NOTICES

[6560-01]

ENVIRONMENTAL PROTECTION

AGENCY

[FRL 884-73

TOXIC SUBSTANCES CONTROL

Second Report of the Interagency Testing

Committee; Receipt and Request for Comments

AGENCY: Environmental Protection

Agency (EPA).

ACTION: This Notice requests com- ments on the Interagency Testing

Committee's recommendations of

chemicals for priority consideration

for testing.

SUMMARY: The Interagency Testing

Committee established under section

4(e) of the Toxic Substances Control

Act (TSCA) has transmitted to the

EPA its Second Official Report. This

Report identifies additional chemical

substances and mixtures which the

Committee recommends to EPA for

priority consideration for promulgation of testing rules under section 4 of

the Act. The Committee's recommen- dations revise and update recommen- dations made in the Commttee's Initial Report. The Second Report appears in its entirety following this

Notice. The Agency invites interested

persons to submit comments on the

Report.

BACKGROUND: Section 4 of TSCA

authorizes the EPA Administrator to

promulgate regulations requiring testing of chemicals to develop data relating to the risks which-such chemicals

may'present to human health and the

environment.

Section 4(e) established an Interagency Testing Committee and directed

the Committee to recommend to the

Administrator chemical substances

and mixtures for priority consideration for test rule promulgation by October 1, 1977. The Committee's initial

recommendations were published in

the FEDERAL REGISTER on October 12,

1977 (42 FR 55026). Section 4(e) also

directs the Committee to revise the

list every six months as necessary. The

Second Report recommends the addition of chemicals and groups of chemicals to the Committee's initial list and

includes the Committee's reasons for

each addition. The Agency is required

to initiate rulemaking for these chemicals within 12 months of their inclusion on the priority list or to publicly

state its reasons for not doing so.

AvAnABILrry

The Committee's report making these revisions appears in the FEDERAL

REGISTER following this notice. Those

persons who received the Committee's

initial report will be mailed this report

automatically within two weeks. Other

persons wishing to receive copies

should call or write to: John B. Ritch,

Jr., Director, Industry Assistance

Office, Office of Toxic Substances,

EPA, Washington, D.C. 20460. Call toll

free 800-424-9065; in Washington,

D.C. call 554-1404.

In developing its recommendations,

the Committee relied almost exclusively on published or other generally

available information. A number of

general references were given in the

Committee's initial report.

In addition, references for specific

chemicals being added to the list at

this time will be included in the dossiers which the Committee will transmit to EPA in the next few weeks.

REQUEST FOR COMMENTS

EPA invites interested persons to

submit comments on the Committee's new recommendations. In view of the

statutory deadline for Initiating rulemaking (or stating reasons for not

doing so), the Agency requests that

comments be submitted no later than

July 21, 1978.

Comments should bear the identifying notation OTS-040004 and should

.be submitted to Joan Urquhart; U.S.

Environmental Protection Agency,

Office of Toxic Substances (TS-788),

Federal Register Section, 401 M Street

SW., Washington, D.C. All written

comments will be available for public

inspection in Room 623 East Tower, at

the same address, between 8:30 a.m. and 4:30 p.m., weekdays.

Dated: April 14, 1977.

WAuEN R. Mum,

ActingAssistant Administrator

for Toxic Substances.

Toxic SUBSTANCES CONTROL ACT, INTERAGENCY TESTING COMMTTE,

Washington, D.C., April 10, 1978.

HoN. DOUGLAS M. COSTLE,

Administrator,

Environmental Protection Agency, Washington, D.C.

DEAR MR. CosTLE: In-accordance with the

requirements of the Toxic Substances Control Act, the TSCA Interagency Testing Committee is now recommending the addition of eight designated entries to the Section 4(e) Priority List. These revisions and

the Committee's reasons for recommending them are presented in the enclosed document entitled, "Second Report of the TSCA

Interagency Testing Committee to the Administrator, Environmental Protection

Agency." The representatives of the statutory member agencies are in consensus on these revisions.

Also, the report contains two special rec- ommendations which bear on the activities

of the Environmental Protection Agency. First, it is recommended that EPA consider

taking the initiative in the development of a comprehensive survey of health and environmental effects testing facilities in the

United States. And secondly, your agency is

encouraged to Join In the effort to provide increased training support In the fields of

mammalian and environmental toxicology, pathology, occupational health and epidemiology as these fields relate to the need

for greater numbers of qualified personnel

to meet the increasing demand for testing, The Committee has not yet completed Its

review of all of those chemical substances

and categories of substances Identified

during our Initial activities in 1977. This

review Is to continue and will be a subject of

future Committee reports. In addition, can. didate chemicals recommended by the Committee members or public comment will be

reviewed by the Committee as such Information is made available.

We trust that this report will be of value

to EPA as it continues to carry out the

Toxic Substances Control Act, Sincerely,

MARvI E. STEPMnsoN, Chairperson, TSCA Interagency

Testing Committee

SECOND REPORT OF THE TSCA INmEAcEoY

TEsTING COMME To THE ADMIvUSTInA.

TOR, ENVIRONMENTAL PROTI s0o AoENCY

APRIL 1978

CONTENTS

CoLrnTri MEmrmEsIP

Acknowledgments

Summary

CHAPTER 1. INTRODUCTION

1.1 Committee establishment and responsi. bilities.

1.2 Initial report. 1.3 Cominittee activities during this report- ing period. 1.4 Future activities of the committee.

CHAPTER 2. CONsIDERATION OF AVAILABILITY OF

TESTING FACILITIES AND PERSONNIIEL

CHAPTER 3. RECOMMENDATIONS OF THE

COMMITT=R

3.1 Substances and categories of substances recommended for testing. 3.2 Reasons for recommending testing of

the additional substances and categories of substances.

3.2.A Acrylamide. 3.2.B Aryl phosphates. 3.2.C Chlorinated naphthalenes. 3.2.D Dichloromethane.

3.2E Halogenated alkylepoxides. 3.2.F Polychlorinated terphenyls. 3.2.G Pyridine. 3.2.H 1,1,1-trichloroethane.

TSCA INTERAGENCY TFmrNo CoMIr.

Statutory MemberAgencies

COUNCIL ON ENVIRONMENTAL QUALITY

Carroll Leslie Bastian

Nathan J. Karch,.Alternate

DEPARiTMENT OF COLIRCE

Orville E. Paynter Bernard Grelfer, Alternate

ETVIRONIENTAL PROTECTION AGENCY

Warren R. Muir

Joseph J. Merenda, Alternate

NATIONAL SCIENCE FOUNDATION

Marvin E. Stephenson, Chairperson Carter Schuth, Alternate

NATIONAL INSTITUTE OF ENVIROIIENTAL

HEALTH SCIENCES

Hans L Falk

FEDERAL REGISTER, VOL 43, NO. 76-WEDNESDAY, APRIL 19, 1970

16*684
NOTICES

Warren T. Piver, Alternate

NATIONAL INSTITUTE FOR OCCUPATIONAL

AFETY AND W'4ALTH

Jean G. French, Vice Chairperson

Vera W. Hudson, Alternate

NATIONAL CANCER INSTITUTE

James M. Sontag

OCCUPATIONAL SAFETY AND HEMBVI

ADMINISTRATION

Joseph K. Wagoner

Fred W. Clayton, Alternate

Liaison Agencies

DEPARTMENT OF D ESE

Seymour L. Friess

FOOD AND DRUG AD!IUSTRATIONi

Allen H. Helm

Winston deMonsabert

DEPAIR.MENr OF rTHE INERIOR

Charles R. Walker

Raymond E. Corcoran

U.S. cONSUMRP RODUCT SAFETY cor MaSSON

Robert M. Hehir

Joseph McLaughlin

Committee Staff

Executive Secretary:. Carol A. Mapes

Secretary:. Phyllis D. Tucker

AcKNOWioaN'TS

The Committee wishes to acknowledge

the important contributions of the many Individuals and groups who have significantly

aided us in our work. These Include:

The Federal agencies who have cooperated by providing support through the liaison

members;

Clement Associates, Inc., technical support contractor,

The National Science Foundation, for

funding and managing the technical support contract and the National Institute of

Environmental Health Sciences, for assisting in that funding;

Former Committee members: Sidney R.

Gaiter, Department of Commerce; William

M. Upholt, Environmental Protection

Agency; Norbert P. Page, National Institute

for Occupational Safety and Health; Grover

C. Wrenn, Occupational Safety and Health

Administration.

EPA staff members who assisted the Committee in a variety of activities, and particularly: Donald G. Barnes, Office of Tonic

Substances; John W. Lyon, Office of General Counsel; Ralph C. Northrop, Jr., Office of

Toxic Substances.

The numerous e-perts who prepared presentations and materials for the Committee;

and

The many individuals and organizations

who rezponded to the Committe's Initial

Report to the Administrator, ravironmental Protection Agency.

SUBmMARY

A central provision of the Tonic Substances Control Act (TSCA, Pub. I. 9d-469) concerns the testing of chemical substances

and mixtures which are used in commerce or may represent an unreasonable rLsis of

injury to human health or the environment.

The Act provides for continuing advice from

certain Federal agencies having common Interests in Identifying chemical substance or mixture. for testing. Accordingly, the TCA&

Interagency Testing Committee, which Is

composed of representatives from those con. cerned Federal agencies, regularly provide3

to the Administrator of the Environmental

Protection Agency (EPA) recommendations

on chemicals and mixtures to which the Administratr should give priority con.-deration for the promulgation of testing rules.

As a result of Its deliberations during the

past six months, the Committee has elected

to revise the TSCA Section 4(e) Priority ILIt

by the addition of four Individual substances and four categories of substances.

The Committee considers these additions to

be of the same priority as the previouly

designated entries. The chemical substance,

or categories being designated for addition

to the Priority List and the testing recommendatlons are presented alphabetically es

follovs

Substance or Catory and Testing

Recommended

AcrylamIde-Carclnogenlc- Ity, mutagenlclty. teratogenlcity, environmental effects

and epldemiological study.

Aryl phos-phates-Carcinogen!clty, mutagenlclty, teratogeniclty. other chronic effects, environmental effects and eptdemlological study.

Chlorinated naphthalene--CarinogenIcity, mutagenIcity, teratogenIcIty, other

chronic effects, environmental effects and

epldemiological study. -Dlchloromethane--Carcinogena€lty. mutagenlcity, teratozenlclty, other chronic effects, environmental effects and epldemiological study.

Halogenated alkyl cpoxlders-Carcnogenicity, mutageniclty, teratogenilcity, other

chronic effects, and epldemlological study.

Polychlorinated terphenylz-CarcinogenIcIty, mutacenicity, teratogeniclty, other

chronic effects, and environmental effects.

Pyrldlne-Carclaogenlcity, mutagenlcity,

teratogenicity, other chronic effects environmental effects and epldcmlologlcal

study.

l,1,l-Trlchloroethane - Carcinogenicity,

mutagenlity, teratogenlcity, other chronic

effects, and epidemnlological study.

A set of dossiers containing Information on the additional entries designated to the

Priority Lit Y711 be forwarded to the EPA

Administrator within a few weeks.

SzcoD RErorr oF mm TCA INea-m;cy

Trsrrz ComrIuTI= To Tac AnrINsruATop, E moloe;==X Pjsorrcre Aon--Cr, Arar 1978

GHAPM 1. INTUODUCTION

1.1 Committee Establishment and R.

sponsiliict The Toxic Sub-tances Control Act (Pub. L. 94-469) estblbbh the

TSCA Interagency Testing Committee

under Zectlon 4(e). The Commltte h- the

continuing re-ponsibIlity to Identify and

recommend to the Adminitrator of the Znvironmental Protection A.ency (EPA)

chemical substances or mlxture7 which

should be tested to determine their hazard

to human health or the environment. The

statute requires that the Committee co nid.

er revision to Its previous recommendat!on3

at least every slx months.

The Committee has eight statutory mem- bers appointed by the Federal ageni e3 Iden.

tifled for membership In Section d(e l(2A)

of the Act, a number of alternate mimb.sr

as permitted by Section 4(e)(2LBil), and IIason members from several Federal agencde with programs related to the control of

tonic substunces. Current Committee mem- bers, alternates, and tal-on representatives

are identified at the beginning of this

report.

1.2 Initial Repo t In July 1977, the Committee published a Preliminary List of 330

chemical substances and categories of such

substance3 Including background Information describing the methods used by the

Committee In making those selections (Reference No. 1). The Preliminary List contains

substances and categorles selected primarily

on the basis of their potential for human

exposure and environmental relese. Subsequently, the chemicals on the Preliminary

List and chemicals added to the Preliminary

Ist on the basis of public commentz and

Committee recommendations were screened

further by the Committee. The screening

process was based primarily on the chemicls potential for causing adverse human

and/or environmental effects but also conddered their exposure potential. Available

data on these chemicals were re7fewed with

regard to: potential for carcinogenic, mutagenic. teratogec , and chronic toxic effect4

their ability to boaccumulate or cause deleterfous environmental effects; and pozsible

tonic Lmpuritis. A scoring syztem was used

In thL- process which took Into account both

available inforation and the lack of it for

thee factors. The Committee further nar- rowed the it of substances end categories

under conzlderatlon on the basis of Its scientifli Judguinct and the scozing results, and

requested Its technical contractor to prepare dossiers on these chemicals. The Co=-

rnttee was able to review about one-half of

these substance3 and categories aided by information In the dossfer Four individual

chemicals and six categories of chemical

substans v.ere selected for incluzion in the

Initial Report to the Admnistrator, Envlronmental Protection Agency (Reference

1to. 2) dated October 1, 1977.

In addition to the liting of the chemical

d-Ignated by the Committee for cons.deration by EPA, the report contabn a detailed

d-scriptlon of the methods used in developIng the Commlttea'z Lnitial recommendations Including data sources and methods

used for production, release and expo-ure

ciores, as well as biological and environmental corei. Later, on February 7, 1978, a fin3aed sat of supporting do s-Iers on the

delgnted entries on the Priority LIst w-z

offIcilly tzansmitted to the AdminL-trator.

1.3 Committee Actirlties During 27:ts Fartir Fer ozL Since cDmpletion of Its I!ntl recommendations In October1977, the

Committee has continued to consIder IndlvIduaI chercal substances and mixtures

Identified for In-depth consideration by the

screening proce:s mentioned in the preceding section.

This revw b- given -;ecWc cansideratlon to the factor, described in T3CA S='-

tlon 4eX1(KA) and other relevant facto

Identifled by the Committee. 1e.;dfy allable Inferm-.ton on th=e factors and the

lmowlcdge and professional judent Of the

Committee members have been employed to

select additMonal entries to the-TZCA Sectlon 4(e) Priorlty Lst-. On the basis of the

raer of more, but not al of the pre-.auy

requestcd ds:iFer, the Committe nc7

recomamending the add ion of four chamical subs=ta . and four categ-orie of chemical sub-tanc= to the 4(e) Priority lsTz.

1.4 FaturcActfritiez of the Committea In

the courzse of de-eloping Itz third rapot the

FEDIAL RECISTEP, VOL 43, KO. 76-WEDIZZDAY, APIL 19, 197"

16685
NOTICES

Committee expects to continue reviewing

those dossiers in hand and consider new dossiers on additional chemicals and groups.

CHAPTER 2. CONSIDERATION OF AVAILABILITY OF

TESTING FACILITIES AND PERSONNEL

Section 4(e)(1)(A) of TSCA requires that

the Committee consider, among other factors, the reasonably foreseeable availability

of facilities and persQnnel for carrying out

the testing on the substances or mixtures

recommended to the Administrator for priority cqnsideration. The Committee con- cludes that testing capabilities are presently

adequate to carry out the recommended

health effects and environmental tests on the chemicals listed in Table 1. However,

the concerns expressed by the Committee in

its first report (Reference No. 2, p. 55048)

regarding the limited national capability for

conducting long-term tests for environmental effects are reiterated.

The expansion of testing facilities by industry, contracting laboratories, and universities seems to be proceeding at a satisfactory rate, especially in the area of health effects testing. Estimates indicate a significant increase in facilities over the next five

years. While this is encouraging, the Committee is aware that the increasing requirements of various government agencies are creating competition for the same testing

facilities and personnel. Therefore, the projected need and capacity for health and en- vironmental effects testing is somewhat uncertain and should be more accurately sur- veyed. The Committee recommends that

EPA assume the leadership in the development of a comprehensive survey of availability of current Federal and private

health effects testing facilities in the United

States and the projected annual capacity of

such facilities during the next five years. In

those cases where testing is likely to involve

animal bioassay, the survey should include an evaluation of the capacity to provide ap--

propriate and sufficient populations of test

species.

Of paramount concern to the Committee

is the availability of qualified personnel. All

indices contained in the Report of the

Second Task Force for Research Planning in

the Environmental Health Sciences (Refer- ence No. 3) indicate a current and future

shortage of research professionals in the

fields of mammalian and environmental

toxicology, pathology, occupational health,

add epidemiology. There will be a dearth of

professionals and supporting tecbnical'personnel in these various skills for many years

unless increased training efforts occur at

the national level The Committee notes

that several Federal agencies are involved in

augmenting training support and recom- mends that EPA join in these efforts in a significant way.

There is also a need to maintain viable

basic research programs in toxicology and

other related health fields. This basic need

should not be neglected in order to assure short-term gains in the practical application

of the present state of the art. Because of

the interdisciplinary nature of toxicology.

and environmental health research, the

educational training for some of the disciplines can be provided only by facilities with

personnel engaged in this type of research.

The Committee believes that the Civil

Service Commission could do much to stimulate interest in these professions by creating professional series and registers for such scarce categories as toxicologists, pathologists, epidemiologists and other scientific

fields in environmental protection. Recogni- tion of these environmental health professions by the Commission could encourage

students to investigate careers in fields thus

far hidden as Federal employment opportunities. It is concluded that such an action by

the Commission would have the effect of increasing the available scientific manpower

in these specialty fields both in the Government and in industry where the demand for

such personnel exists.

CHAPTER 3. RECOMMENDATIONS OF THE

cotuTrEE

3.1 Substances and Categories of Sub- stances Recommended for Testing. On the

basis of the review and evaluation of chemical substances which was carried out according to the methods and procedures described in Sections 1.2 and 1.3, the Committee is revising the TSCA Section 4(e) Priority List to add certain substances and categories of substances for which specific testing is recommended. The Priority List and

the date each item was placed on the List are given in Table 1. The testing recommen- dations and reasons for such recommendations are indicated in Section 3.2 for the

new entries. Supporting dossiers of information are being prepared in final form and

will be forwarded to the Administrator,

EPA, at an early date.

All additions to the List are designated

chemical substances and categories of

chemical substances which the Committee

has determined require the Administrator's

action under TSCA Section 4(a) within

twelve months. The Committee considers

these addition to be of the same priority as

the previously designated entries. In recom- mending a category of chemical substances

for testing (e.g., the aryl phosphates), the

Committee recognizes that certain chemicals which are members of the category may

have been tested previously for an effect of concern. For those chemicals no additional

testing may be warranted if the results of

previously completed tests are Judged adequate for assessing the effect of concern. The Committee also recognizes that tho

definition and inclusive limits of a given

listed category of substances may require

additional specification or change in speclfication as the testing rule is developed,

Unless stated otherwise, the chemical substance recommended for testing should be

the product to which the population Is ex- posed.

3.2 Reasons for Recommending Testing

of the Additional Substances and Categories

of Substances. In accordance with tho re- porting requirements of the Act, the Committee has listed in the following sections

the test recommendations and reasons for

recommending testing for those entries

being placed on the Priority List at this

time. Table 2 presents a summary of the

testing recommendations for each addition

to the List.

TABLE 1.-The TSCA Section 4(e) Priority

List, by Alphabetical Arrangement

Designated entry Date of entry

Acrylamide ................................... ........ April 1978.

Alkyl epoxides .............. October 1977.

Alkyl phthalates ......................... .October 1977, Aryl phosphates ............. April 1978.

Chlorinated benzenes, mono- and dl- October 1977.

Chlorinated naphthalenes .................. April 1978.

Chlorinated paraffins .......................... October 1977.

Chloromethane ............. October 1977.

Cresols ............... . October 1977, Dichloromethane .................... April 1978.

Halogenated alkyl epoxides ................ April 1978.

Hexachloro-1,3-butadlene ................... October 1977.

Nltrobenzene ......................................... October 1977.

Polychiorinated terphenyls ................ April 1978.

Pyridine ............................................... April 1978, Toluene .................................................. October 1977, 1.1,1-trichloroethane ......... April 1978.

Xylenes .................................................. October 1977.

TABLE 2.-Summary of testing recommendations by the TSCA4.InteragcncY Testing

Committee

Carcino- Muta- Terato- Other Environ- Eplide- Substance or category genicity genicity genicity chronic mental miology effects effects rtudy

Acrylamide ................ . ......... X X X ..................... X X

Aryl phosphates .................... . X X X X X X

Chlorinated naphthalenes .. X X X X X X

Dichoromethane ................... X X X X X X

Halogenated alkyl epoxides.. X X X X ............... X

Polychlorinated terphenyls.. X X X X ...... Pyridine ............... . X X X X X X

1,,1-trichloroethane . .. X ............ .

3.2.A Acryamlde.

Testing recommendations: Carcinogenicity,

mutagenicity, teratogenicity, environmen-,

tal effects, and epidemiology.

Substance Identification: CAB No. 79-06-1.

R msONS FOR REcoMMENDATIoNs

Production, release, and exposure, The

1976 U.S. production of acrylamide monomer Is estimated at 64 million pounds, and

indications point to a high growth rate of

around 12 percent for the next decade.

Eighty percent of the acrylamide produced

is used captively in polymer production for

water treatment, papermaking and

wastewater clarification. About 5 percent Is

used in chemical grouts as the acrylamide

monomer, for soil stabilization and sewer re- habilitation. The remainder s consumed in

FEDERAL REGISTER, VOL 43, NO. 76-WEDNESDAY, APRIL 19, 1978

16686
NOTICES

other chemical syntheses. Other uses are In

the paper and paperboard Industry, coal industry, mining and ore benefication indus

try, and secondary oil recovery Industry.

Acrylamide release to the environment

(usually ending up in surface and ground

water) occurs at manufacuring sites, soil grouting sites, polymer application sites and

In handling. General population, low-level

exposure to acrylamide s likely to occur

wherever polyacrylamides are utilized. No

data are available on release rates into the

environment or actual concentration levels.

NIOSH estimates that 20.000 workers are potentially exposed in the workplace. Carcinogenicity. Acrylamide has not been

tested for carciongenicity. Because of widespread low-level exposure to the population,

acrylamide should be tested for carcinogen- Icity.

mutagenicity. Although the results of two

independently reported Ames tests were

negative, the Committee believes that additional tests, employing other systems, are required to evaluate the mutagenic poten- tial of this chemical.

Terutogenict. Transplacental transport of acrylamide was demonstrated in rats;

therefore, It should be tested conclusIvely for teratogenicity.

Environmentca effectsa In view of the high degree of neurotoxicity and neuropathy caused by cumulative exposure and the extensive use of this material In waste water

treatment and soil grouting, Studies should

be initiated to determine the degree of

leaching of the monomer from the polymer with water and various solvents. Further, the potential for environmental exposures to the aquatic ecosystem, movement In sofl

solution and leachate from soil waste must

be determined for biological effects on plant and animal life.

Ep&joogy. No epidemiological reports on acrylamide have been found In the literature. Studies are needed to provide information on human exposure to acrylamide and

to determine the relationship between airborne concentrations and observed effects on humans.

3.2.B Aryl phosphates.

Testing recommendations: carcinogeniclty. mutagenicity, teratogenicIty, other chronic effects, environmental effects, and epi- demiology.

Category identification: This category con- sists of phosphate esters of phenol or of

alkyl-substituted phenols. Tri-aryl and

mixed alkyl and arly esters are Included.

but trl-alkyl esters are excluded.

Rnmsos Foa RmooimaxrOS

Production, releas, and exposur. As a category, the aryl phosphates are produced in quantities exceeding 65 million pounds/

year. Several individual arYl phosp hates, such as tritolyl phosphate and triphenyl phosphate, have annual production greater than 10 million pounds. Aryl phosp hates re

widely used as plasticizers In polyners (prin- cipal y in polyvinyl chloride) and In hydru- lie fluids and highpressure lubrican3t Such uses provide opportunity for ex-tenive occu- pational exposure to theze compounds beyond that encountered in their manufacture. NIOSH estimates that over 2 miluton

workers are so exposed. Because of the

nature of their uses, most of the arl phcsphates manufactured will ultimately be re- leased Into the environment, although those used as plasticizers may be released quite slowly. Persistence of aryl phosphates In

the environment for significant pertods a.

least on the order of months) is indicated by

the available data.

Carcinogenfctz, With the exception of

several tests of Inadequate duration uing

trIphenyl phosphate, the carclnoenlc potential of aryl pohosphates has not bean as. sessed. Carcinogeniclty testing should be

performed on aryl phosphates having substantinl human exposure and/or environ.

mental release.

Mutagenfcfty, No mutagenicity te-ti ha

been reported for aryl phos-hate3. Such

testing should be performed because of the

potential of these substances for widespread

environmental release and human exposure.

Teratogentcfty. No teratogenicity testing

has been reported for aryl phovpha.-. Such

testing should be conducted for aryl phosphates having substantial human exposure

and/or environmental release.

Oier chronic effccb. The neurotoxicity of

certain ryl phosphates Is well documented,

The Committee recommends that aryl phosphates be tested for chronic effects with

special emphasis on neurotoxtc activift.

Envfronmenta effccL% Available data, although limited, indicate a potential for persistence of aryl phosphates In the aquatio

environment, as well as a potential for their

bloaccumulation in aquatic specles. There Ievidence of chronic toxicity of aryl phoophate hydraulle fluids to fish. Several aryl

phosphates potentiate the toxic effects of

organophosphate pesticides on Insects and one (trl-o-cresyl phosphate) has been shown

to potentlate such effects In nontarget or- gantss Including mam ls. In view of this,

the environmental fate and effects on aquatic and terrestrial systems should be

evaluated for aryl phosphate.

Epmfoogy. Because of the large-:cale

production and potential for substantial cc. cupational exposure of certain aryl phonphates, the Committee recommends that*

epidemiological studies be conducted.

3.2.C Chlorinated Naphthlensc.

Testing recommendations: Carcinot-gncilty. mutagencIty, teratogenicIty, other chronic effects, environmental effecta, and ep.-

demiology.

Category identification: Thin category can- sists of chlorinated derivatives of naph.

thalene (empirical formula CtHCi,'

where x+y=8).

Rsson RzC0==MJM0N3

Producton, res, and exposure. Available data indicate a production volume on the order of millions of pounds annually.

These products have both moderately d.

persive uses (e.g., lubricating and cutting oll

additives) and enclosed uses (e.g., dielectic

for automotive ,capacitors). Althourh

NIOSH has estimated that cveral thou.and

workers are, exposed to these compound.,

little I- known about the ultimate rele=s of

these materials from the workplac-, durin,

product ue, or as a result of dispo- l

Healthi effect,% Ail1 studies and nl!

of human exposure reveal that thc:e com- pounds are biologically active, with rcsprts

of dermatological (e.g., chorace) and sy,-

temlc (liver) effects. To date, there ara no reported data on the carcnogeniclty, muta.

genleity, or teratogenicity of thcse com. pounds. Thus, there Is a need to conduct

such studies, as well as to Investgate mora thoroughly the chronic effects of thez2 in.

tends. Epldenilologlcal studles choutl t2

undertaken -where appropriate.

Environmental rffect_ Little lnformation on the ecological effects of these matcvrlls

13 available, but the detection of chlorinated

naphthalene3 In stream sedimentz, fsh, and

fish-eating birds point to their dispersal.

pers- ence, and bloaccumulation In the

food cbam. Therefore, testing Is needed to

obtain data for Judging the environmental

effects of these chemicals.

3.2D DfchorometArre,

Testing recommendations: Carcinogenicity.

mutagenicity, teratogenolty, other chronto effects, environmental effects, and epldemiology.

Substance Identiffcation: CAS NO. '75-09-2.

Rzasoxs roa Rrcomwz-wAxo.s

Productior rele e, ard expourt. The

1976 US. production of dlchloromethane

(also known as methylene chloride) exceeded 00 million pounds,, a 12 percent increase

over the 1972 level. An averge 9 percent

annual growth rate I- projected over the

next several years as this chemical enter.

markets dominated by fluorochlorocarbons

in the past. Approximately / of the volume

produced 13 thought to be released to the

environment through activities at Industrial

site,_ In homes and elsewhere. NIOSH estmated that 2.5 million workers are exposed

to this material at their place of work. Its ue In an array of aerosol spray products

and other household products brings a large

fraction of the general population into contact with this chemical.

C4rdrcoenicity. No carcinogenicity test

data were found In the searched literature.

There Is sufficient concern based for the

Committee to recommend this chemical for

such teatinga. The Committee is aware of

two studies currently under way, however,

whose results may be Judged adequat to

obviate the need for additional testing.

Muta -enficty. No mutagenIcity test data

have been reported. Such studies should be

conducted In view of the widespread expocure to this chemical and its demonstrated

bioloalml activity. Terato3icWt. One study ha reported euMvoal findings of abnormalit es In the

oWfe of pregnant ratn and mice exposed

to this chcmicaL Additlonal testing Inecded to aw3 this potential hazard

Other chronfe ecs.t Iaboratory Investgations and case studies have reported that

dlobllorometha-e can affect various org-s

(e.g., lung s and eye) and "ystems (blood), as eU as behavior. Given the wide-pread u of this chemical und-r many different conditIers, this information indlcates a need

for further t, -tngEnrniromentaZ ects. Dlchloromethana

Is b:ng released In large quanUtIes and In a broad dLpersion pattern throughout the en- %ironment. Low-Ievl residu2s have been m asured In water, The exact nature of this

e-posure and Its chronic effects on the biotanced to te determined.

EPfrirfolo7 Xpldemloloatcal studies

should te conducted to ass hm n rislL

3i.213Hl tdthlEies

Tesating recommandattons Carcinogani-aty. mutnuenlolty. tcratoaanIcity, other chronCategory Id.ntiftcaton: This category con- syzts of hao,-gnated noncyclic aliphatfz

hydrocarbons with one or more epa.,

functional Croup:;.

1rcdU.tiorn, fc%=e, and Exrosure. The

lI75 U.S prcdlzction of eplchiorohydnina (I- cbow-2.3-cvozypropana.) exceeded sea maiMED.AL PEGISTC, VOL 43, NO, 76-WEO Z":AV, AtMIL 19, M J

166S7
NOTICES

lion pounds. NIOSH estimates that between

50,000 and 140,000 workers are exposed to

epichlorohydrin annually. While epichloro- hydrin Is currently the only widely used halogenated alkyl epoxide, advertising and

trends In the chemical industry lead the

Committee to the conclusion that chemicals

of this type may find wider use In the

future.

Carcinogenicity. Halogenation of an alkyl epoxide enhances its activity as an alkylatIng agent and hence Its biological activity.

Halogenated alkyl epoxides also may inhibit

detoxifying enzymes in mammals. Equivocal

results of recent carcinogenicity studies on eplchlorohydrin further point out the need

for testing this chemical category for potential carcinogenicity.

Mutageniteity. Epichlorohydrin has been

shown to be mutagenic to mice and bacteria.

The potential human toxicity of this and

other halogenated alkyl expo;ides should

be evaluated.

Teratogenicity. No informAtion could be

found on the potential for teratogenicity of

the halogenated alkyl epoxides and they should be studied for this effect.

Other Chronic Effects. Epichlorohydrin

has been reported to penetrate human skin

and cause systemic effects. This raises con- cern for other toxic effects and target organ

toxicity of all the halogenated alkyl epoxides. Appropriate studies for these effects are recommended.

Epidemiology. No epidemiological studies

of any of the halogenated alkyl epoxides were found in the literature. Studies are needed to provide information on the effects of human exposure to these compounds.

3.2.F Polychlorinated terphenyl.

Testing recommendations: Carcinogenicity,

mutagenicity, teratogenclty, other chronIc effects, environmental effects.

Category identificatlon This category con- sists of the polychlorinated ortho-, meta- and para-terphenyls.

REASONS FOR RECO=DATIONS

Production, Release and Exposure. Although the production of polychlorinated terphenyls was discontinued in the United

States in 1972, there has been an increase in

imports of polychlorinated terphenyls from

160,000 pounds in 1973 to 400,000 pounds in

1975. Polychlorlnated terphenyls are presently used in waxes for investment casting

and this use leads to wide environmental

dispersion. Residues of polychlorinated terphenyls have been found in human fat and

milk and in samples of water and sludge. In a group of 27 individuals tested for blood

levels of polychlorinated terphenyls and polychorinated biphenyls, the average con- cerntration of polychlorinated terphenyls in

the blood was greater than that of polychlorinated biphenyls, despite a far greater industrial use of polychlorinated biphenyls in

the area of study.

Carcinogenicity. No reports of long-term

carcinogenicity studies of polychlorinated

terphenyls were found in the searched literature. The Committee recommends that

polychlorinated terphenyls be 'tested for

carcinogenicity.

Mutagenicity No information on the mu- tageniclty of polychlorinated terphenyls was found In the see .hed literature. The

Committee recomme .ds that mutagenicity

tests be conducted.

Teratogenicity. N information on the teratogenicity of polychlorinated terphenyls

was found in the searched literature. The

Committee recommends that teratogenicity

tests be conducted.

Other Chronic Effects. Liver, skin and hematopoletic effects have been observed at

high level exposures. Effects at lower levels

cannot be characterized from existing data.

Chronic studies to evaluate the effects of

prolonged exposures are recommended.

Environmental Effects. The limited available data indicate a potential for bloaccumulation. No adequate information Is available on the ecological effects of these

chemicals.

3.2.G PYRIDINE.

Testing recommendations: Carcinogenicity,

mutagenicity, teratogenicity, other chronic effects, environmental effects, epidemiology.

Substance identification: CAS No. 110-86-1.

REAsoNs FOR RECOM=EMnATIONS

Production, Release, and Exposure. The

annual production of pyridine is estimated

to be in excess of '60 million pounds, based

bn production amounts for 1976. Although

the amouht of pyridine released into the en- vironment is unknown, its production

volume and variety of uses raise concern with respect to human exposure. NIOSH es- timates that 249,000 workers may be ex- posed to pyridine.

Carcinogenicity. Only one limited carcinogenicity study was found in the searched literature. By current standards, the study is

Judged inadequate as an evaluation of the

carcinogenic potential of pyridine. The

Committee, therefore, recommends that ap- propriate carcinogenicity testing be undertaken on pyridine.

Mutagenicity. No mutagenicity studies on pyridine were found in the searched litera- - ture. Given its known biological activity,

production volume, and human exposure, it

is recommended that appropriate mutagenIcity testing be undertaken on pyridine.

Teratogenicity. Only one limited teratogenicity study was found in the searched literature on pyridine. It indicated that pyridine produced abnormalities in chicken em- bryos. An evaluation of teratogene effects

should be undertaken in other species.

Other Chronic Effects. The carcinogenicity

study cited above Is the only investigation

lasting one year or longer found in the

searched literature on the possible chronic

effects of pyridine. Short-term studies indicate that pyridine affects the central ner- vous system and causes degeneration in the

liver and kidneys. Chronic effects on these

and other systems should be evaluated in

appropriate long-term studies.

Environmental Effects. The environmental release of pyridine may pose a hazard to

aquatic biota and terrestrial life. Residues

have been detected in water and uptake in

plants has been reported. Although a wide

range of toxicity has been measured for

plant and animal life in short-term bioassay

tests, the results of one longer-term expo- sure to Daphnia magna indicates a potential for chronic toxicity. More testing Is

needed to determine the biological signifi- cance of residues and the potential effects

of long-term exposures on both plant and

animal life.

Epidemiology. Pyridine has been reported

to have an effect on the central nervous system in humans, as well as to produce

injury to the liver and kidney. Given the

large number of workers exposd, epidemiological studies should be undertaken.

3.2.H 1,11-Trichloroethane.

Testing recommendations: Carcinogenicity,

mutagenicity, teratogenicity, other chronic effects, epidemiology.

Substance Identification: CAS No. 71-55-0,

REAsoN roR RECom OA=0119

Production, Release, and Exposure This

compound is produced primarily for use as a cleaning solvent for metals and other materials. 1,1,1-Tricholoroethane (methyl chloroform) has the potential to replace the chlorinated ethylenes in a variety of solvent formulations used commercially. The U.S. production of this compound totaled approximately 630 million pounds in 1976. Current

release rates are not known; however, It Is

estimated that over 300 millon pounds of

this compound are employed in dispersive uses which would principally result In re- leases to the atmosphere. The significant

adverse effects on the upper atmosphere

have been evaluated. Minor amounts may

also enter the acquatic and terrestrial environment. NIOSH estimates that about

3,000,000 persons may be exposed to this

material in the workplace.

Carcinogenicity. The currently availablo

Information, including recent results from

the NCI carcinogenesis bloassay program,

indicates that data are not adequate to

make a judgment on the carcinogenic potential of 1,1,1-trichloroethane. The Committee

recommends that this chemical be evaluated

with respect to carcinogenicity.

Mutagenicity. The absence of Information on the mutagenilcity of this compound Indicates that such studies should be undertaken.

Teratogenicity. The Committee concludes

that the current available Information on teratogenc effects Is insufficient to judge

the hazard potential of this material. Consequently, it s recommended that appropriate

teratogenesis studies be undertaken on 1,1,1-trichloro- ethane.

Other Chronic Effects. There Is Insuffflclent evidence regarding the impact of

chronic, low-level exposure to 1,1,1-trichlor.

oethane. Chronic effects, with spccific attention to neurological, cardiovascular and

renal systems, should be evaluated In appro. priately designed studies. . EpIdemiology. ,No Investigations of health

effects in occupational workers exposed to

1,1,1-trichloroethane were found during the

Committee's review of this material. Given

the large population of workers exposed to

this compound, It is recommended that ap.

propriate epidemiological investigations be

conducted.

1. Preliminary List of Chemical Sub. stances for Further Evaluation, Toxic Substances Control Act Interagency Testing

Committee, July 1977.

2. Initial Report to the Administrator, Environmental Protection Agency, TSCA Interageney Testing Committee, October 1,

1977. Published In the FEveznn REoraxnm,

Vol. 42, No. 197, Wednesday, October 12,

1977, pp. 55026-55080. The report and the

supporting dossiers also were published by

the Environmental Protection Agency, EPA

560-10-78/001, January 1978.

3. Human Health and the EnvironmentSome Research Needs, A report of the

Second Task Force for Research Planning

in Environmental Health Sciences, DHEV

Publication No. NIH 77-127, Chapter 10,

1977.

[FR Doe. 78-10573 Filed 4-18-78; 8:45 am]

FEDERAL REGISTER, VOL 43,' NO. 76-WEDNESDAY, APRIL 19, 1978

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