[Federal Register Volume 61, Number 168 (Wednesday, August 28, 1996)]
[Notices]
[Pages 44308-44311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21822]
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ENVIRONMENTAL PROTECTION AGENCY
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00445; FRL-5390-7]
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 final testing guidelines
for the following two series: Series 830-Product Properties Test
Guidelines and Series 860-Residue Chemistry Test Guidelines. Guidelines
in these series were peer reviewed on September 27, 1995, by the
Scientific Advisory Panel (SAP) and have been revised in response to
SAP and public comments. This notice also describes the unified library
of OPPTS Test Guidelines. The Agency issues 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), internet: http://fedbbs.access.gpo.gov, or call (202)
512-1532 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 questions on series 830: Robert Boethling, (202) 260-
3912, e-mail: [email protected] or Francis Griffith,
(703) 305-5826, e-mail: [email protected].
For technical questions on series 860: Randolph Perfetti, (703)
305-5381, e-
[[Page 44309]]
mail: [email protected] or Richard Loranger, (703) 305-
6912, 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)
has been engaged in 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 submits substantively revised and new test
guidelines to peer review by 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 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
EPA program office. Printed versions of the unified library of OPPTS
test guidelines will also be available to the public through the GPO.
For purposes of this Federal Register notice, ``publication'' of the
unified library of guidelines generally describes the availability of
these final guidelines through the GPO and Internet. 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 revised in the future. These efforts will
ensure that industry is provided with testing guidelines that are
current.
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
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 and OPPT numbers.
II. OPP and OPPT Procedures
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 available
through GPO and Internet be consulted instead of those test guidelines
that were published through NTIS. Once final guidelines are available
through GPO and Internet earlier guidelines will be removed from 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 Pesticide Registration (PR) Notices as well as 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 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 (series 860) and
submitted the revisions to these series to peer review by the FIFRA
Scientific Advisory Panel (SAP) on September 27, 1995. EPA also made
these revised guidelines available to the public for comment through
the EPA docket. Guidelines in these series have been revised in
response to peer review and public comment. In the 830 series, a
comprehensive background guideline (OPPTS 830.1000) was added to
provide general guidance on test methods and data reporting and an
overview of the use of this series of test guidelines for pesticides.
Additional standard test methods as suggested by SAP and public comment
were added to individual test guidelines. For the 860 series, the
Agency responded to SAP comments by revising the appropriate
guidelines. The table ``Raw Agricultural and Processed Commodities and
Livestock Feeds Derived from Field Crops'' in OPPTS guideline 860.1000
was also revised as a result of workshops held during the revision
process. These workshops involved experts from academia, government,
and the pesticide and livestock production industries, thus ensuring
that the table is the end product of extensive peer
[[Page 44310]]
involvement. Additional comments received from the public were mainly
editorial in nature and the guidelines were revised as appropriate.
Copies of the Agency's comment/response documentation are available
through the Public Response and Program Resources Branch and also on
the EPA Public Access Gopher. See ``ADDRESSES'' at the beginning of
this notice for the mailing address, telephone number, or public access
gopher address.
The Agency has also updated and harmonized test guidelines for
Health Effects (series 870). These guidelines were made available for
public comment in June 1996 (61 FR 31522, June 20, 1996) (FRL-5367-7)
and will be peer reviewed in October 1996. Harmonized draft test
guidelines for OPPTS in Ecological Effects (series 850) and OPPT
guidelines in Fate, Transport and Transformation (series 835) were peer
reviewed at a SAP meeting on May 29-30, 1996 (61 FR 16486, April 15,
1996) (FRL-5363-1). Final testing guidelines for the following three
series: Occupational and Residential Exposure (series 875),
Biochemicals (series 880), and Microbial Pesticides (series 885) were
made available in March 1996 (61 FR 8279, March 4, 1996) (FRL-4990-3).
EPA is also announcing that later in 1996, it intends to make
available through GPO and the Internet the Spray Drift test guidelines
(series 840) without any substantive changes. In addition, the revised
test guidelines for Fate, Transport, and Transformation for application
to pesticides (series 835) and Product Performance (series 810) will be
made available for public comment during 1996.
IV. Notice of Availability of Final Test Guidelines
This notice announces the availability of final test guidelines in
the 830 and 860 series. The following is the list of guidelines being
made available at this time.
Series 830--Product Properties Test Guidelines
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Existing Numbers EPA Pub.
--------------------------------- no.
OPPTS Number Name ----------
OTS OPP OECD 712-C-
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830.1000 Background for product properties none none none 96-310
Group A--Product Identity,
Composition, and Analysis Test
Guidelines.
830.1550 Product identity and composition none 158.155 none 96-006
830.1600 Description of materials used to none 158.160 none 96-007
produce the product
830.1620 Description of production process none 158.162 none 96-008
830.1650 Description of formulation process none 158.165 none 96-009
830.1670 Discussion of formation of none 158.167 none 96-010
impurities
830.1700 Preliminary analysis none 158.170 none 96-011
830.1750 Certified limits none 158.175 none 96-012
830.1800 Enforcement analytical method none 158.180 none 96-013
830.1900 Submittal of samples none 64-1 none 96-015
Group B--Physical/Chemical
Properties Test Guidelines.
830.6302 Color none 63-2 none 96-019
830.6303 Physical state none 63-3 none 96-020
830.6304 Odor none 63-4 none 96-021
830.6313 Stability to normal and elevated none 63-13 none 96-022
temperatures, metals, and metal
ions
830.6314 Oxidation/reduction: chemical none 63-14 none 96-023
incompatabiity
830.6315 Flammability none 63-15 none 96-024
830.6316 Explodability none 63-16 none 96-025
830.6317 Storage stability none 63-17 none 96-026
830.6319 Miscibility none 63-19 none 96-027
830.6320 Corrosion characteristics none 63-20 none 96-028
830.6321 Dielectric breakdown voltage none 63-21 none 96-029
830.7000 pH 796.1450 63-12 none 96-030
830.7050 UV/Visible absorption 796.1050 none 101 96-031
830.7100 Viscosity none 63-18 114 96-032
830.7200 Melting point/melting range 796.1300 63-5 102 96-033
830.7220 Boiling point/boiling range 796.1220 63-6 103 96-034
830.7300 Density/relative density/bulk 796.1150 63-7 109 96-035
density
830.7370 Dissociation constants in water 796.1370 63-10 112 96-036
830.7520 Particle size, fiber length, and 796.1520 none 110 96-037
diameter distribution
830.7550 Partition coefficient (n-octanol/ 796.1550 63-11 107 96-038
water), shake flask method
830.7560 Partition coefficient (n-octanol/ 796.1720 63-11 none 96-039
water), generator column method
830.7570 Partition coefficient (n-octanol/ 796.1570 63-11 117 96-040
water), estimation by liquid
chromatography
830.7840 Water solubility: Column elution 796.1840 63-8 105 96-041
method; shake flask method
830.7860 Water solubility, generator column 796.1860 63-8 none 96-042
method
830.7950 Vapor pressure 796.1950 63-9 104 96-043
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[[Page 44311]]
Series 860--Residue Chemistry Test Guidelines
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Existing Numbers EPA Pub.
-------------------------------- no.
OPPTS Number Name -----------
OTS OPP OECD 712-C-
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860.1000 Background none 170-1 none 95-169
860.1100 Chemical identity none 171-2 none 95-170
860.1200 Directions for use none 171-3 none 95-171
860.1300 Nature of the residue--plants, none 171-4a,b none 95-172
livestock
860.1340 Residue analytical method none 171-4c,d none 95-174
860.1360 Multiresidue method none 171-4m none 95-176
860.1380 Storage stability data none 171-4e none 95-177
860.1400 Water, fish, and irrigated crops none 171-4f,g, none 95-178
h, 165-5
860.1460 Food handling none 171-4i none 95-181
860.1480 Meat/milk/poultry/eggs none 171-4j none 95-182
860.1500 Crop field trials none 171-4k none 95-183
860.1520 Processed food/feed none 171-4l none 95-184
860.1550 Proposed tolerances none 171-6 none 95-186
860.1560 Reasonable grounds in support of none 171-7 none 95-187
the petition
860.1650 Submittal of analytical reference none 171-13 none 95-016
standards
860.1850 Confined accumulation in none 165-1 none 95-188
rotational crops
860.1900 Field accumulation in rotational none 165-2 none 95-189
crops
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List of Subjects
Environmental protection, Test guidelines.
Dated: August 21, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 96-21822 Filed 8-27-96; 8:45 am]
BILLING CODE 6560-50-F