7
"7
7—>
/
/
I
7
b
.
te.,
; r v
Chemicals-in-Progress
\ Bulletin
- <• •
t'
~ 1 -


-J
y *
-------
What's Happening in OTS—Charles L. Elkins
My first six months in OTS have brought me some new perspectives on some strategic future directions
for the office which I would like to share with you.
The 99th Congress directed EPA to take a much more aggressive stance when addressing health and
environmental issues related to toxic and hazardous substances. For example, the recent Superfund
amendments implement several right-to-know requirements ranging from toxicological profiles on cer-
tain chemicals found at Superfund sites to an inventory of how much of certain chemicals are being dis-
charged by manufacturers to water, air, and land. What this means for OTS, as well as other EPA pro-
grams, is a revisiting of what our statutes enable us to accomplish in meeting our new responsibilities
Specifically OTS has been assigned implementation responsibilities in the above-mentioned Superfund
amendments. In carrying out these assignments we will look for ways to bring our TSCA authorities to
bear on these same problems.
There is increasing emphasis both within the Agency and in Congress on correctly characterizing the
environmental and health risks that we as a society confront, and on making choices based on the de
gree of risk, in order to set priorities, and to determine the most appropriate risk reduction response. Risk assessment is becoming a key activity
in all EPA offices, as it has been for many years in OTS.			,	--	
We all have an interest in seeing more of society's decisions on toxics being driven by a scientifically sound assessment of risk, but this re-
quires good hazard and exposure data. The risk assessment "engine" by its very nature needs data for its "fuel-and a lot of it. 	*
For us in OTS, this means a renewed dedication to using the unique authorities of TSCA to obtain the data which are essential to the Agency's
future risk management decisions.	3
Where we are able to require the development of information and data on chemicals of Agency concern-we will Where we can require the
submission of relevant data and mforma ion that has already been developed will. Where we can make these data available to decision-
makers in a more useful manner—we will.
OTS has already demonstrated the authority and the ability to accomnlish theco	u
support is necessary lo assure lhat »e use our OTS authorities and aMties to taS,'°	"hate'"* dire°"°"
Wllh -«• •»1	OTS*	cons,!
and
consistent
Two-Day Session in May To Cover
Industrial Obligations Under TSCA
On May 5 and 6, 1987, EPA will hold its second annual seminar
on industrial obligations under TSCA at the Twin Bridges Marriott
Hotel, in Arlington, Virginia.
Representatives of companies that make, import, mix or re-
package chemicals for distribution in commerce will find this sem-
inar informative. The sessions will offer an opportunity to learn
first hand from the drafters of the TSCA rules. There will be exten-
sive time for questions. On both days, meetings will run from 9
a.m. to 4:30 p.m.
Seminar reservations should be made by calling the TAO at (202)
554-1404. The seminar is limited to 450 people. There is no res-
ervation fee but $50.00 will be collected on the morning of May 5
at the reservation table. The funds collected will offset the cost of
refreshments and the luncheon.
The May 5 agenda will focus on a discussion of company require-
ments under TSCA, including reporting to EPA; keeping records;
records inspections; sharing testing costs; rules on importing and
exporting; control of "existing" chemicals; status of the Com-
prehensive Assessment Information Rule (CAIR); the TSCA In-
ventory Update Status, and TSCA assistance for small com-
panies.
Also on May 5 there will be a discussion on the Emissions Inven-
tory of Toxic Chemicals Release [Superfund Amendments and
Reauthorization Act (SARA); Right-to-Know Section 313 of Title
III]; and TSCA support for other EPA programs.
On May 6, the discussion will be on "new" chemicals and the Pre-
manufacturing Notice (PMN) program. In the morning the pro-
gram will be a general review. In the afternoon the program will
be devoted to details of the process.
EPA Denies TSCA Citizen's Petition
EPA has denied a citizen's petition filed under section 21 of
TSCA by Valley Watch Inc. on October 2, 1986. The petition
asked EPA to issue an order under section 5(e) of TSCA to pro-
i it t e manufacture, processing, distribution in commerce, use,
or disposal of two chemicals that will be processed by Unison
orp. at a PCB-disposal facility in Henderson, Kentucky. The
gency denied the petition because it does not have the authority
Tcir^A Gk?UC^ 3n order for listing chemicals under section 5(e) of
,.o c " otice of EPA's decision on the petition was published in
Federal Register of January 9, 1987 (52 FR 862).
rPonD?0n IV iSSUed ,he P8rmit' effective January 16, 1987, for
- isposal facility at Henderson, in response to an applica-
lon submitted by Unison as required by section 6(e) of TSCA. At
e aci ity, Unison will process two chemicals whose specific
emical names are claimed confidential business information,
c nison assigned the generic names TF-1 and TF-2 to the chemi-
bp nrn^"'0" ^ 'S reaSOn ,0 belieV0 ,hat TF"1 and TF"2' ,0
and 1	? the ,aCili1y' con,ain 1.2,4-trichlorobenzene (TCB)
are suhin^itetra^lorobenzene (1,2,4,5-TCB). These chemicals
8 1 Qfifi/K, cDoC!1|0r,na,ed benzene test rule EPA issued on July
implemented » J1' Valley Wa,ch asked ,hat the 5(e) order be
derson dkn	denial of an °Pera'ing permit for the Hen-
chemicals ?s comSedUn,il ,eSt'ng °f ,he hea',h 6,fec,S °f ,he ,W°
when theAnf '° 'he Petiti0n' EPA said section 5(e) applies only
ical substanr ^ "f r0vlewln9 a notice submitted for a new chem-
S EPA sa^-i ! T!™1 new use of an chemi"
Tsca Thp An i are no1 new chemicals as defined by
ess did nn?ra	° Sa'd that the Unison PCB disposal proc-
ess d,d not represent a "significant new use" of TF-1 and TF-2.
-------
EPA Sets a New Nationwide PCB Cleanup Policy
EPA has published a new policy for the cleanup of spilled poly-
chlorinated biphenyls (PCBs). The policy establishes the meas-
ures that EPA considers to be adequate cleanup for the majority
of situations where PCB contamination occurs during activities
regulated by TSCA. Compliance with the policy will create a pre-
sumption against enforcement for penalties or further cleanup.
However, if the disposal violation is the result of gross negligence
or knowing violation, EPA will pursue enforcement actions. The
policy appeared in the April 2,1987 issue of the Federal Register
(52 FR 10688). Copies of the new policy are available from the
TAO.
From 1978 until recently, cleanup standards for PCB spills were
set by each of EPA's 10 regional offices on a case-by-case basis.
The new policy provides uniform nationwide predictable require-
ments for the majority of spill situations.
"EPA's new PCB spill cleanup policy is a culmination of several
years of effort," said John A. Moore, EPA's Assistant Administra-
tor for Pesticides and Toxic Substances. "This nationwide policy
will reduce the risks from PCB spills to public health and the en-
vironment by encouraging rapid and effective cleanup and restor-
ation of the site."
The criteria and standards are now based upon EPA's evaluation
of the potential routes of exposure and potential risks associated
with the more common types of PCB spills, as well as the costs
associated with cleanup following such spills. Typical PCB spills
under TSCA involve the limited release of PCBs during the
course of EPA-authorized activities, such as the use of electrical
equipment, the servicing of electrical equipment and the storage
of PCBs for disposal.
The policy sets standards for spill cleanups resulting from the re-
lease of materials containing PCBs at concentrations of 50 parts
per million (ppm) or greater. Covered by the new policy are spills,
leaks or other uncontrolled discharges of PCBs that occur after
the effective date of the policy. The policy requires responsible
parties to notify EPA and initiate cleanup within 24 hours of dis-
covering each spill.
The new policy was developed, in part, from a proposal given to
the Administrator by a concerned group of environmental and in-
dustrial people. EPA had been working on the new policy for over
two years.
PCB Information
A package containing key PCB Federal Register notices
and related PCB information is available. Write or call the
TAO (202) 554-1404.
EPA Proposes 2-Year Oral Oncogenicity Testing of EH
EPA is proposing that manufacturers and processors of 2-eth-
ylhexanol (EH) be required, under section 4 of TSCA, to conduct
2-year oral oncogenicity bioassays in rats and mice (December
19,1986,51 FR 45487). The Agency is proposing to use the data
to better assess the oncogenic potential of EH. Additional testing
of the chemical beyond this proposed testing may be warranted
later.
EPA proposed the rule because the National Toxicology Program
(NTP) which planned oncogenicity testing of EH (CAS No. 104-
76-7) no longer plans to conduct the bioassay for the chemical.
EPA believes the 2-ethylhexyl moiety, which occurs in EH and in
other chemicals that have been found to be carcinogenic in labo-
ratory animals, may be an active oncogenic agent to which peo-
ple may be exposed. Also EPA planned to use the NTP testing of
EH to assess the oncogenic potential of 2-ethylhexanoic acid
(EHA).
EPA Proposes SNUR For Three Chemicals
EPA proposed a Significant New Use Rule (SNUR) under section
5(a)(2) of TSCA for three chemicals that are members of the
halogenated alkyl expoxides category (January 2,1987, 52 FR
107). The Agency also is proposing section 8(a) action for one of
the chemicals. The three chemicals are:
Trichlorobutylene oxide (TCBO)	3083-25-8
Epibromohydrin	(EBH)	3132-64-7
Hexafluoropropylene oxide (HFPO)	428-59-1
EPA believes the three substances may be hazardous to human
health and proposes that any use of TCBO or EBH to be a signifi-
cant new use. Ali uses of HFPO, other than use as an intermedi-
ate in the manufacture of fluorinated substances in an enclosed
process, would be a significant new use under this proposal. The
proposed rule would require any person who intends to manufac-
ture, import or process any of the three chemicals to notify EPA at
least 90 days before beginning such action.
EPA also proposed that persons who intend to manufacture, im-
port or process HFPO for use as an intermediate in the manufac-
ture of fluorinated substances in an enclosed process be required
to notify EPA within 30 days after making the management deci-
sion to commit financial resources for the manufacturing, import-
ing or processing of the chemical. The authority for this reporting
action is section 8(a) of TSCA. Small businesses that manufac-
ture, import or process HFPO, and HFPO manufacturers and
processors who have previously reported under the TSCA Pre-
liminary Assessment Information Rule would be exempt from the
section 8(a) reporting rule.
Friable Asbestos In Schools Program Continues
Funds for loans and grants to schools are now available for dis-
tribution to schools with severe asbestos hazards and financial
need. Congress did not act by March 15,"1987 to uphold Presi-
dent Reagan's request for recision of these funds, so EPA is now
moving ahead with plans to award loans and grants to school.
The loan and grant program is administered under the Asbestos
School Hazard Abatement Act (ASHAA). EPA will consider
school ASHAA applications that are holdovers from last year In
addition to new applications submitted in 1987. "EPA has already
been conducting technical assistance inspections for the remain-
ing high priority projects which were not funded in the 1986 award
cycle," said John A. Moore, EPA's Assistant Administrator for
Pesticides and Toxic Substances, "These holdover applicants
were awarded about $30 to $35 million on April 1. The remaining
$8 to $12 million in ASHAA funds will be awarded to new appli-
cants in June 1987, " Dr. Moore said.
In March, EPA sent letters to 45,000 schools that did not apply for
ASHAA funds in 1986, informing them that applications are avail-
able from EPA regional offices and designated State officials.
New applications are to be returned to State designees by April
30,1987. EPA plans to conduct inspections in May 1987 to re-
view and rank schools according to financial need and the sever-
ity of each applicant's asbestos problems.
ASHAA was enacted in 1984 to establish a program to distribute
Federal loan and grant funds to schools that have severe as-
bestos hazards and financial need. Since 1984, EPA has dis-
tributed $90 million to 370 school districts for 430 asbestos abate-
ment projects. Only schools that have asbestos-containing friable
materials are eligible for ASHAA funds. Friable materials are
those that when dry, can be crumbled, pulverized or reduced to
powder by hand pressure. There is a health threat to humans
when friable asbesto-containing material is damaged and the re-
leased fibers enter the air that people inhale.
3
-------
Review of Genetically Modified Microorganisms Continues
Three PMNs concerned with field testing of three genetically en-
gineered strains of a microorganism were the subject of a March
23,1987 meeting of a subcommittee of EPA's Biotechnology Sci-
ence Advisory Committee (BSAC).
The three PMNs submitted by Biotechnica International, Inc. con-
cern the company's plans to conduct a small-scale field test in
Wisconsin. The test is to determine the ability of two strains of mi-
crooganisms to fix nitrogen which would increase alfalfa crop
yields. The BSAC subcommittee advised EPA on the risk review
of the three PMNs. The Agency is seeking expert assistance in
the risk assessment of genetically modified microorganisms re-
leased to the environment until it develops its own expertise in
this new area.
The all-day meeting was closed in part to the public to discuss
confidential business information but was open for most of the
sessions. A written determination that parts of the meeting were
to be closed was made by the EPA Administrator.
BACKGROUND: EPA Biotechnology Policy
On June 26, 1986, EPA published in the Federal Register a pol-
icy statement explaining how certain products of biotechnology
are subject to review and reporting requirements under TSCA.
This statement was published with notices from the Office of Sci-
ence and Technology Policy and other Federal agencies describ-
ing a coordinated Federal regulatory framework for biotechnol-
ogy.
Microorganisms used for purposes such as waste degradation,
chemical production, conversion of biomass to energy, and other
environmental and industrial uses are subject to TSCA. The
Agency is implementing or promulgating rules to implement the
following provisions for regulating certain biotechnology products
under TSCA:
•	Microorganisms defined as "new" are subject to PMN re-
quirements if they are to be manufactured for TSCA purposes.
•	Environmental testing of "new" microorganisms during Re-
search and Development (R&D) will not fall under the exemption
from PMN that is accorded to other R&D substances.
•	New environmental uses of genetically engineered patho-
genic microorganisms will be subject to a "Significant New Use
Rule."
•	All other environmental uses of microorganisms that are sub-
ject to TSCA but not subject to the PMN or significant new use re-
quirements will be subject to section 8(a) reporting requirements.
The June 26th notice also explains how the U.S. Department of
Agriculture and EPA plan to coordinate reviews when the two
agencies have overlapping responsibilities, as in this case where
the microorganisms are subject to TSCA and the Plant Pest Act.
BACKGROUND: PMN Review Process
TSCA gives EPA the authority to regulate chemical substances
that pose an unreasonable risk of injury to human health or the
environment, while not creating unnecessary economic barriers
to technological innovation.
The Agency's goal in reviewing new microorganisms is to deter-
mine whether an unreasonable risk may be posed by the micro-
organism's use in the environment. The review and decisionmak-
ing process for this product is generally similar to the Agency's
review of other new chemical substances.
EPA has 90 days to review the information submitted by the com-
pany (extendable to 180 days), before the microorganism is
tested in the environment. In the three PMNs submitted by Bio-
technica International, Inc. the company submitted information
on identity, production, human exposure, and release, the ge-
netic engineering techniques used to enhance nitrogen fixation,
human health considerations, the location of the proposed field
test, design and supervision of the test, methods of applications,
monitoring and control procedures, environmental fate and
effects, and greenhouse efficacy data. Under TSCA, the com-
pany may claim certain information to be confidential. The non-
confidential portions of the submissions are available in the public
file for this notice.
As a risk/benefit statute, TSCA requires that benefits be esti-
mated and considered in judging whether the risk may be unrea-
sonable. While the risk assessments are being developed,
Agency economists will estimate the benefits of the product
based on information from the submitter, independent economic
research, and consultation with non-Agency experts. EPA staff
will then prepare a summary of the risks and benefits to use in
reaching regulatory decisions.
The Agency may come to one of the three decisions at the con-
clusion of a PMN review:
i)	There is sufficient information to determine that the risks are
reasonable.
ii)	There is sufficient information to determine that the risks are
unreasonable, or
iii)	There is insufficient information to make a reasoned evalua-
tion of risk and either the substance may present an unreason-
able risk or the substance will be produced in substantial quan-
tities, and there may be significant or substantial human
exposure to it or substantial environmental release.
In the case of ii) or iii) the Agency has authority to prohibit release
of the organism or impose restrictions on its use.
The Agency's decision will be announced to the public at the end
of the review period.
EPA Issues Test Standards for Ca Fraction
On January 23,1987, EPA issued a Phase II rule that specifies
test standards and reporting requirements for testing of the C9
aromatic hydrocarbon fraction, or C9 fraction, (52 FR 2522).
In 1982, the ITC designated ethyltoluenes (mixed isomers) and
1,2,4-trimethylbenzene for priority testing consideration (May 23,
1982, 47 FR 22585) and recommended that other tri-
methylbenzenes (1,2,3- and 1,3,5-isomers) be considered for
testing (December 3,1982,47 FR 54624). EPA responded to the
designation by Issuing a proposed test rule for the C9 fraction
(May 23,1983,48 FR 23088) and a final Phase I rule requiring
testing of the C9 fraction on May 17,1985 (50 FR 20662),
Shortly thereafter, manufacturers and processors of the C9 frac-
tion submitted proposed study plans through the American Pe-
troleum Institute and later revised study plans for testing the C9
fraction. In a March 27,1986 notice, EPA proposed that the re-
vised study plans, along with certain additions and reporting re-
quirements, be adopted as the test standards and reporting re-
quirements for testing of the C8 fraction (51 FR 10557). After
review of public comments, EPA issued the final Phase II rule
4
-------
Section 8(e)... Substantial Risk
Below, is a list of 15 initial section 8(e) notices recently placed in
of notices can be acquired see page 7 of this Bulletin.
Pages*
3
16
CAS No.
75-21-8
Log No. 8EHQ-
1086-0641
1186-0641 Supp.
Ethylene Oxide
An abstract'' The Neurological Manifestations of Chronic Eth-
ylene Oxide Exposure"
1086-0642
Vinyl Acetate	1	108-05-4
Preliminary results of a 2-year inhalation study in mice
1186-0643
Nitrosamines	6
An interim report of the production and release of low molecular
weight nitrosamines during the foaming of two silicone
elastomer foams
1186-0644
3,3,3-Trifluoropropinoaldehyde	3	460-40-2
Report on the chemical's production when fluorosilicone fluids
and greases are held at elevated temperatures for extended
periods
1286-0645
C.I. Direct Yellow 28	3	8005-72-9
Summarized results of an Ames mutagenicity test
1186-0646 S
Acrylate Mixture	3
Summarized preliminary results from a number of in vitro and in
vivo genotoxicity studies
1186-0647
Tetraoximinosilane	12 34206-40-1
Methyloxlminosilane	22984-54-9
Summarized results from a series of acute in vivo and in vitro
studies
EPA's public file. For an explanation of section 8(e) and how copies
1286-0648
Diethyltoluenediamine	12 68479-98-1
Summarized findings from a subchronic feeding study in rats
0187-0649 S
Alkoxylated aromatic diamine	36
Summarized results from several in vitro genotoxicity studies
0187-0650
Vinyl Acetate	1	108-05-4
Preliminary results of a 2-year inhalation study in rats
0187-0651
Unknown	25
Preliminary findings assessing mortality of corporate employees
0287-0652 S
Amine Mixture	3
Summary results of rabbit skin and eye irritation studies
0287-0654	16
3-Methyl-2-benzothiazolinone hydrazone hydrochloride
Summarized results of a number of acute in vivo and in vitro
studies
0287-0655 S	8
1-Phenyl substituted 2-pyrazolin-5-one
Summarized results of an acute oral toxicity study in rats
0287-0657S	15	99-42-3
Methyl ester of 4-hydroxy-3-nitrobenzoic acid
Summarized results of an acute oral toxicity study in rats
"S" at the end of a Log Number means a sanitized version is available.
'Page count as of publication date. New data are constantly being added to section
8(e) (lies. The page total at the time a request is received may exceed the 125-paoe
cutoff and a charge must be made. For additional information on obtaining section 8(e)
files see page 7 of this issue.
EPA Issues New Volume of Section 8(e) Status Reports
EPA recently published a fifth volume of preliminary evaluations
of initial section 8(e) substantial risk notices. The volume covers
the January 1,1985 to December 31,1986 period.
The volume contains status reports prepared by the Office of
Toxic Substances (OTS) for initial section 8(e) submissions re-
ceived by EPA from chemical manufacturers, importers, proc-
essors and distributors. EPA published the volume to make the
reported information more accessible. Specific examples of sub-
mitted information and EPA's evaluation of it are included in the
volume. OTS believes that the information in the volume may be
helpful to companies which handle chemicals subject to 8(e)
notices in making risk management decisions. In addition, by re-
ferring to the volume, persons subject to section 8(e) will be able
to understand better the types of Information that should be sub-
mitted.
A limited supply of volume 5 is available through the TSCA As-
sistance Office (202) 554-1404, or by writing the TSCA Assist-
ance Office (TS-799), EPA, Washington, DC 20460. Once this
free supply is exhausted, copies will be available for purchase
from the U.S. Commerce Department's National Technical Infor-
mation Service (NTIS).
EPA's supply of the earlier volumes in the series is exhausted;
they can be bought from NTIS, 5285 Port Royal Rd., Springfield,
VA 22161. The NTIS order desk number is (703) 487-4650, The
NTIS numbers for the first four volumes are PB 80-221609, PB
81-415732, PB 83-187815 and PB 87-129409.
5
-------
Latest FYI Submissions
In recent weeks EPA received 11 FVIs (For Your Information)
submissions. For additional information on FYls see page 7 of
this Bulletin.
Chemical Name
Pages*
3
CAS No.
CBI
OTS-1186-0520 S
Amine solvent
Report on nitrosamine levels in a recycled stream sample
OTS-1186-0521	9	101-77-9
Methylenedianiline
Summarized final results from a 2-year chronic dermal toxicity
and skin tumorigenicity study in mice
OTS-1286-0522	13
Benzene	71-43-2
Gasoline	unknown
Report from an epidemiology study of gasoline station workers
and automobile mechanics in the State of New Hampshire
AX-1286-0523	1
Drilling fluids	none
Status report on the fate and effects of drilling fluids in nearshore
water
106-46-7
OTS-1286-0524	23
Paradichlorobenzene
In vivo mutagenicity study
OTS-1286-0525	16
1,3-Butadiene	106-99-0
Styrene-butadiene polymer	9003-55-8
Summarized preliminary results of a 3-year epidemiology study
of styrene-butadiene workers
AX-1286-0526	22
Petroleum hydrocarbons	none
Progress report on the evaluation of fish carcinogenesis models
OTS-0187-0527	4
Irgaform 1266	13047-13-7
Summarized preliminary results from a 28-day subchronic toxicity
study in rats
OTS-0187-0529	53
Benzene	71-43-2
Report on the incidence of leukemia among oil refinery workers
and residents in surrounding communities
AX-0187-0531	26
Petroleum distillate	unknown
Final report from an in vitro mouse lymphoma mutation assay
OTS-0187-0532	61
Silicones	nons
Product report and updated epidemiological study on employees
in the silicone industry
"S" at the end ot a Log Number means a sanitized version Is available.
CBI = Confidential Business Information
"Page count as of publication date. New data are constantly being added to the FYI
files. If the page total at the time of a request exceeds the 125-page cutoff, a charge
must be made. For additional information on obtaining FYI files see page 7 of this issue.
EPA Accepts DETA Study Plans
On February 3, 1987, EPA issued a final rule accepting an indus-
try consortium's revised study plans, with certain revisions, as the
test standards and reporting requirements for diethylenetriamine
(DETA) (52 FR 3230).
In 1981 DETA was designated by the Interagency Testing Com-
mittee (ITC) for priority testing consideration (May 22,1981, 46
FR 28138). In 1982, EPA responded by issuing a proposed test
rule for the chemical and in 1985 a final Phase I rule (May 23,
1985,	50 FR 21398) requiring testing of DETA.
On August 6, 1985, three DETA manufacturers notified EPA of
their intent to sponsor the testing required in the final Phase I test
rule for the chemical. On October 7, 1985, EPA received a set of
study plans for all the testing required from the consortium com-
posed of the three manufacturers of DETA, a future manufacturer
and other current manufacturers or importers. Then, on Decem-
ber 2, 1985, the Agency received a revised set of study plans
submitted by the consortium. Next, EPA proposed a rule that the
December 2,1985 study plans be adopted, with certain revisions,
as the test standards and reporting requirements for the testing of
DETA (April 10, 1986, 51 FR 12344). Based on that proposed
rule and comments received, EPA issued the Phase II rule for
DETA, establishing further revisions of the proposed test stand-
ards and reporting requirements for DETA as the final test stand-
ards and requirements.
Subsequent to the final Phase II test rule for DETA, EPA ap-
proved minor modifications to the final test standards for this sub-
stance in a March 9, 1987 letter to the industry consortium. The
EPA approved minor changes, primarily consisting of changes in
personnel to be utilized in conducting the studies, and other non-
substantive changes. These modifications to the final test stand-
ards will be published in a Federal Register notice to be issued by
the Agency in the near future.
New Added Asbestos Abatement Protection
For Certain State and Local Government Workers
Many State and local government employees involved in as-
bestos abatement work now have additional protection because
of a new EPA rule (.February 25,1987, 52 FR 5618).
Private sector workers involved in the removal of asbestos from
buildings are covered by the U.S. Occupational Safety and
Health Administration (OSHA) rules, or rules under OSHA-ap-
proved State plans. However, in about half the States, local gov-
ernment and State employees who take part in asbestos abate-
ment projects are not covered by rules under OSHA-approved
State plans. In July 1985, EPA stepped in with an immediately
effective TSCA proposed rule for these workers.
On April 25,1986, EPA followed with a final rule protecting these
workers. EPA took this action knowing that OSHA at that time
was in the process of revising its asbestos standard. In June
1986,	OSHA issued its new asbestos workplace standards, with
one standard for "general industry" and another for the "con-
struction sector," including asbestos abatement. EPA's 1987 rule
extends this new OSHA protection to those State and local gov-
ernment employees covered by EPA's April 25,1986 rule (51 FR
15722).
The Agency's rule differs somewhat from OSHA's by retaining
certain features of the 1986 EPA rule. The EPA rule is not as
broad-based as OSHA's; it applies soiely to activities involved in
asbestos abatement projects. It also retains EPA's definition of
asbestos. The new rule keeps the reporting requirements con-
tained in the 1986 EPA rule. These reporting requirements help
EPA monitor compliance. Employers, with certain exceptions,
must notify EPA that they intend to undertake an abatement proj-
ect covered by the rule at least 10 days before beginning abate-
ment activity. Persons associated with State and local govern-
ment employees engaged in asbestos abatement can get a copy
of the February 25,1987 EPA rule from the TAO office.
6
-------
On this page are explanations of sections of TSCA that are
cited In this issue of the Bulletin. For additional Information
about TSCA's provisions, call (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 insuf-
ficient data available with which to perform a reasoned risk as-
sessment; and that testing is necessary to generate such data. A
test rule may also be based on an EPA finding of substantial pro-
duction and exposure to humans or the environment, 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 consid-
eration for the promulgation of section 4 test rules. The ITC can
designate up to 50 chemicals or categories of chemicals for test-
ing and must make revisions to this section 4 priority list as
needed. In turn, EPA must respond within one year after the ITC
adds a substance to the priority list by starting rulemaking under
section 4 or giving reason 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 obtain
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 cer-
tain 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.
Substantial Risk... Section 8(e)
Under section 8(e), persons who obtain new information that rea-
sonably supports the conclusion that a substance or mixture
which they manufacture, import, process or distribute presents
substantial risk of injury to human health or the environment,
must notify EPA within 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 submissions
and status reports are located in the OTS Public Reading Room,
ground floor, Northeast section, 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.
For Your Information (FYI)
For Your Information (FYI) submissions are submitted voluntarily
to the Agency or to the Office of Toxic Substances (OTS) on
chemical toxicity and/or exposure. FYls are submitted by chemi-
cal manufacturers, processors and distributors, trade associa-
tions, labor organizations, Federal, State or local agencies, for-
eign governments, academia, public interest and environmental
groups, as well as by the general public. Microfiche copies of
these submissions are located in the OTS Public Reading Room,
ground floor, Northeast section, Waterside Mall, 401 M Street,
S.W., Washington, D.C. To obtain a copy of an FYI, follow the
procedure outlined under section 8(e) Substantial Risk just
above.
Cltiiens' Petition... Section 21
Under section 21 of TSCA any person may petition the EPA Ad-
ministrator to begin a proceeding for the issuance, amendment or
repeal of a rule under section 4,6 or 8 of TSCA, or an order under
section 5(e) or 6(b) of the Act. Within 90 days after the petition is
filed the Administrator must either grant or deny the petition. The
Administrator may hold a public hearing or conduct an investiga-
tion or proceeding as deemed appropriate in order to determine
whether the petition should be granted. If the petition is denied,
the Administrator must publish the reasons for the denial in the
Federal Register. If the petition is granted, the Administrator must
promptly initiate an appropriate proceeding in accordance with
section 4,5,6 or 8 of TSCA.
7
-------
Background—ECAD
The Existing Chemical Assessment Division (ECAD) is
one of six divisions within EPA's Office of Toxic Sub-
stances (OTS). It is involved in data collection, chemical
screening, risk analysis and test rule development author-
ized under the Toxic Substance Control Act (TSCA).
ECAD gathers information about the use, toxicity, and ex-
posure of particular chemicals. When necessary, it re-
quires manufacturers of a chemical to test for health or en-
vironmental effects or both. ECAD then evaluates the risk
based on collected data.
ECAD's risk assessments are used in OTS risk manage-
ment actions, as well as by EPA's other programs or by
other Federal agencies.
The Division's TSCA products include section 4 test rule
data, Chemical Hazard Information Profiles or CHIPs,
Chemical Advisories, and data collected under the provi-
sions of the Act's Sections 8(a) and 8(d).
More detailed information about ECAD is available upon
request from TAO.
On January 13, 1987, EPA issued a rule, making minor
changes in the test standards for the bisphenol A test rule
(January 13,1987,52 FR 1330). The test sponsors asked
that the 90-day dust inhalation study required by the
bisphenol A test rule be modified.
NOTICE
New Address for PAIR and 8(d) Submissions
The Office of Toxic Substances no longer maintains a Post
Office Box in Rockville, MD, for the receipt of PAIR sub-
missions and 8(d) health and safety data studies. OTS
now requires submitters to send their submissions to EPA
Headquarters. The proper mailing address is:
Document Processing Center (TS-790)
Office of Toxic Substances
U.S. Environmental Protection Agency
Room L-100
401 M Street, S.W.
Washington, D.C. 20460
ATTN: (insert either PAIR or 8(d) Reporting)
TSCA Assistance Office (TS-799)	omcw
Office of Pesticides & Toxic Substances	,or "**
U.S.E.P.A.
Washington, D.C. 20460.
First Claaa Mall
Po»t»g» and Fhi p.ld
EPA
Parmlt No. Q-3S
THE TSCA CHEMICALS-IN-PROGRESS BULLETIN
-------