Federal Register / Vol. 48, No. 220 / Monday, November 14, 1983 / Notices

V. Decision Not To Initiate Rulemaking

The ITC was concerned about the

health effect§ of TOTM primarily

because of its structural similarity to

DEHP and the presence of the 2-

ethylkhexyl moiety in the TOTM

molecule. Concern about th6 toxicity of

the 2-ethylhexyl moiety will be directly

addressed in the NTP testing program.

In addition to the testing already

completed, 2-ethylhexanol and mono(2-

ethylhexyl)phthalate, which are

structurally similar to TOTM, will be

tested for carcinogenesis, and 10 other 2-

ethylhexanol compounds will be tested

for genotoxic effects. This additional

information on structurally similar

substances may significantly contribute

to the Agency's ability to predict the

toxic effects of TOTM.

EPA believes that pursuing the TEP

proposed testing program for mutagenic,

subchronic and environmental effects,

together with the data resulting, from

ongoing studies on related substances

sponsored by the Phthalate Esters Panel,

will provide the type of screening data

the ITC recommended obtaining.

Included among these data will be the

identification of the metabolites of

TOTM. When data are available upon

completion of the testing planned by

NTP and the testing proposed by the

CMA Trimellitate Esters Panel, along

with data gathered in the PEPP studies,

a complete assessment of further testing

needs for TOTM and its metabolites will

be made. For these reasons, EPA has

decided not to initiate rulemaking under

section 4(a) of TSCA to require testing

of TOTM at this time.

VI. References

(1) ACGIH. 1982. American Conference of

Governmental Industrial Hygienists. TLVs ®

Threshold limit values for chemical

substances in work air adopted by ACGIH

for 1982. Cincinnati, OH: ACGIH. pp. 32-33.

(2) Canter, D. A. 1983. National Toxicology

Program. U.S. Department of Health and

Human Services. Memorandum to Members,

Chemical Evaluation Committee and Liaison

Staff. Subject: Nomination of Additional

Compounds Containing the 2-Ethylhexyl Moiety for NTP Testing.

(3) Chemical Manufacturers Association.

1983. (June 13, 1983) Tris(2-

ethylhexyl)trimellitate: A Voluntary Testing

Program under Section 4 of the Toxic

Substances Control Act.

(4) Dougherty PC, Cassis FA. 1962. Amoco

Chemicals Corporation. Vinyl plasticizers

from trimellitic'anhyride. Soc. Plast. Eng.

Tech. Pap. 18 (session 22):1-9.

(5) Eastman Chemical Products, Inc. 1982

(Feb.) Product literature.

KODAFLEX 1 TOTM. Trioctyl trimellitate

(tri[2-ethylhexylltrimellitatel. Coatings

Chemicals Division, B-280, Kingsport, TN

37662.

(6) Kevy, S. V., Jacobson, N. S., and

Harmon, W. E., "The Need For a New

Plasticizer For Po lyvinyl Chloride Medical

Devices," Trans. Am. Soc. Artif. In'tern.

Organs, Vol. XXVII, pgs. 286-390, 1981.

(7) Nuodex, Inc..1981. 28 day hepatotoxicity

study in rats conducted for Tenneco

Chemicals, Incorporated with samples

NUOPLAZ TOTM and NUOPLAZ DOP.

878220032.

(8) Spangler, W. J. Capital Systems Group,

Inc. and Dynamac Corporation. 1983. Final

technical support document: Tris(2-

ethylhexyl) trimellitate. Washington, D.C.:

Office of Pesticides and Toxic Substances.

U.S. Environmental Protection Agency.

Contract no. 68-01-6530.

(9) USEPA. 1982. U.S. Environmental

Protection Agency. Meeting SummaryMeeting with CMA Subcommittee on

TOTM-]anuary 18, 1983. Arlington, VA.

(10) USFDA. 1981. U.S. Food and Drug

Administration. Summary for Basis of

Approval BB--NDA 80-77/04. Washington,

D.C.

VII. Public Record

The EPA has established a public

record of this testing decision (docket

number OPTS-42040). This record

includes: •

(1) Federal Register notice designating

TOTM to the priority list and comments

received thereon.

(2) Communications before industry

testing proposal consisting of letters,

contact reports'of telephone

conversations, and meeting summaries.

(3) Testing proposals and protocols.

(4) Published and unpublished data,

including the references cited above.

(5) Federal Register notice requesting

comment on the negotiated testing

proposal and comments received in

response thereto.

The record, containing the basic

information considered by the Agency in

developing the decision, is available for

inspection in the OPTS Reading Room

from 8:00 a.m. to 4:00 p.m., Monday

through Friday, except legal holidays, in

Rm. E-107, 401 M St., SW., Washington,

D.C. 20460. The Agency will supplement

this record periodically with-additional

relevant information received.

(Sec. 4, 90 Stat. 2003; (15 U.S.C. 2601))

Dated: November 3, 1983.

William D. Ruckelshaus,

Administrator.

[FR Doc. 53-30535 Filed 11-10-83; 8:45 am]

BILUNG CODE 6560-50-M

[OPTS-42039; BH-FRL 2450-31

Bis(2-Ethylhexyl)Terephthalate;

Response to the Interagency Testing

Committee

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: The Eleventh Report of the

Interagency Testing Committee (ITC)

designated bis(2-ethylhexyl)-

terephthalate, also known as dioctyl

terephthalate (DOTP), for health and

environmental effects testing

consideration. Subsequent to the ITC

designation, Eastman Kodak Company

presented to EPA a testing program for

the health and environmental effects

testing of DOTP. Also, the National

Toxicology Program (NTP) has

nominated a variety of chemicals

containing the 2-ethyihexyl moiety and

2-ethylhexanol for toxicity testing. The

Agency has concluded that these

programs are sufficient to evaluate .he

health and environmental effects of

DOTP as recommended for iesting by

the ITC and is not initiating rulemaking

under section 4(a) of the Toxic

Substances Control Act [TSCA) at this

time. This notice constitutes the

Agency's response to the ITC's

designation of DOTP, as mandated by

section 4(e) of TSCA.

DAfE: Interested persons are invited to

comment on this proposed decision: All

comments should be submitted on or

before December 29, 1983.

ADDRESS: Written comments should

bear the document control number,

(OPTS-42039) and should be submitted

in triplicate to: TSCA Public Information

Officer (TS-793), Office of Pesticides

and Toxic Substances, Environmental

Protection Agency, Room E-108, 401 M

St., SW., Washington, D.C. 20460.

FOR FURTHER INFORMATION CONTACT:

Jack P. McCarthy, Director, TSCA

Assistance Office (TS-799), Office of

Toxic Substances, Environmental

Protection Agency, Room E-543,

Washington, D.C. 20460; Toll Free: (800-

424-9065), Outside the USA: (Operator

202-554-1404).

SUPPLEMENTARY INFORMATION:

1. Background

Section 4(a) of the Toxic Substances

Control Act (TSCA) (Pub. L. 94-469, 90

Stat. 2003 et seq., 15 U.S.C. 2601 et seq.)

authorizes EPA to promulgate

regulations which require manufacturers

and processors to test chemical

substances and mixtures. Data

developed through these test programs

are used by EPA to assess the risks that

such chemicals may present to health

and the environment. Section 4(e) of

(TSCA) established an Interagency

Testing Committee (ITC) to recommend

to EPA a list of chemicals'to be

considered for the promulgation of

testing rules under section 4(a) of the

51845
Federal Register / Vol. 48, No. 220 / Monday, November 14, 1983 / Notices

Act. The ITC may designate up to 50 of

its recommendations at any one time for

priority consideration by EPA. EPA is

required to respond within 12 months of

the date of designation, either by \

initiating rulemaking under section 4(a)

or publishing in the Federal Register

reasons for not doing so.

On November 1982, the ITC

forwarded to EPA its Eleventh Report

which designated bis(2-

ethylhexyl)terephthalate (DOTP) for

priority consideration by EPA (Ref. 1).

The ITC recommended that bis(2-

ethylhexyl)terephthalate be considered

for health and environmental effects and

chemical fate testing. The health effects

testing recommendations included

mutagenicity, chemical disposition,

metabolism, and subchronic effects

testing. The environmental effects and

chemical fate testing included acute and

chronic toxicity to fish and aquatic

invertebrates, toxicity to plants,

bioconcentration and chemical fate

testing. These health and environmental

effects testing recommendations were

based primarily on a lack of data to

adequately characterize the effects. The

ITC's testing recommendations were

also based on the analogy that bis(2-

ethylhexyl)terephthalate would have a

similar metabolic profile to its isomer

bis(2-ethylhexyl)phthalate. The ITC

presumed that DOTP would be expected

initially to hydrolyze the 2-ethylhexyl

alcohol during metabolism, thereby,

resulting in hepatic peroxisome

proliferation. The ITC also indicated

that terephthalic acid (TPA), a possible

metabolite of DOTP, had induced

bladder calculi in Fisher-344 rats when

fed at levels of three percent or more in

the diet. Hence, the ITC felt that studies

on the metabolic disposition of DOTP

were needed to determine the relative

levels of these toxic metabolites that are

formed. Also, subchronic experiments

were recommended to determine if

DOTP causes peroxisomal proliferation.

Based on a structural similarity to

dialkyl phthalates and significant

amounts of DEHP accumulated by

aquatic plants and invertebrates, the

ITC expected DOTP to be released and

persist in the aquatic environment,

especially sediments. The

environmental effects recommendations

made by the ITC were partially based

on problems that could result from

accumulation of the chemical in

sediments, including: (1) Toxic effects on

benthic invertebrates; (2)

bioaccumulation and resultant toxic'

effects of DOTP on fish; and (3)

redistribution of DOTP in the aquatic

environment. The ITC recommended

chemical fate testing to better

characterize the transformations and

persistence of DOTP in the aquatic

environment.

Subsequent to the ITC report,

Eastman Kodak Company, the only U.S.

manufacturer of DOTP, submitted to

EPA additional information concerning

consumer use and industrial exposure,

and additional biological effects data. It

subsequently submitted for EPA

consideration a proposed program for

testing DOTP's health and

environmental effects. EPA has also

considered the data reported by

Eastman Kodak under TSCA section

8(a) which included production volume,

use, exposure and release information.

EPA has used these data, in conjunction

with other information, to reach its

decision not to initiate rulemaking on

DOTP under iection 4(a)'at this time.

II. Assessment of Exposure, Health and

Environmental Effects

A. Production, Use, and Exposure

DOTP (CAS No. 6422-86-2) is a clear,

viscous, odorless liquid with low

volatility. It is also relatively insoluble

in water. Eastman Kodak Company is

the sole U.S. producer of DOTP. Annual

production of DOTP is in the range Qf.2.5

to 25 million pounds (1,100 to 11,000 kkg)

(Ref. 2). DOTP is used as a plasticizer

for polyvinyl chloride and related

plastics. Approximately 50 percent of

the annual production of DOTP is used

in 60°C insulation for electrical wire and

cable. Approximately 35 percent of the

DOTP produced is used for pond liners,

vinyl coated fabrics, shoe soles, and

gaskets. Some of the remaining uses of

DOTP include weatherstripping, outdoor

carpeting, coatings, automotive hose and

sealants, and water stops (Refs. 2 and

4).

Due to the batch process by whicl

DOTP is produced, Eastman Kodak

estimates that no more than 20 workers are exposed to DOTP during its

production, with a maximum duration of

exposure of 140 hours per worker per

year. No data are available on the

number of workers exposed to DOTP

during the preparation of plastic

products. DOTP issued as a plasticizer

in vinyl plastics where high resistance to

water extraction, high lacquer mar

resistance and low volatility are

desirable (Refs. 2 and 4).

No data are available from the

National Occupational Hazard Survey

(NOHS) on the numbers of workers

occupationally exposed to DOTP or on

the occupations/industries in which

workers may be exposed. Furthermore,

no threshold limit value (TLV) has been

recommended by the American

Conference of Governmental Industrial

Hygienists (ACGIH) for DOTP nor has a

Federal limit been established.

B. Health Effects Information

Eastman Kodak has performed

preliminary investigations on the acute

toxicity of DOTP in mice, guinea pigs,

rats and rabbits. Preliminary data

indicate that the LD5o values for DOTP

in both rats and mice are greater than

3,200 mg/kg after oral administration

and intraperitoneal injection (Refs. 2, 5

and 6). DOTP has been determined to be

a slight skin irritant when the undiluted

liquid is in contact with depilated guinea*

pig skin for 24 hours. Also, slight eye

irritation was reported in rabbits one

hour after 0.1 ml of DOTP was applied

(Refs. 2, 4, 5 and 6).

Eastman Kodak has also conducted

10-day feeding and inhalation studies in

rats. No systemic organ toxicity was

reported in rats that consumed as much

as 890 mg/kg/day for 10 days. In

addition, no compound-related effects

were found in rats exposed to 46.3 mg/

ml of DOTP 8 hours/day for 10 days

(Refs. 2, 4, 8 and 9).

C. Environmental Effects Information

Eastman Kodak has performed a

limited number of investigations on the

acute aquatic toxicity of DOTP (Refs. 2

and 5). Thses data show that the static

96-hour LCo for DOTP to fathead

minnows and kelisoma snails is greater

than 1,000 mg/L. It should be noted that

some of the lethalities may have

resulted from organisms becoming

entrapped in DOTP floating on the

surface of the aquaria because DOTP is

relatively water insoluble (<4 mg/L)

(Refs. 2 and 4).

III. Ongoing Testing

Eastman Kodak Compdny has in

progress in vitro and in vivo metabolism

studies and mutagenicity studies on

DOTP. The in vitro metabolism of DOTP was investigated using intestinal

homogenates prepared from SpragueDawley rats with which the rate of

disappearance of DOTP was measured

during a 30-minute incubation period at

37°C. Preliminary in vitro metabolism

study results indicated that the

calculated half-life for DOTP is 32

minutes and the DOTP is converted to

two moles of 2-ethylhexanol and one

mole of terephthalic acid. In the in vivo

metabolism study, the rats were given a

single dose by gavage of 100 mg/kg of 14 C labeled DOTP. The preliminary

results from this study indicate that

(14 C) DOTP was excreted by the rat in

the feces and urine. An average of 40.6

percent of the (14 C) DOTP administered

was recovered unchanged in the feces.

51846
Federal Register / Vol. 48, No. 220 / Monday, November 14; 1983 / Notices

Mono(2-ethylhexyl) terephthalate was

also detected in the feces. Terephthalic

acid was identified in the urine and

additional urinary metabolites are being

further studied. DOTP was negative in

mutagenicity tests, both with and

without activation, in the standard

Ames Salmonella! Microsome Assay

(Refs. 2, 7,. 8, and 9)..

Terephthalic acid (TPA) has been

identified as a possible metabolite of

DOTP (Refs. 2). The primary adverse

effects associated with TPA are renal

and bladder calculi in Fischer-344 rats

fed TPA at dietary levels of 3-5 percent

(Refs. 10, 11, 12 and 14]. No tumors or

toxic effects were noted in rats fed TPA

for two years at levels below one

percent (Refs. 13). Also TPA gave

negative results in the Salmonella

microsomal assay (Ref. 15).

The NTP/NCI bioassay program has

nominated a large number of chemcials

that contain the ethylhexyl moiety (as

does DOTP) to determine their

metabolic-toxicologic profiles. There are

presently 13 chemcials that contains the

ethylhexyl moiety selected for

toxicologic testing by NTP. 2-

Ethylhexanol and mono(2-

ethylhexyl)phthalate, two chemicals

similar to the metabolites of DOTP

identified in preliminary studies, have

been nominated for genotoxicity testing

by the NTP. Completion of the testing of

the 13 chemicals that contain the

ethylhexyl moiety and other chemical

analogues of di(2-ethylhexyl)phthalate

should provide a sound data base for

determining the structure-activity

relationship for the phthalate acid esters

(Ref. 3). "

IV. Planned Testing

Eastman Kodak Company has

proposed a testing program for DOTP

(Ref. 2). This program is designed to

accommodate the health and

environmental effects testing concerns

recommended by the ITC.

The health effects tests that Eastman

Kodak proposes to perform includes

mutagenicity, chemical disposition and

metabolism (currently ongoing), and a

90-day feeding study. The Ames

Salmonella/Microsome test, the

chromosomal aberration test and the

Chinese Hamster Ovary Hypoxanthine

Guanine Phosphoribosyl Transferase

Forward Mutation Assay (CHO/

HGPRT) are the mutagenicity tests that

Eastman Kodak Company proposes to

perform. Also a 90-day subchronic

feeding study will be performed. This

study will include histopathologic

examinations and examine peroxisomal

proliferation. The physico-chemical

properties and chemical fate tests that

Eastman Kodak Company will conduct

include the development of a sensitive

analytical method for determining the

concentration of DOTP in water,

octanol-water partition coefficient, the

water solubility of DOTP and a shakeflask biodegradation test. The acute and

chronic toxicity to fish and aquatic

invertebrate tests for DOTP that

Eastman Kodak intends to perform are a

2-week dynamic LC50 value for rainbow

trout, a 96-hour ECho value for oyster

shell deposition, and a 77-day rainbow

trout embryo larval study. The

bioconcentration factor for DOT will

be determined in oysters using 4 C

labeled DOTP. Using the various grasses

recommended by the TSCA testing

guidelines, the Eastman Kodak

Company will conduct seed germination

and early plant growth tests for DOTP.

The health and environmental effects

tests will be conducted using the TSCA

testing guidelines.

Agency scientists have reviewed

Eastman Kodak's program and believe

that the program should provide

sufficient information to assess the

various health and environmental

effects of bis(2-ethylhexyl)terephthalate.

The testing program and protocols are

available for examination in the public

record of this proceeding. Eastman

Kodak has provided the Agency with

preliminary laboratory selection

information and a proposed schedule

predicated on final program acceptance

in June, 1984. The mutagenicity studies

are scheduled to begin in July, 1984, with

final reprts submitted to the Agency in

February, 1985. The 90-day feeding

study will begin in September, 1984 and

be concluded with the submission of a

final report by August, 1985. The

development of an analytical method to

measure DOTP in water will begin in

July, 1984, with the final report being

available in November, 1984. Using that

method, the wate solubility and octanol/

water partition coefficient

determinations will then begin and final

reports will be delivered in March, 1985.

Biodegradation studies, acute rainbow

trout, acute oyster studies and plant

growth determinations will be initiated

in March, 1985. Final reports from these

investigations will be available in July,

1985. The rainbow trout embryo-larval

study and the oyster bioconcentration

test will begin in July, 1985 and the final

report will be submitted in March, 1986.

Eastman Kodak has agreed to adhere

to the Good Laboratory Practice

Standards issued by the U.S. Food and

Drug Administration is published in the

Federal Register of December 22, 1978

(43 FR 59986). Eastman Kodak Company

has also agreed to permit laboratory

inspections and study audits in

accordance with the provisions outlined

in TSCA section 11 at the request of

authorized representatives of the EPA

for the purpose of determining

compliance wtih this agreement. These

inspections may be conducted for

purposes which include verification that

testing has begun, that schedules are

being met, that reports accurately reflect

the underlying raw data and

interpretations and evaluations thereof,

- and that the studies are being conducted

according to Goo Laboratory Practice

Provisions.

Eastman Kodak Company has further

agreed that all raw data, documentation,

records, protocols, specimens, and

reports generated as a result of each

study will be retained for at least 10

years from the date of publication of the

acceptance of any protocols by EPA and

made available during an inspection or

submitted to EPA if requested by EPA or

its designated representative.

Documentation which will be retained

includes correspondence and other

documents relating to the conduct,

interpretation, or evaluation of data

other than that included in the final

report. Eastman Kodak understands that

the Agency plans to publish quarterly in

the Federal Register a notice of the

receipt of any test data submitted under

this agreement. Subject to TSCA section

14, the notice will provide information

similar to that described in TSCA

section 4(d). Except as otherwise

provided in TSCA section 14, any data

submitted will be made available by

EPA for examination by any person.

Eastman Kodak Company

understands that failure to conduct the

testing according to the specified

protocols and failure to follow Good

Laboratory Practice procedures may

invalidate the tests. In such cases, a

data gap may still exist, and the Agency

may decide to require further testing.

Also, should Eastman Kodak Company

fail to make a good faith effort to adhere

to its testing program outlined above,

EPA may initiate rulemaking to require

testing.

V. Decision Not To Initiate Rulemaking

• As noted above, Eastman Kodak has

included both health and environmental

effects testing for DOTP in their

proposed testing program. The health

effects tests that Eastman Kodak has

proposed to conduct include a battery of

mutagenicity tests, chemical disposition

and metabolism studies, and a 90-day

subchronic feeding study that includes

histopathologic examinations. The

environmental effects and chemical fate

tests for DOTP includes the

determination of the physico-chemical

properties of DOTP, a shake-flask CO 2

51847
Federal Register / Vol. 48, No. 220 / Monday, November 14, 1983 / Notices

biodegradation test, acute and chronic

toxicity to fish and aquatic

invertebrates, an oyster

bioconcentration test and plant toxicity

tests.

EPA believes that the testing program

proposed by Eastman Kodak Company

will provide sufficient data to

reasonably determine or predict the

biologic effects of bis(2-

ethylhexyl)terephthalate. The health

and environmental testing

recommendations made by the ITC will

be adequately addressed by the

proposed testing program developed by

the Eastman Kodak Company. 2-

Ethylhexanol and mono-(2-

ethylhexyl)phthalate are two chemicals

similar to the metabolites of DOTP that

have been nominated for genotoxicity

testing by the National Toxicology

Program. Also, 13 chemicals that contain

the same ethylhexyl moiety as does

DOTP have been selected for toxicologic

testing by the NTP. Completion of

Eastman Kodak Company's proposed

testing program and the NTP testing

should provide sufficient data to

adequately characterize the health and

environmental effects of DOTP.

Therefore, EPA has decided not to

initiate rulemaking under section 4(a) of

TSCA to require testing of DOTP at this

time. •

VI. References

(1) U.S. Environmental Protection Agency,

1982. Eleventh Report of the Interagency

Testing Committee, Bis(2-Ethylhexyl)

Terephthalate Recommendation, Federal

Register 47:54634-54636, December 3.

(2) Proposed Di(2-Ethylhexyl)Terephthalate

Testing Program: A Testing Program Under

Section 4 of the Toxic Substances Control

Act. Submitted to the U.S. Environmental

Protection Agency by the Eastman Kodak

Company, Submitted April 11, 1983; Revised

June 20 and August 4, 1983.

(3) Department of Health and Human

Services, 1983. Memorandum: Nomination of

Additional Compounds Containing the 2-

Ethylhexyl Moiety for NTP Mutagenicity

Testing from Dorothy A. Canter, NTP to

Members, Chemical Evaluation Committee

and Liaison Staff (Laurence S. Rosenstein,

U.S. EPA) May 31, 1983.

(4) Eastman Chemical Products, Inc. 1980.

Technical data sheets. KODAFLEX ® DOTP.

Dioctyl terephthalate (bis[2-ethylhexyl]

terephthalate). I-187C. Kingsport, TN 37662.

(5) Eastman Kodak Company. 1975a.

Unpublished data. Basic toxicology of bis(2-

ethylhexyl)terephthalate (dioctyl

terephthalate), DOTP. Washington, DC:

Office of Toxic Substances, U.S.

Environmental Protection Agency.

(6) Eastman Kodak Company. 1975b.

Unpublished data. Toxicity and health

hazard summary. Washington, DC: Office of

Toxic Substances, U.S. Environmental

Protection Agency.

(7) Eastman Kodak Company. 1980.

Unpublished data. Bacterial mutagenicity test

results. Washington, DC: Office of Toxic

Substances, U.S. Environmental Protection

Agency.

(8] Eastman Kodak Company. 1983a (Apr.

11). Health, Safety, and Human Factors

Laboratory, Rochester, NY 14650. Proposal.

Di(2-ethylhexyl]terephthalate: a testing

program under section 4 of the Toxic

Substances Control Act: Submitted to U.S.

Environmental Protection Agency.

(9) Eastman Kodak Company. 1983b (Jan.

18): Summary of health effects data on DOTP,

presented by H.B. Lockhart at TRDB Focus

Meeting on bis(2-ethylhexyl)terephthalate,

USEPA, Washington, DC.

(10) CIIT. 1981. Chemical Industry Institute

of Toxicology. A twenty-four month

toxicology study in Fischer-344 rats given

terephthalic acid. Eighteen-month Interim

Status Report. Performed by lIT for CIIT.

(11) CIIT. 1982. A ninety-day study of

terephthalic acid-induced urolithiasis and

reproductive performance in Wistar and CD

rats. Final Report. Joint study: Research

Triangle Institute, Experimental Pathology

Laboratories, Inc., and CIIT. '

(12) Chin Ty. Tyl RW, Popp JA, Fleck H

d'A. 1981. Chemical Urolithiasis. I.

Characteristics of bladder stone induction by

terephthalic acid and dimethyl terephthalate

in weanling Fischer-344 rats. Toxicol. Appl.

.Pharmacol. 58:307-321.

(13) Gross J'. 1974. The effects of prolonged

feeding of terephthalic acid (TPA) to rats.

Project FG-ls-175, USDA, Agricultural

Research Service, Washington, D.C.

(14) Heck H d'A. 1981. Chemical

urolithiasis 2. Thermodynamic aspects of

bladder stone induction by terephthalic acid

and dimethyl terephthalate in weanling

Fischer-344 rats. Fund. Appl. Tox. 1:299-308.

(15) NTP. 1981a. National Toxicology

Program. NTP, EMTDP Lab. Results by

Chemicals as of 10/26/81. NTP

Environmental Mutagenesis Test

Development Program, 1981.

VII. Public Record

EPA has established a public record

for this rulemaking (docket number

OPTS-42039) which is available for

inspection in the OPTS Reading Room

from 8:00 a.m. to 4:00 p.m., Monday

through Friday, except legal holidays in

Rm. E-107, 401 M St. SW., Washington,

D.C.

This record includes the basic

information the Agency considered in

developing this notice, and other

appropriate Federal Register notices.

The Agency will supplement the record

with additional information as it is

received. This record includes:

(1) Federal Register notices pertaining

to this notice consisting of:

(a) Notice containing the ITC

designation of Bis(2-

Ethylhexyl)Terephthalate to the priority

list (47 FR 54634, December 3, 1982).

(2) Support Documents Consisting of:

(a) Economic Analysis DocumentLevel I analysis.

(b) Eastman Kodak Company's

Proposed Testing Program-Original

and revised submissions.

(c) Telephone Contact Reports.

(d) Memoranda.

(e) Letters.

(f) Meeting Summaries.

Dated: November 3, 1983.

William D. Ruckelshaus,

Administrator.

[FR Doec. 83-30536 Filed 11-10-83: 8:45 aml

BILLING CODE 6560-50-M

IAD-FRL 2468-81

Control Techniques Guideline

Document; Control of Volatile Organic

Compound Emissions From

Manufacture of High-Density

Polyethylene, Polypropylene, and

Polystyrene Resins

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Release of final control

techniques guideline (CTG) document.

SUMMARY: A final CTG document for

control of volatile organic compund

(VOC) emissions from manufacture of

high-density polyethylene,

polypropylene, and polystyrene resins is

available. This final CTG document

provides guidance for the States in

determining reasonably available

control technology (RACT) for VOC

emissions from manufacture of highdensity polyethylene, polypropylene,

and polystyrene resins.

ADDRESSES: Copies of the final CTG

document may be obtained by

contacting the Environmental Research

Library (MD-35), (919) 541-2777, U.S.

Environmental Protection Agency,

Research Triangle Park, North Carolina

27711. Please refer to "Guidelines

Series-Control of Volatile Organic

Compund Emissions from Manufacture

of High-Density Polyethylene,

Polypropylene, and Polystyrene Resins,"

EPA-450/3--83-008. Comments received

on the draft CTG document are attached as an appendix to each final CTG

document and are also available for

public inspection and copying between

8:30 a.m. and 4:00 p.m., Monday through

Friday, at the Chemicals and Petroleum

Branch, Room 736, U.S. Environmental

Protection Agency, 411 West Chapel Hill

Street, Durham, North Carolina 27701.

FOR FURTHER INFORMATION CONTACT:

Mr. James C. Berry, (919) 541-5605,

Chemicals and Petroleum Branch (MD13), Emission Standards and Engineering

Division, US. Environmental Protection

Agency, Research Triangle Park, North

Carolina 27711.

51848