Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 / Notices 41845

ENVIRONMENTAL PROTECTION

AGENCY

[OPP–00499; FRL–5740–1]

Test 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 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-hotline@epa.gov.

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:

cimino.michael@epa.gov.

For technical questions on other

Series 870 test guidelines: William

Sette, (703) 305–6375; e-mail:

sette.william@epa.gov.

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
41846 Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 / Notices

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 chemicalspecific test rules in part 799. To the

extent that a person is subject to a test

rule which references a preharmonization 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 OPP00499 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.
Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 / Notices 41847

Series 870—Health Effects Test Guidelines

OPPTS

Number Name

Existing Numbers EPA Pub.

no.

OPPT OPP OECD 712–C–

Group A—Acute Toxicity Test Guidelines.

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 study 798.4900 83–3 414 98–207

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/carcinogenicity 798.3320 83–5 453 98–212

Group D—Genetic Toxicity Test Guidelines.

870.5100 Bacterial reverse mutation test 798.5100,

.5265

84–2 471, 472 98–247

870.5140 Gene mutation in Aspergillus nidulans 798.5140 84–2 none 98–215

870.5195 Mouse biochemical specific locus test 798.5195 84–2 none 98–216

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 in Drosophila melanogaster 798.5275 84–2 477 98–220

870.5300 In vitro mammalian cell gene mutation test 798.5300 84–2 476 98–221

870.5375 In vitro mammalian chromosome aberration test 798.5375 84–2 473 98–223

870.5380 Mammalian spermatogonial chromosomal aberration test 798.5380 84–2 483 98–224

870.5385 Mammalian bone marrow chromosomal aberration test 798.5385 84–2 475 98–225

870.5395 Mammalian erythrocyte micronucleus test 798.5395 84–2 474 98–226

870.5450 Rodent dominant lethal assay 798.5450 84–2 478 98–227

870.5460 Rodent heritable translocation assays 798.5460 84–2 none 98–228

870.5500 Bacterial DNA damage or repair tests 798.5500 84–2 none 98–229

870.5550 Unscheduled DNA synthesis in mammalian cells in culture 798.5550 84–2 482 98–230

870.5575 Mitotic gene conversion in Saccharomyces cerevisiae 798.5575 84–2 481 98–232

870.5900 In vitro sister chromatid exchange assay 798.5900 84–2 479 98–234

870.5915 In vivo sister chromatid exchange assay 798.5915 84–2 none 98–235

Group E—Neurotoxicity Test Guidelines.

870.6100 Acute and 28-day delayed neurotoxicity of organophosphorus substances 798.6450,

.6540,

.6560

81–7,

82–5,

82–6

418, 419 98–237

870.6200 Neurotoxicity screening battery 798.6050,

.6200,

.6400

81–8,

82–7,

83–1

424 98–238

870.6300 Developmental neurotoxicity study none 83–6 none 98–239

870.6500 Schedule-controlled operant behavior 798.6500 85–5 none 98–240

870.6850 Peripheral nerve function 798.6850 85–6 none 98–241

870.6855 Neurophysiology: Sensory evoked potentials 798.6855 none none 98–242

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
41848 Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 / Notices

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

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6135–9]

Notice of Proposed NPDES General

Permit for Discharges From Petroleum

Bulk Stations and Terminals in Texas

(TXG340000)

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of draft NPDES general

permit.

SUMMARY: EPA Region 6 is proposing to

issue a general NPDES permit

authorizing discharges of facility waste

water and contact storm water from

petroleum bulk stations and terminals

in Texas. This permit covers facilities

having Standard Industrial

Classification (SIC) Code 5171.

As proposed, the permit has limits on

Total Petroleum Hydrocarbons,

benzene, Total BTEX (sum of benzene,

toluene, ethyl benzene and xylene),

Total Lead and pH. There is also a

requirement of no acute toxicity as

determined by requiring greater than

50% survival in 100% effluent using a

24 hour acute test. In addition, the

permit has limits on arsenic, barium,

cadmium, chromium, copper,

manganese, mercury, nickel, selenium,

silver and zinc as contained in Texas

Natural Resource Conservation

Commission (TNRCC) Regulations for

Hazardous Metals (30 TAC 319,

Subchapter B), as well as requirements

for no discharge of floating solids or

visible foam in other than trace

amounts, and no discharge of visible oil.

There is also the requirement to develop

and implement a pollution prevention

plan for the storm water discharges

authorized by this permit.

DATES: Comments on this proposed

permit must be submitted by October 5,

1998.

ADDRESSES: Comments on this proposed

permit should be sent to the Regional

Administrator, EPA Region 6, 1445 Ross

Avenue, Dallas, Texas 75202–2733.

FOR FURTHER INFORMATION CONTACT: Ms.

Wilma Turner, EPA Region 6, 1445 Ross

Avenue, Dallas, Texas 75202–2733,

telephone (214) 665–7516. Copies of the

complete fact sheet and proposed

permit may be obtained from Ms.

Turner. The fact sheet and proposed

permit can also be found on the Internet

at http://www.epa.gov/earth1r6/6wq/

6wq.htm. In addition, the current

administrative record on the proposal is

available for examination at the Region’s

Dallas offices during normal working

hours after providing Ms. Turner 24

hours advanced notice.

SUPPLEMENTARY INFORMATION: Regulated

categories and entities include:

Category Examples of regulated entities

Industry ......... Operators of petroleum bulk

stations and terminals.

This table is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

regulated by this action. This table lists

the types of entities that EPA is now

aware could potentially be regulated by

this action. Other types of entities not

listed in the table could also be

regulated. To determine whether your

(facility, company, business,

organization, etc.) is regulated by this

action, you should carefully examine

the applicability criteria in Part I,

Section A.1 of this permit. If you have

questions regarding the applicability of

this action to a particular entity, consult

the person listed in the preceding FOR

FURTHER INFORMATION CONTACT section.

Section 301(a) of the Clean Water Act

(CWA or the Act), 33 U.S.C. 1311(a),

makes it unlawful to discharge

pollutants to waters of the United States

in the absence of authorizing permits.

CWA section 402, 33 U.S.C. 1342,

authorizes EPA to issue National

Discharge Elimination System (NPDES)

permits allowing discharges on

condition they will meet certain

requirements, including CWA sections

301, 304, and 401 (33 U.S.C. 1331, 1314

and 1341). Those statutory provisions

require that NPDES permits include

effluent limitations requiring that

authorized discharges: (1) Meet

standards reflecting levels of

technological capability, (2) comply

with EPA-approved state water quality

standards and (3) comply with other

state requirements adopted under

authority retained by states under CWA

510, 33 U.S.C. 1370.

Two types of technology-based

effluent limitations must be included in

the permit proposed here. With regard

to conventional pollutants, i.e., pH,

BOD, oil and grease, TSS and fecal

coliform, CWA section 301(b)(1)(E)

requires effluent limitations based on

‘‘best conventional pollution control

technology’’ (BCT). With regard to

nonconventional and toxic pollutants,

CWA section 301(b)(2)(A), (C), and (D)

require effluent limitations based on

‘‘best available pollution control

technology economically achievable’’

(BAT), a standard which generally

represents the best performing existing

technology in an industrial category or

subcategory. BAT and BCT effluent

limitations may never be less stringent

than corresponding effluent limitations

based on best practicable control

technology (BPT), a standard applicable

to similar discharges prior to March 31,

1989 under CWA 301(b)(1)(A).

National guidelines establishing BPT,

BCT and BAT standards have not been

promulgated for discharges from

petroleum bulk stations and terminals.

The BCT and BAT requirements for

these discharges have, therefore, been

established using best professional

judgement, as required by CWA section

402(a)(1). All of the limitations in this

proposed permit, except for the

requirement to develop and implement

a storm water pollution prevention plan,

are also current requirements in TNRCC

Regulations 30 TAC 321, Subchapter M,

for discharges from petroleum bulk

stations and terminals. The storm water

pollution prevention plan requirements

are those currently required by the

NPDES Storm Water Multi-Sector

General Permit for storm water

discharges associated with petroleum

bulk stations and terminals. All of the

discharges authorized by this permit are

also those authorized by 30 TAC 321,

Subchapter M.

In addition to requiring the

development and implementation of a

storm water pollution prevention plan,

the following limits are proposed:

Daily maximum

(mg/l)

Monitoring

frequency

Total petroleum hydrocarbons ...................................................................................................................................... 15 1/week (3).

Benzene ........................................................................................................................................................................ 0.05 1/week (3).

Total BTEX (1) .............................................................................................................................................................. 0.5 1/week (3).