81658 Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 799

[OPPTS–42213A; FRL–6758–4]

RIN 2070–AD16

Testing of Certain High Production

Volume Chemicals

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing a test rule

under section 4(a)(1)(B) of the Toxic

Substances Control Act (TSCA) to

require manufacturers (including

importers) and processors of certain

high production volume (HPV) chemical

substances to conduct testing for acute

toxicity; repeat dose toxicity;

developmental and reproductive

toxicity; genetic toxicity (gene

mutations and chromosomal

aberrations); ecotoxicity (in fish,

Daphnia, and algae) and environmental

fate (including five tests for physical

chemical properties and

biodegradation). EPA has preliminarily

determined that each of the 37 chemical

substances included in this proposed

rule is produced in substantial

quantities and that there is substantial

human exposure to each of them.

Moreover, EPA believes that there are

insufficient data to reasonably

determine or predict the effects on

health or the environment of the

manufacture, distribution in commerce,

processing, use, or disposal of the

chemicals, or any combination of these

activities. EPA has concluded that this

proposed testing program is needed and

appropriate for developing such data.

Data developed under this proposed

rule will provide critical information

about the environmental fate and

potential hazards associated with these

chemicals which, when combined with

information about exposure and uses,

will allow the Agency and others to

evaluate potential health and

environmental risks and take

appropriate follow up action. Persons

who export or intend to export any

chemical substance included in the final

rule based on this proposed rule would

be subject to the export notification

requirements in TSCA section 12(b)(1)

and at 40 CFR part 707, subpart D. EPA

has also taken steps, as described in this

document, to consider animal welfare

and to provide instructions on ways to

reduce or in some cases eliminate

animal testing, while at the same time

ensuring that the public health is

protected.

DATES: Comments, identified by docket

control number OPPTS–42213A, must

be received by EPA on or before April

25, 2001. If you want to request an

opportunity to present oral comments,

refer to Unit I.E. of the SUPPLEMENTARY

INFORMATION. Your request must be in

writing and must be received by EPA on

or before January 25, 2001. Only if such

a request is received, would EPA

schedule a public meeting on this

proposed rule, which would be

announced in a subsequent document in

the Federal Register and held in

Washington, DC.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, it is imperative

that you identify docket control number

OPPTS–42213A in the subject line on

the first page of your response.

FOR FURTHER INFORMATION CONTACT: For

general information contact: Barbara

Cunningham, Acting Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

numbers: (202) 554–1404; e-mail

address: TSCA-Hotline@epa.gov.

For technical information contact:

Keith Cronin, Chemical Control

Division (7405), Office of Pollution

Prevention and Toxics, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460;

telephone number: (202) 260-8130; fax

number: (202) 260–1096; e-mail address:

ccd.citb@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you manufacture (defined by statute to

include import) or process any of the

chemical substances that are listed in

§ 799.5085(j) of the proposed regulatory

text. Any use of the term ‘‘manufacture’’

in this document will encompass

‘‘import,’’ unless otherwise stated. In

addition, as described in Unit VI. , once

the Agency issues a final rule, any

person who exports, or intends to

export, any of the chemical substances

included in the final rule will be subject

to the export notification requirements

in 40 CFR part 707, subpart D.

Potentially affected entities may

include, but are not limited to:

TABLE 1.—ENTITIES POTENTIALLY AFFECTED BY THE PROPOSED TESTING REQUIREMENTS

Type of entity NAICS codes Examples of potentially affected entities

Chemical Manufacturers (including Importers)325, 32411 Persons who manufacture (defined by statute to include import) one

or more of the subject chemical substances.

Processors 325, 32411 Persons who process one or more of the subject chemical substances.

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in Table 1 of this unit

could also be affected. The North

American Industrial Classification

System (NAICS) codes have been

provided to assist you and others in

determining whether this action might

apply to certain entities. To determine

whether you or your business is affected

by this action, you should carefully

examine the applicability provisions in

Unit V.E. entitled Would I be required

to test under this rule? and consult the

proposed regulatory test. If you have

any questions regarding the

applicability of this action to a

particular entity, consult the technical

person listed under FOR FURTHER

INFORMATION CONTACT.

If you are an entity identified in Table

1 of this unit, you would only be subject

to the testing requirements contained in

this proposed rule if you manufacture or

process any of the chemical substances

that are listed in § 799.5085(j) of the

proposed regulatory text.

B. How Can I Get Additional

Information, Including Copies of this

Document or Other Related Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules 81659

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

You may also access additional

information about the Chemical Rightto-Know Program at http://ww.epa.gov/

chemrtk/ or about the TSCA testing

program at http://www.epa.gov/

opptintr/chemtest/. For your

convenience, EPA may have also

provided some non-EPA internet

addresses. In doing so, the Agency has

verified the accuracy of these addresses

at the time of signature. However, since

EPA is not responsible for these nonEPA sites, the Agency does not have any

control over these addresses. A paper

copy of any document referenced in this

way has been included in the public

version of the official record for this

document as described in Unit I.B.2.

2. In person. The Agency has

established an official record for this

action under docket control number

OPPTS–42213A. The official record

consists of the documents referenced in

this action, any public comments

received during an applicable comment

period, and other information related to

this action, including information

claimed as Confidential Business

Information (CBI). This official record

includes the documents that are

physically located in the docket, as well

as the documents that are referenced in

those documents. The public version of

the official record does not include any

information claimed as CBI. The public

version of the official record, which

includes printed, paper versions of any

electronic comments submitted during

an applicable comment period, is

available for inspection in the TSCA

Nonconfidential Information Center,

Rm. NE B–607, 401 M St., SW.,

Washington, DC. The Center is open

from noon to 4 p.m., Monday through

Friday, excluding legal holidays. The

telephone number for the Center is (202)

260–7099.

C. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. To

ensure proper receipt by EPA, it is

imperative that you identify docket

control number OPPTS–42213A in the

subject line on the first page of your

response.

1. By mail. Submit your comments to:

Document Control Office (7407), Office

of Pollution Prevention and Toxics

(OPPT), Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

2. In person or by courier. Deliver

your comments to: OPPT Document

Control Office (DCO), East Tower Rm.

G–099, Waterside Mall, 401 M St., SW.,

Washington, DC. The DCO is open from

8 a.m. to 4 p.m., Monday through

Friday, excluding legal holidays. The

telephone number for the DCO is (202)

260–7093.

3. Electronically. You may submit

your comments electronically by e-mail

to: oppt.ncic@epa.gov or mail your

computer disk to the address identified

above. Do not submit any information

electronically that you consider to be

CBI. 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 standard computer

disks in WordPerfect 6/7/8/9 or ASCII

file format. All comments in electronic

form must be identified by docket

control number OPPTS–42213A.

Electronic comments may also be filed

online at many Federal Depository

Libraries.

D. How Should I Handle CBI That I

Want to Submit to the Agency?

Do not submit any information

electronically that you consider to be

CBI. You may claim information that

you submit to EPA in response to this

document as CBI 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.

In addition to one complete version of

the comment that includes any

information claimed as CBI, a copy of

the comment that does not contain the

information claimed as CBI must be

submitted for inclusion in the public

version of the official record.

Information not marked confidential

will be included in the public version

of the official record without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

consult the technical person listed

under FOR FURTHER INFORMATION

CONTACT.

E. Can I Request an Opportunity to

Present Oral Comments to the Agency?

You may submit a request for an

opportunity to present oral comments.

This request must be made in writing.

If such a request is received on or before

January 25, 2001, EPA will hold a

public meeting on this proposed rule in

Washington, DC. This written request

must be submitted to the address

provided in Unit I.C.1 and 2. If such a

request is received, EPA will announce

the scheduling of the public meeting in

a subsequent document in the Federal

Register. If a public meeting is

announced, and if you are interested in

attending or presenting oral and/or

written comments at the public meeting,

you should follow the instructions

provided in the subsequent document

announcing the public meeting.

F. What Should I Consider as I Prepare

My Comments for EPA?

EPA invites you to provide your

views on the various options proposed,

new approaches not yet considered, the

potential impacts of the various options

(including possible unintended

consequences), and any data or

information that you would like the

Agency to consider during the

development of the final rule. You may

find the following suggestions helpful

for preparing your comments:

1. Explain your views as clearly as

possible.

2. Describe any assumptions that you

used.

3. Provide copies of any technical

information and/or data you used that

support your views.

4. If you estimate potential burden or

costs, explain how you arrived at the

estimate.

5. Provide specific examples to

illustrate your concerns.

6. Offer alternative ways to improve

the rule or collection activity.

7. Make sure to submit your

comments by the deadline listed under

DATES.

8. To ensure proper receipt by EPA,

be sure to identify the docket control

number assigned to this action in the

subject line on the first page of your

response. You may also provide the

name, date, and Federal Register

citation.

II. Authority

This document proposes a test rule

under section 4(a)(1)(B) of TSCA, 15

U.S.C. 2603(a)(1)(B), that would require

certain health and environmental tests

for 37 chemical substances that are

produced in substantial quantities, and

that enter or may reasonably be

anticipated to enter the environment in

substantial quantities and/or to which

there is or may be significant or

substantial human exposure. The tests

pertain to acute toxicity; repeat dose

toxicity; developmental and

reproductive toxicity; genetic toxicity

(gene mutations and chromosomal

aberrations); ecotoxicity (tests in fish,

Daphnia, and algae); and environmental

fate (including five tests for physical

chemical properties and

biodegradation). Some or all of these

81660 Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules

tests would be required for a particular

chemical substance, depending upon

what data are already available for that

substance.

Section 2(b)(1) of TSCA, 15 U.S.C.

2601(b)(1), states that it is the policy of

the United States that ‘‘adequate data

should be developed with respect to the

effect of chemical substances and

mixtures on health and the environment

and that the development of such data

should be the responsibility of those

who manufacture [which is defined by

statute to include import] and those

who process such chemical substances

and mixtures [.]’’ To implement this

policy, TSCA section 4(a) mandates that

EPA require by rule that manufacturers

and processors of chemical substances

and mixtures conduct testing if the

Administrator finds that:

(1)(A)(i) the manufacture, distribution in

commerce, processing, use, or disposal of a

chemical substance or mixture, or that any

combination of such activities, may present

an unreasonable risk of injury to health or the

environment,

(ii) there are insufficient data and

experience upon which the effects of such

manufacture, distribution in commerce,

processing, use, or disposal of such substance

or mixture or of any combination of such

activities on health or the environment can

reasonably be determined or predicted, and

(iii) testing of such substance or mixture

with respect to such effects is necessary to

develop such data; or

(B)(i) a chemical substance or mixture is or

will be produced in substantial quantities,

and (I) it enters or may reasonably be

anticipated to enter the environment in

substantial quantities or (II) there is or may

be significant or substantial human exposure

to such substance or mixture,

(ii) there are insufficient data and

experience upon which the effects of the

manufacture, distribution in commerce,

processing, use, or disposal of such substance

or mixture or of any combination of such

activities on health or the environment can

reasonably be determined or predicted, and

(iii) testing of such substance or mixture

with respect to such effects is necessary to

develop such data [.]

If EPA makes these findings for a

chemical substance or mixture, the

Administrator must require by rule that

testing be conducted on that chemical

substance or mixture. The purpose of

the testing would be to develop data

about the substance or mixture’s health

and environmental effects where there

is an insufficiency of data and

experience, in order to support a

determination that the manufacture,

distribution in commerce, processing,

use or disposal of the substance or

mixture, or any combination of such

activities, does or does not present an

unreasonable risk of injury to health or

the environment.

Once the Administrator has made a

finding under TSCA section 4(a)(1), EPA

may require any type of health or

environmental effects testing necessary

to address unanswered questions about

the effects of the chemical substance.

EPA need not limit the scope of testing

required to the factual basis for the

TSCA section 4(a)(1)(A)(i) or (B)(i)

findings, as long as EPA finds that there

are insufficient data and experience

upon which the effects of the

manufacture, distribution in commerce,

processing, use, or disposal of such

substance or mixture or of any

combination of such activities on health

or the environment can reasonably be

determined or predicted, and that

testing is necessary to develop the data.

This approach is explained in more

detail in EPA’s statement of policy for

making findings under TSCA section

4(a)(1)(B) (frequently described as the

‘‘B’’ policy) in the Federal Register of

May 14, 1993 (58 FR 28736) (Ref. 24 at

28738–28739).

In this proposed rule, EPA intends to

use its broad TSCA section 4 authority

to obtain the data necessary to support

the development of preliminary or

‘‘screening level’’ hazard and risk

characterizations for certain HPV

chemical substances (see § 799.5085(j)

of the proposed regulatory text for the

list of chemicals). EPA has made

preliminary findings for these chemicals

under TSCA section 4(a)(1)(B) that:

They are produced in substantial

quantities; there is or may be substantial

human exposure to them; existing data

are insufficient to determine or predict

their health and environmental effects;

and testing is necessary to develop such

data. Testing for additional HPV

chemical substances (Ref. 1) will be

proposed at a later date as the Agency

learns more about these additional

substances with respect to human

exposure, release, and sufficiency of the

data and experience available on the

hazards of the substances.

III. Background

A. Why is EPA Pursuing Hazard

Information on HPV Chemicals?

EPA found that, of those nonpolymeric organic substances produced

or imported in amounts equal to or

greater than 1 million pounds per year

based on 1990 reporting for EPA’s

Inventory Update Rule (IUR) (40 CFR

part 710), only 7% have a full set of

publicly available internationally

recognized basic health and

environmental fate/effects screening test

data (Ref. 2). Of the over 2,800 U.S. HPV

chemicals based on 1990 data, 43%

have no publicly available basic hazard

data. For the remaining chemicals,

limited amounts of the data are

available. This lack of available hazard

data compromises EPA’s and others’

ability to determine whether these HPV

chemicals pose potential risks to human

health or the environment, as well as

the public’s right-to-know about the

hazards of chemicals that are found in

their environment, their homes, their

workplaces, and the products that they

buy. It is EPA’s intent to close this

knowledge gap. EPA believes that for

most of the HPV chemicals, insufficient

data are readily available to reasonably

determine or predict the effects on

health or the environment from the

manufacture (including importation),

distribution in commerce, processing,

use, or disposal of the chemicals, or any

combination of these activities. EPA has

concluded that a program to collect and,

where needed, develop basic screening

level toxicity data is necessary and

appropriate to provide information in

order to assess the potential hazards/

risks that may be posed by exposure to

HPV chemicals.

On April 21, 1998, a national effort,

known as the ‘‘Chemical Right-ToKnow’’ (ChemRTK) Program, was

announced in order to empower citizens

with knowledge about the most

widespread chemicals in commerce—

chemicals that people may be exposed

to in the places where they live, work,

study, and play. EPA’s ChemRTK

Program is being designed in such a way

as to make certain basic information

about HPV chemicals available to the

public.

EPA plans to make available to the

public the summarized data obtained on

HPV chemicals. Additional information

that EPA receives will also be shared

with the public, other Federal agencies,

and any other interested parties. As

appropriate, this information will be

used to ensure a scientifically sound

basis for risk assessment/management

actions. This effort, will serve to further

the Agency’s goal of identifying and

controlling human and environmental

risks as well as providing greater

protection and knowledge to the public.

In addition, EPA and other parties

agreed to work with other nations and

international groups to ensure

commensurate increases in the pace of

complementary voluntary international

data collection and development efforts

on HPV chemicals.

This ChemRTK Program is consistent

with the U.S. policy as presented in the

TSCA. Section 2(b)(1) of TSCA, 15

U.S.C. 2601(b)(1), states that it is the

policy of the United States that

‘‘adequate data should be developed

with respect to the effect of chemical

Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules 81661

substances and mixtures on health and

the environment and that the

development of such data should be the

responsibility of those who manufacture

and those who process such chemical

substances and mixtures.’’

B. What Do We Currently Know About

the Basic Health and Environmental

Hazards of HPV Chemicals?

The information relevant to

understanding the basic health and

environmental hazards of HPV

chemicals is derived from a battery of

tests agreed upon by the international

community as appropriate for screening

international HPV chemical substances

for toxicity. Six basic testing endpoints

have been adopted by the Organization

for Economic Cooperation and

Development (OECD) as the minimum

required to screen international HPV

chemical substances for toxicity (Ref. 4).

The agreed-upon testing endpoints,

known as the OECD’s Screening

Information Data Set (SIDS) include:

Acute toxicity; repeat dose toxicity;

developmental and reproductive

toxicity; genetic toxicity (gene

mutations and chromosomal

aberrations); ecotoxicity (studies in fish,

Daphnia, and algae); and environmental

fate (including physical/chemical

properties [melting point, boiling point,

vapor pressure, n-octanol/water

partition coefficient, and water

solubility], photolysis, hydrolysis,

transport/distribution, and

biodegradation). As conceived by the

OECD, the ‘‘SIDS battery’’ of tests can be

used by governments to conduct an

initial assessment of the hazards and

risks posed by HPV chemical substances

and prioritize HPV chemicals to identify

those in need of additional, more indepth testing and assessment.

A need for basic screening level data

on HPV chemicals has been identified

and supported by various data

availability studies conducted by EPA

and others. Toxic Ignorance, which was

prepared by Environmental Defense

(formerly the Environmental Defense

Fund), raised a variety of concerns

about the untested chemicals that are

produced in and/or imported into the

United States (Ref. 28). Environmental

Defense found that baseline data on

health effects were not publicly

available for a selected set of 100 HPV

chemicals.

In April 1998, EPA completed a study

entitled Chemical Hazard Data

Availability Study: What Do We Really

Know About the Safety of High

Production Volume Chemicals? (Ref. 2)

that evaluated the public availability of

screening level health hazard data and

environmental hazard/fate data on U.S.

HPV chemicals. EPA’s study found

major gaps in the basic information on

HPV chemicals that is readily available

to EPA and to the public, and reinforced

the need for governmental leadership on

this issue. The study analyzed the

availability of test data for 2,863 HPV

chemicals (defined as those nonpolymeric organic substances produced

in or imported into the United States in

amounts equal to or greater than 1

million pounds per year based on 1990

reporting for EPA’s IUR (40 CFR part

710). EPA searched for publicly

available data on these chemicals and

learned that most of them may never

have been tested for any or most of the

SIDS endpoints. The search strategy

used a total of 11 publicly accessible

data bases in its analysis. Details of the

search strategy can be found in the

report (Ref. 2). The major conclusions of

EPA’s study are described in Unit III.A.

In June 1998, the American Chemistry

Council (ACC, formerly the Chemical

Manufacturers Association (CMA))

issued a report (Ref. 3) regarding public

data availability for HPV chemicals

based on a study conducted with 11

main data sources, including data

sources other than those searched by

EPA for its study. The ACC report,

entitled Public Availability of SIDSRelated Testing Data for U.S. High

Production Volume Chemicals (Ref. 3)

reached conclusions similar to EPA, that

is, that only limited toxicity and

environmental fate data appear to exist

in the public domain for many U.S. HPV

substances. Details of the search strategy

used can be found in the ACC report

(Ref. 3).

EPA recognizes that additional data

may exist beyond those identified

through either the EPA, ACC, or

Environmental Defense studies. To the

extent that additional relevant data are

known to exist, EPA is particularly

interested in receiving this information

as part of the HPV Initiative (see Unit

III.D.), including a full citation for

publications and ‘‘robust’’ (i.e., detailed)

summaries of pertinent published and

unpublished studies. If relevant

scientifically adequate existing data are

submitted at any time before testing is

initiated, including after the final rule is

issued, the Agency will consider such

data to determine if they satisfy the

testing requirement and will take

appropriate necessary action to ensure

that unnecessary testing is no longer

required. In addition, exemption

procedures to be used are found at 40

CFR 790.80 and 790.82. Guidance on

the preparation of robust summaries is

available on EPA’s ChemRTK website

(Ref. 34).

C. Why is EPA Focusing on HPV

Chemicals?

It is generally accepted that chemicals

having a high level of production have

an increased potential for exposure in

comparison to low production volume

chemicals. The focus on HPV chemicals

is derived from the experience gained

over the past 15 years by EPA and the

OECD. The OECD is an

intergovernmental organization

consisting of 29 developed countries,

including the United States, with

advanced worldwide market economies.

The OECD is helping coordinate a

cooperative, international effort to

secure basic toxicity information on

HPV chemicals in use worldwide.

The OECD, after considering a variety

of priority setting approaches,

concluded in 1990 that consideration of

HPV status provided a useful and

effective organizing focus for a

voluntary testing and assessment effort

to screen and thereby identify priorities

among international HPV chemicals.

In the late 1980s, OECD initiated a

voluntary program to ensure that basic

information is available on international

HPV chemicals. This program, which is

a part of the OECD’s program on

existing chemicals, produced an

internationally agreed upon set of basic

SIDS screening tests and is working to

develop complete SIDS data sets for all

international HPV chemicals. The SIDS

includes information on the identity of

each chemical, uses, sources and extent

of exposure; physical and chemical

properties; environmental fate; and

certain limited toxicity data for humans

and the environment. The SIDS is not

intended to describe a chemical

thoroughly, but rather is intended to

provide enough information to support

an initial (or screening) assessment and

to assign a priority for further work. By

1990, the United States and 13 other

OECD member countries established a

voluntary international testing program

to develop the basic data set for all

international HPV chemicals. To date,

the OECD has initiated or completed

work on approximately 500 chemicals.

The OECD threshold for high

production volume chemicals is 2.2

million pounds (equivalent to 1 million

kilograms) reported in any member

country. (Note that the OECD HPV

threshold, like the U.S. HPV threshold,

is not applied to polymers. However,

the OECD threshold, unlike the U.S.

HPV threshold, is applied to inorganics

(Ref. 5)). The presence of a chemical on

the OECD’s list of HPV chemicals was

and continues to be accepted (Ref. 5) by

OECD member countries as providing a

sufficient indicator of potential

81662 Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules

exposure to warrant testing at the SIDS

level.

EPA does not believe that a

production volume threshold which is

chosen for an international program on

existing chemicals and which is the

only trigger for entry into that program

should be determinative of the

threshold chosen for ‘‘substantial

production’’ under TSCA section

4(a)(1)(B)(i). See EPA’s ‘‘B’’ policy (Ref.

24). Among the reasons is that the TSCA

section 4(a)(1)(B)(i) finding of

substantial production is not the sole

finding EPA must make to require

testing based on TSCA section

4(a)(1)(B). EPA must also find that there

is substantial release, or substantial or

significant human exposure under

TSCA sections 4(a)(1)(B)(i)(I) and (II). In

addition, EPA must find that data are

insufficient and testing is necessary

under TSCA sections 4(a)(1)(B)(ii) and

(iii).

In response to EPA’s proposed ‘‘B’’

policy (Ref. 23), both ACC and the

Society of the Plastics Industry Inc.,

commented that EPA’s proposed

production volume threshold of 1

million pounds is a reasonable

interpretation of ‘‘substantial

production’’ under TSCA (Ref. 6 and 7).

Additionally, they indicated that the

OECD 2.2 million pound threshold

would be preferable to achieve

consistency between EPA’s activities

under TSCA section 4 and the OECD

HPV SIDS program.

The 1 million pound threshold for

production normally used by EPA under

the ‘‘B’’ policy generally narrowed the

universe of chemicals potentially

subject to TSCA section 4(a)(1)(B) to

11% of the TSCA Inventory of chemical

substances (see TSCA sections 8(a) and

8(b)), using Inventory information

available in 1988 (Ref. 23 at 32296).

However, that small percentage of the

Inventory accounts for 95% of total

chemical production in the United

States. EPA believes it reasonable to use

this information as a basis for making a

finding of ‘‘substantial production’’ for

substances produced at or above that

threshold. Furthermore, EPA equates

‘‘substantial production’’ with

production in ‘‘high volumes.’’

The United States committed to

conducting SIDS testing and assessment

on 25% of the international HPV

chemicals as its contribution to the

OECD HPV SIDS effort; other countries’

commitments for conducting SIDS

testing and assessment on international

HPV chemicals vary in proportion to the

size of the country’s gross domestic

product. Because most of the

international HPV chemicals are also

commercially available in the United

States, EPA considers the OECD HPV

SIDS program to be an integral part of

domestic testing activities. EPA, in

developing and implementing the OECD

HPV SIDS program, worked jointly with

industry and environmental groups in

the United States and with governments

and industry in other OECD member

countries to achieve the common goal of

developing this minimum level of

testing for HPV chemicals. EPA

continues to work with other parties

(international organizations,

environmental groups, unions, animal

welfare groups, other Federal agencies,

and others) to secure their interest and

continued support for this effort.

Nevertheless, because of the slow

pace of the OECD’s international efforts

to generate the needed data (which

would have potentially required over 30

years to complete), the OECD has

recognized the need to accelerate its

efforts in order to ensure the availability

of the basic data needed to support

screening level assessments of

international HPV chemicals. EPA has

also recognized the need to accelerate

its efforts to develop SIDS data on US

HPV chemicals to support domestic

efforts on chemicals. The HPV Initiative,

which is described in Unit III.D., reflects

EPA’s interest in collecting, developing

and making publicly available these

needed data.

D. Why is EPA Proposing to Take this

Action?

A major component of the Agency’s

ChemRTK activity is the HPV Initiative,

which is a data collection and

development program established by

EPA for existing U.S. HPV chemicals.

Under this Initiative, HPV chemicals are

defined as non-polymeric organic

chemicals manufactured (including

imported) at or above 1 million pounds

per year based on information submitted

under the 1990 TSCA IUR. The strategy

and overall approach that EPA is using

to address data collection needs for U.S.

HPV chemicals are discussed in a

separate document entitled Data

Collection and Development on High

Production Volume (HPV) Chemicals

that is published elsewhere in this issue

of the Federal Register (Ref. 27).

Through the HPV Initiative, which

includes a voluntary component (the

HPV Challenge Program), certain

international efforts, and rulemaking

under TSCA such as this proposed rule,

basic screening level hazard data

necessary to provide critical information

about the environmental fate and

potential hazards associated with HPV

chemicals will be collected or, where

necessary, developed. Data collected

and/or developed under the HPV

Initiative, when combined with

information about exposure and uses,

will allow the Agency and others to

evaluate and prioritize potential health

and environmental effects and take

appropriate follow up action. The HPV

Initiative will generally be carried out in

a manner consistent with the OECD

HPV SIDS program to ensure that the

data and information generated can be

contributed to the international effort

and, conversely, that international SIDS

testing and assessments can be used to

fulfill the data gaps identified as part of

the HPV Initiative. Additional detailed

information is available on the SIDS

website (http://www.oecd.org/ehs/

sidsman.htm) and EPA’s ChemRTK

website (http://www.epa.gov/chemrtk).

The following is a brief summary of

this HPV Initiative. For additional

background information related to the

HPV Initiative, please refer to the

document that is published elsewhere

in this issue of the Federal Register

(Ref. 27).

1. Voluntary HPV Challenge Program.

A primary component of this HPV

Initiative is the voluntary HPV

Challenge Program, which was created

in cooperation with industry,

environmental groups, and other

interested parties, and is designed to

assemble and make publicly available

basic screening level data on the

potential hazards of U.S. HPV chemicals

while avoiding unnecessary or

duplicative testing. The voluntary HPV

Challenge Program is described in detail

the document that is published

elsewhere in this issue of the Federal

Register (Ref. 27).

As of November 9, 2000, EPA has

received full or provisional

commitments from 469 companies,

individually or through 187 consortia to

sponsor 2,155 chemicals under in the

voluntary HPV Challenge Program.

Continually updated information

regarding the chemicals being

sponsored under the voluntary HPV

Challenge Program and the names of

company sponsors and consortia can be

found on EPA’s ChemRTK website

(http://www.epa.gov/chemrtk/

sumresp.htm), and on the US HPV

Chemical Tracking System (http://

www.hpvchallenge.com).

Under the voluntary HPV Challenge

Program, alternatives to the testing

proposed under this proposed rule are

available. For example, under the OECD

HPV SIDS program, some instances

have been identified where, using

chemical category approaches, less than

a full set of SIDS tests for every

chemical in the category has been

judged sufficient for screening purposes.

In addition, the OECD HPV SIDS

Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules 81663

program allows some use of structure

activity relationships (SAR) analysis for

individual chemicals. These strategies

have the potential to reduce the time

required to complete the program, the

number of tests actually conducted, and

the number of test animals needed.

While EPA is encouraging the use of

scientifically appropriate categories of

related chemicals and SAR under the

voluntary component of the HPV

Initiative, these approaches are not

included in this proposed rule.

However, EPA has not identified any

possibilities that will allow inclusion of

the category and SAR approach for any

chemicals listed in this proposed rule.

EPA believes that the incorporation of

such elements in a test rule would

require complex, time consuming, and

resource intensive procedural steps,

such as multi-phase rulemaking. EPA

specifically solicits comments and

suggestions on procedures that would

allow inclusion of such approaches in

HPV test rules. EPA solicits comments

on simplified procedures which would

allow inclusion of such approaches in

TSCA section 4 HPV SIDS rulemaking.

Although the Agency believes that

none of the chemicals included in this

proposed rule appear to be candidates

for these approaches, persons who

believe that a chemical under this

proposed rule can be dealt with using a

category or SAR approach are

encouraged to submit appropriate

information, along with their comments

which substantiate this belief. If, based

on submitted information and other

information available to EPA, the

Agency determines that a chemical

meets the requirements for

consideration under a category or SAR

approach, and that practicable measures

are available at the time to modify the

testing requirement, EPA will take such

measures as are necessary to avoid

unnecessary testing. Modifications can

also be applied for after the final rule

issues under 40 CFR 790.55 up to 60

days before the specified reporting

deadline. Category or SAR approaches

which represent significant alterations

in the scope of testing, however, would

likely require multi-phase rulemaking

involving publication of additional

Federal Register document(s) soliciting

comment on the proposed procedures to

be used. Comment is specifically

requested on simplified approaches

which might allow for the efficient and

effective handling of category and SAR

approaches via rulemaking.

a. Can I still participate in the

voluntary HPV Challenge Program?

Certainly. Although the participants in

the voluntary HPV Challenge Program

were asked to submit commitments by

December 1, 1999, you can still

volunteer through a viable commitment

(as described in Unit III.D.1.b) to

sponsor chemicals under the HPV

Challenge Program. Sponsors who wish

to use alternative approaches to those

proposed for a chemical listed in a

proposed TSCA section 4 HPV SIDS

rulemaking should seriously consider

sponsoring that chemical in this under

the voluntary HPV Challenge Program

prior to the close of the comment period

for that rulemaking.

b. How can I participate in the

voluntary HPV Challenge? At this stage,

persons who wish to sponsor a chemical

through a viable commitment under the

HPV Challenge Program must submit

the following:

i. Commitment letter;

ii. Test plan, robust summaries of

existing studies with full citations of

published studies and full copies of

unpublished studies; and

iii. Robust summaries of any newly

conducted studies, and full copies of

these studies.

Commitments must be consistent with

the guidance available on the ChemRTK

website. Full commitments must specify

the names and the Chemical Abstract

Service (CAS) numbers of the chemicals

to be sponsored, the year in which

sponsors will begin the assessment of

each chemical, and the name and

contact information for the technical

person within the company who should

be reached for more information.

Commitment letters under the voluntary

HPV Challenge Program must be

submitted to the EPA Administrator

according to the instructions on the

ChemRTK website (Ref. 35).

EPA encourages industry and other

interested parties to identify and

provide any additional existing data

which are relevant to the hazard

characterization to avoid any

unnecessary or duplicative testing.

Furthermore, anyone may provide any

relevant information to the Agency that

indicates that certain endpoints need

not be tested. If EPA judges the available

data to be adequate, the data gap

identified in the HPV Initiative will be

considered to be filled. To the extent

that additional data relevant to the HPV

chemicals are known to exist, EPA is

interested in receiving this information

under the voluntary HPV Challenge

Program. In addition to submitting the

full citation for published studies and

full copies of any unpublished studies,

Commenters under the HPV Challenge

Program and/or a proposed TSCA

section 4 HPV SIDS rule(s) who wish to

submit any additional relevant studies,

are encouraged to also prepare a robust

summary (Ref. 34) for each study to

facilitate making the information

publicly available, as well as facilitate

its review.

EPA plans to include in a final TSCA

section 4 HPV SIDS rulemaking any

chemical that is listed in a proposed

rule, unless a sponsor, in addition to

agreeing to making a viable commitment

under the voluntary HPV Challenge

Program, provides the following

additional information:

i. Evidence that work is underway

and proceeding in a timely manner;

ii. Data required to complete the SIDS

battery are developed within the time

frame set by EPA in the proposed rule;

and

iii. Robust summaries, and full copies

of all final study reports from new

studies and existing data submitted to

EPA in a timely manner.

Viable commitments that involve SAR

and categories and that are consistent

with the guidance available on the

website (Ref. 30 and 31) regarding SAR

and categories under the voluntary

component of the HPV Initiative can

still be submitted to EPA, but

submission as early as possible will best

avoid unnecessary or duplicative

testing. If a viable commitment is made

and kept, and the information is deemed

adequate, EPA would not include that

chemical in a final TSCA section 4 HPV

SIDS rulemaking.

Additional information on the

voluntary HPV Challenge Program is

available on the ChemRTK website.

2. Certain international efforts. To fill

any data gaps not addressed as part of

the voluntary HPV Challenge Program,

EPA is continuing to participate in the

international efforts coordinated by the

OECD to secure basic hazard

information on HPV chemicals in use

worldwide, including some of those on

the U.S. HPV chemicals list. This

includes agreements to sponsor a U.S.

HPV chemical under either the OECD

HPV SIDS Program, including

sponsorship by OECD member countries

beyond the United States, or the

international HPV Initiative that is being

organized by International Council of

Chemical Associations (ICCA). The

OECD HPV SIDS Program has already

been described in Unit III.C. The ICCA

consists of representatives of chemical

industry trade associations from the

United States, Europe, Japan, Australia,

Canada, Mexico, Brazil, New Zealand,

and Argentina. The ICCA HPV Initiative

calls for the testing and screening-level

assessment of 1,000 ‘‘high priority’’

chemicals by the end of the year 2004.

Most of the chemicals on the ICCA

working list (Ref. 8) are also U.S. HPV

chemicals. The ICCA testing/assessment

work will be tied directly to that under

81664 Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules

the OECD HPV SIDS Program and to the

U.S. HPV Initiative.

Any U.S. HPV chemicals that are

handled under the OECD HPV SIDS

Program or the ICCA HPV Initiative are

considered by EPA to be ‘‘sponsored’’

and are not intended to be addressed in

either the voluntary HPV Challenge

Program or in any TSCA section 4 HPV

SIDS rulemaking unless the

international commitments are not met.

3. TSCA rulemaking. In establishing

the HPV Initiative in 1998, the Agency

indicated that data needs which remain

unmet in the voluntary HPV Challenge

Program or through international efforts

may be addressed through TSCA

rulemaking. This proposed rule is the

first rulemaking associated with the

HPV Initiative, and addresses the unmet

data needs of the 37 chemicals that are

included in this proposed rule.

E. What Information is being Collected

on HPV Chemicals?

In identifying the data needs for

chemicals contained in the HPV

Initiative, EPA is utilizing information

and sources in EPA’s study, the

Chemical Hazard Data Availability

Study (Ref. 2), and ACC’s report, i.e,

Public Availability of SIDS-Related

Testing Data for U.S. High Production

Volume Chemicals (Ref. 3), to determine

whether screening level data for

characterizing the hazards of these HPV

chemicals are publicly available. If no

data are available for a SIDS testing

endpoint, there cannot be sufficient data

to characterize the potential hazards and

risks associated with the chemical. As

the Agency found in its study,

insufficient data are available to

characterize the hazards and risks of

many of the U.S. HPV chemicals with

respect to the internationally accepted

SIDS testing endpoints, including acute

toxicity, repeat dose toxicity,

developmental and reproductive

toxicity, genetic toxicity (gene

mutations and chromosomal

aberrations), ecotoxicity (tests in fish,

Daphnia, and algae), and for

environmental fate (including five tests

for physical chemical properties

[melting point, boiling point, vapor

pressure, n-octanol/water partition

coefficient, and water solubility], and

biodegradation). As a result, EPA and

others cannot reasonably determine or

predict the human health and

environmental effects resulting from

manufacture, processing, and use of

these chemical substances.

The OECD HPV SIDS Program is part

of the OECD overall program on existing

chemicals, and includes information on

the identity of each chemical, its uses,

sources and extent of exposure; physical

and chemical properties; environmental

fate; and certain limited toxicity data for

humans and the environment. The SIDS

data set is not intended to describe a

chemical thoroughly, but rather is

intended to provide enough information

to support an initial (or screening level)

assessment and to assign a priority for

further work, if necessary. To date, the

OECD has initiated or completed work

on approximately 500 HPV chemicals.

The OECD HPV SIDS Program seeks the

development of test data, if such data

are not already available, related to six

health and environmental effects

endpoints for international HPV

chemicals (see Unit III.B.). The SIDS

data set is regarded as the minimum

data set required to make an informed

preliminary judgment about the hazards

of a given HPV chemical.

EPA is implementing the HPV

Initiative as part of its domestic

industrial chemical screening efforts, in

a manner that is consistent with OECD

efforts. The information to be gathered

under EPA’s HPV Initiative comes from

the same battery of tests agreed upon by

the OECD member countries as being

appropriate for screening international

HPV chemicals for toxicity and

environmental fate (Ref. 4). As

conceived by the OECD, the SIDS data

set can be used by governments and

others worldwide to conduct an initial

assessment of the hazards and risks

posed by HPV chemical substances and

to prioritize chemicals to identify those

which are in need of additional, more

in-depth testing and assessment, as well

as those of lesser concern.

This proposed test rule is intended to

obtain needed SIDS testing for 37 of the

approximately 2,800 chemicals

(excluding polymers and inorganics)

that are produced and/or imported at

high volumes in the United States. EPA

has chosen this group of 37 chemicals

for its initial TSCA section 4 HPV SIDS

rulemaking because of their high

production and/or importation volumes

and their potential for exposure to a

substantial number of workers.

In developing the list of candidates

for this proposed test rule, EPA

included only chemical substances

which were reported on 1994 TSCA

section 8(a) IUR as being manufactured

(including imported) in the United

States in amounts greater than or equal

to one million pounds. In addition, each

of the candidate chemical substances

listed in this proposed rule was

identified in the National Occupational

Exposure Survey (NOES) as having a

total potential exposure of greater than

1,000 or more workers. A potential

exposure of 1,000 or more workers to a

chemical substance is a threshold for

‘‘substantial human exposure’’ under

EPA’s ‘‘B’’ Policy (Ref. 24).

The data availability study conducted

by EPA, discussed in Unit III.B.,

demonstrated that only a limited

number of HPV chemicals have a full set

of publicly available SIDS data. For

chemicals for which some data are

available on one or more SIDS

endpoints, EPA is not requiring testing

for those endpoints. However, no

definitive determination has been made

as to the adequacy of those data for an

initial assessment of a chemical’s

hazards or risks to health or the

environment. The Agency intends to

promulgate additional test rules for any

HPV chemicals for which SIDS testing

is needed and for which a voluntary

commitment to collect, develop, and

make publically available the needed

data has not been received.

F. What Role do Existing Data Play

Under the HPV Initiative?

The HPV Initiative, including this

rulemaking, is designed to make

maximum use of scientifically adequate

existing test data and to avoid

unnecessary, duplicative testing,

thereby avoiding the excessive use of

animal testing. If at any time, including

after this rule is finalized, the Agency

receives adequate existing data that

fulfill a specific data gap, EPA will

ensure that unnecessary testing is not

required.

During the continued development of

the HPV Initiative, EPA was encouraged

to consider the relationship between

existing data submitted under the HPV

Initiative and reporting requirements

under TSCA section 8(e). In response to

these concerns, and as part of the

Agency’s efforts to ensure the fullest use

of existing test data, EPA intends to

consider existing data submissions in

the manner described in an October 14,

1999, letter to the voluntary HPV

Challenge Program participants (herein

after ‘‘the October 14, 1999, letter’’) (Ref.

29). EPA’s guidance document on

literature searches, which deals with

part of this issue, is available on the

Agency’s ChemRTK website (Ref. 36).

EPA believes that it is in the economic

best interest of companies to identify

and make publicly available all relevant

existing data in order to reduce possible

testing costs.

Studies that have been conducted as

specified in appropriate OECD test

guidelines (as noted in the SIDS Manual

(Ref. 4) or comparable EPA test

guidelines (such as the OPPTS

Harmonized Guidelines available at

http://www.epa.gov/opptsfrs/home/

guidelin.htm), and appropriate Good

Laboratory Practice Standards (GLPS)

Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules 81665

like those for TSCA (40 CFR part 792)

consistently generate data adequate to

fulfill the HPV Initiative needs. Data

from studies that did not follow these

procedures, however, may not be

adequate.

As stated in the October 14, 1999,

letter to the voluntary HPV Challenge

Program participants, in analyzing the

adequacy of existing data, participants

shall conduct a thoughtful and

qualitative analysis rather than using a

rote checklist approach (Ref. 29). The

same principle applies to persons

evaluating existing data in connection

with this rulemaking. If EPA judges the

available data to be adequate, the data

gap identified in the HPV Initiative will

be considered to be filled. EPA has

developed a guidance document on

determining data adequacy which is

available on EPA’s ChemRTK website

(Ref. 37).

EPA solicits comment concerning the

availability of SIDS data on the

chemicals included in the HPV

Initiative and encourages industry and

other interested parties to identify and

provide any additional existing data

which are relevant to hazard

characterization to avoid any

unnecessary or duplicative testing.

Anyone may provide any relevant

information to the Agency that indicates

that certain endpoints need not be

tested. If EPA judges the available data

to be adequate, the data gap identified

in the HPV Initiative will be considered

to be filled. To the extent that additional

data relevant to the HPV chemicals are

known to exist, EPA is interested in

receiving this information, including a

full citation for publications and full

copies of unpublished studies. Although

the Agency encourages anyone with

such information to submit it to EPA

during the early stages of this Initiative

in order to avoid any unnecessary

testing, such submissions may be made

at any time to allow EPA to take

appropriate action. Commenters are also

encouraged to prepare a robust

summary (Ref. 34) for each study to

facilitate EPA’s review of the full study

report or publication. It is important to

note that EPA does not intend to

include any chemicals which are

Generally Recognized as Safe (GRAS)

for a particular use by the Food and

Drug Administration (FDA) in this

initial TSCA section 4 HPV SIDS

rulemaking. However, such chemicals

may be included in a future TSCA

section 4 HPV SIDS rulemaking where

SIDS data needs remain unmet.

G. How Would the Data Developed

Under this Test Rule be Used?

The availability of hazard information

on individual chemicals is fundamental

to EPA’s ability to accomplish its

mission of environmental protection—

risk assessment, risk management,

safeguarding children’s health,

expanding the public’s right-to-know,

and promoting the pollution prevention

ethic. Activities to ensure the

availability of basic hazard information

on HPV chemicals are an integral part

of meeting these objectives.

The testing proposed is essentially

identical in scope and applicability to

that which has been internationally

agreed upon by the OECD as providing

the minimum needed to screen HPV

chemicals and identify priorities for

additional testing or assessment. While

the SIDS data set does not fully measure

a chemical’s toxicity, it does provide a

consistent minimum set of information

that can be used to determine the

relative hazards and risks of chemicals

and to judge if additional testing or

assessment is necessary. Thus, EPA will

use the data obtained from this

proposed test rule to support

development of preliminary hazard and

risk assessments for these HPV

chemicals. Furthermore, the data

obtained under this testing program will

be used to set priorities for further

testing that will produce hazard

information on these chemicals which is

needed by EPA , other Federal agencies,

the public, industry, and others, to

support adequate risk assessments. EPA

has used data from test rules to support

such activities as the development of

water quality criteria, Toxic Release

Inventory listings, chemical advisories,

and reduction of workplace exposures.

H. What is the Role of this Proposed

Rule with Regard to the HPV Initiative?

To fill data gaps not addressed as part

of the voluntary HPV Challenge Program

or international efforts, EPA indicated

in the document that is published

elsewhere in this issue of the Federal

Register (Ref. 27) that it would

supplement the voluntary HPV

Challenge Program and international

efforts with rulemaking under TSCA.

Specifically, EPA intends to use its

authority under section 4 of TSCA to

propose the testing of those chemicals

listed at http:/www.epa.gov/chemrtk/

hpvchmtl.htm which have an indicator

value of ‘‘0,’’ which identifies a

chemical as a candidate for sponsorship

under the voluntary HPV Challenge

Program and a sponsorship status value

of ‘‘N,’’ i.e., not sponsored. EPA intends

to issue additional test rules as needed

to cover chemicals with unmet data

needs or if voluntary HPV Challenge

Program commitments are not met. U.S.

HPV chemicals that have been or are

being handled through the OECD HPV

SIDS Program or under a

complementary program being

coordinated by the ICCA (Ref. 8) will

not be listed in any of these follow-up

TSCA section 4 HPV SIDS rulemaking,

unless commitments under those

international programs are not met (see

Unit. IV.G. of the document that is

published elsewhere in this issue of the

Federal Register (Ref. 27) for more

information on these programs). In

addition, as indicated in Unit IV.B.2. of

the document that is published

elsewhere in this issue of the Federal

Register (Ref. 27), chemicals identified

as GRAS for a particular use by FDA are

only intended to be included in a future

TSCA section 4 HPV SIDS rulemaking if

SIDS data needs remain unmet.

As indicated in the October 14, 1999,

letter to the participants in the

voluntary HPV Challenge Program (Ref.

29), and restated in the document that

is published elsewhere in this issue of

the Federal Register (Ref. 27), EPA

intends for the TSCA section 4 HPV

SIDS rulemaking to proceed in a manner

that is consistent with the principles

outlined in the letter for the participants

in the voluntary program. As such, EPA

has incorporated the criteria established

under the voluntary HPV Challenge

Program into this rulemaking to the

extent possible, and has also considered

improvements based on experiences

with implementing that Program.

• Potential endpoints for testing under

test rules. As with the voluntary HPV

Challenge Program, the test data needs

that are addressed in this proposed rule

pertain to physical/chemical properties,

acute toxicity; repeat dose toxicity;

developmental and reproductive

toxicity; genetic toxicity, ecotoxicity;

and environmental fate. Testing for

some or all of these endpoints would be

required for a particular chemical

substance where such data are not

already available for that substance. The

specific testing, reporting, and

recordkeeping requirements contained

in this proposed rule are described for

each chemical substance in the

proposed regulatory text.

• Potential timetable for testing under

test rules. EPA stated in the October 14,

1999, letter to the participants in the

voluntary HPV Challenge Program (Ref.

29), that testing of closed system

intermediates shall be deferred until

2003; and that testing of individual

chemicals (i.e., those HPV chemicals not

proposed for testing in a category) that

require further testing on animals shall

81666 Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules

be deferred until November 2001. EPA

will use these time frames in the

effective dates of TSCA section 4 HPV

SIDS rulemakings as well.

• Existing data submissions during

the rulemaking phase. As indicated in

Unit III.B., if relevant scientifically

adequate existing data are submitted to

EPA during the comment period for this

proposed rule, EPA does not intend to

include that HPV chemical in the final

rule. If relevant scientifically adequate

existing data are submitted to EPA after

the final rule is issued, or at any other

time before testing is initiated, the

Agency will consider such data to

satisfy the testing requirement and will

take any necessary action to ensure that

unnecessary testing is not required.

• Treatment of testing endpoints

under HPV SIDS test rules. EPA

proposes that testing under this

proposed rule be consistent with the

voluntary HPV Challenge Program’s

treatment of the following endpoints:

—Acute aquatic toxicity studies

would not always be needed under the

TSCA section 4 HPV SIDS rulemaking

associated with this Initiative (See Unit

V.A.3.).

—Dermal toxicity or terrestrial

toxicity testing would not be included

in TSCA section 4 HPV SIDS

rulemaking associated with this

Initiative (See Unit III.I. and Unit V.A.).

—The LD50 test (OECD 401) would

not be needed for mammalian acute

toxicity testing under the TSCA section

4 HPV SIDS rulemaking associated with

this Initiative (See Unit V.A.4.).

—EPA will encourage persons subject

to the TSCA section 4 HPV SIDS

rulemaking to use in vitro testing unless

there are chemical properties (including

chemical class considerations) or other

aspects which may call its use into

question (see Unit V.A.5.).

—EPA will consider combining some

of the mammalian toxicity protocols

under TSCA section 4 HPV SIDS

rulemaking associated with this

Initiative (See Unit V.A.6.).

If necessary for a particular chemical

and/or endpoint, any variations are

described in detail in this proposed

rule.

I. How are Animal Welfare Issues being

Considered in the HPV Initiative?

EPA recognizes the concerns that

have been expressed about the use of

test procedures that require the use of

animals. As discussed in Unit II.E. of

the document that is published

elsewhere in this issue of the Federal

Register (Ref. 27), EPA is making every

effort to ensure that as the HPV

Initiative is implemented, unnecessary

or duplicative testing is avoided and the

use of animals is minimized. As a

general matter, EPA does not require

that tests on animals be conducted if an

alternative scientifically validated

method is found acceptable and

practically available for use. Where

testing must be conducted to develop

adequate data, the Agency is committed

to reducing the number of animals used

for testing, to replacing test methods

requiring animals with alternative test

methods when acceptable alternative

methods are available, and to refining

existing test methods to optimize animal

use when there is no substitute for

animal testing. EPA believes that these

reduction, replacement, and refinement

objectives are all important elements in

the overall consideration of alternative

testing methods.

The governmental and nongovernmental scientific community is

working to design, validate, and employ

new methods of toxicity testing that are

more accurate, less costly, and that

reduce the need to use live animals.

Over the years, significant research has

been pursued to develop and validate

non-animal test methods. U.S. scientists

in academia, government, and industry

have participated in both domestic and

international efforts to develop

alternative, non-animal tests. As part of

the enterprise, the National Institute of

Environmental Health Sciences (NIEHS)

established a Federal Interagency

Committee, the Interagency

Coordinating Committee on Validation

of Alternative Methods (ICCVAM), to

review the status and validation of

toxicological test methods including

those that are performed in vitro. EPA

scientists have contributed significantly

to this body of knowledge and are

continuing to play a vital role by

developing test methods for

consideration. Many test methods have

begun the process of validation and

several have completed the steps

leading to government-wide regulatory

acceptance. Within the SIDS battery of

tests, certain in vitro genotoxicity tests,

such as the Ames test for gene

mutations in bacteria, have received

uniform acceptance among regulatory

agencies.

In addition, as part of the voluntary

HPV Challenge Program, EPA asked

participants in that program to observe

certain principles laid out in the

October 14, 1999, letter, in which the

Agency also indicated its intention that

related TSCA rulemaking proceed in a

manner consistent with the principles

(Ref. 29). This letter is available in the

public version of the official record for

this rulemaking, as well as on EPA’s

ChemRTK website. In the letter, EPA

requested that participants conduct a

thoughtful, qualitative analysis of

existing data before testing. EPA also

asked that all animal testing on

individual chemicals (as opposed to

testing of categories of chemicals) under

the voluntary HPV Challenge Program,

or under an associated rule(s), not be

initiated earlier than November 2001,

and that testing of chemicals solely

manufactured as closed system

intermediates not begin earlier than

2003. This proposed rule reflects many

of the principles presented in the

referenced voluntary HPV Challenge

Program letter. Certain components of

these principles, however, are not

pertinent to this proposed rule. For

example, this proposed rule does not

require any dermal toxicity testing or

any terrestrial toxicity testing.

Furthermore, a primary focus of the

HPV Initiative, including the voluntary

HPV Challenge Program and associated

TSCA section 4 HPV SIDS rulemaking is

to implement these efforts as

contributors to a larger international

activity with global involvement and in

a manner consistent with meeting the

needs of the OECD HPV SIDS program

and to further the goals under

Programme Area (c) of Agenda 21,

Chapter 19 of the United Nations

Conference on Environment and

Development (UNCED) concerning

information exchange on toxic

chemicals and chemical risks. EPA

solicits comment on the potential

approaches that may be used to

incorporate the principles contained in

the October 14, 1999, letter in the

context of TSCA section 4 HPV SIDS

rulemakings (Ref. 29).

IV. EPA Findings

A. What is the Basis for EPA’s Proposal

to Test These Chemical Substances?

As indicated in Unit II., in order to

develop a rulemaking under TSCA

section 4(a) requiring the testing of

chemical substances or mixtures, EPA

must make certain findings regarding

either risk (TSCA section 4(a)(1)(A)(i));

or production and either chemical

release or human exposure (TSCA

section 4(a)(1)(B)(i)), with regard to

those chemicals. EPA is proposing to

require testing of the chemical

substances included in this proposed

test rule based on its preliminary

findings under TSCA section

4(a)(1)(B)(i) relating to ‘‘substantial’’

production and ‘‘substantial human

exposure,’’ as well as findings under

TSCA sections 4(a)(1)(B)(ii) and (iii).

In EPA’s ‘‘B’’ policy (see Unit II.),

‘‘substantial production’’ of a chemical

substance or mixture is generally

interpreted to be aggregate production

Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules 81667

(including import) volume equaling or

exceeding 1 million pounds per year of

that chemical substance or mixture.

(Ref. 24 at 28747). For workers, the ‘‘B’’

policy threshold for ‘‘substantial human

exposure’’ is the exposure of 1,000

workers annually to that chemical

substance or mixture. (Ref. 24) See

EPA’s ‘‘B’’ policy for further discussion

on how EPA makes decisions under

TSCA section 4(a)(1)(B)(i). For the

reasons set out in the ‘‘B’’ policy, EPA

believes that the thresholds included in

the ‘‘B’’ policy are appropriate for use in

this proposed rule. (Ref. 24)

EPA has found preliminarily that,

under TSCA section 4(a)(1)(B)(i), each of

the 37 chemical substances included in

this proposed rule is produced in

‘‘substantial’’ quantities (see Unit IV.B.)

and that there is or may be ‘‘substantial

human exposure’’ to each chemical

substance (see Unit IV.C.). In addition,

under TSCA section 4(a)(1)(B)(ii), EPA

believes that there are insufficient data

and experience to reasonably determine

or predict the effects of the manufacture,

processing, or use of these chemical

substances, or of any combination of

such activities, on human health or the

environment (see Unit IV.D.). In

particular, EPA has preliminarily

determined that there are insufficient

data on these chemicals. EPA has also

found preliminarily that testing the 37

chemical substances identified in this

Federal Register document is necessary

to develop such data (TSCA section

4(a)(1)(B)(iii)) (see Unit IV.E.). EPA has

not identified any ‘‘additional factors’’

as discussed in the ‘‘B’’ policy (Ref. 24

at 28746) to cause the Agency to use

decisionmaking criteria other than those

described in the policy.

The chemical substances included in

this proposed test rule are listed in

§ 799.5085(j) of the proposed regulatory

text along with their CAS numbers.

B. Are These Chemical Substances

Produced and/or Imported in

Substantial Quantities?

Each of the chemical substances

included in this proposal is produced

and/or imported in an amount equal to

or greater than one million pounds per

year (Ref. 9), based on information

gathered pursuant to the 1998 TSCA

section 8(a) IUR (40 CFR part 710)

which is the most recently available

compilation of TSCA Inventory data,

and which is contained in the TSCA

Chemical Update System. EPA also

considered the fact that all of these

chemicals were produced and/or

imported above 1 million pounds

annually based on the 1990 and 1994

IUR. EPA believes that these annual

production and/or importation volumes

are ‘‘substantial’’ as that term is used

with reference to production in TSCA

section 4(a)(1)(B)(i). (See also Ref. 24 at

28746).

C. Are a Substantial Number of Workers

Exposed to These Chemicals?

EPA finds that the manufacture,

processing, and uses of the chemical

substances included in this action result

or may result in exposure to a

substantial number of workers. These

chemical substances are used in a wide

variety of industrial applications, which

result in potential exposures to workers,

as described in the exposure support

document for this proposed rule (Ref.

10).

EPA defines chemical exposure as the

contact of a chemical with a person’s

outer boundary (for example, the skin or

lungs) (Ref. 11). Worker exposure is the

chemical exposure that occurs while a

person is working. Exposure to workers

may have various causes. Chemical

releases are a common cause of

exposure. For example, a chemical

manufacturing plant can release a

chemical from pumps as fugitive

emissions, from reactor and condenser

vents as stack emissions, and/or as a

particulate. Diffusion and air currents

may carry a chemical through the air in

the plant. Plant workers breathe air

containing this chemical, resulting in

exposures. Human activity such as

manually transferring a chemical from

one container to another may cause

exposures.

For each of the chemicals in this

proposed rule, estimates for the number

of exposed workers were identified in

the National Occupational Exposure

Survey (NOES). The NOES was a

nationwide data gathering project

conducted by the National Institute for

Occupational Safety and Health

(NIOSH), which was designed to

develop national estimates for the

number of workers potentially exposed

to various chemical, physical and

biological agents and describe the

distribution of these potential

exposures. Begun in 1980 and

completed in 1983, the survey involved

a walk-through investigation by trained

surveyors of 4,490 facilities in 523

different types of industries. Surveyors

recorded potential exposures when a

chemical agent was likely to enter or

contact the worker’s body for a

minimum duration. These potential

exposures could be observed or inferred.

Information from these representative

facilities was extrapolated to generate

national estimates of potentially

exposed workers for more than 10,000

different chemicals (Ref. 12). The NOES

survey is the most recent and

comprehensive source of this kind of

information.

Each of the chemicals in this

proposed rule was identified in the

NOES as having a total potential worker

exposure of greater than 1,000 workers

(Ref. 10). EPA believes that an exposure

of over 1,000 workers to a chemical

substance is ‘‘substantial’’ as that term

is used with reference to ‘‘human

exposure’’ in section 4(a)(1)(B)(i) of

TSCA. EPA believes, based on

experience gained through case-by-case

analysis of existing chemicals, that an

exposure of 1,000 workers or more to a

chemical substance is a reasonable

interpretation of the phrase ‘‘substantial

human exposure’’ in TSCA section

4(a)(1)(B)(i). See 58 FR 28736, 28746.

D. Do Sufficient Data Exist for These

Chemical Substances?

In developing the testing

requirements for chemicals contained in

this proposed rule, EPA utilized

information and sources in EPA’s study,

the Chemical Hazard Data Availability

Study (Ref. 2), and in ACC’s study, the

Public Availability of SIDS-Related

Testing Data for U.S. High Production

Volume Chemicals (Ref. 3), to determine

whether screening level data for

characterizing the risks of these HPV

chemicals are available. Section

799.5085(j) of the proposed regulatory

text lists each chemical and the tests for

which no data are currently available to

the Agency. If no data are available for

a SIDS testing endpoint, there cannot be

sufficient data to characterize the risk

associated with exposure to the

chemical. The Agency preliminarily

finds that for the SIDS testing

endpoints, including acute toxicity,

repeat dose toxicity, developmental and

reproductive toxicity, genetic toxicity

(gene mutations and chromosomal

aberrations), ecotoxicity (tests in fish,

Daphnia, and algae), and for

environmental fate (including five tests

for physical chemical properties

[melting point, boiling point, vapor

pressure, n-octanol/water partition

coefficient, and water solubility], and

biodegradation), there are insufficient

data and experience to reasonably

determine or predict the human health

and environmental effects resulting

from manufacture, processing, and use

of the chemical substances included in

this proposal.

EPA solicits comment concerning the

availability of SIDS data on these

substances and encourages industry and

others to identify and provide any

additional existing test data which are

relevant to the proposed testing. If EPA

judges such data to be sufficient,

corresponding testing will not be

81668 Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules

included in the final rule. To the extent

that additional data relevant to the

testing proposed in this rulemaking are

known to exist, EPA strongly

encourages the submission of this

information as comments to the

proposed rule, including full citations

for publications and full copies of

unpublished studies. Commenters are

also encouraged to prepare a robust

summary (Ref. 34) for each such study

to facilitate EPA’s review of the full

study report or publication. EPA has not

included any chemicals in this proposal

which are GRAS for a particular use by

the FDA. As indicated in Unit III.F.,

such chemicals may be included in a

future TSCA section 4 HPV SIDS

rulemaking where SIDS data needs

remain unmet.

E. Is Testing Necessary for These

Chemical Substances?

Of the nearly 3,000 chemicals that the

U.S. manufactures at more than 1

million pounds per year, EPA’s study

concluded that 43% of them have no

SIDS data. For the remaining chemicals,

generally limited amounts of the data

appear to be available (see Unit III.A.

and Ref. 2). The lack of available data

compromises EPA’s and others’ ability

to determine whether these chemicals

pose unreasonable risks to human

health or the environment, as well as

the public’s right to know about the

hazards of chemicals that are found in

their environment, their homes, their

workplaces, and the products that they

buy. It is EPA’s intent to close this

knowledge gap. EPA will use the data

obtained from this proposed rule to

support development of preliminary

hazard and risk assessments for these

HPV chemicals and to set priorities for

further testing that will produce more

definitive hazard information where

needed on such chemicals. Such

additional information is needed by

EPA, other Federal agencies, the public,

industry, and others to ensure that

adequate hazard and risk assessments

can be conducted on these chemicals.

EPA has used data from test rules to

support such activities as the

development of water quality criteria,

Toxic Release Inventory listings,

chemical advisories, and input for

actions resulting in reduction of

workplace exposures.

EPA believes that conducting the

needed SIDS testing identified for the 37

subject chemicals will provide data

relevant to a determination of whether

the manufacture, processing, and use of

the chemical substances does or does

not present an unreasonable risk of

injury to human health and the

environment.

V. Proposed Rule

A. What Testing is being Proposed in

this Action?

EPA is proposing specific testing and

reporting requirements for the chemical

substances specified in § 799.5085(j) of

the proposed regulatory text.

All of the proposed testing

requirements are listed in Table 2 in

§ 799.5085(j) of the proposed regulatory

text and consist of a series of test

methods covering many of the

endpoints in the OECD HPV SIDS

testing battery. Most of the proposed

testing requirements for a particular

endpoint are specified in one test

standard, although in the case of certain

endpoints, any of one or more listed

methods could be used. The following

endpoints and proposed test standards

would be required under this proposed

rule. For several of the proposed test

standards, EPA has identified and is

proposing certain ‘‘Special Conditions’’

as discussed below in this unit. Because

terrestrial toxicity testing will normally

be considered to belong at the OECD

post-SIDS tier, EPA is not proposing any

terrestrial toxicity testing (including

avian toxicity) in this rulemaking.

1. Physical/Chemical Properties.

Melting Point: American Society

for Testing and Materials (ASTM) E 324

(capillary tube)

Boiling Point: ASTM E 1719

(ebulliometry)

Vapor Pressure: ASTM E 1782

(thermal analysis)

n-Octanol/Water Partition

Coefficient: Method A (40 CFR

799.6755—shake flask)

Method B (ASTM E 1147—

liquid chromatography)

Method C (40 CFR

799.6756—generator column)

Water Solubility: Method A: (ASTM

E 1148—shake flask)

Method B: (40 CFR

799.6784—shake flask)

Method C: (40 CFR

799.6784—column elution)

Method D: (40 CFR

799.6786—generator column)

For the n-Octanol/Water Partition

Coefficient and Water Solubility

endpoints, EPA is proposing that certain

‘‘Special Conditions’’ in the form of the

chemical substance’s physical/chemical

properties or physical state (acute only)

be considered by test sponsors in

determining the appropriate test method

that would be used from among those

included for these endpoints in Table 2

in § 799.5085(j) of the proposed

regulatory text.

For the ‘‘n-Octanol/Water Partition

Coefficient’’ endpoint, the test method,

if any, would be determined by the test

substance’s estimated n-octanol/water

partition coefficient (log 10 basis; ‘‘log

Kow’’). EPA proposes three methods for

measuring the substance’s n-Octanol/

Water Partition Coefficient. The method

that would be required would be based

on the test substance’s estimated log

Kow. Prior to determining the

appropriate standard to use, if any, to

measure the n-octanol/water partition

coefficient, EPA is recommending that

the log Kow be quantitatively estimated.

EPA suggests that the method described

in Atom/Fragment Contribution Method

for Estimating Octanol-Water Partition

Coefficients (Ref. 13) be used in making

such an estimation. EPA is proposing

that test sponsors be required to submit

with the final study report the

underlying rationale for the test

standard selected for this endpoint. EPA

is proposing this approach in

recognition of the fact that depending

on the chemical substance’s log Kow, one

or more test methods can be expected to

provide adequate information for

determining the log Kow. In general, EPA

believes that the more hydrophobic a

subject chemical is, the less well

Method A (799.6755—shake flask) will

work and Method B (ASTM E 1147) and

Method C (799.6756—generator column)

become more suitable, especially

Method C. The proposed test

methodologies have been developed to

meet a wide variety of needs and, as

such, are silent on experimental

conditions related to pH. Therefore,

EPA highly recommends that all

required n-Octanol/Water Partition

Coefficient tests be conducted at pH 7

to ensure environmental relevance. The

proposed test standards and log Kow

ranges that would determine which tests

must be conducted for this endpoint are

shown below:

Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules 81669

Testing category Test requirements and references Special conditions

Physical/Chemical Properties n-Octanol/Water Partition Coefficient:

The appropriate n-Octanol/Water Partition Coefficient

test, if any, would be selected from those listed

below—see Special Conditions in the adjacent column.

Method A: 40 CFR 799.6755 (shake flask)

Method B: ASTM E 1147 (liquid chromatography)

Method C: 40 CFR 799.6756 (generator column)

n-Octanol/Water Partition Coefficient:

Which method is required, if any, would be determined by the test substance’s estimated n-octanol/

water partition coefficient (log 10 basis). Test sponsors would be required to submit in the final study

report the underlying rationale for the method selected. In order to ensure environmental relevance,

EPA is recommending that the selected study be

conducted at pH 7.

log Kow <0: no testing required.

log Kow range 0—1: Method A or B.

log Kow range 1–4: Method A or B or C.

log Kow range 4—6: Method B or C.

log Kow>6: Method C.

For ‘‘Water Solubility,’’ the test method, if any among the four proposed, would be determined by the test substance’s

estimated water solubility. EPA recommends that water solubility be quantitatively estimated prior to initiating this

study. One recommended method for estimating water solubility is described in Improved Method for Estimating Water

Solubility From Octanol/Water Partition Coefficient (Ref. 14). EPA is also proposing that test sponsors be required

to submit in the final study report the underlying rationale for the test standard selected for this endpoint. The proposed

test methodologies have been developed to meet a wide variety of needs and, as such, are silent on experimental

conditions related to pH. Therefore, EPA highly recommends that all required Water Solubility tests be conducted

at pH 7 to ensure environmental relevance. The estimated water solubility ranges that EPA is proposing for use in

selecting an appropriate proposed test standard are shown below:

Testing category Test requirements and references Special conditions

Physical/Chemical Properties Water solubility: Water Solubility:

The appropriate method to use, if any, to test for

Water Solubility would be selected from those listed below—see Special Conditions in the adjacent

column .

Method A: ASTM E 1148 (shake flask)

Method B: 40 CFR 799.6784 (shake flask)

Method C: 40 CFR 799.6784 (column elution)

Which method is required, if any, would be determined by the test substance’s estimated water solubility. Test sponsors would be required to submit

with the final study report the underlying rationale

for the method selected. In order to ensure environmental relevance, EPA recommends that the

selected study be conducted at pH 7.

Method D: 40 CFR 799.6786 (generator column) >5,000 milligram/Liter (mg/L): Method A or B.

<5,000 mg/L but > 10 mg/L: Method A, B, C, or D.

<10 mg/L but > 0.001 mg/L: Method C or D.

<0.001 mg/L: No testing required.

2. Environmental Fate and Pathways.

Inherent Biodegradation: ASTM

1625–94 (Semicontinuous Activated

Sludge Test) or International Standards

Organization (ISO) 9888 (Zahn-Wellens

Method)

3. Aquatic Toxicity.

Test Group 1: Acute toxicity to

fish (ASTM E 729)

Acute toxicity to Daphnia

(ASTM E 729)Toxicity to plants (algae)

(ASTM E 1218)

Test Group 2: Chronic toxicity to

Daphnia (ASTM E 1193)

Toxicity to plants (algae)

(ASTM E 1218)

For ‘‘Aquatic Toxicity,’’ the OECD

HPV SIDS test battery recognizes that

for certain chemicals acute toxicity

studies are of limited value in assessing

the substances’ aquatic toxicity. This

issue arises when considering chemicals

with high log Kow values. In such cases,

toxicity is unlikely to be observed over

the duration of acute toxicity studies

because of reduced uptake, and the

extended amount of time required for

such substances to reach toxic

concentrations in the test organism. For

such situations, the OECD HPV SIDS

battery recommends use of chronic

toxicity testing in Daphnia in place of

acute toxicity testing in fish and

Daphnia. EPA is proposing that the

testing requirement be determined

based on the test substance’s log Kow as

determined by using the approach

outlined in Unit V.A.1. ‘‘n-Octanol/

Water Coefficient’’ and in Table 2 in

§ 799.5085(j) of the proposed regulatory

text. For test substances determined to

have a log Kow of less than 4.2, one or

more of the following tests (described as

‘‘Test Group 1’’ in Table 2 in

§ 799.5085(j) of the proposed regulatory

text) are proposed: Acute toxicity to fish

(ASTM E 729); Acute toxicity to

Daphnia (ASTM E 729); and Toxicity to

plants (algae) (ASTM E 1218). For test

substances determined to have a log Kow

that is greater than or equal to 4.2, one

or both of the following tests (described

as ‘‘Test Group 2’’ in Table 2 in

§ 799.5085(j) of the proposed regulatory

text) are proposed: Chronic toxicity to

Daphnia (ASTM E 1193) and Toxicity to

plants (algae) (ASTM E 1218). As

outlined in Table 2 in § 799.5085(j) of

the proposed regulatory text, depending

on the testing proposed in Test Group

1, the Test Group 2 chronic Daphnia test

may substitute for either or both the

acute fish toxicity test and the acute

Daphnia test.

EPA recognizes that in some

circumstances, acute aquatic toxicity

testing (Test Group 1) may be relevant

81670 Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules

for certain chemical substances having a

log Kow equal to or greater than 4.2.

Using SAR, a log Kow of 4.2 corresponds

with a fish bioconcentration factor

(BCF) of about 1,000 (Refs. 15, 16, and

17). A chemical with a fish BCF value

of 1,000 or more is characterized as

having a tendency to accumulate in

living organisms relative to the

concentration of the chemical in the

surrounding environment (Ref. 18). For

the purposes of this proposed

rulemaking, EPA’s use of a log Kow equal

to or greater than 4.2 (which

corresponds with a fish BCF value of

1,000) is consistent with the approach

taken in the Agency’s proposed

Persistent, Bioaccumulative and Toxic

(PBT) Policy Statement under section 5

of TSCA (63 FR 53417, October 5, 1998)

(FRL–5771–6) Policy Statement under

TSCA section 5 entitled Category for

Persistent, Bioaccumulative, and Toxic

New Chemical Substances (64 FR

60194, November 4, 1999) (FRL–6097–

7)] (Ref. 25). EPA has also used a

measured BCF that is ‘‘equal to or

greater than 1,000x or, in the absence of

bioconcentration data, a log P [same as

log Kow] value equal to or greater than

4.3’’ to help define the potential of a

new chemical substance to cause

significant adverse environmental

effects (Significant New Use Rules;

General Provisions For New Chemical

Follow-Up under sections 5 and 26(c) of

TSCA (54 FR 31307, July 27, 1989; see

also 40 CFR 721.3) (Ref. 26). EPA

considers the difference between the log

Kow of 4.3 cited in the 1989 Federal

Register document and the log Kow

value of 4.2 cited in this proposed TSCA

section 4 test rule to be negligible.

Chemical substances that are

dispersible in water (e.g., surfactants,

detergents, aliphatic amines, and

cationic dyes) may have log Kow values

greater than 4.2 and may still be acutely

toxic to aquatic organisms. One

approach for dealing with such

chemicals would be to allow test

sponsors who wish to conduct Test

Group 1 studies on chemicals with a log

Kow greater than or equal to 4.2 to

submit to EPA for approval a written

request to conduct these Test Group 1

studies. The written request would have

to include the rationale for conducting

these Test Group 1 studies and be

approved by the Agency prior to (e.g.,

90 days before) initiating these Test

Group 1 studies. EPA is soliciting public

comment on this approach as well as

other alternative approaches in this

area.

4. Mammalian Toxicity—Acute.

Acute Inhalation Toxicity (rat):

Method A (40 CFR 799.9130)

Acute Oral Toxicity (rat): Method B

(ASTM E 1163–98 or 40 CFR

799.9110(d)(1)(i)(A))

For the ‘‘Mammalian Toxicity—

Acute’’ endpoint, EPA is proposing that

certain ‘‘Special Conditions’’ in the form

of the chemical substance’s physical/

chemical properties or physical state be

considered in determining the

appropriate test method that would be

used from among those included for this

endpoint in Table 2 in § 799.5085(j) of

the proposed regulatory text. The OECD

HPV SIDS program recognizes that for

most chemical substances, the oral route

of administration will suffice for this

endpoint. However, consistent with the

approach taken under the voluntary

HPV Challenge Program, EPA is

proposing that for test substances that

are gases at room temperature (25° C),

the acute mammalian toxicity study be

conducted using inhalation as the

exposure route (described as Method A

(40 CFR 799.9130) in Table 2 in

§ 799.5085(j) of the proposed regulatory

text). In the case of a potentially

explosive test substance, care must be

taken to avoid the generation of

explosive concentrations. For all other

chemicals (i.e., those that are either

liquids or solids at room temperature),

EPA is proposing that the acute toxicity

testing be conducted via oral

administration using an ‘‘Up/Down’’

test method (described as Method B

(ASTM E 1163–98 or 40 CFR

799.9110(d)(1)(i)(A)) in Table 2 in

§ 799.5085(j) of the proposed regulatory

text). Dermal toxicity testing is not

required in this rulemaking, and the

Agency does not intend to include any

dermal toxicity testing in any TSCA

section 4 HPV SIDS rulemakings.

5. Mammalian Toxicity—

Genotoxicity.

Gene Mutations:

Bacterial Reverse Mutation Test

(in vitro): 40 CFR 799.9510

Chromosomal Damage:

In Vitro Mammalian

Chromosome Aberration Test (40 CFR

799.9537), or use either the In Vivo

Mammalian Bone Marrow Chromosomal

Aberration Test (rodents: mouse

(preferred species), rat, or Chinese

hamster): 40 CFR 799.9538, or the In

Vivo Mammalian Erythrocyte

Micronucleus Test (sampled in bone

marrow) (rodents: mouse (preferred

species), rat, or Chinese hamster): 40

CFR 799.9539.

Persons required to conduct testing

for chromosomal damage are

encouraged to use in vitro genetic

toxicity testing (Mammalian

Chromosome Aberration Test) to

generate needed genetic toxicity

screening data, unless known chemical

properties preclude its use. These could

include, for example, physical chemical

properties or chemical class

characteristics. A primary focus of both

the voluntary HPV Challenge Program

and this proposed rule is to implement

this program in a manner consistent

with the OECD HPV SIDS program and

as part of a larger international activity

with global involvement. This proposed

approach provides the same degree of

flexibility as that which currently exists

under the OECD HPV SIDS testing

program (Ref. 4). A subject person who

uses one of the in vivo methods instead

of the in vitro method to address this

end-point must submit to EPA a

rationale for conducting that alternate

test in the final study report. EPA

solicits comment on whether the

Agency should instead require that a

subject person wishing to use an

alternate testing scheme submit to EPA

a notice that includes the rationale for

conducting the alternative tests prior to

planned initiation of those studies.

Comments should include suggestions

for efficient procedures for such a

notification process.

6. Mammalian Toxicity—Repeated

Dose/Reproduction/Developmental.

Combined Repeated Dose

Toxicity Study with the Reproduction/

Developmental Toxicity Screening Test:

40 CFR 799.9365

Reproduction/Developmental

Toxicity Screening Test: 40 CFR

799.9355

Repeated Dose 28-Day Oral

Toxicity Study: 40 CFR 799.9305

For ‘‘Mammalian Toxicity—Repeated

Dose/Reproduction/Developmental,’’

EPA recommends the use of the

Combined Repeated Dose Toxicity

Study with the Reproduction/

Developmental Toxicity Screening Test

(40 CFR 799.9365). EPA recognizes,

however, that there may be reasons to

test a particular chemical using both the

Reproduction/Developmental Toxicity

Screening Test (40 CFR 799.9355) and

the Repeated Dose 28-Day Oral Toxicity

Study (40 CFR 799.9305) instead of the

Combined Repeated Dose Toxicity

Study with the Reproduction/

Developmental Toxicity Screening Test

(40 CFR 799.9365). With regard to such

cases, a subject person who uses the

combination of the Reproduction/

Developmental Toxicity Screening Test

and the Repeated Dose 28-Day Oral

Toxicity Study in place of the Combined

Repeated Dose Toxicity Study with

Reproduction/Developmental Toxicity

Screen must submit to EPA a rationale

for conducting these alternate tests in

the final study reports. EPA solicits

comment on whether the Agency should

instead require that a subject person

Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules 81671

wishing to use an alternate testing

scheme submit to EPA a notice that

includes the rationale for conducting

the alternative tests prior to planned

initiation of those studies. Comments

should include suggestions for efficient

procedures for such a notification

process.

Certain of the chemicals for which

Mammalian Toxicity—Repeated Dose/

Reproduction/ Developmental testing is

proposed may be used solely as ‘‘closed

system intermediates,’’ as described in

the EPA guidance document developed

for the voluntary HPV Challenge

Program (Ref. 32). As described in that

guidance, such chemicals may be

eligible for a reduced testing battery

which substitutes a developmental

toxicity study for the SIDS requirement

to address repeated dose (e.g.,

subchronic), reproductive, and

developmental toxicity. In other words,

since only the developmental toxicity

study would be conducted for those

chemicals that qualify for a reduced

testing battery, repeated dose (e.g.,

subchronic) and reproductive studies

would not be conducted. At the present

time, EPA does not have sufficient

information to know with any degree of

certainty which if any of the chemicals

that are listed in the proposed

regulatory text are solely closed system

intermediates as defined by OECD/SIDS

guidelines. Persons who believe that a

chemical fully satisfies the terms

outlined in the guidance document are

encouraged to submit appropriate

information along with their comments

which substantiate this belief. If, based

on submitted information and other

information available to EPA, the

Agency believes that a chemical is

considered likely to meet the

requirements for use solely as a closed

system intermediate, EPA will address

any developmental toxicity testing need

in a subsequent rulemaking. In those

cases in which the Agency can

determine that chemicals are solely

closed system intermediates, it plans to

handle them in accordance with the

existing OECD procedures. EPA intends

that actual initiation of testing of closed

system intermediates be deferred until

2003.

B. When Would any Testing Imposed by

this Rulemaking Begin?

The testing requirements contained in

this proposed rule are not effective until

and unless the Agency issues a

subsequent final rule. Based on the

effective date of the final rule, which is

typically 30 days after the publication of

a final rule in the Federal Register, the

test sponsor may plan the initiation of

any required testing as appropriate to

submit the required final report by the

deadline indicated as the number of

months after the effective date that

would be shown in § 799.5085(j) of the

proposed regulatory text. As indicated

previously, in establishing the time

frame for testing under this rulemaking,

the Agency will consider the time

frames used under the voluntary HPV

Challenge Program. Specifically, any

testing of closed system intermediates

(as described in Unit III.I.) will be

deferred until 2003; and any testing of

individual chemicals (i.e., those HPV

chemicals not proposed for testing in a

category) that require further testing on

animals will be deferred until November

2001.

C. How Would the Studies Proposed

Under this Test Rule be Conducted?

Persons required to comply with the

final rule would have to conduct the

necessary testing in accordance with

those testing and reporting

requirements, and with the TSCA GLPS

(40 CFR part 792).

D. What Substances Would be Tested

Under this Rule?

EPA is proposing two distinct

approaches for identifying the specific

substances that would be tested under

this proposed rule, the application of

which would depend on whether the

substance is considered to be a ‘‘Class

1’’ or a ‘‘Class 2’’ chemical substance.

First introduced when EPA compiled

the TSCA Chemical Substance

Inventory, the term Class 1 chemical

substance refers to a chemical substance

having a chemical composition that

consists of a single chemical species

(not including impurities) that can be

represented by a specific, complete

structure diagram. By contrast, the term

Class 2 chemical substance refers to a

chemical substance having a

composition that cannot be represented

by a specific, complete chemical

structure diagram, because such a

substance generally contains two or

more different chemical species (not

including impurities). Table 2 in

§ 799.5085(j) of the proposed regulatory

text identifies the listed substances as

either Class 1 or Class 2 substances.

EPA is proposing that, for the Class 1

chemical substances that are listed in

the proposed rule, the test substance

have a purity of 99% or greater. EPA has

generally applied this standard of purity

to the testing of Class 1 chemical

substances in the past under TSCA

section 4(a) testing actions, except for

substances where it has been shown that

such purity is unattainable. EPA is

soliciting comment on whether a purity

level of 99% or greater cannot be

attained for any of the Class 1

substances listed in this proposed rule.

For the Class 2 chemical substances that

are listed in the proposed rule, EPA is

proposing that the test substance be any

representative form of the chemical

substance, to be defined by the test

sponsor(s).

In proposing a different approach for

identifying the substance to be tested

with regard to Class 2 substances, EPA

recognizes two characteristics which

further distinguish Class 1 from Class 2

chemical substances. First, unlike for

Class 1 substances, knowledge of the

composition of commercial Class 2

substances can vary in quality and

specificity from substance to substance.

The composition of the chemical

species which comprise a Class 2

substance may be:

• Well-characterized in terms of

molecular formulae, structural

diagrams, and compositional

percentages of all species present (for

example, methyl phenol);

• Less well-characterized, for

example, characterized only by

molecular formulae, non-specific

structural diagrams, and/or by

incomplete or unknown compositional

percentages of the species present (for

example, C12–C14 tert-akyl amines); or

• Poorly characterized because all that

is known is the identity of only some of

the chemical species present and their

percentages of composition, or of only

the feedstocks and method of

manufacture used to manufacture the

substance (for example, nut shell liquor

of cashew).

Secondly, the composition of some

Class 2 substances may vary from one

manufacturer to another, or, for a single

manufacturer, from production run to

production run, because of small

variations in feedstocks, manufacturing

methods, or other production variables.

A ‘‘Class 2’’ designation most frequently

represents a group of substances

comprising substances that have similar

combinations of different chemical

species and/or that were prepared from

similar feedstocks using similar

production methods. By contrast, Class

1 substances generally represent a much

narrower group of substances for which

the only variables are their impurities.

EPA believes that, for purposes of this

proposed rule which would require

basic screening-level testing, the testing

of any representative form of a subject

Class 2 substance would be relevant to

a determination of whether the chemical

substance would or would not present

an unreasonable risk to human health or

the environment. However, EPA would

encourage the selection of

representative forms of test substances

81672 Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules

that meet industry or consensus

standards, where they exist. In

accordance with TSCA GLPS at 40 CFR

part 792, the final study report must

include test substance identification

information, including name, CAS

number, strength, purity, and

composition, or other appropriate

characteristics. See 40 CFR 792.185.

As an alternative to requiring the

testing of a representative form of a

Class 2 substance designated by a

person subject to the final rule, EPA is

considering whether the Agency should

specify the particular form of each

substance that must be tested, and, if so,

what criteria EPA should use to identify

the particular representative form that

would be tested. EPA might specify, for

example, a form of a substance that

meets an industry or consensus

specification, if one exists, or the form

with the highest production volume,

which could potentially be identified

via information reported under a TSCA

section 8(a) rule, or by other means.

Under both of the approaches

described in this unit, manufacturers

and processors of each chemical

substance listed in the rule would be

jointly responsible for the testing of a

representative form of each Class 2

substance.

EPA is also considering whether, for

some or all Class 2 substances, more

than one form of a substance should be

tested. Regardless of which of the above

approaches for testing Class 2

substances is ultimately chosen (i.e.,

persons subject to the rule choosing vs.

EPA choosing the forms(s) of the Class

2 substances to be tested), EPA is

considering requiring that persons

applying for an exemption provide data

to EPA that would allow the Agency to

determine whether:

1. The form of the Class 2 substance

with respect to which an exemption

application is being submitted is

equivalent to the form of a test

substance for which data required under

the rule have been or will be submitted;

and

2. The submission of the required test

data concerning a particular form of a

Class 2 substance would be duplicative

of data that have been or will be

submitted to EPA in accordance with

the test rule.

To facilitate EPA’s review of

exemption applications under this

alternative, the Agency would require

the submission of certain chemical

substance-identifying data, including

characteristics and properties of the

exemption applicant’s substance, such

as boiling point, melting point, chemical

analysis, additives (if any), and spectral

data information.

EPA solicits comment on the

proposed alternative approaches to the

testing of Class 2 substances included in

this proposed rule. Additionally, EPA

solicits comment on whether the

proposed approach for testing Class 1

substances in the proposed rule, i.e.,

that Class 1 test substances have a

purity of 99% or greater, should be

applied to any Class 2 substances in the

proposed rule. Similarly, EPA solicits

comment on whether the proposed or

alternative approaches for the testing of

Class 2 substances should be applied to

any Class 1 substances.

E. Would I Be Required to Test Under

this Rule?

Under TSCA section 4(a)(1)(B)(ii),

EPA has made preliminary findings that

there are insufficient data and

experience to reasonably determine or

predict health and environmental effects

resulting from the manufacture,

processing, or use of the chemical

substances listed in this rulemaking. As

a result, under TSCA section 4(b)(3)(B),

manufacturers and processors of these

substances would be subject to the rule

with regard to those listed chemicals

which they manufacture or process.

1. Would I be subject to this rule? You

would be subject to this rule and may

be required to test if you manufacture or

process, or intend to manufacture or

process, one or more chemical

substances listed in this proposed rule

during the time period discussed in

Unit V.E.2 , entitled When would my

manufacture or processing (or my intent

to do so) cause me to be subject to this

rule? However, if you do not know or

cannot reasonably ascertain that you

manufacture or process a listed test

substance (based on all information in

your possession or control, as well as all

information that a reasonable person

similarly situated might be expected to

possess, control, or know, or could

obtain without unreasonable burden),

you would not be subject to the rule.

2. When would my manufacture or

processing (or my intent to do so) cause

me to be subject to this rule? You would

be subject to this rule if you

manufacture or process, or intend to

manufacture or process, a substance

listed in the rule at any time from the

effective date of the final test rule to the

end of the test data reimbursement

period. The term ‘‘reimbursement

period’’ is defined at 40 CFR 791.3(h)

and may vary in length for each

substance to be tested under a final

TSCA section 4(a) test rule, depending

on what testing is required and when

testing is completed. See Unit V.E.4. ,

entitled How do the reimbursement

procedures work?

3. Would I be required to test if I were

subject to the rule? It depends on the

nature of your activities. All persons

who would be subject to this TSCA

section 4(a) test rule, which

incorporates EPA’s generic procedures

applicable to TSCA section 4(a) test

rules (contained within 40 CFR part

790), would fall into one of two groups,

designated here as Tier 1 and Tier 2.

Persons in Tier 1 (those who would

have to initially comply with the final

rule) must either:

• Submit to EPA letters of intent to

conduct testing, conduct this testing,

and submit the test data to EPA; or

• Apply to and obtain from EPA

exemptions from testing.

Persons in Tier 2 (those who would

not have to initially comply with the

final rule) need not take any action

unless they are notified by EPA that

they are required to do so, as described

in Unit V.E.3.d , entitled What would

my obligations be if I were in Tier 2?

Note that persons in Tier 1 who obtain

exemptions and persons in Tier 2 would

nonetheless be subject to providing

reimbursement to persons who actually

conduct the testing, as described in Unit

V.E.4. , entitled How do the

reimbursement procedures work?

a.Who would be in Tier 1 and Tier 2?

All persons subject to this rule would be

considered to be in Tier 1 unless they

fall within Tier 2. The following table

describes who is in Tier 1 and Tier 2.

TABLE 2.—PERSONS SUBJECT TO THE RULE: PERSONS IN TIER 1 AND TIER 2

Tier 1 (Persons initially required to comply) Tier 2 (Persons not initially required to comply)

Persons who manufacture (as defined at TSCA section 3(7)), or intend

to manufacture, a test rule substance, and who are not listed under

Tier 2

Persons who manufacture (as defined at TSCA section 3(7)) or intend

to manufacture a test rule substance solely as one or more of the

following:

—As a byproduct (as defined at 40 CFR 791.3(c));

—As an impurity (as defined at 40 CFR 790.3));

—As a naturally occurring substance (as defined at 40 CFR 710.4(b));

Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules 81673

TABLE 2.—PERSONS SUBJECT TO THE RULE: PERSONS IN TIER 1 AND TIER 2—Continued

Tier 1 (Persons initially required to comply) Tier 2 (Persons not initially required to comply)

—As a non-isolated intermediate (as defined at 40 CFR 704.3);

—As a component of a Class 2 substance (as described at 40 CFR

720.45(a)(1)(i));

—In amounts of less than 500 kg (1,100 lbs) annually (as described at

40 CFR 790.42(a)(4)); or

—In small quantities solely for research and development (as described at 40 CFR 790.42(a)(5))

Persons who process (as defined at TSCA section 3(10)) or intend to

process a test rule substance (see 40 CFR 790.42(a)(2))

b. When would it be appropriate for

a person in Tier 1 to apply for an

exemption rather than to submit a letter

of intent to conduct testing? You may

apply for an exemption if you believe

that the required testing will be

performed by another person (or a

consortium of persons formed under

TSCA section 4(b)(3)(A)) in Tier 1. You

can find procedures relating to

exemptions in 40 CFR 790.80 through

790.99, and § 799.5085(c)(2), (c)(5), and

(c)(7) of the proposed regulatory text. In

this rule, EPA would not require

equivalence data (i.e., data

demonstrating that your substance is

equivalent to the substance actually

being tested) as a condition for approval

of your exemption. See § 799.5085(j) of

the proposed regulatory text for a

description of the substances that would

be tested under this proposed rule.

c. What would happen if I were in

Tier 1 and I submitted an exemption

application? EPA believes that requiring

the collection of duplicative data is

unnecessarily burdensome. As a result,

if EPA has received a letter of intent to

test from another source or has received

(or expects to receive) the test data that

would be required under this rule, the

Agency would conditionally approve

your exemption application under 40

CFR 790.87. The Agency would

terminate conditional exemptions if a

problem occurs with the initiation,

conduct, or completion of the required

testing, or the submission of the

required data to EPA. EPA may then

require you to submit a notice of intent

to test or an exemption application. See

40 CFR 790.93 and § 799.5085(c)(6) of

the proposed regulatory text. Note that

persons in Tier 1 who obtain

exemptions and persons in Tier 2 would

nonetheless be subject to providing

reimbursement to persons who do

actually conduct the testing, as

described in Unit V.E.4., entitled How

do the reimbursement procedures work?

d. What would my obligations be if I

were in Tier 2? If you are in Tier 2, you

would be subject to the rule and you

would be responsible for providing

reimbursement to persons in Tier 1, as

described in Unit V.E.4. You are

considered to have an automatic

conditional exemption. You would not

need to take any action unless you are

notified by EPA that you are required to

do so.

If a problem occurs with the

initiation, conduct, or completion of the

required testing, or the submission of

the required data to EPA, the Agency

may require you to submit a notice of

intent to test or an exemption

application. See 40 CFR 790.93 and

§ 799.5085(c)(6) of the proposed

regulatory text.

In addition, you would need to

submit a notice of intent to test or an

exemption application if:

• No manufacturer in Tier 1 has

notified EPA of its intent to conduct

testing; and

• EPA has published a document in

the Federal Register directing all

persons in Tier 2 to submit to EPA

letters of intent to conduct testing or

exemption applications. See 40 CFR

790.48(b) and § 799.5085(c)(4) and (c)(5)

of the proposed regulatory text. The

Agency would conditionally approve an

exemption application under 40 CFR

790.87 if EPA has received a letter of

intent to test or has received (or expects

to receive) the test data required under

this rule.

e. How did EPA decide who would be

in Tier 1 and Tier 2 and who would be

excluded from the rule?

Under 40 CFR 790.2, EPA may

establish procedures applying to

specific test rules that differ from the

generic procedures governing TSCA

section 4 test rules in 40 CFR part 790.

For the purposes of this proposed rule,

EPA is proposing to set forth certain

requirements that differ from those

under 40 CFR part 790.

Under 40 CFR part 790, in TSCA

section 4(a) test rules EPA traditionally

has treated the persons specified below

as being in Tier 2. (These rules are

found at 40 CFR part 799, subparts B

and D.):

• Processors (40 CFR 790.42(a)(2));

• Manufacturers of less than 500 kg

(1,100 lbs) per year (‘‘small-volume

manufacturers’’) (40 CFR 790.42(a)(4));

and

• Manufacturers of small quantities

for research and development (‘‘R&D

manufacturers’’) (40 CFR 790.42(a)(5)).

EPA has historically placed

processors in Tier 2 because the Agency

‘‘expected that, in most cases, testing

will be performed by the manufacturers

and that part of the cost of testing will

be passed on to processors through the

pricing mechanism, thereby enabling

them to share in the costs of testing’’ (50

FR 20652, 20654, May 17, 1985). In

addition, ‘‘[t]here are so many

processors that it would be difficult to

include them all in the technical

decisions about the tests and in the

financial decisions about how to

allocate the costs’’ (48 FR 31786, 31789,

July 11, 1983).

EPA has historically placed smallvolume manufacturers and R&D

manufacturers in Tier 2 because this

type of manufacturing ‘‘normally

represents a small percentage of the

overall production volume [and] test

sponsors are not expected to expend the

administrative resources to recover the

small proportional amounts of the

testing costs from these manufacturers’’

(55 FR 18881, May 7, 1990).

In this proposed test rule, EPA has

reconfigured these tiers. EPA has added

the following persons to Tier 2:

Byproduct manufacturers; impurity

manufacturers; manufacturers of

naturally occurring substances;

manufacturers of non-isolated

intermediates; and manufacturers of

components of Class 2 substances. The

Agency took administrative burden and

complexity into account in determining

who was to be in Tier 1 in this proposed

rule. EPA believes that those persons in

Tier 1 who would conduct testing under

this proposed rule, when finalized,

would generally be large chemical

manufacturers who, in the experience of

the Agency, have traditionally

conducted testing or participated in

81674 Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules

testing consortia under previous TSCA

section 4(a) test rules.

TSCA section 4(b)(3)(B) requires all

manufacturers and processors of a

chemical substance to test that chemical

substance if EPA has made findings for

that chemical substance, and therefore

issued a TSCA section 4(a) test rule

requiring testing. However, practicality

must be a factor in determining who is

subject to a particular test rule. Thus,

persons who do not know or cannot

reasonably ascertain that they are

manufacturing or processing a substance

would not be subject to the proposed

rule. See Unit V.E.1. and

§ 799.5085(b)(2) of the proposed

regulatory text.

Under 40 CFR 790.42(a)(4), certain

small-quantity manufacturers (i.e., those

who manufacture less than 500 kg

(1,100 lb) of the test rule chemical

annually) do not initially need to submit

letters of intent to test or exemption

applications under a test rule unless

EPA specifically requires them to do so.

EPA established this provision because

such small-quantity manufacturing

normally represents a small percentage

of the overall production volume, so

that test sponsors are not expected to

expend the administrative resources

necessary to seek reimbursement of the

associated small proportional amounts

of the testing costs from these smallquantity manufacturers. As a result,

EPA determined that the reason for

requiring an exemption application to

be filed did not exist for these

manufacturers (55 FR 18881, at 18881,

May 7, 1990).

During interagency review, it was

suggested that EPA consider increasing

the small-quantity amount in this

proposed rule in order to eliminate the

need for certain persons subject to the

rule to initially submit a letter of intent

to test or an exemption application. As

a result this group of persons would be

shifted to Tier 2. As with the existing

tiering system, these persons would still

be subject to reimbursement

requirements and could potentially be

required to conduct testing (for

example, if Tier 1 entities do not submit

letters of intent to test).

EPA is interested in receiving

comment on whether the 1,100 lb (500

kg) small-quantity threshold in this

proposed rule should be raised (e.g., to

5,000, 10,000, or 25,000 lbs) in order to

shift certain small-quantity

manufacturers from Tier 1 to Tier 2.

These persons would represent a small

percentage of the overall production

volume of a chemical in the test rule

such that test sponsors would not be

expected to expend the administrative

resources necessary to seek

reimbursement from these

manufacturers. EPA is particularly

interested in comments on the

appropriate annual production amount

at which test sponsors would not be

expected to seek reimbursement such

that the reason for requiring an

exemption application to be filed by

these manufacturers would not exist.

Please provide a rationale and

supporting information for any

alternative threshold(s) suggested.

EPA is also soliciting comment on

who should be included in Tier 1 and

Tier 2. The Agency may define these

categories differently in response to

comments received. EPA is also

soliciting comment on who should not

be subject to the rule. The latter persons

are described in Unit V.E.1. and

§ 799.5085(b)(2) of the proposed

regulatory text.

4. How do the reimbursement

procedures work? In the past, persons

subject to test rules have independently

worked out among themselves their

respective financial contributions to

those persons who have actually

conducted the testing. However, if

persons are unable to agree privately on

reimbursement, they may take

advantage of EPA’s reimbursement

procedures at 40 CFR part 791,

promulgated under the authority of

TSCA section 4(c). These procedures

include: The opportunity for a hearing

with the American Arbitration

Association; publication by EPA of a

document in the Federal Register

concerning the request for a hearing;

and the appointment of a hearing officer

to propose an order for fair and

equitable reimbursement. The hearing

officer may base his or her proposed

order on the production volume formula

set out at 40 CFR 791.48, but is not

obligated to do so. Under this proposed

rule, amounts manufactured as

impurities would be included in

production volume (40 CFR 791.48(b)),

subject to the discretion of the hearing

officer (40 CFR 791.40(a)). The hearing

officer’s proposed order may become the

Agency’s final order, which is

reviewable in federal court (40 CFR

791.60).

F. What are the Reporting Requirements

Proposed Under this Test Rule?

You would be required to submit a

final report for a specific test by the

deadline indicated as the number of

months after the effective date of the

final rule, which would be shown in

§ 799.5085(j) of the proposed regulatory

text.

G. What Would I Need to do If I Cannot

Complete the Testing Required by the

Final Rule?

A company who submits a letter of

intent to test under the final rule and

who subsequently anticipates

difficulties in completing the testing by

the deadline set forth in the final rule

may submit a modification request to

the Agency, pursuant to 40 CFR 790.55.

EPA will determine whether

modification of the test schedule is

appropriate, and may first seek public

comment on the modification.

H. Would There be Sufficient Test

Facilities and Personnel To Undertake

the Testing Proposed Under this Test

Rule?

Yes. In 1996, EPA conducted a study

of TSCA testing laboratories to evaluate

the expected capacity of these

laboratories to conduct various tests

through the year 2000 (Ref. 19). The

results suggest that laboratory capacity

is expected to expand at a rate such that

the testing that would be required by

this proposed rule should be readily

accommodated by testing laboratories

(Ref. 9).

I. Might EPA Seek Further Testing of the

Chemicals in this Proposed Test Rule?

If EPA determines that it needs

additional data regarding any of the

chemical substances included in this

proposed rule, the Agency might seek

further health and/or environmental

effects testing for these chemical

substances. Should the Agency decide

to seek such additional testing, EPA

would initiate a separate action for this

purpose.

VI. Export Notification

Any person who exports, or intends to

export, one of the chemical substances

contained in this proposed rule in any

form will be subject to the export

notification requirements in TSCA

section 12(b)(1) and at 40 CFR part 707,

subpart D, but only after the final rule

is issued and only if the chemical is

contained in the final rule. However,

export notification would generally not

be required for articles, as provided by

40 CFR 707.60(b).

VII. Public Comment

As discussed in Unit III.D, EPA is

interested in comments regarding

specific procedures for incorporating

the use of categories and SAR into this

proposed rule.

Comments which identify existing

data that may meet the requirements of

studies under this proposed rule should

include the data with the submission of

comments to EPA. Data submitted to

Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules 81675

EPA to meet the requirements of testing

under this proposed rule must be in the

form of full copies of unpublished

studies or full citations of published

studies, and may be accompanied by a

robust summary (Ref. 34). To the extent

that studies required under this

proposed rule are currently available,

and the data are judged sufficient by

EPA, testing for the endpoint/chemical

combination will not be required in the

final rule based on this proposed rule.

EPA solicits public comment on the

test methods proposed in this, the

approach discussed in Unit V.E. entitled

Would I be required to test under this

rule?, and the analysis detailing the

burdens and costs for the regulatory

impacts resulting from this rule.

In addition, EPA solicits comment on

the proposed and alternative approaches

to the testing of Class 2 substances,

whether the proposed approach for

testing Class 1 substances (i.e., that each

Class 1 substance be tested at a purity

of 99% or more) should be applied to

any Class 2 substances, and whether the

proposed or alternative approaches for

the testing of Class 2 substances (i.e.

that a representative sample of each

Class 2 substance be tested) should be

applied to any Class 1 substances.

VIII. Documents in the Official Record

The official record for this proposed

rule has been established under docket

control number OPPTS–42213A, and

the public version of the official record

is available for inspection as specified

in Unit I.B.2. The following is a listing

of the documents that have already been

placed in the official record for this

proposed rule, including those

specifically referenced in this

document. For your convenience, EPA

may have also provided some non-EPA

internet addresses to allow you to access

the electronic version of the referenced

document. In doing so, the Agency has

verified the accuracy of these addresses

at the time of signature. However, since

EPA is not responsible for these nonEPA sites, the Agency does not have any

control over these web addresses. A

paper copy of any document referenced

in this way has been included in the

public version of the official record for

this document as described in Unit

I.B.2.

1. EPA, OPPT. ChemRTK, HPV

Challenge Program Chemical List. (This

list is updated periodically, and is

available electronically at http://

www.epa.gov/chemrtk/hpvchmlt.htm).

2. EPA, OPPT. Chemical Hazard Data

Availability Study: What Do We Really

Know About the Safety of High

Production Volume Chemicals? (April

1998) (An electronic copy of this

document is available on the EPA

website at http://www.epa.gov/opptintr/

chemtest/hazchem.htm).

3. ACC (formerly CMA). Public

Availability of SIDS-Related Testing

Data for U.S. High Production Volume

Chemicals (June 12, 1998). Copies of

ACC’s report can be obtained by writing

to ACC at 1300 Wilson Blvd., Arlington,

VA 22209 or by calling ACC at (703)

741-–226.

4. OECD Secretariat. SIDS Manual.

Third Ed. Screening Information Data

Set Manual of the OECD Programme on

the Co-Operative Investigation of High

Production Volume Chemicals. Paris,

France (July 1997). Electronic copies of

this Manual can be obtained from OECD

at http://www.oecd.org/ehs/

sidsman.htm, or by accessing EPA’s

ChemRTK website at http://

www.epa.gov/chemrtk/sidsappb.htm.

5. OECD. Decision-Recommendation

on the Co-Operative Investigation and

Risk Reduction of Existing Chemicals—

C(90)163/FINAL (January 31, 1991).

6. ACC. Comments on EPA’s TSCA

section 4(a)(1)(B) Proposed Statement of

Policy submitted to the TSCA Public

Docket Office, EPA (September 17,

1991).

7. Epoxy Resin Systems Task Group of

the Society of the Plastics Industry, Inc.

Comments on EPA’s TSCA section

4(a)(1)(B) Proposed Statement of Policy

TSCA Public Docket Office, EPA

(September 17, 1991).

8. ICCA. ICCA HPV Working List 22–

040–1999; Chemicals Common to 2 or

more of the Regions: Canada, European

Union (EU), Japan, and USA (1999).

(Electronic copies of this list can be

obtained from the ICCA website at http:/

/www.icca-chem.org/hpv).

9. EPA, OPPT. Economic Impact

Analysis of a Section 4 Test Rule for

High Production Volume Chemicals

(December 2000).

10. EPA. Comparison of 1990 High

Production Volume (HPV) Chemicals

with National Occupational Exposure

Survey (NOES) Database (November 13,

1998).

11. EPA. Guidelines for Exposure

Assessment, Federal Register (57 FR

28888, May 29, 1992).

12. Seta, J.A. et al., National Exposure

Survey Field Guidelines. Cincinnati

Ohio: National Institute for

Occupational Safety and Health. DHHS

(NIOSH) Publication No. 88–106 (1988).

13. Meylan WM, and Howard PH.

Atom/Fragment Contribution for

Estimating Octanol-Water Partition

Coefficients. Journal of Pharmaceutical

Sciences. Vol.84, No.1 (January 1995).

14. Meylan WM, Howard PH, and

Boethling, RS. Improved Method for

Estimating Water Solubility From

Octanol/Water Partition Coefficient.

Environmental Toxicology and

Chemistry. Vol. 15, No.2, pp. 1006–106

(1996).

15. Veith GD and Kosian P. Estimating

bioconcentration potential from octanol/

water partition coefficients, in Physical

Behavior of PCB’s in the Great Lakes

(MacKay, Paterson, Eisenreich, and

Simmons, eds.), Ann Arbor Science,

Ann Arbor, MI. (1982).

16. Bintein S, DeVillers J, and Karcher

W. Nonlinear dependence of fish

bioconcentration on n-octanol/water

partition coefficient. SAR and QSAR in

Environmental Research, Vol.1, pp. 29–

39 (1993).

17. Meylan WM, Howard PH,

Boethling RS, Aronson D, Printup H,

and Gouchie S. Improved method of

estimating bioconcentration/

bioaccumulation factor from octanol/

water partition coefficient.

Environmental Toxicology and

Chemistry, Vol.18, No.4, pp 664–672)

(1999).

18. Smrchek JC and Zeeman MG.

Assessing Risks to Ecological Systems

from Chemicals, pp. 24–90. In. P.

Callow (ed.), Handbook of

Environmental Risk Assessment and

Management, Blackwell Science Ltd.,

Oxford, UK. (1998).

19. EPA. EPA Census of TSCA

Laboratories, Washington, DC (October

10, 1996).

20. EPA. Treatment of 12(b) Export

Notification Unit Costs for Section 4

Test Rule Analyses, OPPT/EETD/EPAB,

Washington, DC (April 1, 1999).

21. EPA. Economic Analysis in

Support of the TSCA 12(b) Information

Collection Request, OPPT/EETD/EPAB,

Washington, DC (October 30, 1998).

22. EPA. April 1999 Agenda of

Regulatory and Deregulatory Actions;

Semiannual regulatory agenda.

Chemical Right-to-Know, sequence

#3424 (64 FR 21898, April 26, 1999)

(FRL–6238–9).

23. EPA. TSCA section 4(a)(1)(B)

Proposed Statement of Policy (56 FR

32297, July 15, 1991).

24. EPA. TSCA section 4(a)(1)(B)

Final Statement of Policy (58 FR 28736,

May 14, 1993).

25. EPA. Document containing EPA’s

Policy Statement under TSCA section 5

entitled Category for Persistent,

Bioaccumulative, and Toxic New

Chemical Substances (64 FR 60194,

November 4, 1999) (FRL–6097–7). (An

electronic copy is available at http://

www.epa.gov/opptintr/newchems/

pbtpolcy.htm).

26. EPA. Significant New Use Rules;

General Provisions for New Chemical

Followup under sections 5 and 26(c) of

TSCA (54 FR 31307, July 27, 1989).

81676 Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules

27. Document describing the HPV

Initiative, entitled Data Collection/

development on High Production

Volume (HPV) Chemicals; Notice,

which is published elsewhere in this

issue of the Federal Register (FRL–

6754–6). (An electronic copy of this

document is available on the EPA

website at http://www.epa.gov/fedrgstr/

).

28. Environmental Defense (formerly

EDF). Toxic Ignorance. New York, New

York (Summer 1997). Copies of Toxic

Ignorance can be obtained by accessing

Environmental Defense’s website (http:/

/www.environmentaldefense.org/

Reports/ToxicIgnorance) or by calling

1–800–684–3322.

29. EPA, Office of Prevention,

Pesticides, and Toxic Substances

(OPPTS). Letter from Susan H. Wayland,

Deputy Assistant Administrator, to

participants in the voluntary HPV

Challenge Program (October 14, 1999)

(An electronic copy of this document is

available on the EPA website at http://

www.epa.gov/chemrtk/ceoltr2.htm).

30. EPA, OPPT. The Use of StructureActivity Relationships (SAR) in the

High Production Volume Chemicals

Challenge Program (August 26, 1999).

(An electronic copy of this document is

available on the EPA website at http://

www.epa.gov/chemrtk/sarfinl1.htm).

31. EPA, OPPT. Development of

Chemical Categories in the HPV

Challenge Program (Draft) (August 25,

1999). (An electronic copy of this

document is available on the EPA

website at http://www.epa.gov/chemrtk/

categuid.htm).

32. EPA, OPPT. Guidance for Testing

Closed System Intermediates for the

HPV Challenge Program (Draft) (March

17, 1999). (An electronic copy of this

document is available on the EPA

website at http://www.epa.gov/chemrtk/

closed9.htm).

33. EPA, OPPT. Procedures for

Removing Chemicals that are No longer

HPV and Not Likely to Become HPV

Again from the HPV List (Draft) (March

17, 1999). (An electronic copy of this

document is available on the EPA

website at http://www.epa.gov/chemrtk/

nolohpv8.htm).

34. EPA, OPPT. Draft Guidance on

Developing Robust Summaries (October

27, 1999). (An electronic copy of this

document is available on the EPA

website at http://www.epa.gov/chemrtk/

robsumgd.htm).

35. EPA, OPPT. ChemRTK HPV

Challenge Program Making

Commitments (June 29, 2000). (An

electronic copy of this document is

available on the EPA website at http://

www.epa.gov/chemrtk/makecom.htm).

36. EPA, OPPT. Draft Guidance on

Searching for Chemical Information and

Data (August 1999). (An electronic copy

of this document is available on the EPA

website at http://www.epa.gov/chemrtk/

srchguid.htm).

37. EPA, OPPT. Determining the

Adequacy of Existing Data (February 10,

1999). (An electronic copy of this

document is available on the EPA

website at http://www.epa.gov/chemrtk/

datadfin.htm).

38. SBA. Office of AdvocacyStatistics-Major Industry, Firms,

Establishment, Employment, Payroll

and Receipts, 1995. Information from

the Small Business Administration on

the Internet (http://www.sba.gov/advo/

stats/us-ind95.html. Downloaded on

December 10, 1998).

IX. Regulatory Assessment

Requirements

A. Executive Order 12866

Under E.O. 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993), the Office of

Management and Budget (OMB) has

designated this proposed rule a

‘‘significant regulatory action’’ subject to

review by OMB under E.O. 12866,

because this action may raise novel legal

or policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in section 3(f)(4)

of the E.O. EPA therefore submitted this

proposed rulemaking to OMB for review

under E.O. 12866, and any comments or

changes made during that review have

been documented in the public version

of the official record for this rulemaking.

In addition, EPA has prepared an

economic assessment entitled Economic

Impact Analysis for the Proposed

Section 4 Test Rule for High Production

Volume Chemicals (Ref. 9), a copy of

which has been placed in the public

version of the official record for this

rulemaking. This economic assessment

evaluates the potential for significant

economic impacts as a result of the

testing that would be required by this

proposal. The analysis covers 49

chemicals, 12 more than identified in

the proposal, therefore, the costs

presented here are expected to be an

overestimate. The total social cost of

providing test data on the 49 chemicals

that were evaluated in this economic

analysis is estimated to be $13 million

(Ref. 9).

While legally subject to this test rule,

processors of a subject chemical would

be required to comply with the

requirements of the rule only if they are

directed to do so by EPA as described

in § 799.5085(c)(5) and (c)(6) of the

proposed regulatory text. EPA would

only require processors to test if no

person in Tier 1 has submitted a notice

of its intent to conduct testing, or if

under 40 CFR 790.93, a problem occurs

with the initiation, conduct, or

completion of the required testing, or

the submission of the required data to

EPA. Because EPA has identified at least

one manufacturer in Tier 1 for each

subject chemical, the Agency assumes

that, for each chemical in this proposed

rule, at least one such person will

submit a letter of intent to conduct the

required testing and that person will

conduct such testing and will submit

the test data to EPA. Because processors

would not need to comply with the

proposed rule initially, the economic

assessment does not address processors.

To evaluate the potential for an

adverse economic impact of testing on

manufacturers of the chemical

substances in this proposed rule, EPA

employed a screening approach that

estimated the impact of testing

requirements as a percentage of each

chemical’s sale price. This measure

compares annual revenues from the sale

of a chemical to the annualized testing

costs for that chemical to assess the

percentage of testing costs that can be

accommodated by the revenue

generated by that chemical. Annualized

testing costs divide testing expenditures

into an equivalent, constant yearly

expenditure over a longer period of

time. To calculate the percent price

impact, testing costs (including

laboratory and administrative

expenditures) are annualized over 15

years using a 7% discount rate.

Annualized testing costs are then

divided by the estimated annual

revenue of the chemical to derive the

cost-to-sales ratio. EPA estimates the

total annualized compliance cost of

testing for the 49 chemicals evaluated in

the economic analysis to be $ 1.5

million under the average cost scenario.

In addition, the TSCA section 12(b)

export notification requirements

(included in the total and annualized

cost estimates) that would be triggered

by the final rule are expected to have a

negligible impact on exporters. The

estimated cost of the TSCA section 12(b)

export notification requirements, which,

under the final rule, would be required

for the first export to a particular

country of a chemical subject to the

rule, is estimated to be $83.38 for the

first time that an exporter must comply

with TSCA section 12(b) export

notification requirements, and $19.08

for each subsequent export notification

submitted by that exporter (Refs. 9, 20,

and 21). The Agency’s estimated total

costs of testing (including both

Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules 81677

laboratory and administrative costs)

annualized testing cost, price impacts,

and public reporting burden hours for

this proposed rule are presented in the

economic assessment.

Under a least cost scenario, 28 out of

the 45 chemicals for which price data

were available (62%) would have a

price impact at less than the 1% level.

Similarly, 28 out of the 45 chemicals

(58%) would be impacted at less than

the 1% level under an average cost

scenario. Thus, the potential for adverse

economic impact due to the proposed

test rule is low for at least 58% of the

chemicals in this proposed rule.

Approximately 17 (19) chemicals (38%

(42%)) of the 45 chemicals for which

price data are available would have a

price impact at a level greater than or

equal to 1% under the least (average)

cost scenario.

The Agency computed ‘‘critical

prices’’ for all 49 chemicals, including

the 37 chemicals included in this

proposed TSCA section 4 HPV SIDS

rule. Using chemical specific volume

and test cost data, the critical price per

pound that would result in a 1% impact

on the annual revenue of the chemical

was estimated. The critical prices are

particularly informative for the 4

chemicals for which price data are

unavailable because they represent the

minimum price that is required to

support testing at the 1% level.

Of the 4 chemicals for which price

data were unavailable, an approximate

price range could be inferred for 2

chemicals based on the knowledge of

the nature of these chemicals. Based on

the critical prices and basic information

on their nature or use, it is expected that

neither of these chemicals is likely to be

impacted at greater than the 1% level.

For the remaining 2 chemicals without

price information, it is unclear whether

they will be impacted at greater than the

1% level.

EPA believes, on the basis of these

calculations, that the proposed testing of

the chemicals presents a low potential

for adverse economic impact for the

majority of chemicals. Because the

subject chemical substances have

relatively large production volumes, the

annualized costs of testing, expressed as

a percentage of annual revenue, are very

small for most chemicals. There are,

however, some chemicals for which the

price impact is expected to exceed 1%

of the revenue from that chemical. The

potential for adverse economic impact is

expected to be higher for these

chemicals. In these cases, companies

may choose to use revenue sources

other than the profits from the

individual chemicals to pay for testing.

Therefore, the Agency also compared

the costs of compliance to company

sales for small businesses.

B. Regulatory Flexibility Act

Pursuant to section 605(b) of the

Regulatory Flexibility Act (RFA), 5

U.S.C. 601(b) et seq., the Agency hereby

certifies that this rulemaking, if

promulgated as proposed, will not have

a significant economic impact on a

substantial number of small entities.

The factual basis for the Agency’s

determination is presented in the small

entity impact analysis prepared as part

of the economic analysis for this rule

(Ref. 9), and is briefly summarized here.

Two factors are examined in EPA’s

small entity impact analysis (Ref. 9) in

order to characterize the potential small

entity impacts of this rule:

1. The size of the adverse impact

(measured as the ratio of the cost to

sales or revenue), and

2. The total number of small entities

that experience the adverse impact.

Section 601(3) of the RFA establishes

as the default definition of ‘‘small

business’’ the definition used in section

3 of the Small Business Act, 15 U.S.C.

632, under which the Small Business

Administration (SBA) establishes small

business size standards (13 CFR

121.201). For this rulemaking, EPA has

analyzed the potential small business

impacts using the size standards

established under this default

definition. The SBA size standards,

which are primarily intended to

determine whether a business entity is

eligible for government programs and

preferences reserved for small

businesses (13 CFR 121.101), ‘‘seek to

ensure that a concern that meets a

specific size standard is not dominant in

its field of operation.’’ (13 CFR

121.102(b)). See section 632(a)(1) of the

Small Business Act. In analyzing

potential impacts, the RFA recognizes

that it may be appropriate at times to

use an alternate definition of small

business. As such, section 601(3) of the

RFA provides that an agency may

establish a different definition of small

business after consultation with the

SBA Office of Advocacy and after notice

and an opportunity for public comment.

Even though the Agency has used the

default SBA definition of small business

to conduct its analysis of potential small

entity impacts for this proposed rule,

EPA does not believe that the SBA size

standards are generally the best size

standards to use in assessing potential

small entity impacts with regard to

TSCA section 4(a) test rules.

The SBA size standard is generally

based on the number of employees an

entity in a particular industrial sector

may have. For example, in the chemical

manufacturing industrial sector (i.e., SIC

28 and SIC 29), approximately 98% of

the firms would be classified as small

businesses under the default SBA

definition. The SBA size standard for

75% of this industry sector is 500

employees, and the size standard for

23% of this industry sector is 750,

1,000, or 1,500 employees. As a result,

when assessing the potential impacts of

test rules on chemical manufacturers,

EPA believes that a standard based on

total annual sales may provide a more

appropriate means to judge the ability of

a chemical manufacturing firm to

support chemical testing without

significant costs or burdens.

EPA is currently determining what

level of annual sales would provide the

most appropriate size cutoff with regard

to various segments of the chemical

industry usually impacted by TSCA

section 4(a) test rules, but has not yet

reached a determination. As stated

above, therefore, the factual basis for the

RFA determination for this proposed

rule is based on an analysis using the

default SBA size standards. Although

EPA is not currently proposing to

establish an alternate definition for use

in the analysis conducted for this

proposed rule, the analysis for this

proposed rule also presents the results

of calculations using a standard based

on total annual sales (40 CFR 704.3).

EPA is interested in receiving comments

on whether the Agency should consider

establishing an alternate definition for

small business to use in the small entity

impact analyses for future TSCA section

4(a) test rules, and what size cutoff may

be appropriate.

The SBA has developed 6 digit NAICS

code-specific size standards based on

employment thresholds. These size

standards range from 500 to 1,500

employees for the various 6 digit NAICS

codes that are potentially impacted (Ref.

9). For a conservative estimate of the

number of small businesses affected by

the HPV rule, the Agency chose an

employment threshold of less than

employees 1,500 for all businesses

regardless of the NAIC-specific

threshold to determine small business

status.

For each manufacturer of the 49

chemicals in the economic analysis, the

parent company (ultimate corporate

entity, or UCE) was identified and sales

and employment data were obtained for

companies where data was available.

The search determined that there were

103 affected UCEs. Sales and

employment data could be found for

102 of these UCEs (99%).

Parent company sales data were

collected to identify companies that

qualified for ‘‘small business’’ status.

81678 Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules

Based on the SBA size standard applied,

35 companies were identified as small.

Employment data were unavailable for 1

company. A separate analysis,

contained in the economic assessment

prepared for this proposed rule, was

conducted for these companies to

determine the potential economic

impact of this proposed rule.

The significance of this proposed HPV

rule’s impact on small businesses was

analyzed by examining the number of

small entities that experienced different

levels of costs as a percentage of their

sales. Small businesses were placed in

the following categories on the basis of

cost-to sales ratios: less than 1%, greater

than 1%, greater than 3%. This analysis

was conducted under both the least and

the average cost scenarios.

Of the 35 companies that qualified for

small business status per the SBA size

standards, only 1 had cost-to-sales ratios

of greater than 1% under least and

average cost scenarios. None were

impacted at greater than the 3% level.

Given these results, there does not

appear to be a significant impact on a

substantial number of small entities as

a result of this proposed rule.

As stated earlier in this unit,

employment data were unavailable for 1

of the identified 103 companies (1%).

While data on their company level sales

were also unavailable, the volumes of

the chemicals included in this proposed

rule that it produced could be identified

from the 1994 IUR database. Combining

secondary data on chemical prices with

production volume data, the sales value

of these chemicals could be estimated

for this company. In addition, the

minimum critical sales level that would

be needed to avoid an impact at the 1%

and the 3% levels was calculated. These

critical sales were then compared to the

sales estimated using the method

described in this unit. Using these

estimates, EPA concluded that this

company is not impacted at greater than

1% of sales in the least or average cost

scenarios

The estimated cost of the TSCA

section 12(b)(1) export notification,

which, as a result of the final rule,

would be required for the first export to

a particular country of a chemical

subject to the rule, is estimated to be

$83.38 for the first time that an exporter

must comply with TSCA section

12(b)(1) export notification

requirements, and $19.08 for each

subsequent export notification

submitted by that exporter (Refs. 9, 20,

and 21). EPA has concluded that the

costs of TSCA section 12(b)(1) export

notification would have a negligible

impact on exporters of the chemicals in

the final rule, regardless of the size of

the exporter.

Therefore, the Agency certifies that

this proposed rule, if finalized, would

not have a significant economic impact

on small entities. Information relating to

this determination has been included in

the public version of the official record

for this proposed rule. This information

will also be provided to the SBA Chief

Counsel for Advocacy upon request.

Any comments regarding the impacts

that this action may impose on small

entities, or regarding whether the

Agency should consider establishing an

alternate definition of small business to

be used for analytical purposes for

future test rules and what size cutoff

may be appropriate, should be

submitted to the Agency in the manner

specified under ADDRESSES.

C. Paperwork Reduction Act

Pursuant to the Paperwork Reduction

Act (PRA), 44 U.S.C. 3501 et seq., an

agency may not conduct or sponsor, and

a person is not required to respond to,

an information collection request unless

it displays a currently valid OMB

control number. The OMB control

numbers for EPA’s regulations, after

appearing in the preamble of the final

rule, are listed in 40 CFR part 9, and

included on the related collection

instrument. The information collection

activities related to chemical testing

under TSCA section 4(a) have already

been approved under OMB control

number 2070–0033 (EPA ICR No.1139),

and the information collection activities

related to export notification under

TSCA section 12(b)(1) are already

approved under OMB control number

2070–0030 (EPA ICR No. 0795). This

action does not contain any new

information collection activities

requiring additional OMB review and

approval.

Although the information collection

activities contained in this proposed

rule have already been approved by

OMB, the total burden hours currently

approved for the information collection

activities related to chemical testing

may not reflect the estimated burden

hours specifically related to the

activities contained in this proposed

rule because the total number of

chemicals included in this proposed

rule exceeds the total number of

chemicals estimated in the ICR. As

described in the information collection

instrument for chemical testing (EPA

ICR No. 1139), the Agency’s total

burden estimate specifically accounts

for the potential issuance of

approximately three average test rules

per year, each assumed to involve five

chemicals and three sponsors. With an

estimated burden of approximately 263

hours for each study, the Agency

estimated an average burden of 14,444

hours per test sponsor . When a final

rule based on this proposed rule is

issued, EPA will verify that the

approved burden hours contained in the

ICR are sufficient to cover the estimated

burden for the final rule. If not, EPA

will request that the total approved

burden hour for the ICR be increased

accordingly.

The standard chemical testing

program involves the submission of

letters of intent to test (or exemption

applications), study plans,

administering the tests, progress reports,

and test results. For this proposed rule,

EPA estimates that the information

collection activities related to chemical

testing for all chemicals in this proposal

(representing the submission of letters

of intent or exemption applications,

administering the tests, and submitting

the final reports—the study plan is

represented by this proposed rule and

progress reports are not required by this

proposed rule because testing will be

completed within 1 year) would result

in an annual public reporting burden of

approximately 12,942 hours per

sponsor, assuming seven chemicals per

sponsor.

The annual public reporting burden

related to export notification is

estimated to be 0.5–1.5 burden hours for

each chemical/country combination

(Ref. 9). In estimating the total burden

hours approved for the information

collection activities related to export

notification, the Agency has included

sufficient burden hours to accommodate

any export notifications that may be

required by the Agency’s issuance of

final chemical test rules. As such, EPA

does not expect to need to request an

increase in the total burden hours

approved by OMB for export

notifications.

As defined by the PRA and 5 CFR

1320.3(b), ‘‘burden’’ means the total

time, effort, or financial resources

expended by persons to generate,

maintain, retain, or disclose or provide

information to or for a Federal agency.

This includes the time needed to:

review instructions; develop, acquire,

install, and utilize technology and

systems for the purposes of collecting,

validating, and verifying information,

processing and maintaining

information, and disclosing and

providing information; adjust the

existing ways to comply with any

previously applicable instructions and

requirements; train personnel to be able

to respond to a collection of

information; search data sources;

complete and review the collection of

Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules 81679

information; and transmit or otherwise

disclose the information.

Comments are requested on the

Agency’s need for this information, the

accuracy of the provided burden

estimates, and any suggested methods

for minimizing respondent burden,

including through the use of automated

collection techniques. Send comments

to EPA as part of your overall comments

on this proposed action in the manner

specified under ADDRESSES. In the

final rule, the Agency will address any

comments received regarding the

information collection requirements

contained in this proposal.

D. Unfunded Mandates Reform Act and

Executive Orders 13084 and 13132

Pursuant to Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA),

Public Law 104–4, EPA has determined

that this rulemaking does not contain a

Federal mandate that may result in

expenditures of $100 million or more

for State, local, and tribal governments,

in the aggregate, or the private sector in

any 1 year. It is estimated that the total

aggregate costs of this proposed rule,

which are summarized in Unit XI.A. ,

would be $13 million. The total

annualized costs of this proposed rule

are estimated to be $1.5 million. In

addition, EPA has determined that this

proposed rule does not significantly or

uniquely affect small governments.

Accordingly, this proposed rule is not

subject to the requirements of sections

202, 203, 204, and 205 of UMRA.

Under E.O. 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19, 1998), EPA has

determined that this proposed rule

would not significantly or uniquely

affect the communities of Indian tribal

governments. This determination is

based on the Agency’s experience over

the years which indicates that, as a

practical matter, the burden of chemical

testing under TSCA section 4(a) rules

has traditionally fallen on large, private

sector manufacturers rather than on

tribal governments. Accordingly, the

requirements of section 3(b) of E.O.

13084 do not apply to this proposed

rule. Nor will this action have a

substantial direct effect on States, on the

relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government, as specified in

E.O. 13132, entitled Federalism (64 FR

43255, August 10, 1999).

In the history of the TSCA section 4(a)

testing program, the Agency has never

received a letter of intent to test or an

exemption application from a State,

local, or tribal government. EPA is

requesting comment on whether any

State, local, or tribal government is

engaged in the manufacture or

processing of these HPV chemicals such

that they might be subject to the

requirements of this proposed rule. On

the basis of these comments, EPA may

determine that it is appropriate to

consult with representatives of

potentially affected State, local, or tribal

governments prior to promulgating the

final rule.

E. Executive Order 12898

This proposed rule does not involve

special considerations of

environmental-justice issues pursuant to

E.O. 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994).

F. Executive Order 13045

E.O. 13045, entitled Protection of

Children from Environmental Health

Risks and Safety Risks (62 FR 19885,

April 23, 1997), does not apply to this

proposed rule, because it is not

designated as an ‘‘economically

significant’’ regulatory actions as

defined under E.O. 12866, and it does

not establish an environmental standard

that is intended to mitigate

environmental health or safety risks that

EPA has reason to believe may have a

disproportionate effect on children. EPA

interprets E.O. 13045 as applying only

to those regulatory actions that establish

an environmental standard intended to

mitigate health or safety risks, such that

the analysis required under section 5-

501 of the Order has the potential to

influence the regulation.

Although this proposed rule is not

subject to this E.O., the information

obtained by the testing proposed in this

rule will be used to inform the Agency’s

decision making process regarding

chemicals to which children may be

disproportionately disposed. This

information will also assist the Agency

and others in evaluating these chemical

substances for potential health or safety

risk concerns, and will serve to further

the Agency’s goal of identifying and

controlling human and environmental

risks as well as provide greater

protection and knowledge to the public.

In addition, in a separate Federal

Register document (64 FR 46673,

August 26, 1999), EPA announced the

initiation of a stakeholder involvement

process to involve stakeholders in the

design and development of a voluntary

program to test commercial chemicals to

which children may have a high

likelihood of exposure. The purpose of

the voluntary testing program is to

obtain toxicity data needed to assess the

potential risks resulting from childhood

exposure to certain commercial

chemicals.

G. National Technology Transfer and

Advancement Act

Section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 (NTTAA), Public Law 104–

113, section 12(d) (15 U.S.C. 272 note),

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 and business

practices) that are developed or adopted

by voluntary consensus standards

bodies. The NTTAA directs EPA to

provide Congress, through OMB,

explanations when the Agency decides

not to use available and applicable

voluntary consensus standards.

If the Agency has made findings

under TSCA section 4(a), EPA is

required by TSCA section 4(b) to

include specific standards for the

development of data in test rules. For

some of the testing that would be

required by this rule, EPA is proposing

the use of voluntary consensus

standards issued by the ASTM and ISO

which evaluate the same type of toxicity

as the TSCA and OECD test guidelines,

where applicable. Copies of the ASTM

and ISO standards referenced in this

proposed rule have been placed in the

public version of the official record for

this rulemaking. In the final rule, EPA

intends to seek approval from the

Director of the Federal Register for the

incorporation by reference of the ASTM

and ISO standards used in the final rule

in accordance with 5 U.S.C. 552(a) and

1 CFR part 51.

EPA is not aware of any potentially

applicable voluntary consensus

standards which evaluate partition

coefficient (n-octanol/water) generator

column, water solubility (column

elution and generator column), acute

inhalation toxicity, bacterial reverse

mutations, in vivo mammalian bone

marrow chromosomal aberrations,

combined repeated dose with

reproductive/developmental toxicity

screen, repeated dose 28-day oral

toxicity screen, or the reproductive

developmental toxicity screen which

could be considered in lieu of the TSCA

guidelines, 40 CFR 799.6756, 799.6784,

799.6786, 799.9130, 799.9510, 799.9538,

799.9365, 799.9305, and 799.9355,

respectively, upon which the test

standards in this proposed rule are

81680 Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules

based. The Agency invites comment on

the potential use of voluntary consensus

standards in this rulemaking, and,

specifically, invites the public to

identify potentially applicable

consensus standard(s) and to explain

why such standard(s) should be used

here.

H. Executive Order 12630

EPA has complied with E.O. 12630,

entitled Governmental Actions and

Interference with Constitutionally

Protected Property Rights (53 FR 8859,

March 15, 1988), by examining the

takings implications of this rule in

accordance with the Attorney General’s

Supplemental Guidelines for the

Evaluation of Risk and Avoidance of

Unanticipated Takings issued under the

E.O.

I. Executive Order 12988

In issuing this proposed rule, EPA has

taken the necessary steps to eliminate

drafting errors and ambiguity, minimize

potential litigation, and provide a clear

legal standard for affected conduct, as

required by section 3 of E.O. 12988,

entitled Civil Justice Reform (61 FR

4729, February 7, 1996).

List of Subjects in 40 CFR Part 799

Environmental protection, Chemicals,

Hazardous substances, Laboratories,

Reporting and recordkeeping

requirements.

Dated: December 14, 2000.

Susan H. Wayland,

Acting Assistant Administrator for

Prevention, Pesticides and Toxic Substances.

Therefore, it is proposed that 40 CFR

chapter I, subchapter R, be amended as

follows:

PART 799—[AMENDED]

1. The authority citation for part 799

would continue to read as follows:

Authority: 15 U.S.C. 2603, 2611, 2625.

2. By adding § 799.5085 to subpart D

of part 799 that would read as follows:

§ 799.5085 Testing of certain High

Production Volume (HPV) chemicals.

(a) What substances will be tested

under this section? Table 2 in

§ 799.5085(j) identifies the chemical

substances that must be tested under

this section. For the chemical

substances identified as ‘‘Class 1’’

substances in Table 2, the purity of each

substance must be 99% or greater,

unless otherwise specified in this

section. For the chemical substances

identified as ‘‘Class 2’’ substances, a

representative form of each substance

must be tested.

(b) Am I subject to this section? (1) If

you manufacture (including import) or

intend to manufacture, or process or

intend to process, any chemical

substance listed in Table 2 in

799.5085(j) at any time from the

effective date of the final rule to the end

of the test data reimbursement period as

defined in 40 CFR 791.3(h), you are

subject to this section with respect to

that chemical substance.

(2) If you do not know or cannot

reasonably ascertain that you

manufacture or process a chemical

substance listed in Table 2 in

§ 799.5085(j) during the time period

described in paragraph (b)(1) of this

section (based on all information in

your possession or control, as well as all

information that a reasonable person

similarly situated might be expected to

possess, control, or know, or could

obtain without unreasonable burden),

you are not subject to this section with

respect to that chemical substance.

(c) If I am subject to this section, when

must I comply with it? (1) (i) Persons

subject to this section are divided into

two groups, as set forth in Table 1: Tier

1 (persons initially required to comply)

and Tier 2 (persons not initially

required to comply). If you are subject

to this section, you must determine if

you fall within Tier 1 or Tier 2, based

on Table 1.

TABLE 1.—PERSONS SUBJECT TO THE RULE: PERSONS IN TIER 1 AND TIER 2

Persons initially required to comply with this section

(Tier 1) Persons not initially required to comply with this section (Tier 2)

Persons not otherwise specified in column 2 of this

table that manufacture (as defined at TSCA section

3(7)) or intend to manufacture a chemical substance included in this section.

Persons that manufacture (as defined at TSCA section 3(7)) or intend to manufacture a

chemical substance included in this section solely as one or more of the following:

—As a byproduct (as defined at 40 CFR 791.3(c));

—As an impurity (as defined at 40 CFR 790.3);

—As a naturally occurring substance (as defined at 40 CFR 710.4(b));

—As a non-isolated intermediate (as defined at 40 CFR 704.3);

— As a component of a Class 2 substance (as described at 40 CFR 720.45(a)(1)(i));

—In amounts of less than 500 kilograms (kg) (1,100 lbs) annually (as described at 40

CFR 790.42(a)(4)); or

—For research and development (as described at 40 CFR 790.42(a)(5)).

Persons that process (as defined at TSCA section 3(10)) or intend to process a chemical

substance included in this section (see 40 CFR 790.42(a)(2)).

(ii) Table 1 expands the list of persons

specified in 40 CFR 790.42(a)(2), (a)(4)

and (a)(5), who, while legally subject to

this section, must comply with the

requirements of this section only if

directed to do so by EPA under the

circumstances set forth in paragraphs

(c)(4) and (c)(5) of this section.

(2) If you are in Tier 1 with respect

to a chemical substance listed in Table

2 in § 799.5085(j), you will be required

to comply with this section with regard

to that chemical substance, as described

in paragraph (d) of this section, no later

than 30 days after the effective date of

the final rule. Sections 790.45(a) and

790.80(b)(1) of this chapter do not apply

to this section.

(3) If you are in Tier 2 with respect

to a chemical substance listed in Table

2 in § 799.5085(j), you are considered to

have an automatic conditional

exemption and you will be required to

comply with this section with regard to

that chemical substance only if directed

to do so by EPA under paragraphs (c)(5)

or (c)(6) of this section.

(4) If no person in Tier 1 has notified

EPA of its intent to conduct one or more

of the tests required by this section on

any chemical substance listed in Table

2 in § 799.5085(j) within 30 days after

the effective date of the final rule, EPA

will publish a Federal Register

document that will specify the test and

the chemical substance for which no

letter of intent has been submitted.

Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules 81681

Section 790.48(b)(2) of this chapter does

not apply to this section.

(5) If you are in Tier 2 with respect

to a chemical substance listed in Table

2 in § 799.5085(j), and if you

manufacture or process this chemical as

of the effective date of the final rule, or

within 30 days after publication of the

Federal Register document described in

paragraph (c)(4) of this section, you

must do the following: For each test on

that chemical specified in the Federal

Register document described in

paragraph (c)(4) of this section, either

notify EPA by letter of your intent to test

or submit to EPA an exemption

application. You must comply within 30

days after the date of publication of the

Federal Register document described in

paragraph (c)(4) of this section. Sections

790.48(b)(3), and 790.80(a)(2) and (b)(1)

of this chapter do not apply to this

section.

(6) If a problem occurs with the

initiation, conduct, or completion of the

required testing or the submission of the

required data with respect to a chemical

substance listed in Table 2 in

§ 799.5085(j), under the procedures in

40 CFR 790.93 and 790.97 EPA will

terminate all testing exemptions with

respect to that substance and may notify

persons in Tier 1 and Tier 2 that they

are required to submit letters of intent

to test or exemption applications within

a specified period of time. Notification

will be given by certified letter or by

publication in the Federal Register.

(7) If you are required to comply with

this section, but your manufacture or

processing of a chemical substance

listed in Table 2 in § 799.5085(j) begins

after the applicable compliance date

referred to in paragraphs (c)(2), (c)(5) or

(c)(6) of this section, you must comply

by submitting a letter of intent to test or

an exemption application as of the day

you begin manufacture or processing.

Sections 790.45(d)(1) and (d)(2), and

790.80(b)(2) and (b)(3) of this chapter do

not apply to this section.

(d) What must I do to comply with

this section? (1) To comply with this

section you must either:

(i) submit to EPA a letter of intent to

test, conduct the testing specified in

Table 2 in § 799.5085(j), and submit the

test data to EPA; or

(ii) apply to and obtain from EPA an

exemption from testing.

(2) You must also comply with the

procedures governing test rule

requirements in part 790 of this chapter,

as modified by this section, including

the submission of letters of intent to test

or exemption applications, the conduct

of testing, and the submission of data;

Part 792—Good Laboratory Practice

Standards of this chapter; and this

section.

(e) If I do not comply with this section,

when will I be considered in violation of

it? You will be considered in violation

of this section as of one day after the

date by which you are required to

comply with this section. Sections

790.45(e) and (f) of this chapter do not

apply to this section.

(f) How are EPA’s data reimbursement

procedures affected for purposes of this

section? If persons subject to this section

are unable to agree on the amount or

method of reimbursement for test data

development for one or more chemical

substances included in this section, any

person may request a hearing as

described in 40 CFR part 791. In the

determination of fair reimbursement

shares under this section, if the hearing

officer chooses to use a formula based

on production volume, the total

production volume amount will include

amounts of a chemical substance

produced as an impurity.

(g) Who must comply with the export

notification requirements? Any person

who exports, or intends to export, a

chemical substance listed in Table 2 in

§ 799.5085(j) is subject to part 707,

subpart D, of this chapter.

(h) What test standards must I follow?

Follow the guidelines and other test

methods described in Table 2 in

§ 799.5085(j).

(i) Reporting requirements. A final

report for a specific test must be

submitted by the deadline indicated in

Table 2 in § 799.5085(j).

(j) Designation of specific chemical

substances and applicable testing

requirements. The substances identified

by name and the Chemical Abstract

Service (CAS) number in Table 2 of this

section must be tested in accordance

with the designated testing

requirements, the requirements

described in Part 792—Good Laboratory

Practice Standards of this chapter, and

any additional requirements and

limitations specified in the following

Table 2:

TABLE 2—CHEMICAL SUBSTANCES AND APPLICABLE TESTING REQUIREMENTS

CAS No. Chemical name Chemical

class

Required tests (See

Key)

Deadline for final report (Months from

effective date of final rule)

55–63–0 1,2,3-Propanetriol, trinitrate 1 A, C6, E2, F2. 13

62–56–6 Thiourea 1 A. 13

74–95–3 Methane, dibromo- 1 A, C1, E2, F2. 13

75–36–5 Acetyl chloride 1 A, B, C2, E2, F1. 13

75–75–2 Methanesulfonic acid 1 A, C1, E1, E2, F1. 13

78–11–5 1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-,

dinitrate (ester)

1 A, B, C6, F2. 13

84–65–1 9,10-Anthracenedione 1 A, F2. 13

84–69–5 1,2-Benzenedicarboxylic acid, bis(2-

methylpropyl) ester

1 A, E2, F2 13

88–18–6 Phenol, 2-(1,1-dimethylethyl)- 1 A, C2, D, E1, E2, F1. 13

90–00–6 Phenol, 2-ethyl- 1 A, B, C1, E2, F2. 13

90–15–3 1-Naphthalenol 1 A, C5, F2 13

98–11–3 Benzenesulfonic acid 1 A, C3, E2, F1. 13

105–67–9 Phenol, 2,4-dimethyl- 1 A, C6, E2, F2. 13

107–16–4 Acetonitrile, hydroxy- 1 A, B, C1, E2, F2. 13

107–18–6 2-Propen-1-ol 1 A, C6, E2. 13

108–19–0 Imidodicarbonic diamide 1 A, B, C1, D, E1, E2,

F1.

13

110–44–1 2,4-Hexadienoic acid, (E,E)- 1 A, C4, F2. 13

112–52–7 Dodecane, 1-chloro- 1 A, B, C3, D, E1, E2,

F1

13

118–82–1 Phenol, 4,4’-methylenebis[2,6-bis(1,1-

dimethylethyl)-

1 A, B, D, E1, E2, F2. 13

81682 Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules

TABLE 2—CHEMICAL SUBSTANCES AND APPLICABLE TESTING REQUIREMENTS—Continued

CAS No. Chemical name Chemical

class

Required tests (See

Key)

Deadline for final report (Months from

effective date of final rule)

131–57–7 Methanone, (2-hydroxy-4-

methoxyphenyl)phenyl1 A, C1, D, E2, F2. 13

149–44–0 Methanesulfinic acid, hydroxy-, monosodium

salt

1 A, B, C1, E2, F1. 13

409–02–9 Heptenone, methyl- 2 A, B, C1, D, E1, E2,

F1.

13

594–42–3 Methanesulfenyl chloride, trichloro- 1 A, B, C1, E1, E2, F2. 13

624–83–9 Methane, isocyanato- 1 A, C1. 13

732–26–3 Phenol, 2,4,6-tris(1,1-dimethylethyl)- 1 A, C2, E1, E2, F1. 13

870–72–4 Methanesulfonic acid, hydroxy-, monosodium

salt

1 A, B, C1, E1, E2, F1. 13

1324–76–1 Benzenesulfonic acid, [[4-[[4-

(phenylamino)phenyl][4-(phenylimino)-2,5-

cyclohexadien-1-

ylidene]methyl]phenyl]amino]-

2 A, B, C1, D, E1, E2,

F1.

13

1333–39–7 Benzenesulfonic acid, hydroxy- 2 A, B, C1, E1, E2, F1. 13

2941–64–2 Carbonochloridothioic acid, S-ethyl ester 1 A, B, C1, E2, F1. 13

3622–84–2 Benzenesulfonamide, N-butyl- 1 A, B, C1, E1, E2, F2. 13

6473–13–8 2-Naphthalenesulfonic acid, 6-[(2,4-

diaminophenyl)azo]-3-[[4-[[4-[[7-[(2,4-

diaminophenyl)azo]-1-hydroxy-3-sulfo-2-

naphthalenyl]azo]phenyl]amino]-3-

sulfophenyl]azo]-4-hydroxy-, trisodium salt

1 A, B, C1, D, E1, E2,

F1.

13

8005–02–5 C.I. Solvent Black 7 2 A, B, C1, D, E2, F1. 13

28188–24–1 Octadecanoic acid, 2-(hydroxymethyl)-2-[[(1-

oxooctadecyl)oxy]methyl]-1,3-propanediyl

ester

1 A, B, C1, D, E1, E2,

F1.

13

65996–78–3 Light oil, coal, coke-oven 2 A, B, C1, D, E1, E2,

F1.

13

68153–30–0 Quaternary ammonium compounds,

benzylbis(hydrogenated tallow alkyl)methyl,

salts with bentonite

2 A, B, C1, D, E1, E2,

F1.

13

68611–64–3 Urea, reaction products with formaldehyde 2 A, B, C1, D, E1, E2,

F1.

13

68953–58–2 Quaternary ammonium compounds,

bis(hydrogenated tallow alkyl)dimethyl, salts

with bentonite

2 A, B, C1, D, E1, E2,

F1.

13

KEY TO THE TEST REQUIREMENTS FOR THE CHEMICALS LISTED IN TABLE 2 AND SPECIFIED BY ALPHANUMERIC SYMBOLS

(E.G., A OR C5)

Testing category Test

symbol Test requirements and references1 Special conditions

Physical/Chemical Properties A 1. Melting Point: ASTM E 324 (capillary tube) n-Octanol/Water Partition Coefficient:

2. Boiling Point: ASTM E 1719 (ebulliometry) Which method is required, if any, is determined by the test substance’s estimated2

n-octanol/water partition coefficient (log 10

basis). Test sponsors are required to provide in the final study report the underlying

rationale for the method selected. In order

to ensure environmental relevance, EPA

highly recommends that the selected study

be conducted at pH 7.

3. Vapor Pressure: ASTM E 1782 (thermal

analysis)

4. n-Octanol/Water Partition Coefficient: (See

Special Conditions for the n-Octanol/Water

Partition Coefficient test requirement and

select the appropriate method to use, if

any, from those listed below.)

Method A: 40 CFR 799.6755 (shake

flask)

Method B: ASTM E 1147 (liquid chromatography)

Method C: 40 CFR 799.6756 (generator

column)

log Kow <0: no testing required.

log Kow range 0–1: Method A or B.

log Kow range 1–4: Method A or B or C.

log Kow range 4–6: Method B or C.

log Kow >6: Method C.

Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules 81683

KEY TO THE TEST REQUIREMENTS FOR THE CHEMICALS LISTED IN TABLE 2 AND SPECIFIED BY ALPHANUMERIC SYMBOLS

(E.G., A OR C5)—Continued

Testing category Test

symbol Test requirements and references1 Special conditions

5. Water Solubility: (See Special Conditions

for the Water Solubility test requirement

and select the appropriate method to use,

if any, from those listed below.)

Method A: ASTM E 1148 (shake flask)

Method B: 40 CFR 799.6784 (shake

flask)

Method C: 40 CFR 799.6784 (column

elution)

Method D: 40 CFR 799.6786 (generator

column)

Water Solubility:

Which method is required, if any, is determined by the test substance’s estimated3

water solubility. Test sponsors are required

to provide in the final study report the underlying rationale for the method selected.

In order to ensure environmental relevance, EPA highly recommends that the

selected study be conducted at pH 7.

>5,000 mg/L: Method A or B.

< 5,000 mg/L but > 10 mg/L: Method A, B, C,

or D.

<10 mg/L but > 0.001 mg/L: Method C or D.

< 0.001 mg/L: no testing required.

Environmental Fate and Pathways—

Inherent Biodegradation

B For B, choose either of the following methods:

1. ASTM 1625 (semicontinuous activated

sludge test) OR

2. ISO 9888 (Zahn-Wellens method)

None

Aquatic Toxicity C1 For C1, Test Group 1 or Test Group 2 below

must be used to fulfill the testing requirements—See Special Conditions.

Test Group 1 for C1:

1. Acute Toxicity To Fish: ASTM E 729

2. Acute Toxicity To Daphnia: ASTM E 729

3. Toxicity To Plants (Algae): ASTM E

1218

Test Group 2 for C1:

1. Chronic Toxicity To Daphnia: ASTM E

1193

2. Toxicity To Plants (Algae): ASTM E

1218

The following are the Special Conditions for

C1, C2, C3, C4, C5, and C7 testing; there

are no Special Conditions for C6.

log Kow <4.2: Test Group 1 is required

log Kow ≥ 4.2: Test Group 2 is required

Which test group is required is determined by

the test substance’s log Kow as obtained

under A.

C2 For C2, Test Group 1 or Test Group 2 below

must be used to fulfill the testing requirements—See Special Conditions.

Test Group 1 for C2:

1. Acute Toxicity To Daphnia: ASTM E 729

2. Toxicity To Plants (Algae): ASTM E

1218

Test Group 2 for C2:

1. Chronic Toxicity To Daphnia: ASTM E

1193

2. Toxicity To Plants (Algae): ASTM E

1218

C3 For C3, Test Group 1 or Test Group 2 below

must be used to fulfill the testing requirements—See Special Conditions.

Test Group 1 for C3:

1. Acute Toxicity To Fish: ASTM E 729

2. Toxicity To Plants (Algae): ASTM E

1218

Test Group 2 for C3:

1. Chronic Toxicity To Daphnia: ASTM E

1193

2. Toxicity To Plants (Algae): ASTM E

1218

81684 Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules

KEY TO THE TEST REQUIREMENTS FOR THE CHEMICALS LISTED IN TABLE 2 AND SPECIFIED BY ALPHANUMERIC SYMBOLS

(E.G., A OR C5)—Continued

Testing category Test

symbol Test requirements and references1 Special conditions

C4 For C4, Test Group 1 or Test Group 2 below

must be used to fulfill the testing requirements—See Special Conditions.

Test Group 1 for C4:

1. Acute Toxicity To Fish: ASTM E 729

2. Acute Toxicity To Daphnia: ASTM E 729

Test Group 2 for C4:

1. Chronic Toxicity To Daphnia: ASTM E

1193

C5 For C5, Test Group 1 or Test Group 2 below

must be used to fulfill the testing requirements—See Special Conditions.

Test Group 1 for C5:

1. Acute Toxicity To Daphnia: ASTM E 729

Test Group 2 for C5:

1. Chronic Toxicity To Daphnia: ASTM E

1193

C6 Toxicity To Plants (Algae): ASTM E 1218

C7 For C7, Test Group 1 or Test Group 2 below

must be used to fulfill the testing requirements See Special Conditions.

Test Group 1 for C7:

1. Acute Toxicity To Fish: ASTM E 729

Test Group 2 for C7:

1. Chronic Toxicity To Daphnia: ASTM E

1193

Mammalian Toxicity—Acute D See Special Conditions for this test requirement and select the required method to

use from those listed below.

Method A: Acute Inhalation Toxicity (rat): 40

CFR 799.9130

Method B: EITHER:

1. Acute (Up/Down) Oral Toxicity (rat):

ASTM E 1163

OR

2. Acute (Up/Down) Oral Toxicity (rat): 40

CFR 799.9110(d)(1)(i)(A)

Which testing method is required is determined by the test substance’s physical

state at room temperature (25oC). For

those test substances that are gases at

room temperature, Method A is required;

otherwise, use of either of the two methods

listed under Method B is required.

In Method B, 40 CFR 799.9110(d)(1)(i)(A) refers to the OECD 425 Up/Down test methodology.

NOTE: In the case of a potentially explosive

test substance, care must be taken to

avoid the generation of explosive concentrations.

Mammalian Toxicity—Genotoxicity E1 Bacterial Reverse Mutation Test (in vitro): 40

CFR 799.9510

None

E2 Conduct any one of the following three tests

for chromosomal damage:

In vitro Mammalian Chromosome Aberration

Test: (40 CFR 799.9537 )

OR

In vivo Mammalian Bone Marrow Chromosomal Aberration Test (rodents: Mouse

(preferred species), rat, or Chinese hamster): 40 CFR 799.9538

OR

In vivo Mammalian Erythrocyte Micronucleus

Test [sampled in bone marrow] (rodents:

Mouse (preferred species), rat, or Chinese

hamster): 40 CFR 799.9539

Persons required to conduct testing for chromosomal damage are encouraged to use

the in vitro Mammalian Chromosome Aberration Test to generate the needed data

unless known chemical properties (e.g.,

physical/chemical properties, chemical

class characteristics) preclude its use. A

subject person who uses one of the in vivo

methods instead of the in vitro method to

address this end-point must submit to EPA

a rationale for conducting that alternate test

in the final study report.

Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / Proposed Rules 81685

KEY TO THE TEST REQUIREMENTS FOR THE CHEMICALS LISTED IN TABLE 2 AND SPECIFIED BY ALPHANUMERIC SYMBOLS

(E.G., A OR C5)—Continued

Testing category Test

symbol Test requirements and references1 Special conditions

Mammalian Toxicity—Repeated

Dose/Reproduction/Developmental

F1 Combined Repeated Dose Toxicity Study

with the Reproduction/Developmental Toxicity Screening Test: (40 CFR 799.9365)

OR

Reproduction/Developmental Toxicity Screening Test: (40 CFR 799.9355) (Identified as

F2 below)

AND

Repeated Dose 28-Day Oral Toxicity Study in

rodents: 40 CFR 799.9305) (Identified as

F3 below)

EPA recommends use of the Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening

Test. However, EPA does recognize that

there may be valid reasons to test a particular chemical using both F2 and F3 to fill

Mammalian Toxicity Repeated Dose/Reproduction/Developmental data needs. A

subject person who uses the combination

of F2 and F3 in place of the Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening

Test must submit to EPA a rationale for

conducting these alternate tests in the final

study reports.

F2 Reproduction/Developmental Toxicity Screening Test: (40 CFR 799.9355)

F3 Repeated Dose 28-Day Oral Toxicity Study in

rodents: (40 CFR 799.9305)

1 Copies of the ASTM and ISO standards referenced in this proposed rule have been placed in the public version of the official record for this

rulemaking. For the final rule, EPA intends to seek approval from the Director of the Federal Register for the incorporation by reference of the

ASTM and ISO standards used in the final rule in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 2 EPA recommends, but does not require, that log Kow be quantitatively estimated prior to initiating this study. One method, among many similar methods, for estimating log Kow is described in Atom/Fragment Contribution Method for Estimating Octanol-Water Partition Coefficients (Ref.

1).3 EPA recommends, but does not require, that water solubility be quantitatively estimated prior to initiating this study. One method, among

many similar methods, for estimating water solubility is described in Improved Method for Estimating Water Solubility From Octanol/Water Partition Coefficient (Ref. 2).

(k) Effective date. (1) The effective

date of this section is [insert effective

date of the final rule.]

(2) The guidelines and other test

methods cited in this section are

referenced as they exist on the effective

date of this section. You can apply for

a modification under 40 CFR 790.55.

[FR Doc. 00–32497 Filed 12–22–00]

BILLING CODE 6560–50–S