Chemicals
in Progress
VOLUME 13 /N0.2
SEPTEMBER 1992
745N92002
ulletin
OFFICE OF POLLUTION PREVENTION AND TOXICS
U.S. ENVIRONMENTAL PROTECTION AGENCY
highlights
2 Organizations Recognized for
Outstanding Achievement in
Preventing Pollution
10 Study Finds CBI Claims Limit
Access to TSCA Data
12 Proposal of New Biotechnology
Regualations Planned
16 Summary of Existing Chemicals
Program's RM2 Process
TRI Releases Decrease by 600 Million Pounds in 1990
In May 1992, EPA announced that industrial releases of toxic chemicals to the
nation's environment declined by 600 million pounds, or 11 percent, from
1989 to 1990. The decline is reported in the initial results of the 1990 Toxics
Release Inventory (TRI). The 23,648 industrial facilities reporting to TRI
released a total of 4.8 billion pounds of toxic chemicals to the nation's environ-
ment in 1990.
"We continue to be encouraged by the downward trend in TRI data," said EPA
Administrator William K. Reilly. "Only the United States has a program that
is founded on the principle of the community's right to know and that provides
a publicly accessible multimedia database of toxic releases to the environment.
The successes of the TRI program have attracted international attention, and
the U.S. experience with TRI has advanced the case for right-to-know prin-
ciples," Mr. Reilly said.
A summary of the 1990 TRI data shows that 2.2 billion pounds of toxic chemi-
cals were released to the air, a decrease of 14 percent from the 1989 total of 2.5
billion pounds. Releases to the land dropped 3 percent, from 454 million
pounds in 1989 to 440 million pounds in 1990. Releases to the nation's rivers,
lakes, streams, and other bodies of water increased by 2 percent, or 4 million
pounds, in 1990.
Releases to some especially sensitive ecosystems also declined. From 1989 to
1990, for example, total releases of toxic chemicals into the Great Lakes Basin
declined by 20 percent. Total releases in states bordering the Gulf of Mexico
decreased by 9 percent, and in states bordering the Chesapeake Bay, releases
dropped by 20 percent.
The TRI data serve two broad purposes.
First, TRI is a source of information on the amounts, locations, and types of
toxic emissions. The information is useful to citizens who are interested in
TRI Releases continued on page 8
VOL.13 /N0.2 SEPTEMBER 1992
-------
Pollution-Prevention Activity
Seventeen Win EPA Awards for Preventing Pollution
On May 13, 1992, EPA Administrator
William K. Reilly presented
Administrator's Awards to 17 organi-
zations for outstanding achievements
in preventing pollution. The
Administrator's Awards were estab-
lished in 1991 to recognize excellence
in efforts toward a cleaner environ-
ment. Last year, the awards focused on
recycling.
"Pollution prevention is a central part
of the Bush administration's environ-
mental strategy for protecting human
health and the environment," Mr.
Reilly said in announcing the award
winners.
"We are delighted with the tremen-
dous response to this year's awards
program and with the high quality of
pollution-prevention projects, which
made selection of our winners a very
difficult task. In fact, all of the final-
ists were outstanding," Mr. Reilly said.
Winners were awarded in the follow-
ing categories: environmental, com-
munity, and nonprofit organizations;
large and small business; educational
institutions; federal government; state
government; and local government.
EPA regional offices received more
than 840 applications for the awards.
The regional administrators chose 225
of these for further consideration. A
panel of pollution-prevention experts,
convened by the independent group
Renew America, narrowed the field to
35 finalists, and Mr. Reilly chose the
17 award winners.
Award winner profiled on page 3.
I Administrator's Award Winners
Organization
Program
State
Environmental, nonprofit, and community organizations
Inform, Inc. Chemical Hazards Prevention Program
North Carolina Alternative Energy-Efficient Lighting for Poultry
Energy Corp.
Green Star Program
Alaska Center for
the Environment
Small and large business
Kryptonics, Inc.
Statler Tissue Co.
IBM Corp.
Chrysler Corp.
Mead Corp.
Eastman Chemical
Local government
Orange County
Bourne, Plymouth, and
Wareham Planning Boards
Osage Municipal Utilities
State government
Department of Natural
Resources
Department of Economic
and Community Development
Federal government
U.S. Navy
U.S. Air Force
Educational institution
Virginia Polytechnic Institute
Mold Release Spray System
Hazardous Materials Minimization Program
Aqueous Processes Eliminate CFC Use
for Disk Drive Parts Cleaning
Jefferson North Assembly Plant Design
Volatile Organic Compound
Reduction Program
Texas Eastman Pollution Prevention
Program
Pollution Prevention Sanitation District
Buttermilk Bay Nitrogen Overlay
Protection District
Demand-Side Management Project
Agricultural-Energy-Environmental
Initiative
Energy Management Technical
Assistance Program
Development and Implementation
of Unicoat
Comprehensive Pollution Prevention
Program
Agricultural Nonpoint Source Pollution
Prevention
New York
North Carolina
Alaska
Colorado
Maine
California
Michigan
Georgia
Texas
California
Massachusetts
Iowa
Iowa
North Carolina
Pennsylvania
Washington
Virginia
CHEMICALS IN PROGRESS
-------
Y
Pollution-Prevention Activity
EPA Region 7 Expands the 33/50 Concept
A community-oriented approach to
reducing toxic emissions is gaining a
foothold in some parts of the nation.
Facilities in six counties and four
metropolitan areas in the Midwest are
working to voluntarily cut their ag-
gregate toxic releases from 425.4
million pounds in 1988 to 281.6
million pounds in 1995.
Over 550 facilities are expected to
participate in the program, which
covers the more than 325 toxic
chemicals reportable to the Toxics
Release Inventory (TRI). The agree-
ments will achieve the reductions
years ahead of what the Clean Air Act
Amendments of 1990 and other laws
require.
The largest commitment received to
date is from Sedgwick County, Kan-
sas, where McConnell Air Force Base
and 2 5 companies are participating in
the program. If the facilities meet
their targets, their TRI emissions
will drop from 152 million pounds in
1988 to 10.4 million pounds in
1995, a 93 percent reduction. Re-
ductions will result from recycling,
point-source reduction projects, pro-
cess changes, conservation, and sub-
stitution of materials.
Part of national strategy
EPA believes that voluntary efforts to
prevent pollution have a great poten-
tial for reducing risks. In the 33/50
Program, initiated in January 1991,
the agency asked industry to volun-
tarily reduce releases of 17 toxic
chemicals. Staff in EPA's Region 7,
which encompasses Iowa, Kansas,
Missouri, and Nebraska, decided to
Region 7 continued on page 4
Profile of an Administrator's Award Winner
Mead Packaging Division
The Mead Corporation's packaging
division won the EPA Adminis-
trator's Award for reducing its emis-
sions of volatile organic compounds
by more than 900,000 pounds. The
reduction took place over 15 years
and reflects the company's
longstanding commitment to prevent
pollution.
In 1975, the management of Mead
Packaging Division decided to switch
from solvent-based inks to water-
based inks at all five of its plants.
Concerns had been raised about the
toxicity of methyl ethyl ketone and
toluene, constituents of the solvent-
based inks. These substances also
contribute to volatile organic com-
pound (VOC) emissions, which con-
tribute to ozone pollution.
Few water-based inks were available
in 1975. So, the packaging division
set out to develop the inks, coatings,
and application techniques that were
needed. Since the effort began, the
Mead Corporation has reduced its
VOC emissions by over 85 percent.
The company has also begun to sell its
water-based inks and varnishes, help-
ing other companies cut VOC emis-
sions.
The Mead Corporation participates in
EPA's 33/50 Program to achieve vol-
untary reductions of toxics, and the
company is continuing to seek ways to
minimize or eliminate pollution.
VOL.13/N0.2 SEPTEMBER 1992
-------
Pollution-Prevention Activity
Region 7 continued from page 3
develop a similar program with a
geographic focus.
Region 7 staff pinpointed the areas in
each state with the highest TRI re-
leases. EPA Regional Administrator
Morris Kay and state environmental
program directors then asked repre-
sentatives from facilities associated
with TRI releases as well as facilities
not required to report to TRI (in-
cluding federal facilities and utility
companies), county and local officials,
and representatives from trade orga-
nizations and public interest groups
to make an areawide commitment to
reduce total toxic releases and trans-
fers by 50 percent by 1995.
"We made it easier to see the connec-
tion to long-term benefits for their
own communities," said Carl Walter,
33/50 Program coordinator for Re-
gion 7. For instance, Mr. Walter
said, McConnell Air Force Base,
which as a federal facility is not re-
quired to report to TRI, was "eager
to participate and work to make the
community better."
At meetings held in 10 geographical
areas, one or more participants volun-
teered to take the lead in organizing
the group and setting emissions-
reduction goals. Region 7 staff are
supporting the voluntary efforts by
providing information about waste
minimization, pollution prevention,
and technology.
Getting the jump on meeting
federal requirements
The Clean Air Act Amendments of
1990 and other statutes are tighten-
ing the controls on toxic releases to
the environment. "A number of
facilities are looking at the environ-
mental regulations corning down the
road and searching for ways to meet
them," Mr. Walter said.
EPA believes that
voluntary efforts to
prevent pollution have
a great potential for
reducing risks.
"I don't think we can write enough
regulations to control everything.
Voluntary programs like this one
give companies a bookkeeping
method to look at what they are do-
ing to the environment and a stimu-
lus to try to improve," Mr. Walter
said.
Activity in other geographic areas
In addition to Sedgwick County,
industrial facilities in nine other
areas, listed below, are working to
formulate 1995 release-reduction
goals. Several of these areas cross
state boundaries, and senior officials
from these states, EPA Region 5, and
EPA Region 7 are working
collaboratively to achieve the goals.
St. Louis metropolitan area (Mis-
souri and Illinois)
Lancaster County and Lincoln (Ne-
braska)
Polk County and Des Moines
(Iowa)
Quad Cities metropolitan area
(Bettendorf, Iowa; Davenport,
Iowa; Rock Island, Illinois; Moline,
Illinois)
Kansas City metropolitan area
(Kansas and Missouri)
Douglas County and Lawrence
(Kansas)
Black Hawk County, Waterloo,
and Cedar Rapids (Iowa)
Omaha/Council Bluffs metropoli-
tan area (Nebraska and Iowa)
Springfield and Green Counties
(Missouri)
For more information
To obtain more information about
EPA Region 7's pollution-prevention
initiative, contact Rowena L.
Michaels, director, Office of Public
Affairs, U.S. EPA, Region 7, 726
Minnesota Avenue, Kansas City,
Kansas 86101; telephone, (913) 551-
7003.
CHEMICALS IN PROGRESS
-------
Pollution-Prevention Activity
Pollution Prevention Information Clearinghouse
Information on source reduction and
recycling in the United States and
internationally is available from
EPA's Pollution Prevention Informa-
tion Clearinghouse. The clearing-
house consists of a pollution-preven-
tion hotline, a repository of docu-
ments, and a number of databases
available through a computer net-
work.
Pollution-prevention hotline
Technical specialists are available to
help locate and provide general and
industry-specific information and to
assist users of the clearinghouse's
electronic network. The Pollution
Prevention Information Clearing-
house Technical Assistance Service
(pollution-prevention hotline) oper-
ates Monday through Friday, from 9
a.m. to 5 p.m. Eastern time.
Information repository
The clearinghouse repository contains
state, national, and international
information on reducing or eliminat-
ing industrial hazardous waste. The
pollution-prevention hotline provides
information searches of the repository
when requested and sends materials
to the public. To obtain a list of
documents available for distribution
from the repository, contact the
hotline.
Pollution Prevention Information
Exchange System (PIES)
PIES is an interactive network that is
available free to users 24 hours a day.
PIES provides access to
hundreds of case studies on reduc-
ing pollution;
a bulletin board for exchanging
information with other PIES users;
a directory of more than 400 state
and federal pollution-prevention
contacts;
summaries of corporate, state, and
federal pollution-prevention grant
programs, research projects, and
training and outreach activities;
information about state and federal
pollution-prevention legislation
that has been introduced or signed
into law; and
a number of mini-exchanges on
specialized topics.
How to access PIES
PIES can be accessed through any
personal computer equipped with a
1200-baud or 2400-baud modem and
appropriate communications soft-
ware. The specifications needed to
access PIES are
NUmber (703) 506-1025
MOde Call
DAta
PArity
STop
GO
8
N
1
A free PIES User Guide is available
from the pollution-prevention
hotline.
Access to PIES is free
There is no charge for using PIES,
but use is limited to one hour a day
for each user.
State and local governments can ac-
cess PIES using a toll-free number.
To obtain the number, call (703)
821-4800.
PIES can also be accessed through a
local call from anywhere in the
United States or internationally via
SprintNet. To obtain local-access
information, call (800) 877-5045.
How to obtain information
By phone. The pollution-preven-
tion hotline can be reached at (703)
821-4800.
By FAX. Requests for documents
can be faxed to the clearinghouse at
(703) 821-4775.
By mail. Documents can be re-
quested by writing to Pollution
Prevention Information Clearing-
house, Science Applications Inter-
national Corporation, 7600A
Leesburg Pike, Falls Church, Vir-
ginia 22043.
Through a computer bulletin
board. Documents can be ordered
by leaving a message on the PIES
bulletin board.
Other resources for information about
hazardous waste minimization
The Resource Conservation and
Recovery Act/Superfund
Hotline: (800) 424-9346
The Small Business Ombudsman
Hotline: (800) 358-5888
VOL.13/N0.2 SEPTEMBER 1992
-------
Design for the Environment
Information will Help Small Companies Make Environmentally Sound Decisions
The Office of Pollution Prevention
and Toxics (OPPT) has developed a
program to provide information
about chemical risks to small busi-
nesses. The information will help
owners and managers of small busi-
nesses weigh the use of one chemical
over another, compare the benefits
and disadvantages of different pro-
cesses and technological alternatives,
and take actions to reduce the pollu-
tion their companies generate.
OPPT's efforts are part of its Design
for the Environment (DfE) initiative.
The goal of the DfE initiative is to
encourage industry to voluntarily
shift toward designing chemicals,
processes, and end products that are
environmentally sound.
DfE activities for small business are
focused on three industries: dry
cleaning, printing, and aerosol spray
paint manufacturers. OPPT's objec-
tive is to provide information from
preliminary screening of chemicals to
businesses quickly, so they can put it
to use, rather than waiting until full
studies are completed. OPPT will
disseminate this preliminary screen-
ing information, as well as other
pollution-prevention information, to
small businesses through trade asso-
ciations, video teleconferences, and
other means, as appropriate.
Printing Companies Join EPA In Pollution-Prevention Project
In choosing products for individual
applications, printers work with
chemicals contained in hundreds of
inks and solvents. Frequently, print-
ers use these products without access
to information about the comparative
risks of the chemicals they contain.
Last year, Printing Industries of
America, an industry trade group,
asked EPA to help (1) identify safer
substitutes and work practices for
printers and (2) sort out the myriad
environmental regulations printing
companies must comply with.
EPA's Office of Pollution Prevention
and Toxics (OPPT) responded by
developing a joint EPA-industry
project to provide printers with infor-
mation on the comparative risks of
alternative chemicals, processes, and
technologies. This information will
allow printing companieswhich
generally are small businesses and
unaware of the pollution they gener-
ateto make informed choices about
establishing safer operations. The
joint pollution-prevention program is
part of OPPT's Design for the Envi-
ronment (DfE) initiative.
Project activities
EPA and representatives from the
printing industry launched the
project with two meetings in the
summer of 1992. At the meetings,
EPA outlined how the printing
project is developing pollution-pre-
vention information for the printing
industry. The agency also asked rep-
resentatives from graphic arts trade
associations, chemical and equipment
suppliers and manufacturers, printing
companies, and other interested par-
ties to join the industry-EPA effort.
Almost all of the more than 90 people
who attended the meetings signed up
for follow-up subcommittee sessions.
Specific project activities include
assessing the potential risks from
chemicals and processes used in
printing;
developing testing protocols to
evaluate how well substitute chemi-
cals and processes perform;
seeking printers to use substitute
chemicals and processes;
working with industry to develop
pollution-prevention materials pro-
moting use of safer chemicals, tech-
nologies, and work practices; and
developing the means to communi-
cate information to small- and me-
dium-sized printing companies,
including pollution-prevention
manuals and a nationwide video-
teleconference scheduled for 1993.
Integrated permit
EPA is studying the possibility of
developing a single cross-media permit
(covering discharges to air, water, and
land) that will help small printing
companies comply with all relevant
EPA regulations. At present, many
small printing operations are confused
by the multiple regulations governing
discharges to environmental media.
Printing continued on page 7
CHEMICALS IN PROGRESS
-------
Design for the Environment
Roundtable Held on Pollution Prevention in the Dry Cleaning Industry
A growing awareness of potential risks
from solvents used in dry cleaning has
prompted dry cleaning operators,
trade associations, and governments to
act. Examining options for prevent-
ing or controlling pollution from dry
cleaning solvents was the subject of an
international roundtable held in May
by EPA's Office of Pollution Preven-
tion and Toxics (OPPT).
Options for reducing PCE exposures
The cleaning solvent perchloroethyl-
ene (PCE) is a pollutant of particular
concern for the dry cleaning industry.
In the United States, about 28,000
dry cleaning machines use PCE,
which is a possible carcinogen. Do-
mestic and international studies have
found elevated levels of PCE in food
and air in apartments and food estab-
lishments located near dry cleaning
facilities; elevated PCE concentrations
in homes due to freshly dry-cleaned
clothing; and PCE-contaminated soil
and ground water in California,
Florida, and Maryland.
Among the experts attending the
roundtable was a representative from
Germany, which has imposed strict
emissions restrictions on PCE. These
restrictions are designed to reduce
workers' exposures to the solvent and
to decrease concentrations of the sol-
vent in rooms adjacent to or near dry
cleaners. German manufacturers have
developed dry cleaning machines to
meet these emission requirements.
Experts from the Netherlands and
Japan also participated. Both coun-
tries regulate the dry cleaning industry
and have conducted extensive research
on dry cleaning technology and reduc-
ing residual solvent levels in clothing.
In the United States, PCE is among
the first group of pollutants that will
be regulated under the 1990 Clean Air
Act Amendments. The domestic dry
cleaning industry consists of small
businesses that are generally unaware
of their polluting practices or of ways
to prevent pollution. They may also
lack the capital to invest in environ-
mentally sound alternatives. Dry
cleaning industry associations have
been actively working since 1988 to
publicize environmentally sound man-
agement and disposal practices among
their members.
Sessions held
Also speaking at the roundtable were
researchers, representatives from state
and local governments in California,
New York, and New England, and
representatives from EPA, the Food
and Drug Administration, and the
Small Business Administration. Ses-
sions were held on the following
topics:
sources of dry cleaning exposures;
methods to reduce exposures;
regulatory approaches to exposure
reduction;
options for financing upgraded
equipment; and
communicating information about
risks.
For more information
For more information about the
roundtable or to obtain a copy of the
proceedings, contact Ohad Jehassi,
Economics and Technology Division
(TS-779), U.S. EPA, 401 M Street,
S.W., Washington, D.C. 20460;
telephone, (202) 260-6911; FAX,
(202)260-0981.
Printing continued from page 6
EPA expects to pilot the integrated
permit within the next year.
Coordination of regulations
OPPT Director Mark A. Greenwood
is heading an agencywide printing
cluster group that will coordinate
new EPA regulations to control land
and air pollution caused by printing
processes. The regulations, expected
to take effect in 1993 and 1994, will
be promulgated under the Resource
Conservation and Recovery Act
(RCRA) and the Clean Air Act
Amendments of 1990. The regula-
tions are expected to set (1) maximum
levels for emissions of 189 hazardous
air pollutants discharged by major
sources and (2) guidelines for control-
ling emissions of volatile organic com-
pounds from lithographic printers.
The agency is also considering new
solvent listings under RCRA provi-
sions for hazardous wastes from non-
specific sources (F listings).
To obtain additional information
about the project, contact Cathie
Ramus, Economics and Technology
Division (TS-779), U.S. EPA, 401 M
Street, S.W., Washington, D.C.
20460; telephone, (202) 260-1707;
FAX, (202) 260-0981.
VOL.13/N0.2 SEPTEMBER 1992
-------
Toxics Release Inventory
New Form R Required for TRI Reporting
EPA has revised Form R, which is
used by industry to report releases to
the Toxics Release Inventory (TRI).
The revised form includes new re-
porting elements for data EPA is
required by the Pollution Prevention
Act of 1990 to collect.
Form R submitters should use the
revised form to report TRI informa-
tion for the 1991 calendar year.
Forms published by EPA to report
TRI data for the years prior to 1991
do not include the new reporting
elements and should not be used.
Section 313 of the Emergency Plan-
ning and Community Right-to-
Know Act (EPCRA), which estab-
lished the TRI, requires reporting of
environmental releases and off-site
disposal of about 300 chemicals and
20 chemical categories.
EPCRA requires annual reporting of
the previous year's releases by July 1.
However, EPA was not able to obtain
approval of the new Form R from the
Office of Management and Budget
until May 19. EPA is aware that the
delay in the distribution of the re-
porting package has created concern
about potential enforcement actions
for those facilities reporting after the
July 1, 1992, deadline. In response
to these concerns, EPA will not ini-
tiate enforcement proceedings against
facilities that file accurate Form R
reports between July 1, 1992, and
September 1, 1992. Reports for the
1991 reporting year that are filed
after September 1, 1992, or that con-
tain inaccurate or incomplete infor-
mation may be subject to EPA en-
forcement, including, but not limited
to, civil penalties.
Key changes to reporting
The key changes to TRI reporting for
1991 are (1) off-site transfers of
chemicals for recycling and energy
recovery are now reportable and (2)
section 8 of Form R, which had re-
quested optional information on
waste minimization, has been ex-
panded and made mandatory. A
summary of the information that
section 8 requires follows.
Reporting is required on the indi-
vidual quantities of chemicals (1)
released on site and disposed of off
site, (2) treated on site and off site,
(3) used for energy recovery on site
and off site, and (4) recycled on site
and off site.
Separate reporting is required on
the quantity of chemicals released
to the environment through reme-
dial actions, catastrophic events,
and other one-time events. This
information should not be included
when reporting on individual
quantities of chemicals released,
treated, used for energy recovery,
and recycled on site or off site.
A ratio or index that indicates the
level of industrial production or
activity that generated reportable
quantities must be provided.
Information about source-reduction
activities that were implemented
for the reported chemicals during
the reporting year must be pro-
vided, along with the reason the
activity was implemented.
Facilities have the option to submit
additional information on source
reduction, recycling, or pollution-
control activities with Form R.
TRI Releases continued from page 1
determining the relative effect that
such releases may have on their health
and the environment. To support use
of data for this purpose, the state
rankings that appear in this year's
printed report were determined by
total facility releases, rather than by
combined release and off-site transfer
data as in the past.
The second purpose that TRI data
serve is to identify pollution-preven-
tion opportunities. For this purpose,
EPA has combined waste-generation
data, data on off-site transfers, and
data on releases. The agency has also
provided transfer data by state,
chemical, and industry. EPA believes
that the understanding of how waste
generation and off-site transfers con-
tribute to the total picture will im-
prove next year with the availability
of pollution-prevention data for 1991.
The TRI is required by the 1986
Emergency Planning and Commu-
nity Right-to-Know Act. Certain
industrial facilities that employ 10 or
more persons full-time must provide
annual emissions estimates for over
300 toxic chemicals and 20 chemical
categories if those facilities manufac-
ture, process, or use those substances
in excess of certain threshold
amounts. EPA received over 83,000
reports for 1990.
CHEMICALS IN PROGRESS
-------
Toxics Release Inventory
How to Obtain TRI Data
ThrOUQh a Computer network. Online access to national and state TRI data is available from the National Library of
Medicine's TOXNET. To obtain an account, call (301) 496-6531, or write TRI Representative, Specialized Information
Services, National Library of Medicine, 8600 Rockville Pike, Bethesda, Maryland 20894. Account holders also have
access to other National Library of Medicine databases on toxicology, health, and chemical substances.
At the library. Access to state TRI data is available at most federal depository and county public libraries. The deposi-
tory libraries holding the fiche or CD-ROM in their collection are listed in Federal Depository Libraries: Your Source for the
Toxic Release Inventory; the names and addresses of the public libraries that have TRI on fiche are listed in the Directory of
Public Libraries. To obtain a list of the libraries that provide TRI access or to obtain the brochure Public Access to the Toxic
Release Inventory, call EPA's EPCRA Information Hotline at (800) 535-0202 or (703) 920-9877.
By purchasing one of these formats: CD-ROM, microfiche, diskette, magnetic tape, or written report. These formats
can be purchased from the National Technical Information Service (NTIS), the U'.S. Government Printing Office
(GPO), or the Department of Commerce (DOC). Listed below are the years for which the data are available. For addi-
tional information, please contact NTIS at (703) 487-4650; GPO at (202) 783-3238 (microfiche, CD-ROM, and report
form) or (202) 275-0186 (magnetic tape and diskette); or DOC at (202) 377-1986 (CD-ROM).
TRI Data Available for Purchase*
NTIS
GPO
DOC
CD-ROM
1989 complete
report (included in
the "National
Economic, Social,
and Environmental
Data Bank")
Microfiche
Diskette
Magnetic Tape Report
1987 national
inventory
1987-1 989 national
inventory
1 987 national 1 987 national
inventory inventory
1987-1989 1988 national
national inventory inventory
1987 and 1988
individual state
1987, 1988, 1989
national inventory
1987, 1988, 1989
individual state
1988 and 1989
national inventory
1988 and 1989
individual state
1987 national
inventory
1988 national
inventory
1989 national
inventory
1990 national
inventory
1987 national
inventory
1988 national
inventory
1989 national
inventory
1990 national
inventory
1987 complete
report
1987 executive
summary
1987 complete
report
1 987 executive
summary
1988 complete
report
1989 complete
report
* Order numbers can be obtained from the Emergency Planning and Community Right-to-Know Act (EPCRA) Information Hotline at (800) 535-0202 or (703) 920-9877.
VOL.13/N0.2 SEPTEMBER 1992
-------
TSCA Confidential Business Information
Study Examines Effects of CBI on Access to TSCA Data
IMD Director Travers Discusses Results of Research
Last year, the Office of Pollution
Prevention and Toxics (OPPT) com-
missioned a study to review confiden-
tial business information (CBI) regu-
lations and procedures for data sub-
mitted under the Toxic Substances
Control Act (TSCA). The objective
of the study was to determine how
TSCA's CBI requirements affect
OPPT's programs. In the following
interview, Linda A. Travers, director
of OPPT's Information Management
Division (IMD), discusses the find-
ings of the study.
Q: Why did you undertake the study?
MS. Travers: TSCA allows companies
to claim information submitted to
EPA as confidential, provided the
information meets certain criteria.
There has been a tremendous increase
in the number of CBI claims in the
past 15 years. We were concerned
that many of the claims are inappro-
priate and therefore deny the public
access to information to which they
would otherwise be entitled. In addi-
tion, there are large costs to EPA to
protect CBI.
Q: What were the overall findings of
the study?
MS. Travers: Overall, the study found
that CBI claims severely limit access
to TSCA data, that the majority of
claims have not been substantiated,
and that a significant fraction of the
claims do not appear to be support-
able under the statute. From 1977 to
1990, the volume of CBI claims sub-
mitted to the agency increased dra-
matically. The study confirmed that
the number of CBI claims denies the
public access to a large amount of
TSCA data and requires the agency to
spend additional funds to keep the
information secure.
"We will explore both
regulatory and
nonregulatory methods
of reducing unnecessary
CBI claims."
Linda Travers
Q: How much information is actually
claimed as CBI?
MS. Travers: An extremely large per-
centage of TSCA data is claimed as
CBI, including more than 90 percent
of all premanufacture notices for new
chemicals and more than 95 percent
of all polymer exemption submis-
sions. Additionally, over 25 percent
of all substantial risk notifications
and over 20 percent of all health and
safety studies are submitted as CBI,
which defeats the purpose of notify-
ing the public about chemicals of
concern.
The problem appears to be somewhat
specific to TSCA CBI. A comparison
between the Toxics Release Inventory
(TRI) and the TSCA Preliminary
Assessment Information Rule, two
comparable information-collection
systems, suggests that TSCA data are
subject to substantially more confi-
dential claims than TRI data. The
study also found that some of the
data claimed as CBI under TSCA
may be available under TRI. We
have discovered that many CBI
claims are submitted because compa-
nies are unsure as to what are legiti-
mate claims. We began a CBI Chal-
lenge Program two years ago, and
companies have withdrawn or modi-
fied their CBI claims in every case
that EPA attorneys have challenged.
Q: How do CBI claims affect OPPT and
its program?
MS. Travers: Besides placing a signifi-
cant burden on OPPT in terms of
CBI handling costs, the sheer volume
of CBI claims restricts the amount of
information the public can obtain
about chemicals. An excellent ex-
ample is silicone. EPA provided the
Food and Drug Administration with
all of our non-CBI information on
silicone. However, the agency has
additional confidential silicone infor-
mation that the public could find
valuable if there were a way it could
be released.
CHEMICALS IN PROGRESS
-------
TSCA Confidential Business Information
Q: Does the study make any specific
recommendations?
MS. Travers: The study does not make
actual recommendations but instead
identifies a number of different strat-
egies that either Congress or EPA can
undertake. Congressional options
include statutory authority to make
so-called class determinations of what
will and will not be accepted as confi-
dential, adopting the trade-secret
framework used in the Emergency
Planning and Community Right-to-
Know Act (EPCRA), authorizing the
sharing of CBI with state govern-
ments, and enacting sunset provisions
for CBI claims. Options for the
agency include promulgating regula-
tory class determinations, streamlin-
ing burdensome agency procedures
for handling CBI, issuing report
cards on individual companies' CBI
claims patterns, requiring upfront
substantiations of CBI claims, issuing
regulatory sunset provisions, and
requiring fees for CBI claims.
Q: What do you mean by class
determinations?
MS. Travers: By classifying the types
of information that we will and will
not accept as confidential, we would
be able to identify frivolous or clearly
invalid claims at the time of submis-
sion, thus saving resources. For ex-
ample, the agency could prohibit
claims that a chemical name is confi-
dential business information when
health and safety studies are submit-
ted under section 8(e) of TSCA. Au-
thority for use of class determinations
can be either statutory or regulatory.
Q: What is a sunset provision?
Ms. Travers: A sunset provision
would limit how long a claim could
remain confidential. For example,
instead of a CBI claim in a
premanufacture notice remaining
CBI forever, the claim would expire
in, say, four or five years. Each type
of claim could have a different expira-
tion date, based on the importance of
its remaining confidential. Of
course, a claim could remain confi-
dential longer than the standard pe-
riod for that type of claim if the com-
pany submits a substantiation of why
it must remain CBI.
Q: How does OPPT plan to proceed?
MS. Travers: While Congress is con-
sidering amending TSCA, which
might change CBI procedures, OPPT
will go ahead and implement some of
the strategies discussed in the study.
We will explore both regulatory and
nonregulatory methods of reducing
unnecessary CBI claims. We will
also discuss voluntarily limiting CBI
claims with industry.
Q: What will be the benefits of
reducing the CBI burden?
Ms. Travers: The program will really
benefit everyone. Declassifying more
of our CBI data will help industry
and the public better understand our
decision and rulemaking processes.
What we are trying to eliminate are
unnecessary CBI submissions. It just
doesn't make sense for a company to
submit information under TSCA as
CBI and then turn around and sub-
mit the same information under
EPCRA or to another federal agency
without any restrictions. Of course,
OPPT will continue to protect valid
confidential claims. If a chemical
process is truly confidential business
information today, it will be treated
as confidential business information
tomorrow.
EPA will also experience enormous
savings since we provide the same
level of protection to a frivolous CBI
claim as we do to a valid CBI claim.
Clearly articulated CBI procedures
will also ease the burden on compa-
nies trying to determine what consti-
tutes a valid CBI claim. Overall, the
program will simplify procedures for
the agency and industry and provide
the public better access to the infor-
mation, which was Congress's inten-
tion in enacting TSCA.
VOL.13 /N0.2 SEPTEMBER 1992
-------
New Chemicals Program
EPA Continues to Review Microorganisms under 1986 Policy Statement
Agency Plans to Propose New Regulations
EPA is planning to propose new regu-
lations to fully implement its program
for microorganisms under the Toxic
Substances Control Act (TSCA). The
agency plans to send draft proposed
rules to the Office of Management and
Budget later this year. Until final
rules are promulgated, EPA will con-
tinue to assess living microorganisms
under its 1986 policy statement,
which was issued as part of an
interagency statement on federal regu-
lation of biotechnology.
This article (1) provides information
about the current requirements of
EPA's biotechnology program and (2)
indicates how the draft proposed rules
would affect current requirements.
Microorganisms are regulated
under TSCA
TSCA authorizes EPA to regulate all
chemical substances except those cov-
ered by other federal laws or under the
jurisdiction of other agencies. EPA
considers living microorganisms to be
chemical substances subject to review
under TSCA just as traditional chemi-
cals are. EPA assesses new microor-
ganisms produced for environmental,
industrial, or consumer uses that are
subject to TSCA. These uses include
bioremediation of Superfund sites,
enhanced oil recovery, metal extrac-
tion and concentration, and specialty
chemical production.
The agency is proposing new rules
that specifically address potential risks
posed by certain new microorganisms
because the concerns they raise differ
from those raised by traditional
chemicals.
Microorganisms subject to review
under section 5 of TSCA
Current requirements. TSCA section 5
mandates review of new chemical
substances. The statute defines a
"new chemical substance" as any sub-
stance not listed on the TSCA Chemi-
cal Substance Inventory, commonly
referred to as the TSCA Inventory.
The inventory is a compilation of
chemical substances that were in the
U.S. marketplace in 1975 or have
since entered the marketplace.
Anyone who plans to manufacture or
import a new chemical substance
must submit a premanufacture notice
(PMN) to EPA at least 90 days prior
to the activity. The New Chemicals
Program, which is part of the Office
of Pollution Prevention and Toxics
(OPPT), reviews PMN submissions
and identifies new chemical sub-
stances that require regulatory action.
In determining which microorgan-
isms warrant PMN review, EPA first
differentiated microorganisms that
occur in nature from genetically
modified microorganisms. (The
agency's policy is to treat naturally
occurring traditional chemicals and
naturally occuring microorganisms as
if they are listed on the TSCA Inven-
tory.) EPA then distinguished be-
tween microorganisms that have been
modified to contain different genera-
called intergeneric microorganisms
and other genetically modified micro-
organisms.
The agency determined that interge-
neric microorganisms are the microor-
ganisms most likely to exhibit traits
and behaviors not found in nature.
The unpredictability of their behav-
ior presents significant uncertainties
about their risks. In the 1986 policy
statement, EPA defined "new micro-
organisms" as intergeneric microor-
ganisms. Since then, intergeneric
microorganisms have been subject to
PMN review.
The document Points to Consider in the
Preparation and Submission of TSCA
Premanufacture Notices (PMNs) for
Microorganisms contains guidance on
the subject. For information on how
to obtain the document, see the end
of this article.
Proposed changes. EPA's draft pro-
posed rules would require PMN sub-
missions for new microorganisms
that contain deliberately modified
hereditary traits. Microorganisms
would be excluded from reporting if
they are naturally occurring or fall
into one of four exclusion categories
that encompass microorganisms that
exhibit behaviors likely to be found
in nature. Excluding these categories
from PMN review would allow EPA
to focus on screening genetically
modified microorganisms that pose
greater potential risks.
Changes in significant new use rules
(SNURs) are also proposed. First, the
draft proposed rules would establish
reporting requirements for significant
new uses of new microorganisms. No
specific SNURs are proposed, how-
ever. Second, the agency proposes
dropping its current policy of re-
questing voluntary SNUR reporting
for new uses of certain nonagricul-
CHEMICALS IN PROGRESS
-------
New Chemicals Program
tural releases of pathogens. Until the
new rules become final, the current
policy remains in effect.
Exemptions from PMN reporting for
research and development
Current requirements. Section 5 of
TSCA allows EPA to exempt new
chemical substances manufactured in
small quantities for use solely in re-
search and development from PMN
and SNUR reporting requirements.
However, because small quantities of
microorganisms released into the
environment can reproduce and
spread beyond the amount originally
released, EPA in 1986 indicated it
planned to allow the exemption for
research and development to be ap-
plied only to new microorganisms
used in contained systems.
Since 1986, the agency has asked
companies engaged in research and
development to voluntarily (1) sub-
mit PMNs prior to releasing new
microorganisms into the environment
and (2) report any releases into the
environment of modified pathogens.
(For information about the research
and development exemption, see 40
CFR section 720.36.)
Proposed changes. The draft proposed
rules would (1) abbreviate the report-
ing process for research and develop-
ment involving environmental re-
leases; (2) continue to apply the re-
search and development exemption
only to research conducted in con-
tained structures; and (3) establish an
exemption process for certain envi-
ronmental research and development
activities. "Contained structure" is
defined broadly, so that structures
other than fermentation systems
would be eligible for inclusion.
Exemptions from PMN reporting for
use in closed systems
Current requirements. Section 5 of
TSCA allows EPA to exempt from
PMN reporting new chemical sub-
stances that the agency finds will not
present unreasonable risks. To date,
consistent with the 1986 policy state-
ment, the only new microorganisms
exempted from PMN reporting have
been those produced in small quanti-
ties solely for research and develop-
ment in closed systems.
Proposed changes. In 1986, EPA indi-
cated that it would explore exempt-
ing from PMN reporting general
commercial uses of new microorgan-
isms in closed systems, such as fer-
mentation systems. EPA has deter-
mined that new microorganisms used
in closed systems generally present
lower risks to human health and the
environment than do the same micro-
organisms released to the environ-
ment. The draft proposed rules
would exempt from PMN reporting
certain general commercial uses of
specified microorganisms in con-
tained structures. The microorgan-
isms and the specific criteria for the
exemption will be listed in the draft
proposed rules.
Reviews completed thus far
Since publication of the 1986 policy
statement, EPA has completed re-
views of 31 intergeneric microorgan-
isms. Twenty of these reviews were
for microorganisms used in field tests
for research and development. All
but one of these microorganisms
were nitrogen-fixing bacteria that
were genetically modified for en-
hanced nitrogen fixation and specific
antibiotic resistance. Through TSCA
section 5(e) consent orders, the PMN
Biotechnology continued on page 14
I Effect of Policy on
Bioremediation Industry
Bioremediation involves the use of
microorganisms to degrade persistent
and often toxic chemicals. To date,
the bioremediation industry has used
naturally occurring microorganisms,
which are not subject to
premanufacture notice (PMN) report-
ing. However, companies are seeking
to increase degradative capabilities of
microorganisms through development
of genetically modified microorgan-
isms.
Companies conducting research and
development using intergeneric mi-
croorganisms, which contain genetic
material from different genera, in
contained systems are exempt from
PMN reporting. EPA encourages
voluntary submission of a PMN be-
fore intergeneric microorganisms are
tested in the environment. Compa-
nies are required to submit a PMN to
EPA before an intergeneric microor-
ganism can enter commerce.
For more information, a contact is
provided at the end of the main ar-
ticle on page 14.
VOL.13/N0.2 SEPTEMBER 1992
-------
New Chemicals Program
Biotechnology continued from page 13
submitters in all of these cases agreed
to limit use of the intergeneric mi-
croorganisms to specific field tests.
EPA has reviewed data from the field
tests and found no harmful effects.
The other 11 PMN reviews were for
intergeneric microorganisms used as
intermediates in closed fermentation
systems to produce specialty chemi-
cals. In nine of these cases, no regu-
latory action was necessary. In the
other two cases, EPA allowed limited
production of the microorganisms
under test-marketing exemptions.
For more information
A draft of the proposed rules is avail-
able to the public as part of a package
of material prepared for a meeting of
EPA's Biotechnology Science Advi-
sory Committee in June 1991- The
draft proposal and the Federal Register
notice describing EPA's current
policy (51 FR 23313, June 26, 1986)
are available from the TSCA Assis-
tance Information Service (TSCA
hotline). See page 38 for information
on contacting the hotline.
For information about whether spe-
cific microorganisms are subject to
reporting under section 5 of TSCA,
contact Ellie Clark at (202) 260-3402
or David Giamporcaro at (202) 260-
6362, or write to them at the follow-
ing address: Chemical Control Divi-
sion (TS-794), U.S. EPA, 401 M
Street, S.W., Washington, D.C.
20460; FAX, (202) 260-1216.
EPA Proposes PMN Rule
Amendments
Summaries of Meeting on Pollution Prevention
Are Available
EPA is proposing to amend four
regulations affecting new chemical
substances subject to agency review
under section 5 of the Toxic Sub-
stances Control Act (TSCA). Public
comment is being accepted on the
proposed amendments, which were
published in the Federal Register this
summer.
The proposed amendments would
affect the premanufacture notice
(PMN) rule, the polymer rule, the
low-volume exemption rule, and the
generic significant new use rule
(SNUR). (A more complete descrip-
tion of these proposed rules is in
Chemicals-in-Progress Bulletin, volume
13, number 1.)
Representatives from the chemical
industry, EPA, and environmental
groups attended a symposium in
Washington, D.C., in April to dis-
cuss how to encourage pollution pre-
vention during development of new
chemical substances. Among the
issues discussed were agency efforts to
incorporate pollution-prevention
information into review of new
chemicals and establishment of an
EPA award to industry to encourage
pollution prevention in the develop-
ment of new chemicals. Representa-
tives from Allied Signal Corporation
and 3M Corporation also presented
information about their companies'
new-chemical pollution-prevention
activities.
EPA's New Chemicals Program and
the Chemical Manufacturers Associa-
tion sponsored the symposium. Sum-
maries of the presentations and
breakout sessions are available from
the TSCA Assistance Information
Service (TSCA hotline). For informa-
tion on contacting the hotline, see
page 38.
Related article on page 15-
CHEMICALS IN PROGRESS
-------
New Chemicals Program
Pollution-Prevention Data Can Influence EPA's Review of New Chemical Substances
Whenever possible, EPA incorporates
pollution-prevention information
into its review of new chemical sub-
stances. The agency asks companies
to voluntarily include this informa-
tion on page 11 of the premanu-
facture notices (PMNs) they submit
to EPA before manufacturing or im-
porting a new substance. Providing
pollution-prevention information to
EPA may result in reduced regulation
of the new chemical if the informa-
tion sufficiently mitigates agency
concerns about the toxicity of the
new substance, human exposures to
the substance, and releases of the
substance to the environment.
Some pollution-prevention data,
however, are too vague for EPA to
use in assessments. This article pro-
vides some general information about
the types of data the agency finds
helpful in evaluating the pollution-
prevention potential of new chemical
substances. Questions about indi-
vidual cases can be discussed with the
prenotice coordinators at (202) 260-
1745 or (202) 260-3937.
Some examples of pollution-prevention
information
EPA is interested in assessing overall
net reductions in toxicity and expo-
sures and avoiding the potential
transfer of risks from one medium to
another.
In determining what types of infor-
mation to provide to EPA, consider
the following:
1. Look at the environmental effects
of the new substance over its entire
life cycle.
This process includes considering the
chemical's potential for preventing
pollution due to design, the way it
will be produced, how it will be used
at a customer site or at the site of the
customer's customer, how it will be
disposed of, and factors that will
lower occupational or consumer expo-
sure.
2. Take a broad view of what pol-
lution prevention is.
One PMN submitter, for example,
claimed a new chemical would pro-
duce a more durable final product.
The agency considered this a valid
claim since a more durable product
would result in less frequent disposal
and would reduce manufacturing and
processing of replacement products
and generation of concomitant
wastes.
3. Provide EPA with information
to use in evaluating pollution-pre-
vention claims.
Simply claiming that a new chemical
can substitute for an existing volatile
organic chemical (VOC) is not
enough. The submitter should pro-
vide the name of the VOC, as well as
any toxicity information on the VOC
that has not already been submitted
to the agency. An estimate of the
reduction in VOC emissions should
also be provided, if possible.
4. Note whether the new chemical
can be used as a substitute for com-
mercial chemicals.
If a new chemical is a possible substi-
tute for a chemical already on the
market, EPA is interested in informa-
tion describing possible reductions in
toxicity, human exposures, and envi-
ronmental releases that would result
if the substitution occurred.
5. Brag a little.
EPA encourages PMN submitters to
make any claims that are consistent
with the definition of pollution pre-
vention in the Pollution Prevention
Act of 1990.
For more information
EPA's Office of Pollution Prevention
and Toxics expects the incorporation
of pollution-prevention information
into the New Chemicals Program to
continue evolving. For more infor-
mation about this, contact Roy
Seidenstein, Chemical Control Divi-
sion (TS-794), U.S. EPA, 401 M
Street, S.W., Washington, D.C.
20460; telephone, (202) 260-2252.
VOL.13 / N0.2 SEPTEMBER 1992
-------
Existing Chemicals Program
OPPT's RM2 Process Identifies Risk-Management Options for Existing Chemicals
The Toxic Substances Control Act
(TSCA) gives EPA the authority to
identify and control chemical hazards
to human health or the environment.
This article focuses on how the
agency carries out this mandate for
"existing chemicals," or chemicals
currently in commerce. It focuses
specifically on Risk Management
Two (RM2), the second level of re-
view, and follows the chemical
chloroethane through several stages
of RM2 review. (The Risk Manage-
ment One (RM1) process, the first
level of review, was summarized in
Chemicals-in-Progress Bulletin, volume
12, number 3.) EPA's Office of Pol-
lution Prevention and Toxics (OPPT)
administers the Existing Chemicals
Program.
During RM1 review, OPPT identi-
fies existing chemicals (1) for which
additional testing is needed and (2)
that present potentially significant
risk-management concern. Chemi-
cals in need of additional testing are
placed on the Master Testing List,
EPA's testing agenda for the next
two years. Chemicals presenting
potentially significant risk-manage-
ment concern are placed on the risk
reduction list at the conclusion of
RM1. RM2 evaluation begins when
a chemical is selected from the risk
reduction list.
The objective of RM2 is to answer
the following questions:
During which portions of a
chemical's life does it pose a risk?
What is the estimated magnitude
of the risk? Does this risk warrant
priority risk management?
Are there potential solutions to the
problem?
Can the potential risk from the
chemical be mitigated through
voluntary measures, or will regula-
tions be necessary?
Chloroethane in RM2 review
Chloroethane entered RM1 review
because (1) a 1989 National Toxicol-
ogy Program (NTP) study showed
the chemical causes cancer in mice
and (2) reports to the Toxics Release
Inventory (TRI) showed high indus-
trial air and water releases of the
chemical in 1989. OPPT's RM1
review raised concerns about risks
posed by facilities' air releases of
chloroethane to nearby populations.
Due to this concern, OPPT Director
Mark A. Greenwood selected the
chemical for RM2 review.
Preliminary life-cycle and pollution-
prevention assessment (RM2 assess-
ment)
OPPT begins the RM2 process by
identifying all uses of the chemical
under review. In the case of
chloroethane, OPPT staff used pub-
lished sources to identify four uses of
the chemical. Phone calls to industry
identified a fifth use, as a blowing
agent in the manufacture of polysty-
rene foam insulation.
OPPT conducted a life-cycle analysis
for each use to identify where expo-
sures to the chemical might occur.
OPPT then assessed any risks the
chemical might pose to human health
or the environment at every stage of
its life. The final step of the process
was to evaluate options to eliminate
or reduce these risks.
The life-cycle analysis mitigated
agency concerns about exposures to
chloroethane from four of the
chemical's uses. However, the analy-
sis showed potential risks from expo-
sure to chloroethane released from
polystyrene foam insulation. The
agency became concerned about (1)
consumers' exposure to chloroethane
released from polystyrene foam insu-
lation after installation in residential
structures, (2) workers' exposure to
chloroethane during its manufacture
and processing in industrial settings,
and (3) workers' exposure to
chloroethane released from polysty-
rene foam insulation during installa-
tion. Regarding occupational expo-
sures, EPA was concerned about the
Occupational Safety and Health
Administration's (OSHA) permis-
sible exposure limit (PEL) of 1,000
parts per million, which was estab-
lished prior to identification of
oncogenicity concerns for
chloroethane and does not take that
hazard into consideration.
Stakeholders' dialogue
OPPT established "stakeholders'
dialogues" with Dow Chemical Com-
pany and Amoco Corporation. Dow
manufactures chloroethane, and Dow
and Amoco are the sole domestic
manufacturers of polystyrene foam
insulation using chloroethane. Dow
and Amoco were aware of the NTP
study and had taken actions to re-
spond to it. Specifically, OPPT
learned the following:
CHEMICALS IN PROGRESS
-------
Existing Chemicals Program
Dow voluntarily lowered its indus-
trial hygiene standard of
chloroethane exposure to 150 parts
per million.
Dow has an active product steward-
ship program. The company has
(1) worked with customers to re-
duce occupational exposures of
their employees to chloroethane to
Dow's standard of 150 parts per
million and (2) developed material
safety data sheets for distribution
to customers.
Dow evaluated consumer exposure
to chloroethane released from poly-
styrene foam insulation in residen-
tial structures. The data showed
EPA had overestimated the lifetime
exposure of chloroethane to occu-
pants of buildings insulated with
polystyrene foam.
Exposure monitoring at Amoco
found 5 parts per million to 117
parts per million of chloroethane in
the air at its manufacturing facili-
ties.
Amoco is working toward finding a
substitute for chloroethane by
1994.
Dow and Amoco provided OPPT
with exposure studies, occupational
exposure data, and other information
about chloroethane. The RM2 team
used this information to reestimate
consumer exposure to chloroethane
released from polystyrene foam insu-
lation installed in residences. These
new exposure estimates were used to
recharacterize the potential risks
posed by chloroethane. The data
alleviated OPPT's concerns about
risks to consumers from chloroethane
in polystyrene foam.
Background on stakeholders' dialogues
Chloroethane was one of the first
chemicals discussed at a stakeholders'
dialogue. The idea for stakeholders'
dialogues came from OPPT's desire to
involve all stakeholders, both in in-
dustry and other sectors of the public,
in the RM2 process. OPPT will
identify some stakeholders in the
course of researching a chemical, as it
did for chloroethane. In other cases,
Stakeholders' dialogues
allow OPPT to obtain
technical information
from industry, other gov-
ernment agencies, envi-
ronmental groups, and
the public.
however, OPPT expects industry,
environmentalists, and members of
the public to let OPPT know they are
interested in a particular chemical.
This can be done by (1) contacting
the project manager and (2) submit-
ting data to the RM1 and RM2 Ad-
ministrative Record. OPPT will
consult the administrative record logs
when setting up stakeholders' dia-
logues. (For information on how to
contact a project manager or submit
data to the administrative record, see
page 21.)
Stakeholders' dialogues are intended
to
allow OPPT to obtain technical
information from industry, other
government agencies, environmen-
tal groups, and the public;
give industry, environmental
groups, and other sectors of the
public an opportunity to react to
the RM2 assessment;
identify possible risk-management
options beyond those identified by
OPPT for reducing risk; and
indicate opportunities for voluntary
risk-reduction measures.
RM2 exit decisions
After the RM2 assessment and stake-
holders' dialogue are completed,
OPPT decides whether the risk-man-
agement options considered for the
chemical should be implemented. If
the answer is no, OPPT ceases activity
on the chemical. If the answer is yes,
OPPT makes a preliminary decision
about whether to take a regulatory
approach or a voluntary approach.
After this decision, the chemical
moves into a post-RM2 implementa-
tion process.
In the case of chloroethane, OPPT
will work cooperatively with industry
to reduce the potential risks posed by
the chemical.
RM2 continued on page18
VOL.13/N0.2 SEPTEMBER 1992
-------
Existing Chemicals Program
RM2 continued from page 17
Post-RM2 implementation
OPPT is working with Dow and
Amoco to formulate voluntary com-
mitments from the companies to
manage the potential risks from
chloroethane. EPA expects to sign
agreements with Dow and Amoco
that will recognize the responsible
care the companies have shown in (1)
recognizing the potential risks posed
by chloroethane, (2) evaluating poten-
tial exposures, and (3) taking action
to reduce exposures to workers. The
companies are expected to agree to
continue their programs to reduce
use of chloroethane in polystyrene
foam insulation;
continue researching and developing
substitutes for chloroethane in poly-
styrene foam insulation; and
sponsor an industry effort to lower
the American Conference of Govern-
mental Industrial Hygienists'
(ACGIH) recommended limits of
chloroethane to which workers can
be exposed during the workday
without adverse effects (OSHA fre-
quently bases PEL standards on
ACGIH's recommended limits).
In addition, OPPT expects to work
with OSHA and polystyrene manufac-
turers to jointly design a label for
polystyrene foam insulation that in-
cludes a warning about chloroethane
releases. OSHA's hazard communica-
tion regulations require kbeling of
products containing toxic substances.
RM2 information is available to the public
OPPT initiated the RM1 and RM2
processes in 1990 to increase the num-
ber and effectiveness of actions taken
to address potential risks from existing
chemicals.
OPPT is committed to informing and
involving the public in the RM pro-
cesses. The administrative record
documents activities in RM1, RM2,
and post-RM2 implementation activi-
ties. (See article on page 21.)
Existing Chemicals Program RM1 and RM2 Activity as of July 1992
Chemical Name
Acrylic acid
Acrylonitrile
Alpha-chlorohydrin
Antimony compounds
Aromatic blocked
isocyanates
Bromoethane
Butylated hydroxytoluene
Butyraldehyde
Carpet emissions
Chloranil (dioxin risk
contamination issue)
RM1 Activity
Testing
Risk reduction
Dropped
Dropped
Dropped
Dropped
Dropped
Testing
Exposure-reduction activities
Decided against feasibility ot epidemiologic
study ot carpet emissions
Risk reduction
RM2 Activity
Holding stakeholders' dialogue
Voluntary testing agreements
Voluntary industry agreement to convert to cleaner product
CHEMICALS IN PROGRESS
-------
Existing Chemicals Program
RM1 and RM2 Activity as of July 1992, Continued
Chemical Name
Chloroethane
4-Chloro-2-methylaniline
3-Chloro-2-methylpropene
2-Chloronitrobenzene
Cresols
Cumene
Cyclohexane
Cyclohexanone
DDE Resin
Diethylenetriamine
Diallyl phthalate
1 ,2-Dibromoethane
Dichlorobenzidine
2,3-Dichloro-1 ,4-dioxane
1 ,2-Dichloroethane
1,2-Dichloropropane
Dicyclopentadiene
Diethylene glycol
butyl ether/acetate
Diisodecyl phenyl phosphite
Dimethylaniline
1 ,3-Dioxolane
Ethylene oxide
2-Ethylhexanoic acid
Hydrazine
Hydrogen cyanide
Hydroquinone
Interagency Testing Committee
(ITC) Section 4(e) Priority Testing
List: Acetaldehyde, Acetonitrile, Ethylene,
Ethylene glycol, Methyl ethyl ketone,
Methyl isobutyl ketone
Isophorone
RM1 Activity RM2 Activity
Risk reduction Exited RM2 in July 1992
Dropped
Dropped
Dropped
Dropped
Dropped
Testing
Dropped
Dropped
Dropped
Dropped
Dropped
Benzidine pigments and dyes combined Assessment under way
for screening
Dropped
Risk reduction Assessment under way
Dropped
Dropped
Dropped
Dropped
Testing
Dropped
Dropped
Dropped
Risk reduction Assessment under way
Dropped
Dropped
Testing
Dropped
Continued on next page
VOL.13/N0.2 SEPTEMBER 1992
-------
Existing Chemicals Program
RM1 and RM2 Activity as of July 1992, Continued
Chemical Name
Lead, nonresidential
paint
Lead, nonplumbing solder
2-Mercaptobenzothiazole
Mesityl oxide
N-Methylpyrrolidone
2-Nitropropane
Nonylphenol
Oleylamine
o-Toluidine and aniline
Perchloroethylene (dry cleaning)
Petroleum refining cluster (aromatic
hydrocarbons)
2-Phenoxyethanol/acetate
Phosphoric acid waste
Proposed endpoint rule candidates:
Acetone, Acrylonitrile, p-Aminophenol,
n-Amyl acetate, Bromochloromethane,
1-Butanol, n-Butyl acetate,
Carbon disulfide, Diethyl ether,
Dodecylphenol, 2-Ethoxyethanol,
Ethyl acetate, 2-Ethylhexanol,
Hexadecanoic acid, o-Hydroxyphenol,
Isobutyl alcohol, Methyl isobutyl ketone,
2-Methylpropanoic acid,
Methyl ester octanoic acid,
Terephthalic acid, 2,4-Toluenediamine
RM1 Activity
Risk reduction
Risk reduction
Risk reduction
Testing
Risk reduction
Risk reduction
Screening under way
Dropped
Dropped
Risk reduction
Screening under way
Dropped
Risk reduction
Testing
RM2 Activity
Assessment under way
Stakeholders' dialogue under way
Entered in queue for assessment
Assessment being initiated as part of paint-stripping
use cluster
Assessment under way
Entered in queue for assessment
Stakeholders' dialogue initiated. RM2 exit anticipated
in August 1992
Tetrahydrofuran
Propylene glycol t-butyl ether
Propylene oxide
Refractory ceramic fibers
Sodium cyanide
Sulfolane
1 ,1 ,2,2-Tetrachforoethane
1,1,1-Trichloroethane
Vinyl acetate
4-Vinylcyclohexane
Testing
Dropped
Risk reduction
Risk reduction
Dropped
Dropped
Dropped
Dropped
Testing
4(f) announced. Regulatory investigation initiated
Exited RM2 in March 1992
I" CHEMICALS IN PROGRESS
-------
Existing Chemicals Program
RM1 and RM2 Activity as of July 1992, Continued
Chemical Cluster
Aryl phosphates
Brominated flame retardants
C-9 Aromatic hydrocarbons
Chlorinated paraffins
Chlorinated solvents
Consumer products/indoor air cluster
Diisocyanates
Direct blue 15
Glycidols
Glycol ethers
Persistent bioaccumulators
Terpenes
Tri (alkyl/alkoxy) phosphates
TRI screening rule candidates
Paint-stripping cluster
RM1 Activity
Notice of proposed rulemaking under
development
Testing
Dropped
Risk reduction
Dropped
Screening under way
Risk reduction
Benzidine pigments and dyes combined
for screening
Section 4 testing
Dropped
Screening level testing needs identified
Dropped
Dropped
Screening level testing needs identified for
100 chemicals
Risk reduction
RM2 Activity
Assessment under way
Entered in queue for assessment
Assessment under way
Assessment under way
RM Administrative Record Is Open to the Public
The administrative record for chemi-
cals undergoing review in the Office
of Pollution Prevention and Toxics'
(OPPT) risk-management program is
available to the public. The adminis-
trative record contains documents
that record OPPT's preregulatory and
nonregulatory risk-management deci-
sions on existing chemicals.
The administrative record is orga-
nized in files by chemical or class of
chemicals. Each file contains infor-
mation from the Risk Management
One (RM1) and Risk Management
Two (RM2) processes and is indexed.
As of June 1992, the administrative
record contained files on 72 chemi-
cals and chemical clusters. The fol-
lowing information is placed in these
files as it becomes available.
From the RM1 process: supporting
rationale for screening decision,
which includes a summary of expo-
sure and hazard information; sum-
maries of major studies; summaries
of meetings; letters sent to industry
citing EPA's concerns about certain
chemicals, along with any industry
replies; press releases; and public
comments.
From the RM2 process: RM2 life-
cycle and pollution-prevention
assessments (RM2 assessments);
summaries of meetings held with
industry, environmental groups,
labor unions, and other interested
parties (known as stakeholders'
dialogues); memoranda on exit
decisions; and the newly developed
Public continued on page 22
VOL.13 /N0.2 SEPTEMBER 1992
-------
Existing Chemicals Program
Public continued from page 21
chemical status sheet. The chemi-
cal status sheet indicates where the
chemical is in the RM2 process and
projects the timeframe for an RM2
exit. It is updated quarterly.
How to become involved in a dialogue
To notify OPPT of interest in partici-
pating in a stakeholders' dialogue on
a particular chemical, contact the
RM2 project manager for that chemi-
cal. RM2 project managers are listed
on the chemical status sheet, which is
part of the administrative record.
How to gain access to information
The public can gain access to the
administrative record in four ways:
1. In person, by going to the Public
Reading Room, in room G-004 of
the Northeast Mall, EPA head-
quarters, 401 M Street, S.W.,
Washington, D.C., between 8:00
a.m. and noon and 1:00 p.m. and
4 p.m., Monday through Friday.
2. By writing to EPA/OPPT/PDB
(TS-793), Attention: RM Admin-
istrative Record, Room G-004,
Northeast Mall, 401 M Street,
S.W., Washington, D.C. 20460.
3. By calling (202) 260-3587.
4. By FAXing (202) 260-4655, At-
tention: RM Administrative
Record.
I Who Uses the RM Administrative Record?
Between October 1, 1991, and June 1, 1992, the RM Administrative Record
received 206 requests for materials used during OPPT's risk-management pro-
ceedings.
User
Percentage of Requests
Industry
EPA and EPA contractors
Trade associations
Law firms
Media
Health associations
Schools
Federal, state, and local agencies
Private citizens
EPA regional offices
26%
19%
14%
10%
10%
8%
6%
3%
2%
2%
Distribution of RM1 and RM2 materials
EPA distributes RM1 data to other
federal agencies to promote consoli-
dation of chemical activities. For
instance, information about chemi-
cals that are likely to raise occupa-
tional concerns are sent to the ONE
Committee. The ONE Committee
consists of representatives from the
Occupational Safety and Health
Administration (OSHA), the Na-
tional Institute for Occupational
Safety and Health (NIOSH); the
Mine Safety and Health Adminis-
tration; and EPA.
RM1 information on chemicals for
which EPA required industry to
develop test data under section 4 of
the Toxic Substances Control Act
(TSCA) is sent to OSHA, NIOSH,
the American Conference of Gov-
ernmental Industrial Hygienists,
the Consumer Product Safety Com-
mission, and the company or com-
panies that developed the test data.
RM2 assessments are automatically
sent to anyone who has submitted
information to the administrative
record for a particular chemical and
to other stakeholders whom EPA
has identified.
Expanded distribution considered
EPA is considering expanding its
distribution of RM1 and RM2 mate-
rials to meet the growing interest in
its assessment of existing chemicals.
OPPT is also considering notifying
interested parties when a chemical
enters RM2 assessment.
CHEMICALS IN PROGRESS
-------
Existing Chemicals Program
Companies Receiving RM1 Inquiry Letters Provide Data to EPA
During preliminary reviews per-
formed from May 1990 through
April 1992, EPA identified eight
chemicals currently in the market-
place that may pose a potential risk
to human health or the environment.
As a result, the agency has sent 109
letters of concern, now known as
RM1 (Risk Management One) in-
quiry letters, to 77 companies notify-
ing them of agency concerns. Each of
the 77 companies has a facility that
manufactures, processes, or uses one
or more of the chemicals.
The letters also asked the companies
to provide to the RM1 administrative
record any information they believe is
pertinent to the case. (See page 21
for a description of the administrative
record.) In addition, the letters en-
couraged the companies to voluntarily
act to reduce exposures to the chemi-
cals, implement pollution-prevention
practices, and undertake their own
hazard and exposure assessments.
Response is positive
A number of companies receiving
RM1 inquiry letters have contacted
EPA with information about the
chemicals. Among the types of infor-
mation provided were descriptions of
improvements to facilities to better
protect employees, voluntary chemical
substitutions, and pollution-preven-
tion programs. Some companies pro-
vided notification that the company
no longer uses a particular chemical,
made technical comments, or pro-
vided data about chemical volumes,
uses, waste generation, and waste
minimization.
EPA's Office of Pollution Prevention
and Toxics (OPPT) continues to as-
sess the chemicals through the Risk
Management Two (RM2) stage of its
Existing Chemicals Program. In
RM2, OPPT decides whether the
potential problems posed by a par-
ticular chemical warrant risk man-
agement. Any information or cor-
rected data provided in response to
the RM1 inquiry letters are consid-
ered during RM2 assessment and can
influence its outcome.
Industry Agrees to Switch to Low-Dioxin Chloranil from Contaminated Chloranil
EPA and industries making or using
chloranil-derived products have en-
tered into voluntary agreements to
use only low-dioxin chloranil. By
switching to low-dioxin chloranil,
the industries will reduce potential
risks to health and the environment.
Chloranil is an industrial intermedi-
ate used in tire manufacturing and
dye and pigment production. In May
1990, EPA received test results
showing that chloranil was heavily
contaminated with dioxins. Dioxin,
a generic term for a group of 75 re-
lated compounds, is a highly toxic
chemical. It is classified as a prob-
able human carcinogen, and it per-
sists in the environment and can
accumulate in the tissue offish, other
wildlife, and people.
Over the past two years, EPA learned
that manufacturers could reduce di-
oxin contamination levels in chloranil
by over two orders of magnitude,
from more than 3,100 parts per bil-
lion to less than 20 parts per billion,
by changing the feedstocks and
manufacturing process. The result-
ing product is referred to as low-
dioxin chloranil.
Upon learning of low-dioxin
chloranil, EPA's Office of Pollution
Prevention and Toxics (OPPT) began
efforts to complete an industrywide
switch from the contaminated
chloranil to low-dioxin chloranil. No
chloranil is manufactured in this
country, so the agency sought volun-
tary agreements with chloranil im-
porters and domestic manufacturers
who use chloranil in their products.
OPPT held a signing ceremony on
May 4, 1992, for manufacturers and
importers who agreed to switch to
low-dioxin chloranil. Voluntary
agreements were mailed to companies
that were unable to send representa-
tives to attend the ceremony. In all,
sixteen companies signed the volun-
tary agreements.
VOL.13 /N0.2 SEPTEMBER 1992
-------
International Activities
U.S. Is Participating in UN Program to Promote Safe Management of Chemicals
The United States is one of 110 na-
tions participating in a program to
exchange technical information on
pesticides and industrial chemicals.
The Prior Informed Consent (PIC)
program, developed by the United
Nations (UN), focuses specifically on
substances that participating nations
have banned or severely restricted to
protect human health or the environ-
ment. PIC's objectives are to
establish an effective international
information-sharing network on
pesticides and industrial chemicals;
give importing countries, especially
developing nations, adequate infor-
mation to determine whether to
allow imports of these substances;
establish an international process for
preventing export of banned or se-
verely restricted substances to na-
tions that do not want to accept
them; and
monitor and control the introduc-
tion of dangerous substances into
developing countries until those
countries establish the necessary
chemical-management infrastruc-
ture.
EPA's Office of Prevention, Pesticides,
and Toxic Substances (OPPTS), which
is the U.S. contact for PIC, has devel-
oped a list of pesticides and industrial
chemicals that are banned or severely
restricted domestically. EPA has pro-
vided this list to the UN's Interna-
tional Register of Potentially Toxic
Chemicals (IRPTC) and is incorporat-
ing aspects of the PIC system into the
export notification programs required
by the Toxic Substances Control Act
(TSCA) and the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA).
The PIC process
The PIC process has four key parts:
Participating nations notify the
IRPTC when they ban or severely
restrict a chemical or pesticide.
The IRPTC summarizes the haz-
ards of, controls for, and other rel-
evant information about the chemi-
cal or pesticide and provides the
summary to participating coun-
tries.
Each importing nation notifies the
IRPTC regarding its decision to
allow, restrict, or halt imports of
the substance.
Exporting countries are responsible
for preventing chemicals or pesti-
cides from being exported to na-
tions that have notified the IRPTC
that they do not want imports of
those substances.
The PIC procedure is designed to
operate within the limits of national
authorities and to be consistent with
fair trade practices.
U.S. industry participation
The UN has formally adopted the PIC
program, and it has wide international
support. However, industry participa-
tion in the PIC program is voluntary.
EPA is working with trade groups and
industry to ensure voluntary compli-
ance. The agency has mailed informa-
tion about the PIC program to indus-
try and will hold a public meeting in
Washington, D.C., to further inform
industry and other interested parties
about the PIC program.
Industry trade groups have indicated
that U.S. industry will comply with
decisions by importing countries to
prohibit or limit imports of PIC sub-
stances. EPA will monitor compliance
by tracking industry reports made to
EPA's existing export notification
programs under TSCA and FIFRA.
For more information
For information about the chemicals
component of the PIC program, con-
tact Jim Willis, Existing Chemical
Assessment Division (TS-778), U.S.
EPA, 401 M Street, S.W., Washing-
ton, D.C. 20460; telephone, (202)
260-3489; FAX, (202) 260-8168.
For information about the pesticides
component of the PIC program, con-
tact Dan Rosenblatt, Office of Pesti-
cide Programs (H7501C), U.S. EPA,
401 M Street, S.W., Washington,
D.C. 20460; telephone, (703) 305-
7102; FAX, (703) 305-6244.
EPA has established an administrative
record for the PIC program. The ad-
ministrative record can be used by (1)
going to the Public Reading Room, in
room G-004 of the Northeast Mall,
EPA headquarters, 401 M Street,
S.W., Washington, D.C., between
8:00 a.m. and noon and 1:00 p.m. and
4 p.m., Monday through Friday; (2)
writing to EPA/OPPT/PDB (TS-793),
Attention: PIC Program, Room G-
004, Northeast Mall, 401 M Street,
S.W., Washington, D.C. 20460; (3)
calling (202) 260-3587; and (4)
FAXing (202) 260-4655.
CHEMICALS IN PROGRESS
-------
International Activities
Chemicals and Pesticides Proposed by EPA for UN PIC List
Banned chemical substance
Polychlorinated biphenyls
Severely restricted chemical substances
All fully halogenated
chlorofluoroalkanes
Certain halons
Carbon tetrachloride
Methylchlorofbrm
l-Chloro-2-bromoethane
Hexamethylphosphoramide
Methyl n-butyl ketone
Pentachloroethane
Urethane
Tris(2,3-dibromopropyl)phosphate
Polybrominated biphenyls
Asbestos
Banned Pesticides
Aldrin
Benzene hexachloride (BHC)
2,3,4,5-Bis(2-butylene)tetrahydro-
2-furaldehyde (repellent-11)
Bromoxynil butyrate
Cadmium compounds
Calcium arsenate
Captafol
Carbon tetrachloride
Chloranil
Chlordimeform
Chlorinated camphene (toxaphene)
Chlorobenzilate
Chloromethoxypropylmercuric
acetate (CPMA)
Copper arsenate
Cyhexatin
Dibromochloropropane (DBCP)
Decachlorooctahydro-1,3,4-
metheno-2H-cyclobuta(cd)
pentalen-2-one (chlordecone)
Dichloro diphenyl trichloroethane
(DDT)
Dieldrin
Dmoseb and salts
Di(phenylmercury)-
dodecenylsuccinate (PMDS)
Endrin
O-ethyl o-p-nitrophenyl
phenylphosphonthioate (EPN)
Ethyl hexyleneglycol (6-12)
Hexachlorobenzene (HCB)
Lead arsenate
Leptophos
Mirex
Monocrotophos
Nitrofen (TOK)
Octamethylpyrophosphoramide
(OMPA)
Phenylmercuric oleate (PMO)
Potassium 2,4,5-trichlorophenate
(2,4,5-TCP)
Pyriminil (vacor)
Safrole
Silvex
Sodium arsenate
Sodium arsenite
Dichloro diphenyl dichloroethane
(TDE)
Terpene polychlorinates (strobane)
Thallium sulfate
2,4,5-Trichlorophenoxyacetic acid
(2,4,5-T)
Vinyl chloride
Severely restricted pesticides
Arsenic trioxide
Carbofuran
Chlordane
Daminozide
Ethylene dibromide (EDB)
Heptachlor
Mercurous chloride
Mercuric chloride
Phenylmercury acetate
Tributyltin compounds
VOL.13/N0.2 SEPTEMBER 1992
-------
I
International Activities
OECD Nations Discuss Development of International Guidelines for
Assessing Chemical Exposures
Meeting Improves Understanding of Current Practices
Experts from eleven nations met in
February to discuss how to improve
assessments of occupational and con-
sumer exposures to chemicals pro-
duced in large quantities worldwide.
EPA hosted the Organization for Eco-
nomic Cooperation and Development
(OECD) workshop in Orlando,
Florida.
As participants in OECD's Screening
Information Data Set (SIDS) program,
all the attending nations assess data to
determine whether certain chemicals
warrant further testing. The objec-
tives of the workshop were to
identify simple methods for devel-
oping initial estimates of occupa-
tional and consumer exposures to
chemicals where limited data are
available;
develop guidance on how and when
to use these methods in assessing
SIDS chemicals; and
identify data that would improve
the quality of the initial assessment
but are not now included in the
dossiers of available information
collected for each SIDS chemical.
Representatives of the Commission of
the European Community, the Busi-
ness and Industry Advisory Commit-
tee to OECD, and the International
Register of Potentially Toxic Chemi-
cals of the United Nations Environ-
ment Programme also attended the
workshop.
The OECD Workshop on Occupa-
tional and Consumer Exposure Assess-
ment was a significant step toward
developing an international under-
standing of existing approaches for
assessing occupational and consumer
exposures to chemicals. The general
recommendations and conclusions of
the two working groups follow.
Working Group on Occupational
Exposure Assessment
1. Actual measured exposure data are
usually preferred to estimates of
exposure. The SIDS program
should encourage submission of
such data.
2. In the absence of actual data, a
number of procedures for estimat-
ing exposure are available. The
choice of which to use will depend
on individual circumstances.
However, a complete description of
the approach should be included in
the assessment to allow assessors in
other countries to confirm or refine
the estimate.
3. The SIDS program should encour-
age further development of expo-
sure estimation protocols to
achieve greater consistency in per-
forming assessments.
Working Group on Consumer Exposure
Assessment
1. Key information for assessments
may be available from manufactur-
ers. The SIDS program should
request this information.
2. The working group on consumer
exposure assessment has developed
guidance for performing exposure
assessments. The SIDS program
should require that the principles
set forth in this guidance be fol-
lowed.
3. On a regular basis, SIDS partici-
pants should exchange information
on approaches used to perform
consumer exposure assessments.
4. OECD members should share the
burden of developing and refining
approaches for assessing consumer
exposures.
5. Efforts to harmonize certain ele-
ments required for assessments
e.g., agreement on inhalation rates
or other physiological param-
etersshould be encouraged.
For more information
For more details on the OECD
Workshop on Occupational and Con-
sumer Exposure Assessment or to
obtain a copy of the workshop's draft
report, contact Sid Abel, Exposure
Evaluation Division (TS-798), Office
of Pollution Prevention and Toxics,
U.S. EPA, 401 M Street, S.W.,
Washington, D.C. 20460; tele-
phone, (202) 260-3920; FAX, (202)
260-0018.
CHEMICALS IN PROGRESS
-------
International Activities/General Information
U.S. and EC Are Comparing How Different Test Data Requirements Affect
Evaluation of New Chemicals
A major difference between the new-
chemicals programs in the United
States and the European Community
(EC) is their test data requirements.
In the United States, the Toxic Sub-
stances Control Act does not require
that test data be generated on new
chemicals prior to submission of a
premanufacture notice to EPA. In
contrast, the EC requires submission
of a base set of test data for each new
chemical that will be produced in
quantities exceeding one metric ton.
The EC's "minimum premarketing
dataset" (MPD) requirement does not
apply to polymers.
The MPD requirement gives EC
nations hard data to use in their as-
sessment of new chemicals. In the
absence of such data, EPA assesses a
new chemical's similarity to known
toxic chemicalscalled a structure-
activity relationship (SAR)to pre-
dict toxicity. The underlying error
rate of EPA's SAR approach is un-
known.
Comparison of U.S. and EC methods
A study is under way to compare EC's
MPD data on a series of approxi-
mately 150 new chemicals with EPA's
predictions about those same chemi-
cals. Both the EC and EPA will com-
pare the results of EPA's SAR analysis
with the EC's MPD test results.
The purpose of the study is to (1)
determine the extent to which EPA's
SAR-based hazard predications would
change in the presence of a base set of
data; (2) determine the frequency with
which EPA's SAR-based approach
identifies potential concerns beyond
those included in MPD data; and (3)
develop data about the "error rates"
for EPA's SAR-based approach.
In November 1991, EPA provided its
SAR analyses to the EC, and the EC
provided copies of its MPD packages
to EPA in March 1992. The two
organizations were scheduled to com-
plete their individual reviews in late
summer. An expert meeting to dis-
cuss the study and its outcomes is
expected to take place this fall.
Changes are possible
The EC is interested in whether the
results of the study will suggest
changes that should be made to MPD
requirements in Europe. It is also
evaluating the possible use of SAR-
based analysis to set priorities in its
existing chemicals program. Simi-
larly, EPA's Office of Pollution Pre-
vention and Toxics, which adminis-
ters the agency's New Chemicals
Program, will analyze the study's
results to determine the strengths
and weaknesses of the SAR approach
and to consider any implications for
the current U.S. program on new
chemicals.
Consent Order Signed for Testing of Acrylic Acid
EPA has signed a consent order with
BASF Corporation, Dow Chemical
Company, Hoechst Celanese Chemi-
cal Group, Rohm and Haas Com-
pany, and Union Carbide Chemicals
and Plastics, Inc., for testing of
acrylic acid (57 FR 7656, March 4,
1992). The Interagency Testing
Committee recommended testing of
acrylic acid in its 27th Report, pub-
lished in March 1991.
The Basic Acrylic Monomer Manu-
facturers, an association of manufac-
turers and users of acrylic acid and
acrylic acid esters, will conduct an
inhalation developmental toxicity
study, an oral (drinking water) two-
generation reproductive toxicity
study, and a bioavailability study.
Information on the bioavailability of
acrylic acid will be used to develop
pharmacokinetic models that will be
helpful in interpreting the results of
the toxicity studies on acrylic acid.
VOL.13 / N0.2 SEPTEMBER 1992
-------
General Information
Linda Fisher Testifies before Congress on the Future of EPA's Toxics Program
In March 1992, Linda J. Fisher, EPA
assistant administrator for Preven-
tion, Pesticides, and Toxic Sub-
stances, testified before the U.S.
House of Representatives Subcom-
mittee on Environment, Energy, and
Natural Resources and the U.S. Sen-
ate Subcommittee on Toxic Sub-
stances, Environmental Oversight,
Research, and Development.
Ms. Fisher devoted part of her testi-
mony to the future of the agency's
toxics program in the aftermath of
the October 1991 remand of the
asbestos ban and phaseout rule. (In-
formation about the court ruling is in
Chemicals in Progress Bulletin, volume
13, number 1.) While Ms. Fisher
acknowledged that the court's deci-
sion poses challenges for the agency
as it considers other possible actions
under section 6 of the Toxic Sub-
stances Control Act (TSCA), she af-
firmed that EPA will continue to use
section 6 to address unreasonable
risks from toxic substances.
Summarized excerpts from Ms.
Fisher's testimony on the future of
the agency's toxics program follow.
Key principles for the future
As a result of our changing program
and in the aftermath of the asbestos
court decision, we have examined
what the basic objectives of a toxics
program should be. While we want
to use the traditional regulatory tools
TSCA provides, we also see opportu-
nities to use our statutory authorities
in fresh ways, consistent with new
trends in environmental manage-
ment. The Office of Pollution Pre-
vention and Toxics (OPPT) has iden-
tified four key principles to help
guide future efforts to reduce health
and environmental risks from toxic
substances under the various statutes
we administer.
"We see opportunities to
use our statutory authori-
ties in fresh ways."
Linda Fisher
1. Promoting pollution prevention.
A primary mission of OPPT is to
encourage the use of pollution-pre-
vention principles. OPPT will work
with other EPA offices to identify
regulations that should be targeted
for pollution-prevention options and
to develop creative nonregulatory
strategies for reaching public health
and environmental goals.
We will be carrying the pollution-
prevention message outside the
agency as well, by providing informa-
tion, training and education, and
grant assistance. Last September, for
example, we announced a grant to the
University of Michigan to establish
the National Pollution Prevention
Center. [The center was described in
Chemicals in Progress Bulletin, volume
12, number 4.} The center's primary
purpose is to develop model under-
graduate and graduate curricula for
engineering, natural resources, and
business schools. The ultimate aim is
to educate those who will design,
develop, and market chemical prod-
ucts about the prevention ethic.
EPA's traditional focus has been the
industrial sector. In the future, our
pollution-prevention initiatives will
carry us into new areas, such as agri-
culture, energy, and transportation.
We will work with other federal
agencies and outside groups to pro-
mote the idea that pollution preven-
tion can be an environmentally sound
and economically prudent way to
approach decisions in all sectors of
our society.
2. Using TSCA to promote the de-
sign, development, and application
of safer chemicals.
For OPPT, adoption of a pollution-
prevention ethic is a logical develop-
ment, given the focus of our program
on improving environmental protec-
tion through changes in the manufac-
ture, processing, and use of chemi-
cals. Fundamentally, our role is to
push for use of safer chemicals and
processes in the basic operations of
the industrial sector.
Our New Chemicals Program illus-
trates the essence of prevention. In
addition to keeping chemicals that
will pose significant risks out of the
CHEMICALS IN PROGRESS
-------
General Information
marketplace, the program also serves
as a mechanism for identifying prom-
ising alternatives to existing chemi-
cals. We have revised our premanu-
facture notification form, for ex-
ample, to allow submitters to show
how a proposed new chemical might
serve as a better substitute for an
existing chemical.
In the Existing Chemicals Program,
we see an increasing emphasis on
evaluating clusters of chemicals used
in particular industrial processes,
with an eye toward promoting safer
chemicals and technologies. Looking
at clusters, we believe, will eventually
replace the tendency to focus on
single chemicals, an approach that
may sometimes lead to inadequate
consideration of the risks of substi-
tutes.
3. Providing stewardship for
high-risk chemicals.
OPPT continues to face the task of
managing several high-risk chemi-
cals, such as lead, asbestos, and poly-
chlorinated biphenyls (PCBs), that
have been widely used for years.
Asbestos and PCBs are sometimes
referred to as OPPT's "first-genera-
tion" chemicals. These substances
have been around a long time; their
health risks are well documented and
widely known; and management of
problems caused by their past use
will be necessary well into the future.
We have established, for example, a
comprehensive framework for ad-
dressing asbestos in schools and a
national accreditation network for
asbestos inspection and abatement
personnel. We also recently produced
guidance on proper practices and
procedures for managing asbestos in
place.
Although lead contamination in the
environment is widespread and the
risks from lead are well known, some
of our initiatives to deal with prob-
lems related to past use of lead are
new or still under development.
OPPT has developed a multimedia,
agencywide strategy to address health
risks from lead. This strategy encom-
passes a wide range of activities, in-
cluding development of informational
materials to help parents reduce their
children's exposure to lead, studies of
the efficacy of lead abatement alterna-
tives, and new TSCA regulatory in-
vestigations of lead in plumbing fit-
tings, fixtures, and solder.
4. Acquiring and disseminating
information about chemical risks
and pollution prevention.
The Toxics Release Inventory (TRI)
has stimulated pollution-prevention
efforts by providing an opportunity
for both citizens and industry to un-
derstand the volume of toxic chemical
emissions. The result has been that
both groups are working to reduce
those emissions. We have recognized
that the right-to-know objectives of
TRI can be merged with the informa-
tion-gathering powers of TSCA to
make additional data available to all
those who have a role in environmen-
tal decision making.
OPPT continues to make publicly
available some 66,000 health and
safety studies submitted under
TSCA. In addition, OPPT has un-
dertaken a number of efforts to im-
prove access to and availability of
data, including the following:
developing the TSCA Test Submis-
sions computerized database, a
publicly available, easily accessible
index of all test data submitted
under TSCA;
entering test results received under
section 4 of TSCA into the Na-
tional Institute of Occupational
Safety and Health Registry of
Toxic Effects of Chemical Sub-
stances, which provides access
online and through print and mag-
netic media;
systematically reviewing and, when
appropriate, challenging confiden-
tial business information claims for
TSCA information submissions on
commercially available chemicals;
commissioning a review and inven-
tory of all TSCA submissions
claimed as confidential, to allow
the agency to assess the effective-
ness of existing TSCA confidential-
ity provisions; and
establishing a pollution-prevention
clearinghouse to provide free, easily
accessible information on source
reduction and recycling efforts in
the United States and other coun-
tries.
VOL13/N0.2 SEPTEMBER 1992
-------
General Information
EPA Is Reviewing Comments on Proposed Grout Rule
EPA is reviewing the rulemaking
record on its 1991 proposed rule for
an immediate ban on the manufac-
ture, distribution, and use of
acrylamide grout. The proposed rule
would also ban all uses of N-
methylolacrylamide (NMA) grout
except for sewer line repair. That
use, along with the manufacture,
importation, and distribution in
commerce of the NMA grout, would
be banned after a period of three
years. Public comment on the pro-
posed rule was completed in March
1992.
In its monomeric form, acrylamide
has only a few end uses, the largest of
which is sewer grouting. NMA is a
derivative of acrylamide. In its non-
toxic polymeric form, acrylamide is
also widely used as a suspension
agent in the water treatment and
petroleum industries.
Background information
In 1978, the Interagency Testing
Committee (ITC), established under
the Toxic Substances Control Act
(TSCA), recommended that
acrylamide be tested for carcinogenic -
ity, mutagenicity, teratogenicity, and
environmental effects. At that time,
the substance's neurotoxicity was
already well documented.
Dow Chemical Company, American
Cyanamid Company, and other
acrylamide producers initiated a can-
cer bioassay. The results of the can-
cer bioassay showed significant in-
creases in tumors in both male and
female rats. EPA and the National
Institute for Occupational Safety and
Health conducted exposure studies,
which indicated significant dermal
exposures to grouting workers. In
response to these studies, EPA began
a regulatory investigation of
acrylamide grout in 1987.
Proposed rule
On October 2, 1991, the agency
published a notice of proposed
rulemaking (56 FR 49863) for
acrylamide and NMA grouts under
the authority of sections 6 and 8 of
TSCA. The proposed rule was based
on EPA's finding that use of
acrylamide and NMA grouts presents
an unreasonable risk of injury to hu-
man health. Acrylamide is a power-
ful human neurotoxin whose effects
include damage to both the periph-
eral and central nervous systems.
EPA has classified acrylamide as a
probable human carcinogen. EPA
believes the health effects from expo-
sure to NMA are comparable to those
from exposure to acrylamide.
At the March 1992 public hearing on
the proposed rule, Avanti Interna-
tional, the American Cyanamid Com-
pany, Geochemical Corporation, and
the National Association of Sewer
Service Companies delivered presen-
tations. EPA is now reviewing its
original analyses, public comments,
and testimony presented at the hear-
ing to formulate final rulemaking.
Grouters now import acrylamide grout
or use substitutes
Shortly after the ITC recommended
acrylamide for testing, the American
Cyanamid Company, the sole pro-
ducer of acrylamide grout in the
United States, stopped making the
grouting because of concerns about
its potential risk to human health.
While numerous state and local gov-
ernments have stopped using
acrylamide-based grouts because of
serious concerns for worker health,
other domestic users have sought
foreign sources of acrylamide grout.
The approximately 650,000 pounds
of acrylamide grout used in the
United States each year is imported
by a single distributor, Avanti Inter-
national, from a Japanese manufac-
turer.
During the course of EPA's regula-
tory investigation, the agency col-
lected a large amount of information
about substitutes for acrylamide and
NMA grouts. Four main types of
substitutes are currently available:
acrylates, low-viscosity polyurethane,
high-viscosity polyurethane, and
polyacrylamide.
EPA has received testimony and nu-
merous comments regarding the
efficacy of these grouts. Much of the
testimony supports EPA's belief that
the substitutes are viable alternatives
to acrylamide and NMA grouts that
will effectively accomplish the grout-
ers' objectives and protect workers
from serious neurological and other
health-related problems. Some cur-
rent users of acrylamide have testified
that the substitutes are slightly more
expensive than acrylamide and re-
quire different equipment and skills
to use.
CHEMICALS IN PROGRESS
-------
General Information
ITC Revises TSCA Section 4(e) Priority Testing List
The committee encour-
ages manufacturers,
processors, and users
to voluntarily submit
additional use, exposure,
release, and physical
chemical property data
not required under the
two rules.
In its 30th Report, the TSCA
Interagency Testing Committee
(ITC) placed two chemical groups
siloxanes and chloroalkyl
phosphateson the Toxic Substances
Control Act (TSCA) Section 4(e)
Priority Testing List and deferred
action on another group of
chloroalkyl phosphates. EPA gives
substances on the Priority Testing
List priority consideration in promul-
gation of test rules.
Reporting requirements
EPA automatically adds ITC-recom-
mended substances to the TSCA
section 8(a) Preliminary Assessment
Information Rule (PAIR) and the
TSCA section 8(d) Health and Safety
Data Reporting Rule. These rules
require anyone who manufactures,
imports, processes, or distributes the
chemicals to report production, use,
unpublished health and safety data,
and exposure-related information to
EPA. (See 40 CFR parts 712 and
716 for more information about
TSCA sections 8(a) and 8(d).)
The committee encourages manufac-
turers, processors, and users to volun-
tarily submit additional use, expo-
sure, release, and physical chemical
property data not required under the
two rules. This information will help
the ITC to make informed decisions
before designating chemicals for test-
ing. When the ITC designates a
chemical for testing, EPA must re-
spond within 12 months by begin-
ning rulemaking under section 4 of
TSCA or publishing its reasons for
not doing so in the Federal Register.
Recommended
Siloxanes
Testing: autoimmune effects, can-
cer, reproductive effects, developmen-
tal toxic ity, and epidemiological
studies.
Rationale: The Food and Drug Ad-
ministration (FDA) requested that
the ITC review the health effects of
siloxanes in light of recent questions
related to the safety of siloxanes for a
number of medical uses, including
breast implants. The ITC recom-
mended siloxanes for testing because
of FDA's request, because production
volumes are substantial, because of
uncertainties related to human expo-
sure, and because of the paucity of
publicly available health effects data
for these substances.
The ITC added a group of 56 silox-
anes to the TSCA Section 4(e) Prior-
ity Testing List. By recommending
these chemicals, the ITC is providing
manufacturers, processors, and dis-
tributors the opportunity to submit
data under TSCA section 8 and to
voluntarily submit physical and
chemical property data, and use expo-
sure information.
ITC continued on page 32
VOL.13/N0.2 SEPTEMBER 1992
-------
General Information
ITC continued from page 31
Chloroalkyl phosphates
Testing: physical and chemical
property, chemical fate, health ef-
fects, and ecological effects screening.
Rationale: The ITC deferred action
on five chloroalkyl phosphates that it
recommended for testing in 1988.
The Chemical Manufacturers Associa-
tion and several chloralkyl phosphate
producers have approached the ITC
and EPA to discuss voluntary testing
for certain of the chloroalkyl phos-
phates. The ITC deferred action
until these discussions are completed.
The ITC recently identified four
additional commercially available
chloroalkyl phosphates. The ITC has
added these four substances to the
TSCA Section 4(e) Priority Testing
List because there are insufficient
data to reasonably determine or pre-
dict the substances' physical and
chemical properties, persistence, and
health and ecological effects.
EPA Endorses Use of Revised Methods for Testing PCBs
In 1989 and 1990, the American Soci-
ety for Testing and Materials (ASTM)
revised 12 of its test procedures for
polychlorinated biphenyls (PCBs).
EPA has reviewed the new procedures
and determined that they can be used
to meet the agency's PCB testing re-
quirements.
The agency published a final rule to
update references to ASTM test meth-
ods at 40 CFR part 761 on April 16,
1992. The ASTM publishes standard
test methods for a variety of industries.
Designations
The designations, of the new test meth-
ods are listed in the adjacent column.
The last two digits of the designation
refer to the year in which ASTM re-
vised the standard; ASTM organizes its
publication of test standards according
to year.
New designation
Old designation
ASTM D-93-90
ASTM D-482-87
ASTM D-524-88
ASTM D-808-87
ASTM D-923-89
ASTM D-1266-87
ASTM D-1796-83 (reapproved 1990)
ASTM D-1836-87
ASTM D-2158-89
ASTM D-2709-88
ASTM D-2784-89
ASTM D-3278-89
For more information
Copies of the standards may be ob-
tained from ASTM, 1916 Race
Street, Philadelphia, Pennsylvania
19103.
The revised test methods are available
for public inspection at the OPPT
ASTM D-93-85
ASTM D-482-80
ASTM D-524-81
ASTM D-808-81
ASTM D-923-86
ASTM D-1266-80
ASTM D-1796-83
ASTM D-1836-83
ASTM D-2158-85
ASTM D-2709-82
ASTM D-2784-80
ASTM D-3278-78 (reapproved 1982)
Public Docket Office, located in
Room G-004 in the Northeast Mall
at EPA headquarters, 401 M Street,
S.W., Washington, D.C. The public
docket is open from 8 a.m. to noon
and from 1 p.m. to 4 p.m., Monday
through Friday.
CHEMICALS IN PROGRESS
-------
EPA Is Preparing
National Plan to Reduce
Childhood Exposure to
Lead-Based Paint
An EPA plan for coordinating and
implementing various federal strate-
gies for reducing childhood exposure
to lead-based paint is being reviewed
by the Federal Interagency Lead-
based Paint Task Force, which is
composed of 18 federal agencies.
After the task force completes its
review, the report will be sent to
Congress.
The House of Representatives di-
rected EPA to work with the Depart-
ment of Housing and Urban Develop-
ment (HUD) and the Department of
Health and Human Services (HHS) to
develop the plan. EPA, HUD, and
HHS have been at the forefront of
federal efforts to reduce children's
exposure to lead. In December 1990,
HUD released its lead strategy, the
Comprehensive and Workable Plan
for the Abatement of Lead-based
Paint in Privately Owned Housing.
EPA released its Strategy for Reduc-
ing Lead Exposures in February 1991.
At the same time, HHS announced
its Strategic Plan for the Elimination
of Childhood Lead Poisoning.
These strategies form the basis of the
implementation plan. The report to
Congress will describe efforts to meet
strategic goals within these three
agencies and will also characterize
lead-based paint activities in other
federal agencies.
General Information
Update: Lead-Abatement Training
Courses on proper techniques for inspecting for and abating lead are available
from EPA Regional Lead Training Centers. EPA established the national net-
work of centers earlier this year. The five university-based consortia are respon-
sible for setting up training and outreach networks throughout their regions.
For information about courses
The regional centers began operations in July 1992. Training is available for
state and local officials, lead inspectors, and other interested parties. Information
about courses, schedules, and locations is available from the contacts listed here.
Center
Charles E. Gilbert
University of Massachusetts
Amherst, Massachusetts 01003
Telephone: (413)545-4222
FAX: (413)545-4692
Scott Clark
University of Cincinnati
Cincinnati, Ohio 45267-0056
Telephone: (513)558-1749
FAX: (513)558-1756
and
James Keogh
University of Maryland
at Baltimore, School of Medicine
Baltimore, Maryland 21201
Telephone: (410)328-7464
FAX: (410)328-8326
David Jacobs
Georgia Institute of Technology
Atlanta, Georgia 30332
Telephone: (404) 894-8090
FAX: (404)894-2184
Lani Himegarner
University of Kansas
Overland Park, Kansas 66211
Telephone: (913)491-0221
FAX: (913)491-0509
David W. Carey
University of California, San Diego
LaJolla, California 92093-0176
Telephone: (619)534-6157
FAX: (619)558-8156
States and Territories Covered
Maine, Vermont, New Hampshire, Massachu-
setts, Rhode Island, Connecticut, New York,
New Jersey, Puerto Rico, and the Virgin Islands
Pennsylvania, Maryland, West Virginia, Dela-
ware, Virginia, the District of Columbia, Wiscon-
sin, Michigan, Minnesota, Illinois, Indiana, and
Ohio
Kentucky, Tennessee, North Carolina, South
Carolina, Georgia, Alabama, Mississippi, Florida,
New Mexico, Texas, Oklahoma, Arkansas, and
Louisiana
Nebraska, Iowa, Kansas, Missouri, Montana,
Wyoming, Utah, Colorado, North Dakota, and
South Dakota
Washington, Oregon, Idaho, California, Nevada,
Arizona, Alaska, Hawaii, American Samoa, and
Guam
«1 VOL.13 / N0.2 SEPTEMBER 1992
-------
I
General Information
Update: Indoor Air Activities
EPA has identified indoor air as a
major pathway of human exposure to
numerous chemicals. EPA's Office of
Pollution Prevention and Toxics
(OPPT) is involved in two projects
that are concerned with identifying
and reducing the indoor sources of
chemical contamination.
Indoor Air Source Characterization
Project
The agency's Indoor Air Source Char-
acterization Project is defining the
sources of indoor exposures and the
risks these exposures pose to people's
health. Indoor air sources are broadly
defined to include most materials used
indoors, including building materials,
consumer and commercial products,
furniture, and fixtures.
The indoor air environments included
in the project are single-family and
multifamily residences, schools, hospi-
tals, nursing homes, office buildings,
public-access buildings, hotels, restau-
rants, vehicles used for mass transit,
and individually owned vehicles.
The project is classifying products
used indoors into groups for review.
For example, carpets, wood floors, and
vinyl sheet goods have been classified
as floor coverings. This approach will
allow EPA to compare and evaluate
substitute products for each category
as data become available.
A major component of the Indoor Air
Source Characterization Project is
development of a source-ranking
database. The database will provide a
way to (1) systematically review large
numbers of indoor-air source catego-
ries and (2) assign priorities for fur-
ther evaluation. A prototype source-
ranking database is expected to be
completed by October 1992. The
basic elements of the database will
include
a product classification scheme;
expos ure-related data: chemical-
specific or total emission rates,
estimated amount of product used
per person, populations exposed to
the product, the duration and fre-
quency of exposure, and character-
ization of the environment;
hazard information: qualitative
judgments of effects of concern and
benchmark values, such as reference
dose, unit risk, and irritant level;
and
an approach for combining hazard
and exposure elements to arrive at
an overall ranking for the product
categories.
OPPT is collaborating with EPA's
Office of Air and Radiation and
EPA's Office of Research and Devel-
opment on the Indoor Air Source
Characterization Project.
Indoor Air Cluster Project
A team of toxicologists has screened
more than 270 chemicals found in
consumer and commercial products
used in people's homes. Use of these
products may affect indoor air quality.
The team developed a relationship
between each chemical's structural
similarity to known toxic chemicals
called a structure-activity relation-
shipto predict its toxicity and bio-
logical effects. The biological effects
considered were oncogenicity, muta-
genicity, developmental and repro-
ductive toxicity, neurotoxicity, acute
toxicity, absorption, and irritancy.
The team also considered blood, kid-
ney, and liver effects.
Based on its health effects, each
chemical was ranked as being a high,
medium, or low health hazard. All
but 32 chemicals were ranked as be-
ing of moderate or high concern.
EPA will further evaluate those
chemicals commonly found in prod-
ucts to identify the substances for
which toxicity testing is needed to
develop reference concentrations,
which are estimates of how much of a
chemical people can inhale or ingest
daily without experiencing deleteri-
ous effects during part or all of their
lifetime.
A screening-level risk assessment for
the aerosol spray paint category is
scheduled to go to Risk Management
One (RM1) in September. RM1 is
the first stage of the agency's review
of existing chemicals.
CHEMICALS IN PROGRESS
-------
Enforcement
Judge Rules Statute of Limitations Does Not Apply to Assessment
Of TSCA Civil Penalties
The general five-year federal statute
of limitations does not apply to as-
sessment of civil penalties under the
Toxic Substances Control Act
(TSCA), EPA's chief judicial officer
has ruled.
The ruling resulted from EPA's ap-
peal of a case involving the Minne-
sota Mining and Manufacturing (3M)
Company, based in Minneapolis,
Minnesota. In September 1988, EPA
assessed a $1.3 million fine against
the company for importing two new
chemical substances between 1980
and 1986 without submitting a
premanufacture notice (PMN) to the
agency for review, as required by
section 5 of TSCA.
EPA Chief Judge Henry Frazier re-
duced the penalty to $104,700, say-
ing he viewed the violations as "inad-
vertent" and that EPA had not given
sufficient weight to the company's
compliance effort. The 3M Com-
pany, which imports a large number
of chemicals each year, has a well-
developed compliance program.
EPA appealed the reduction of the
penalty on the ground that Judge
Frazier had not properly applied
EPA's TSCA section 5 enforcement
response policy to the facts of the
case. During the appeal, the 3M
Company maintained that charges
should not have been brought against
the company for the violations. The
company argued that Judge Frazier
erred in narrowly construing the
general statute of limitations as not
applicable to an administrative action
for the assessment of a civil penalty
under TSCA.
In ruling on EPA's appeal, Chief
Judicial Officer Ronald McCallum
upheld reduction of the penalty. He
stated that the 3M Company's com-
pliance efforts and the inadvertence of
the violations should not be consid-
ered in calculating the gravity-based
penalty. These factors, he ruled, did
warrant consideration during the
adjustment phase of analysis under
the TSCA section 5 enforcement
response policy.
As to whether EPA was barred from
filing charges for TSCA violations
more than five years after an event
had occurred, Chief Judicial Officer
McCallum noted, "Federal courts
have held that the United States is
not bound by statutes of limitation
unless Congress clearly manifests
such an intention."
In a related case in May 1992, EPA's
Environmental Appeals Board re-
manded an administrative case
against Bethlehem Steel, of Pennsyl-
vania, to Administrative Law Judge
J.F. Greene, who had earlier ruled
that the complaint was barred by the
federal statute of limitations. (The
Environmental Appeals Board now
handles appeals that were formerly
heard by the chief judicial officer.)
I Other Enforcement Actions
EPA proposed a $15,000 fine against the New Hampton School for violations
of polychlorinated biphenyl (PCB) regulations under the Toxic Substances
Control Act (TSCA). EPA alleged that the New Hampton, New Hampshire,
school failed to properly mark the vault door where a PCB transformer was
located, stored combustible materials near a PCB transformer, and failed to
register its PCB transformer with the local fire department.
A school was ordered to develop an asbestos-management plan as required by
the Asbestos Hazard Emergency Response Act (AHERA). EPA sought a
$4,000 penalty for failure to develop a plan after the Delana Day School, in
Chicago, Illinois, failed to comply with a notice of noncompliance and did not
respond to a motion for default. The school was ordered to use the $4,000
civil penalty to develop an asbestos-management plan and to pay any remain-
ing amount to EPA.
VOL.13 / N0.2 SEPTEMBER 1992
-------
Asbestos
National Directory of Courses for Asbestos Professionals Is Available
EPA has published a national direc-
tory of training courses for asbestos
professionals. The courses are re-
quired for the accreditation of asbes-
tos workers and have been approved
by EPA or the state in which they are
offered.
State and regional lists are available
The National Directory ofAHERA-
Accredited Courses (NDAAC) was first
published in November 1991 and is
updated quarterly. Specialized lists of
courses, such as those available in cer-
tain regions, states, or other geo-
graphically defined areas, are also
available.
The NDAAC is provided free to fed-
eral and state regulatory agencies in-
volved in implementing the Asbestos
Hazard Emergency Response Act
(AHERA) and to others for a nominal
fee.
For more information
A brochure containing information
about ordering, fees, and how to make
special requests is available from the
NDAAC Clearinghouse at ATLIS
Federal Services, Inc., 6011 Executive
Boulevard, Rockville, Maryland
20852; telephone, (301) 984-1929.
EPA Awards Grants for Asbestos-Abatement Training
In May 1992, EPA offered $1.5 mil-
lion in grants to seven labor manage-
ment training trust funds to support
training for asbestos-abatement work-
ers. The trust funds are cooperative
ventures between labor unions and
the management of the unions' associ-
ated industries. Each union will pro-
vide a matching contribution of at
least 5 percent of the project cost.
The asbestos-abatement training sup-
ported by the grants includes
initial and refresher courses to meet
the demands for asbestos-abatement
workers, supervisors, and instruc-
tors;
refresher training materials that
incorporate the newest technologies
and innovative teaching techniques;
and
programs to meet the expected
changes to the Model Accreditation
Plan standards mandated by the
Asbestos School Hazard Abatement
Labor-Management Trust Fund
Grant Amount
Laborers-AGC Education and Training Fund
United Brotherhood of Carpenters Health
and Safety Fund
Insulation Industry International Apprenticeship
and Training Fund
United Union of Roofers,
Apprenticeship and Allied Workers
Engineers' Research and Education
Cooperative Trust
National Training Fund (Sheet Metal and
Air Conditioning Industry)
National Ironworkers and Employers
Apprenticeship Training and
Journeyman Upgrading Fund
$350,000
$345,000
$325,000
$210,000
$140,000
$110,000
$ 20,000 (start-up funds)
Reauthorization Act of 1990
(ASMARA).
The funds are available only to joint
labor-management training trust
funds. EPA's Office of Pollution
Prevention and Toxics received pro-
posals from seven of the eight labor-
management training trust funds and
offered funds to each of them. All
the projects that were funded meet
the more stringent federal accredita-
tion standards expected to become
effective late this year.
CHEMICALS IN PROGRESS
-------
Asbestos
New Asbestos Training and Accreditation Requirements To Take Effect
The date on which new asbestos
training and accreditation require-
ments take effect has been extended
until November 28, 1992. The new
training requirements were mandated
by the Asbestos School Hazard
Abatement Reauthorization Act
(ASMARA) of 1990.
ASMARA requires EPA to (1) in-
crease the amount of training that
asbestos-abatement workers must
have to become accredited and (2)
require accreditation for certain as-
bestos-control personnel working in
public and commercial buildings.
Current accreditation requirements
apply only to people working in
school buildings.
Tightening accreditation standards
Under the Asbestos Hazard Emer-
gency Response Act (AHERA), EPA
developed a model accreditation plan
in 1987 that established minimum
federal training and accreditation
standards for asbestos-control profes-
sionals working in schools. States
were required to adopt accreditation
programs no less stringent than the
EPA model accreditation plan.
ASHARA mandates that EPA increase
the minimum number of training
hours, including hands-on health and
safety training, required for accredita-
tion. EPA is developing training
requirements to satisfy ASHARA and
will publish them in a revised model
accreditation plan around November
1992.
The revised model accreditation plan
will also extend accreditation require-
ments to asbestos inspectors, project
designers, and contractor supervisors
and employees working in public and
commercial buildings. Asbestos-
management planners were excluded
by ASHARA and will not be re-
quired to obtain accreditation to
work in public and commercial
buildings.
For more information
For more information about the ex-
tension of the asbestos accreditation
requirements, see 57 FR 1913 (Janu-
ary 16, 1992) and 57 FR 20438 (May
13, 1992). A copy of the Federal
Register notices can be obtained from
the TSCA Assistance Information
Service (TSCA hotline). See page 38
for information about contacting the
hotline.
School Districts Awarded $54.5 Million for Asbestos Abatement
On April 27, 1992, EPA awarded
$54.5 million in fiscal 1992 funds to
school districts to undertake asbestos-
abatement projects. The agency of-
fered funds to 128 school districts for
261 abatement projects in 198
schools. Three hundred sixty-two
local education agencies applied for
assistance.
The funds were awarded under the
reauthorized Asbestos School Hazard
Abatement Act. The 1992 awards
consisted of approximately $14.8
million in grants and $39-7 million
in interest-free loans to schools. EPA
estimates that these asbestos projects
will eliminate more than 3.1 million
hours of exposure to asbestos per week
for students and school employees.
Since 1985, EPA has provided $346
million for asbestos abatement in
2,138 schools. EPA believes these
abatement projects have eliminated 25
million student and school-employee
exposure hours to asbestos per week
since 1985.
Criteria for eligibility
The statute directs EPA to assist
school districts that have serious asbes-
tos problems and a demonstrated
financial need. The statute also
directs EPA to consider abatement
projects in order of hazard priority
and to then determine what assis-
tance should be offered until avail-
able funds are expended.
For information about future aid
EPA will notify school districts by
November 15, 1992, if Congress
appropriates funds for awards in
fiscal 1993.
VOL.13 / N0.2 SEPTEMBER 1992
-------
TSCA Hotline/TSCA Section 8(e) and FYI Information
TSCA Hotline: Call (202) 554-1404
The TSCA Assistance Information Service (TSCA hotline) operates Monday
through Friday, from 8:30 a.m. to 5 p.m. Eastern time. To speak to an
information specialist, call (202) 554-1404. FAX requests for documents
are received every day, at all times, on (202) 554-5603. Documents can
also be requested by deaf persons who have TDD equipment by dialing
(202)554-0551.
To request assistance by mail, write to the Environmental Assistance Divi-
sion at the address provided on page 39-
FYI Submissions
For Your Information (FYI) submis-
sions are voluntary submissions that
cover a wide variety of information
and may include data on chemical
toxicity and exposure, epidemiology,
monitoring, and environmental fate.
FYIs are submitted by chemical
manufacturers, chemical processors,
federal, state, and local agencies, for-
eign governments, academic institu-
tions, public interest and environmen-
tal groups, and the general public.
The agency established the FYI classi-
fication system to distinguish such
submissions from notices submitted
formally to EPA under section 8(e) of
the Toxic Substances Control Act
(TSCA). The Office of Pollution Pre-
vention and Toxics received six FYI
submissions from January 1, 1992,
through March 31, 1992.
TSCA Section 8(e) Notices
Under section 8(e) of the Toxic Sub-
stances Control Act (TSCA), anyone
who obtains information that indi-
cates a chemical may pose a substan-
tial risk of injury to human health or
the environment must report that
information to EPA within 15 work-
ing days of obtaining it.
The Office of Pollution Prevention
and Toxics (OPPT) received more
than 800 TSCA section 8(e) notices
from January 1, 1992, through
March 31, 1992. Most of these no-
tices were submitted by companies
participating in EPA's Compliance
Audit Program.
In the past, Chemicals-in-Progress Bul-
letin has listed recent section 8(e)
submissions. Because of the volume
of notices recently submitted, how-
ever, the list is not being published
in this issue. For information on how
to obtain an index of section 8(e)
notices or copies of the notices, see
the related article on this page.
Availability of 8(e)
Notices and FYI
Submissions
Section 8(e) notices and FYI submis-
sions are available to the public in a
number of ways, which are listed
below. Note that EPA no longer
issues submission summaries of sec-
tion 8(e) notices.
Section 8(e) notices and FYI sub-
missions can be reviewed and pho-
tocopied at EPA headquarters in
the OPPT Public Reading Room,
NE-G004, U.S. EPA, 401 M
Street, S.W., Washington, D.C.
20460; telephone, (202) 260-7099.
The room is open from 8 a.m. to
noon and 1 p.m. to 4 p.m., Monday
through Friday.
A copy of a full section 8(e) or FYI
submission can be obtained by
writing to Freedom of Information
Office (A101), U.S. EPA, 401 M
Street, S.W., Washington, D.C.
20460. Duplication of the first
166 pages of any document is free.
At the 167th page, there is a $25
fee and an additional $0.15 charge
for each page. For example, dupli-
cation of a 167-page document will
cost $25.15.
Chronological indices of section
8(e) and FYI notices are avaikble
from the TSCA Assistance Informa-
tion Service (TSCA hotline) two to
three months after the end of each
fiscal quarter. The fiscal quarters
end on September 30, December
31, March 31, and June 30. See
this page for information on how to
contact the hotline.
CHEMICALS IN PROGRESS
-------
For More Information
Send All Correspondence to
Environmental Assistance Division (TS-799)
Office of Pollution Prevention and Toxics
U.S. EPA
401 M Street, S.W.
Washington, D.C. 20460
Editor: Jane Gurin
Would You Like to Receive the
Chemicals-in-Progress Bulletin?
The Chemicals-in-Progress Bulletin is published by EPA's Office of Pollu-
tion Prevention and Toxics. If you are not currently receiving the bulle-
tin and would like to become a subscriber, or if you would like to stop
receiving the bulletin, please fill out and send in the form below. Or,
tape a mailing label onto it.
D Please add my name to the mailing list for the Chemicals-in-Progress
Bulletin.
Q I no longer want to receive the Chemicals-in-Progress Bulletin.
CH I'd like a copy of the following publication(s):
New Publications
From the TSCA Hotline
Single copies of these publications
can be obtained by calling or sending
a FAX to the TSCA hotline or by
filling out and mailing the form on
this page.
Risk Assessment, Management, Com-
munication: A Guide to Selected
Sources, Volume 4, Number 1
PCBs in Underground Mines, a bro-
chure published by EPA and the
Mine Safety and Health Adminis-
tration of the U.S. Department of
Labor
New Chemicals Exposure-Based
Environmental Fate Testing Pro-
gram (description of program)
Pollution Prefention through Compli-
ance and Enforcement: A Review of
OPTS Accomplishments
33/50 Program information pack-
age
Chlorinated Dioxins and Furans in
the General U.S. Population: NHATS
FY87 Results. This publication can
also be ordered from the National
Technical Information Service
(NTIS), 5285 Port Royal Road,
Springfield, Virginia 22161; tele-
-------
TSCA Hotline: Question & Answer
TSCA Hotline: Question & Answer
Ql If I remove some fluorescent light
fixtures that contain polychlorinated
biphenyls (PCBs) from a building I
own, what EPA regulations am I
required to follow?
A: Fluorescent light fixtures manu-
factured before 1979 usually contain
PCBs, which were used to insulate
the small capacitors in the light's
ballast. The balkst, which is the
primary electric component of fluo-
rescent fixtures, is generally located
within the fixture under a metal
cover plate.
The Toxic Substances Control Act
(TSCA) requires that building owners
dispose of PCB-insulated capacitors
as a hazardous waste if leaking has
occurred. The Comprehensive Envi-
ronmental Response, Compensation,
and Liability Act (CERCLA) requires
that building owners notify the Na-
tional Response Center if they dis-
pose of or move (from one location to
another) more than one pound of
To identify fluorescent lights that
contain PCBs, check the balkst label.
Ballasts manufactured since 1979 are
labeled with a sticker that states they
do not contain PCBs. Ballasts with-
out a sticker should be treated as if
they contain PCBs. Or, verify their
contents by calling the manufacturer
and providing the ballast make and
model number.
Many states also regulate the disposal
of light ballasts containing PCBs.
So, before acting, check with re-
gional, state, or local authorities in
the area in which the light ballasts
are located and, if applicable, the area
in which they will be disposed of.
EPA encourages recycling
EPA encourages the recycling of
PCB-containing ballasts and fluores-
cent lamps, which contain small
amounts of mercury, cadmium, and
antimony. Recycling companies
remove the capacitors from the bal-
lasts, pack them in drums and send
maining materials to recover the
mercury, cadmium, and antimony.
For more information
To obtain the document Light
Brief: Is there a Right Way to Dispose
of Your Old Light Ballasts?, which
discusses issues concerning light
ballasts, call EPA's Green Lights
program at (202) 479-6936. The
Green Lights program can also
provide lists of ballast and fluores-
cent lamp recyclers and state dis-
posal contacts.
For information on CERCLA re-
porting requirements, contact the
Superfund hotline at (800) 424-
9346.
The National Response Center
telephone numbers are (800) 424-
8802 and (202) 426-2675.
For more information about TSCA
policies, call the TSCA Assistance
Information Service (TSCA hotline)
at (202) 554-1404. See page 38 for
additional information on contact-
-------
For More information
Send All Correspondence to
Environmental Assistance Division (TS-799)
Office of Pollution Prevention and Toxics
U.S. EPA
401 M Street, S.W.
Washington, D.C. 20460
Editor: Jane Gurin
Would You Like to Receive the
Chemicals-in-Progress Bulletin!
The Chemicals-in-Progress Bulletin is published by EPA's Office of Pollu-
tion Prevention and Toxics. If you are not currently receiving the bulle-
tin and would like to become a subscriber, or if you would like to stop
receiving the bulletin, please fill out and send in the form below. Or,
tape a mailing label onto it.
Q Please add my name to the mailing list for the Chemicals-in-Progress
Bulletin.
CD I no longer want to receive the Chemicals-in-Progress Bulletin.
EH I'd like a copy of the following publication(s):
Name
Title
Company or Organization Name
Type of Business
Street Address
City
State
Zip Code
New Publications
From the TSCA Hotline
Single copies of these publications
can be obtained by calling or sending
a FAX to the TSCA hotline or by
filling out and mailing the form on
this page.
Risk Assessment, Management, Com-
munication: A Guide to Selected
Sources, Volume 4, Number 1
PCEs in Underground Mines, a bro-
chure published by EPA and the
Mine Safety and Health Adminis-
tration of the U.S. Department of
Labor
New Chemicals Exposure-Based
Environmental Fate Testing Pro-
gram (description of program)
Pollution Prevention through Compli-
ance and Enforcement: A Review of
OPTS Accomplishments
33/50 Program information pack-
age
Chlorinated Dioxins and Furans in
the General U.S. Population: NHATS
FY87 Results. This publication can
also be ordered from the National
Technical Information Service
(NTIS), 5285 Port Royal Road,
Springfield, Virginia 22161; tele-
phone, (703) 487-4650. The cost
of ordering the document from
NTIS is $35; its NTIS order num-
ber is PB92-180157/AS.
From the EPA Public Information Center
The updated report Current Federal
Indoor Air Quality Activities can be
obtained by writing to Public Infor-
mation Center (PM-211B), U.S.
EPA, 401 M Street, S.W., Washing-
ton, D.C. 20460.
£M VOL.13/N0.2 SEPTEMBER 1992
-------
TSCA Hotline: Question & Answer
TSCA Hotline: Question & Answer
Q." If I remove some fluorescent light
fixtures that contain polychlorinated
biphenyls (PCBs) from a building I
own, what EPA regulations am I
required to follow?
A: Fluorescent light fixtures manu-
factured before 1979 usually contain
PCBs, which were used to insulate
the small capacitors in the light's
ballast. The ballast, which is the
primary electric component of fluo-
rescent fixtures, is generally located
within the fixture under a metal
cover plate.
The Toxic Substances Control Act
(TSCA) requires that building owners
dispose of PCB-insulated capacitors
as a hazardous waste if leaking has
occurred. The Comprehensive Envi-
ronmental Response, Compensation,
and Liability Act (CERCLA) requires
that building owners notify the Na-
tional Response Center if they dis-
pose of or move (from one location to
another) more than one pound of
PCBs within 24 hours. Ten to thirty
ballasts would generate roughly one
pound of PCBs.
To identify fluorescent lights that
contain PCBs, check the ballast label.
Ballasts manufactured since 1979 are
labeled with a sticker that states they
do not contain PCBs. Ballasts with-
out a sticker should be treated as if
they contain PCBs. Or, verify their
contents by calling the manufacturer
and providing the ballast make and
model number.
Many states also regulate the disposal
of light ballasts containing PCBs.
So, before acting, check with re-
gional, state, or local authorities in
the area in which the light ballasts
are located and, if applicable, the area
in which they will be disposed of.
EPA encourages recycling
EPA encourages the recycling of
PCB-containing ballasts and fluores-
cent lamps, which contain small
amounts of mercury, cadmium, and
antimony. Recycling companies
remove the capacitors from the bal-
lasts, pack them in drums and send
them to incinerators or chemical
waste landfills, and recycle the re-
maining materials to recover the
mercury, cadmium, and antimony.
For more information
To obtain the document Light
Brief: Is there a Right Way to Dispose
of Your Old Light Ballasts?, which
discusses issues concerning light
ballasts, call EPA's Green Lights
program at (202) 479-6936. The
Green Lights program can also
provide lists of ballast and fluores-
cent lamp recyclers and state dis-
posal contacts.
For information on CERCLA re-
porting requirements, contact the
Superfund hotline at (800) 424-
9346.
The National Response Center
telephone numbers are (800) 424-
8802 and (202) 426-2675.
For more information about TSCA
policies, call the TSCA Assistance
Information Service (TSCA hotline)
at (202) 554-1404. See page 38 for
additional information on contact-
ing the hotline.
vvEPA
United States
Environmental Protection Agency
(TS-799)
Washington, D.C 20460
Official Business
Penalty for Private Use
$300
U J '* 1 " 9
r. FfFAT LA^-^S
ii i i.r»A C:?^
?5T S. D Al;
pan
First Class Mail
Postage and Fees Paid
EPA
Permit No. G-3S
f
------- |