4
Existing Chemical Assessment Division
700K88100
Regional Risk Screening and Assessment Support
What Kind of Risk Assessment Support is Available?
The ECAD Regional Risk Guidance Staff (RRGS) provides Agency-coordinated, technical assistance on chemical
risk-related issues. One section of the RRGS, the Chemical Assessment Desk, provides quick responses to in-
quiries about toxic chemicals. Another section, called the Risk Guidance Team, develops tools and guidance
documents to support site-specific risk screening and risk assessments.
Who hut Access to this Support? ;, ", ' ;,5*;S- , ; -' :-r .'?.".
EPA and other f5edefal agency staff have direct" access to the ERGS, whiecsiatei ^dlo
have-Indirect aceess,'The services erf the ElGS^are available to the tm£M R^$^^ ;
and to all EPA headquarters offices. The.Chemical Assessment CN^-resp^rwi^ .
agencies and additional requests as t«ne:aad resources permit. States and' Idcarfovernififertt^ m|»y direct
requests for assistance from the Risk Guidance "Ram in developing site-specific rfekscreening wd,assessments'
through the EPA Regional Offices. : ' ;
Chemical Assessment Desk Services
Provides a single Office of Toxic Substances focal point to access:
Consultation on risk assessment and risk management activities for chemicals that have been evaluated
in the OTS Existing Chemicals Program
',
Unpublished information submitted to OTS
Estimates of toxicity and environmental fate based on structure-activity relationships
Assistance in identifying risk assessment activities in other EPA offices and Federal agencies
Comments on technical aspects of non-OTS evaluations and risk assessments.
Contact:
Terry O'Bryan (202-382-3483; E-Mail EPA7487; FTS 382-3483) or
Elaine Suriano (202-382-6902; E-Mail EPA7591; FTS 382-6902)
U.S. Environmental Protection Agency (TS-778)
401 M Street, SW
Washington, D.C. 20460
U.S. Environmental Protection Agency q/Rfi
Office of Toxic Substances '
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Risk Guidance Team Services
Provides a single Office of Toxic Substances focal point to access:
"The Risk Screening Guide," a guidance manual for State and local governments to:
respond to health and ecological inquiries from the public on toxic chemical emissions data
(Toxic Release Inventory)
identify and prioritize potential risks to humans and ecological organisms resulting from
facility emissions of toxic chemicals
Geographic risk assessment support using "The Risk Screening Guide" and computerized environmental
modeling and mapping methodologies
Technical guidance on complex, risk-related, science policy issues
Risk screening and assessment training.
Contact:
David Klauder
Director, Regional Risk Guidance Staff (TS-778)
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
Telephone: (202) 382-3628/FTS 382-3628
E-Mail EPA7441
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KAD
Existing Chemical Assessment Division
International Activities on Existing Chemicals
ECAD participates in international activities that foster the exchange of information on existing chemicals.
Among them are: the Organization for Economic Cooperation and Development (OECD) chemical clearinghouses,
the OECD EXICHEM data base, and the International Registry of Potentially Toxic Chemicals (IRPTC)
computerized registry of Chemicals Currently being Tested for Toxic Effects (CCTTE). Also, ECAD's Risk Analysis
Branch (RAB) manages OTS' participation in a cooperative agreement with the World Health Organization
(WHO)/International Programme on Chemical Safety (IPCS).
OECD Clearinghouses
OECD established its first chemical-specific clearinghouses in 1987. These clearinghouses facilitate the exchange
of information, some of which is not readily accessible through normal channels, among member countries,
and encourage the identification, planning and conduct of cooperative efforts in chemical testing and evaluation.
Coordination of international research efforts expedites studies on the health and safety effects of chemicals
and enables researchers to avoid duplication of effort in areas of testing and risk/hazard evaluation. Through
the RAB, EPA heads two clearinghouses and contributes to those headed by other OECD member countries.
In the first year of operation, the clearinghouse activities have resulted in numerous bilateral and multilateral
discussions that will serve as the basis for further cooperative efforts.
EXICHEM Data Base
RAB/ECAD is the contact point for United States submissions to the EXICHEM data base. This data
base contains information from OECD member countries on ongoing and planned activities on existing
chemicals. The data base accommodates areas for information gathering, health and environmental effects
testing, chemical fate testing, environmental monitoring, hazard evaluation, and risk management. EXICHEM
contains over 3,500 entries from 33 different government and industrial sources within OECD. It is updated
twice a year and distributed to OECD member countries who make it available to the public. The Testing
Priority Committee data base managed by RAB is the source for updates to the EPA portion of EXICHEM.
Chemicals Currently Being Tested for Toxic Effects
The computerized registry of Chemicals Currently being Tested for Toxic Effects (CCTTE) is compiled by
the International Registry of Potentially Toxic Chemicals, a project of the United Nations Environment Programme.
RAB contributes information on all toxicological testing that program offices within the agency are performing
in order to avoid duplication at the national and international levels. This data base is updated twice yearly
from information contained in the Testing Priority Committee data base.
** EDA U.S. Environmental Protection Agency
^^^' * * Of-ftr>o rvf TXvir1 Qiihctanr'oc
Office of Toxic Substances 9/88
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WHO/IPCS Cooperative Agreement
Among the programs under this cooperative agreement, the Risk Analysis Branch develops draft
Environmental Health and Criteria (EHC) documents and Health and Safety Guides (HSG) on selected
chemicals. RAB also anticipates an active role in development of International Chemical Safety Cards.
In addition, RAB participates in the review of EHCs and HSGs developed by other participating institutions.
Through the development of EHCs and HSGs, information obtained under Sections 4 and 8 of TSCA
and the results of OTS existing chemical risk assessments are more effectively brought to the attention
of the international community.
Through these programs, EPA extends its capabilities overseas in an information and technology transfer
outreach activity.
For further information regarding these international existing chemical activities or access to the EXICHEM
data base, please contact:
Staff Contact
Joanne M. Kla or
Karen J. Boswell
Risk Analysis Branch (TS-778)
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Telephone: (202) 382-3832
Management Contact
Dr. Laurence S. Rosenstein
Chief, Risk Analysis Branch (TS-778)
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Telephone: (202) 382-3832
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Existing Chemical Assessment Division
TSCA Section 4 Test Rules
When Congress passed the Toxic Substances Control Act (TSCA) in 1976, it authorized EPA to require
companies to test chemicals they manufacture to determine their potential effects on human health and the
environment. Under Section 4 of TSCA, the Existing Chemical Assessment Division (ECAD) develops test rules
for chemicals or consent orders to require such testing.
How are chemicals chosen?
The TSCA Interagency Testing Committee (ITC) was established to recommend chemicals to EPA for priority
testing consideration. Most Section 4 testing candidates to date have been recommended by the ITC.
Individual EPA program offices may also recommend chemicals for Section 4 rulemaking. The OTS Testing
Priority Committee (TPC), established in 1986, coordinates these testing requests.
Who can use Section 4 test rales? " --'"'-. ' ',
The Section 4" teat rules approach Is interdiscipltoatry; Other SPA offices* inducting the Office of Solid
Waste, Office of Air Progyains, and Office of Water/ItiWe.Msid See|ion,'4.testing fefuiwmetrts to;gather
data to support their regulatory programs. Chemiqftls'irelerwi.fy',tfce ite/art teteragtney in.scope'and
reflect a widespread need for the data. " -.''-'.--.'-'"'
What criteria are used?
In order to require testing, EPA must find that the chemical may present an "unreasonable risk" to human
health or the environment, or it is produced in "substantial" quantities that could result in substantial human
exposure or environmental release. In addition, EPA must determine that there are insufficient data about the
effects of the chemical, and that testing is needed to develop these data.
What types of tests can be required?
The testing that can be required for a chemical depends on the findings made and the data already available.
Health effects tests may include: acute, subchronic, reproductive and developmental toxicity, neurotoxicity,
skin sensitization, mutagenicity, pharmacokinetics, and carcinogenicity.
Environmental effects tests may include: acute and chronic tests for terrestrial, aquatic, and benthic organisms.
Chemical fate tests may include: water solubility, vapor pressure, partition coefficients, biodegradation,
photolysis, hydrolysis, and melting point.
U.S. Environmental Protection Agency
Office of Toxic Substances 9/88
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Standard test methods are available for the above types of tests; chemical-specific test procedures also can
be required where appropriate.
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For additional information about Section 4 test rules contact:
Chief, Test Rules Development Branch (TS-778)
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Telephone: (202) 475-8130
E Mail EPA7446
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K?sD
Existing Chemical Assessment Division
Testing Priority Committee
Why was the TPC Established?
Different programs within EPA frequently need information about the same chemical compounds, creating
a need for coordinated and multi-faceted research efforts. OTS saw the formation of the TPC as a mechanism
with which to combine extensive testing activities under the Toxic Substances Control Act with those of other
EPA programs, thereby avoiding any duplication of effort.
: What is the
. ^^
all program
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For further information regarding the Testing Priority Committee, please contact:
Staff Contact
Jeffrey Davidson, Chairman (202) 475-8148 or
Agnes Revesz, Chemical Selection Coordinator (202) 382-3998
Risk Analysis Branch (TS-778)
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Management Contact
Dr. Laurence S. Rosenstein (202) 382-3832
Chief, Risk Analysis Branch (TS-778)
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Telephone (202) 382-3832
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KAD
Existing Chemical Assessment Division
TSCA Section 5(a)(2)
Significant New Use Rules for Existing Chemicals
What Are Significant New Use Rules?
Section 5(a)(2) of the Toxic Substances Control Act (TSCA) allows EPA to designate, through a rulemaking
process, some or all uses of a chemical substance as "significant new uses." Such rules are known as Significant
New Use Rules (SNURs). Subsequently, persons who intend to manufacture, import, or process such substances
for a significant new use must notify EPA at least 90 days before commencing that activity. The Office of Toxic
Substances (OTS) evaluates such notices and can, if necessary, take immediate action to prevent or modify the
intended activity.
How Can SNURs Be Used to Control Health and Environmental Risks?
In cases where EPA believes a substance may be hazardous to human health or the environment, and the
uses identified may result in significant exposure, Section 5(a)(2) directs EPA to evaluate the intended use(s),
and monitor the potential exposure and risk. If necessary, EPA can prohibit or limit that activity until adequate
data have been developed and evaluated to determine health and environmental risks. Where unreasonable
risks are found, EPA may take immediately effective control action to prevent such risks.
Can SNURs Be Used to Monitor Environmental Concerns of Non-OTS Programs?
l in
For further information regarding TSCA Section 5(a)(2), please contact:
Frank Kover
Chief, Chemical Screening Branch
TS-778
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Telephone: (202) 382-3436
U.S. Environmental Protection Agency
Office of Toxic Substances 9/88
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KAD
Existing Chemical Assessment Division
"For Your Information" (FYI) Submissions
An Overview
The "For Your Information" (FYI) submission classification system was established by EPA's Office of Toxic
Substances (OTS) to distinguish such submissions from "substantial risk" notices submitted formally to EPA
under Section 8(e), a mandatory reporting provision of the Toxic Substances Control Act (TSCA).
Since 1977, OTS has received FYI submissions covering a wide variety of chemical substances and mixtures
from chemical companies, trade associations, unions, public interest groups, civic associations, private citizens,
academic institutions, State and other Federal agencies, as well as similar organizations/agencies in foreign
countries. These notices contain information on human exposure, epidemiology, toxicity test results, monitoring
studies, environmental fate, and other information that may be pertinent to risk assessment.
All FYI submissions that enter the OTS FYI document process are reviewed and evaluated in a timely manner
as part of the chemical "screening" process within the OTS Existing Chemicals Program (ECP). In recent years,
the FYI reporting mechanism has been used by OTS to solicit voluntary submissions of unpublished chemical
toxicity and exposure data for preparation of "Chemical Hazard Information Profiles" (CHIPs).
Many FYI submissions contain negative or equivocal findings that the submitting organizations wish to share
with EPA. OTS also receives FYI notices containing positive data of the type required for submission to EPA
under Section 8(e) of TSCA. The submission of positive data to EPA on an FYI basis usually occurs because
the submitting organization does not have a TSCA reporting obligation or does not believe that the data are
reportable under Section 8(e) of TSCA. In such cases, the OTS review of the data may result in an EPA
determination that the submitted information should have been reported formally to EPA under TSCA Section
8(e). Such a determination on the part of EPA results in a referral to EPA's Office of Compliance Monitoring
(OCM) for action(s) in accordance with the Agency's TSCA Sections 8, 12, and 13 Enforcement Response Policy
(ERP).
The evaluation of and appropriate followup attention given to FYI submissions by OTS helps in bringing
about heightened awareness of the potential hazards/risks posed by chemicals, often leading to voluntary actions
designed to protect human health and the environment. Many of the organizations providing information to
EPA on an FYI basis have reported that they have initiated the following types of health and environmental
protection measures:
Notification of workers, customers, and others
Product labeling and/or Material Safety Data Sheet changes
Manufacturing, processing, and/or chemical handling changes
Manufacture or use halted temporarily or discontinued
Additional toxicity or exposure studies conducted.
High-level scientific and administrative contacts in each of EPA's Program Offices and in other Federal agencies
(e.g., NIOSH, OSHA, CPSC, FDA, NTP) are maintained by OTS in order to provide a mechanism for timely
dissemination of information regarding newly discovered hazards/risks associated with chemical substances
or mixtures. The information is also available to interested persons via the OTS public files.
For further information regarding FYI submissions, please contact:
Jacqueline Favilla (TS-778)
FYI Coordinator
Office of Toxic Substances, U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Telephone: (202) 475-8823
U.S. Environmental Protection Agency
Office of Toxic Substances 9/88
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FYI Processing
/ ; >
(Notice
] / |nterna7Reviews N
, I eg HERD EED etc. J
) ^ - - -i - : - '
Direct Referrals
e.g. Ongoing EPA assessments
other agencies
Section Head Approval
CRIS
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I conversion
' Other Activities |
e.g. PEP, consider for
I CHIP. SNUR J
Acronyms:
IMD: Information Management Division/OTS
CRIS: Chemical Risk Identification Section/CSB
HERD: Health & Environmental Review Division/OTS
EED: Exposure Evaluation Division
DCO: Document Control Office/IMD
Jacqueline Favilla
FYI Coordinator/CRIS/CSB
Telephone: (202) 475-8823
FTS: 475-8823
James F. Darr
Section Head/CRIS/CSB
Telephone: (202) 382-3470
FTS: 382-3470
Frank D. Kover
Branch Chief/CSB
Telephone: (202) 382-3436
FTS: 382-3436
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KAD
Existing Chemical Assessment Division
Comprehensive Assessment Information Rule (CAIR)
Using the authority provided in section 8(a) of the Toxic Substances Control Act (TSCA), the Existing Chemical
Assessment Division gathers chemical-specific information from manufacturers, importers, and processors of
chemical substances. ECAD has developed CAIR to make this effort more efficient and the collected information
more useable. Anticipating the questions of potential users, the Division has prepared the following answers.
What is CAIR?
CAIR is a standardized, yet flexible, approach to gathering information on chemicals as they are defined
under TSCA. It consolidates a comprehensive set of reporting provisions and questions into a model rule.
Moreover, it provides a list of questions from which reporting requirements can be selected for various chemicals.
Responses can be tailored to only those items of interest to data users.
Who can use CAIR?
The universe of potential users is broad. It includes EPA and other Govemnwrtt offices needing information
from industry to support risk identification, risk assessment/ and regulation of chemical substances. It
also includes other organizations that are involved in efforts related to health and/or the environment
and that require information already available on a CAIR
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Manufacturing process descriptions
Waste generation, treatment, and disposal
Worker exposure.
How are chemicals added to CAIR?
EPA and other Federal agencies selected 19 chemicals for the first use of CAIR. Reasons for adding chemicals
to CAIR include the following: adverse health or environmental effects are suspected, significant data gaps
exist, and high priorities have been assigned to completing the chemical assessments.
Where is more information available about CAIR?
Information on CAIR is available at the following office:
Joan Kuchkuda (TS-778)
Chemical Screening Branch
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Telephone: (202) 382-3467
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£[i
Existing Chemical Assessment Division
Section 8(e) of the Toxic Substances Control Act
An Overview
Section 8(e) of the Toxic Substances Control Act (TSCA) states that "any person who manufactures, [im-
ports], processes, or distributes in commerce a chemical substance or mixture and who obtains information
which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury
to health or the environment shall immediately inform the [EPA] Administrator of such information unless
such person has actual knowledge that the Administrator has been adequately informed of such information."
Section 8(e) became effective on January 1, 1977, the effective date of TSCA.
A Section 8(e) policy statement ("Statement of Interpretation and Enforcement Policy; Notification of Substantial
Risk"), which clarified the types of information to be submitted and the procedures for doing so, was published
in the Federal Register on March 16, 1978 (43 FR 11110).
Since January 1, 1977, a large number of Section 8(e) notices covering a wide range of chemical toxicity/ex-
posure information have been received and given priority evaluation and appropriate followup attention by
the Office of Toxic Substances (OTS).
Upon receipt of a Section 8(e) submission, OTS prepares a status report which contains a description and
preliminary assessment of the submitted information, a statement regarding production and use(s) of the sub-
ject chemical(s), and recommendations for appropriate OTS followup actions/activities.
EPA's implementation of Section 8(e) has brought about heightened corporate awareness of potential chemical
risks, leading to voluntary company actions designed to protect human health and the environment.
Many companies have reported that in direct response to submitted chemical toxicity/exposure information,
the following types of health and environmental protection measures were initiated:
Notification of workers, customers, and others
Labeling and Material Safety Data Sheet (MSDS) changes
Manufacturing, processing, and/or handling changes
Chemical production or use halted temporarily or discontinued altogether
Additional toxicity/exposure studies performed.
The chemical industry's increased awareness of potential risks posed by chemicals to health and the environ-
ment is evidenced further by many voluntary industry submissions received by OTS on a "For Your Informa-
tion" (FYI) basis.
High-level scientific and administrative contacts have been established by OTS in each of EPA's Program
Offices and in other Federal agencies (e.g., NIOSH, OSHA, CPSC, FDA, NTP) in order to provide a mechanism
for timely and prioritized dissemination of information concerning newly discovered hazards/risks associated
with exposure to chemical substances or mixtures. The information is also made available to all interested per-
sons via the OTS public files.
For further information regarding TSCA Section 8(e), please call:
David R. Williams (TS-778)
TSCA Section 8(e) Coordinator
Office of Toxic Substances
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Telephone: (202) 382-3468
U.S. Environmental Protection Agency
Office of Toxic Substances 9/88
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Processing of 8(e) Notices of Substantial Risk
CRIS. C
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CSB: C
OGC: C
OCM: (
DCO. [
David R. Williams
Section 8(e) Coon
Telephone: (202)
FTS: 382-3468
James F. Darr
Section Head/CRI
Telephone: (202)
FTS. 382-3470
Frank D. Kover
Branch Chief/CSB
Telephone: (20
FTS: 382-3436
TSCA CBI Procedures
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Existing Chemical Assessment Division
TSCA Section 8(c)
Allegations of Significant Adverse Reactions
What is Section 8(c)?
Section 8(c) of the Toxic Substances Control Act (TSCA) requires manufacturers and processors of chemical
substances and mixtures to maintain records of allegations of adverse effects to human health or the environment
believed to have been caused by the chemical substances or mixtures. Any person may make such an allegation,
including an employee, a private citizen, a plant neighbor, or another company representative on behalf of
its employees. While the allegation need not be supported by scientific or medical evidence, for the purposes
of §8(c), it must establish a link between a chemical substance or mixture, a particular company's product,
process, or effluent, and any "significant adverse reaction" experienced by the public or environment.
Manufacturers and processors are required to collect, record, file, and retain these allegations.
What purpose does 8(c) serve?
Section 8(c) of TSCA requires that a worker or consumer allegation be recognized and retained by industry.
EPA expects that individual companies will use the 8(c) records to identify problems associated with the chemicals
that they manufacture, and will subsequently take steps toward resolving identified problems.
This section also serves to create a historical record of significant adverse reactions alleged to have been caused
by a chemical substance, mixture, process, or effluent. It thus provides a means to identify previously unknown
chemical hazards and to reveal patterns of adverse effects that might otherwise either go unnoticed or go undetected
for long periods of time.
What are the 8(c) major provisions?
The final rule implementing Section 8(c) of the Toxic Substances Control Act was promulgated on August
22, 1983 and became effective on November 21, 1983. (See 40 CFR Part 717.)
Industries must keep allegations of adverse health effects filed by employees for 30 years, and keep all other
allegations for 5 years. Both written and oral allegations must be retained. EPA may inspect these records and
require submission of copies.
Who can use 8{c)? . -".-. ' ''\ ; ~ ' ,.'._:'k v.-v-.:
EC AD eaa require i
program offttfes and other goveirrtmeft
available ${c) information from .a central file,
For further information regarding TSCA Section 8(c), please contact:
TSCA Assistance Office, TS-799
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Telephone: (202) 554-1404
A videotape ia also available on TSCA Section 8(c) and can be obtained by calling the above number.
** PP/V U.S. Environmental Protection Agency
^Cnr\ office of Toxic Substances 9/88
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BGMD
Existing Chemical Assessment Division
Chemical Advisories
What Are Chemical Advisories?
Chemical Advisories alert people to the toxic effects of chemicals, the potential for human and environmental
exposure to chemicals, and ways to reduce chemical risks. They are compiled by the Risk Analysis Branch of
EPA's Office of Toxic Substances (OTS) after consultation with representatives from the chemical industry, public
interest groups, and relevant government agencies. OTS issues Chemical Advisories to encourage people to take
action to reduce potential chemical hazards when regulatory control is not appropriate, or as interim measures
while regulatory action is under consideration.
How Are Chemical Advisories Used?
The EPA distributes Chemical Advisories to individuals and organizations alike to answer questions about
the health and environmental risks posed by chemicals, as well as to advise on the safe handling and disposal
of chemicals. The advisories are used where an increased awareness of potential risk is likely to lead to meaningful
precautions and are distributed directly to persons able to take action to reduce chemical risks.
What Substances Have Been Addressed in Chemical Advisories?
OTS has issued advisories on the substances listed below and plans to continue issuing them as necessary.
When drawing up chemical advisories, the Agency considers the specific needs of the affected user population(s),
and tailors the notices accordingly. Consequently, advisories on used motor oil and nitrosamines are available
in two versions.
1. Notice of Potential Risk: Used Motor Oil.
(February 1984/Spanish language version available)
2. Notice to Workers of Potential Risk: Nitrosamines in Metalworking Fluids.
(September 1984)
3. Notice to Formulators of Metalworking Fluids: Potential Risk from Nitrosamines.
(September 1984)
4. Notice of Potential Risk: p-tert-Butyl Benzoic Acid and Derivatives.
(March 1985)
5. Notice of Potential Risk: 4,4'-Methylene Bis (2-Chloroaniline).
(June 1985)
6. Notice of Potential Risk: Burning Used Oil in Space Heaters.
(November 1985)
7. Notice of Potential Risk: Toluenediamines.
(September 1986)
8. Notice of Potential Risk: 2-Nitropropane.
(December 1986/Spanish language version available.)
U.S. Environmental Protection Agency
Office of Toxic Substances 9/88
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Additional Information
Further information on Chemical Advisories is available by contacting:
Dr. Laurence S. Rosenstein
Chief, Risk Assessment Branch TS-778
U.S. Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
Telephone (202) 382-3832
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