Test Guidelines; Notice of Availability

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.

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Series 870--Health Effects Test Guidelines

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Existing Numbers EPA Pub.

-------------------------------- no.

OPPTS Number Name -----------

OPPT OPP OECD 712-C-

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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