[Federal Register Volume 61, Number 120 (Thursday, June 20, 1996)]
[Notices]
[Pages 31522-31524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15810]



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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00434; FRL-5367-7]


Proposed Testing Guidelines; Notice of Availability and Request 
for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability and request for comments.

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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 proposed testing 
guidelines for Series 870-Health Effects Test Guidelines. These test 
guidelines have been updated and harmonized, to the extent possible, 
with the Organization for Economic Cooperation and Development (OECD) 
guidelines for testing of chemicals, and other relevant international 
standards. A FIFRA Scientific Advisory Panel (SAP) meeting to review 
the Series 870 test guidelines will be scheduled for this summer. 
Complete details of this meeting will be announced in a Federal 
Register notice.

DATES: Comments must be received on or before August 19, 1996.

ADDRESSES: Interested persons are invited to submit written comments in 
triplicate to: By mail: Public Response and Program Resources Branch, 
Field Operations Division (7506C), Environmental Protection Agency, 401 
M St., SW., Washington, DC 20460. In person: Bring comments to: Rm. 
1132, CM#2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically by sending 
electronic mail (e-mail) to: [email protected]. Electronic 
comments must be submitted as an ASCII file avoiding the use of special 
characters and any form of encryption. Comments and data will also be 
accepted on disks in WordPerfect in 5.1 file format or ASCII file 
format. All comments and data in electronic form must be identified by 
the docket number ``OPP-00434'' (FRL-5367-7). No Confidential Business 
Information (CBI) should be submitted through e-mail. Electronic 
comments on this document may be filed online at many Federal 
Depository Libraries. Additional information on electronic submissions 
can be found under ``SUPPLEMENTARY INFORMATION.''
    Information submitted as a comment in response to this notice may 
be claimed confidential by marking any part or all of that information 
as CBI. Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2. A copy of the 
comment that does not contain CBI must be submitted for inclusion in 
the public docket. Information not marked confidential will be included 
in the public docket without prior notice. All statements will be made 
part of the record.

FOR FURTHER INFORMATION CONTACT: By mail: Leonard Keifer, Office of 
Pollution Prevention and Toxics (7403), U.S. Environmental Protection 
Agency, 401 M Street, SW., Washington, DC 20460; telephone: (202) 260-
1548; e-mail: [email protected].
    By mail: William Sette, Office of Pesticide Programs (7509C), U.S. 
Environmental Protection Agency, 401 M Street, SW., Washington, DC 
20460; telephone: (703) 305-6375; e-mail: 
[email protected].
    Copies of documents may be obtained by contacting: By mail: Public 
Docket and Freedom of Information Section, Field Operations Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. In person or for courier pick-up: 
Office location and telephone number: Rm. 1132, CM #2, 1921 Jefferson 
Davis Highway, Arlington, VA, (703) 305-5805. By internet: e-mail 
requests to: [email protected] or via the EPA Public Access 
Gopher (gopher.epa.gov) under the heading ``Environmental Test Methods 
and Guidelines.''

SUPPLEMENTARY INFORMATION: The Agency is revising its test guidelines 
for Series 870--Health Effects Test Guidelines. Guidelines in the 870 
Series are for use by the Office of Pesticide Programs (OPP) and the 
Office of Pollution Prevention and Toxics (OPPT) and have been 
harmonized with those of OECD. The proposed guidelines are being made 
available for comment. All interested parties are encouraged to submit 
comments on the proposed guidelines. Specific comments should reference 
the specific number and paragraph or subparagraph of the appropriate 
proposed guideline. Recommended technical or scientific changes/
modifications should be supported by current scientific/technical 
knowledge and include supporting references. References may be to the 
published literature, studies submitted to the Agency in support of 
registration, and unpublished data. Citations must be sufficiently 
detailed so as to allow the Agency to obtain copies of the original 
documents and unpublished data supplied to allow their evaluation.
    A record has been established for this notice under docket number 
``OPP-00434'' (including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:00 a.m. 
to 4:30 p.m., Monday through Friday, excluding legal holidays. The 
public record is located in Rm. 1132 of the Public Response and Program 
Resources Branch, Field Operations Division (7506C), Office of 
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2, 
1921 Jefferson Davis Highway, Arlington, VA.
    Electronic comments can be sent directly to EPA at:
    [email protected]
    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this notice, as well as the public version, 
as described above will be kept in paper form. Accordingly, EPA will 
transfer all comments received electronically into printed, paper form 
as they are received and will place the paper copies in the official 
record which will also include all comments submitted directly in 
writing. The official record is the paper record maintained at the 
address in ``ADDRESSES'' at the beginning of this document.
    The following is the complete list of proposed guidelines being 
made available at this time:

[[Page 31523]]



                                   Series 870--Health Effects Test Guidelines                                   
----------------------------------------------------------------------------------------------------------------
                                                                              Existing Numbers          EPA Pub.
                                                                     ---------------------------------    no.   
          OPPTS Number                           Name                                                 ----------
                                                                           OTS         OPP      OECD     712-C- 
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                                  Group A--Acute Toxicity Test                                                  
                                                                                                                
870.1000                          Acute toxicity testing--background      none        none      none     96-189 
                                                                                                                
870.1100                          Acute oral toxicity                   798.1175      81-1      401      96-190 
                                                                                                                
870.1200                          Acute dermal toxicity                 798.1100      81-2      402      96-192 
                                                                                                                
870.1300                          Acute inhalation toxicity             798.1150      81-3      403      96-193 
                                                                                                                
870.1350                          Acute inhalation toxicity with          none        none      none     96-291 
                                   histopathology                                                               
                                                                                                                
                                  Group B--Specific Organ/Tissue                                                
                                   Toxicity Test Guidelines.                                                    
                                                                                                                
870.2400                          Acute eye irritation                  798.4500      81-4      405      96-195 
                                                                                                                
870.2500                          Acute dermal irritation               798.4470      81-5      404      96-196 
                                                                                                                
870.2600                          Skin sensitization                    798.4100      81-6      406      96-197 
                                                                                                                
                                  Group C--Subchronic Toxicity Test                                             
                                   Guidelines.                                                                  
                                                                                                                
870.3100                          90-Day oral toxicity                  798.2650      82-1      408      96-199 
                                                                                                                
870.3150                          Subchronic nonrodent oral               none        82-1      409      96-200 
                                   toxicity--90-day                                                             
                                                                                                                
870.3200                          Repeated dose dermal toxicity--21/      none        82--2     410      96-201 
                                   28 days                                                                      
                                                                                                                
870.3250                          Subchronic dermal toxicity--90        798.2250      82-3      411      96-202 
                                   days                                                                         
                                                                                                                
870.3465                          Subchronic inhalation toxicity        798.2450      82-4      413      96-204 
                                                                                                                
870.3500                          Preliminary developmental toxicity    798.4420      none      none     96-205 
                                   screen                                                                       
                                                                                                                
870.3600                          Inhalation developmental toxicity     798.4350      none      none     96-206 
                                   study                                                                        
                                                                                                                
870.3700                          Prenatal developmental toxicity       798.4900      83-3      414      96-207 
                                   study\1\                                                                     
                                                                                                                
870.3800                          Reproduction and fertility            798.4700      83-4      416      96-208 
                                   effects\1\                                                                   
                                                                                                                
                                  Group D--Chronic Toxicity Test                                                
                                   Guidelines.                                                                  
                                                                                                                
870.4100                          Chronic toxicity                      798.3260      83-1      452      96-210 
                                                                                                                
870.4200                          Carcinogenicity                       798.3300      83-2      451      96-211 
                                                                                                                
870.4300                          Combined chronic toxicity/            798.3320      83-5      453      96-212 
                                   carcinogenicity                                                              
                                                                                                                
                                  Group E--Genetic Toxicity Test                                                
                                   Guidelines.                                                                  
                                                                                                                
870.5100                          Escherichia coli WP2 and WP2 uvrA     798.5100      84-2      471,     96-247 
                                   reverse mutation assays                                       472            
                                                                                                                
870.5140                          Gene mutation in Aspergillus          798.5140      84-2      none     96-215 
                                   nidulans                                                                     
                                                                                                                
870.5195                          Mouse biochemical specific locus      798.5195      84-2      none     96-216 
                                   test                                                                         
                                                                                                                
870.5200                          Mouse visible specific locus test     798.5200      84-2      none     96-217 
                                                                                                                
870.5250                          Gene mutation in Neurospora crassa    798.5250      84-2      none     96-218 
                                                                                                                
870.5265                          The Salmonella typhimurium reverse    798.5265      84-2      471,     96-219 
                                   mutation assay                                                472            
                                                                                                                
870.5275                          Sex-linked recessive lethal test      798.5275      84-2      477      96-220 
                                   in Drosophila melanogaster                                                   
                                                                                                                
870.5300                          Detection of gene mutations in        798.5300      84-2      476      96-221 
                                   somatic cells in culture                                                     
                                                                                                                
870.5375                          In vitro mammalian cytogenetics       798.5375      84-2      473      96-223 
                                                                                                                
870.5380                          In vivo mammalian cytogenetics        798.5380      84-2      none     96-224 
                                   tests: spermatogonial chromosomal                                            
                                   aberrations                                                                  
                                                                                                                
870.5385                          In vivo mammalian cytogenetics        798.5385      84-2      475      96-225 
                                   tests: Bone marrow chromosomal                                               
                                   analysis                                                                     
                                                                                                                
870.5395                          In vivo mammalian cytogenetics        798.5395      84-2      474      96-226 
                                   tests: Erythrocyte micronucleus                                              
                                   assay                                                                        
                                                                                                                
870.5450                          Rodent dominant lethal assay          798.5450      84-2      478      96-227 
                                                                                                                
870.5460                          Rodent heritable translocation        798.5460      84-2      485      96-228 
                                   assays                                                                       
                                                                                                                
870.5500                          Bacterial DNA damage or repair        798.5500      84-2      none     96-229 
                                   tests                                                                        
                                                                                                                
870.5550                          Unscheduled DNA synthesis in          798.5550      84-2      482      96-230 
                                   mammalian cells in culture                                                   
                                                                                                                
870.5575                          Mitotic gene conversion in            798.5575      84-2      481      96-232 
                                   Saccharomyces cerevisiae                                                     
                                                                                                                
870.5900                          In vitro sister chromatid exchange    798.5900      84-2      479      96-234 
                                   assay                                                                        
                                                                                                                
870.5915                          In vivo sister chromatid exchange     798.5915      84-2      none     96-235 
                                   assay                                                                        
                                                                                                                
                                  Group F--Neurotoxicity Test                                                   
                                   Guidelines.                                                                  
                                                                                                                
870.6100                          Delayed neurotoxicity of              798.6450,   81-7, 82-   418,     96-237 
                                   organophosphorus substances            .6540,     5, 82-6     419            
                                   following acute and 28-day             .6560                                 
                                   exposure                                                                     
                                                                                                                
870.6200                          Neurotoxicity screening battery       798.6050,   81-8, 82-   none     96-238 
                                                                          .6200,     7, 83-1                    
                                                                          .6400                                 
                                                                                                                
870.6300                          Developmental neurotoxicity study       none        83-6      none     96-239 
                                                                                                                
870.6500                          Schedule-controlled operant           798.6500      85-5      none     96-240 
                                   behavior                                                                     
                                                                                                                
870.6850                          Peripheral nerve function             798.6850      85-6      none     96-241 
                                                                                                                
870.6855                          Neurophysiology: Sensory evoked       798.6855      none      none     96-242 
                                   potentials                                                                   
                                                                                                                
                                  Group G--Special Studies Test                                                 
                                   Guidelines.                                                                  
                                                                                                                

[[Page 31524]]

                                                                                                                
870.7200                          Domestic animal safety                  none        none      none     96-349 
870.7485                          Metabolism and pharmacokinetics\2\    798.7485      85-1      417      95-244 
870.7600                          Dermal penetration                      none        85-3      none     96-350 
870.7800                          Immunotoxicity                          none        85-7      none     96-351 
                                                                                                                
                                  Group H--Health Effects Chemical-                                             
                                   Specific Test Guidelines.                                                    
                                                                                                                
870.8223                          Pharmacokinetic test                   795.223      none      none     96-250 
                                                                                                                
870.8245                          Dermal pharmacokinetics of DGBE        795.225      none      none     96-251 
                                   and DGBA                                                                     
                                                                                                                
870.8300                          Dermal absorption for compounds        795.226      none      none     96-252 
                                   that are volatile and metabolized                                            
                                   to carbon dioxide                                                            
                                                                                                                
870.8320                          Oral/dermal pharmacokinetics           795.228      none      none     96-253 
                                                                                                                
870.8340                          Oral and inhalation                    795.230      none      none     96-254 
                                   pharmacokinetic test                                                         
                                                                                                                
870.8360                          Pharmacokinetics of isopropanol        795.231      none      none     96-255 
                                                                                                                
870.8380                          Inhalation and dermal                  795.232      none      none     96-256 
                                   pharmacokinetics of commercial                                               
                                   hexane                                                                       
                                                                                                                
870.8500                          Toxicokinetic test                     795.235      none      none     96-257 
                                                                                                                
870.8600                          Developmental neurotoxicity screen     795.250      none      none     96-258 
                                                                                                                
870.8700                          Subchronic oral toxicity test          795.260      none      none     96-259 
                                                                                                                
870.8800                          Morphologic transformation of          795.285      none      none     96-260 
                                   cells in culture                                                             
----------------------------------------------------------------------------------------------------------------
\1\Notice of availability published at 61 FR 8282, March 4, 1996.                                               
\2\Notice of availability published at 60 FR 45158, August 30, 1995.                                            



List of Subjects

    Environmental protection, Test guidelines.

    Dated: June 12, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
[FR Doc. 96-15810 Filed 6-19-96; 8:45 am]
BILLING CODE 6560-50-F