UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION. PESTICIDES
AND TOXIC SUBSTANCES
JUL 3 0 1992
MEMORANDUM
SUBJECT: TSCA REVITALIZATION BRIEFING
FROM: Mark A. Greenwood, Director
Office of Pollution Prevention /& Toxics
TO: OPPT Staff
On July 9, 1992, I presented a briefing to Deputy
Administrator Hank Habicht to discuss the revitalization of OPPT.
The briefing, entitled "Revitalization of the Toxics Program (It's
Not Just TSCA Anymore)", highlighted many of the accomplishments of
our program, and was very well received by Mr. Habicht.
Attached is a copy of the Habicht briefing package. I think
it reflects a culmination of the efforts you, the OPPT staff, have
dedicated to making OPPT a "top-notch" program within the Agency.
At a time when we are undergoing change, it may seem difficult
to determine what is good about what we are doing. However, the
successes of the program, as shown in the briefing package, are an
indication that we're still on the right track.
Attachment
cc: Joe Carra
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REVITALIZATION OF THE TOXICS PROGRAM
(It's Not Just TSCA Anymore)
TALKING POINTS
(in italics)
July 8, 1992
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TRADITIONAL AGENDA OF THE TOXICS PROGRAM
Administering the Many Different and Disjointed Pieces of TSCA
Existing Chemicals Program
New Chemicals Progra'm
Chemical Testing
Information Gathering
Biotechnology
PCBs
Elements Have Been Added Over Time to the Toxics Agenda
Asbestos (ASHAA and AHERA)
Lead (Pb)
Toxics Release Inventory (EPCRA)
Pollution Prevention
Special Voluntary Programs (e.g., 33/50)
-------
OPPT
Pie Charts of FY88 and FY92 FTE
+ We're doing more with less.
-------
TRADITIONAL STRENGTHS OF THE TOXICS PROGRAM
Information Collection and Dissemination
Quality Science in Real Time for New Chemicals
+ 20,000 new substances reviewed since 1979
+ 90-day assessment period
+ on average, 2,000 new substances reviewed a year
+ approximately 10% (or 200) of these reviews result in full blown risk assessments
Rapid Risk Assessments That Are Truly Multi-Media
We analyze risks throughout the life cycle, including:
occupational risks
— consumer risks
environmental release and disposal risks
Effective Decision-Making and Risk Reduction on New Chemicals
+ Regulatory action taken on 1700 of new chemicals reviewed
+ + 500 chemicals subject to consent orders to control risks pending the
development of additional data
+ + 400 chemicals subject to complete prohibition on manufacture pending the
completion of upfront testing
800 chemicals withdrawn voluntarily in the face of EPA's regulatory
findings
-------
OPPT'S NEW VISION FOR THE TOXICS PROGRAM
Integrates OPPT's Activities into Four Principles:
PROMOTE POLLUTION PREVENTION AS A PRINCIPLE OF FIRST
CHOICE;
+ Promote pollution prevention within the Agency
+ Promote pollution prevention outside the Agency through information,
training, and grants; National Pollution Prevention Center
+ Extend focus to non-industrial sectors: agriculture, energy, transportation;
work with other Federal agencies
* PROMOTE THE DESIGN, DEVELOPMENT AND APPLICATION OF SAFER
CHEMICALS, PROCESSES AND TECHNOLOGIES IN THE INDUSTRIAL
SECTOR OF THE ECONOMY;
PROMOTE RISK REDUCTION AND RESPONSIBLE RISK MANAGEMENT
PRACTICES THROUGHOUT THE LIFE CYCLE OF MAJOR CHEMICALS OF
CONCERN; and
+ The reorganized OPPT will have a single division where all work on Pb,
asbestos, and PCBs will be integrated.
PROMOTE PUBLIC UNDERSTANDING OF THE RISKS OF CHEMICALS
+ TRI
+ pollution prevention clearinghouse
+ publicly available database of all TSCA test submissions
+ share information with other companies, federal agencies, and organizations
+ actively review and, where appropriate, challenge claims of confidential
business information
Reflects OPPT's Mission Beyond TSCA
Utilizes QATs, in Areas such as Risk Assessment and Chemical
Testing Reform, to Reinforce These Principles and Their
Implementation.
-------
OPPT VISION PRINCIPLES AND PROGRAM ELEMENTS
Principles
Pollution Prevention Advocacy
SAFER CHEMICALS, PROCESSES, 6
TECHNOLOGIES
Life-Cycle Management of
Major Chemicals
Environmental Information for
the Public
Elements
EXISTING CHEMICALS PROGRAM
NEW CHEMICALS PROGRAM
CHEMICAL TESTING
Information Gathering
Biotechnology
PCBs
Asbestos
Lead
TRI
Pollution Prevention
Special Voluntary Progranms
-------
CHANGES WE ARE MAKING TO PROMOTE SAFER EXISTING CHEMICALS
1. Increasing Productivity Through Better Management
2. Integrating Our Approach to TSCA
3. Producing Quality Science in Real Time
4. Taking the Program Public
5. Orienting the Program Around Pollution Prevention
6. Managing Risk Creatively
7. Strengthening Relations with Other Agencies and Governments
8. Linking the Toxics Program to Other EPA Programs
-------
1. INCREASING PRODUCTIVITY THROUGH BETTER MANAGEMENT
Clarifying Risk Management Process
RM1/RM2 decision points and timeframes
%
+ Refer to flow chart on the RM process
Clarifying Risk Management Agenda
The Master Testing List
+ Allows EPA to ensure that limited testing resources are optimally used to
meet the highest data needs.
Tracking Status of Chemicals
Recording improvements
+ development of an automated system that lets you know where a chemical is
in the assessment process and where it has been.
+ Identifying and managing lower-profile chemicals Cgrazing buffaloes")
which may have received earlier attention, but had not been carefully
tracked or assigned a "risk management* action. [In response to GAO
report]
+ from an initial set of 296 "unfrocked" chemicals, 136 cases are now being
managed with the program.
+ The remaining 160 cases have been logged into a tracking system and are
being prioritized for entry into the new program.
Standardizing Methodologies
Standard pollution prevention analysis of major RM2
projects
Examples of Results
1] Improved chemical testing productivity
> Turn to slides from Synar hearing
+ In the 9 years from 1980 to 1989, EPA proposed testing actions on 201
chemicals
-------
+ During 1990 and 1991 alone, testing actions were proposed for 262
additional chemicals — 163 of these as part of the High Production
Volume - Screening Information Data Set (HPV-SIDS) testing program of
the OECD.
+ During about the same period during the 1980s, final action was taken to
initiate testing on 165 chemicals.
+ In 1991 alone, we took final action on 40 chemicals, again with 37
chemicals through the HPV-SIDS program.
2] Improved RM1 productivity
+ since the beginning of the new process in April 1990, some 575 chemicals
have passed through RM1
3] RM2 outputs are now also slowly rising
+ 11 cases are now in the RM2 assessment state where, among other steps,
pollution prevention and cost analyses are occurring.
+ Example of the cases we're working on:
* RCFs
an insulation material used in a variety of industrial and
high-technology applications and which appears to be a potent
carcinogen.
1st Section 4(f) case initiated since 1985.
Industry has established a model product stewardship
program that goes a long way in addressing our concerns to
reduce RFC exposure
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10
2. INTEGRATING OUR APPROACH TO TSCA
o Actively Pursuing Data Submissions
Section 8(e) Compliance Audit Program
v
+ Encourages companies to submit delinquent information with set penalties
+ To date, EPA has received approximately 2,000 CAP submissions.
o Linking Testing and Risk Management
Use RM process to set testing agenda
+ CAA chemicals; high emission TRI chemicals
Use RM process to respond to testing submissions
+ Set time frame for review of incoming test data
+ Put into RM1 queue
+ Ex: action on RCFs began with 8(e) submission
o Integrating the Intent of Two Special TSCA Sections into the
New Process
Sections 4(f) and 9
-------
11
3. PRODUCING QUALITY SCIENCE IN REAL TIME
Transferring This Traditional Strength in the New Chemicals
Program to Existing Chemicals
+ We already review, on average, 2,000 substances a year through the new chemicals
program.
Embodying This Strength in the RM1 Step of the Existing
Chemical Review Process
RM1 profiles are completed within 12 weeks and are in
demand due to their quality.
+ requests from inside and outside EPA
-------
12
4. TAKING THE PROGRAM PUBLIC
Making Agency Decisions on Chemicals Publicly Available
+ creation of an administrative record
\
Notifying the Affected Industry
+ sending "letters of concern" to companies
+ some companies have responded with voluntary chemical substitutions or emission
reductions
Promoting Stakeholders' Involvement
Policy dialogues
Effecting a Client Base
+ Example: public and industry interest in write-up of chemicals we've dropped
-------
13
5. ORIENTING THE PROGRAM AROUND POLLUTION PREVENTION
o Embodying Prevention Principles in the RM2 Step of the
Existing Chemical Review Process
+ Pollution prevention analysis is always done
\
•f We use the environmental management hierarchy approach in developing solutions
o Targeting a Chemical Cluster (Rather than Chemical-by-
Chemical) Approach
+ Enhances our ability to look for source reduction
+ Enhances our ability to determine which chemical, process, or technology is the
safest
o Examples:
Indoor air — spray paints, varnishes
Formaldehyde — indoor air sources of emissions
Design for the Environment (DFE)
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14
DESIGN FOR THE ENVIRONMENT
DfE: Building Environmental Health Considerations into the
Design of Chemical Products and Processes
Examples: BMW
INTEL
Long-Term Investments
University of Michigan .Pollution Prevention Center
Chemical Design
New Initiatives (e.g., insurance, accounting)
Short-Term Investments
Printing pilot
Dry cleaning
Possible new areas (metalworking fluids, electroplating)
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15
6. MANAGING RISK CREATIVELY
+ Problem: Agency doesnt traditionally recognize efforts that quietly reduce risk
Promoting Voluntary Approaches
x
Examples:
33/50
carpet dialogue
RCFs
+ RCF companies have voluntarily submitted a wide variety of data on
production levels, exposure, and animal testing
+ RCF companies have voluntarily agreed to negotiate a consent
agreement on exposure testing
Using Significant New Use Rules (SNUR)
+ Negotiate phaseout
+ Seal with a SNUR
+ Example: metalworking fluids containing amines
Negotiating Risk Management of Chemicals In Lieu of Requiring
Chemical Testing
-I- negotiating consent agreements with companies to reduce emissions of high-release
TRI chemicals in lieu of requiring costly testing
Pursuing an Integrated"Strategy
Example: Chloranil
+ combined effort of: initial consent order
test data from a test rule
voluntary agreements
enforcement initiatives
SNUR (under consideration)
Holding Companies to Their "Responsible Care" Commitments
-------
16
7. STRENGTHENING RELATIONS WITH OTHER AGENCIES AND GOVERNMENTS
OSHA NIOSH EPA (ONE) Committee
+ Coordinating activities and exchanging information through monthly meetings
\
+ Examples of coordination: asbestos in buildings
acrylamide
RCFs
Toxics in Consumer Products Committee
Developing CPSC relationship
+ Example: formaldehyde strategy: working to develop a voluntary
national consensus standard in lieu of section 6 rulemaking
International Forum
OECD - Screening Information Data Set (SIDS)
+ As noted earlier, our participation in this program is dramatically increasing
our testing productivity.
Information Exchange on Major Projects
Paint Stripping
Dry Cleaning
+ May 1992
+ Heavy European and Japanese participation and a strong pollution
prevention orientation
Pulp and Paper
+ August 1992 (He was scheduled to be briefed on July 7th about this)
+ Foreign participation for technological and chemical alternatives to
conventional bleaching
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17
8. LINKING THE TOXICS PROGRAM TO OTHER EPA PROGRAMS
o Linking EPA Programs
o Examples:
Indoor Air
OSWER Projects
Testing for Air Program
Support for SRRP
o Linking Beyond Traditional Technical Support
Support for Emergency Response
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18
ROLE OF THE NEW CHEMICAL PROGRAM
o Well-established for many years
o Traditional role — preventing high-risk chemicals from
entering commerce
High productivity
+ 20,000 new substances reviewed since 1979
+ on average, 2,000 new substances reviewed a year
+ approximately 10% of these reviews result in full blown risk assessments
Efficiency
+ 90-day review period
Creative approaches and innovative solutions to reduce
risk
4- triggers testing
+ regulation pending development of test data
+ use limitations
o New Directions
Fostering pollution prevention
+ Pollution prevention information added to PMN reporting form,
+ Considering requiring "pollution prevention plans" under section 5(e) orders
Identifying safer-alternatives to existing chemicals
+ Examples:
Lead substitute: new substance, which might traditionally have been banned
by EPA due to possible cancer and systemic effects, was allowed by EPA to
be manufactured and used under controlled conditions
Chlorine bleach substitute: new substance allowed after company completed
studies which showed the substance posed no unreasonable risk to human
health and the environment
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19
SUMMARY
Program Has Made Major Progress
Elements of the program are clear
V
Real outputs are occurring
Increased Public Interest in the Toxics Program
Ex: June 11 American Chemical Society Forum
+ Broad participation
+ Looked at program/management objectives and statutory problems with
TSCA
Future Issues
Crafting the Agenda to Serve Multiple Interests
Integrating New and Existing Chemical Programs
Developing Strategy for Information Programs
Impact of the Asbestos Decision
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ATTACHMENT
RM OUTPUTS
RMl
CHEMICALS TO RMl
FY90
FY91
FY92
Total
FY90
^Y91
FY92
Total
97
127
306
530
RMl
Test
75
37
106
218
DECISION
RM2
12
66
3
81
Drop/Other
10
24
197
231
iM2 Chemicals
N-Methylpyrrolidone (paint stripping)
2-N itropropane
Phosphoric Acid Waste
Chlorinated Paraffins
Benzidine Pigments/Dye Cluster
Acrylonitrile
Chloroethane
1,2 Dichloroethane
Hydrazine
Lead, non-residential paint
Lead, non-plumbing solder
-------
Post RM2 Chemicals
Carpet Emissions Reduction Program
Chloranil
v
Refractory Ceramic Fibers
Sodium Cyanide
Acrylamide
Dioxin in Sludge
Formaldehyde
Lead fittings
Lead solder
Lead in industrial uses
Asbestos Ban
Nitrates in Metalworking Fluids
Environmental Hazard Communication
-------
REVITALIZATION OF THE TOXICS PROGRAM
(It's Not Just TSC A Anymore)
JIIL 9 1992
-------
TRADITIONAL AGENDA OP THE TOXICS PROGRAM
Administering the Many Different Elements of TSCA
Existing Chemicals Program
New Chemicals Program
Chemical Testing
Information Gathering
Biotechnology
PCBs
Elements Have Been Added Over Time to the Toxics Agenda
Asbestos (ASHAA and AHERA)
Lead (Pb)
Toxics Release Inventory (EPCRA)
Pollution Prevention
Special Voluntary Programs (e.g., 33/50)
-------
OPPf
FY88 FTE
FY92 FTE
SCENCE POLICY
TESTING
NEW CHEM.
EX. CHEM
PCB
E3 ASB
0 TRI
E3 33/50
B3 LEAD
-------
TRADITIONAL STRENGTHS OP THE TOXICS PROGRAM
Information Collection and Dissemination
Quality Science in Real Time for New Chemicals
Rapid Risk Assessments That Are Truly Multi-Media
We analyze risks throughout the life cycle, including:
occupational risks
consumer risks
environmental release and disposal risks
Effective Decision-Making and Risk Reduction on New Chemicals
J
-------
OPPT'S NEW VISION FOR THE TOXICS PROGRAM
Integrates OPPTs Activities Into Four Principles:
v/ PROMOTE POLLUTION PREVENTION AS A PRINCIPLE OF FIRST CHOICE
*/ PROMOTE THE DESIGN. DEVELOPMENT AND APPLICATION OF SAFER CHEMICALS.
PROCESSES AND TECHNOLOGIES IN THE INDUSTRIAL SECTOR OF THE ECONOMY
%/ PROMOTE RISK REDUCTION AND RESPONSIBLE RISK MANAGEMENT PRACTICES
THROUGHOUT THE LIFE CYCLE OF MAJOR CHEMICALS OF CONCERN
%/ PROMOTE PUBLIC UNDERSTANDING OF THE RISKS OF CHEMICALS
Reflects OPPTs Mission Beyond TSCA
Utilizes QATs, In Areas such as Risk Assessment and Chemical Testing Reform, to Reinforce These
Principles and Their Implementation.
-------
OPPT VISION PRINCIPLES AND PROGRAM ELEMENTS
PRINCIPLES
Pollution Prevention Advocacy,
ELEMENTS
Safer Chemicals. Processes and Technologies
Life-cycle Management of Major Chemicals
Environmental Information for the Public
Existing Chemicals Program
New Chemicals Program
Chemical Testing
Information Gathering
Biotechnology
PCB's
Asbestos
Lead
TRI
Pollution Prevention
Special Voluntary Programs
-------
CHANGES WE ARE MAKING TO PROMOTE SAFER EXISTING CHEMICALS
1. Increasing Productivity Through Better Management
2. Integrating Our Approach to TSCA
3. Producing Quality Science In Real Time
4. Taking the Program Public
5. Orienting the Program Around Pollution Prevention
6. Managing Risk Creatively
7. Strengthening Relations with Other Agencies and Governments
i
8. Linking the Toxics Program to Other EPA Programs
-------
1. INCREASING PRODUCTIVITY THROUGH BETTER MANAGEMENT
Clarifying Risk Management Process
- RM1/RM2 decision points and timeframes
Clarifying Risk Management Agenda
- The Master Testing List
Tracking Status of Chemicals
- Recordkeeplng Improvements
Standardizing Methodologies
- Standard pollution prevention analysis of major RM2 projects
An Example of Results: Improved Chemical Testing Productivity
-------
EPA EXISTING CHEMICALS PROGRAM
-------
resting Program Outputs: 1980-1992
Proposed Testing Actions
Number of Chemicals
250
200
150
100
81 82 83 84 85 86 87 88_ 89 90 91 92
Year
DSIDS
I Section 4
\0
-------
resting Program OuTputs: 1980-1992
Final Testing Actions
Number of Chemicals
100
80 81 82 83 84 85 86 87 88 89 90 91 92
Year
DSIDS
I Section 4
l\
-------
2. INTEGRATING OUR APPROACH TO TSCA
Actively Pursuing Data Submissions
Section 8(e) Compliance Audit Program
Linking Testing and Risk Management
Use RM process to set testing agenda
Use RM process to respond to testing submissions
Integrating the Intent of Two Special TSCA Sections into the New Process
Sections 4(0 and 9
12
-------
3. PRODUCING QUALITY SCIENCE IN REALTIME
Transferring This Traditional Strength in the New Chemicals Program to Existing Chemicals
Embodying This Strength in the RM1 Step of the Existing Chemical Review Process
RM1 profiles are completed within 12 weeks and are In demand due to their quality.
13
-------
4. TAKING THE PROGRAM PUBLIC
Making Agency Decisions on Chemicals Publicly Available
Notifying the Affected Industry
Promoting Stakeholders' Involvement
Policy dialogues
Effecting a Client Base
14
-------
5. ORIENTING THE PROGRAM AROUND POLLUTION PREVENTION
Embodying Prevention Principles In the RM2 Step of the Existing Chemical Review Process
Targeting a Chemical Cluster (Rather than Chemlcal-by-Chemlcal) Approach
»•
Examples:
- Indoor air — spray paints, varnishes
- Formaldehyde — Indoor air sources of emissions
- Design for the Environment (DfE)
15
-------
DESIGN FOR THE ENVIRONMENT
DflE: Building Environmental Health Considerations Into the Design of Chemical
Products and Processes.
- Examples: BMW
INTEL
Long-Term Investments
University of Michigan Pollution Prevention Center
Chemical Design
New Initiatives (e.g., insurance, accounting)
Short-term Investments
Printing pilot
Dry cleaning
Possible new areas (metalworklng fluids, electroplating)
16
-------
6. MANAGING RISK CREATIVELY
Promoting Voluntary Approaches
Examples:
— 33/50
— carpet dialogue
— RCFs
Using Significant New Use Rules (SNUR)
Negotiating Risk Management of Chemicals In Lieu of Requiring Chemical Testing
Pursuing an Integrated Strategy
- Chloranil
Holding Companies to Their "Responsible Care" Commitments
17
-------
7. STRENGTHENING RELATIONS WITH OTHER AGENCIES AND GOVERNMENTS
QSHA NJOSH £PA (ONE) Committee
Toxics and Consumer Products Committee
- Developing CPSC relationship
International Forum
- OECD - Screening Information Data Set (SIDS)
- International Exchange on Major Projects
v/ paint stripping
%/ dry cleaning
•S pulp and paper
18
-------
8. LINKING THE TOXICS PROGRAM TO OTHER EPA PROGRAMS
Linking EPA Programs
Examples:
*/ Indoor Air
v/ OSWER Projects
\S Testing for Air Program
-------
ROLE OP THE NEW CHEMICAL PROGRAM
• Well-established for Many Years
• Traditional Role — Preventing High-risk Chemicals from Entering Commerce
High productivity
Efficiency
Creative approaches and solutions to reduce risk
• New Approaches
Fostering pollution prevention
Identifying safer alternatives to existing chemicals and processes
20
-------
SUMMARY
• Program Has Made Major Progress
- Elements of program are clear
- Real outputs are occurring
• Increased Public Interest In Toxics Program
- E.g.. June 11, American Chemical Society Forum
• Future Issues
- Crafting the agenda to serve multiple Interests
- Integrating new and existing chemical programs
- Developing strategy for information programs
- Impact of the asbestos decision
21
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ATTACHMENT
RM OUTPUTS
RMl
CHEMICALS TO RMl
FY90 97
FY91 127
FY92 206
Total 530
DECISION
FY90
FY91
FY92
Test
75
37
106
RM2 prpl
12 10
66 24
1 121
Total 218 81 231
RK2 chemicals *
N-Methylpyrrolidone (paint stripping)
2-Nitropropane
Phosphoric Acid Waste
Chlorinated Paraffins
Benzidine Pigments/Dye Cluster
Acrylonitrile
Chloroethane
1,2 Dichloroethane
Hydrazine
Lead, non-residential paint
Lead, non-plumbing solder
-------
Post RM2 Chemicals
Carpet Emissions Reduction Program
Chloranil
Refractory Ceramic Fibers
Sodium Cyanide
Acrylamide
Dioxin in Sludge
Formaldehyde
Lead fittings
Lead solder
Lead in industrial uses
(Asbestos Ban
Nitrates in Metalworking Fluids
Environmental Hazard Communication
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