[Federal Register Volume 61, Number 120 (Thursday, June 20, 1996)]
[Notices]
[Pages 31522-31524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15810]
=======================================================================
-----------------------------------------------------------------------
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: guidelines@epamail.epa.gov. 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: keifer.leonard@epamail.epa.gov.
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:
sette.william@epamail.epa.gov.
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: guidelines@epamail.epa.gov 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:
guidelines@epamail.epa.gov
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
----------------------------------------------------------------------------------------------------------------
\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
