vvEPA
OFFICE OF POLLUTION PREVENTION AND TOXICS
SUMMER 1994 EPA-745-N-94-002
highlights
10 TRI Industry Expansion
Focuses on Five Sectors
11 TSCA 1994 Inventory
Update Rule Collection
Opens Aug. 25
31 EPA's Proposed TSCA
Biotechnology Signed by
the Administrator
39 Six Industries Selected to
Spearhead Common
Sense Initiative
Chemicals in Progress
lletin
OPPT Pursues
Environmental Justice Strategy
by Ernestine Hall
President Clinton issued Executive Order 12898 in February 1994
which requires federal agencies to address the issue of environmental
justice. Environmental justice (EJ) is defined as the fair treatment of all
races, cultures, incomes and educational levels with respect to the
development, implementation, and enforcement of environmental
laws, regulations and policies. Fair treatment implies that no subgroup
of people should be forced to shoulder a disproportionate share of the
negative environmental impacts of pollution or hazards due to a lack
of political and/or economic strength. EPA has been given the mission
of developing a strategy to implement environmental justice into
Justice continued on page 2
A New Vision for TSCA
by Colleen Michuda
A new future may be in sight for the eighteen-year-old Toxic Sub-
stances Control Act of 1976 (TSCA). Action is already underway in the
Senate for the reauthorization of TSCA. Senator Harry Reid of Nevada,
Chairman of the Subcommittee on Toxic Substances, Environmental
Oversight, Research and Development (a subcommittee of the Commit-
tee on Environment and Public Works), is leading the initiative. Sen.
Reid held a preliminary hearing on May 17 and a second hearing on
July 13. Ultimately, Reid hopes to introduce legislation by the start of
the next Congress in January. Realistically, though, passage of a TSCA
reauthorization bill is not likely before late 1995 or 1996.
At the May hearing, Dr. Lynn Goldman, Assistant Administrator of the
Office of Prevention, Pesticides and Toxic Substances (OPPTS), presented
TSCA continued on page 5
VOL. 15/NO. 2 SUMMER 1994
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Table of Contents
Contents
General
1 OPPT Pursues Environmental
Justice Strategy
1 A New Vision For TSCA
6 Final Action Plan for TSCA CBI
Reform
39 Six industries Selected to
Spearhead Common Sense
Initiative
TRI
7 Regions and States Make Broad
Use of TRI Data in 1993
10 TRI Industry Expansion
Focuses on Five Sectors
Existing Chemicals Program
11 TSCA 1994 Inventory Update
Rule Collection Begins Aug. 25
12 Q's & A's on the Inventory
Update Rule
13 Enforcement Initiative Targets
Late 1990 IUR Reporters
13 SIETIS Database Created for
Silicone
14 OPPT's Chemical Testing
Program The Year in Review
16 34th Report of the TSCA
Interagency Testing Committee
17 Update on Machine Fluicls-
LFAW Section 21 Petition
18 RM2 and Post-RM2 Activity
Chart
Design for the Environment
21 DfE Project Updates
Pollution Prevention
23 P2 Round-Up of Activities
24 10th Annual P2 Conference
Lead, Asbestos, PCBs
26 Asbestos Accreditation
Extended to Public &
Commercial Buildings
27 Agency Proposes to Simplify
Reclassification of PCB
Transformers
28 Final Rule on PCB Exemption
Petitions Published
29 EPA Lead Paint Program
Highlights
Biotechnology
31 EPA's Proposed TSCA
Biotechnology Rule
Signed by the Administrator
33 Request to Commercialize
Genetically-Modified Bacteria
Expected
34 Ecological Tier Testing
Schemes for Microorganisms
Workshop
TSCA Hotline
36 Exporter Responsibilities:
Clarification
Resources
36 New Documents from PPIC
International
37 Final Report on Joint U.S./E.U.
Study of SAR
Send all Correspondence to:
Environmental Assistance
Division (7408)
U.S. EPA
401 M Street, S.W.
Washington, D.C. 20460
Environmental Justice
Justice from page 1
existing pollution prevention
projects and to develop new
projects highlighting the EJ initia-
tive. EPA has directed each pro-
gram office to develop a strategy
that will ultimately become a part
of the Agency's overall strategy on
environmental justice.
The Office of Pollution Prevention
and Toxics (OPPT) has been
working to create a strategy that
will deal with all aspects of the EJ
issue. The Environmental Assis-
tance Division (HAD) has been
given the lead in organizing an EJ
Workgroup to develop a strategy
for OPPT, and to catalogue the
diverse ongoing projects within
OPPT that address EJ issues.
OPPT's major activities involving
EJ are divided into two categories:
(1) activities that OPPT has the
lead in developing because of
legislative authority or particular
expertise, and (2) activities that
OPPT plays a significant role in
developing.
OPPT Environmental
Justice Activities
Geographical Targeting of
Toxic Chemicals
OPPT is examining new methods
for analyzing the geographic
distribution of Toxics Release
Inventory (TRI) releases and
transfers relative to U.S. popula-
tions. These activities are being
conducted together with the EPA
Office of Environmental Equity,
Justice continued on next page
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CHEMICALS IN PROGRESS
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I
General
Environmental Justice
Justice from previous page
the Office of Research and Devel-
opment (ORD), and geographic-
analysis teams in the EPA Re-
gional Offices.
OPPT has been developing
different approaches for combin-
ing TRI data on facility locations
and toxic emissions, with data
from the Census Bureau on the
distribution of population traits
(population density, race, income,
etc.). These techniques, although
preliminary, have proved useful.
One case study involves the
Lower Mississippi River Industrial
Corridor in Louisiana. As a result
of this case, several reports on
environmental justice have been
cited, most notably the report of
the Louisiana Advisory Committee
on Civil Rights, The Battle for
Environmental Justice in Louisi-
ana: Government, Industry and
the Public. OPPT plans to expand
the capabilities and extent of its
geographic information system
(GIS) to support similar studies
throughout the United States, and
is working with other EPA offices
and regions to ensure that sound
scientific approaches are used.
Lead Exposure Targeting
OPPT has instituted a project to
develop a risk-based geographic
targeting system for lead, to
address the need for effective
methods to determine geographic
areas with the highest potential
for lead exposure. This project
will enable EPA and States to
target compliance, abatement, and
educational efforts. The targeting
system is undergoing a technical
evaluation stage, and has re-
viewed existing analyses of the
relationship between housing and
socioeconomic characteristics and
elevated blood levels to identify
predictive variables. If this is
effective, there is potential to
create a "user friendly" version of
the system to be made available
to the general public. Similar tools
to enhance access to TRI data are
also under consideration.
FY95 Pollution Prevention
Grants for Environmental
Justice
In FY95, EPA is prepared to
provide approximately $6M in
grants to community groups for
pollution prevention actions in
areas with environmental justice
concerns. These grants would
also deal with ongoing pollution
prevention grants to states. In
many instances, grants are also
being used to address environ-
mental justice concerns from a
pollution prevention perspective.
In applying these grants, local
governments and community
groups could address a wide
range of toxic chemical concerns
by focusing on reducing or
eliminating the use of waste
generation of the substances.
Reduction of Toxics Exposures
from Personal Use Practices
OPPT examines the spectrum of
exposure routes in its review of
chemicals under TSCA. The Office
has begun working with Latino and
other community groups to provide
information on the potential haz-
ards of mercury and other heavy
metals often used in its elemental
state, or incorporated in folk
medicines, religious materials, or
other articles for personal use.
Exposure to these substances has
severely affected a number of
Americans, frequently including
children. OPPT is developing
outreach materials on their
potentially hazardous substances
and practices, and will make them
available to community groups for
distribution.
OPPT is also focusing significant
attention on the concerns of
communities whose diet depends
on subsistence fishing. Contami-
nation by mercury and other
persistent pollutants that
bioaccumulate in fish is receiving
increased attention in OPPT's
outreach and control efforts.
Environmental Justice
Activities with OPPT
Participation
Lead Abatement Training Grants
FY94 is the fourth year that Con-
gress has provided EPA with funds
for grants to non-profit community
groups to deliver lead abatement
worker training. This year's funds
total $2.8M, a significant increase
over $500K available in FY93. The
FY94 notice of funds availability
was published on April 20, 1994
with grant pre-proposals due May
20. Also new for FY94 was a
significantly reduced requirement
for matching funds, down from
30% last year to 5%. EPA is princi-
pally interested in funding non-
Justice continued on next page
VOL. 15/NO. 2 SUMMER 1994
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General
Environmental Justice
from previous page
profit community-based programs
that offer lead abatement training
opportunities for minorities and
low income residents. This grass
roots initiative will provide oppor-
tunities for communities to develop
local lead abatement businesses
that will employ area residents.
Two groups receiving these grants
in FY93, the Bronx Legal Services
and Baltimore Jobs in Energy,
have introduced innovative and
commendable programs. The
training includes classroom studies
as well as an extensive apprentice-
ship where lead abatement work is
actually performed. In addition to
training and employing local
workers, the program puts work-
ers to work in homes where the
homeowner could not otherwise
afford the lead abatement work.
Special emphasis is placed on
teaching a portion of the class
graduates supervisory or contractor
skills to improve their future
employment opportunities in the
lead abatement field.
Mexico Border Activities
OPPT has had a lengthy involve-
ment with pollution prevention
activities along the U.S.-Mexico
border through its participation in
a number of activities: the Pollu-
tion Prevention (P2) Border
Workgroup, TSCA Section 21
petitions regarding the New River
which flows from Mexico into the
U.S., EPA follow-up to health and
environmental concerns in the
Brownsville-Matamoros area, and
more recently, follow-up on the
environmental side agreement
negotiated under NAFTA. In order
to facilitate broad outreach, many
of EPA's pollution prevention
materials have been translated into
Spanish for wide distribution.
OPPT involvement in U.S.-Mexico
environmental issues is expected
to increase in FY94 and FY95.
The Office is engaged in dialogue
with Mexican officials and inter-
national organizations such as the
United Nations Institute for
Training and Research (UNITAR)
to foster pollution prevention
training in Mexico and elsewhere.
OPPT has also provided funding
to Region 6 for state grants to
promote cross-border P2 activi-
ties. We are tracking closely the
activities of border-area projects
such as the Arizona Toxics Infor-
mation project, and the State of
California's request for emissions
data from California companies
that operate maquilcidoros in
Mexico. EPA has also requested
information from U.S. parent
companies on their operations in
Mexico in the Mexacali area,
where the New River originates.
Conclusion
OPPT is making positive strides to
incorporate the environmental
justice ethic into the entire pro-
gram. OPPT activities outlined
here represent just the beginning
of the projects under consider-
ation. OPPT's vision is to incorpo-
rate an environmental justice
perspective into all existing and
new projects within OPPT,
We at EPA are deeply
committed to the principle of
environmental justice: fair
environmental protection for
all people regardless of race,
ethnic background or income
status. We believe that EPA
has the responsibility for
coordinating the efforts and
duties of the federal, tribal,
state and local governments
to provide a clean and safe
environment for every
resident, in every community,
in the United States.
Carol M. Browner,
Administrator
U.S. Environmental
Protection Agency
January 1994
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CHEMICALS IN PROGRESS
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I
General
A New Vision for TSCA
TSCA from page 1
her vision for a successful toxics
program. The cornerstone of this
vision is the belief that both
pollution prevention and public
participation are vital to any effort
to protect the environment, With
these priorities in mind. Dr.
Goldman outlined several key
issues for consideration as Congress
takes up reauthorization.
Two potential areas of reform
include TSCA's role in information
collection and dissemination. The
efficiency and effectiveness of the
information collection process,
she noted, could be improved by
focusing on priority categories of
chemicals and by authorizing the
collection of chemical use infor-
mation. Dr. Goldman also sug-
gested reforming the disclosxire
process, paying careful attention
to information claimed as confi-
dential business information (CBI).
Dr. Goldman noted that it should
be possible to expand access to CBI
while still being mindful of .
legitimate business interests.
The new chemical program is
another area deserving attention,
Although it may be appropriate,
as some propose, that industry
bear a higher burden in justifying
the introduction of new chemicals
into commerce, it is important to
consider how to "level the playing
field" between new and existing
chemicals, Statutory changes that
build in a bias against new chemi-
cals will not promote overall
pollution prevention.
Dr. Goldman also suggested that
Congress focus on how to better
target risk management actions
for situations needing pollution
prevention. In particular, Congress
may want to consider incorporat-
ing the pollution prevention
hierarchy into TSCA Section 6
unreasonable risk determinations.
The President's Executive Order
calling for the purchase of "envi-
ronmentally preferable products"
by the federal government has
brought forth an era of
ecolabeling and requires the
development of new environmen-
tal policies. Dr. Goldman sug-
gested that Congress focus on
EPA's role in accurately informing
consumers of the environmental
attributes of products.
Two final issues raised by Dr.
Goldman were enforcement and
streamlining. Since TSCA is now
eighteen years old, existing
enforcement provisions may need
to be reevaluated. In addition,
Congress might also investigate
simplifying or streamlining some
parts of the statute to make the
toxics program more efficient and
focused on priority activities.
It is uncertain at this point how
Senator Reid or others in Con-
gress envision revamping TSCA.
Clearly, it will be a lengthy and
painstaking process, but EPA has
pledged to assist Senator Reid in
crafting a legislative proposal.
It is important to consider
how to "level the playing
field" between new and
existing chemicals.
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VOL. 15/NO. 2 SUMMER 1994
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General
Final Action Plan for TSCA CBI Reform
OPPT has completed its examina-
tion of TSCA confidential business
information (CBI) and incorpo-
rated its findings into a Final
Action Plan. In the plan, OPPT
identifies the specific actions the
Office will undertake to reduce
inappropriate CBI claims. Nine
action items are identified that
encompass nonregulatory activi-
ties, industry voluntary activities,
and formal regulatory and policy
amendments. Copies of the Action
Plan may be obtained from the
TSCA Hotline (202-554-1404).
The Final Action Plan represents a
significant milestone in EPA's
efforts to increase public aware-
ness and utility of data received
under TSCA. Since the enactment
of TSCA, attempts to disseminate
TSCA data have been challenged
by continuing CBI claims, some of
which are legally inappropriate.
OPPT recognized early in its
review process that the issue of
confidentiality generated strong
opinions in both the business
community and among identified
potential users of TSCA data
including states, environmentalists,
and labor. For this reason, OPPT
opted to elicit maximum public
input on the issue by making its
reform deliberations entirely open
to the interested public.
OPPT hired a contractor to ana-
lyze TSCA CBI issues, identify
problems, and offer possible
solutions. The purpose of the
study was to frame the issues so
that OPPT and the interested
public, including both experi-
enced TSCA practitioners and
toxics generalists, could achieve a
basic understanding of the law,
concerns, and positions of inter-
ested parties.
OPPT staff then held a series of
public meetings to solicit com-
ments, and also met with inter-
ested constituencies. By "going
public" in its deliberations,
OPPT sought to achieve an
understanding of the needs of
each of the constituencies and
some consensus on solutions.
The final action plan reflects the
understanding achieved, explicitly
recognizing that reform actions
need to carefully balance the
public's "Right-To-Know" with the
need to protect proprietary infor-
mation. Each of the nine action
items in the plan is designed to
increase the amount of information
on chemicals available to the
public and to foster a better
understanding of the Agency's
chemical management activities.
The action items include two
critical activities: EPA's continuing
efforts to disseminate toxics data,
and a voluntary industry effort to
provide education on CBI claims.
The Office has observed that
inappropriate claims are reduced
when information on proper CBI
claims procedure is disseminated
to the regulated community.
EPA will be working to strengthen
Inappropriate claims are
reduced when information
on proper CBI claims
procedure is disseminated
to the regulated
community.
its CBI regulations to ensure that
only information which is actually
proprietary is claimed as CBI. The
final action plan discusses sunset
provisions for CBI claims, upfront
substantiations, and signing of
CBI claims by senior manage-
ment, and it identifies a clear plan
for incorporating these provisions
into regulations.
Efforts are already underway to
accomplish each of the items
identified in the plan. OPPT is
committed to making significant
progress on each item by January
1995. For further information on
the TSCA CBI Final Action Plan,
contact Frank Caesar at (202) 260-
0425 or Scott Sherlock at (202)
260-1536, both of the Information
Management Division.
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CHEMICALS IN PROGRESS
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TRI
Regions and States Make
Broad Use of TRI Data in 1993
The Toxics Release Inventory
(TRI) is widely used by many
private sector groups, as de-
scribed in earlier issues of this
Bulletin. What about the use of
TRI by federal and state TRI
program managers? On an ongo-
ing basis, staff use TRI to:
Target facilities for compliance
and enforcement inspections. In
1993, 798 inspections were
conducted using TRI data. To
date, proposed fines totaling $40
million have been assessed by
EPA Regional Offices against
facilities that either did not report,
reported late, or sent in poor
quality data. Ohio, the state with
the most aggressive Emergency
Planning and Community Right-
to-Know Act (EPCRA) section 313
enforcement program, conducted
over 100 inspections in 1993.
Develop approaches for inte-
grating TRI with other databases
to identify industries or geo-
graphic areas of concern. TRI has
been used by Regions 3, 4, and 9
to identify sites for environmental
justice projects. Seventeen states
are conducting CIS studies using
TRI and eight states have used or
are using the TRI for environmen-
tal justice studies.
Identify and report on pollution
prevention practices by reporting
facilities. These analyses have
lead to the development of
technical assistance and peer
information exchange programs in
a number of Regions. A majority
of the states have toxics use
reduction or pollution prevention
legislation that uses TRI data to
track progress,
Generate interest in, and aware-
ness of, EPA's Right-to-Know
program in order to foster a better
informed public. TRI demonstra-
tions and presentations have been
given at a variety of educational
institutions which have led to the
development of course offerings
which include the TRI as tool.
Following are more detailed
descriptions of how some of the
EPA Regional Offices and states
are using the TRI data.
Regions' Use of TRI
MERIT Partnership
EPA Region 9 is leading an effort
to develop a partnership between
industry and regulatory agencies
to reduce the level of emissions in
southwest Los Angeles County by
fostering and implementing
pollution prevention projects. This
area was selected due to its high
concentration of industrial facili-
ties. Data from TRI have shown
that the area's toxic releases are
the highest in the state and in
Region 9.
The central theme of the partner-
ship named "Mutual Efforts to
Reduce Industrial Toxics" or
MERIT is to support industry-
driven, Agency-supported, volun-
tary pollution prevention projects.
All projects submitted by industry to
the partnership will be evaluated
with respect to the pollution preven-
tion hierarchy of media reductions
and must go "beyond compliance"
(below allowable limits, ahead of
schedule, and include voluntary
action). Projects must make good
business sense with a suitable return
on investment, particularly in an
area such as Los Angeles County
which has experienced a severe
business downturn.
Region 9 has drafted a set of
guidelines for the partnership that
will help companies voluntarily
assess their emissions, and work
with other companies and agen-
cies to develop pollution preven-
tion projects. A community
advisory board is being established
to provide input into the program.
Participants will be eligible for
expedited processing of permit
applications, and can receive
compliance assistance from other
partnership companies. Participat-
ing companies will also have an
opportunity to provide meaning-
ful input to regulators on how to
encourage additional pollution
prevention projects.
Examples of MERIT partnership
projects are the following:
The Oil Refinery Roundtable
and the Metal Finishers Waste
TRI Data continued on next page
VOL. 15/NO.2 SUMMER 1994
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TRI
TRI Data
TRI continued from previous page
Minimization Audit Workshop
are designed to identify pollu-
tion prevention options that are
available, transferable, and free
of legal, regulatory, and propri-
etary barriers.
A project associated with
electric car development which
involves the principles of
"Design for the Environment"
engineering to design batteries
for disassembly and recycling/
reuse, while avoiding hazard-
ous waste disposal problems.
TRIPQUIC
The Air and Toxics Division in
EPA Region 6 has used TRI data
to analyze releases and transfers
in areas of interest to its states, in
particular the Louisiana industrial
corridor, the Houston metropoli-
tan area, the U.S./Mexico border,
and the Gulf of Mexico.
TRIPQUIC, a TRI data manipula-
tion and mapping tool, is being
used to produce numerical tables,
bar graphs, pie charts, and maps
that help federal and state officials
better understand and analyze the
data. Some of these TRIPQUIC
analyses assisted Region 6 staff in
negotiations with industrial groups
to arrange for 33/50 and pollution
prevention workshops. TRI data
were also used to aid the EPA staff
in the development of environ-
mental justice calculation software.
States'Use of TRI
In Arizona: Healthy
People 2000
The Arizona Department of Health
Services (ADHS), in support of the
objectives of the U.S. Public Health
Service's (PHS) "Healthy People
2000" program, has established
goals to reduce human exposure
to toxic agents by reducing the
total pounds of those agents
released into the air, water, and
soil each year. The baseline for
Arizona will come from two
sources: the 1988 TRI and the
Arizona Department of Environ-
mental Quality 1991 Toxic Data
Reports (which includes state filers
not otherwise subject to TRI).
ADHS will monitor the number of
pounds reported which are DHHS-
listed carcinogens and toxic agents
listed by the Agency for Toxic
Substances and Disease Registry.
In South Carolina: TRI Used to
Identify Customers
South Carolina has created TRI
software that allows users to work
with the data much more effi-
ciently, and customize searches
and reports on one year's entire
database. Michael Juras, South
Carolina's EPCRA 313 Coordina-
tor, has advertised the availability
of this software program in state
trade publications, noting, "My
thought was to at least make it
easier to market pollution preven-
tion technology for those firms
who need detailed information on
waste streams. Enabling the free
enterprise resolution of toxic
pollution is an important goal."
South Carolina's new Air Toxics
Program and Storm Water Pro-
gram staff are using the TRI
package to identify their own
customers.
In Florida: Waste Reduction
Assistance Program
The Florida Department of Envi-
ronmental Regulation sponsors a
voluntary, cooperative, non-
regulatory waste reduction pro-
gram known as the Waste
Reduction Assistance Program
CWRAP). Retired engineers are
sent out at the request of a facility
to provide expertise in reducing
the use of hazardous substances,
the generation of hazardous
wastes, and releases of air toxics.
The program covers facilities
handling TRI chemicals. The
initial focus of the visit is on
housekeeping issues but inven-
tory management, preventive
maintenance, and potential
process modifications are also
examined. Upon completion of
the visit, the engineer provides
the facility with a list of sugges-
tions to reduce waste generation
and save related expenses. Typi-
cal suggestions include materials
substitution, such as replacing
1,1,1-trichloroethane with less
hazardous materials or non-toxic
cleaners, or recycling used water
in electroplating operations.
Over the past four years, more
than 184 facilities have partici-
pated in the program, including
a number of Department of
Defense facilities. More than $3.7
million in economic savings have
TRI Data continued on next page
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CHEMICALS IN PROGRESS
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TRI
TRI Data
TRI continued from previous page
been achieved by Florida businesses
and government facilities as a result
of these source reduction efforts.
In North Carolina: Multi-Media
Waste Reduction Targeting
North Carolina's Department of
Environment, Health, and Natural
Resources has developed a database
that contains emissions and waste
reduction data from a variety of
sources to facilitate waste reduction
assessment by the North Carolina
Pollution Prevention Program. The
objectives of the project are to:
(1) integrate multi-media environ-
mental release data into other state-
wide waste reduction efforts,
including technical assistance,
training, grants, research; and
(2) demonstrate hazardous
waste reduction.
Currently, this database is used by
North Carolina's Office of Waste
Reduction to determine multi-
media waste releases by industries
in preparation for site visits and
technical assistance. Ongoing
projects utilizing these data
include: using the data to assist
industries in waste reduction
plans; and evaluating the toxico-
logical factors versus the risk
factors of various chemicals in the
database and directing technical
assistance efforts towards the
reduction of those chemicals. The
database will also be used as a
basis for targeting problem sectors
(e.g., SIC codes, geographic
regions, company sizes), and
allocating funding, resources, and
technical assistance.
State Environmental Justice
Projects
The National Conference of State
Legislatures (NCSL) 1994 State TRI
Assessment study identified six
states that were using TRI data for
environmental justice projects.
They are:
Arizona analysis of a south
Phoenix neighborhood
California state comparative
risk project
Connecticut detecting toxic
release trends in minority
communities
Georgia analysis of TRI data
in response to specific ques-
tions
Louisiana study of East
Baton Rouge Parish, comparing
facilities and releases to the
location of low income com-
munities
South Carolina provided the
state Black Caucus with data as
part of an effort to develop an
environmental equity bill in the
SC legislature
NCSL's study indicated that Texas
and Washington plan to initiate
environmental justice projects
using TRI data in the future. For
more information, contact George
Hagevik at NCSL, (303) 830-2200
or fax (303) 863-8003.
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TRI
TRI Industry Expansion Focuses on Five Sectors
The fundamental purpose of the
Toxics Release Inventory is to
improve and enhance communi-
ties' "right-to-know." Expanding
the universe of facilities required
to report to TRI will substantially
increase the usefulness of TRI.
Communities across America will
have more information about
toxics in their environment, and
pollution prevention will receive a
boost as facilities and the public
become more aware of the use
and release of toxic substances.
TRI industry expansion represents
the next phase of an overall
expansion and enhancement of
TRI. As the first phase of expan-
sion nears completion with the
proposed addition of 313 chemical
substances to the list of reportable
chemicals, attention is now focus-
ing on expanding the list of facili-
ties required to report under TRI.
At the April 19 announcement of the
annual TRI data release, OPPTS
Assistant Administrator Lynn
Goldman indicated that EPA would
be moving forward with TRI industry
expansion and would be focusing its
attention on five industry sectors:
energy production
materials extraction
materials distribution,
waste management, and
transportation.
These industry sectors contain
facilities which have significant
releases of both listed and pro-
posed TRI chemicals, and are
engaged in activities directly
related to the support of manufac-
turing activities currently covered
in TRI. These sectors provide the
raw materials or energy necessary
for manufacturing; distribute
finished products as well as raw
materials; and treat and dispose of
the wastes generated in manufac-
turing. This relationship, coupled
with the fact that preliminary
analysis of available data (prima-
rily from other EPA databases)
indicates significant use and
release of TRI chemicals, provides
the impetus for focusing further
analysis on these sectors and
engaging industries in these
sectors in a public dialogue.
One element of the public dia-
logue on industry expansion is
focus groups. A series of focus
groups was kicked off on May 23
with a meeting for representatives
of the utility industry; they will
continue, with meetings slated for
mining, airports, publicly-owned
and commercially-operated waste
treatment facilities, oil and gas
exploration and production, and
freight and warehousing facilities. A
focus group will also be convened
with representatives of environ-
mental organizations.
The goal of the focus groups is to
engage interested parties in
discussions regarding EPA's
analysis and rulemaking activities
in order to clarify and refine EPA's
approach to industry expansion.
The discussions are intended to
be informal and substantive,
focusing on the processes within
these industries that use and
release TRI chemicals.
The focus groups represent only
one part of the outreach effort for
industry expansion. Other public
meetings will be held, and an
ongoing information exchange
will be conducted with industry,
environmental organizations, and
state and local governments.
EPA intends to draft a proposed
rule to expand reporting to those
industrial sectors determined to
be suitable for TRI reporting
during the latter part of the
calendar year 1994. Publication of
a proposed rule is expected by
March of 1995.
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CHEMICALS IN PROGRESS
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I
Existing Chemicals Program
TSCA1994 Inventory Update Rule
Collection Opens August 25
The third Inventory Update Rule
(IUR) reporting period com-
mences August 25. As observed
by Mark Greenwood, Director of
the OPPT, "The 1994 IUR collec-
tion affords the Agency an oppor-
tunity to secure a snapshot of the
chemical manufacturing industry.
The information collected what
is manufactured, by whom, where,
and in what quantity provides a
good baseline starting point for
OPPTs chemical review process."
Through the IUR, EPA is requiring
manufacturers and importers to
report FY 1993 data on the
production volume, plant site,
and site-limited status of organic
chemicals, as well as inorganic
chemicals subject to various rules
and orders under TSCA sections
4, 5, 6 and 7. Reporting require-
ments for the 1994 reporting
period are identical to those of
the 1990 period.
In early July, IUR information
packages containing the Federal
Register notice, reporting instruc-
tion manual, forms, and rule
questions and answers were sent
to facilities that filed reports during
the 1990 reporting period. Addi-
tional copies of the packages may
be obtained from the TSCA Hotline
(202-554-1404). The Instruction
Manual and the IUR Q's and A's are
also available through Internet
(address: Gopher.epa.gov).
In support of the information
collection, EPA has published a
revised TSCA Chemical Sub-
stances Inventory on a set of
floppy disks and tapes. The
diskettes and tapes will contain
the entire non-confidential TSCA
Inventory. Both the diskettes and
tapes are available from the
National Technical Information
Service (NTIS). Further informa-
tion on the products may be
obtained directly from NTIS at
(703) 487-4650 or (800) 553-NTIS.
Additionally, Chemical Abstracts
Service has introduced a CD-ROM
tool containing all chemicals on
the TSCA Inventory, including
generic chemical identities.
Information on this product may
be obtained from CAS Customer
Service at (800) 753-4227.
Interest in IUR reporting data has
increased over the past several
years. Since 1986, EPA has utilized
IUR data as the primary source of
information for first level screen-
ing in the TSCA chemical review
process. The data have been
routinely utilized to support TSCA
chemical management efforts.
lUR-derived data were used to
support the TRI expansion rule.
Recently, lUR-derived data were
also used to support activities
outside OPPT. The Office of
Water used the data to identify
chemical contaminants of water
for possible review.
OPPT has also made a concerted
effort to make IUR data available
to states. The Office has provided
IUR data to 17 states since 1992.
The information has been used by
these states for a wide variety of
purposes including risk assess-
ments, emergency preparedness
reviews, and state environmental
compliance activities.
One reflection of the importance
of the IUR is the resources the
Agency has committed to enforc-
ing the rule. Two separate enforce-
ment efforts have been initiated
against late IUR submitters. At the
time of the most recent initiative,
Steve Herman, EPA's Assistant
Administrator for the Office of
Enforcement and Compliance
Assurance said:
"The actions announced today
are part of a comprehensive
national cross-program effort
by EPA to ensure the quality
and integrity of data submitted
to and relied upon by EPA and
the states under all environ-
mental statutes. These lawsuits
demonstrate the Agency's
serious intention to improve
data quality that is equally
important in other environmen-
tal laws such as the Safe Drink-
ing Water Act."
For further information on the
Inventory Update Rule, contact
Henry Lau of the Economics,
Exposure and Technology Divi-
sion at (202) 260-1555 or Scott
Sherlock of the Information Man-
agement Division at (202) 260-1536.
VOL. 15/NO. 2 SUMMER 1994
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I
Existing Chemicals Program
Q's & A's on the Inventory Update Rule
Q. What Is the Inventory Up-
date Rule (IUR)?
A. The IUR requires manufactur-
ers and importers of selected
chemical substances included on
the TSCA Chemical Substance
Inventory to report current data
on the production volume, plant
site, and site-limited status of
these substances. The rule was
promulgated under the authority
of section 8(a) of TSCA, and is
codified in Part 710, Subpart B of
Title 40, Code of Federal Regula-
tions (40 CFR Part 710).
Q. What substances need to be
reported under the IUR?
A. To be reportable under the
Inventory Update Rule, a chemi-
cal substance must meet two
criteria:
1. The substance must be on the
TSCA Chemical Substance Inven-
tory as of August 25, 1994; and
2. The substance must not be of a
type exempt from reporting under
the Inventory Update Rule.
Q. What substances are exempt
from reporting under the IUR?
A. Polymers, inorganics, microor-
ganisms, and naturally-occurring
chemical substances are generally
excluded from the reporting
requirements. However, this
exclusion does not apply if the
chemical substance is the subject
of a rule proposed or promul-
gated under section 4, 5(a)(2),
5(b)(4), or 6 of TSCA or is the
subject of an order issued under
section 5(e) or 5(0 of TSCA, or is
the subject of relief that has been
granted under a civil action under
section 5 or 7 of TSCA. (Note: a
list of all substances which fall
into these categories is contained
in Appendix A of EPA's "Instruc-
tions for Reporting for the 1994
Partial Updating of the TSCA
Chemical Inventory Database,"
June 1994).
Hydrates of chemicals which are
on the TSCA Inventory in the
anhydrous form are not report-
able; however, the corresponding
anhydrous form is subject to
reporting requirements.
Substances that have been
delisted from the TSCA Inventory
should not be reported.
Q. Does my company need to
complete a Form U for each
reportable chemical manufac-
tured or for each manufactur-
ing site?
A. A company is required to
complete a Form U for each plant
site that produces 10,000 pounds
or more of a reportable chemical,
according to CFR 710.32(a). All
reportable chemicals manufac-
tured at a facility may be included
on the same form. When reporting
for imported chemicals, section
710.32 states: "the site for a person
who imports a chemical substance
is the site of the operating unit
within the person's organization
which is directly responsible for
importing the substance and which
controls the import transaction,
and may in some cases be the
organization's headquarters office
in the U.S." Thus, a company
conducting import transactions
from its U.S. headquarters would
be required to complete only one
Form U.
CHEMICALS IN PROGRESS
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I
Existing Chemicals Program
SIETIS Database Created for Silicone
SIETIS is the acronym for the
Silicones Environmental Health and
Safety Council (SEHSC) - TSCA
Interagency Testing Committee
(ITC) - EPA Toxicity Information
System. SIETIS is a dbase-driven
computer application developed
by SEHSC, the ITC's Silicone
Chemicals Subcommittee and EPA's
Information Management and
Chemical Control Divisions. The
incentive for developing SIETIS was
the magnitude of the resource
demands facing ITC's Silicone
Chemicals Subcommittee in
reviewing the thousands of TSCA
section 8(d) health and safety
studies that are expected to be
submitted as a result of ITC's
recommendation of 56 silicone-
containing chemicals in its 30th
Report to the EPA Administrator
(57 FR 30608, July 7, 1992).
The benefits of SIETIS to the ITC,
SEHSC, and EPA were outlined in a
March 9, 1994 briefing of the
Chemical Manufacturers Association.
The ITC hopes that SIETIS will serve
as a model for other industry
associations that will be submitting
data to ITC in response to testing
recommendations. Since SIETIS was
developed to be compatible with
TSCATS (the Toxic Substances
Control Act Test Systems database),
the ITC and SEHSC have been
working with EPA to electronically
incorporate all the study summaries,
index terms, chemical descriptors,
and other information into TSCATS
for public access.
Enforcement Initiative Targets Late 1990IUR Reporters
The Office of Enforcement and Compliance
Assurance (OECA), OPPT, and nine EPA Regional
Offices filed 39 lawsuits with over $2.9 million in
proposed penalties for failure to report in a timely
and accurate manner to the 1990 Inventory
Update Rule. These cases, filed the week of June
20th, emphasize the importance that EPA attaches
to chemical accountability and compliance with
TSCA reporting requirements. The enforcement
initiative was specifically timed to heighten the
awareness of the regulated community to the
upcoming 1994 IUR.
This major enforcement initiative, the first by the
newly organized OECA, continues the policy of
emphasizing the quality of OPPT's information
resources. This was the second initiative by EPA
against IUR late submitters. In the first, in July 1993,
EPA filed 27 lawsuits with nearly $3.1 million in
proposed penalties.
Many of these cases were filed against companies
who self-reported their TSCA violations. As an
incentive to such self-reporting, the proposed civil
penalties for self-reporters were reduced by more
than 50 percent, in accordance with the Agency's
penalty policy.
For further information contact Carl Eichenwald,
Attorney-Advisor, OPPT Information Management
Division, at (202) 260-3956.
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VOL 15/NO.2 SUMMER 1994
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I
Existing Chemicals Program
OPPT's Chemical Testing Program
The Year in Review
Following is a round-up of
OPPT's testing-related action
during 1993-94.
TSCA §4 Test Rules
The TSCA §4 Multi-Chemical
Neurotoxicity End-Point Final Rule
on 10 chemicals was published on
July 27, 1993. Data obtained
through this rule will help EPA
assess the neurotoxicologic risk
posed by exposure to selected
high-volume solvents. On Octo-
ber 8, 1993, the Chemical Manu-
facturers Association (CMA) filed
a lawsuit against EPA on this final
rule. A settlement agreement was
reached with CMA this spring.
The TSCA §4 Final Test Rule
covering four chemicals of inter-
est to EPA's Office of Water (OW)
was published on November 10,
1993. The subject chemicals are
unregulated drinking water
contaminants for which OW
needs data to develop 1-day, 10-
day and lifetime Health Adviso-
ries. After the rule was issued, the
Dow Chemical Company (along
with PPG) and the American
Petroleum Institute filed indepen-
dent lawsuits against EPA on two
of the subject chemicals; settle-
ment negotiations are underway.
The TSCA §4 Proposed Test Rule
for five chemicals designated by
the TSCA Interagency Testing
Committee (ITC) in its 27th
Report was published on Novem-
ber 22, 1993. The proposed test
rule solicits parties who are
interested in particpating in TSCA
§4 Enforceable Consent Agree-
ment (EGA) negotiations for
testing the subject chemicals.
OPPT is currently working on
proposed TSCA §4 testing actions
for a number of chemicals includ-
ing about 10 persistent
bioaccumulators; 56 chemicals
designated by the ITC for skin
absorption testing to meet OSHA
data needs; machining fluid
products/components in response
to a TSCA §21 Citizens Petition
filed by the United Automobile
Workers; approximately 25 "Haz-
ardous Air Pollutants" for EPA's
Office of Air and Radiation; and
approximately 10 "Tox Profile"
chemicals referred by the Agency
for Toxic Substances and Disease
Registry (ATSDR).
TSCA §4 Enforceable
Consent Agreements
During this past year, a TSCA §4
Enforceable Consent Agreement
(EGA) on N-methylpyrrolidone
was finalized. EGA negotiations
are underway for the diglycidyl
ether of bisphenol A, cyclohex-
ane, t-amyl methyl ether (TAME),
and ethyl t-butyl ether (ETBE).
Work in support of upcoming
EGA negotiations is continuing on
12 aryl phosphates, alkyl C12-14
glycidyl ether, glycidyl methacry-
late, phenol, seven silicone-based
glycidyl ethers, and five bromi-
nated flame retardants.
Voluntary Testing/Product
Stewardship Programs
EGAs and voluntary testing agree-
ments provide industry with the
opportunity of combining testing
actions with pollution prevention
or other product stewardship
efforts designed to reduce or
eliminate exposures to hazardous
chemicals. OPPT recently com-
pleted negotiations for a voluntary
product stewardship program
with three major manufacturers of
the diglycidyl ether of bisphenol A
(DGEBPA). This agreement,
which is an adjunct to testing that
will be conducted via an EGA,
involves pollution prevention,
waste minimization, exposure
reduction and hazard/risk com-
munication activities. In another
case, manufacturers of cyclohex-
ane will work with their custom-
ers to reduce environmental
releases of cyclohexane over the
next several years.
An important component of the
Chemical Testing Program is the
voluntary chemical testing that is
taking place under the Organiza-
tion for Economic Cooperation
and Development (OECD)
"Screening Information Data Set"
(SIDS) program. More than 230
high production volume chemi-
cals are currently being handled
res/% continued on next page
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CHEMICALS IN PROGRESS
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I
Existing Chemicals Program
OPPT's Chemical
Testing Program
Testing from previous page
in this cooperative international
testing and assessment program.
A key feature of the OECD/SIDS
program is that the testing burden
is shared among OECD member
countries; the United States is
responsible for testing 25% of the
SIDS chemicals.
A voluntary testing agreement
with the American Forest and
Paper Association was signed in
April 1994 concerning the land
application of wood pulp and
paper mill sludge contaminated
by polychlorinated dioxins and
furans (D/F). The testing program
includes D/F concentration
determinations in these types of
sludge and the impact of process
changes on D/F concentrations.
OPPT is currently developing a
voluntary Cooperative Research
and Development Agreement
("CRADA") under which the
National Particleboard Assocation
(NPA) would fund a pilot study to
investigate formaldehyde concen-
trations in indoor air of newly
contructed homes. Earlier this
year, as a follow-up to a January
1993 public meeting on this topic,
NPA agreed to fund the testing
program. The CRADA negotia-
tions with NPA should be com-
pleted and the pilot study initiated
in the near future.
Ongoing and Completed
Testing Programs
Testing is expected to begin this
fiscal year on approximately 50
chemicals and testing is already
underway on approximately 150
substances. Since July 1993, the
following test programs have
been completed: acrylic acid,
tributyl phosphate, 2,4,6-
tribromophenol, tetrabromo-
bisphenol A bisethoxylate, the
allyl ether of tetrabromobisphenol
A, methyl ethyl ketoxime, commer-
cial hexane, o-phenylenediamine, p-
phenylenediamine, nonyl phenol,
1,1,1-trichlorethane, antimony
trioxide, octamethylcyclotetrasiloxane,
and 25 OECD/SIDS chemicals. Testing
programs for an additional 40-50
chemicals are expected to be
completed this fiscal year. All test
data from completed testing pro-
grams enter OPPT's Existing Chemi-
cal Program Risk Management (RM)
assessment process.
VOL 15/NO. 2 SUMMER 1994
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I
Existing Chemicals Program
34th Report of the TSCA Interagency
Testing Committee
The 34th Report of the TSCA
Interagency Testing Committee
(ITC) was transmitted to EPA
Administrator Carol Browner on
May 17, 1994. The report contains
the most recent revisions to the
TSCA section 4(e) Priority
Testing List, and includes three
revisions that are deemed neces-
sary to prioritize chemicals for
testing to meet the government's
data needs. These revisions are:
changing white phosphorus from
a recommendation to a designa-
tion, recommending testing for
two fuel oxygenates (ethyl tert-
butyl ether and terf-amyl methyl
ether) and removing eight chemi-
cals from the Priority Testing List.
A designation is the highest
priority testing action that the ITC
can take because it requires the
EPA Administrator to take action
under TSCA section 4(a) within 12
months. White phosphorus is
being designated to meet the data
needs of the Department of
Interior (DOI) because of con-
cerns about adverse effects on
wildlife that feed on white phos-
phorus-contaminated sediments,
and the effects on endangered
species that feed on carcasses of
wildlife that have died from white
phosphorus poisoning. ITC
discussions are ongoing with
other member organizations to
coordinate their data needs with
those of DOI. These ITC organiza-
tions include ATSDR, the Depart-
ment of Defense and EPA.
The ITC recommends chemicals for
testing in order to obtain TSCA
section 8(d) health and safety data,
to share these data with U.S. Gov-
ernment organizations represented
on the ITC that need such data, to
review the data, and to determine
whether the recommended chemi-
cals should be designated for testing
or removed from the Priority Testing
List. Ethyl tert-butyl ether and tert-
amyl methyl ether are being recom-
mended for health effects testing
because EPA needs the data for
ongoing assessments.
The ITC removes chemicals from
the Priority Testing List as a result
of its data reviews or because EPA
takes an action under TSCA
section 4(a). Methyl methacrylate
and diethyl phthalate are being
removed from the List because the
ITC obtained dermal absorption
rate data that are likely to satisfy
the data needs of OSHA. N-
Phenyl-1-naphthylamine is being
removed from the List because
studies reviewed by the ITC did
not increase concerns for cancer
and the ITC's priorities do not
include designating the chemical at
this time. Acetophenone, phenol,
AfAklimethylaniline, ethyl acetate
and 2,6-dimethylphenol are being
removed from the List because
EPA proposed the testing desig-
nated by the ITC in its 27th Report.
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CHEMICALS IN PROGRESS
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I
Existing Chemicals Program
Update on Machine Fluids-UAW Section 21 Petition
On December 22, 1993, the
International Union, United
Automobile, Aerospace & Agricul-
tural Implement Workers of
America (UAW) petitioned EPA
under TSCA section 21 to promul-
gate section 4 test rules for health
and environmental effects of
machining fluids. UAWs petition
pertained to all machining fluids,
including straight oils, soluble oils
and synthetic fluids, and drawing
compounds for metal stamping to
the extent that such compounds
are similar in composition to
machining fluids.
UAW specifically asked for testing
of components of machining
fluids and partial combinations of
the components. The petition
appeared to constitute a very
broad request to test chemicals
that are used by themselves as
machining fluids, chemicals that
are added to machining fluids, and
any combination of such chemicals.
This petition potentially applied to
several hundred chemicals.
UAW has also petitioned OSHA to
take immediate action to protect
workers from exposure to oil
mists from machining fluids (by
way of, for example, emergency
temporary standards restricting
exposures to oil mists at 1/10 the
current OSHA permissible expo-
sure limit (PEL) of 5 mg per cubic
meter). In its petition to OSHA,
UAW asks that agency to "ap-
proach EPA to determine the need
for test rules for particular ingredi-
ents of metalworking fluids, using
the authority under the Toxic
Substances Control Act." The
OSHA petition was signed by
Owen Bieber, the UAW president.
The petition to EPA was filed by
Franklin Mirer, the head of UAWs
Health and Safety Department.
On February 18, 1994, EPA pre-
sented its proposal to the OSHA,
NIOSH, EPA (ONE) Committee to
form an Interagency Workgroup
to address the concerns articu-
lated by the UAW in their TSCA
section 21 petition. This proposed
approach was well received by
OSHA and NIOSH. EPA has
received letters from both OSHA
and NIOSH affirming their sup-
port for this Interagency
Workgroup. On March 24, 1994,
the Interagency Workgroup
presented a status report on its
activities to the ONE Committee.
In addition, the role of the ONE
Committee in relation to the
Interagency Workgroup was
formalized. That is, following
review by the ONE Committee of
the Workgroup's recommenda-
tions to require testing (including
monitoring) of specific machining
fluid chemicals or mixtures, the
ONE Committee will refer the
testing needs to EPA for the devel-
opment of proposed test rule(s).
We believe that this process will
enable EPA to achieve the results
sought by UAW in a reasoned and
practical way. Members of the
Interagency Workgroup have
already identified a few sub-
stances as possible subjects for
We believe that this
process will enable EPA to
achieve the results sought
by UAW in a reasoned and
practical way.
test rules; however, further con-
sideration is needed to determine
the specific chemicals to be tested
and the specific testing needs.
An April 19, 1994 Federal Register
notice describes the establishment
of the Interagency Workgroup, its
interaction with the ONE Commit-
tee, and the other actions EPA has
taken or is taking to limit expo-
sure to machining fluids.
EPA believes that a review of this
category of chemical substances is
prudent. Many concerns have
been raised for chemicals which
are included in this category and
certain regulatory activities have
been or are being undertaken.
At press time, EPA, NIOSH,
OSHA, the Independent Lubricant
Manufacturers Association, and
UAW had made tentative plans to
meet in Cincinnati in the fall to
discuss various issues related to
metalworking fluids.
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VOL. 15/NO. 2 SUMMER 1994
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I
Existing Chemicals
RM2 and Post-RM2 Activity Chart
Chemical Name
Acrylamide/
N-methylacrylamide
(NMA)
Aerosol Spray
Paints
Benzidine Dyes
Source/Why
is it in RM?
In 1991, EPA
proposed a rule to
(1) immediately ban
acrylarnide from all
grouting uses; (2)
immediately ban
NMA from all
grouting uses except
sewer applications;
and <3) ban the
sewer applications
use in three years.
To investigate
pollution prevention
opportunities
Benzidine has been
classified by EPA as
a group A "known
human" carcinogen.
Benzidine congeners
have not yet been
classified by EPA;
however, due to
animal data and
mechanistic
similarities to known
human carcinogens,
they fit the definition
for group B2
"probable human"
carcinogens
Concerns
Cancer and
neurotoxic concerns
for workers exposed
to acrylarnide and
NMA during
grouting
Some chemicals
found in aerosol
spray paints may
cause health effects
- Concern for
consumers and
workers who use
aerosol spray paints
in indoor air
environments
Cancer concerns for
workers exposed to
these chemicals
Stage in
Process
Developing
responses to
comments on
proposed rule and
preparing final rule
Assess risks for
solvents and their
substitutes, identify
formulations
containing methyl-
ene chloride
Negotiations with
industry, labor
unions, and
environmental
groups
Next Steps
Issue final rule
Stakeholders'
Dialogues this
Summer
Complete rule
requiring notifica-
tion of EPA before
benzidine-based
dyes may be
produced, imported
or used
- Voluntary
agreement with
industry on means
of addressing the
risks from manufac-
ture and use of
benzidine congener
dyes, by the
summer of 1994
- Regulatory
mechanisms will be
pursued if a
voluntary agreement
cannot be reached
Projected
Resolution
Anticipate issuing a
final rule in 1994
Complete RM2 by
Fall 1994
Three stage phase-
out of benzidine-
congener dyes that
present significant
concerns
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CHEMICALS IN PROGRESS
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I
Existing Chemicals
Chemical Name
Consumer and
Small Shop Paint
Stripping Use
Cluster
Cultural Uses of
Mercury
Formaldehyde - New
Homes Testing
Nitrosamines
Source/Why
is it in RM?
CPSC raised
questions regarding
; the safety of
substitutes for
methylene chloride
in consumer paint
strippers
-During the RM2
assessment of NMP
(N-methyl
Pyrrolidone), an
alternative to
methylene chloride,
OPPT identified
other components
of paint strippers for
which there are
potential concerns
Referral from State
of California that
certain ethnic
groups were using
mercury in some of
their religious
practices
TSCA Section 4(f)
Request from the
United Rubber
Workers Union to
evaluate the
potential risks posed
by these chemicals
Concerns
Carcinogenicity,
reproductive and
developmental
effects, central
nervous system
effects and flamma-
bility- Consumers
and small shops are
not subject to OSHA
regulations
Neurotoxicity and
other adverse health
effects in individu-
als, particularly
infants and small
children, who are
exposed to mercury
in these practices
Formaldehyde
emissions from
pressed wood
building materials
can pose risks of
some acute eye/
nose/throat irritation,
and a low risk of
cancer
Cancer concerns for
workers in the
rubber manufacture
and leather tanning
industries
Stage in
Process
Conducting
screening assess-
ments of paint
stripper components
- Industry conduct-
ing glove permeabil-
ity tests and
organizing materials
for consumer
education
Developing outreach
and education
campaign targeting
affected communities
Developing
voluntary testing
program with
industry
Stakeholder's
dialogue held in July
1993
Currently incorpo-
rating new informa-
tion into review
Next Steps
RM2 assessments
on a subset of
chemical compo-
nents; inclusion
based upon results
of screening
assessments
Develop radio
program on risks,
and distribute
outreach materials
to states and local
organizations
Negotiate final
agreement with
industry on funding
and conduct of tests,
develop quality
assurance plan
Further review, and
discussion of risk
reduction methods
with stakeholders
Projected
Resolution
RM2 draft assess-
ment to be released
late 1994, antici-
pated completion of
industry glove
testing efforts in
summer 1994
-OPPT decision on
further action, either
regulatory or
through voluntary
means, expected in
late 1994/early 1995
Anticipate
completion of
outreach efforts in
Summer 1994
Expecting final
agreement with
industry and final
quality assurance
plan in September
1994
RM2 Dossier
expected in Fall
1994
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VOL. 15/NO. 2 SUMMER 1994
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Existing Chemicals
Chemical Name
Land-Applied Sludge
Octabromodiphenyl
oxide and
Decabromodiphenyl
oxide
Solvents, and their
substitutes, which
are affected by the
Halogenated
Solvents Cleaning
NESHAP
("Degreasing"
MACT),andthe
Metal Products and
Machinery Effluent
Guidelines ("Sol-
vents Project")
Source/Why
is it in RM?
In 1991 EPA
proposed a rule to
govern the land
application of pulp
and paper mill
sludge contaminated
with dioxins and
furans
Information
obtained through
test rule for dioxins/
furans raised
exposure concerns
for workers
In 1993, the
Assistant Adminis-
trators for OAR, OW
and OPPT agreed to
coordinate efforts to
assist those
industry sectors
affected by both the
OAR "Degreasing"
M ACT and the OW
Effluent Guideline on
Metal Products and
Machinery
Concerns
Dioxins and furans
have potential
carcinogenic,
reproductive and
developmental
effects on humans
and wildlife
Dioxins have
potential carcino-
genic, reproductive
and developmental
effects
The Agency is
reviewing those
solvents affected by
both the MAC! and
the Effluent
Guideline in order to
provide information
which will allow
persons to make
environmentally
informed decisions
regarding compli-
ance with the two
rules
Stage in
Process
Voluntary agreement
with the pulp and pa-
per industry trade as-
sociation signed on
4/14/94
-Agreement will set up
guidelines for land ap-
plication, Dioxin/Furan
standards, and man-
agement practices and
to obtain data to im-
prove our understand-
ing of the ecological
risks of sludge land
application
Obtain additional
information
regarding occupa-
tional exposure and
product stewardship
Polling industry to
determine what
information will be
most useful
regarding compli-
ance with the two
rules, and how this
information can best
be presented
Next Steps
Implementation and
expansion of
voluntary agreements
Re-examine original
risk assessment in
light of new
information
Proceed with
information
collection, assess-
ment, and presenta-
tion based upon the
results of the
industry poll
Projected
Resolution
EPA will determine
the necessity of
further regulation of
the land application
of dioxin-contami-
nated pulp and
paper mill sludge
after the impacts of
the proposed
effluent guidelines
for pulp and paper
mills are assessed.
Dioxin levels in
sludge are expected
to decrease as a
result of process
changes mills make
to comply with
these guidelines
Project completion
anticipated in Fall
1994
Project completion
scheduled to
coincide with
promulgation of
OAR MACT in
November, 1994
CHEMICALS IN PROGRESS
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Design for the Environment
DfE Project Updates
EPA's Design for the Environment
(DfE) Program continues to forge
successful pollution prevention
strategies through voluntary
cooperation among government,
scientists, industry and the
general public.
The DfE Dry Cleaning
Project expects to release
Phase I of its Cleaner Technol-
ogy Substitutes Assessment
(CTSA) to stakeholders in late
summer. The CTSA will com-
pare several existing dry clean-
ing solvents and alternatives
such as multiprocess wet
cleaning, machine wet clean-
ing, supercritical CO2 technol-
ogy, and microwave drying; it
will also include process
descriptions, performance
information, and human health
and environmental risk assess-
ments. The Dry Cleaning
Project is now setting up sites
to demonstrate the perfor-
mance of alternative processes
and encourage the use of less-
toxic solvents; the opening of
the first demonstration shop in
Chicago this September will be
followed shortly by other
facilities in Los Angeles and
Indianapolis. DfE is also devel-
oping brochures, fact sheets
and case studies to communi-
cate information about the Dry
Cleaning Project.
The DfE Printing Project
completed a 30-day screen
printing/ screen reclamation
performance demonstration
involving 23 volunteer printing
facilities; 11 screen reclamation
product systems and one
alternative technology were
submitted for demonstration by
the screen printing industry.
DfE will present its technical
results at the October Screen
Print '94 convention sponsored
by the Screen Printers Associa-
tion International. Initial devel-
opment of information
products, including case studies
and a training videotape, is
underway. A draft of the CTSA
for the screen printing sector is
planned for completion by late
summer; preliminary sections
are currently under industry
review. Industry participants in
the lithographic printing project
have revised the protocol for
demonstrating the performance
of alternative blanket washes.
The demonstration is planned
to be completed by November.
The DfE Aerospace Project
has two components. One, the
Lean Aircraft Initiative (LIA), is
a joint venture between the Air
Force, the aerospace industry,
and MIT. The LIA targets
aircraft design and manufacture
to streamline the industry and
improve its competitiveness.
EPA funds the LIA through the
Environmental Technology
Initiative (ETI) to include an
examination of the environ-
mental implications of changes
in design. Also through the ETI,
EPA is funding research by
NASA, DOE, and the Coast
Guard on paint-stripping in
general aviation. DfE is investi-
gating the environmental and
occupational hazards associated
with current paint stripping
practices and potential alterna-
tives to these practices. Some
performance demonstration will
also be conducted.
The DfE Printed Wiring
Boards (PWB) Project is
collaborating with the PWB
industry to identify and evaluate
alternative manufacturing
processes for PWBs. DfE staff
held a kickoff meeting for the
project at the PC Expo '94, an
industry trade show sponsored
by the Institute for Interconnect-
ing and Packaging Electronic
Circuits in Boston on April 25.
Industry was very interested in
beginning work on the project,
and industry participants are
currently identifying possible
use-clusters for evaluation.
Another industry meeting is
planned for early fall and
technical work is planned to
begin by November. Since the
electronics industry was chosen
to participate in EPA's recently-
announced Common Sense
Initiative, OPPT will coordinate
a regulatory and technological
review of certain sectors of the
electronics industry, including
the PWB manufacturing sector.
As part of the Surface Finish-
ing Project, DfE is working
DfE Project Updates continued on next page
B
VOL 15/NO.2 SUMMER 1994
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Design for the Environment
DIE Project Updates
DK Updates from previous page
with the Industry Technical
Institute in Ann Arbor, MI to
develop an auditing tool for
Energy, Environment and
Manufacture. The tool will
enable small businesses in the
metal stamping, metal finishing
and screw machine industries
to improve their efficiency and
environmental performance.
The Project expects to generate
a use-cluster and industry
profile by this fall. DfE is also
cooperating with the National
Institute of Standards and
Technology (NIST) to establish
a National Environmental
Resource Center to supply
technical-assistance-providers
in the metal finishing industry
with information on alternative
manufacturing processes.
Working jointly with the Public
Buildings Service of the Gen-
eral Services Administration
(GSA), DfE has undertaken an
effort to encourage the pur-
chase of environmentally
preferable products. As part
of this effort, the agencies
recently assessed the perfor-
mance of 19 cleaning products
at a federal courthouse in
Philadelphia and ranked them
by relative health and ecologi-
cal risk. The project is also
developing a guide for vendors
describing the information
they should supply to enable
purchasers to make informed
decisions about environmen-
tally preferable products.
The DfE Chemical Design
Project continues to find novel
approaches to "green chemis-
try." DfE is working with the
National Science Foundation
and Los Alamos National
Laboratory to promote the
development of alternative
synthetic pathways that are
more environmentally benign.
The Project is also collaborating
with the National Pollution
Prevention Center at the Uni-
versity of Michigan and the
Emission Reduction Research
Center to incorporate "green
chemistry" into undergraduate,
graduate and professional-level
curricula. Efforts to develop
structurally safer chemicals,
pollution-detecting sensors for
manufacturing processes, and
biofeedstocks and biocatalyses
processes are ongoing. Details
of several major projects will be
presented at the August na-
tional meeting of the American
Chemical Society.
For more information on DfE activi-
ties, please contact Jean E. Parker,
Chief, Design for the Environment
Staff, (202) 260-1678.
CHEMICALS IN PROGRESS
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I
Pollution Prevention
P2 Round-Up of Activities
OPPT continues to advance
pollution prevention through its
various programs. Here are some
recent activities within the Pollu-
tion Prevention Division (PPD):
Selection of Industry Sectors
for Common Sense Initia-
tive. The Common Sense
Initiative, previously referred to
as the Industry Sectors and the
Green Sectors Project, is one
means the Agency is using to
advance pollution prevention
in key industries, PPD is par-
ticipating on a cross-program
workgroup to decide which
industry sectors will be the
focus of the Common Sense
Initiative. Chosen industries will
be the focus of industry sector
workgroups within EPA that
will examine closely the differ-
ent regulatory requirements
that the industry is subject to
for harmonization and pollution
prevention opportunities. (Con-
tact John Robison at 260-3590.)
Grants to States. Recipients of
1994's Pollution Prevention
Incentives for States grants will
be announced at the end of
this fiscal year. EPA's Regional
Offices have taken the lead in
distributing these grant funds
supporting state pollution
prevention efforts. (Contact
Lena Hann at 260-2237.)
Guidance for Green Prod-
ucts. Executive Order 12873,
signed by President Clinton on
October 20, 1993, requires EPA
to "issue guidance that recom-
mends principles that Executive
Agencies should use in making
determinations for the prefer-
ence and purchasing of envi-
ronmentally preferable
products." PPD is involved in
the process of establishing a
usable and implementable set
of guiding principles that
agencies can use to identify
environmentally preferable
products. (Contact Eun-Sook
Goidel at 260-3296.)
Working Pollution Preven-
tion into EPA Regulations.
Under the Source Reduction
Review Project (SRRP), PPD
staff and others in OPPT are
working with other EPA offices
to facilitate the incorporation of
pollution prevention elements
into regulatory actions. One of
the recent regulatory actions
that is undergoing the SRRP
process would establish effluent
guidelines for facilities which
manufacture metal products and
machinery. (Contact Jocelyn
Woodman at 260-4418.)
VOL. 15/NO. 2 SUMMER 1994
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I
Pollution Prevention
10th Annual P2 Conference
by Daniete Fuligni
The 10th Annual Woods Hole
Pollution Prevention Conference,
entitled "Putting a P2 Spin on
Regulation," was held on June 14
-17 at the National Academy of
Sciences facility in Woods Hole,
Massachusetts. The conference,
which draws together some of the
nation's top authorities on pre-
vention, is funded by a coopera-
tive grant through EPA's OPPT,
ORD, and Office of Solid Waste
and is managed by the Waste
Watch Center, a non-profit organi-
zation. In attendance were repre-
sentatives of state and local
governments, federal agencies,
industry, and private non-profits.
Dr. Lynn R. Goldman, Assistant
Administrator for Prevention,
Pesticides and Toxic Substances,
was also present and addressed
the group on Thursday evening.
Dr. Goldman's speech touched on
the parallels between the field of
public health and pollution
prevention, and stressed the
importance of working together in
cooperative partnerships. She
emphasized that, to get the job
done, we need to break down
adversarial relationships among
federal agencies, environmental
groups, industry, and Congress
and stressed that pollution pre-
vention has as much to do with
reengineering cultures as engi-
neering process changes.
The key focus of the meeting was
pollution prevention in regulation;
presentations and discussions
focused on regulatory review and
new regulations, permitting, and
compliance and voluntary pro-
grams. Additional sessions were
held on environmentally prefer-
able products and environmental
technology. The conference was
organized to allow for presenta-
tion of issues from a variety of
perspectives, including not only
EPA's but those of industry, states
and environmentalists. The
following is a brief summary of
discussions in each of the major
topic areas.
Regulatory Review and New
Regulations
Because of the various impend-
ing reauthorizations, participants
agreed that this is a particularly
opportune time for determining
the role of pollution prevention
in regulations.
Incorporating pollution preven-
tion into the framework of regula-
tory development is essential
since regulations are the founda-
tion that determine the rest of the
process. In attempting to integrate
pollution prevention into regula-
tions, the goal should be to create
a package of both public and
private policies that, when tar-
geted at an industry sector, makes
protection of human health and
the environment competitively
advantageous. However, EPA
needs to be careful to include
Permitting is "where the
rubber meets the road" in
environmental protection.
enough flexibility so as to set a
floor rather than a ceiling for
industry's achievements, and to
allow for innovation and creativity.
Permitting
The goal of this session was to
explore how to get more environ-
mental protection through pollu-
tion prevention, using the permit
process at the facility level.
Permitting is "where the rubber
meets the road" in environmental
protection; a key question raised
in this session is whether existing
statutes provide sufficient flexibil-
ity to incorporate pollution
prevention in permits. It was
suggested that permits, as they
currently exist, can be technol-
ogy-fixing; in order to encourage
innovation and continual im-
provement, permits should be
focused on emissions rather than
specifying technologies. One
panelist expressed the view that
federal dollars should go toward
pilot projects and encouraging
experimentation in incorporating
pollution prevention into permits
before conducting training for
permit writers and implementation.
P2 Conference continued on next page
CHEMICALS IN PROGRESS
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Pollution Prevention
P2 Conference
from previous page
Voluntary and Compliance
Programs
Panelists identified flexibility as
the most important issue with
regard to voluntary and compli-
ance programs. Although regula-
tions are clearly still needed, they
need to be simple and easy to
understand. Programs aimed at
assisting industry should remain
voluntary and confidential. Addi-
tional concern was expressed that
targeting specific chemicals for
reduction and prevention may turn
some customers away and that a
more successful approach might
be to let facilities pick their own
pollution prevention projects.
Environmentally
Preferable Products
This session covered the current
status of the guidance being
developed to implement Execu-
tive Order 12873 ("Federal Acqui-
sition, Recycling and Waste
Prevention") and the challenges it
presents. Specifically, EPA faces
the challenge of defining what
"environmentally preferable prod-
ucts" should mean, and the difficul-
ties of incorporating environmental
considerations into the existing
federal acquisition processes in
terms that can be readily and
consistently used by procurement
officials. A number of issues were
discussed in this session, including
whether environmentally preferable
products should include any
unacceptable ingredients; whether
we are striving to encourage
"preferable" products or merely
"acceptable" products; and how to
factor efficacy into the equation,
e.g., how to evaluate the trade-offs
involved if it takes twice the amount
of a preferable product to do the job
as a competing product.
Environmental Technology
Environmental technology is any
system that identifies, prevents,
remediates, or communicates
environmental impacts. EPA needs
to improve the coordination,
management and funding of
federal programs that contribute
to developing environmental
technology, ensuring that environ-
mental technology incorporates
the necessary elements for effec-
tive pollution prevention with
primary emphasis on source
reduction, multi-media protection,
and incorporation of life cycle
assessment. Participants discussed
the need for a comprehensive
strategy based on legislative,
regulatory, and corporate reform
that will encourage the develop-
ment and widespread utilization
of environmental technology with
a focus on source reduction.
Panelists identified
flexibility as the most
important issue with regard
to voluntary and
compliance programs.
Although regulations are
clearly still needed, they
need to be simple and easy
to understand.
VOL 15/NO.2 SUMMER 1994
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I
Lead, Asbestos, PCBs
Asbestos Accreditation
Extended to Public & Commercial Buildings
With the enactment of the Asbes-
tos School Hazard Abatement
Reauthorization Act of 1990
(ASMARA), Congress directed EPA
to amend its Model Accreditation
Plan (MAP) to extend training and
accreditation requirements to
cover asbestos abatement workers
in public and commercial build-
ings. Previously, under the Asbes-
tos Hazard Emergency Response
Act (AHERA), these requirements
had applied only to persons
performing asbestos-related work
in the nation's public and private
not-for-profit schools. In addition
to extending the coverage for
accreditation, ASMARA further
directed EPA to increase the
minimum number of training
hours required for accreditation
and to effect other changes to the
MAP as might be necessary to
implement the mandate.
EPA complied with this Congres-
sional mandate by publishing a
revised MAP as an interim final
rule in the Federal Register on
February 3, 1994 (59 FR 5236).
This revised MAP has replaced
the original MAP (published on
April 30, 1987) in its entirety.
The new requirements apply to
those persons who prepare
management plans for schools,
who inspect for asbestos-contain-
ing materials (ACM) in schools or
public and commercial buildings,
and who design and conduct
response actions with respect to
friable ACM in schools or public
and commercial buildings. A
public and commercial building is
defined to include any building
that is not a school building,
except that the term does not
include residential apartment
buildings of fewer than ten units.
This covers a wide assortment of
buildings, including government-
owned buildings, colleges, muse-
ums, for-profit schools,
preschools, airports, hospitals,
churches, retail stores, warehouses
and factories. The regulation,
however, only applies to the ACM
on the interiors of such buildings,
except for porticos, exterior
hallways, and mechanical systems
used to condition interior space.
In revising this rule to comply
with ASMARA, EPA was careful to
ensure the greatest possible
consistency in its regulatory
approaches to both schools and
public and commercial buildings.
Consequently, the only significant
differences are those established
by the statute itself. Unlike the
requirements for schools, man-
agement plans and inspections
are not required for public and
commercial buildings. Similarly,
certain air clearance and sampling
and analytical requirements which
continue to apply to schools are
only recommended for public and
commercial buildings. EPA did,
however, increase the length of
both the worker and contractor/
supervisor training programs with
the addition of an extra day of
hands-on training.
EPA plans to publish its revised
MAP as a final rule. However, in
the meantime, the Agency is
conducting outreach to promote
awareness of the new require-
ments and is working closely with
state programs to assist them in
making the necessary transition.
CHEMICALS IN PROGRESS
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I
Lead, Asbestos, PCBs
Agency Proposes to Simplify
Reclassification of PCB Transformers
Reclassification of PCB Transform-
ers and PCB-Contaminated Trans-
formers is permitted under 40 CFR
§76l.30(a)(2)(v). The reclassifica-
tion process is used to reduce
PCB concentrations and to change
the regulatory status of a trans-
former. For a transformer to be
reclassified, the regulations
require that it be drained of PCB
oil, refilled with non-PCB dielec-
tric fluid, operated under loaded
electrical conditions to reach a
50° Centigrade (C) temperature,
and then tested after 90 days to
verify successful reclassification.
EPA may also approve alternate
methods of reclassification that
simulate the in-service loading of
PCB transformers.
A transformer can be reclassified
from the status of PCB trans-
former O500 ppm), to PCB-
contaminated status (5-499 ppm)
or to non-PCB status (<50 ppm).
The reclassification reduces the
potential risks to human health
and the environment as well as the
economic and regulatory burdens
on PCB equipment owners.
EPA has proposed a rule to
amend the reclassification proce-
dure. There are several reasons
for modifying these requirements.
First, it is not technically possible
for some transformers to attain
the 50° C temperature required.
Statistical analyses indicate that
many transformers which never
reach 50° C still reduce PCB
concentrations through properly
conducted retrofilling procedures.
Additionally, safety risks to
employees and to the general
public may occur in mandating
strict adherence to the current
regulations. Finally, EPA has
received statistical data that
leachback of PCBs from the
internal components of transform-
ers is not accelerated by elevating
temperatures to 50° C.
The proposed rule would change
the reclassification process by.
1. Removing the 50° C require-
ment for all PCB and PCB-
contaminated transformers.
2. Modifying the 90-day require-
ment to allow PCB transformers
with less than 1,000 ppm PCB to
be tested after a three-week time
period; at that point, if the PCB
concentration is under 25 ppm,
the transformer may be immedi-
ately reclassified to non-PCB
status. (If the PCB concentration
is >25 ppm but <500 ppm, the
transformer may be reclassified
to PCB-contaminated status.)
3. Eliminating a post-retrofill
testing requirement of PCB-
contaminated transformers
(<500 ppm PCB) after a properly
conducted retrofill procedure.
The reclassification procedures for
transformers 1,000 remain
unchanged except for the drop-
ping of the 50° C requirement.
The Agency is soliciting com-
ments and/or data on whether the
procedures proposed for trans-
formers <1,000 ppm PCB would
also be viable for transformers
1,000 ppm PCBs. In addition, EPA
is proposing to change the ap-
proval authority for granting the
use of alternate methods to
simulate loaded conditions of in-
service use when reclassifying
electromagnets, switches and
voltage regulators from the
OPPTS Assistant Administrator to
the Director of the Chemical Man-
agement Division (CMD). The
Director of CMD currently has this
approval authority for transformers
being reclassified and the proposed
change is for the sake of consistency.
The proposed rule was published
in the Federal Register on Novem-
ber 18, 1993 (58 FR 60970). The
comment period for the proposed
rule closed on January 3, 1994; a
total of 54 comments were re-
ceived during this initial comment
period. A public hearing was held
on March 9, 1994, and several
additional comments were re-
ceived. Publication of the final
rule is expected later this year.
For further information, contact
Tom Simons at (202) 260-3991.
VOL. 15/NO.2 SUMMER 1994
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I
Lead, Asbestos, PCBs
Final Rule on PCS Exemption Petitions Published
On April 11, 1994, EPA published
a final rule in the Federal Register
(59 FR 1699D addressing five
exemption petitions submitted
under TSCA section 6(e)(3)(B).
These petitions are for exemp-
tions from the ban on the manu-
facture, processing, and
distribution-in-commerce of PCBs.
The proposed rule was published
in the Federal Register on March
2, 1992 (57 FR 7349).
Of the five petitions addressed in
this rule, EPA is granting three,
and denying two. The three
petitions being granted all involve
research and development analy-
sis. The first is for ManTech
Environmental Technology, Inc.
to export small quantities of PCBs
for research and development.
The second is for Restek Corpora-
tion to process and distribute in
commerce for export, small
quantities of PCBs for research
and development. The third
petition granted is for R.T. Corpo-
ration to process and distribute in
commerce analytical reference
samples derived from actual
waste materials. EPA is also
issuing a use authorization for
users of analytical reference
samples derived from waste
materials, where the samples have
been processed and distributed in
commerce pursuant to the R.T.
Corporation's petition.
EPA is denying two exemption
petitions. National Chem Lab
petitioned to import from Canada
PCBs in oil and soil for laboratory
analysis. EPA is denying the
petition because the petitioner did
not demonstrate why there is a
necessity for the PCBs to be
imported into the United States
solely for the purpose of analysis,
since there are analytical laborato-
ries within Canada that conduct
PCB analyses. Joseph Simon &
Sons' request to export PCB-
contaminated transformers for
salvage to the Far East was denied
due to the large amounts of PCBs
involved and the availability of
alternative options.
A sixth petition from General
Motors Corporation (GM) was
included in the proposed rule;
however, GM subsequently
withdrew it from consideration.
GM wished to import from
Canada voltage transformers with
PCBs for the purpose of disposal.
For further information, contact
Geraldine Hilton at (202) 260-3992.
CHEMICALS IN PROGRESS
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I
Lead, Asbestos, PCBs
EPA Lead Paint Program Highlights
EPA has been extremely busy
implementing activities mandated
by Title X, the Residential Lead-
Based Paint Hazard Reduction Act
of 1992, and other programs to
support this effort. Important
progress has been made in virtually
every project. Title X and related
programs will continue to be the
focus of our activity for years to
come, as the program shifts from
developing regulations to revising
or enhancing those regulations as
required by law and as new infor-
mation becomes available.
1. Major Title X Activities
Training and Certification
Regulations, Promulgation of a
Model State Plan
This proposed regulation was
signed by the Administrator on
August 19, 1994. The proposal
consists of a comprehensive lead-
based paint activities training,
accreditation, and certification
program. The program includes
residential, public, and commer-
cial buildings, as well as bridges
and other superstructures. Addi-
tionally, EPA is developing stan-
dards for lead-based paint
activities to ensure that these
activities are conducted "safely,
reliably, and effectively." The
Agency, in promulgating this
regulation, will include a Model
State Plan as prescribed under
§404 of TSCA, Title IV. The Model
State Plan may be used by states
interested in seeking EPA ap-
proval to administer and enforce
their own lead training and
certification programs. In addi-
tion, OPPT in consultation with
the Office of Solid Waste, will be
developing and promulgating a
regulation establishing appropri-
ate disposal standards for lead-
based paint architectural debris.
State Program Grants
EPA is authorized to make grants to
states to develop and carry out
authorized state programs. On May
17, EPA announce its award alloca-
tions of $11.2 million in state grant
funding to 46 states, the District of
Columbia and 17 Native American
Tribes to support development of a
Lead Training, Accreditation, and
Certification program.
Outreach
EPA is required to sponsor public
education and outreach activities
to increase public awareness of
lead poisoning. In FY 1992, EPA
entered into a cooperative agree-
ment with the National Safety
Council to administer and manage
a Federal Hotline and Information
Clearinghouse for Lead. The
Hotline, funded jointly by EPA,
HUD, and CDC serves as a na-
tional information dissemination
center for the public to obtain
information about lead hazards.
The Hotline was completed in
November 1992, and the Clearing-
house was completed in April
1993. EPA is currently expanding
lead hazard informational literature
into non-English languages and
developing new outreach activities
associated with increasing aware-
ness about lead hazards.
Renovation and Remodelling
Guideline
This guideline will advise
homeowners and workers of
potential hazards of conducting
renovation and remodelling (R & R)
activities in the presence of lead-
based paint. It was published in
the Federal Register in April 1994
(the Title X deadline). The guide-
line, in brochure format, is called
"Reducing Lead Hazards When
Remodelling Your Home".
R & R Study
EPA is conducting a saidy of the
extent to which persons engaged in
various types of R&R activities are
exposed to lead or create a lead-
based hazard. The study will
include environmental monitoring
and limited blood sampling of
workers. The report on the evalua-
tion is planned for April 1995. The
results will be used as the basis for
regulation of remodelling and
renovation workers. The results
from this field study will be of
interest to policy makers, trade
associations, workers engaged in
such work, and the general public.
The environmental data collection
has been completed; the study of
worker blood lead levels wili begin
upon receipt of OMB approval.
Laboratory Accreditation
Program
In cooperation with other federal
agencies, EPA has established a
framework to ensure there are
effective voluntary lead laboratory
accreditation programs. EPA is
continued on next page
VOL 15/NO.2 SUMMER 1994
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I
Lead, Asbestos, PCBs
EPA Lead Paint Program
from previous page
establishing Memoranda of Under-
standing (MOUs) with accrediting
organizations to accredit individual
labs, which will then be recog-
nized by EPA as proficient in
analyzing for lead in paint, dust,
and soil. MOUs were established
with the American Association for
Laboratory Accreditation and the
American Industrial Hygiene
Association in December 1993. A
list of fully recognized laboratories
will be available from the National
Lead Information Center Clearing-
house by January 1995. In the
interim, the clearinghouse provides
the public with a list of labs which
are successfully participating in the
proficiency testing program, as
well as any fully recognized labs.
Hazardous Levels of Lead
Title X requires EPA to promul-
gate a regulation to identify
hazardous levels of lead in paint,
soil, and dust by April 28, 1994.
This regulation is running quite a
bit behind schedule, primarily
because EPA does not believe that
an adequate technical basis for
this rulemaking is available.
However, in light of the need for
guidance on this subject, EPA
released a guidance document in
July 1994, which identifies haz-
ards based on the location and
condition of lead-based paint, and
the levels of lead in house dust
and yard soil, based on our best
knowledge at this point. We are
also performing additional evalua-
tions of both epidemiologic
studies and the Integrated Uptake/
Exposure Biokinetic Model, and
hope to propose a rule in 1995.
Lead Hazard Brochure
EPA is required to publish, after
notice and comment, a lead
hazard brochure to be used in
conjunction with requirements
under sections 1018 and 406(b).
This draft brochure has been
developed and its availability was
announced in the Federal Register
on March 9, 1994, with the 406(b)
proposed regulation. EPA is
reviewing public comments and
has held several focus group
reviews. We plan to finalize the
brochure in October 1994.
Renovation Information Rule
EPA has proposed a regulation to
require renovators, prior to
beginning work, to provide their
customers with an EPA-developed
brochure describing lead hazards
and how they can be minimized.
The statutory deadline for pro-
mulgation is October 28, 1994.
This regulation was proposed on
March 9, 1994. We are currently
reviewing public comments and
plan to finalize the regulation in
the spring of 1995.
Task Force on Lead Hazard
Reduction and Financing
HUD and EPA together established
this public/private task force to
examine issues central to success-
ful ongoing lead-based paint
abatement programs particu-
larly those involving finance,
mortgage, insurance, and real
estate interests. EPA has prepared
and distributed a number of issue
papers for the task force to base its
discussions. The task force has
organized three subcommittees on
Financing, Insurance, and Imple-
mentation. They have thus far held
several meetings and have pro-
vided EPA's Administrator with five
preliminary recommendations
covering training, abatement
debris, and lead soil hazards. The
task force is scheduled to provide
its final recommendations after
eighteen months.
Disclosure of Lead Hazards
During Real Estate Transac-
tions
EPA and HUD are required to
jointly promulgate regulations to
require that landlords and sellers
of target housing disclose the
presence of lead and lead hazards
to prospective renters and pur-
chasers, and provide them with an
EPA-developed brochure. Purchas-
ers must also be given the oppor-
tunity to have a lead inspection
performed. The statutory dead-
line for promulgation is October
28, 1994. The proposal will be
issued shortly.
CHEMICALS IN PROGRESS
-------
Biotechnology
EPA's Proposed TSCA Biotechnology
Rule Signed by the Administrator
EPA has moved one step closer to
fully implementing its program for
microorganisms under TSCA. The
proposed TSCA hiotechnology rule
was signed by the Administrator
on August 19, 1994. EPA will
publish the proposal in the Federal
Register for public comment. EPA
hopes to publish a final rule
following receipt of public com-
ments and final revisions.
With publication of the final rule,
EPA's TSCA program for microor-
ganisms will be complete. This
ailemaking has been under
development for several years.
Some living microorganisms were
reported to the original TSCA
Inventory established in the late
1970s. However, in 1984, EPA
clarified that living microorganisms
were considered "chemical sub-
stances" and thus potentially
subject to TSCA, just like more
traditional chemicals. In 1986, EPA
and the other federal agencies
with oversight for different prod-
ucts of biotechnology indicated
how they would exercise that
oversight in a Federal Register
announcement called the "Coordi-
nated Framework for Regulation of
Biotechnology." EPA indicated in
1986 that it could begin to imple-
ment its biotechnology program
for microbial products but that full
implementation would require
additional rulemaking.
Although plants and animals
could also be considered "chemi-
cal substances" under TSCA, as a
matter of policy, EPA has limited
its current TSCA biotechnology
program to microorganisms. In
the future, EPA will consider
whether it would be appropriate
to develop a program under TSCA
to include transgenic plants and
animals. TSCA authorizes EPA to
regulate any chemical substance
except for certain substances
covered by other federal statutes.
The specific TSCA exclusions
most relevant to microorganisms
are exclusions for (1) pesticides,
and (2) foods, food additives,
drugs, and cosmetics. Examples of
uses of microorganisms that are
subject to TSCA include specialty
chemical production, nitrogen
fixation, bioremediation,
biosensors, biomass conversion,
and mineral recovery,
TSCA only requires reporting for
"new chemical substances" which
are chemical substances not on
the TSCA Inventory. Traditionally,
naturally occurring substances
have not been regarded as "new"
but have been considered to be
implicitly included on the TSCA
Inventory. It is more difficult to
decide where to draw the line for
naturally occurring microorgan-
isms than it is for traditional
chemicals. Under the 1986 policy
statement, EPA decided that new
microorganisms would consist of
intergeneric microorganisms not
listed on the TSCA inventory.
Intergeneric microorganisms are
defined as those which contain
deliberate combinations of genetic-
material from source organisms in
different taxonomic genera. EPA
chose to focus on intergeneric
microorganisms because they are
more likely to contain new traits
not occurring naturally. Because
some of the product uses subject
to TSCA are beginning to involve
intergeneric microorganisms, it
has become more important for
EPA to have its entire TSCA
microorganism program in place.
Much of EPA's biotechnology
program was developed from the
TSCA premanufacture notice
(PMN) program that had been put
in place for traditional chemicals.
On that basis, EPA could immedi-
ately begin requiring PMN report-
ing for new microorganisms before
their initial use in commerce.
The biggest difference between
traditional chemicals and living
microorganisms is that when
microorganisms are released into
the environment, they have the
ability to reproduce and spread
beyond the site of their initial
release. Because traditional
chemicals do not increase in amount,
EPA had exempted from reporting
under TSCA small amounts of
traditional chemicals used only for
research and development (R&D)
activities. EPA did not believe that
such an exemption from reporting
Biotechnology Rule continued on next page
VOL 15/NO. 2 SUMMER 1994
-------
Biotechnology
EPA's Proposed TSCA
Biotechnology Rule
Biotechnology Rule from previous page
was appropriate for R&D activities
using microorganisms in the envi-
ronment, because the microorgan-
isms can reproduce and spread. In
the 1986 policy statement, EPA
indicated that it wanted to require
reporting for environmental testing
of living microorganisms to address
any risks before the microorganisms
were released. Because the New
Chemicals Program did not have a
reporting process in place for R&D
uses of chemicals, EPA could only
ask for voluntary reporting of R&D
releases of microorganisms until it
could publish a final Rile.
Since the publication of the 1986
policy statement, EPA has reviewed
both mandatory PMNs for commer-
cial uses of microorganisms and
voluntary PMNs for R&D activities
involving releases of microorgan-
isms. Based on the experience
gained through both types of
reviews, EPA has proposed many
changes to streamline and tailor the
reporting process to the Jevel of risk
and the type of product. EPA believes
that the proposed rule contains many
modifications which will improve the
TSCA microorganism program for
both EPA and submitters. EPA will get
a chance to find out if the public
agrees when the proposed aile is
published for comment.
For More Information
After the proposed rule is pub-
lished in the Federal Register, it
will be available from the TSCA
Hotline (202-554-1404). The
proposed rule and certain sup-
port documents will be available
electronically to the public.
These documents may be ac-
cessed through the Internet at:
gopher.epa.gov.
For information about whether
specific 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 following
address: Chemical Control Divi-
sion (7405), U.S. EPA, 401 M
Street, SW, Washington, D.C.
20460. Fax: (202) 260-0118.
CHEMICALS IN PROGRESS
-------
I
Biotechnology
Request to Commercialize
Genetically-Modified Bacteria Expected
Field trials on Rhizobium meliloti have been underway for seven years
Research Seeds, Inc., a small seed
company based in St. Joseph,
Missouri, has initiated agricultural
field trials with genetically-
modified Rhizobium meliloti
bacteria. In its natural state,
Rhizobium meliloti lives in nod-
ules on the roots of alfalfa and
other legumes and converts
nitrogen from the air into a form
usable by the plant for photosyn-
thesis. Legumes and rhizobia have
a natural symbiotic relationship.
Because legumes are important
agricultural crops, farmers have
been exploiting the rhizobium/
legume relationship for over 100
years to improve crop yield.
Consequently, because of their
importance, rhizobia have been
extensively studied.
The modified traits of interest in
these new strains of Rhizobium
meliloti are the nitrogen fixation
genes, which were taken from
other rhizobia. The company added
genes to enhance the existing
ability of the rhizobia to fix nitro-
gen. In addition, the company
introduced antibiotic resistance
genes from outside the Rhizobium
genus to serve as markers to allow
the organisms to be identified in soil
samples and alfalfa root nodule
samples. If successful, use of the
genetically-modified Rhizobium
meliloti, could diminish the
amounts of chemical nitrogen
fertilizers added to the soil.
This project was first initiated in
1987 when BioTechnica Agricul-
ture, Inc. submitted a premanu-
facture notice to EPA in
accordance with TSCA section 5
and the 1986 Policy Statement,
which addresses the manner in
which microorganisms would be
regulated (if necessary) under
both TSCA and FIFRA. Under the
1986 Policy Statement, interge-
neric microorganisms (those
created through the exchange of
genetic material from source
organisms in different genera) are
considered "new" chemical
substances under TSCA section 5.
Field trials of the genetically
modified Rhizobium meliloti are
currently regulated under the
terms of a TSCA section 5(e)
consent order. Research Seeds
bought the nitrogen fixation
project from Biotechnica in 1991.
Field tests conducted by
BioTechnica focused on compar-
ing the effect of different strains
of Rhizobium meliloti on alfalfa
yields and on evaluating the
efficacy of these strains in a
variety of soils. Data from field
tests, greenhouse studies and
existing literature led the Agency
to determine that the modified
strains would behave like their
naturally-occurring counterparts.
That is, in the context of these
field tests, the Agency does not
believe an unreasonable risk is
posed to humans or the environ-
ment. In addition, although
Rhizobium meliloti is expected to
survive in the environment fol-
lowing introduction, its extremely
low hazard potential does not
warrant additional controls be-
yond those currently imposed by
the consent order.
EPA expects the company to request
permission to commercialize the
microorganisms. EPA plans to
convene a meeting of its Biotechnol-
ogy Science Advisory Committee, a
panel of outside experts in the field
of biotechnology, to discuss out-
standing issues raised by the com-
mercialization request.
For further information about this
case or rhizobia in general, please
call the TSCA Biotechnology
Program at (202) 260-3725.
VOL. 15/NO.2 SUMMER.1994
-------
Biotechnology
Ecological Tier Testing Schemes
for Microorganisms Workshop
"Development of Ecological Tier
Testing Schemes for Microbial
Biotechnology Applications" was
the subject of a workshop held in
the Washington, D.C. area on
January 11-13, 1994. Jointly
sponsored by Environment
Canada and EPA's OPPT and
ORD, the workshop brought
together nearly 100 experts from
American and Canadian industry,
academia, and government to
discuss the potential risks associ-
ated with the use of microorgan-
isms in various technologies that
may be subject to TSCA. These
technologies could include
bioremediation, biomining, coal
transformations, desulfurization of
petroleum, oil recovery, fuel
production, biomass conversion,
waste treatment, nitrogen fixation,
and closed system fermentation for
the production of specialty chemicals.
The emphasis of the workshop
was on genetically-modified
microorganisms (GMMs), although
naturally-occurring microorgan-
isms were also discussed since
Environment Canada regulates
these as well. Both EPA and
Environment Canada were inter-
ested in developing tier testing
schemes for use as internal
guidance for risk assessment of
microorganisms. In these testing
schemes, effects or concerns ob-
served in a lower tier would trigger
further testing at a higher tier.
Participants were asked to review
existing tier testing schemes used
in other applications, and then to
develop ecological tier testing
schemes (consisting of both
hazard and exposure endpoints of
concern) that could apply to
genetically-modified microorgan-
isms and these technologies. The
goal of the workshop was to
develop a tier testing scheme(s)
that would be appropriate for
technologies across all levels of
"containment," including (1)
closed or contained technologies,
(2) semi-contained technologies,
and (3) open, intentional releases
to the environment.
On the first day of the workshop,
participants were divided into five
workgroups. Two groups, chaired
by Drs. Terry Schultz of the
University of Tennessee and
Wolfgang Bauer of Ohio State
University, discussed the unique
hazard and exposure scenarios
associated with the technologies
listed above. Another group,
chaired by Dr. Guenther Stotzky
of New York University, was
tasked with identifying effects and
exposure/fate endpoints that are
ecologically significant and
require examination with the use
of GMMs. A fourth group, chaired
by Dr. Madilyn Fletcher of the
University of Maryland at Balti-
more, was asked to discuss the
potential pathogenicity or toxicity
of GMMs used in these technolo-
gies and to discuss when testing
would be necessary, and what
types of tests, such as screening-
level tests, were available. The
final group, chaired by Dr. Charles
Hendricks (of EPA-ERL/Corvallis),
was tasked with developing a
"strawman" tier testing scheme
consisting of basic hazard and
exposure components that would
be elaborated upon by the contain-
ment-based breakout groups during
the last two days of the workshop.
The first two groups were able to
provide details on the microor-
ganisms involved, the ecosystems
exposed, the number of microor-
ganisms used or applied and the
frequency of application, dissemi-
nation routes, and potential
hazards associated with the
technologies. The ecological
effects and fate group identified
the endpoints, or testing of
importance with GMMs. These
effects endpoints were: primary
productivity (CO2 fixation),
mineralization and losses (cycling)
of limiting nutrients, community
(diversity) structure, and effects
on grazers and on sensitive
species. The exposure/fate end-
points of significance identified
were survival/proliferation of the
microorganism, and persistence of
the GMM and the novel DNA. In
response to specific questions
posed to the group, it was de-
cided that assessing the pathoge-
nicity/toxicity of microorganisms
Tier Testing continued on next page
CHEMICALS IN PROGRESS
-------
Biotechnology
Ecological Tier Testing
Schemes
Tier Testing from previous page
should be done in a system-
specific manner (considering the
subject organism, the potentially
affected organisms, the receiving
environment, and the conditions
of use). Lists of pathogens in the
scientific literature are not neces-
sarily complete, and there are no
simple screening level tests that are
appropriate for ascertaining the
pathogenicity of all microorganisms.
The strawman tier testing scheme,
(see box below), which was
developed by the last workgroup,
contains only slight modifications
to the scheme developed during
an EPA/Environment Canada
Bioremediation Risk Assessment
Workshop held in June 1993 in
Duluth, Minnesota.
On the last two days of the
workshop, participants were re-
grouped based on the technology
containment categories, and were
tasked with integrating all the
information obtained on Day 1
(the unique hazards and exposure
scenarios, the ecologically signifi-
"Strawman" Tier Testing Scheme
TierO
/. Organism Characterization
2. Site Characterization
3. Mode of Action or Intended Efficacy
4. Application Characterization
5. Manufacturing and Distribution Characterization
Tier 1 Exposure Assessment Hazard Assessment
1. Exposure Controls 1. QSAR Analysis (when appropriate)
2. Fate Models2. Pathogenicity of Related Taxa
3. Microbial Growth/Persistence 3. Toxicity Tests
4. Pathogenicity Tests
5. Other Tests
6. Ecological Effects
Tier 2 - Residual Questions from Tier I/Expanded Horizons
1. Community Structure -in full or partially contained & controlled
2. Community Function systems (eg. microcosms/mesocosms)
Tier 3 - Open or Limited Field Tests in Selected Environments
(with monitoring considerations)
cant effects and fate endpoints,
and pathogenicity/ toxicity test-
ing) into the strawman scheme.
The final schemes from each of
the three containment groups
were modifications of the
strawman scheme, ensuring it was
appropriate for all the technolo-
gies falling within that contain-
ment category. Group I, the
contained/closed technologies
(chaired by Drs. Morris Levin of
the University of Maryland and
George Pierce of Cytec Indus-
tries), consisted of experts on
bioremediation (bioreactors),
desulfurization of petroleum,
biomass conversion, fuel produc-
tion, and closed system fermenta-
tion for specialty chemicals.
Group II, the semi-contained
technologies (chaired by Drs.
Charles Hendricks of EPA-ERL/
Corvallis and Charles Hagedorn of
Virginia Polytechnical Institute),
consisted of experts in
bioremediation, biomining, coal
transformations, oil recovery, and
waste treatment. The testing
scheme for the open, intentional
release applications such as
bioremediation, oil recovery, and
nitrogen fixation, was developed
by Group III which was chaired
by Drs. Robert Miller of Oklahoma
State University and James Clark of
Exxon Biomedical Sciences.
For the final schemes, all three
groups considered poor tax-
onomy/identification of the
organism a concern; accurate
classification helps to identify the
hazards and testing needed.
Unanimous concerns were persis-
continued on next page
VOL. 15/NO.2 SUMMER 1994
-------
Biotechnology
Ecological Tier Testing
Schemes
from previous page
tence or build-up of the microor-
ganism and the novel DNA, and
pathogenicity/toxicity of the
microorganism and/or its
byproducts. Tier 1 consisted of
both exposure and hazard assess-
ments, both of which may not be
necessary depending on the
specific technology. Tier 2 testing
consisted of more complex,
elaborate microcosm and
mesocosm testing, particularly for
New Documents from PPIC
Following are new publications available for distribution from the
Pollution Prevention Information Clearinghouse, Tel: 202-260-1023,
Fax: 202-260-0178:
Determinants of Effectiveness for Environmental Certification
and Labeling Programs (EPA 742-R-94-001), April 1994, 98 pages.
EPA Pollution Prevention Accomplishments: 1993. Policy Leads
to Action (EPA 100-R-94-002), Spring 1994, 24 pages.
Encouraging State Innovation: Preventing Pollution through
Grant Flexibility (EPA 100-R-94-003), Spring 1994, 30 pages.
State Pollution Prevention Initiatives Utilizing Media Program
Grant Flexibility (EPA 100-R-94-001), March 1994.
Stakeholders' Action Agenda: A Report of the Workshop on
Accounting and Capital Budgeting for Environmental Costs (EPA
742-R-94-003), May 1994, 76 pages.
Workshop Proceedings: Accounting and Capital Budgeting for
Environmental Costs Workshop, December 5-7, 1993 (EPA 742-R-
94-002), May 1994, 254 pages.
Directory of EPA's Environmental Network for Managerial Ac-
counting and Capital Budgeting (EPA 742-B-94-004), May 1994
revised, 121 pages.
Summary of Focus Group Discussions with Screen Printers and
Lithographers for the Design for the Environment Printing
Project (EPA 742-R-94-004), June 1994, 89 pages.
Pollution Prevention Incentives for States (EPA 742-K-93-001),
Spring 1994, 20 pages.
Pollution Prevention in the Federal Government: Guide for
Developing Pollution Prevention Strategies for Executive Order
12856 and Beyond (EPA 300-B-94-007), April 1994, 72 pages.
ecological effects, or to address
concerns observed at Tier 1. The
groups also decided that in some
circumstances proceeding to field
tests (Tier 3) directly from Tier 1
(by-passing Tier 2) was appro-
priate. Monitoring was also an
important consideration in the
three ecological tier testing
schemes developed.
Proceedings from the workshop
containing the final schemes are
currently being drafted and will
be available later this year. For
further information, contact Dr.
Gwendolyn McClung, US EPA
(7403), 401 M St., SW, Washing-
ton, DC 20460, Tel: (202) 260-
1272, Fax: (202) 260-1236.
TSCA Hotline 202-554-1404
Exporter Responsibilities:
Clarification
The article entitled, "Exporter
Responsibilities," which ap-
peared on page 37 of the
Spring 1994 edition of the
Bulletin (Vol. 15/No.l), stated
that "any exporter who sub-
mits a notice...does not have to
repeat submission of identical
notices in the years following
1994." This sentence should
have read, "any exporter who
submitted a notice prior to
1994, does not have to repeat
submission of identical notices,
since these notices satisfy the
one-time reporting require-
ment established in the July
27, 1993 rule."
CHEMICALS IN PROGRESS
-------
International
Final Report Issued on Joint U.S./E.U. Study of SAR
One of the unique features of the
U.S. New Chemicals Program is
that testing is not required prior to
notification. Over 50% of the
Premanufacture Notifications
(PMNs) are submitted without any
test data. To handle these PMNs,
EPA has developed techniques
based on Structure Activity Rela-
tionships (SAR) to predict and
assess the fate and effects of new
chemicals. Other systems, most
notably the premarketing notifica-
tion scheme used in the European
Union (E.U.), require that notifiers
submit a Minimum Premarket
Dataset (MPD) or "base set" of
testing on new chemicals. EPA and
the E.U. recently concluded a joint
study to compare the results of
assessing a series of new chemi-
cals using the two methods SAR
and MPD testing and to esti-
mate the extent to which the U.S.
hazard conclusions on new chemi-
cals might change if a base set of
test data were available.
Despite some limitations in
design, the SAR/MPD study
concluded that the SAR approach
to screening new chemicals is
useful and effective in identifying
chemicals that may be in need of
further scrutiny for U.S. regulatory
purposes. However, the SAR
approach appears to have limita-
tions in predicting physical/
chemical properties under some
circumstances and in predicting
the exact type and level of toxic-
ity of the chemical, especially
with regard to general systemic
(health) effects. The study sug-
gests ways that the U.S. approach
could be improved through
selective incorporation of specific
testing requirements. Following
are some of the key findings.
Physical Chemical
Properties
The analysis of vapor pressure
and water solubility showed that
64% and 66%, respectively, of the
U.S. estimated values were in
agreement (-1 log unit) with the
measured E.U, values. These
property estimates were judged to
have marginal acceptability since
the values were both over- and
under-estimated by the U.S. Log P
estimates showed good agreement
where estimation techniques were
appropriate; however, there were
several classes of chemicals (e.g.,
ionic compounds, organometallics,
inorganics) where estimation
methods were inadequate.
Biodegradation
Evaluation of this endpoint was
complicated by differences in the
measures used (ultimate biode-
gradability versus half-life). Using
a mutually agreed set of criteria,
however, there was a 91% concor-
dance. The study concluded that
the present U.S. modeling scheme
appears to be reasonably effective
in predicting biodegradability.
Health Effects
For acute effects the U.S. predic-
tions corresponded to the E.U.
results approximately 80-90% of the
time. Eye irritation had the lowest
agreement and dermal irritation,
the highest. For acute toxicity, the
predictive approach worked
reasonably well and is judged to be
acceptable for screening purposes
(i.e., qualitative assessment). The
U.S. predictions for mutagenicity
corresponded to the E.U. results 94%
of the time. In general, the causes of
disagreements were readily identi-
fied in the analysis.
For long-term and sub-chronic
effects, the U.S. routinely predicts
systemic toxicity as well as devel-
opmental and reproductive
toxicity, neurotoxicity, and
oncogenicity. In contrast, the E.U.
base set data includes only a 28-
day repeat-dose study (thus these
other endpoints could not be
evaluated under the study).
Systemic toxicity was analyzed by
comparing the U.S. predictions
with the 28-day data; the outcome
from each method was scored
according to severity of effect
which was predicted/observed.
Analysis showed there was
agreement 57% of the time.
Further analysis of the non-
concordant scores revealed that
the U.S. tends to under-predict
systemic toxicity (effects and/or
severity) as observed in the
MPD's 28-day study, although the
magnitude of the differences was
relatively small. When, in a
separate analysis, health concerns
Final Report continued en next page
B
VOL 15/NO.2 SUMMER 1994
-------
International
Study of SAR
Final Report from previous page
not addressed by the MPD were
considered and the predicted
scores adjusted accordingly, the
overall U.S. prediction of toxicity
was correct in 78% of the cases.
Of the chemicals which had 28-
day toxicity data, the U.S. identi-
fied concerns for developmental
toxicity, oncogenicity, neurotoxic-
ity, and reproductive toxicity in
32%, 23%, 15%, and 9% of the
cases, respectively.
Ecotoxicity
In contrast to the E.U. which
requires only acute fish and
daphnid data, the SAR analysis
evaluates a broad spectrum of
environmental endpoints (acute
and chronic toxicity to fish,
invertebrates, algae, etc.). When
EPA-predicted fish and daphnid
acute toxicity levels were com-
pared with the MPD-measured
acute values, the agreement (-1
order of magnitude) for fish and
daphnid acute toxicity was 77%
and 59%, respectively. For fish
toxicity the U.S. tended to over-
predict toxicity, but for daphnid
toxicity, over- and under-predic-
tion occurred at about the same
rate. Potential reasons for the
under- and over-prediction in
both species were identified and
appeared to be largely the same.
Conclusions
The MPD/SAR study provided a
unique opportunity to gain insight
into the strengths and weaknesses
of the SAR approach in assessing
the potential fate and effects of
new chemicals. Analysis of the
results of this study have shown
that while the SAR approach has
been largely successful in identify-
ing chemicals of concern, the
process could be improved by
selectively incorporating specific
testing schemes into the process.
This would serve two purposes:
to gain insight into chemical
toxicities and to improve our
predictive capabilities. Such a
focused testing effort would
provide valuable data while not
presenting large overall cost
implications. EPA is currently
evaluating the results of the study
and considering possible adminis-
trative changes which could be
made in the New Chemicals
Program to address the points
raised by the study.
While the SAR approach
has been largely successful
in identifying chemicals of
concern, the process could
be improved by selectively
incorporating specific
testing schemes into the
process.
A limited number of summaries of
the report are available from the
TSCA Hotline. The full report is
available from OECD (OECD
Environment Monograph No. 88)
and will be available in the U.S.
from NTIS, GPO, and Internet in
the near future.
Correction
The article "Green Chemistry:
Benign by Design" in the
Spring 1994 Bulletin was co-
authored by Paul Anastas and
Joe Breen. CIPB regrets the
omission of Mr. Anastas' name.
CHEMICALS IN PROGRESS
-------
General
NEWS FLASH!
Common Sense Initiative: Six Industries Selected
On July 20, Administrator Carol
Browner announced the selection
of the first six major U.S. industries
that will participate in the Com-
mon Sense Initiative. The initiative
is intended to strengthen environ-
mental protection by creating
pollution control and prevention
strategies on an industry-by-
industry basis, rather than on a
pollutant-by-pollutant basis.
The six industries chosen for the
first pilot phase of the Initiative
are: auto manufacturing, comput-
ers and electronics, iron and steel,
metal finishing and plating,
petroleum refining, and printing.
The chosen industries are among
the nation's largest, employing
almost 4 million Americans and
representing close to 15 percent
of gross domestic product (GDP).
Representing a cross-section of
American business, the industries
include both small and large
businesses, high technology and
traditional manufacturing, and a
wide range of regulatory issues.
As a group, the six industries
spent over $8,2 billion in 1992 on
compliance with environmental
laws, and released 345 million
pounds of toxic pollutants into
the environment.
For each industry, EPA will as-
semble a team of senior Agency
staff, coupled with representatives
of industry leaders, environmental
organizations, state and local
governments, labor unions, and
other groups. Each team will
develop a blueprint based on the
following six principles: (1) a
comprehensive review of every
EPA rule applicable to the industry;
(2) pollution prevention as a
guiding principle; (3) easier
reporting procedures and wider
public access to environmental
information; (4) strong enforce-
ment; (5) an improved permitting
process; and (6) encouragement of
new technology and innovation.
'The current regulatory
system is about going from
Ato Band BtoC. The
changes we undertake today
are about going from A to Z."
Administrator Carol Browner
July 20, 1994
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VOL. 15/NO.2 SUMMER 1994
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