[Federal Register Volume 63, Number 150 (Wednesday, August 5, 1998)]
[Notices]
[Pages 41845-41848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20898]
[[Page 41845]]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00499; FRL-5740-1]
Test Guidelines; Notice of Availability
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.
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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 final test guidelines
for the Series 870--Health Effects Test Guidelines. The final
guidelines have been harmonized between the Office of Pesticide
Programs (OPP) and the Office of Pollution Prevention and Toxics (OPPT)
and, to the extent possible, with the Organization for Economic
Cooperation and Development (OECD) Guidelines for the Testing of
Chemicals. The test guidelines have been reviewed at various Scientific
Advisory Panel (SAP) meetings, the most recent of which was held on
October 29 and 30, 1996, as announced by notice in the Federal Register
(61 FR 31522, June 20, 1996) (FRL-5367-7). The guidelines have been
revised where appropriate in response to SAP and public comments. This
notice also describes the unified library of OPPTS test guidelines.
ADDRESSES: The guidelines are available from the U.S. Government
Printing Office (GPO), Washington, DC 20402 on disks or paper copies:
call (202) 512-0132. The guidelines are also available electronically
in PDF (portable document format) from EPA's World Wide Web site
(http://www.epa.gov/epahome/research.htm) under the heading
``Researchers and Scientists/Test Methods and Guidelines/OPPTS
Harmonized Test Guidelines.''
FOR FURTHER INFORMATION CONTACT: For general information: By mail:
Toxic Substances Control Act (TSCA) information: Contact the TSCA
Hotline at: TAIS/7408, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. Telephone number: (202) 554-1404; fax (202) 554-
5603; e-mail: TSCA-hotline@epa.gov.
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
information: Contact the Communications Services Branch (7506C), Field
and External Affairs Division, Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Telephone number: (703) 305-5017; fax (703) 305-5558.
For technical questions on Series 870 Genetic Toxicity test
guidelines: Michael Cimino, (202) 260-3451; e-mail:
cimino.michael@epa.gov.
For technical questions on other Series 870 test guidelines:
William Sette, (703) 305-6375; e-mail: sette.william@epa.gov.
SUPPLEMENTARY INFORMATION:
Electronic Availability: Electronic copies of this document and
various support documents are available from the EPA Home Page at the
Federal Register--Envirnonmental Documents entry for this document
under ``Laws and Regulations'' (http://www.epa.gov/fedrgstr/EPA-TOX/
1998/).
I. EPA's Process for Developing a Unified Library of Test
Guidelines
EPA's Office of Prevention, Pesticides and Toxic Substances has
been engaged in a multi-year project to harmonize and/or update test
guidelines among the Office of Pesticide Programs, the Office of
Pollution Prevention and Toxics, and the Organization for Economic
Cooperation and Development. The goals of the project include the
formulation of harmonized OPP and OPPT guidelines for those in common
between the two programs, the harmonization of OPPT and/or OPP
guidelines with those of the OECD, as well as the updating of any
guidelines unique to OPP or OPPT programs.
Test guidelines that are changed substantively from the existing
test guidelines in the Pesticide Assessment Guidelines or 40 CFR
158.795 through 158.799 in the harmonization process or through other
updating/amending activities, or which are new (e.g., for a previously
unaddressed test endpoint) are made available for public comment by
notice in the Federal Register. Additionally, EPA submits substantively
revised and new test guidelines to peer review by the FIFRA SAP and
other expert scientific panels. Guidelines which are reformatted but
not changed in any substantive way are not made available for public
comment or submitted to peer review.
All final guidelines are available through the Internet on the EPA
World Wide Web Home Page as a unified library of OPPTS test guidelines
for use by either EPA program office. Printed versions of the unified
library of OPPTS test guidelines are also available to the public
through GPO, see ``ADDRESSES'' at the beginning of this document. For
purposes of this Federal Register notice, ``publication'' of the
unified library of guidelines generally describes the availability of
these final guidelines through GPO and the Internet. Because
harmonization and updating is an ongoing task, some guidelines
available via GPO and the Internet may be revised in the future. These
efforts will ensure that industry is provided with test guidelines that
are current.
The test guidelines appearing in the unified library are given
numerical designations that are different from the designations
provided in the Code of Federal Regulations (CFR) at 40 CFR parts 158,
795, 796, 797, 798, and 799. OPPTS test guidelines will be published in
10 disciplinary series as follows:
Series 810--Product Performance Test Guidelines
Series 830--Product Properties Test Guidelines
Series 835--Fate, Transport and Transformation Test Guidelines
Series 840--Spray Drift Test Guidelines
Series 850--Ecological Effects Test Guidelines
Series 860--Residue Chemistry Test Guidelines
Series 870--Health Effects Test Guidelines
Series 875--Occupational and Residential Exposure Test Guidelines
Series 880--Biochemicals Test Guidelines
Series 885--Microbial Pesticide Test Guidelines
The Agency issues Federal Register notices periodically announcing
any new test guidelines added to the OPPTS unified library. As each set
of guidelines is published, it will be accompanied by a ``Master List''
which cross references the new OPPTS guideline numbers to the original
OPP, OPPT, and OECD numbers.
II. OPP and OPPT Procedures
For pesticide registration, explicit test requirements are set out
in 40 CFR part 158 which refers to specific guidelines by guideline
number. Once final revised guidelines are available through GPO and the
Internet, the earlier Pesticide Assessment Guidelines that were
available through the National Technical Information Service (NTIS)
will be removed from distribution. Studies initiated 45 days or more
after publication of the notice of availability in the Federal Register
should be performed in accordance with the revised guidelines; however,
registrants should discuss effective dates for long term studies with
the EPA Product Manager. As test guidelines are published, the Agency
will inform industry and the general public by means of Federal
Register notices. In addition, Data Call In letters to pesticide
registrants will carry a dual numbering system for test guidelines
until all test guidelines have been published. Part 158, which is
currently being revised, will also carry a dual numbering system
[[Page 41846]]
for test guidelines when it is proposed in the Federal Register.
In contrast, OPPT had previously published its pre-harmonization
test guidelines in 40 CFR parts 795 through 798. Recent TSCA test
guidelines, based on harmonized test guidelines, have been published in
part 799. TSCA test guidelines are referenced in test standards
promulgated in chemical-specific test rules in part 799. To the extent
that a person is subject to a test rule which references a pre-
harmonization guideline published in 40 CFR parts 795 through 798, the
test rule still requires compliance with the pre-harmonization test
guideline that was referenced by the rule. However, if the person
subject to the test rule is interested in seeking a modification to the
requirement to comply with the test standard promulgated in the test
rule, EPA encourages that person to consult the modification procedures
outlined in 40 CFR part 790. EPA has removed and will continue to
remove from the CFR those pre-harmonization guidelines that are no
longer referenced in an applicable test rule.
III. Peer Review of Series 870 Health Effects Test Guidelines
The Agency has updated and harmonized test guidelines for health
effects (870 Series) and submitted the revisions to peer review by the
FIFRA SAP on October 29 and 30, 1996. EPA also made these revised
guidelines available to the public for comment through the OPP docket
and on the Internet through the EPA Home Page. Guidelines in this
series have been revised in response to peer review and public comment.
In addition, the series includes four new guidelines: Neurophysiology,
Sensory Evoked Potentials (OPPTS 870.6855); Domestic Animal Safety
(OPPTS 870.7200); Dermal Penetration (OPPTS 870.7600); and
Immunotoxicity (OPPTS 870.7800). Two guidelines have been deleted:
Preliminary Developmental Toxicity Screen (OPPTS 870.3500) and
Inhalation Developmental Toxicity Study (OPPTS 870.3600). One guideline
has been removed from the harmonized category: Acute Inhalation with
Histopathology (OPPTS 870.1350). Three guidelines have been totally
revised and updated: Prenatal Developmental Toxicity (OPPTS 870.3700);
Reproduction and Fertility Effects (OPPTS 870.3800); and Metabolism and
Pharmacokinetics (OPPTS 870.7485). The sub-chronic guidelines for all
routes of exposure have been updated to match the new OECD Guidelines
408 and 409. Under genetic toxicology testing, two guidelines
addressing reverse mutation have been combined into one guideline:
Bacterial Reverse Mutation Test (OPPTS 870.5100). Six guidelines have
been harmonized with the most recent OECD updated tests. One new
guideline has been added: Mammalian Spermatogonial Chromosome
Aberration Test (OPPTS 870.5380). One OPPT guideline (40 CFR 798.5955
Heritable Translocation Test in Drosophila melanogaster) was not
updated due to lack of use. The remaining twelve mutagenicity
guidelines were not changed substantively, but were reformatted for
consistency with other harmonized 870 Series guidelines. A detailed
description of the response to comments and the changes to guidelines
are available under docket control number OPP-00499 in the Public
Information and Records Integrity Branch, Information Resources and
Services Division, Office of Pesticide Programs, Rm. 119, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA; telephone: (703) 305-
5805, or by mail: Public Information and Records Integrity Branch,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460.
IV. Request for Comment on Potential Voluntary Consensus Standards
to Consider for Future Regulatory Actions
This notice of availability does not involve a proposed regulatory
action that would require the Agency to consider voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Pub. L. 104-113, section 12(d) (15
U.S.C. 272 note). Section 12(d) directs EPA to use voluntary consensus
standards in its regulatory activities unless to do so would be
inconsistent with applicable law or otherwise impractical. Voluntary
consensus standards are technical standards (e.g., materials
specifications, test methods, sampling procedures, business practices,
etc.) that are developed or adopted by voluntary consensus standards
bodies. The NTTAA requires EPA to provide Congress, through OMB,
explanations when the Agency decides not to use available and
applicable voluntary consensus standards when the NTTAA directs the
Agency to do so.
As indicated earlier, these guidelines represent an Agency effort
to harmonize the test guidelines between OPP and OPPT, as well as
harmonizing the OPP and OPPT test guidelines with those of the OECD.
The process for developing and amending these test guidelines includes
the extensive involvement of the scientific community, including peer
review by the FIFRA SAP and other expert scientific panels, and
providing extensive public comment.
In the future, these test guidelines could be incorporated into
regulatory actions taken by EPA pursuant to TSCA section 4. Although
the NTTAA requirements do not specifically apply to the issuance of
these particular test guidelines today, EPA invites your comment on
whether or not there are any voluntary consensus standards that should
be considered during the development of any future action under TSCA.
Future actions under TSCA section 4 would go through notice and comment
rulemaking or be negotiated as voluntary testing enforcement
agreements/consent orders/decrees, allowing for additional public
comment on this issue. Nevertheless, the Agency is interested in
whether or not there are any voluntary consensus standards that EPA
should considered in leu of these test guidelines when the Agency
develops any future regulatory action that incorporates these test
guidelines. Any comments provided will assist the Agency in complying
with the NTTAA by facilitating the Agency's identification of voluntary
consensus standards that should be considered during the development of
a proposed regulatory action that incorporates any standards included
in these test guidelines. Please submit your comments to the technical
person for TSCA that is identified in the ``FOR FURTHER INFORMATION
CONTACT'' section at the beginning of this document.
V. Notice of Availability of Final Test Guidelines
This notice announces the availability of final versions of all
test guidelines in the 870 Health Effects Series. The following is the
list of test guidelines being made available at this time.
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Series 870--Health Effects Test Guidelines
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Existing Numbers EPA Pub.
-------------------------------- no.
OPPTS Number Name -----------
OPPT OPP OECD 712-C-
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Group A--Acute Toxicity Test
870.1000 Acute toxicity testing-background none none none 98-189
870.1100 Acute oral toxicity 798.1175 81-1 401 98-190
870.1200 Acute dermal toxicity 798.1100 81-2 402 98-192
870.1300 Acute inhalation toxicity 798.1150 81-3 403 98-193
870.2400 Acute eye irritation 798.4500 81-4 405 98-195
870.2500 Acute dermal irritation 798.4470 81-5 404 98-196
870.2600 Skin sensitization 798.4100 81-6 406 98-197
Group B--Subchronic Toxicity Test
Guidelines.
870.3100 90-Day oral toxicity in rodents 798.2650 82-1 408 98-199
870.3150 90-Day oral toxicity in nonrodents none 82-1 409 98-200
870.3200 21/28-Day dermal toxicity none 82--2 410 98-201
870.3250 90-Day dermal toxicity 798.2250 82-3 411 98-202
870.3465 90-Day inhalation toxicity 798.2450 82-4 413 98-204
870.3700 Prenatal developmental toxicity 798.4900 83-3 414 98-207
study
870.3800 Reproduction and fertility effects 798.4700 83-4 416 98-208
Group C--Chronic Toxicity Test
Guidelines.
870.4100 Chronic toxicity 798.3260 83-1 452 98-210
870.4200 Carcinogenicity 798.3300 83-2 451 98-211
870.4300 Combined chronic toxicity/ 798.3320 83-5 453 98-212
carcinogenicity
Group D--Genetic Toxicity Test
Guidelines.
870.5100 Bacterial reverse mutation test 798.5100, 84-2 471, 472 98-247
.5265
870.5140 Gene mutation in Aspergillus 798.5140 84-2 none 98-215
nidulans
870.5195 Mouse biochemical specific locus 798.5195 84-2 none 98-216
test
870.5200 Mouse visible specific locus test 798.5200 84-2 none 98-217
870.5250 Gene mutation in Neurospora crassa 798.5250 84-2 none 98-218
870.5275 Sex-linked recessive lethal test 798.5275 84-2 477 98-220
in Drosophila melanogaster
870.5300 In vitro mammalian cell gene 798.5300 84-2 476 98-221
mutation test
870.5375 In vitro mammalian chromosome 798.5375 84-2 473 98-223
aberration test
870.5380 Mammalian spermatogonial 798.5380 84-2 483 98-224
chromosomal aberration test
870.5385 Mammalian bone marrow chromosomal 798.5385 84-2 475 98-225
aberration test
870.5395 Mammalian erythrocyte micronucleus 798.5395 84-2 474 98-226
test
870.5450 Rodent dominant lethal assay 798.5450 84-2 478 98-227
870.5460 Rodent heritable translocation 798.5460 84-2 none 98-228
assays
870.5500 Bacterial DNA damage or repair 798.5500 84-2 none 98-229
tests
870.5550 Unscheduled DNA synthesis in 798.5550 84-2 482 98-230
mammalian cells in culture
870.5575 Mitotic gene conversion in 798.5575 84-2 481 98-232
Saccharomyces cerevisiae
870.5900 In vitro sister chromatid exchange 798.5900 84-2 479 98-234
assay
870.5915 In vivo sister chromatid exchange 798.5915 84-2 none 98-235
assay
Group E--Neurotoxicity Test
Guidelines.
870.6100 Acute and 28-day delayed 798.6450, 81-7, 82- 418, 419 98-237
neurotoxicity of organophosphorus .6540, 5, 82-6
substances .6560
870.6200 Neurotoxicity screening battery 798.6050, 81-8, 82- 424 98-238
.6200, 7, 83-1
.6400
870.6300 Developmental neurotoxicity study none 83-6 none 98-239
870.6500 Schedule-controlled operant 798.6500 85-5 none 98-240
behavior
870.6850 Peripheral nerve function 798.6850 85-6 none 98-241
870.6855 Neurophysiology: Sensory evoked 798.6855 none none 98-242
potentials
Group F--Special Studies Test
Guidelines.
870.7200 Companion animal safety none none none 98-349
870.7485 Metabolism and pharmacokinetics 798.7485 85-1 417 95-244
870.7600 Dermal penetration none 85-3 none 98-350
870.7800 Immunotoxicity none 85-7 none 98-351
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[[Page 41848]]
List of Subjects
Environmental protection, Test guidelines.
Dated: July 29, 1998.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 98-20898 Filed 8-4-98; 8:45 am]
BILLING CODE 6560-50-F
