[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]



-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY
[OPP-00423; FRL-4990-3]


Testing Guidelines; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

-----------------------------------------------------------------------

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  
----------------------------------------------------------------------------------------------------------------



                                    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  
----------------------------------------------------------------------------------------------------------------




                                 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                                                        
----------------------------------------------------------------------------------------------------------------



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]
BILLING CODE 6560-50-F