[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Notices]
[Pages 8279-8282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4964]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00423; FRL-4990-3]
Testing 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 testing guidelines for
the following three series: Series 875-Occupational and Residential
Exposure Test Guidelines, Series 880-Biochemicals Test Guidelines, and
Series 885-Microbial Pesticide Test Guidelines. The guidelines in these
three series have been minimally edited for re-publication, but have
not been changed in any substantive way. Issuance of guidelines in
these three series initiates the publication of the unified library of
OPPTS Test Guidelines. This notice also describes the process of
developing this unified library of OPPTS Test Guidelines. The Agency
intends to issue Federal Register notices periodically as new test
guidelines are added to the OPPTS unified library.
ADDRESSES: The guidelines are available from the U.S. Government
Printing Office, Washington, DC 20402 on The Federal Bulletin Board. By
modem dial (202) 512-1387, telnet and ftp: fedbbs.access.gpo.gov (IP
162.140.64.19), or call (202) 512-1530 for disks or paper copies. The
guidelines are also available electronically in ASCII and PDF (portable
document format) from the EPA Public Access Gopher (gopher.epa.gov)
under the heading ``Environmental Test Methods and 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: [email protected].
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
information: Contact the Communications Branch (7506C), Field
Operations Division, Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Telephone
number: (703) 305-5017; fax is (703) 305-5558.
For technical information on series 875: Alan Nielsen, (703) 305-
5242, e-mail: [email protected].
For technical information on series 880 and series 885: William
Schneider, (703) 308-8683, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. EPA's Process for Developing a Unified Library of Test
Guidelines
EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS)
is close to completion of a multi-year project to harmonize and/or
update test guidelines among the Office of Pesticide Programs (OPP),
the Office of Pollution Prevention and Toxics (OPPT), and the
Organization for Economic Cooperation and Development (OECD). 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.
Testing guidelines that are changed substantively in the
harmonization process or through other updating/amending activities, or
which are new (e.g., for a previously unaddressed testing endpoint)
will be made available for public comment by notice in the Federal
Register. Additionally, EPA will submit these substantively revised and
new test guidelines to peer review by expert scientific panels.
Guidelines which are reformatted but not changed in any substantive way
will not be made available for public comment or submitted to peer
review. Because harmonization and updating is an ongoing task that will
periodically result in modified guidelines, some guidelines being made
available via GPO and Internet will be subject to revisions in the
future. These efforts will ensure that industry is provided with
testing guidelines that are current.
All final guidelines will be made available through the GPO
Electronic Bulletin Board and the Internet on the EPA Public Access
Gopher as a unified library of OPPTS Test Guidelines for use by either
program office. Printed versions of the unified library of OPPTS test
guidelines will also be available through the GPO. For purposes of this
Federal Register notice, ``publication'' of the unified library of
guidelines generally describes the availability of these guidelines
with the GPO and Internet.
The test guidelines appearing in the unified library will be given
numerical designations that are different from the designations
provided 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
[[Page 8280]]
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 intends to issue Federal Register notices periodically
as new test guidelines are 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 and OPPT numbers.
II. Impact on OPP and OPPT
Currently, OPP makes its test guidelines available through the
National Technical Information Service (NTIS) as a series of twelve
subdivisions. Explicit test requirements for pesticide registration are
set out in 40 CFR part 158 which refers to specific guidelines by
guideline number. EPA recommends that the test guidelines published
through GPO and Internet be consulted instead of those test guidelines
that were published through NTIS; studies initiated 45 days or more
after final publication should be performed in accordance with the
revised guidelines. As test guidelines are published, the Agency will
inform industry and the general public by means of PR Notices as well
as FR Notices. In addition, Data Call In letters to pesticide
registrants will carry a dual numbering system in reference to test
guidelines until all test guidelines have been published. Part 158,
which is currently under revision, will also carry a dual numbering
system for test guidelines when it is proposed and finalized in the
Federal Register.
In contrast, OPPT has been publishing its test guidelines in the
Code of Federal Regulations (CFR) in 40 CFR parts 795 through 798 and
are referenced on a chemical-specific basis in its TSCA section 4 test
rules in 40 CFR part 799. Although OPPT is currently evaluating whether
to continue to publish its test guidelines in the CFR, OPPT test
guidelines and modifications to those test guidelines that have been
incorporated by an existing test rule will be retained in the CFR until
OPPT announces that it will no longer publish its test guidelines in
the CFR. Therefore, to the extent that a manufacturer or processor
became subject to a test rule prior to the adoption of a harmonized
test guideline, that test rule still requires compliance with the test
guideline that was referenced by the test rule and published in the
CFR. However, if the manufacturer or processor subject to the test rule
is interested in seeking a modification to the requirement to comply
with the test guideline that appears in the CFR, and which is
incorporated by reference in that test rule, EPA encourages that
manufacturer or processor to consult the modification procedures
outlined in 40 CFR part 790. EPA has removed, and will continue to
remove from the CFR those test guidelines that are no longer
incorporated by reference in an existing and applicable test rule.
III. Peer Review of Test Guidelines
The Agency has updated and harmonized test guidelines for Product
Properties (830 series) and Residue Chemistry (860 series) (60 FR
44343, August 25, 1995) (FRL-4974-3). EPA submitted the revisions to
those series to peer review by the FIFRA Scientific Advisory Panel on
September 27, 1995. EPA also made these revisions available to the
public for comment through the EPA docket. They will be revised in
response to all comments received and published as final guidelines
early in 1996.
EPA is also announcing that it intends to make available for public
comment prior to peer review meetings the revised test guidelines for
Ecological Effects (850 series), Health Effects (870 series), and Fate
and Transport (840 series) during 1996.
IV. Notice of Availability of Republished Test Guidelines
This notice announces the availability of OPP unique test
guidelines in the 875, 880, and 885 series. The test guidelines in
series 875, 880, and 885 have been minimally edited for publication
with GPO and Internet, but have not been changed in any substantive
way. Guideline Series 880 is drawn from Subdivision M of the Pesticide
Assessment Guidelines and pertains to special testing approaches to
biochemical pesticides. Only those guidelines from Subdivision M which
are truly unique to biochemical pesticides are being published in
series 880. The other non-unique tests for biochemical pesticides
should be performed using the guidelines for chemical pesticides.
Although the Agency is in the process of revising its test guidelines
for Post-Application Exposure (875B), the current guidelines are still
official and are being published as part of the unified library of
OPPTS test guidelines. When EPA has completed the process for revising
the Post-Application Exposure guidelines in 1997, the revised
guidelines will replace the current guidelines. In the interim,
registrants are advised to contact EPA's Occupational and Residential
Exposure Branch, within the Office of Pesticide Programs, at (703) 305-
6094.
The following is the complete list of guidelines being made
available at this time.
Series 875--Occupational and Residential Exposure Test Guidelines
----------------------------------------------------------------------------------------------------------------
Existing Numbers EPA Pub.
-------------------------------- no.
OPPTS Number Name -----------
OTS OPP OECD 712-C-
----------------------------------------------------------------------------------------------------------------
Group A--Applicator Exposure
875.1000 Background for application none 230 none 96-261
exposure monitoring test
guidelines
875.1100 Dermal exposure--outdoor none 231 none 96-262
875.1200 Dermal exposure--indoor none 233 none 96-209
875.1300 Inhalation exposure--outdoor none 232 none 96-263
875.1400 Inhalation exposure--indoor none 234 none 96-213
875.1500 Biological monitoring none 235 none 96-264
875.1600 Application exposure monitoring none 236 none 96-265
data reporting
Group B--Postapplication Exposure
Monitoring Test Guidelines.
875.2000 Background for postapplication none 130, 131 none 96-266
exposure monitoring test
guidelines
[[Page 8281]]
875.2100 Foliar dislodgeable residue none 132-1 none 96-267
dissipation
875.2200 Soil residue dissipation none 132-1 none 96-243
875.2400 Dermal exposure none 133-3 none 96-269
875.2500 Inhalation exposure none 133-4 none 96-270
875.2600 Biological monitoring none 235 none 96-271
875.2800 Descriptions of human activity none 133-1 none 96-283
875.2900 Data reporting and calculations none 134 none 96-272
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Series 880--Biochemicals Test Guidelines
----------------------------------------------------------------------------------------------------------------
Existing Numbers EPA Pub.
-------------------------------- no.
OPPTS Number Name -----------
OTS OPP OECD 712-C-
----------------------------------------------------------------------------------------------------------------
Group A--Product Analysis Test
Guidelines.
880.1100 Product identity and composition none 151-10 none 96-273
880.1200 Description of starting materials, none 151-11 none 96-274
production and formulation
process
880.1400 Discussion of formation of none 151-12 none 96-275
impurities
Group B--Toxicology Test
Guidelines.
880.3550 Immunotoxicity none 152-18 none 96-280
880.3800 Immune response none 152-24 none 96-281
Group C--Nontarget Organisms and
Environmental Testing Test
Guidelines.
880.4350 Nontarget insect testing none 154-11 none 96-285
880.4425 Dispenser water leaching none 155-5 none 96-286
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Series 885--Microbial Pesticide Test Guidelines
----------------------------------------------------------------------------------------------------------------
Existing Numbers EPA Pub.
-------------------------------- no.
OPPTS Number Name -----------
OTS OPP OECD 712-C-
----------------------------------------------------------------------------------------------------------------
885.0001 Overview for microbial pest none 150A none 96-290
control agents
Group A--Product Analysis Test
Guidelines.
885.1100 Product identity none 151A-10 none 96-292
885.1200 Manufacturing process none 151A-11 none 96-293
885.1300 Discussion of formation of none 151A-01 none 96-294
unintentional ingredients
885.1400 Analysis of samples none 151A-13 none 96-295
885.1500 Certification of limits none 151A-15 none 96-296
. Group B--Residues Test Guidelines.
885.2000 Background for residue analysis of none 153A-1 none 96-299
microbial pest control agents
885.2100 Chemical identity none 153A-4 none 96-300
885.2200 Nature of the residue in plants none 153A-6 none 96-302
885.2250 Nature of the residue in animals none 153A-7 none 96-311
885.2300 Analytical methods--plants none 153A-8a none 96-301
885.2350 Analytical methods--animals none 153A-8b none 96-305
885.2400 Storage stability none 153A-9 none 96-306
885.2500 Magnitude of residues in plants none 153A-10 none 96-307
885.2550 Magnitude of residues in meat, none 153A-11 none 96-308
milk, poultry, eggs
885.2600 Magnitude of residues in potable none 153A-01 none 96-309
water, fish, and irrigated crops
Group C--Toxicology Test
Guidelines.
885.3000 Background-mammalian toxicity/ none 152A-1 none 96-314
pathogenicity/infectivity
885.3050 Acute oral toxicity/pathogenicity none 152A-10 none 96-315
885.3100 Acute dermal toxicity/pathology none 152A-11 none 96-316
885.3150 Acute pulmonary toxicity/ none 152A-12 none 96-317
pathogenicity
[[Page 8282]]
885.3200 Acute injection toxicity/ none 152A-13 none 96-318
pathogenicity
885.3400 Hypersensitivity incidents none 152A-15 none 96-320
885.3500 Cell culture none 152A-16 none 96-321
885.3550 Acute toxicology, Tier II none 152A-20 none 96-322
885.3600 Subchronic toxicity/pathogenicity none 152A-21 none 96-323
885.3650 Reproductive/fertility effects none 152A-30 none 96-324
Group D--Nontarget Organism and
Environmental Expression Test
Guidelines.
885.4000 Background for nontarget organism none 154A-1, none 96-328
testing of microbial pest control 2, 3, 4,
agents 5
885.4050 Avian oral, Tier I none 154A-16 none 96-329
885.4100 Avian inhalation test, Tier I none 154A-17 none 96-330
885.4150 Wild mammal testing, Tier I none 154A-18 none 96-331
885.4200 Freshwater fish testing, Tier I none 154A-19 none 96-332
885.4240 Freshwater aquatic invertebrate none 154A-20 none 96-333
testing, Tier I
885.4280 Estuarine and marine animal none 154A-21 none 96-334
testing, Tier I
885.4300 Nontarget plant studies, Tier I none 154A-22 none 96-335
885.4340 Nontarget insect testing, Tier I none 154A-23 none 96-336
885.4380 Honey bee testing, Tier I none 154A-24 none 96-337
885.4600 Avian chronic pathogenicity and none 154A-26 none 96-342
reproduction test, Tier III
885.4650 Aquatic invertebrate range none 154A-27 none 96-343
testing, Tier III
885.4700 Fish life cycle studies, Tier III none 154A-28 none 96-344
885.4750 Aquatic ecosystem test none 154A-29 none 96-345
Group E--Environmental Expression
Test Guidelines.
885.5000 Background for microbial none 155A-1, 2 none 96-056
pesticides testing
885.5200 Expression in a terrestrial none 155A-10 none 96-338
environment
885.5300 Expression in a freshwater none 155A-11 none 96-339
environment
885.5400 Expression in a marine or none 155A-12 none 96-340
estuarine environment
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List of Subjects
Environmental protection, Test guidelines.
Dated: February 28, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 96-4964 Filed 2-28-96; 3:49 pm]
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