Proposed Testing Guidelines; Notice of Availability and Request for Comments

ENVIRONMENTAL PROTECTION AGENCY

[OPP-00434; FRL-5367-7]

Proposed Testing Guidelines; Notice of Availability and Request

for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability and request for comments.

-----------------------------------------------------------------------

SUMMARY: EPA has established a unified library for test guidelines

issued by the Office of Prevention, Pesticides and Toxic Substances

(OPPTS), and is announcing the availability of proposed testing

guidelines for Series 870-Health Effects Test Guidelines. These test

guidelines have been updated and harmonized, to the extent possible,

with the Organization for Economic Cooperation and Development (OECD)

guidelines for testing of chemicals, and other relevant international

standards. A FIFRA Scientific Advisory Panel (SAP) meeting to review

the Series 870 test guidelines will be scheduled for this summer.

Complete details of this meeting will be announced in a Federal

Register notice.

DATES: Comments must be received on or before August 19, 1996.

ADDRESSES: Interested persons are invited to submit written comments in

triplicate to: By mail: Public Response and Program Resources Branch,

Field Operations Division (7506C), Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. In person: Bring comments to: Rm.

1132, CM#2, 1921 Jefferson Davis Highway, Arlington, VA.

Comments and data may also be submitted electronically by sending

electronic mail (e-mail) to: [email protected]. Electronic

comments must be submitted as an ASCII file avoiding the use of special

characters and any form of encryption. Comments and data will also be

accepted on disks in WordPerfect in 5.1 file format or ASCII file

format. All comments and data in electronic form must be identified by

the docket number ``OPP-00434'' (FRL-5367-7). No Confidential Business

Information (CBI) should be submitted through e-mail. Electronic

comments on this document may be filed online at many Federal

Depository Libraries. Additional information on electronic submissions

can be found under ``SUPPLEMENTARY INFORMATION.''

Information submitted as a comment in response to this notice may

be claimed confidential by marking any part or all of that information

as CBI. Information so marked will not be disclosed except in

accordance with procedures set forth in 40 CFR part 2. A copy of the

comment that does not contain CBI must be submitted for inclusion in

the public docket. Information not marked confidential will be included

in the public docket without prior notice. All statements will be made

part of the record.

FOR FURTHER INFORMATION CONTACT: By mail: Leonard Keifer, Office of

Pollution Prevention and Toxics (7403), U.S. Environmental Protection

Agency, 401 M Street, SW., Washington, DC 20460; telephone: (202) 260-

1548; e-mail: [email protected].

By mail: William Sette, Office of Pesticide Programs (7509C), U.S.

Environmental Protection Agency, 401 M Street, SW., Washington, DC

20460; telephone: (703) 305-6375; e-mail:

[email protected].

Copies of documents may be obtained by contacting: By mail: Public

Docket and Freedom of Information Section, Field Operations Division

(7506C), Office of Pesticide Programs, Environmental Protection Agency,

401 M St., SW., Washington, DC 20460. In person or for courier pick-up:

Office location and telephone number: Rm. 1132, CM #2, 1921 Jefferson

Davis Highway, Arlington, VA, (703) 305-5805. By internet: e-mail

requests to: [email protected] or via the EPA Public Access

Gopher (gopher.epa.gov) under the heading ``Environmental Test Methods

and Guidelines.''

SUPPLEMENTARY INFORMATION: The Agency is revising its test guidelines

for Series 870--Health Effects Test Guidelines. Guidelines in the 870

Series are for use by the Office of Pesticide Programs (OPP) and the

Office of Pollution Prevention and Toxics (OPPT) and have been

harmonized with those of OECD. The proposed guidelines are being made

available for comment. All interested parties are encouraged to submit

comments on the proposed guidelines. Specific comments should reference

the specific number and paragraph or subparagraph of the appropriate

proposed guideline. Recommended technical or scientific changes/

modifications should be supported by current scientific/technical

knowledge and include supporting references. References may be to the

published literature, studies submitted to the Agency in support of

registration, and unpublished data. Citations must be sufficiently

detailed so as to allow the Agency to obtain copies of the original

documents and unpublished data supplied to allow their evaluation.

A record has been established for this notice under docket number

``OPP-00434'' (including comments and data submitted electronically as

described below). A public version of this record, including printed,

paper versions of electronic comments, which does not include any

information claimed as CBI, is available for inspection from 8:00 a.m.

to 4:30 p.m., Monday through Friday, excluding legal holidays. The

public record is located in Rm. 1132 of the Public Response and Program

Resources Branch, Field Operations Division (7506C), Office of

Pesticide Programs, Environmental Protection Agency, Crystal Mall #2,

1921 Jefferson Davis Highway, Arlington, VA.

Electronic comments can be sent directly to EPA at:

[email protected]

Electronic comments must be submitted as an ASCII file avoiding the

use of special characters and any form of encryption.

The official record for this notice, as well as the public version,

as described above will be kept in paper form. Accordingly, EPA will

transfer all comments received electronically into printed, paper form

as they are received and will place the paper copies in the official

record which will also include all comments submitted directly in

writing. The official record is the paper record maintained at the

address in ``ADDRESSES'' at the beginning of this document.

The following is the complete list of proposed guidelines being

made available at this time:

[[Page 31523]]

Series 870--Health Effects Test Guidelines

----------------------------------------------------------------------------------------------------------------

Existing Numbers EPA Pub.

--------------------------------- no.

OPPTS Number Name ----------

OTS OPP OECD 712-C-

----------------------------------------------------------------------------------------------------------------

Group A--Acute Toxicity Test

870.1000 Acute toxicity testing--background none none none 96-189

870.1100 Acute oral toxicity 798.1175 81-1 401 96-190

870.1200 Acute dermal toxicity 798.1100 81-2 402 96-192

870.1300 Acute inhalation toxicity 798.1150 81-3 403 96-193

870.1350 Acute inhalation toxicity with none none none 96-291

histopathology

Group B--Specific Organ/Tissue

Toxicity Test Guidelines.

870.2400 Acute eye irritation 798.4500 81-4 405 96-195

870.2500 Acute dermal irritation 798.4470 81-5 404 96-196

870.2600 Skin sensitization 798.4100 81-6 406 96-197

Group C--Subchronic Toxicity Test

Guidelines.

870.3100 90-Day oral toxicity 798.2650 82-1 408 96-199

870.3150 Subchronic nonrodent oral none 82-1 409 96-200

toxicity--90-day

870.3200 Repeated dose dermal toxicity--21/ none 82--2 410 96-201

28 days

870.3250 Subchronic dermal toxicity--90 798.2250 82-3 411 96-202

days

870.3465 Subchronic inhalation toxicity 798.2450 82-4 413 96-204

870.3500 Preliminary developmental toxicity 798.4420 none none 96-205

screen

870.3600 Inhalation developmental toxicity 798.4350 none none 96-206

study

870.3700 Prenatal developmental toxicity 798.4900 83-3 414 96-207

study\1\

870.3800 Reproduction and fertility 798.4700 83-4 416 96-208

effects\1\

Group D--Chronic Toxicity Test

Guidelines.

870.4100 Chronic toxicity 798.3260 83-1 452 96-210

870.4200 Carcinogenicity 798.3300 83-2 451 96-211

870.4300 Combined chronic toxicity/ 798.3320 83-5 453 96-212

carcinogenicity

Group E--Genetic Toxicity Test

Guidelines.

870.5100 Escherichia coli WP2 and WP2 uvrA 798.5100 84-2 471, 96-247

reverse mutation assays 472

870.5140 Gene mutation in Aspergillus 798.5140 84-2 none 96-215

nidulans

870.5195 Mouse biochemical specific locus 798.5195 84-2 none 96-216

test

870.5200 Mouse visible specific locus test 798.5200 84-2 none 96-217

870.5250 Gene mutation in Neurospora crassa 798.5250 84-2 none 96-218

870.5265 The Salmonella typhimurium reverse 798.5265 84-2 471, 96-219

mutation assay 472

870.5275 Sex-linked recessive lethal test 798.5275 84-2 477 96-220

in Drosophila melanogaster

870.5300 Detection of gene mutations in 798.5300 84-2 476 96-221

somatic cells in culture

870.5375 In vitro mammalian cytogenetics 798.5375 84-2 473 96-223

870.5380 In vivo mammalian cytogenetics 798.5380 84-2 none 96-224

tests: spermatogonial chromosomal

aberrations

870.5385 In vivo mammalian cytogenetics 798.5385 84-2 475 96-225

tests: Bone marrow chromosomal

analysis

870.5395 In vivo mammalian cytogenetics 798.5395 84-2 474 96-226

tests: Erythrocyte micronucleus

assay

870.5450 Rodent dominant lethal assay 798.5450 84-2 478 96-227

870.5460 Rodent heritable translocation 798.5460 84-2 485 96-228

assays

870.5500 Bacterial DNA damage or repair 798.5500 84-2 none 96-229

tests

870.5550 Unscheduled DNA synthesis in 798.5550 84-2 482 96-230

mammalian cells in culture

870.5575 Mitotic gene conversion in 798.5575 84-2 481 96-232

Saccharomyces cerevisiae

870.5900 In vitro sister chromatid exchange 798.5900 84-2 479 96-234

assay

870.5915 In vivo sister chromatid exchange 798.5915 84-2 none 96-235

assay

Group F--Neurotoxicity Test

Guidelines.

870.6100 Delayed neurotoxicity of 798.6450, 81-7, 82- 418, 96-237

organophosphorus substances .6540, 5, 82-6 419

following acute and 28-day .6560

exposure

870.6200 Neurotoxicity screening battery 798.6050, 81-8, 82- none 96-238

.6200, 7, 83-1

.6400

870.6300 Developmental neurotoxicity study none 83-6 none 96-239

870.6500 Schedule-controlled operant 798.6500 85-5 none 96-240

behavior

870.6850 Peripheral nerve function 798.6850 85-6 none 96-241

870.6855 Neurophysiology: Sensory evoked 798.6855 none none 96-242

potentials

Group G--Special Studies Test

Guidelines.

[[Page 31524]]

870.7200 Domestic animal safety none none none 96-349

870.7485 Metabolism and pharmacokinetics\2\ 798.7485 85-1 417 95-244

870.7600 Dermal penetration none 85-3 none 96-350

870.7800 Immunotoxicity none 85-7 none 96-351

Group H--Health Effects Chemical-

Specific Test Guidelines.

870.8223 Pharmacokinetic test 795.223 none none 96-250

870.8245 Dermal pharmacokinetics of DGBE 795.225 none none 96-251

and DGBA

870.8300 Dermal absorption for compounds 795.226 none none 96-252

that are volatile and metabolized

to carbon dioxide

870.8320 Oral/dermal pharmacokinetics 795.228 none none 96-253

870.8340 Oral and inhalation 795.230 none none 96-254

pharmacokinetic test

870.8360 Pharmacokinetics of isopropanol 795.231 none none 96-255

870.8380 Inhalation and dermal 795.232 none none 96-256

pharmacokinetics of commercial

hexane

870.8500 Toxicokinetic test 795.235 none none 96-257

870.8600 Developmental neurotoxicity screen 795.250 none none 96-258

870.8700 Subchronic oral toxicity test 795.260 none none 96-259

870.8800 Morphologic transformation of 795.285 none none 96-260

cells in culture

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\1\Notice of availability published at 61 FR 8282, March 4, 1996.

\2\Notice of availability published at 60 FR 45158, August 30, 1995.

List of Subjects

Environmental protection, Test guidelines.

Dated: June 12, 1996.

Lynn R. Goldman,

Assistant Administrator for Prevention, Pesticides and Toxic

Substances.

[FR Doc. 96-15810 Filed 6-19-96; 8:45 am]

BILLING CODE 6560-50-F