[Federal Register Volume 63, Number 150 (Wednesday, August 5, 1998)]
[Notices]
[Pages 41845-41848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20898]



[[Page 41845]]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00499; FRL-5740-1]


Test Guidelines; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: EPA has established a unified library for test guidelines 
issued by the Office of Prevention, Pesticides and Toxic Substances 
(OPPTS), and is announcing the availability of final test guidelines 
for the Series 870--Health Effects Test Guidelines. The final 
guidelines have been harmonized between the Office of Pesticide 
Programs (OPP) and the Office of Pollution Prevention and Toxics (OPPT) 
and, to the extent possible, with the Organization for Economic 
Cooperation and Development (OECD) Guidelines for the Testing of 
Chemicals. The test guidelines have been reviewed at various Scientific 
Advisory Panel (SAP) meetings, the most recent of which was held on 
October 29 and 30, 1996, as announced by notice in the Federal Register 
(61 FR 31522, June 20, 1996) (FRL-5367-7). The guidelines have been 
revised where appropriate in response to SAP and public comments. This 
notice also describes the unified library of OPPTS test guidelines.

ADDRESSES: The guidelines are available from the U.S. Government 
Printing Office (GPO), Washington, DC 20402 on disks or paper copies: 
call (202) 512-0132. The guidelines are also available electronically 
in PDF (portable document format) from EPA's World Wide Web site 
(http://www.epa.gov/epahome/research.htm) under the heading 
``Researchers and Scientists/Test Methods and Guidelines/OPPTS 
Harmonized Test Guidelines.''

FOR FURTHER INFORMATION CONTACT: For general information: By mail:
    Toxic Substances Control Act (TSCA) information: Contact the TSCA 
Hotline at: TAIS/7408, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Telephone number: (202) 554-1404; fax (202) 554-
5603; e-mail: TSCA[email protected].
    Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
information: Contact the Communications Services Branch (7506C), Field 
and External Affairs Division, Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
Telephone number: (703) 305-5017; fax (703) 305-5558.
    For technical questions on Series 870 Genetic Toxicity test 
guidelines: Michael Cimino, (202) 260-3451; e-mail: 
[email protected].
    For technical questions on other Series 870 test guidelines: 
William Sette, (703) 305-6375; e-mail: [email protected].

SUPPLEMENTARY INFORMATION:
    Electronic Availability: Electronic copies of this document and 
various support documents are available from the EPA Home Page at the 
Federal Register--Envirnonmental Documents entry for this document 
under ``Laws and Regulations'' (http://www.epa.gov/fedrgstr/EPA-TOX/
1998/).

I. EPA's Process for Developing a Unified Library of Test 
Guidelines

    EPA's Office of Prevention, Pesticides and Toxic Substances has 
been engaged in a multi-year project to harmonize and/or update test 
guidelines among the Office of Pesticide Programs, the Office of 
Pollution Prevention and Toxics, and the Organization for Economic 
Cooperation and Development. The goals of the project include the 
formulation of harmonized OPP and OPPT guidelines for those in common 
between the two programs, the harmonization of OPPT and/or OPP 
guidelines with those of the OECD, as well as the updating of any 
guidelines unique to OPP or OPPT programs.
    Test guidelines that are changed substantively from the existing 
test guidelines in the Pesticide Assessment Guidelines or 40 CFR 
158.795 through 158.799 in the harmonization process or through other 
updating/amending activities, or which are new (e.g., for a previously 
unaddressed test endpoint) are made available for public comment by 
notice in the Federal Register. Additionally, EPA submits substantively 
revised and new test guidelines to peer review by the FIFRA SAP and 
other expert scientific panels. Guidelines which are reformatted but 
not changed in any substantive way are not made available for public 
comment or submitted to peer review.
    All final guidelines are available through the Internet on the EPA 
World Wide Web Home Page as a unified library of OPPTS test guidelines 
for use by either EPA program office. Printed versions of the unified 
library of OPPTS test guidelines are also available to the public 
through GPO, see ``ADDRESSES'' at the beginning of this document. For 
purposes of this Federal Register notice, ``publication'' of the 
unified library of guidelines generally describes the availability of 
these final guidelines through GPO and the Internet. Because 
harmonization and updating is an ongoing task, some guidelines 
available via GPO and the Internet may be revised in the future. These 
efforts will ensure that industry is provided with test guidelines that 
are current.
    The test guidelines appearing in the unified library are given 
numerical designations that are different from the designations 
provided in the Code of Federal Regulations (CFR) at 40 CFR parts 158, 
795, 796, 797, 798, and 799. OPPTS test guidelines will be published in 
10 disciplinary series as follows:
    Series 810--Product Performance Test Guidelines
    Series 830--Product Properties Test Guidelines
    Series 835--Fate, Transport and Transformation Test Guidelines
    Series 840--Spray Drift Test Guidelines
    Series 850--Ecological Effects Test Guidelines
    Series 860--Residue Chemistry Test Guidelines
    Series 870--Health Effects Test Guidelines
    Series 875--Occupational and Residential Exposure Test Guidelines
    Series 880--Biochemicals Test Guidelines
    Series 885--Microbial Pesticide Test Guidelines
    The Agency issues Federal Register notices periodically announcing 
any new test guidelines added to the OPPTS unified library. As each set 
of guidelines is published, it will be accompanied by a ``Master List'' 
which cross references the new OPPTS guideline numbers to the original 
OPP, OPPT, and OECD numbers.

II. OPP and OPPT Procedures

    For pesticide registration, explicit test requirements are set out 
in 40 CFR part 158 which refers to specific guidelines by guideline 
number. Once final revised guidelines are available through GPO and the 
Internet, the earlier Pesticide Assessment Guidelines that were 
available through the National Technical Information Service (NTIS) 
will be removed from distribution. Studies initiated 45 days or more 
after publication of the notice of availability in the Federal Register 
should be performed in accordance with the revised guidelines; however, 
registrants should discuss effective dates for long term studies with 
the EPA Product Manager. As test guidelines are published, the Agency 
will inform industry and the general public by means of Federal 
Register notices. In addition, Data Call In letters to pesticide 
registrants will carry a dual numbering system for test guidelines 
until all test guidelines have been published. Part 158, which is 
currently being revised, will also carry a dual numbering system

[[Page 41846]]

for test guidelines when it is proposed in the Federal Register.
    In contrast, OPPT had previously published its pre-harmonization 
test guidelines in 40 CFR parts 795 through 798. Recent TSCA test 
guidelines, based on harmonized test guidelines, have been published in 
part 799. TSCA test guidelines are referenced in test standards 
promulgated in chemical-specific test rules in part 799. To the extent 
that a person is subject to a test rule which references a pre-
harmonization guideline published in 40 CFR parts 795 through 798, the 
test rule still requires compliance with the pre-harmonization test 
guideline that was referenced by the rule. However, if the person 
subject to the test rule is interested in seeking a modification to the 
requirement to comply with the test standard promulgated in the test 
rule, EPA encourages that person to consult the modification procedures 
outlined in 40 CFR part 790. EPA has removed and will continue to 
remove from the CFR those pre-harmonization guidelines that are no 
longer referenced in an applicable test rule.

III. Peer Review of Series 870 Health Effects Test Guidelines

    The Agency has updated and harmonized test guidelines for health 
effects (870 Series) and submitted the revisions to peer review by the 
FIFRA SAP on October 29 and 30, 1996. EPA also made these revised 
guidelines available to the public for comment through the OPP docket 
and on the Internet through the EPA Home Page. Guidelines in this 
series have been revised in response to peer review and public comment. 
In addition, the series includes four new guidelines: Neurophysiology, 
Sensory Evoked Potentials (OPPTS 870.6855); Domestic Animal Safety 
(OPPTS 870.7200); Dermal Penetration (OPPTS 870.7600); and 
Immunotoxicity (OPPTS 870.7800). Two guidelines have been deleted: 
Preliminary Developmental Toxicity Screen (OPPTS 870.3500) and 
Inhalation Developmental Toxicity Study (OPPTS 870.3600). One guideline 
has been removed from the harmonized category: Acute Inhalation with 
Histopathology (OPPTS 870.1350). Three guidelines have been totally 
revised and updated: Prenatal Developmental Toxicity (OPPTS 870.3700); 
Reproduction and Fertility Effects (OPPTS 870.3800); and Metabolism and 
Pharmacokinetics (OPPTS 870.7485). The sub-chronic guidelines for all 
routes of exposure have been updated to match the new OECD Guidelines 
408 and 409. Under genetic toxicology testing, two guidelines 
addressing reverse mutation have been combined into one guideline: 
Bacterial Reverse Mutation Test (OPPTS 870.5100). Six guidelines have 
been harmonized with the most recent OECD updated tests. One new 
guideline has been added: Mammalian Spermatogonial Chromosome 
Aberration Test (OPPTS 870.5380). One OPPT guideline (40 CFR 798.5955 
Heritable Translocation Test in Drosophila melanogaster) was not 
updated due to lack of use. The remaining twelve mutagenicity 
guidelines were not changed substantively, but were reformatted for 
consistency with other harmonized 870 Series guidelines. A detailed 
description of the response to comments and the changes to guidelines 
are available under docket control number OPP-00499 in the Public 
Information and Records Integrity Branch, Information Resources and 
Services Division, Office of Pesticide Programs, Rm. 119, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA; telephone: (703) 305-
5805, or by mail: Public Information and Records Integrity Branch, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.

IV. Request for Comment on Potential Voluntary Consensus Standards 
to Consider for Future Regulatory Actions

    This notice of availability does not involve a proposed regulatory 
action that would require the Agency to consider voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Pub. L. 104-113, section 12(d) (15 
U.S.C. 272 note). Section 12(d) directs EPA to use voluntary consensus 
standards in its regulatory activities unless to do so would be 
inconsistent with applicable law or otherwise impractical. Voluntary 
consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, business practices, 
etc.) that are developed or adopted by voluntary consensus standards 
bodies. The NTTAA requires EPA to provide Congress, through OMB, 
explanations when the Agency decides not to use available and 
applicable voluntary consensus standards when the NTTAA directs the 
Agency to do so.
     As indicated earlier, these guidelines represent an Agency effort 
to harmonize the test guidelines between OPP and OPPT, as well as 
harmonizing the OPP and OPPT test guidelines with those of the OECD. 
The process for developing and amending these test guidelines includes 
the extensive involvement of the scientific community, including peer 
review by the FIFRA SAP and other expert scientific panels, and 
providing extensive public comment.
    In the future, these test guidelines could be incorporated into 
regulatory actions taken by EPA pursuant to TSCA section 4. Although 
the NTTAA requirements do not specifically apply to the issuance of 
these particular test guidelines today, EPA invites your comment on 
whether or not there are any voluntary consensus standards that should 
be considered during the development of any future action under TSCA. 
Future actions under TSCA section 4 would go through notice and comment 
rulemaking or be negotiated as voluntary testing enforcement 
agreements/consent orders/decrees, allowing for additional public 
comment on this issue. Nevertheless, the Agency is interested in 
whether or not there are any voluntary consensus standards that EPA 
should considered in leu of these test guidelines when the Agency 
develops any future regulatory action that incorporates these test 
guidelines. Any comments provided will assist the Agency in complying 
with the NTTAA by facilitating the Agency's identification of voluntary 
consensus standards that should be considered during the development of 
a proposed regulatory action that incorporates any standards included 
in these test guidelines. Please submit your comments to the technical 
person for TSCA that is identified in the ``FOR FURTHER INFORMATION 
CONTACT'' section at the beginning of this document.

V. Notice of Availability of Final Test Guidelines

    This notice announces the availability of final versions of all 
test guidelines in the 870 Health Effects Series. The following is the 
list of test guidelines being made available at this time.

[[Page 41847]]



                                   Series 870--Health Effects Test Guidelines                                   
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                                                                             Existing Numbers          EPA Pub. 
                                                                     --------------------------------     no.   
          OPPTS Number                           Name                                                -----------
                                                                         OPPT       OPP       OECD      712-C-  
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                                  Group A--Acute Toxicity Test                                                  
870.1000                          Acute toxicity testing-background      none       none      none      98-189  
                                                                                                                
870.1100                          Acute oral toxicity                  798.1175     81-1       401      98-190  
                                                                                                                
870.1200                          Acute dermal toxicity                798.1100     81-2       402      98-192  
                                                                                                                
870.1300                          Acute inhalation toxicity            798.1150     81-3       403      98-193  
                                                                                                                
870.2400                          Acute eye irritation                 798.4500     81-4       405      98-195  
                                                                                                                
870.2500                          Acute dermal irritation              798.4470     81-5       404      98-196  
                                                                                                                
870.2600                          Skin sensitization                   798.4100     81-6       406      98-197  
                                                                                                                
                                  Group B--Subchronic Toxicity Test                                             
                                   Guidelines.                                                                  
                                                                                                                
870.3100                          90-Day oral toxicity in rodents      798.2650     82-1       408      98-199  
                                                                                                                
870.3150                          90-Day oral toxicity in nonrodents     none       82-1       409      98-200  
                                                                                                                
870.3200                          21/28-Day dermal toxicity              none      82--2       410      98-201  
                                                                                                                
870.3250                          90-Day dermal toxicity               798.2250     82-3       411      98-202  
                                                                                                                
870.3465                          90-Day inhalation toxicity           798.2450     82-4       413      98-204  
                                                                                                                
870.3700                          Prenatal developmental toxicity      798.4900     83-3       414      98-207  
                                   study                                                                        
                                                                                                                
870.3800                          Reproduction and fertility effects   798.4700     83-4       416      98-208  
                                                                                                                
                                  Group C--Chronic Toxicity Test                                                
                                   Guidelines.                                                                  
                                                                                                                
870.4100                          Chronic toxicity                     798.3260     83-1       452      98-210  
                                                                                                                
870.4200                          Carcinogenicity                      798.3300     83-2       451      98-211  
                                                                                                                
870.4300                          Combined chronic toxicity/           798.3320     83-5       453      98-212  
                                   carcinogenicity                                                              
                                                                                                                
                                  Group D--Genetic Toxicity Test                                                
                                   Guidelines.                                                                  
                                                                                                                
870.5100                          Bacterial reverse mutation test     798.5100,     84-2    471, 472    98-247  
                                                                         .5265                                  
                                                                                                                
870.5140                          Gene mutation in Aspergillus         798.5140     84-2      none      98-215  
                                   nidulans                                                                     
                                                                                                                
870.5195                          Mouse biochemical specific locus     798.5195     84-2      none      98-216  
                                   test                                                                         
                                                                                                                
870.5200                          Mouse visible specific locus test    798.5200     84-2      none      98-217  
                                                                                                                
870.5250                          Gene mutation in Neurospora crassa   798.5250     84-2      none      98-218  
                                                                                                                
870.5275                          Sex-linked recessive lethal test     798.5275     84-2       477      98-220  
                                   in Drosophila melanogaster                                                   
                                                                                                                
870.5300                          In vitro mammalian cell gene         798.5300     84-2       476      98-221  
                                   mutation test                                                                
                                                                                                                
870.5375                          In vitro mammalian chromosome        798.5375     84-2       473      98-223  
                                   aberration test                                                              
                                                                                                                
870.5380                          Mammalian spermatogonial             798.5380     84-2       483      98-224  
                                   chromosomal aberration test                                                  
                                                                                                                
870.5385                          Mammalian bone marrow chromosomal    798.5385     84-2       475      98-225  
                                   aberration test                                                              
                                                                                                                
870.5395                          Mammalian erythrocyte micronucleus   798.5395     84-2       474      98-226  
                                   test                                                                         
                                                                                                                
870.5450                          Rodent dominant lethal assay         798.5450     84-2       478      98-227  
                                                                                                                
870.5460                          Rodent heritable translocation       798.5460     84-2      none      98-228  
                                   assays                                                                       
                                                                                                                
870.5500                          Bacterial DNA damage or repair       798.5500     84-2      none      98-229  
                                   tests                                                                        
                                                                                                                
870.5550                          Unscheduled DNA synthesis in         798.5550     84-2       482      98-230  
                                   mammalian cells in culture                                                   
                                                                                                                
870.5575                          Mitotic gene conversion in           798.5575     84-2       481      98-232  
                                   Saccharomyces cerevisiae                                                     
                                                                                                                
870.5900                          In vitro sister chromatid exchange   798.5900     84-2       479      98-234  
                                   assay                                                                        
                                                                                                                
870.5915                          In vivo sister chromatid exchange    798.5915     84-2      none      98-235  
                                   assay                                                                        
                                                                                                                
                                  Group E--Neurotoxicity Test                                                   
                                   Guidelines.                                                                  
                                                                                                                
870.6100                          Acute and 28-day delayed            798.6450,  81-7, 82-  418, 419    98-237  
                                   neurotoxicity of organophosphorus    .6540,     5, 82-6                      
                                   substances                            .6560                                  
                                                                                                                
870.6200                          Neurotoxicity screening battery     798.6050,  81-8, 82-     424      98-238  
                                                                        .6200,     7, 83-1                      
                                                                         .6400                                  
                                                                                                                
870.6300                          Developmental neurotoxicity study      none       83-6      none      98-239  
                                                                                                                
870.6500                          Schedule-controlled operant          798.6500     85-5      none      98-240  
                                   behavior                                                                     
                                                                                                                
870.6850                          Peripheral nerve function            798.6850     85-6      none      98-241  
                                                                                                                
870.6855                          Neurophysiology: Sensory evoked      798.6855     none      none      98-242  
                                   potentials                                                                   
                                                                                                                
                                  Group F--Special Studies Test                                                 
                                   Guidelines.                                                                  
                                                                                                                
870.7200                          Companion animal safety                none       none      none      98-349  
870.7485                          Metabolism and pharmacokinetics      798.7485     85-1       417      95-244  
870.7600                          Dermal penetration                     none       85-3      none      98-350  
870.7800                          Immunotoxicity                         none       85-7      none      98-351  
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[[Page 41848]]

List of Subjects

    Environmental protection, Test guidelines.

Dated: July 29, 1998.

Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 98-20898 Filed 8-4-98; 8:45 am]
BILLING CODE 6560-50-F