerns for carcinogenicity and reproductive effects arose
during review of this chemical. The section 5(e) Consent Order
requires use of respirators during spraying operations, gloves,
and face shields, pending a 90-day subchronic inhalation study, a
two-year dermal carcinogenicity study, and a two-generation
reproductive study.
84-341,-342,-343,-344
Chemical Name:
84-341
84-342
84-343
84-344
Poly[oxy(1-oxo-l,6-hexanediyl)]-alpha-
hydro-omega-hydroxy-, ester with
3-hydroxy-2,2-dimethylpropyl-3-hydroxy-
2,2-dimethyl propanoate(?:l), di-2-
propanoate
Poly[oxy(1-oxo-l,6-hexanediyl)]-alpha-
(1-oxo-2-propenyl)-omeqa-[(tetrahydro-2-
furanyl)methoxy]-
Poly[oxy(1-oxo-l,6-hexanediyl)]-alpha-
hydro-omega-hydroxy-, ester with
2,2'-[oxybis(methylene)]bis[2-
(hydroxymethyl)-1,3-propanediol]2-
propenoate, 2-propanoate
2-Propenoic acid, [2-[1,1-dimethyl-2-
[(1-oxo-2-propenyl)oxy]ethyl]-5-ethyl-
1,3-dioxan-5-yl] methyl ester
Carcinogenicity concerns raised by the Agency during review
brought about negotiations for a section 5(e) Consent Order.
Pending a two-year rodent bioassay, the Order requires the use of
protective equipment in the form of impervious gloves, safety
goggles and protective clothing. In addition, the importer will
only sell to those customers who will both process and use these
substances.
-25-
-------
PART B.
INFORMAL REGULATORY ACTIONS
1.
VOLUNTARY TESTING
MANUFACTURED DOMESTICALLY
-27-
-------
VOLUNTARY TESTING
MANUFACTURED DOMESTICALLY
84-18
Chemical Name:
l-(1,1-Dimethylethoxy)-propan-2-01
The Agency raised concerns for potential worker and consumer
exposure to the PMN substance which was believed to cause
blindness and adverse blood effects. The Company provided eye
irritation tests which proved to be negative. The Company is
currently performing 90-day subchronic testinq by the inhalation
route. The review period is suspended pending the receipt of the
additional data.
84-498
Chemical Name:
Fatty Alcohol, Ethoxylated, Propoxylated, Fatty
Acid Ester
Aquatic toxicity concerns prompted the Agency to
further information on this PMN substance by means of
section See) Order. The Company, however, decided to
acute aquatic toxicity testing prior to manufacturinq
substance. Review of the data mitigated the Agency's
the Company was allowed to manufacture the substance.
request
a neqotiated
complete
the
concern, and
84-780
Chemical Name:
Aliphatic Diacrylate
At the Aqency's request, a mouse lymphoma assay was performed
by the Company which submitted this substance for review. The
negative results of this test alleviated the Agency's concerns for
the carcinogenicity of this chemical.
84-792
Chemical Name:
Disubstituted Anthraquinone-2-sulfonic Acid,
Alkali Metal Salt
The PMN substance was reviewed for acute aquatic toxicity
concerns. EPA required a series of acute aquatic toxicity data
before the Company was allowed to manufacture the chemical. The
Company, subsequently, submitted data to address these concerns
under a voluntary suspension. The review of the data indicates
that the chemical will not pose an unreasonable risk.
-29-
-------
VOLUNTARY TESTING
MANUFACTURED DOMESTICALLY
85-30
Carbopolycycle Sulfonate of Substituted
Phenyl Azo Substituted Heteromonocycle
The Company voluntarily performed eye irritation testing to
address acute lethality concerns. The results of the testinq were
negative. Further testing to address aquatic toxicity concerns
was conducted. The PMN was dropped from review followinq the
evaluation of test results.
Chemical Name:
85-321
Chemical Name:
Substituted Phenol/Formaldehyde Resin
EPA raised concerns for the potential aquatic toxicity
effects of the PMN substance. The submitter conducted acute
testing on algae and Daphnia. The test results mitiqated EPA's
concerns for the PMN substance and no formal regulatory action was
taken.
85-410
Chemical Name:
Amine Substituted Imidazolidines
The submitter provided the Agency with aquatic toxicity
testing data to aid in the review of the case. Although test
results indicate a high degree of toxicity to fish and aquatic
invertebrates, the expected concentration levels of the PMN
substance entering the receiving streams mitiqated the Agency's
concerns, and the case was dropped from review.
-30-
-------
PART B.
2.
INFORMAL REGULATORY
VOLUNTARY TESTING
IMPORTED
-31-
ACTIONS
-------
VOLUNTARY TESTING
IMPORTED
83-860
Chemical Name:
Metal Complexed Substituted Aromatic Azo Compound
The Agency raised concern for carcinogenicity of metabolites
of the PMN substance. The Company conducted analytical testing
and metabolism testing of the PMN substance. The results confirm
the formation of the metabolites. The PMN is currently suspended
pending negotiation of additional testing.
83-1006
Chemical Name:
(Amino)-(hydroxy)-(substituted)-(substituted)-
naphthanedisulfonic acid, and (amino)-(hydroxy)-
(substituted)-(substituted)-naphthanedisulfonic
acid, salts with sodium and potassium
Concern over carcinogenicity of potential metabolites brought
about the Agency's request for mutagenicity testing on this
chemical. The Company performed a modified Ames test and results
were received. The results mitiqated the Agency's concerns and
the case was dropped with no further action.
83-1007
Chemical Name:
(Substituted)-(substituted)-hydroxy-naphthalene-
sulfonic acid, sodium salts
A modified Ames test was performed on this substance to
address mutagenicity concerns for potential metabolites. The
results of the voluntary action were sufficient to eliminate the
Agency's concern for mutaqenicity.
83-1012
Chemical Name:
Bis[sulfophenylchlorotriazineaminosulfophenylazo]-
hydroxyaminodisulfonaphthalene
The Company performed a modified Ames test to address the
concerns for mutagenicity. The results were inconclusive.
Following the review of additional data, the Agency's concerns
were mitigated and the case was dropped from review.
-33-
-------
VOLUNTARY TESTING
IMPORTED
83-1018
Chemical Name:
Substituted-naphthalene tetrazodisulfonic acid,
bis[(substituted-hydroxyphenylazo)phenyl]derivative
A modified Ames test, conducted by the submitter to address
carcinogenicity concerns, was positive for the substance. The
case is currently suspended pending negotiation of further testing
or other regulatory options with the Company.
84-64
Chemical Name:
Substituted-phenylamino monochloro-triazinylamino-
sulfophenyl azo-substituted disulfononaphtha-
lenenylazo-naphthalenedisulfonic acid, hexasodium
salt
Mutagenicity (modified Ames) testing was performed on this
PMN substance to address carcinogenicity concerns. Results were
received and reviewed, but required further clarification to be
conclusive. Based on additional data, the Agency subsequently
dropped concern for the PMN substance.
84-68
Chemical Name:
Substituted Anthraquinone Aryl Amine
This PMN compound is believed to present an unreasonable risk
to aquatic organisms based on data included in the PMN and
supporting data on structural analogues. The Agency requested
that the submitter address these concerns by conducting acute
toxicity tests on algae, Daphnia and fish. The Company completed
the aquatic fish testing, submitted the data to EPA, but decided
against further testing and withdrew the PMN.
84-490
Chemical Name:
Substituted Aminofluorane
This submitter performed mutagenicity
Agency's concern for carcinogenicity. The
further review based on the results of the
additional information.
testing to address the
PMN was dropped from
testing and review of
-34-
-------
VOLUNTARY TESTING
IMPORTED
84-927
Chemical Name:
Carbopolycyclic Alkenyl Ether
A sister chromatid exchange test for mutagenic effects was
performed voluntarily on this chemical, with negative results.
The Agency requested testing to address oncoqenicity concerns.
Following evaluation of the test results, the PMN was dropped from
review.
-35-
-------
PART C.
PMN I s WITHDRAWN
1.
PRIOR TO LIKELY SECTION 5(e) ACTION
MANUFACTURED DOMESTICALLY
-37-
-------
PMN's WITHDRAWN IN FACE OF LIKELY ~5(e) ACTION
MANUFACTURED DOMESTICALLY
83-1029
Chemical Name:
Substituted Heterocycle
Mutagenicity, carcinogenicity, liver and central nervous
system effects are the concerns that prompted negotiation of a
section 5(e) Consent Order. The Company later decided to withdraw
the PMN rather than enter into the terms of the Order.
84-306, 84-307
Chemical Name:
84-306
Benzoic acid, 2-[[[[2-[(2-methyl-l-oxo-2-
propenyl)oxy]ethyl] amino] carbonyl]oxy-
methyl ester
2-Propenoic acid, 2-methyl-,2-[[hexahydro-
2-oxo-IH-azepin-l-yl]carbonyl]amino]ethyl
ester
84-307
The Agency raised concerns for carcinogenicity and potential
significant exposure to workers. A section 5(e) Consent Order was
negotiated to limit the use of the PMN substances. The submitter
withdrew the PMN's rather than siqn the section 5(e) Consent
Order.
84-462
Chemical Name:
Substituted Urethane Ester
The Agency required the submitter to conduct mutaqenicity
testing. The submitter decided to withdraw the chemical rather
than perform the testing.
84-840
Chemical Name:
Modified Epoxy Resin
EPA proposed a section 5(e) Consent Order to provide controls
for the workers. The submitter was not willing to require
protective equipment because of the operation methods used in
manufacturing this type of product, and withdrew in the face of
the proposed action.
-39-
-------
PMN's WITHDRAWN IN FACE OF LIKELY ~5(e) ACTION
MANUFACTURED DOMESTICALLY
84-858
Chemical Name:
Polyalkylene Glycol Ether Acrylate
Concerns for carcinogenicity were raised for possihle
significant exposure to workers. A section 5(e) Consent Order was
prepared to address these concerns, and to limit the use of the
substance. The Company chose to withdraw their substance in the
face of these developments.
84-953
Chemical Name:
Reacted Epoxy Resin
A section 5(e) Consent Order was recommended for this PMN,
based on significant exposure and sufficient data to present
health concerns. Concerns involved carcinogenicity, mutaqenicity
and fetotoxicity. The Company instead chose to withdraw the
chemical from premanufacture notice review.
84-1051
Chemical Name:
Halogenated Aromatic Substituted Olefin
This Company chose to withdraw this substance from review
rather than comply with the terms of a section 5(e) Consent
Order. Concerns arose over liver, kidney, neurotoxic,
reproductive and teratogenic effects.
84-1189
Chemical Name:
Modified Acrylamide Polymer
Ecotoxicity concerns prompted a section 5(e) Consent Order
for this substance. The Company, however, did not feel it was
economically feasible to perform the required testing, and
withdrew the chemical.
85-1190
Chemical Name:
Modified Acrylamide Polymer
Ecotoxicity concerns prompted a section See) Consent Order
for this substance. The Company, however, chose to withdraw the
chemical rather than perform the required testinq.
-40-
-------
PMN's WITHDRAWN IN FACE OF LIKELY ~5(e) ACTION
MANUFACTURED DOMESTICALLY
84-1227
Chemical Name:
Halogenated Aromatic Substituted Alkane
During review of this chemical, EPA developed concerns for
neurotoxic, liver, kidney, reproductive, and teratogenic
effects. The Company withdrew the chemical from review rather
than comply with a section 5(e) Consent Order.
85-2
Chemical Name:
Nitro Alcohol
Review of the chemical indicated concerns for oncogenicity,
mutagenicity, neurotoxicity and general toxicity. Exposure to
workers was significant, bringing about the Agency's decision to
develop a section 5(e) Consent Order. The Company chose to
withdraw the chemical from review.
85-152
Chemical Name:
Reacted Epoxy Resin
The concerns identified by the Agency were for possible
ecotoxicity and severe liver toxicity. EPA decided to require
ecotoxicity data prior to manufacture. The results from the
ecotox testing mitigated the ecotox concern. A section 5(e)
Consent Order involving a testing triqger to require a 90-day
subchronic toxicity test was under preparation. The Order also
required protective equipment. The submitter decided to withdraw
the case instead of performing the testing for health concerns.
85-153
Chemical Name:
Reacted Epoxy Resin
EPA recommended a section 5(e) Consent Order requiring
workers to wear protective equipment, based on the Agency's
concerns for oncogenicity. The Company, however, chose to
withdraw.
-41-
-------
PMN's WITHDRAWN IN FACE OF LIKELY S5(e) ACTION
MANUFACTURED DOMESTICALLY
85-297
Chemical Name:
Isophorone Diisocyanate Adduct of a Polyether
Glycol, an Alkanediol, and a Substituted Alkanol
Carcinogenicity concerns brought about a section 5(e) Consent
Order for this chemical. The Company chose to withdraw rather
than comply with the Order requirements.
85-313
Chemical Name:
Substituted Alkanol Adduct of a Long Chain
Diisocyanate
This Company chose
rather than comply with
Order. Carcinogenicity
decision.
to withdraw their chemical from review
requirements of a section 5(e) Consent
concerns were the basis for the Agency's
85-352
Chemical Name:
MDI Adduct with a Polyether Glycol and a Hydroxy
Methacrylate
The submitter withdrew the PMN in face of the Agency's
decision to develop a section 5(e) Consent Order, requiring
protective equipment. Carcinogenicity concerns. which developed
while the case was under review, were the basis for the Agency's
decision to develop the Order.
-42-
-------
PART C.
PMN'S WITHDRA~m
2.
PRIOR TO LIKELY SECTION 5(e) ACTION
IMPORTED
-43-
-------
PMN'S WITHDRAWN IN FACT OF LIKELY ~5(e) ACTION
IMPORTED
83-755
Chemical Name:
4-Hydroxy-6-phenylaminonaphthalene-2-sulfonic Acid
EPA raised concerns for carcinogenicity of the PMN substance
and an impurity. The submitter tested the impurity in a
mutagenicity screen. ~esults were positive. Rather than enter
into a consent agreement pending a two-year bioassay, the Company
withdrew the substance from PMN review.
84-277
Chemical Name:
Spiroglycol
EPA would have required a section 5(e) Consent Order with
protective equipment controls pending testinq if the submitter
decided to commence import or manufacture. The submitter decided
the product would not support the testinq costs and controls.
84-467
Chemical Name:
Hydrogen-2-[alpha-(2-hydroxy-3-sulfo-5-
ethenylsulfonyphenylazo)-benzilidenehydrazino]-5-
substituted, cuprate, sodium salt
EPA requested voluntary testinq to address ecotox concerns.
The Company declined, and when the Agency decided a section 5(e)
Consent Order would be necessary to produce testing, the Company
withdrew the PMN from the review process.
84-543
Chemical Name:
Glycine, N-[4-[2[4-[I-amino-8-hydroxy-7-phenylazo-
3,6-disuITonaphth-2-yl]azo]phenyl]-1,3-benzo-
diazole-6-yl]azo-3-hydroxyphenyl]-, a trisodium
salt
Carcinogenicity and worker exposure concerns brought about
the Agency's requirement for Ames testing under a section 5(e)
Consent Order. The Company withdrew their PMN from the review
process rather than perform testing.
-44-
-------
PMN'S WITHDRAWN IN FACT OF LIKELY ~5(e) ACTION
IMPORTED
84-608
Chemical Name:
Substituted Oxazinium Salt
Oncogenicity concerns developed for this chemical during
review. The Agency requested a two-year bioassay from the
Company, but they chose to withdraw their PMN.
85-98
Chemical Name:
2,2'-(l,3-Phenylene)bis(4,5-dihydro-oxazole)
Neurotoxicity and carcinogenicity concerns for workers
developed during review of this chemical. EPA proposed a section
5(e) Consent Order requiring testing, but the Company chose to
withdraw, for economic reasons, rather than test at this time.
85-232
Chemical Name:
Chromate(2-), [2-[[l-(3-chlorophenyl)-4,5-dihydro-
-3-methyl-5-oxo-lH-pyrazol-4-yl]azo]-5-sulfoben-
zoato-(2)] [2-[4,5-dihydro-5-oxo-l,3-diphenyl-lH-
pyrazol-4-yl]azo]benzoato(2-)]-, sodium hydroqen
(9CI)
This Company chose to withdraw the PMN rather than conduct a
two-year bioassay to address carcinoqenicity concerns, because it
was not economically feasible.
85-325
Chemical Name:
Cobaltate[l-], [N-[8[[5-[aminosulfonyl]-2-
hydroxyphenyl]az()]-7-hydroxy-l-naphthalenyl]
acetamidato[2-]]-[3-[4,5-dihydro-4-[(2-hydroxy 5-
nitrophenyl)azo]-3-methyl-5-oxo-lH-
pyrazol-l-yl]benzene-sulfonamidato(2-)]-,
sodium (9CI).
Due to carcinogenicity concerns and uncontrolled worker
exposure, a section 5(e) Consent Order pendinq a two-year bioassay
was proposed for the PMN substance. Given this likely regulatory
action, the submitter withdrew the PMN from review.
-45-
-------
PMN'S WITHDRAWN IN FACT OF LIKELY ~5(e) ACTION
IMPORTED
85-326
Chemical Name:
Chromate(!-), [3-[4,5-dihydro-4-[(2-
hydroxy-5-nitrophenyl)azo]-3-methyl-5-oxo-
lH-pyrazol-!-yl)benzene-sulfonamidato(2)]
[4-hydroxy-3-[(2-hydroxyl-l-naphthalenyl)
azo]benzenesulfonamidato(2-)]-hydrogen (9CI).
Due to carcinogenicity concerns and uncontrolled worker
exposure, a section 5(e) Consent Order pending a two-year bioassay
was proposed for the PMN substance. The submitter withdrew the
PMN from review, in the face of this likely regulatory action.
-46-
-------
PART C.
PMN I S WITHDRAWN
3.
PRIOR TO LIKELY SECTION 5(f) ACTION
MANUFACTURED DOMESTICALLY
-47-
-------
PMN's WITHDRAWN PRIOR TO LIKELY SECTION 5(f) ACTION
MANUFACTURED DOMESTICALLY
84-841
Chemical Name:
Modified Epoxy Resin
EPA proposed to ban this PMN under section 5(f) on the hasis
of oncogenicity, mutagenicity, and fetotoxicity concerns and
significant exposure. The submitter opted to withdraw the PMN
rather than accept the terms of the section 5(f) action.
-49-
-------
PART C.
pi fAne "'~~I""f'l To
'- vI:.:. /i,'-I un \ j .
~CIC / OT::; Ci-iU/IICP.L LI2':-?ARi
401 M ::;-:-., S. W., TS - 793 .
WAr/I' ,V,'--n 'I
0-",~"j:., D.C. 20460
PMN'S WITHDRAWN
4.
PRIOR TO LIKELY SECTION 5(f) ACTION
IMPORTED
-51-
-------
PMN'S WITHDRAWN PRIOR TO LIKELY SECTION 5(f) ACTION
IMPORTED
84-576
Chemical Name:
4,4' ,6-Trimethyl-2-(1-propenyl)-1,3-dioxane
(cis- and trans-)
The submitter withdrew in face of a section 5(f) Order to ban
the PMN until testing was submitted. There were oncoqenicity
concerns and widespread exposure concerns for this chemical.
-53-
-------
Table 1.
Annual Compilation of PMN Program Actions
Through June 30, 1985
I
U'1
U'1
J
FY'79 FY'80 FY'81 FY'82 FY'83 FY'84 FY'85 'lb ta 1
Valid PMN's Received 8 281 580 839 1301 1 , 1 92 1 , 1 06 5,307
7
5(e) Orders Issued 0 2 (7 PMN' s) 0 1 (2 PMN' s) 2 ( 4 PMN' s) 1 (1 PMN) 1 (1 PMN) (15 PMN's)
54
Consent 5(e) 0 0 0 1 ( 2 PMN' s) 8 (12 PMN's) 19 (40 PMN's) 26 (36 PMN's) (90 PMN' s)
Orders Issued
3
5 ( f) Rules Issued 0 0 0 0 0 3 (4 PMN's) 0 (4 PMN's)
Informal Action - 0 1 10 5 42 20 12 90
Voluntary Testing
PMN's Withdrawn
In Face of Likely 0 1 1 1 18 34 22 77
5(e) Order
PMN' s Withdrawn
In Face Of Likely 0 0 0 1 2 1 1 5
5(f) Order
Total 0 9 11 11 78 100 72 281
*As of June 30, 1985
-------
Table 2: Percentage of Commencement of Manufacture Notices* Received**
Ul
-------
Table 3.
Annual Compilation of PMN Activities by Specific Concern
FY 1984
TOXICITY CONCERN
Voluntary wi thdrawn in
Testing ~5(e) Order the face of a
~5(e) Order
Domestic Import Domestic Import Domestic Import
carcinogenicity/
Mutagenicity 2 7 32 3 6 13
Teratogenicity/
Fetotoxici ty /
Reproductive Effects 2 0 14 1 3 1
Liver/Kidney 0 0 8 0 1 0
Neurotoxicity 3 0 0 0 1 1
Acute Effects 1 0 9 0 0 0
Other Chronic
Toxici ty 0 0 3 0 0 0
Ecotoxici ty 3 2 1 0 0 6
CONCERN FOR EXPOSED POPULATIONS
Voluntary wi thdrawn in
Testing ~5(e) Order the face of a
~5(e) Order
Domestic Impor t Domestic Import Domestic Import
Workers 3 4 40 3 4 9
Consumers 2 0 1 0 0 1
Environment 0 3 0 0 0 5
General Population 0 1 0 0 0 1
-57-
-------
Table 3.
Annual Compilation of PMN Activities by Specific Concern
FY 1985*
TOXICITY CONCERN
Voluntary Withdrawn in
Testing ~5(e) Order the face of a
~5(e) Order
Domes.ti c Import Domestic Impor t Domestic Import
Carcinogenicity/
Mutagenicity 1 6 23 4 8 5
Teratogenicity/
Fetotoxicity/
Reproductive Effects 0 0 7 0 2 0
Liver/Kidney 0 0 9 0 3 0
Neurotoxicity 0 0 4 0 3 1
Acu te Effects 3 0 6 0 0 0
Other Chronic
Toxici ty 1 0 5 0 1 0
Ecotoxicity 4 0 1 0 4 0
CONCERN FOR EXPOSED POPULATIONS
Voluntary Wi thdrawn in
Testing ~5(e) Order the face of a
~5(e) Order
Domestic Import Domestic Import Domestic Import
Workers 1 0 30 4 6 2
Consumers 1 0 6 0 0 0
Environment 0 0 2 0 0 0
General Population 0 0 2 0 0 0
*As of June 30, 1985
-58-
-------
feble 4. Historical Compilation of Specific Concerns Underlying
Formal and Informal Regulatory tetion
Domestic U.S. Import Chemicals
TOXICITY CONCERN
Carcinogenic! ty/Mutagenicity
Terafogenicity/Fetoxicity
Reproductive Effects
Liver/Kidney
Neurotoxicity
Acute Effects
Other Chronic Toxicity
Bcotoxicity
Ft' 80
Domestic
16
3
0
0
4
1
6
Import
0
0
0
0
0
0
0
FY' 81
Domes tic
6
0
0
1
17
0
1
Import
2
0
0
0
2
0
1
FY' 82
Domestic
9
2
7
1
19
4
2
Import
5
0
0
0
2
0
0
FY' 83
Domestic
29
3
15
4
8
0
12
Import
12
4
0
0
1
0
1
FY' 84
Domestic
43
19
9
4
10
3
4
Import
26
0
0
1
0
0
8
FY'85
Domestic
32
9
12
7
9
7
9
Import
15
0
0
1
0
0
0
•totals
Domestic
135
36
43
17
67
15
34
Import
60
4
0
2
5
0
10
CONCERN FOR EXPOSED POPULATIONS
Worker
Consumer
Environment
General Population
FY'
Domestic
14
3
6
0
80
Import
0
0
L °
0
FY'
Domestic
16
3
1
1
81
Import
4
1
0
2
FY'
Domestic
15
6
3
2
82
Import
4
2
1
2
FY' 8:
Domestic
39
3
13
4
1
Import
15
0
1
3
FY'
Domestic
47
3
0
0
84
Import
16
1
8
1
FY'S
Domestic
37
7
2
2
5
Import
6
0
0
0
Tote
Domestic
168
25
25
9
ils
Import
45
4
10
8
•Through June 30, 1985
-------
CHEMICAL CLASSIFICATION
OF ACTIONS TAKEN
DYES & DYE
INTERMEDIATES
ACRYLATES
CATION1C
POLYMERS
HETEROCYCLIC
COMPOUNDS
HALOGENATED
COMPOUNDS
17%
20%
3%
10%
21%
I
CTi
O
I
CARBOXYLIC
ACIDS
1%
GLYCOL
ETHERS
1%
EPOXIDES
10%
OTHER
17%
-------
1600
1400
1200
II!
I 1000
'M
j 800
600
400
200
o
1600
1400
1200
II!
f 1000
'M
J
800
600
400
200
o
Rate of ~C7tlth fer Valid PMNs Received
by EPA since Program Inception
1979
1981
1980
1983
1984 1985 *
* (Flsc21 Year ProJection)
1982
FY RoINs Received
Danestic/Inpcrt PMNs
Valid
PftiIs
D
I
1979
1980
1981
1982
1983
1984
1985
880
281 273 8
580 502 78
839 701 138
1301 1071 230
1192 948 244
1500 1125 375
= - Valid PMNs
- Danestic
- Inpcr t
F'f7 9
FY81
FY83
FY84
* (Fiscal Yeo!lr Projection)
"" u.s. GOVERNMENT PRINTING OFFICE: 1985 -487-937/42074
PMNs t1y Fiscal Year
-61-
-------
Official Business
Penalty for Private Use
$300
THIRD CLASS
......
o
<:)
I
~ ~.
o 18
:(}~ CY)
-
o
\0
1/1
~
p.,
~
&EPA
TS-794
United States
Environmental Protection
Agency
Washington. DC 20460
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