[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                                 
----------------------------------------------------------------------------------------------------------------
                                                                              Existing Numbers          EPA Pub.
                                                                     ---------------------------------    no.   
          OPPTS Number                           Name                                                 ----------
                                                                          OTS        OPP       OECD      712-C- 
----------------------------------------------------------------------------------------------------------------
                                                                                                                
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 
----------------------------------------------------------------------------------------------------------------


[[Page 44311]]



                                  Series 860--Residue Chemistry Test Guidelines                                 
----------------------------------------------------------------------------------------------------------------
                                                                             Existing Numbers          EPA Pub. 
                                                                     --------------------------------     no.   
          OPPTS Number                           Name                                                -----------
                                                                         OTS        OPP       OECD      712-C-  
----------------------------------------------------------------------------------------------------------------
                                                                                                                
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                                                                        
----------------------------------------------------------------------------------------------------------------


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