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VOL. 7 No. 3
INSIDE
August 1986
What's Happening in OTS by Edwin F. Tinsworth,
Use of Consent Agreements to Develop Test Data
PRESIDENT SIGNS FEDERAL BIOTECHNOLOGY RULES, SETS POLICY
NEW DATA AIDS LEAKING UNDERGROUND MOTOR FUEL TANK RULEMAKING
EPA PROPOSES $12 MILLION IN FINES FOR TSCA VIOLATIONS
NEW REQUIREMENTS FOR ASBESTOS REMOVAL PERSONNEL
EPA AWARDS $47 MILLION FOR SCHOOL ASBESTOS ABATEMENT
OTS REVISING SOME WORKPLACE EXPOSURE CALCULATIONS
EPA ISSUES TEST RULE ON CHLORINATED BENZENES
EPA CONSIDERS FEES FOR TSCA SECTION 5 SUBMISSIONS
EPA AND OSHA
EPA Sends MBOCA File to OSHA
EPA Ends Investigation of Workplace Exposure to TDA
RECENT TSCA SECTION 8 ACTIONS
EPA Revised Chlorinated Naphthalene List
MBOCA
EPA Adds 3 Chemicals to Reporting, Recordkeeping Lists
SNURs
EPA Proposes SNURs for 10 Existing Chemicals
Methyl n-Butyle Ketone (MBK)
FOR YOUR INFORMATION
OTS Receives Nine FYI Submissions
TSCA Annual Report Available
OTS Receives 14 Substantial Risk Notices
Clarification of Section 4(a) and 8(d) Reporting Requirements
OTS Opens New Public Reading Room
TAO Videotapes Available
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¦
What's Happening in OTS—Edwin F. Tinsworth
I would like to alert you to what I think will be a significant new step in EPA's testing program un-
der section 4 of TSCA. This new procedure—consent agreements—will speed up the develop-
ment of data necessary for EPA to determine whether a chemical substance or mixture presents
an unreasonable risk of injury to health or the environment.
During the early years of TSCA's implementation, EPA encountered many delays in issuing test
rules to respond to the Interagency Testing Committee's (ITC) recommendations. One approach
pursued by OTS to solve this problem was use of voluntary negotiated testing agreements (NTAs)
which resulted in a number of industry testing programs being started. However, this approach
was successfully challenged in court because of lack of enforceability and failure of the NTAs to
trigger certain other provisions of TSCA.
Working with industry and environmental groups, EPA has now adopted a new consent agree-
ment approach to speed the start of testing where EPA, industry and other interested parties all
can agree on what testing should be done, and one or more companies agree to conduct the tests. Under this approach, EPA will set a
schedule for public negotiation on testing of ITC-recommended chemicals and, if all interested parties reach a timely consensus, EPA will
enter into an Enforceable Consent Agreement (ECA) with the companies who will do the testing. If consensus is not reached, and EPA
believes testing is needed, the Agency will proceed with a test rule.
The ECAs will provide for: (a) equivalent data quality requirements just as for test rules, (b) enforceable schedules, (c) export notification
under section 12(b) of TSCA, (d) disclosure of test results to the public, and (e) equivalent data submission requirements just as for test
rules if EPA should promulgate a significant new use rule for the consent agreement chemicals.
On July 2, 1986 (51 FR 24222) EPA asked persons wishing to participate in negotations concerning chemicals recommended in the ITC s
17th and 18th Reports to identify themselves. I look forward to effective use of this new approach in applicable cases.
The consent agreement procedures are explained in detail in the Federal Register of June 30, 1986 (51 FR 23706). The interim final rule
adopting them became effective on July 30, 1986.
Edwin F. (Rick) Tinsworth
Since 1984, Rick Tinsworth has been Deputy Director of
the Office of Toxic Substances. Prior to joining EPA, Rick
was with the Consumer Product Safety Commission for
11 years where he held a number of positions, including
Director of the Office of Budget, Program Planning and
Evaluation, Associate Executive Director for Field Opera-
tions, and Deputy Director of the Bureau of Compliance.
A graduate of Providence College, Rick began his career
in the Federal Government with the Food and Drug
Administration.
EPA Considering Fees for TSCA Section 5 Submissions
EPA is considering charging a reasonable fee for notices filed
under section 5 of TSCA. The fee would help defray the cost of
administering the program.
Under section 26(b) of TSCA, the EPA Administrator (by issuing
a rule) may establish user fees for persons submitting data un-
der section 4 or 5 of TSCA. Under section 5, this could include
fees for premanufacturing notices, significant new use notices,
and exemption applications.
In a July 11, 1986 notice (51 FR 25250), EPA announced the
availability of a background paper addressing the subject of pos-
sible section 5 fees. The notice also set a closing date of Sep-
tember 9, 1986 for comments on the proposal. Persons inter-
ested in commenting on the matter of section 5 fees should call
or write the TAO for the PMN User Fees Background Paper
and the July 11 Federal Register notice.
Elkins Named Director of OTS
Charles R. Elkins is the new Director of the Office of Toxic Sub-
stances (OTS). He replaces Don R. Clay, who recently became
the Deputy Assistant Administrator in EPA's Office of Air and
Radiation. For the past year Elkins has been Acting Assistant
Administrator of that Office.
"Chuck's experience in the Agency (EPA) makes him well quali-
fied to run the toxics program and to implement my overriding
goal for OTS, which is to use the TSCA information authorities
to supply data to support activities in other Agency programs,
said John A. Moore in announcing Elkins appointment, on July
31. Moore is the Assistant Administrator for Pesticides and
Toxic Substances.
Elkins was the budget examiner for environmental health pro-
grams at the Bureau of the Budget in the late 1960s and played
a major role in the creation and startup of EPA. He has served
three times as Acting Assistant Admininstrator, twice for Air and
Radiation and once in the Office of Hazardous Material Control.
During his years in the latter office he helped create the Office of
Toxic Substances. While serving as Acting Assistant Administra-
tor for Air and Radiation he played a major role in developing
EPA's Air Toxics Strategy.
Elkins is a cum laude graduate of Yale and also is a graduate of
the Yale School of Law.
Moore said Edwin R. Tinsworth will continue as Deputy Director
of OTS.

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President Signs Federal Biotechnology Rules, Sets Policy
President Reagan recently signed a comprehensive biotech-
nology rules package aimed at establishing a thorough Federal
review system to control plants, animals and microorganisms
developed by artificially manipulating genetic structures. The
biotechnology industry is expected to produce new generations
of vaccines, drugs, pesticides, plants, and products with a myr-
iad of possible applications.
The June 26,1986 Statement of Policy (51 FR 23302) describes
how five Federal agencies will apply their existing authorities to
ensuring the safety of biotechnology research and products so
that human health and the environment are protected from po-
tential hazards. Each of the five agencies is charged with as-
sessing a portion of the risks and benefits resulting from artificial
manipulation of the genetic structures of plants, animals or mi-
croorganisms. The policy calls for the use of existing Federal
laws to provide a basic network of jurisdiction over both re-
search and products.
In general terms, the agencies and their particular responsibili-
ties may be grouped as follows:
•	EPA, regulating microorganisms used as pesticides, or for
general industrial or environmental purposes;
•	The Food and Drug Administration, regulating foods, drugs,
cosmetics, medical devices, and animal drugs;
•	The Department of Agriculture, regulating gene-altered animal
vaccines and plants, and working with EPA on microorgan-
isms that are plant pests;
•	The Occupational Safety and Health Administration, reviewing
gene-altered agents used in the-workplace;
•	The National Institutes of Health, setting standards and moni-
toring biomedical genetic engineering research.
EPA's biotechnology policy gives special consideration to three
categories of microorganisms:
1.	Microorganisms that contain new combinations of traits, or
that are new to the environment in which they are used. (Both
of these categories are defined in detail in the notice).
2.	Microorganisms that are pathogens, or contain genetic mate-
rial from pathogens, except those that are native (indigenous)
to the area where they will be released. (The nptice contains
detailed definitions of these microorganisms).
3.	All other microorganisms that are subject to the Federal In-
secticide, Fungicide and Rodenticide Act or TSCA and are
deliberately released into the environment.
As a result of the President's signing the biotechnology rules,
five agency-level committees have been formed.
EPA's agency-level biotechnology committee will provide the
EPA Administrator and the Assistant Administrator for Pesti-
cides and Toxic Substances with advice on scientific issues per-
taining to biotechnology. The EPA committee, to be made up of
11 members, will analyze biotechnology problems, conduct re-
views, hold meetings, issue reports, make recommendations
and be involved in any other activity that meets the committee's
objective. The group has the authority to hire consultants, if nec-
essary. Nine of the EPA Biotechnology Science Advisory Com-
mittee members will be scientists, and two members will repre-
sent the general public. EPA is preparing a list of candidates
from which nominees are to be selected. An announcement on
July 2, (51 FR 24220) requests any interested person or organi-
zation to submit the names of qualified persons. For further de-
tails on the nomination procedure call or write the TAO.
On July 9, 1986, the first public meeting of the Biotech-
nology Science Coordinating Committee (BSCC) was
held in Washington, D.C. The committee conducted gen-
eral business, and received oral comments on the Fed-
eral biotechnology policy from the public. Dr. John A.
Moore, the Assistant Administrator for the Office of
Pesticides and Toxic Substances represented EPA. The
BSCC was established on October 31,1985 and consists
of senior policy officials of the agencies involved in the
oversight of biotechnology research and products. The
BSCC is authorized to hold public meetings in order to
discuss public concerns about scientific and other issues
involving biotechnology. The BSCC is part of the Federal
Coordinating Council for Science, Engineering and Tech-
nology, which is a statutory interagency coordinating
mechanism managed by the Office of Science and Tech-
nology Policy, which operates out of the Executive Office
of the President. Its mission is to coordinate Federal sci-
ence activities among Federal agencies.
The President signed the biotechnology rules package on
June 18,1986 and the Statement of Policy was published
on June 26 (51 FR 23302). A person who wants to under-
stand more fully the background of the Federal role in
biotechnology should also acquire the November 14,
1985 notice (50 FR 47174) and the recent notices of
committee formations. The TAO will supply the entire
package of notices upon request. Public oomment on the
Federal biotechnology policy must be received at the Ex-
ecutive Office of the President before August 25, 1986.
3

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New Data To Aid Leaking Underground Motor
Fuel Storage Tank Rulemaking
A significant proportion of the Nation's estimated 800,000 under-
ground motor fuel storage tanks may be leaking, according to a
new EPA study.
The information obtained in the study will be used by EPA when
developing regulations to control leaking underground storage
motor fuel tanks. Waste storage tanks, not included in the study,
will be subject to an EPA rule shortly.
The study estimates that some 326,000 establishments control
an estimated 796,000 underground motor fuel storage tanks.
The establishments include 79,000 farms having 158,000 under-
ground fuel storage tanks. Other major groups with underground
motor fuel tanks are gas stations, trucking firms, auto dealers,
marinas and firms maintaining private fleets. The study was con-
ducted by OTS for EPA's Office of Underground Storage Tanks
(OUST), which will manage the underground motor fuel tank
program.
Congress authorizes EPA to act on leaking underground motor
fuel tanks in the Hazardous and Solid Waste Amendments of
1984 to the Solid Waste Disposal Act.
On November 8, 1985, under this new authority, EPA issued a
rule requiring all owners of underground tanks that store or have
stored petroleum or hazardous substances in the United States
to notify their appropriate State agencies about the existence
and number of their tanks (50 FR 46602).
In 1987, EPA plans to propose rules on new and used tanks
employed to hold petroleum and chemical products, according
to Ron Brand, director of OU6T. The proposed rules will cover
provisions on leak detection, tank design and construction, in-
stallation, compatibility, repair and closing of tanks, Brand said.
The OTS National Survey was based in a national probability
sample of 890 establishments with 2,400 tanks on the premises.
A random subsample of 218 establishments was chosen for
physical tank testing, and at these sites 433 tank systems were
tested for tightness. An estimated 35 percent of these tank sys-
tems failed the EPA tightness test, which required the tanks to
be filled above normal operating levels. This test method slightly
elevated the normal operating pressure on the tank, which was
corrected for in the statistical analysis of the data.
The survey also found that:
•	The average rate for leaking tanks, adjusted for typical operat-
ing conditions, was 0.31 gallons per hour. Half the leaks were
0.25 gallons per hour or less.
•	EPA found no one type of tank material (such as fiberglass or
steel) or fuel type caused more leakage than any other mate-
rial or fuel type.
•	At comparable ages, fiberglass and steel tanks showed no
significant difference in the rate of failure.
•	Steel tanks make up about 89 percent of all underground mo-
tor fuel storage tanks. Steel tanks show little increase in rate
of failure in the first 20 years of use, but after 20 years the
numbered failures increased substantially.
•	About 14 percent of the establishments have one or more
abandoned tanks on site.
•	The average age of tanks in the United States is 12 years.
•	About 21 percent of the tanks are installed partially or fully be-
low the water table (the depth below which the ground is satu-
rated with water).
Copies of the executive summary of the OTS report are avail-
able through the TAO. The two volumes of the study are avail-
able through the Department of Commerce's National Technical
Information Service (703) 487-4650; 5285 Port Royal Rd.,
Springfield, VA 22161. The NTIS number is PB 86-216512. The
cost is about $45.00. Questions concerning EPA's underground
storage tank program should be directed to Helga Butler, EPA,
WH562A, Washington, D.C. 20460 or by calling her at (202)
382-4756.
TSCA Inventory Computer Tapes Available
Four TSCA Chemical Substances Inventory computer tapes are
now available for purchase from the National Technical Informa-
tion Sen/ice (NTIS), U.S. Department of Commerce.
Requestors should ask for the TSCA Chemical Substance
Inventory:
Production Tape	PB 86-220803	$275
Plant Site Tape	PB 86-220795	$160
Synonym Tape	PB 86-220860	$370
Preferred Name Tape PB 86-220878	$275
NTIS accepts telephone orders (703) 487-4850. Mailed orders
should be sent to: NTIS, 5825 Port Royal Rd., Springfield, VA
22161.
4

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New Requirements For Asbestos Removal Personnel
Being Met
Burnt by reports of poor quality school asbestos abatement
work, the United States Congress included tough new restric-
tions for 1986 federally funded asbestos work in schools.
This year, schools receiving Federal funds for asbestos abate-
ment work must hire only contractors who are either State certi-
fied or who have attended EPA-approved asbestos abatement
training courses. More specifically, all on-site supervisors and a
majority of the hired asbestos abatement workers must be State
certified or have attended the EPA-approved courses.
With the restrictions in place, Congress appropriated $50 million
in fiscal 1986 funds to aid those primary and secondary schools
with a severe asbestos hazard and who cannot afford to abate
the hazard on their own. Such schools can receive a Federal
loan or grant under the program.
In 1984, President Reagan signed the Asbestos School Hazard
Abatement Act (ASHAA). The legislation authorizes EPA to
spend $600 million over seven years to abate asbestos in quali-
fying schools. In fiscal 1985 EPA awarded $45 million in loans
and grants to 340 schools throughout the country.
Moving fast to meet the new congressional requirements, 14
States have certified programs for contractors. They are:
Alabama, Alaska, Arkansas, Illinois, Iowa, Kansas, Maryland,
New Jersey, Ohio, Oklahoma, Rhode Island, South Carolina,
Tennessee and Washington. Because Tennessee requires
only supervisors to have training, EPA is requiring for the
ASHAA program in Tennessee that a majority of a firm's
workers receive training as well.
EPA estimates that within a year an additional nine States will
have qualified certification programs. In the meanwhile, EPA is
providing funding to the National Association of Minority Con-
tractors to conduct training in New York City in early August, in
Detroit in mid-September, and in Los Angeles just before
Thanksgiving. These will be EPA-approved training courses that
will meet the congressional requirement.
EPA in 1986 approved a number of asbestos abatment training
courses for supervisors and workers. EPA-funded training facili-
ties are located at Georgia Tech (Atlanta), University of Kansas
(Kansas City), Tufts (Boston), the University of Illinois (Chicago),
the University of Texas (Arlington), the University of Utah (Salt
Lake City), Drexel University (Philadelphia), and Rutgers Univer-
sity (Piscataway). These facilities offer EPA-approved training
courses for supervisors and workers. The University of
California, (Berkeley) is funded by EPA and will offer EPA-
approved courses later this year. EPA expects to begin approv-
ing other courses for the ASHAA program within the next sev-
eral months.
The National Asbestos Council (NAC) and the Committees on
Occupational Safety and Health also have received EPA ap-
proval and are receiving Agency funds to conduct abatement
worker training courses. These programs are designed for
nonsupervisory workers in the abatement industry. NAC can
send field personnel to a particular project location to train work-
ers on-site.
Training courses approved by any State certification and training
program are EPA-approved courses under the ASHAA program
for contractors in States without training requirements. For ex-
ample, the Association of Wall and Ceiling Industries (AWCI)
training course is approved by Alabama. As a result, the AWCI
course is acceptable in Alabama and in all States without certifi-
cation and training programs.
EPA Awards $47 Million For School Asbestos Abatement
On July 31, EPA awarded $47 million in grants and loans to 173
of the Nation's neediest public and private school districts to
help perform 421 asbestos abatement projects in 295 schools.
The funds were appropriated by Congress under the Asbestos
School Hazard Abatement Act (ASHAA).
"These funds will help our country's financially neediest schools
eliminate a potentially serious threat to the health of students
and employees," said Dr. John A. Moore, EPA's Assistant Ad-
ministrator for Pesticides and Toxic Substances.
All 1,777 schools that applied for ASHAA funds in 1986 were
ranked on a national scale, based on the extent of the health
hazard the friable asbestos posed to students and employees.
Based on that ranking, EPA decided how much money each
school district was to receive. In the past, asbestos was com-
monly used in school buildings as insulation.
EPA considers asbestos to be a threat only when it is friable.
Asbestos Is considered flrable when, if dry, it can be easily
crumbled, pulverized or reduced to powder by hand pressure.
Friable asbestos fibers escapes into the air where humans can
breathe them. Asbestos is a known human carcinogen.
Each school authority awarded money under the EPA program
decides on the most effective remedy, removal, encapsulation
or enclosure of the asbestos. Most of the EPA-supported
schools choose asbestos removal.
"I urge those schools that have not recceived grants or loans
that have severe asbestos problems to address them right away
and not delay abatement projects In anticipation of future Fed-
eral funding," Moore sad.
In February 1986, EPA sent grant and loan application forms to
every school district, private school organizations and individual
private schools in the United States. The districts submitted their
applications to their respective State governor's office by April
11. Each governor's office reviewed the applications received
and submitted them to EPA.
5

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EPA Proposes $12 Million In Fines for TSCA Violations
During the first six months of 1986, EPA issued more than 300
complaints for violations of TSCA and has proposed fines to-
taling more than $12 million. The charges are tor violations of
the PCB rule, the PMN rule, the asbestos-in-schools rule, or fail-
ure to certify (imported chemicals) under section 13. Most of the
complaints were issued by EPA regional compliance monitoring
offices. Few of the complaints have reached final abdication.
Each EPA region has its own compliance staff and issues civil
administrative orders and other administrative orders for EPA vi-
olations in its region.
The TSCA complaints were issued against manufacturers and
importers; the U.S. Air Force; city and State governments; a
turnpike commission; sanitary districts; water, power and tele-
phone utilities; a railroad; a waste disposal firm; a transformer
consultant; a newspaper group; a realty company; a department
store; universities; school districts and church groups.
The listing of the TSCA complaints issued was complied by the
Office of Compliance Monitoring (OCM), which is headed by
A.E. Conroy, II. OCM plans, directs and coordinates the
Pesticides and Toxic Substances (OPTS) compliance program
of EPA. The OCM, located in Washington, is involved in many
national programs. It provides EPA's regional offices and all the
States with national pesticides and toxic substances compliance
overview and policy direction. OCM establishes compliance pri-
orities, provides technical support for litigation activity and con-
curs on regional enforcement actions. The Office also manages
an OPTS laboratory data integrity program which conducts labo-
ratory inspections and audits of testing data.
Conroy's staff in Washington also issues civil administrative
complaints and other administration orders in cases of first im-
pression, in cases of overriding national significance, or whan a
violation takes place in two or more EPA regions.
OTS Revising Some Workplace Exposure Calculations
The Chemical Engineering Branch (CEB) of OTS is revising
some of its methods of calculating workplace exposure to new
chemicals. Some revisions are based on suggestions received
during a February 1986 workshop that reviewed the methodol-
ogies available to assess exposure when data are limited. The
workshop was particularly concerned about inhalation exposure,
dermal contact, engineering controls, and respiratory protection.
CEB evaluates workplace exposure to both existing chemicals
subject to TSCA and new chemicals submitted under the Act's
Premanufacturing Notification review program for OTS.
CEB is supporting research in the areas of volatilization rates,
dustiness of fine solids, permeability of gloves, effectiveness of
local exhaust ventilation, and actual workplace protection af-
forded by respirators,
A synopsis of the workshop proceedings will be published later
in 1986 In the Applied Industrial Hygiene Journal of the Ameri-
can Conference of Governmental and Industrial Hygienists. A
3-page summary of CEB's position on the workshop is available
now through the TAO.
6

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EPA Proposed SNURs For 10 Existing Chemicals
EPA in two recent separate actions proposed Significant New
Use Rules (SNURs) for 10 existing chemicals.
Once a final SNUR (TSCA section 5(a)(2)) for a substance is is-
sued, a person who intends to manufacture, import or process
the substance for any use is required to notify EPA at least 90
days before beginning such an activity. A chemical listed in a
SNUR is subject generally to the same statutory procedures re-
quired under TSCA's premanufacture notice (PMN) rule for a
new chemical. The purpose of the SNUR notice requirement is
to furnish EPA with the opportunity to evaluate the intended use
of the substance and, if necessary, give EPA time to prohibit or
limit the use before it begins. For additional information about
SNURs, see page 11 of this bulletin.
PBBS and Tris
EPA is proposing a SNUR for eight polybrominated biphenyls
(PBBs) and for tris 2,3-dibromoproply phosphate, also know as
Tris. In a July 7, 1986 proposed rule (51 FR 24555) EPA said
any use or related activities involving PBBs or Tris may result in
significant human or environmental exposures.
These chemicals are listed in the TSCA Inventory, but EPA is
not aware of any use of them in the United States since at least
1980. In 1977, under TSCA, EPA began to investigate the need
to control PBBs and Tris. In 1980, EPA issued a TSCA section
8(a) rule requiring submission of a Notice of Manufacture or Im-
portation for PBBs and Tris. That rule included a Sunset provi-
sion that terminated the reporting requirements for these chemi-
cals by May 1, 1985. Since then, EPA has reassessed the
toxicity of PBBs and Tris, past and present exposure, and the
need for further information about these chemicals. The Agency
decided a SNUR would provide the information.
The substances subject to recent proposed SNURs are listed
below:
CAS No.
Name
92-66-0 1,1'-Biphenyl, 4-bromo-(4-Bromobiphenyl)1
92-86-4 1,1 '-Biphenyl, 4,4'-dibromo-(4, 4'-
Dibromobiphenyl)1
2052-07-5 1,1'-Biphenyl, 2-bromo-(2-Bromobiphenyl)1
2113-57-7 1,1 '-Biphenyl, 3-bromo-(3-Bromobipheny()'
13654-09-6 1,1'-Biphenyl, 2, 2', 3, 3', 4, 4', 5,5',
6,6'-decabromo-(Decabromob!phenyl)1
27753-52-2 Nonabromoblphenyl (unspecified location of
bromines)
27858-07-7 Octabromobiphenyl (AR.AR, AR, AR, AP, AR',
AR', AR')
36355-01-8 Hexabromobiphenyl (unspecified location of
bromines)
126-72-7 tris (2,3-dibromopropyl) phosphate (Tris)1
'Common name.
Methyl n-Butyl Ketone (MBK)
On July 7, 1986, EPA proposed a SNUR for methyl n-butyl ke-
tone (MBK) (CAS No. 591-78-6), a chemical listed on the TSCA
Inventory. EPA believes MBK can cause neurotoxic effects in
humans, and any use of it may result in significant human expo-
sure (51 FR 24551). The chemical has been used as a solvent
~or lacquers and in lacquer and vamish removers. MBK also has
been used as a solvent for oils, fats and waxes. In 1979, the
only known MBK manufacturer in the United States discontinued
production of the substance and sold the last of its inventory in
•881. MBK is not now being imported into the United States.
EPA Ends investigation of Workplace Exposure to TOA
On July 10, 1986, EPA announced termination of its investiga-
tion of workplace exposure to toluenediamines (TDAs) (51 FR
25071). EPA made this decision because the chemical's poten-
tial risks in the workplace are a matter of concern for the U.S.
Occupational Safety and Health Administration (OSHA). The
transfer was made under section 9(d) of TSCA. EPA will con-
tinue to investigate the environmental hazards posed by TDAs
in nonoccupational settings arising outside of the workplace.
EPA has transferred its public record on TDA to OSHA.
EPA Issues Final Section 8(a) Reporting for M60CA
On April 18, 1986, EPA issued a final reporting rule (51 FR
13220) for the chemical substance 4,4-methylenebis(2-chloro-
aniline), commonly referred to as MBOCA (CAS No. 101-14-4).
The substance also is identified as 4,4'-methylenebis
(2-chlorobenzenamine). This rule became effective on June 2,
1986, and requires persons to notify EPA if they currently are
manufacturing MBOCA in the United States or if they begin
manufacturing the substance or alter their method of manufac-
ture in the future. The rule excludes importers from its reporting
requirements. This rule is intended to ensure that the Agency
will receive notice of domestic manufacture of MBOCA (and of
changes in manufacturing methods). The rule enables EPA to
evaluate activities which may result in exposure to MBOCA, and
take follow-up regulatory action If necessary to reduce risk to
human health or the environment.
On June 23,1986 (51 FR 22836) EPA announced termi-
nation of its regulatory investigation of MBOCA, which
was begun on May 23, 1983 (48 FR 22954). EPA has
transferred its public file on the chemical to the U.S. Oc-
cupational Safety and Health Administration (OSHA). The
transfer of MBOCA information to OSHA for its consider-
ation was made In accordance with section 9(d) of TSCA.
OSHA has statutory authority to prevent or reduce to a
significant extent the risks associated with the processing
and use of MBOCA in the workplace. OSHA has been
kept informed of EPA activities during the tatter's regula-
tory investigation of the chemical. Previously, EPA issued
a Chemical Advisory to ali MBOCA processors in the
United States. The Agency also issued a TSCA section 8
reporting and recordkeeping requirements applicable to
any person intending to manufacture MBOCA in the
United States (see report on MBOCA just above).

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Section 8(e) ... Substantial Risk
Below, and In the next column, is a list of 14 Initial section
8(e) notices recently placed In EPA's public file. For an ex-
planation of section 8(e) and how copies of notices can be
acquired see page 12 of this Bulletin.
Log No. 8 EHQ-
CAS No.
0386-0594 S
Liquid mixture of octyltin esters, with	15571-58-1
dioctyltin bis(thioglycolic acid), 2-ethylhexyl
ester
Final report of a subchronic feeding study in male and female
rats
0386-0595
2,4-Pentanedione	123-54-6
Summarized final results from an in vitro clastogenicity study
0486-0596 S
Halogenated aliphatic carboxanilide
Summarized results of an acute eye irritation study in rabbits
0486-0597 S
Benzotriazole-2-yl substituted
hydroxyphenyl-propionate ester
Final report from a subacute oral study in male and female rafs
0486-0598
A crylonitrile	107-18-1
Dimethylformamide	68-12-2
Summarized preliminary findings from an epidemiologic study
of male workers
0486-0599
3-Methoxy propanoic acid, methyl ester	3852-09-3
Preliminary results of several ongoing acute oral and inhalation
toxicity studies in male and female rats
0486-0600
Propanoic acid (Propionic Acid)	79-09-4
An article: "Tumorigenic Effects in the Mucosa of the
Forestomach of Rats in [Chronic] Feeding Experiments with
Propionic Acid," Bundesgesundhbl., November 1985
0586-0601
Arsenic	7440-38-2
Sulfur dioxide	7446-09-5
Final report from an epidemiologic study on mortality among
copper and zinc smelter workers in the United States
0686-0602 S
Substances containing an acrylate moiety Confidential
Final reports from a battery of five genotoxicity studies con-
ducted on each of three test materials
0686-0603
1-Propoxy-2-propanol vapor (Propasol®	1569-01-3
Solvent P)
Summarized preliminary results of a short-term repeated inhala-
tion exposure study in male and female rats
0686-0604
Heavy aromatic solvent naphtha	64742-94-5
Summarized preliminary findings from a lifetime skin-painting
study in male mice
0686-0605 S
Mixture of 2 complex organosilane oligomers Confidential
Preliminary results of a subacute inhalation toxicity study in
male and female rats
0686-0606 S
Heteromonocyclic carbomonocyclic urea	Confidential
Summary preliminary results from a 2-year dietary feeding
study in male and female rats
0786-0607 S
2,2,5,6-Tetramethylpiperidine-1-oxyl	_ . 25^4-83-2
Summary results of a series of short-term In vlvo /nha/at/on,
dermal, and eye toxicity studies in rats and rabbits.
"S" at the end of a Log Number means a santized version is
available.
N.B. All toxicity, oncogenicity, teratogenicity and mutagenicity
studies involve animals unless otherwise stated. Additional tests
(e.g., bacterial cell) are noted or are included in the term
"battery."
EPA Issues Test Rule For Chlorinated Benzenes
Manufacturers and processors of certain chlorinated benzenes
are now required to conduct the health tests under TSCA sec-
tion 4 (July 8, 1986 (51 FR 24657).
The substances and the required tests are:
CAS No.	Name
95-50-1 Ortho dlchlorobenzene (1,2-DCB)
95-94-3 1,2,4,5-Tetrachlorobenzene
(1,2,4,5-TCB)
106-46-7 Para dlchlorobenzene (1,4-DCB)
108-90-7 Monochlorobenzene (MCB)
120-82-1 1,2,4-Trichlorobenzene
(1,2,4-TCB)
Test
reproductive effects
reproductive effects
and developmen-
tal toxicity
reproductive effects
reproductive effects
oncogenicity
8

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Latest FYI Submissions
In recent weeks EPA received the nine FYI (For Your Infor-
mation) submissions listed below. For additional informa-
tion on FYls see 11 of this Bulletin.
Document Control No. FYI—	CAS No.
Chemical Name(s)
OTS-0486-0491
Chlorendic Acid	115-28-6
Chlorendic Anhydride	115-27-5
EPA request for information in support of a CHIP in preparation
OTS-0486-0492
Stearyl Trimethyl Ammonium Chloride	112-03-8
C20-22 Trimethyl Ammonium Chloride	68607-24-9
Summarized final results from a battery of actue toxicity studies
in laboratory animals
OTS-0586-0493
Polyamine polymer by-products	Several
Letter discussing levels of contaminants and metabolic trans-
formations in a class of chemicals approved for potable
water treatment
AX-0586-0494
Not chemical specific
Review of dose-response relationships for carcinogens
OTS-0486-0495
2-Nitropropane	79-46-9
EPA request for information In support of an annotated
bibliography
OTS-0686-0496
Disodium Oxydiacetate	35249-69-5
Final report of a 24-hour dermal acute percutaneous toxicity
study in rabbits
OTS-0686-0497 P
Polyurethane Varnish	Several
Letter reporting adverse chronic human effects (high blood
pressure) following acute exposure
OTS-0686-0498
Chlorinated Solvents Substitutes	Several
EPA request for information in support of hazard substitute pro-
files in preparation
OTS-0786-0499
2,3-Dichloropropene	78-88-6
Summarized final results from a 14-day inhalation study in rats
and mice
P=Privacy Act
EPA Revised Chlorinated Naphthalene List
A list of chlorinated naphthalene chemicals, the subject of a
TSCA section 8(a) chemical-specific reporting rule, was incor-
rectly printed in the Code of Federal Regulations. On June 3,
1986, EPA corrected the error by printing the list of substances
in its correct Chemical Abstract Service (CAS) number order (51
FR 19839). For an explanation of section 8(a) see page 11 of
this Bulletin.
The chemicals in CAS order are:
CAS registry number
Chemical substance
90-13-1
Naphthalene,
1-chloro-
91-58-7
Naphthalene,
2-chloro-
1321-64-8
Naphthalene,
pentachloro-
1321-65-9
Naphthalene,
trichloro-
1335-87-1
Naphthalene,
hexachloro-
1335-68-2
Naphthalene,
tetrachloro-
1825-30-5
Naphthalene,
1,5-dichloro-
1825-31-6
Naphthalene,
1,4-dichloro-
2050-69-3
Naphthalene,
1,2-dichloro-
2050-72-8
Naphthalene,
1,6-dichloro-
2050-73-9
Naphthalene,
1,7-dichloro-
2050-74-0
Naphthalene,
1,8-dichloro-
2050-75-1
Naphthalene,
2,3-dichloro-
2065-70-5
Naphthalene,
2,6-dichloro-
2198-75-6
Naphthalene,
1,3-dichloro-
2198-77-8
Naphthalene,
2,7-dichloro-
2234-13-1
Naphthalene,
octachloro-
25586-43-0
Naphthalene,
chloro-
32241-08-0
Naphthalene,
heptachloro-
70776-03-3
Naphthalene,
chloro derivatives
TSCA Annual Report Available
The TSCA 8th annual report to the United States Congress is
now available through the TAO. The report summarizes the ac-
tivities and accomplishments of TSCA in Fiscal Year 1985,
which ended on September 30,1985. The report will aid anyone
who wants to understand how EPA is using TSCA in risk evalu-
ation strategies, how test rulemaking is being streamlined, and
how Information collection procedures are being improved. Risk
management actions, biotechnology, and international activities
of TSCA are highlighted.
This news bulletin is intended to inform all persons concerned
with the Toxic Substances Control Act (TSCA) about recent de-
velopments and near-term plans. For further information or to
request copies of documents mentioned, write the TSCA Assist-
ance Office (TAO). (TS-799) EPA, Washington, D.C. 20460.
The TAO also has a toll-free telephone number (800) 424-9065.
In the Washington D.C. area, or from outside the continental
United States call (202) 554-1404.
9

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EPA Adds 3 Chemicals To Reporting, Recordkeeping Lists
Clarification of TSCA's Section 4(a) and 8(d)
Reporting Requirements
Persons who send a letter of intent to conduct testing un-
der section 4(a). are not required to list that information
under section 8(d). This clarification resolves a potentially
duplicative reporting requirement.
Section 8(d) and its implementing regulations affect man-
ufacturers, importers and processors of the substances
and mixtures listed in the 8(d) model rule at 40 CFR
§ 716.17, or after the effective date, proposes to manu-
facture, import, or process, or is manufacturing,
importing, or processing the substance or mixture, must
submit to EPA a list of health and safety studies that are
initiated after the date the substance or mixture is listed,
and that are conducted by or for them.
Under section 4(a) and its implementing regulations (40
CFR § 790), EPA promulgates test rules which specify
that either manufacturers (including importers), proc-
essors, or both, are required to test the chemical sub-
stance or mixture which is the subject of the rule. Each
test rule indicates who will be required to submit letters of
intent to conduct testing or exemption requests.
OTS recently relocated its Public Reading Room and
TSCA Public Information Office to the Ground Floor of
EPA's new northeast section of Waterside Mall, at 401 M
Street, SW., Washington, D.C. TSCA's rulemaking and
other administrative records are now located in the
northeast section. The new room number for the reading
room and the information office is G-004. Information
specialists are still available to assist visitors with their in-
formation needs.
All TSCA-related Freedom of Information (FOI) requests
should still be addressed to Ms. Jeralene Green (A-101),
EPA, Washington, D.C. 20460.
Please note a recent change in the Agency's fee sched-
ule for duplicating documents. There Is no charge for
duplicating the first 124 pages, but at page 125 of a re-
quest for duplication there is a $25.00 fee and a 20 cent
charge for each additional page (e.g., 126 pages will cost
$25.20).
On May 12, 1986, EPA issued a TSCA section 8(a) and 8(d)
rule (51 FR 17336), with reporting requirements for manufactur-
ers, importers, and processors for the following three chemicals:
P-tert-butylbenzoic acid (P-TBBA)
4-(1,1-dimethyethyl) benzoic acid (CAS No. 98-73-7)
P-tert-butyltoluene (P-TBT)
1-(1,1-dimethylethyl)-4-methylbenzene (CAS No. 98-51-1)
P-tert-butylbenzaldehyde (P-TBB)
4-(1,1-dimethy!ethyl)benzaldehyde (CAS No. 939-97-9)
The section 8(a) reporting provisions require persons to provide
EPA with exposure-related data on their activities involving
these chemicals. The section 8(d) provisions require persons to
provide EPA with unpublished health and safety data on the
substances. The rule became effective on June 25, 1986.
EPA is primarily concerned with the possible human reproduc-
tive effects of exposure to these substances. The purpose of the
May 12 regulatory requirements is to monitor current and future
uses of the three chemicals and to obtain data necessary to
support a more detailed assessment of potential health and en-
vironmental risks posed by these substances.
VIDEOTAPES
Sales have been brisk for two recently produced
videotapes: Reducing the Risks of PCBs, and TSCA In-
ventory Update: An Overview for Chemical Manufactur-
ers and Importers.
The 12-minute tape on polychlorinated biphenyls (PCB)
presents general information on the chemical. The PCB
tape is intended for the utility industry, fire departments,
building owners, scrap and salvage dealers, labor and
public interest groups, and others who are interested in
PCBs.
The 20-minute tape on the Inventory presents detailed in-
formation that should help those people who must report
during the partial updating of the TSCA Inventory. The re-
porting deadline is December 23, 1986.
Both tapes are being sold through Color Film Corp.,
Video Division, 770 Connecticut Ave., Norwalk, CN
06854; (800) 882-1120 or (203) 866-2711.
Reducing the Risks of PCB's:	TSCA Inventory Update:
Beta I or II costs $21.75	Beta I or II costs $23.10
VHS costs $22.65	VHS costs $23.50
% inch costs $29.85	% inch costs $31.25
Connecticut residents and corporations add 7.5%.
Copies of both tapes are available for short loan periods.
Call or write the TAO and your name will be added to the
loan waiting list. You can also ask for brochures and a list
of other tapes available from TAO.
10

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Below and on the next page are explanations of sections of
TSCA that are cited in this issue of the Bulletin. For addi-
tional information about TSCA's provisions, caff (800)
424-9065; in the Washington, D.C. area, (202) 554-1404, or
write the TAO.
Testing of Chemical Substances and Mixtures ... Section 4
Section 4 of TSCA gives EPA authority to require manufacturers
or processors of chemicals to test the toxic effects of a desig-
nated substance. To require testing EPA must find that the
chemical may present an unreasonable risk; that there are in-
sufficient data available with which to perform a reasoned risk
assessment; and that testing is necessary to generate such
data. A test rule may also be based on an EPA finding of sub-
stantial production and exposure to humans or the environ-
ment, in addition to findings of insufficient data and need for
testing.
Under section 4(e) an Interagency Testing Committee (ITC)
was established to recommend chemicals to EPA for priority
consideration for the promulgation of section 4 test rules. The
ITC can designate up to 50 chemicals or categories of chemi-
cals for testing and must make revisions to this section 4 prior-
ity list as needed. In turn, EPA must respond within one year af-
ter the ITC adds a substance to the priority list by starting
rulemaking under section 4 or giving reasons for not doing so.
The ITC is made up of appointed members from eight Federal
agencies, as specified in TSCA. Representatives from six addi-
tional Federal agencies serve in a liaison capacity.
Section 8(a)... Preliminary Assessment Information Rule
Manufacturers (including importers) of chemical substances
listed in the section 8(a) rule must report certain production, use,
and exposure data to EPA using the rule's Report Form. EPA
may add chemicals to the rule when the Agency wishes to ob-
tain Preliminary Assessment Information of those substances.
Health and Safety Data Reporting ... Section 8(d)
Under section 8(d) of TSCA, EPA has issued a model health
and safety data reporting rule. This model rule requires past,
current, or prospective manufacturers, importers, and
processors of certain named substances to submit unpublished
health and safety data to EPA. EPA adds substances to the
model rule as the Agency identifies a need for health and safety
information.
For Your Information (FY!)
For Your Information (FYI) submissions are submitted voluntar-
ily to the Agency or to the Office of Toxic Substances (OTS) o
chemical toxicity and/or expdsure. FYls are submitted by chem -
cal manufacturers, processors and distributors, trade associa-
tions, labor organizations, Federal, State or local agencies, or-
eign governments, academia, public interest and environmenta
groups, as well as by the general public. Microfiche copies o
these submissions are located in the OTS Public Reading
Room, Ground floor, Northeast section, Waterside	. ,
Street, S.W., Washington, D.C. To obtain a copy of an FY1, fol-
low the procedure outlined under section 8(e) Substantial RisK
on this page.
Significant New Use Rules (SNURs)... Section 5(a)(2)
Under section 5(a)(2) EPA may determine by rule that certain
uses of chemical substances are significant new uses. These
rules are referred to as Significant New Use Rules (SNURs). In
making the determination, the Agency considers the potential
exposure associated with the use, the toxicity associated with
the chemical and whether the use is ongoing at the time the rule
is proposed. Persons subject to a SNUR must notify EPA at
least 90 days before manufacturing, importing, or processing the
chemical substance identified in the SNUR for the defined signif-
icant new use or uses.
A SNUR may be issued for any TSCA chemical substance.
SNURs may be written for individual chemicals, for chemical
categories, and for new or existing chemicals. SNURs may be
written in conjunction with a section 5(e) order.
A section 5(e) order can limit or prohibit the use of a chemical
substance that has been the subject of a premanufacture notice
(PMN) or Significant New Use Notice. With regard to new (PMN)
chemicals, once commercial manufacture begins, the chemical
is placed on the Inventory. If no SNUR is issued, the chemical
may be used by other manufacturers without any restrictions. To
establish equity of treatment, EPA issues SNURs to followup
section 5(e) orders, requiring manufacturers to notify EPA be-
fore manufacturing, importing, or processing the substance for
any activities other than those permitted in the section 5(e)
order.
The Agency also writes followup SNURs for certain new chemi-
cals which were not subject to section 5(e) orders. These
SNURs address concerns which did not trigger a section 5(e)
order either because the concerns arose after the completion of
the PMN review or because the uses described in the PMN did
not involve enough exposure to warrant action. Followup
SNURs allow the Agency to permit safe uses of potentially haz-
ardous new substances while ensuring that it has the opportu-
nity to review uses which may lead to significant changes in hu-
man or environmental exposure.
Finally, EPA develops SNURs to support the Existing Chemical
Program's risk assessment and risk management activities.
SNURs for existing chemicals are used to monitor significant
new uses of substances on the TSCA Chemical Substance In-
ventory. As with SNURs for new chemicals, existing chemical
SNURs ensure that the Agency will receive information on sig-
nificant new uses of potentially hazardous substances before
such uses occur. These SNURs also enable EPA to take imme-
diate followup control action (under TSCA section 5(e) or 5(f)) to
limit potential exposure resulting from significant new uses of
existing chemical substances, provided that such followup ac-
tion is necessary.
11

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Substantial Risk ... Section 8(e)
Under section 8(e), persons who obtain new information that
reasonably supports the conclusion that a substance or mixture
which they manufacture, import, process or distribute presents
substantial risk or injury to human health or the environment,
must notify EPA with 15 working days. These notices are then
reviewed by the Office of Toxic Substances (OTS) and an initial
evaluation (status report) is prepared containing, if appropriate,
followup questions to the submitter, referrals to other agencies,
and recommended OTS/EPA followup actions. The 8(e) notices
represent a company's first review of a situation and a judgment
in compliance with the statute to submit a notice within 15 work-
ing days of obtaining the information.
EPA publishes its status reports to make 8(e) information widely
available and understandable to a broad public. The submis-
sions and status reports are located in the OTS Public Reading
Room, first floor, East Tower, Waterside Mall, 401 M Street,
S.W., Washington, D.C.
Persons wishing to obtain a copy of a section 8(e) notice may
write: EPA, Freedom of Information, Ms. Jeralene Green
(A-101), Washington, D.C. 20460. There is no charge for
duplicating the first 124 pages, but at page 125 of a request for
duplication there is a $25.00 fee and a 20 cent charge for each
additional page (e.g., 126 pages will cost $25.20).
Single copies of the section 8(e) status reports (not the full sub-
missions) are available from the TAO.
TSCA Assistance Office (TS-799)	otficix sunn...
Office of Pesticide & Toxic Substances	penalty (or Privat# u»
U.S.E.P.A.	*300
Washington, D.C. 20460.
Plrtt CI«M Mftll
Poltag* and Fm Paid
CPA
Parmll No. 0-3S
•' >O0o -i	;
i'H'vTt-V, Pi?07 -	¦;
PwrbN n: - ' -r y
>6 Fl-rOK.Kni. "'Y;
THE TSCA CHEMICALS-IN-PROGRESS BULLETIN

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