Federal Register/Vol. 64, No. 110/Wednesday, June 9, 1999/Proposed Rules

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 799

[OPPTS-42196; FRL-5760-3]

RIN 2070-AB07

Proposed Test Rule for In Vitro Dermal

Absorption Rate Testing of Certain

Chemicals of Interest to Occupational

Safety and Health Administration

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing a test rule

under section 4(a) of the Toxic

Substances Control Act (TSCA) to

require manufacturers, importers, and

processors of 47 chemical substances of

interest to the Occupational Safety and

Health Administration (OSHA) to

conduct in vitro dermal absorption rate

testing. These chemicals, and others,

were designated for in vitro dermal

absorption rate testing in the 3 1st, 32nd,

and 35th Reports of the TSCA Section

4(e) Interagency Testing Committee

(ITC) to the EPA Administrator. The

dermal absorption rate data obtained

under this testing program would be

used to support OSHA's development of

"skin designations" for the chemical

substances included in this proposed

rule. Skin designations are used by

OSHA to provide specific guidance to

employers concerning whether changes

should be made to processes involving

chemical substances in order to reduce

the hazard of systemic toxicity from

dermal absorption of these chemicals.

Changes to a process might include

changes in engineering controls or

changes in the use of or type of personal

protective equipment. Skin designations

alert industrial hygienists, employers,

and workers to potential adverse health

effects resulting from dermal exposure

to chemicals in the workplace. Persons

who export or intend to export any

chemical substance included in the final

rule based on this proposed rule will be

subject to the export notification

requirements in TSCA section 12(b)(1).

DATES: Comments, identified by docket

control number OPPTS-42196, must be

received by EPA on or before August 9,

1999. Your request to present oral

comments must be in writing and must

be received by EPA on or before July 9,

1999.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Follow the detailed instructions

for each method as provided in Unit I.C.

of the "SUPPLEMENTARY

INFORMATION" section of this

preamble. To ensure proper receipt by

EPA, your comments must identify

docket control number OPPTS-42196 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: For

general information: Christine

Augustyniak, Associate Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460; telephone number: (202)

554-1404; TDD: (202) 554-0551; e-mail

address: TSCA-Hotline @epa.gov.

For technical information: Keith

Cronin, Project Manager, Chemical

Control Division (7405), Office of

Pollution Prevention and Toxics,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460;

telephone number: (202) 260-8157; fax

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

cronin.keith @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

Table 2 of this unit. Use of the term

"manufacture" in this preamble will

encompass "import," unless otherwise

stated. In addition, as described in Unit

VI. of this preamble, once the Agency

issues the final rule, any person who

exports, or intends to export, one of

these chemical substances will be

subject to the export notification

requirements in 40 CFR part 707,

subpart D. The export notification

requirements do not apply until the

Agency issues a final test rule, and then,

only apply to exports of the chemical

substances that are contained in the

final test rule. Therefore, entities

potentially affected by this proposed

rule may include, but are not limited to:

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

Type of entity SIC NAICS Examples of potentially affected entities

Chemical manufacturers 28, 2911 325, 32411 Persons who manufacture (defined by statute to include import) one or more of the

and importers subject chemical substances

Chemical processors 28, 2911 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 Standard

Industrial Classification (SIC) codes and

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.C. of

this preamble entitled "Would I Be

Required To Test Under This Rule?"

and consult the proposed regulatory text

in § 799.5115. If you have any questions

regarding the applicability of this action

to a particular entity, consult the

technical person listed in "FOR

FURTHER INFORMATION CONTACT"

at the beginning of the preamble.

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 47 chemical

substances that are listed in Table 2 of

this unit.

TABLE 2.-LIST OF CHEMICAL

SUBSTANCES PROPOSED FOR TESTING

CAS No. Chemical substance

60-29-7

74-96-4

75-05-8

75-15-0

75-35-4

77-73-6

77-78-1

78-59-1

78-83-1

78-87-5

78-92-2

79-20-9

79-46-9

91-20-3

Ethyl ether

Ethyl bromide

Acetonitrile

Carbon disulfide

Vinylidene chloride

Dicyclopentadiene

Dimethyl sulfate

Isophorone

Isobutyl alcohol

Propylene dichloride

sec-Butyl alcohol

Methyl acetate

2-Nitropropane

Naphthalene

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TABLE 2.-LIST OF CHEMICAL SUBSTANCES PROPOSED FOR TESTINGContinued

CAS No. Chemical substance

92-52-4 Biphenyl

95-49-8 o-Chlorotoluene

95-50-1 o-Dichlorobenzene

97-77-8 Disulfiram

98-29-3 tert-Butylcatechol

99-99-0 p-Nitrotoluene

100-00-5 p-Nitrochlorobenzene

100-01-6 p-Nitroaniline

100-44-7 Benzyl chloride

106-42-3 p-Xylene

106-46-7 p-Dichlorobenzene

107-06-2 Ethylene dichloride

107-31-3 Methyl formate

108-03-2 1 -Nitropropane

108-90-7 Chlorobenzene

108-93-0 Cyclohexanol

109-66-0 Pentane

109-99-9 Tetrahydrofu ran

110-12-3 Methyl isoamyl ketone

111-84-2 Nonane

120-80-9 Catechol

121-69-7 Dimethylaniline

122-39-4 Diphenylamine

123-42-2 Diacetone alcohol

126-99-8 beta-Chloroprene

127-19-5 Dimethyl acetamide

142-82-5 n-Heptane

150-76-5 p-Methoxyphenol

528-29-0 o-Dinitrobenzene

628-63-7 n-Amyl acetate

768-52-5 N-Isopropylaniline

25013-15-4 Vinyl toluene

34590-94-8 Dipropylene glycol methyl

ether

B. How Can I Get Additional

Information or Copies of This Document

or Other Documents?

1. Electronically. You may obtain

electronic copies of this document and

other documents from the EPA Internet

EPA Home Page at http://www.epa.gov/

• On the Home Page select "Law and

Regulations" 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/.

2. In person . The official record for

this proposed rule, which includes the

public version, has been established

under docket control number OPPTS42196. The official record consists of the

documents referenced in this preamble

(see Unit VIII. of this preamble), as well

as the public comments that will be

received during the comment period,

and other information related to this

rulemaking, including information

claimed as Confidential Business

Information (CBI). This official record

includes the documents that are

physically located in the docket, as well

as all documents that are referenced in

those documents. The public version of

the offical 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 that may be

submitted as described in Unit I.C. and

D. of this preamble, 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 12 noon to 4 p.m., Monday

through Friday, excluding legal

holidays. The telephone number of 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, your

comments must identify docket control

number OPPTS-42196 in the subject

line on the first page of your response.

1. By mail. Submit comments to:

Document Control Office (7407), Office

of Pollution Prevention and Toxics,

Environmental Protection Agency, 401

M St., SW., East Tower, Rm. G-099,

Washington, DC 20460.

2. In person or by courier. Deliver

comments to: Document Control Office,

Office of Pollution Prevention and

Toxics, Environmental Protection

Agency, 401 M St., SW., East Tower,

Rm. G-099, Washington, DC. The

telephone number for the OPPT

Document Control Office is (202) 260-

7093.

3. Electronically. Submit your

comments electronically by e-mail to:

oppt.ncic@epa.gov, or you may mail or

deliver your computer disk to the

addresses identified in Units I.C.1. or 2.

of this preamble. Do not submit any

information electronically that you

consider to be CBI. Submit comments as

an ASCII file, avoiding the use of special

characters and any form of encryption.

Comments will also be accepted on

standard disks in WordPerfect 5.1/6.1 or

ASCII file format. All copies of

electronic comments must be identified

by docket control number OPPTS42196. Electronic comments may be

filed online at many Federal Depository

Libraries.

D. How Should I Handle CBI

Information 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 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 comments that include any

information claimed as CBI, a copy of

the comments 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 by EPA without

prior notice. If you have any questions

about CBI or the procedures for claiming

CBI, consult the technical person

identified in "FOR FURTHER

INFORMATION CONTACT"at the

beginning of this preamble.

E. Can IRequestAn Opportunity To

Present Oral Comments To The Agency?

You may submit a request for an

opportunity to present oral comments.

This request must be in writing. If such

a request is received on or before July

9, 1999, 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. of this preamble. If such a

request is received, EPA will announce

the scheduling of the public meeting in

a subsequent Federal Register

document. 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 Federal

Register document announcing the

public meeting.

F. What Should I Consider as I Prepare

My Comments For EPA ?

We invite you to provide your views

on the various options we propose, new

approaches we have not 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:

oExplain your views as clearly as

possible.

oDescribe any assumptions that you

used.

oProvide copies of any technical

information and/or data you used that

support your views.

olf you estimate potential burden or

costs, explain how you arrived at the

estimate.

oProvide specific examples to

illustrate your concerns.

*Offer alternative ways to improve

the rule or collection activity.

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oMake sure to submit your

comments by the deadline in this

document.

eAt the beginning of your

comments, be sure to properly identify

the document you are commenting on.

To ensure proper receipt by EPA, your

comments must 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.

G. Are There Issues On Which EPA Is

Particularly Interested In Receiving

Comment?

EPA invites comment on any aspect of

this proposed rule. EPA is particularly

interested in specific comments on the

approach discussed in Unit V.C. of this

preamble, entitled "Would I Be

Required To Test Under This Rule?"

II. Authority

This document proposes a test rule

under TSCA section 4(a) (15 U.S.C

2603(a)) that would require an in vitro

dermal absorption rate test for 47 of the

chemical substances designated by the

ITC for this testing.

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 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 for which

there is an insufficiency of data and

experience, and which are relevant to 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)(A)(i)

(i.e., a finding that a chemical substance

may present an unreasonable risk of

injury to health or the environment) or

a finding under TSCA section

4(a)(1)(B)(i) (i.e., a finding that a

chemical substance is or will be

produced in substantial quantities and

either it may enter the environment in

substantial quantities or there may be

significant or substantial human

exposure to the chemical substance),

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 also 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 such

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, 28738-

28739).

In this proposed rule, EPA intends to

use its broad TSCA section 4(a)

authority to obtain dermal absorption

rate data necessary to support OSHA's

development of "skin designations" (see

Unit III.C. of this preamble) for the 47

chemical substances included in the

proposed rule. 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 effects; and testing is

necessary to develop such data.

Under TSCA section 10(b), EPA is

responsible, through an interagency

committee, for collecting data and

disseminating the data to other Federal

agencies, such as OSHA, as the Agency

is proposing in this document. EPA has

used its TSCA section 4(a) authority in

the past to support regulatory programs

of other EPA offices as well as other

Federal agencies needing health and/or

environmental effects test data. See, e.g.,

the final test rule for the Office of Water

Chemicals (58 FR 59667, 59673

November 10, 1993).

III. Background

A. Why Is EPA Proposing To Take This

Action ?

Under TSCA section 4(e)(1), the ITC

is responsible for recommending

chemical substances and mixtures to the

EPA Administrator for priority testing

consideration. The chemical substances

and mixtures so designated by the ITC

comprise a list called the Priority

Testing List. OSHA nominated 658

chemical substances and mixtures for

ITC review in September 1991. The

results of the ITC's review were

published in the Federal Register issues

of May 5, 1993 (58 FR 26898, 26900)

and July 16, 1993 (58 FR 38490, 38492-

38493). OSHA requested that the ITC

assess the availability of data relevant to

dermal absorption for these chemical

substances and mixtures and determine

the need for further testing (58 FR

26898, 26900, May 5, 1993). OSHA

indicated to the ITC that it needed

quantitative measures of dermal

absorption to evaluate the potential

hazard of these chemicals to workers (58

FR 38490, 38492, July 16, 1993). These

quantitative measures are expressed as

the dermal absorption rate for a

particular chemical (59 FR 35720,

35725, July 13, 1994).

In its 31st, 32nd, and 35th ITC

Reports to the EPA Administrator (58

FR 26898, May 5, 1993; 58 FR 38490,

July 16, 1993; and 59 FR 67596,

December 29, 1994, respectively), the

ITC designated for in vitro dermal

absorption rate testing a total of 83 of

the chemical substances nominated by

OSHA. In reducing OSHA's list of 658

chemicals to 83 chemicals, the ITC

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grouped the nominated chemicals into

categories as a means of prioritizing the

chemicals for consideration. Chemicals

that were assigned to categories such as

polymers, pesticides, and

chloroflurocarbons were eliminated

from consideration by the ITC. They

were eliminated because, among other

reasons, they are regulated under other

Federal authorities or because EPA,

under TSCA, does not have the

authority to require the testing of certain

chemicals (58 FR 26898, 26900-26902

and 58 FR 38490, 38493). The remaining

chemicals were then grouped by

production volume, and literature

searches were performed.

The ITC performed searches for data

relating to the chemicals on the

following data bases: RTECS (Registry of

Toxic Effects of Chemical Substances),

TOXLINE (TOXicology information

onLINE), MEDLINE (MEDlars onLINE),

TOXLIT (TOXicology LITerature from

special sources), CECATS (OPPT/Risk

Assessment Division/Chemical

Screening Branch's Existing Chemical

Assessment Tracking System), TSCATS

(Toxic Substances Control Act Test

Submissions), and INDEX MEDICUS.

The search strategy was designed to

identify any toxicological tests that used

the dermal route of exposure. The

information from the searches was

collected and the chemicals were

subcategorized based on the number of

postings (58 FR 38490, 38493).

The 83 chemicals designated by the

ITC were identified as follows: The ITC

first ascertained those chemicals having

no dermal information postings in any

of the data bases searched, and, in its

31st ITC Report, the ITC designated this

group of 24 chemicals for priority

testing consideration (58 FR 26898,

26900). A second group of chemicals

with limited dermal toxicity or dermal

absorption data (as determined by the

searches described in this unit) from

which dermal absorption rate could not

be estimated was then identified by the

ITC, which designated this group of 34

chemicals in its 32nd ITC Report (Ref.

1) (58 FR 38490, 38492, 38494). Another

25 chemicals were designated in the

35th ITC Report, after the ITC reviewed

the dermal data of 63 high production

volume chemicals with slightly larger

information bases (59 FR 67596, 67598).

These data were insufficient to estimate

dermal absorption rate because dermal

absorption rate could not be calculated

on the basis of the dermal absorption

data which were available to the ITC.

The ITC then reviewed data from

TSCA section 8(a) and 8(d) rules which

were promulgated by EPA for these 83

chemical substances included in the

31st, 32nd, and 35th ITC Reports (40

CFR 712.30(e) (58 FR 68311, December

27, 1993; 59 FR 5956, February 9, 1994;

60 FR 34879, July 5, 1995)). These rules

required the reporting to EPA of certain

production, use and exposure-related

information, and unpublished health

and safety data concerning these 83

chemicals.

In reviewing the available data

relating to these 83 chemicals, the ITC

determined that the dermal absorption

rate data for methyl methacrylate (Ref.

2), diethyl phthalate (Ref. 3), and

cyclohexanone (Ref. 4) would meet

OSHA's data needs for the chemicals

(59 FR 35720, 35722, July 13, 1994; 60

FR42982, 42985, August 17, 1995).

Accordingly, the ITC withdrew its

designation for these 3 chemicals:

Methyl methacrylate and diethyl

phthalate in the 34th ITC Report (59 FR

35720, 35725, July 13, 1994), and

cyclohexanone in the 36th ITC Report

(60 FR 42982, 42987, August 17, 1995).

Eighty of the chemical substances

nominated by OSHA are thus currently

designated by the ITC for in vitro dermal

absorption rate testing under TSCA. In

the Federal Register notices containing

the 3 1st, 32nd, and 35th ITC Reports,

EPA additionally solicited proposals for

TSCA section 4 enforceable consent

agreements (ECAs) for dermal

absorption rate testing of the 80

chemical substances. EPA received no

proposals for ECAs for dermal

absorption rate testing in response to

these solicitations.

On April 3, 1996 (61 FR 14773), EPA

again solicited interested parties to

submit proposals for ECAs. On June 26,

1996, EPA received a proposal for the

development of an ECA for tert-butyl

alcohol from the ARCO Chemical

Company (ARCO). On March 26, 1998,

EPA received a study entitled "[14C]-tButyl Alcohol: Topical Application:

Dermal Absorption Study in the Male

Rat," from ARCO (Ref. 5). This study

was reviewed and found acceptable as

a means of determining the dermal

absorption rate for tert-butyl alcohol

(Ref. 6). Accordingly, this action does

not propose testing of tert-butyl alcohol.

In this action, EPA is proposing in

vitro dermal absorption rate testing of 47

chemical substances of interest to

OSHA. These chemical substances are

listed in Table 2 of Unit I.A. of this

preamble, entitled "List of Chemical

Substances Proposed for Testing," and

in Table 2 of § 799.5115(i) of the

proposed regulatory text, entitled

"Required Testing: Chemical Substances

Designated for In Vitro Dermal

Absorption Rate Testing." EPA has

selected these 47 chemicals for testing

because the Agency believes that the

production volumes of these chemicals

are higher than the production volumes

of the 32 chemicals remaining out of the

80 chemicals currently designated by

the ITC. Testing of the latter chemicals

for dermal absorption rate will be

addressed at a later date.

B. How Was the Test Standard

Developed For EPA 's Use in This

Proposed Rule?

In the solicitations discussed in Unit

III.A. of this preamble, EPA referenced

an in vitro dermal absorption rate test

protocol for review by potential

submitters in developing their proposed

protocols (Ref. 7). The draft protocol

was developed by a group of scientists

from EPA in conjunction with ITC

member and liaison agencies (Consumer

Product Safety Commission (CPSC),

Department of Defense (DoD), Food and

Drug Administration (FDA), National

Institute for Occupational Safety and

Health (NIOSH), and OSHA) and

consisted of the methods of Bronaugh

and Collier (Ref. 7). EPA received public

comments on the proposed protocol and

entered them, along with the protocol

itself, into the dockets for the 31st,

32nd, and 35th ITC Reports, as

appropriate (docket control numbers

OPPTS-41038, OPPTS-41039, and

OPPTS-41042, respectively). In

addition, the Chemical Manufacturers

Association (CMA) submitted a

proposed protocol outlining an

alternative method (Ref. 8). Scientists

from EPA and other Federal agencies

represented on the ITC (including

OSHA) reviewed the public comments

and the CMA proposal. Based on their

review of the Bronaugh and Collier

protocol, public comments, and the

CMA proposal, EPA and ITC scientists

developed the in vitro dermal

absorption rate test method which is the

test standard used in this proposed rule.

C. How Will The Data Developed Under

This Test Rule Be Used?

This proposed rule would require the

development of quantitative measures of

dermal absorption rate to assist in

evaluating the potential contribution of

dermal absorption of the chemical

substances proposed for testing to total

exposures to workers from chemicals in

the workplace. The dermal absorption

rate data obtained under this testing

program would be used to support

OSHA's development of "skin

designations" for the chemical

substances included in this proposed

rule.

OSHA assigns a skin designation to a

chemical if it determines that cutaneous

exposure (through the skin, eyes, and

mucous membranes) to the chemical

may result in systemic toxicity. Skin

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designations are used by OSHA to

provide specific guidance to employers

concerning whether changes should be

made to processes involving chemical

substances in order to reduce the hazard

of systemic toxicity from dermal

absorption of these chemicals. Changes

to a process might include changes in

engineering controls or changes in the

use or type of personal protective

equipment. Skin designations alert

industrial hygienists, employers, and

workers to potential adverse health

effects resulting from dermal exposure

to chemicals in the workplace.

The information that would be

developed under this test rule would

not only support OSHA's activities, but

also would support chemical risk

assessment activities at EPA as well as

at other Federal agencies. In particular,

these data would provide input for

chemical risk assessments involving

environmental exposure scenarios

which include intentional or incidental

skin contact.

IV. EPA Findings

A. What Is The Basis For EPA's Proposal

To Test These Chemical Substances?

As indicated in Unit II. of this

preamble, in order to develop a rule

under TSCA section 4(a) requiring the

testing of chemical substances or

mixtures, EPA must make certain

findings for those chemicals regarding

either:

1. Hazard (TSCA section 4(a)(1)(A)(i));

or

2. Production and either chemical

release or human exposure (TSCA

section 4(a)(1)(B)(i)).

EPA is proposing to require testing of

the chemical substances included in

this test rule based on its 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, discussed in

Unit II. of this preamble, "substantial"

production of a chemical substance or

mixture is generally interpreted to be

aggregate production (including import)

volume equaling or exceeding one

million pounds (lbs) per year of that

chemical substance or mixture (58 FR

28736, 28746, May 14, 1993). The "B"

policy sets out the numeric threshold

for "substantial human exposure" of

workers to a chemical substance or

mixture of 1,000 workers annually being

exposed to that chemical substance or

mixture. Id. See EPA's "B" policy (58

FR 28736, May 14, 1993) for further

discussion on how EPA makes decisions

under TSCA section 4(a)(1)(B)(i).

EPA has found preliminarily that,

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

the 47 chemical substances proposed for

dermal absorption rate testing is

produced in "substantial quantities"

and there is or may be "substantial

human exposure" to each chemical

substance. 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 manufacturing,

processing, or use of these chemical

substances, or of any combination of

such activities, on human health. In

particular, as discussed in Unit IV.D. of

this preamble, EPA has determined that

there are insufficient data relating to

dermal absorption rate resulting from

human exposure to these chemicals.

EPA also finds that testing the

substances identified in this document

is necessary to develop such data (TSCA

section 4(a)(1)(B)(iii)). EPA has not

identified any "additional factors" as

discussed in the "B" policy (58 FR

28736, 28746, May 14, 1993) to cause

the Agency to use decisionmaking

criteria other than those described in the

policy.

The specific chemical substances

included in this proposed test rule are

listed in Table 2 of Unit I.A. of this

preamble, and in § 799.5115(i) of the

proposed regulatory text.

B. Are These Chemical Substances

Produced in Substantial Quantities?

Each of the chemical substances

included in this proposal is produced in

an amount equal to or greater than one

million lbs per year (Ref. 9), based on

information gathered pursuant to the

1994 TSCA section 8(a) Inventory

Update Rule (40 CFR part 710) and

contained in the TSCA Chemical

Update System. Their production

volumes range from over one million to

well over one billion lbs annually.

Assuming the continued accuracy of

these figures, EPA believes that these

annual production volumes are "substantial" as that term is used with

reference to production in TSCA section

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

May 14, 1993.

C. Are a Substantial Number Of Workers

Exposed To These Chemicals?

EPA finds that the manufacturing,

processing, and use of the chemical

substances included in this document

result or may result in exposure of a

substantial number of workers. Table 3,

entitled "Exposure Information for

Chemical Substances Included in This

Proposed Test Rule," in Unit IV.C. of

this preamble contains an estimate of

the actual and potential worker

exposure to these chemical substances

(Ref. 10). These chemical substances are

used in a wide variety of applications as

industrial solvents, which result in

potential exposures of workers as

described in the exposure support

document for this proposed rule (Ref.

10). EPA believes that the exposure to

each chemical substance of 1,000

workers or more (Table 3 of this unit)

is or may be "substantial" as that term

is used with reference to "human

exposure" in TSCA section 4(a)(1)(B)(i).

See 58 FR 28376, 28746, May 14, 1993.

TABLE 3.-EXPOSURE INFORMATION FOR CHEMICAL SUBSTANCES INCLUDED IN THIS PROPOSED TEST RULE

CAS No. Chemical name Number of workers exposed1

Ethyl ether

Ethyl bromide

Acetonitrile

Carbon disulfide

Vinylidene chloride

Dicyclopentadiene

Dimethyl sulfate

Isophorone

Isobutyl alcohol

Propylene dichloride

sec-Butyl alcohol

Methyl acetate

2-Nitropropane

Naphthalene

Biphenyl

272,746

12,285

31,341

45,761

2,679

6,247

10,482

47,097

256,975

2,944

126,200

20,455

9,817

112,695

32,000

31078

60-29-7

74-96-4

75-05-8

75-15-0

75-35-4

77-73-6

77-78-1

78-59-1

78-83-1

78-87-5

78-92-2

79-20-9

79-46-9

91-20-3

92-52-4
Federal Register/Vol. 64, No. 110/Wednesday, June 9, 1999/Proposed Rules 31079

TABLE 3.-EXPOSURE INFORMATION FOR CHEMICAL SUBSTANCES INCLUDED IN THIS PROPOSED TEST RULE-Continued

CAS No. Chemical name Number of workers exposed1

95-49-8 o-Chlorotoluene 11,617

95-50-1 o-Dichlorobenzene 92,248

97-77-8 Disulfiram 53,525

98-29-3 tert-Butylcatechol 27,528

99-99-0 p-Nitrotoluene 4,354

100-00-5 p-Nitrochlorobenzene 2,949

100-01-6 p-Nitroaniline 1,448

100-44-7 Benzyl chloride 41,075

106-42-3 p-Xylene 20,367

106-46-7 p-Dichlorobenzene 33,980

107-06-2 Ethylene dichloride 83,245

107-31-3 Methyl formate 7,739

108-03-2 1 -Nitropropane 21,535

108-90-7 Chlorobenzene 18,049

108-93-0 Cyclohexanol 112,366

109-66-0 Pentane 38,464

109-99-9 Tetrahydrofuran 356,041

110-12-3 Methyl isoamyl ketone 18,835

111-84-2 Nonane 7,277

120-80-9 Catechol 13,517

121-69-7 Dimethylaniline 30,479

122-39-4 Diphenylamine 155,673

123-42-2 Diacetone alcohol 264,660

126-99-8 beta-Chloroprene 17,752

127-19-5 Dimethyl acetamide 28,944

142-82-5 n-Heptane 449,487

150-76-5 p-Methoxyphenol 250,088

528-29-0 o-Dinitrobenzene 1,358

628-63-7 n-Amyl acetate 265,435

768-52-5 N-Isopropylaniline >1,0002

25013-15-4 Vinyl toluene 25,353

34590-94-8 Dipropylene glycol methyl ether 210,735

1

National Occupational Exposure Survey (NOES) conducted by the NIOSH (1981-1983), unless otherwise indicated. These data are the most

recent available to the Agency (Ref. 10). 2Not listed in NOES data base. The exposure analysis for this chemical is attached to Reference 10.

D. Do Sufficient Data Exist For These

Chem ical Substances?

As discussed in this preamble, dermal

absorption rate is an important factor in

ascertaining the effects of the 47

chemicals in this proposed rule on

human health. EPA has determined that

there are no dermal absorption rate data

for the chemicals in this proposed rule

and, therefore, existing data are

insufficient to reasonably determine or

predict the human health effects relating

to dermal absorption rate that result

from manufacturing, processing, or use

of the subject chemical substances. This

finding is based on the review and

analysis of relevant data by the ITC

(which included EPA participation), as

described in Unit III.A. of this preamble.

E. Is Testing Necessary For These

Chem ical Substances?

EPA believes that the proposed testing

of the 47 subject chemical substances is

necessary to develop dermal absorption

rate data. This testing is needed to

determine if the manufacturing,

processing, or use of these chemical

substances presents an unreasonable

risk of injury to human health.

V. Proposed Rule

A. How Would the Studies Proposed

Under This Test Rule Be Conducted?

EPA is proposing specific testing and

reporting requirements for the chemical

substances specified in Table 2 in

§ 799.5115(i) of the proposed regulatory

text according to the in vitro dermal

absorption rate test standard set forth at

§ 799.5115(h) of the proposed regulatory

text.

The test standard that would be

required under this rule was developed

as described in Unit III.B. of this

preamble. This standard describes the

procedures for measuring a permeability

constant (Kp) and a short-term

absorption rate for chemicals in liquid

form. Measurement of short-term

absorption rates is only required when

a Kp cannot be obtained using this test

standard. For most chemicals, a Kp is

useful in estimating skin permeation.

However, for "harsh" chemicals, i.e.,

those that may damage the skin more

severely with prolonged contact, it is

more appropriate to obtain a short-term

absorption rate measurement.

This test standard utilizes established

in vitro diffusion cell techniques that

allow absorption rate studies to be

conducted using human skin (see the

proposed regulatory text at

§ 799.5115(h)). The in vitro approach

was chosen for practical considerations

because it is efficient in terms of labor

and materials and can be performed

easily by a variety of laboratories. In

addition, in vitro diffusion cell studies

are necessary for measuring a Kp (Ref.

7).

The in vitro dermal absorption rate

test standard allows use of cadaver skin

and static diffusion cells to maintain the

viability of the skin, thus more closely

simulating in vivo conditions. This test

method also requires the use of

radiolabelled chemical substances

unless the test sponsor can demonstrate

that alternative, non-radiolabelled

methods provide sensitivity sufficient to

detect the parent chemical (and its

major metabolites in those cases in

which skin viability is maintained). The

first six parameters that are discussed

(choice of membrane, preparation of

membrane, diffusion cell design,

temperature, testing hydrophobic

chemicals, and vehicle) are similar for

determination of either of the two

percutaneous absorption rate values. In
Federal Register/Vol. 64, No. 110/Wednesday, June 9, 1999/Proposed Rules

contrast, the remaining two parameters

(i.e., dose and study duration) are

different for the two percutaneous

absorption rate values.

Testing under this proposed rule must

be conducted in accordance with TSCA

Good Laboratory Practice (GLP)

Standards (40 CFR part 792).

B. What Substances Would Be Tested

Under This Rule?

EPA is proposing that the chemical

substances listed in Table 2 in

§ 799.5115(i) of the proposed regulatory

text be tested at a purity of at least 99%.

C. Would IBe Required To Test Under

This Rule?

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

has made preliminary findings that

there are insufficient data and

experience to reasonably determine or

predict health effects resulting from the

manufacturing, processing, or use of the

chemical substances listed in this

proposed rule. 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 Ibe subject to this rule?You

would be subject to this rule and may

be required to test if you manufacture

(which is defined by statute to include

import) 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.C.2. of this

preamble, entitled "When would my

manufacturing 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 manufacturing 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.C.4. of this preamble,

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 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 rule) need not take any

action unless they are notified by EPA

that they are required to do so, as

described in Unit V.C.3.d. of this

preamble, 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 do

actually conduct the testing, as

described in Unit V.C.4. of this

preamble, entitled "How do the

reimbursement procedures work?"

a. Who would be in Tier I 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 4.- PERSONS SUBJECT TO THE RULE: PERSONS IN TIER 1 AND TIER 2

Tier 1 (Persons initially required to comply)

*Persons that manufacture (as defined at TSCA section 3(7)),

or intend to manufacture, a test rule substance who are not

listed under Tier 2

Tier 2 (Persons not initially required to comply)

*Persons that 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));

-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 Ibs) 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 that 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 ] 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 in the proposed regulatory

text at § 799.5115(c)(2), (c)(5), and (c)(7).

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. EPA is interested in

evaluating the effects attributable to

each listed substance itself and has

specified almost pure substances for

testing.

c. What would happen if I were in

Tier ] and Isubmitted 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

31080
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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 the proposed regulatory text

at § 799.5115(c)(6). 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.C.4. of this

preamble, 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.C.4. of this

preamble. 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 the

proposed regulatory text at

§ 799.5115(c)(6).

In addition, you would need to

submit a notice of intent to test or an

exemption application if:

i. No manufacturer in Tier 1 has

notified EPA of its intent to conduct

testing and

ii. EPA has published a Federal

Register document 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

the proposed regulatory text at

§ 799.5115(c)(4) and (c)(5).

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 I 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(a) test rules in 40 CFR

part 790. For 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 following persons as

being in Tier 2. (These rules are found

at 40 CFR part 799, subparts B and D).

oProcessors (40 CFR 790.42(a)(2));

oManufacturers 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 the tiers in 40 CFR 790.42.

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 rule, when finalized, would

generally be large chemical

manufacturers who, in the experience of

the Agency, have traditionally

conducted testing or participated in

testing consortia under previous TSCA

section 4(a) test rules.

The Agency also believes that

byproduct manufacturers, impurity

manufacturers, manufacturers of

naturally occurring substances,

manufacturers of non-isolated

intermediates, and manufacturers of

components of Class 2 substances have

not themselves historically participated

in testing or contributed to

reimbursement of those persons who

have conducted testing. EPA

understands that these may include

persons for whom the marginal

transaction costs involved in negotiating

and administering testing arrangements

are deemed likely to raise the expense

and burden of testing to a level that is

disproportional to the additional

benefits of including these persons in

Tier 1. Therefore, EPA does not believe

that the likelihood of the persons

proposed to be added to Tier 2 actually

doing the testing is sufficiently high to

justify burdening these persons with

Tier 1 requirements (e.g., submitting

requests for exemptions). Nevertheless,

these persons, along with all other

persons in Tier 2, would be subject to

providing reimbursement to persons

who do actually conduct the testing, as

described in Unit V.C.4. of this

preamble, entitled "How do the

reimbursement procedures work?"

Section 4(b)(3)(B) of TSCA 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 the

substances subject to this proposed rule,

e.g., manufacturers or processors of the

substances as trace contaminants who

are not aware of these activities, would

not be subject to the rule. See Unit V.C.1

of this preamble and § 799.5115(b)(2) of

the proposed regulatory text.

EPA is 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 at Unit V.C.1 of this

preamble and § 799.5115(b)(2) of the

proposed regulatory text.

f. Should EPA prioritize which

persons in Tier 2 would be required to

perform testing? EPA is considering

subdividing Tier 2 to enable the Agency

to prioritize which persons in Tier 2

would be required to perform testing, if

needed. This would involve subdividing

Tier 2 into:

i. Tier2A. Those who manufacture, or

intend to manufacture, a test rule

substance solely as one or more of the

following: A byproduct; an impurity; a

naturally occurring substance; a nonisolated intermediate; a component of a

Class 2 substance; in amounts less than

1,100 lbs. annually; or in small

quantities solely for research and

development.

31081
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ii. Tier 2B. Those who process, or

intend to process, a test rule substance.

If the Agency needed testing from

persons in Tier 2, EPA would seek

testing from persons in Tier 2A before

proceeding to Tier 2B. EPA believes

that, if the Agency were to subdivide

Tier 2, persons in Tier 2A should be

required to submit letters of intent to

test or exemption applications before

processors are called upon because

testing costs are traditionally passed by

manufacturers along to processors.

EPA is soliciting comment on whether

this subtiering scheme should be

applied in the final rule.

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

Federal Register document 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).

D. WhatAre the Reporting

Requirements Proposed Under This Test

Rule?

You would be required to submit

interim progress reports for each test

every 6 months, beginning 6 months

after the effective date of the final 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 that would be shown

in Table 2 in § 799.5115(i) of the

proposed regulatory text.

E. Would There Be Sufficient Test

Facilities and Personnel To Undertake

the Testing in This Test Rule?

EPA has conducted a study to assess

the availability of test facilities and

personnel to handle the additional

demand for testing services created by

TSCA section 4(a) test rules and has

found that test facilities and personnel

would adequately accommodate the

testing specified in this proposed rule

(Ref. 11).

F. 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 chemicals.

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 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,

notification of export would generally

not be required for articles, as provided

by 40 CFR 707.60(b).

VII. Materials in the Official Record

The official record for this proposed

rule has been established under docket

control number OPPTS-42196. The

following is a listing of the documents

that have already been placed in the

official record for this proposed rule:

A. Supporting Documentation

1. Federal Register documents:

a. Notice containing the 31st ITC

Report to the EPA Administrator (58 FR

26898, May 5, 1993 (FRL-4583-4)).

b. Notice containing the TSCA section

4(a)(1)(B) Final Statement of Policy (58

FR 28736, May 14, 1993 (FRL-4059-9)).

c. Notice containing the 32nd ITC

Report to the EPA Administrator (58 FR

38490, July 16, 1993 (FRL-4630-2)).

d. TSCA Sections 8(a) and 8(d) Final

Rules for Chemicals Contained in the

31st ITC Report to the EPA

Administrator (58 FR 68311, December

27, 1993 (FRL-4644-1)).

e. TSCA Sections 8(a) and 8(d) Final

Rules for Chemicals Contained in the

32nd ITC Report to the EPA

Administrator (59 FR 5956, February 9,

1994 (FRL-4745-5)).

f. Notice containing the 34th ITC

Report to the EPA Administrator (59 FR

35720, July 13, 1994 (FRL-4870-4)).

g. Notice containing the 35th ITC

Report to the EPA Administrator (59 FR

67596, December 29, 1994 (FRL-4923-

2)).

h. TSCA Sections 8(a) and 8(d) Final

Rules for Chemicals Contained in the

35th ITC Report to the EPA

Administrator (60 FR 34879, July 5,

1995 (FRL-4954-9)).

i. Notice containing the 36th ITC

Report to the EPA Administrator (60 FR

42982, August 17, 1995 (FRL-4965-6)).

j. Small Business Size Standards;

Final Rule, issued by the Small Business

Administration (SBA) (61 FR 3280,

January 31, 1996).

k. Notice containing EPA's

Solicitation of Interested Parties for

Proposals for Enforceable Consent

Agreements for Testing of 80 Chemicals

of Interest to OSHA (61 FR 14773, April

3, 1996 (FRL-5359-3)).

2. Correspondence:

a. ARCO Chemical Company. Letter to

Charles M. Auer, USEPA. Proposal for

Development of ECA for Tert-Butyl

Alcohol (June 26, 1996).

b. ARCO Chemical Company. Letter to

Keith Cronin, USEPA. Letter

transmitting a Dermal Absorption Rate

Study in the Male Rat for Tert-Butyl

Alcohol (March 23, 1998).

3. Other support documentation:

EPA. "EPA Interim Guidance for

Implementing the Small Business

Regulatory Enforcement Fairness Act

and Related Provisions of the Regulatory

Flexibility Act." EPA SBREFA Task

Force (February 5, 1997).

B. References

1. ITC. Chemicals Under

Consideration for the 32nd ITC Report;

Summary of Skin Absorption Data on

OSHA Tier 2 Chemicals (September 22,

1993).

2. Zeneca. Methyl Methacrylate: In

Vitro Absorption through Human

Epidermis. Zeneca Central Toxicology

Report No. CTL/P/4025 provided by the

Methacrylate Producers Association,

Washington, D.C. (1993).

3. Scott, R.C., Dugard, P.H., Ramsey,

J.D., and Rhodes, C. In Vitro Absorption

of Some o-Phthalate Diesters through

Human and Rat Skin. Environmental

Health Perspectives. 74:223-227 (1987).

4. Mraz, J., Galova, E., Nohova, H.,

and Vitkova, D. Uptake, Metabolism and

Elimination of Cyclohexanone in

Humans. International Archives of

Occupational Environmental Health.

66:203-208 (1994).

5. ARCO Chemical Company. [14

C]-tButyl Alcohol: Topical Application:

Dermal Absorption Study in the Male

Rat. Huntington Life Sciences (January

7, 1998).

6. OSHA. Review of [14C]-t-Butyl

Alcohol: Topical Application: Dermal

Absorption Study in the Male Rat. (June

24, 1998).

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7. Bronaugh, R.L., and Collier, S.W.

Protocol for In Vitro Percutaneous

Absorption Studies. In Vitro

Percutaneous Absorption: Principles,

Fundamentals, and Applications. R.L.

Bronaugh and H.I. Maibach, Eds. CRC

Press, Boca Raton, FL. pp. 237-241

(1991).

8. Chemical Manufacturers

Association (CMA). Letter to Charles M.

Auer, USEPA. (October 21, 1994).

9. EPA. Economic Impact Analysis

and Small Entity Impact Analysis of

Proposed TSCA Section 4(a) Test Rule

for 47 Chemicals Targeted for In Vitro

Dermal Absorption Rate Testing. OPPT/

EETD/EPAB, Washington, DC (May 5,

1999).

10. EPA. CEB Support to the OSHA

Chemicals Test Rule-Number of

Workers Exposed and TRI Release Data.

OPPT/EETD/CEB, Washington, DC

(March 1998).

11. EPA. EPA Census of TSCA Testing

Laboratories. Washington, DC (October

10, 1996).

12. EPA. Laboratory Cost Estimate for

In Vitro Dermal Absorption Rate

Testing. OPPT/EETD/EPAB,

Washington, DC (April 14, 1999).

13. EPA. "Treatment of 12(b) Export

Notification Unit Costs for Section 4

Test Rule Analyses." OPPT/EETD/

EPAB, Washington, DC (April 1, 1999).

14. EPA. "Economic Analysis in

Support of the TSCA 12(b) Information

Collection Request." OPPT/EETD/

EPAB, Washington, DC (October 30,

1998).

VIII. Regulatory Assessment

Requirements

A. Executive Order 12866

Under Executive Order 12866,

entitled Regulatory Planning and

Review (58 FR 51735, October 4, 1993),

this is not a "significant regulatory

action" subject to review by the Office

of Management and Budget (OMB),

because this action is not likely to result

in a rule that meets any of the criteria

for a "significant regulatory action"

provided in section 3(f) of the Executive

Order.

EPA has prepared an economic

analysis of the potential impact of this

proposed rule, which is contained in a

document entitled "Economic Impact

Analysis and Small Entity Impact

Analysis of Proposed TSCA Section 4(a)

Test Rule for 47 Chemicals Targeted for

In Vitro Dermal Absorption Rate

Testing" (Ref. 9). This document is

available as a part of the public version

of the official record for this action

(instructions for accessing this

document are contained in Unit I.B. of

this preamble), and is briefly

summarized here. The costs developed

in the economic impact analysis are

based on laboratory test cost estimates

that have been placed in the docket for

this proposed rule (Ref. 12).

While legally subject to this test rule,

processors of a subject chemical would

only be required to comply with the

requirements of the rule if they are

directed to do so by EPA as described

in § 799.5115(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 that person

will conduct such testing and will

submit the test data to EPA. Because

processors would not need to comply

with the rule initially, the economic

analysis does not address processors.

To evaluate the potential economic

impact of testing on manufacturers of

the chemical substances in this

proposed rule, EPA estimated the

impact of testing requirements as a

percentage of each chemical's sale price.

This measure compares the annualized

testing costs per pound (based on the

conservative assumption that all

chemicals are produced in volumes of

one million lbs), to the price per pound

for each chemical. First, annualized

testing costs (including laboratory and

administrative expenditures) are

calculated by converting the total testing

costs in the first year into an equivalent

series of expenditures over 15 years

using a 7% discount rate. Second,

annualized testing costs are divided by

one million lbs (the assumed production

volume per chemical) to derive the

annualized unit (per pound) testing

cost. The price impacts-testing costs as

a percentage of each chemical's priceare calculated by dividing the

annualized unit testing cost by each unit

price and multiplying by 100. The

Agency's estimated total costs of testing

(including both laboratory and

administrative costs), annualized testing

cost, price impacts, and public reporting

burden hours for the chemicals are

presented in the economic analysis (Ref.

9).

Based on the economic analysis, the

total one-time cost of this action, if

finalized as proposed, is estimated to be

$1.55 million. When this cost is

annualized over 15 years using a 7%

discount rate, the total annualized cost

is estimated to be $170,576, with an

estimated annualized cost of $3,628 per

chemical. In addition, the estimated cost

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

notification, which, in 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 (Ref. 9, 13,

and 14).

The economic impacts of the testing,

expressed as a percentage of each

chemical's sale price, range from 0.09%

to 3.3%, with an average impact of

0.64%. EPA estimates that 5 of the 35

chemicals for which price data are

available will experience an adverse

impact of 1% or greater under the

assumption that production volumes for

these chemicals are one million lbs. In

fact, these chemicals are all

manufactured or imported in excess of

10 million lbs, reducing the estimated

impact by a factor of 10 to less than 1%.

For the remaining 12 chemicals without

price data, EPA estimates that with

annualized testing costs of $3,628 per

chemical and one million lbs

production volumes each, an economic

impact of 1% or greater would occur

only at a sales price below $0.36 per lb.

Given that the average price for the

other 35 chemicals is $0.97 per lb

(prices range from $0.11 to $3.96 per lb),

that the unavailability of price data for

these 12 chemicals may indicate that

they are higher priced specialty

chemicals, and that their production

volumes are likely to be higher than the

one million lbs minimum, the

likelihood of an adverse impact is low.

B. Executive Order 12898

This proposed rule does not involve

special considerations of

environmental-justice related issues

pursuant to Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629, February 16,

1994).

C. Executive Order 13045

Executive Order 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 "economically

significant" as defined under Executive

Order 12866; and does not concern an

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environmental health or safety risk that

may have a disproportionate effect on

children. This proposed rule would

require the development of quantitative

measures of dermal absorption rate to

assist in evaluating the potential

contribution of the chemical substances

proposed for testing to total exposures

to adult workers. The public is invited,

however, to submit or identify peerreviewed studies and data, of which

EPA may not be aware, that assess

results of early life exposure to the 47

chemicals proposed for testing in this

document.

D. Regulatory Flexibility Act

Pursuant to section 605(b) of the

Regulatory Flexibility Act (RFA), 5

U.S.C. 601 et seq., the Agency hereby

certifies that this rule, 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 proposed rule

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

The costs developed in the small entity

impact analysis are based on the

laboratory test cost estimates that have

been placed in the docket for this

proposed rule (Ref. 12).

For the purpose of analyzing potential

impacts on small entities, EPA used the

RFA definition of small entities in RFA

section 601(6). Under this section, a

small entity may be a small government,

a small non-profit organization, or a

small business. Because EPA does not

believe that governments or non-profit

organizations are likely to be burdened

by testing requirements under this

proposed rule, EPA's analysis presents

only the estimated potential impacts on

small businesses.

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 SBA establishes

small business size standards (13 CFR

121.201). For this proposed rule, EPA

has analyzed the potential small

business impacts using the size

standards established under the RFA

section 601(3) definition.

In addition, in analyzing potential

impacts, the RFA recognizes that it may

be appropriate at times for Federal

agencies to use an alternate definition of

small business. As such, RFA section

601(3) also 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 standards, which are

primarily intended to define whether a

business entity is eligible for Federal

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. 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 industries 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 standards for

23% of this industry sector are 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 in

this unit, 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 proposing to establish an

alternate small business definition in

the small entity impact analysis

conducted for this proposed rule, the

analysis includes the results of

calculations using a size standard based

on total annual sales. EPA is interested

in receiving comments on whether the

Agency should consider establishing an

alternate small business definition to

use in the small entity impact analyses

for future TSCA section 4(a) test rules,

and what size cutoff may be

appropriate.

Based on the Agency's estimated total

costs for this proposed rule, which are

summarized in Unit VIII.A. of this

preamble, EPA estimates that the

annualized cost for the testing in this

proposed rule will be $3,628 per

chemical. As discussed previously, EPA

was unable to obtain any price

information on 12 of the 47 chemicals

in this proposed test rule. Nevertheless,

EPA provides an estimate of the price of

these chemicals in the economic

analysis, and concludes that the total

cost of testing these 47 chemicals as

proposed, will not result in a significant

impact on the chemical manufacturers

subject to the proposed rule, regardless

of their size. EPA identified a total of

102 ultimate corporate entities (UCEs)

that would be potentially impacted by

the proposed test rule. None of these

manufacturers would experience a

significant impact as a result of the rule.

In addition, 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 (Ref. 9, 13,

and 14). 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.

The Agency has also examined the

standard practices that industry uses in

carrying out chemical testing in

response to test rules, such as this one.

Based on that examination, EPA

believes that:

1. Small businesses do not perform

the testing themselves, nor do they

participate in the organization of the

testing effort, because health effects

testing of chemical substances is

generally carried out by consortia of the

large manufacturers or importers of the

chemical substances;

2. A small business would experience

only very minor costs, if any, in

securing an exemption from testing

requirements, because exemption

request requirements, described

generally at 40 CFR 790.80 through

790.99 and the proposed regulatory text

at § 799.5115(c)(2), (c)(5), and (c)(7), are

minimal and EPA does not charge a fee

for filing such a request; and

3. Small businesses are unlikely to be

affected by the reimbursement

requirements because under the

reimbursement provisions described in

40 CFR part 791, manufacturers and

importers with a significant share of

production or importation are the

entities that will likely pay the highest

share of testing costs, and the marginal

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benefit of securing reimbursement from

small contributors may not be worth the

cost.

Information relating to this

determination has been included in the

public version of the official record for

the 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 in Unit I.C. of this preamble.

E. 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, a collection of information that is

subject to approval under the PRA,

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# 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# 0795). Since this

proposed rule does not contain any new

information collection activities,

additional review and approval of these

activities by OMB under the PRA is not

necessary.

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 in

general include an average burden

estimate to cover future test rules. As

described in the information collection

instrument for chemical testing, the

Agency's total burden estimate

specifically accounts for the potential

issuance of approximately 7 final test

rules during the approval period, with

an estimated burden of less than 20,000

burden hours each. EPA believes that

the existing approval includes a

sufficient burden hour allocation to

cover the estimated burden related to

this proposed rule, if finalized as

proposed. When the final rule is issued,

EPA will verify that the approved

burden hours will cover the estimated

burden for the final rule, or request that

the total approved burden hour

allocation be increased accordingly.

The standard chemical testing

program involves the submission of

letters of intent to test (or exemption

applications), study plans, semi-annual

progress reports, and test results. For

this proposed rule, EPA estimates that

the information collection activities

related to chemical testing would result

in 105.4 burden hours for each

chemical, for a total estimated burden

increase of 4,954 hours (Ref. 9). The

estimated burden of the information

collection activities related to export

notification is 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 (Ref. 9, 13, and

14). 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

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 in Unit I.C. of this preamble.

In the final rule, the Agency will

address any comments received

regarding the information collection

requirements contained in this proposal.

F. Unfunded Mandates Reform Act

Pursuant to Title II of the Unfunded

Mandates Reform Act of 1995 (UMRA),

Pub. L. 104-4, EPA has determined that

this proposed rule 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

one-time cost of the rule, which is

summarized in Unit VIII.A. of this

preamble, is $1.55 million, with the

total annualized cost estimated to be

$170,576, and the estimated annual cost

per chemical to be $3,628. In addition,

EPA has determined that this proposed

rule does not significantly or uniquely

affect small governments. Accordingly,

today's proposed rule is not subject to

the requirements of UMRA sections 202,

203, 204, or 205.

G. Executive Order 12875

Under Executive Order 12875,

entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), EPA may not

issue a regulation that is not required by

statute and that creates a mandate upon

a State, local, or tribal government,

unless the Federal government provides

the funds necessary to pay the direct

compliance costs incurred by those

governments, or EPA consults with

those governments. If EPA complies by

consulting, Executive Order 12875

requires EPA to provide to OMB a

description of the extent of EPA's prior

consultation with representatives of

affected State, local, and tribal

governments, the nature of their

concerns, any written communications

from the governments, and a statement

supporting the need to issue the

regulation. In addition, Executive Order

12875 requires EPA to develop an

effective process permitting elected

officials and other representatives of

State, local, and tribal governments "to

provide meaningful and timely input in

the development of regulatory proposals

containing significant unfunded

mandates."

EPA does not believe the today's

proposed rule under TSCA section 4(a)

creates a Federal mandate on State,

local, or tribal governments, and thus,

EPA does not believe that the

requirements of section 1(a) of

Executive Order 12875 apply to this

rule. The Agency does not know of any

State, local, or tribal governments that

would be subject to the requirements of

the rule if it were promulgated as

proposed. In the history of the TSCA

section 4(a) testing program, the Agency

has never received a letter of intent to

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test or an exemption application from a

State, local, or tribal government. EPA is

requesting comment on whether any

State, local, or tribal government would

be subject to the requirements of the

proposed rule. If, on the basis of these

comments, EPA determines that the rule

would create a Federal mandate, the

Agency will consult with

representatives of affected State, local,

or tribal governments in accordance

with the Executive Order prior to

promulgating the final rule.

H. Executive Order 13084

Under Executive Order 13084,

entitled Consultation and Coordination

with Indian Tribal Governments (63 FR

27655, May 19, 1998), EPA has

determined that this proposed rule does

not significantly or uniquely affect the

communities of Indian tribal

governments. This determination is

based on the Agency's belief 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

Executive Order 13084 do not apply to

this proposed rule.

I. National Technology Transfer and

A dvancem ent Act

Section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 (NTTAA) (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. The

testing that would be required under

this rule would be conducted according

to the enforceable in vitro dermal

absorption rate test standard proposed

in this document. This test standard was

developed by EPA in conjunction with

ITC member and liaison agencies (CPSC,

DoD, FDA, NIOSH, and OSHA). It was

based on the methods of Bronaugh and

Collier (Bronaugh, R.L., and Collier,

S.W., Protocol for In Vitro Percutaneous

Absorption Studies, In Vitro

Percutaneous Absorption: Principles,

Fundamentals, and Applications. R.L.

Bronaugh and H.I. Maibach, Eds. CRC

Press, Boca Raton, FL. pp. 237-241

(1991)) (Ref. 7), and modified in

response to public comments. The

group of scientists that developed this

test standard did so based on their

experience with the methodologies

available for conducting this type of

testing. As a result of their collective

expertise in these methodologies, they

considered the method developed for

this testing program to be an effective

and efficient method for testing a large

number of chemicals to determine an in

vitro dermal absorption rate using

human cadaver skin.

EPA is not aware of any potentially

applicable voluntary consensus

standards which needed to be

considered in lieu of the in vitro dermal

absorption rate test standard included in

this proposed rule. The Agency invites

comment on the potential use of

voluntary consensus standards in this

proposed rule, and, specifically, invites

the public to identify potentially

applicable voluntary consensus

standard(s) and to explain why such

standard(s) should be used here.

List of Subjects in 40 CFR Part 799

Environmental protection, Chemicals,

Hazardous substances, Reporting and

recordkeeping requirements,

Laboratories.

Dated: June 1, 1999.

Susan H. Wayland,

ActingAssistantAdm inistratorfor

Prevention, Pesticides and Toxic Substances.

Therefore, it is proposed that 40 CFR

chapter 1, 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 § 799.5115 to subpart D

to read as follows:

§ 799.5115 Chemical testing requirements

for certain chemicals of interest to the

Occupational Safety and Health

Administration.

(a) What substances will be tested

under this section? Table 2 in paragraph

(i) of this section identifies the chemical

substances that must be tested under

this section. The purity of each test

substance must be 99% or greater unless

otherwise specified in this section.

(b)Am Isubject 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 of paragraph

(i) of this section at any time from the

effective date specified in Table 2 of

paragraph (i) of this section 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 of paragraph

(i) of this section 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 lam subject to this section, when

must Icomply with it? (1)(i) Persons

subject to this section are divided into

two groups, as set forth in Table 1 of

this paragraph: 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 of this

paragraph.

31086
Federal Register/Vol. 64, No. 110/Wednesday, June 9, 1999/Proposed Rules

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

+

*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 Ibs) 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 of paragraph (c)(1)(i) of

this section expands the list of persons

specified in § 790.42(a)(2), (a)(4), and

(a)(5) of this chapter, 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 of paragraph (i) of this section, 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 specified in Table

2 of paragraph (i) of this section for that

chemical substance. 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 of paragraph (i) of this section, 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 of paragraph (i) of this section within

30 days after the effective date in Table

2 of paragraph (i)of this section, 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.

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 of paragraph (i) of this section, and if

you manufacture or process this

chemical as of the effective date

specified in Table 2 of paragraph (i) of

this section, 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 of paragraph

(i) of this section, 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. A notification

will be given by certified letter or by

publication of a Federal Register

document.

(7) If you are required to comply with

this section, but your manufacturing or

processing of a chemical substance

listed in Table 2 of paragraph (i) of this

section 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

manufacturing 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 of paragraph (i) of this section,

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,

including the submission of letters of

intent to test or exemption applications,

the conduct of testing, and the

submission of data; part 792 of this

chapter; and this section.

(e) If ldo 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 1 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 of

paragraph (i) of this section is subject to

part 707, subpart D, of this chapter.

(h) What test standard must Ifollow ?

The chemical substances identified by

Chemical Abstract Service (CAS)

registry number and chemical name in

Table 2 of paragraph (i) of this section

must be tested as follows:

31087
Federal Register/Vol. 64, No. 110/Wednesday, June 9, 1999/Proposed Rules

(1)Applicability. This in vitro dermal

absorption rate test standard must be

used for all testing conducted under this

section.

(2) Source. The source used to

develop this test standard is the

"Protocol for In Vitro Percutaneous

Absorption Studies," (Referenced in

paragraph (h)(8)(i)(A) of this section).

(3) Purpose. In the assessment and

evaluation of the characteristics of a

chemical substance or mixture (test

substance), determination of the rate of

absorption of the chemical substance

where dermal exposure to the chemical

substance in the workplace may result

in systemic toxicity is important. This

test standard is designed to develop data

on the rate at which chemicals are

absorbed through the skin so that the

body burden of chemical resulting from

dermal exposure in the workplace can

be better evaluated.

(4) Principles of the test method. This

test standard describes procedures for

measuring a permeability constant (Kp)

and a short-term in vitro absorption rate

for chemical substances in liquid form.

The test standard utilizes in vitro

diffusion cell techniques which allow

absorption studies to be conducted with

human skin. In vitro diffusion studies

are necessary for measuring a Kp. This

test standard specifies the use of

cadaver skin and static diffusion cells to

maintain the viability of the skin, thus,

more closely simulating in vivo

conditions. It also requires the use of

radiolabeled test chemicals unless it can

be demonstrated that procedures

utilizing a non-radiolabeled test

substance are able to measure the

substance with a sensitivity equivalent

to the radiolabeled method.

(5) Test procedure-(i) Choice of

membrane-(A) Skin selection. Human

cadaver skin must be used in all testing

conducted under this test standard. The

most accurate absorption-rate data for

regulatory concerns related to human

health would be obtained with live

human skin. Because this test standard

requires the use of static diffusion cells,

maintenance of skin viability is not

necessary. However, the time elapsed

between death and harvest of the tissue

must be reported.

(B) Number of samples. Data from a

total of at least six samples obtained

from at least three human subjects must

be averaged to allow for biological

variation among subjects.

(C) Anatomical region. In order to

minimize the variability in skin

absorption measurements for these tests,

samples of human skin must be

obtained from the abdominal region of

human subjects of known source and

disease state. Variability in skin

permeation is well known to occur in

different anatomical regions. The trunk

and its extremities have reasonably

similar barrier properties (less than 2-

fold differences). Enhanced absorption

can be observed in regions of the face (4-

fold) and the scrotum (20-fold). Small

differences in regional absorption may

not be significant compared to

intersubject variability

(D) Validation of human skin barrier.

Barrier properties of human skin must

be pretested with a standard compound

such as tritiated water prior to

conducting an experiment with the test

chemical because barrier alteration can

result from surgery or topical scrubbing,

as discussed in the reference in

paragraph (h)(8)(i)(B) of this section.

(ii) Preparation of membrane. Full

thickness skin must not be used.

Because chemicals are taken up by

blood vessels directly beneath the

epidermis in vivo, this in vitro test

standard must be conducted using a

membrane with most of the dermis

removed. This is particularly important

for hydrophobic chemicals that diffuse

slowly through the dermis. A suitable

membrane must be prepared from skin

with a dermatome at a thickness of 200

to 500 millimeters (mm). The

microtomed skin samples can be stored

frozen for up to 2 weeks, if necessary,

provided that they are frozen quickly

and the barrier properties of the samples

are confirmed.

(iii) Diffusion cell design. Static

diffusion cells must be used in these

studies. The testing laboratory must

verify that the difference in the

concentration of the test compound

across the skin membrane does not

decrease by more than 10% during the

experiment. This will ensure that the

test compound concentration in the

receptor fluid does not alter the

penetration rate. Concentration of the

neat liquid must be taken as the density

of the compound.

(iv) Temperature. Skin must be

maintained at a physiological

temperature of 320 Celsius.

(v) Testing hydrophobic chemicals.

Chemicals with water solubility less

than about 10 milligrams/liter do not

freely partition from skin into aqueous

receptor fluid. To increase the water

solubility of such hydrophobic

chemicals, polyethoxyoleate

(polyethylene glycol (PEG) 20 oleyl

ether) must be added to the receptor

fluid at a concentration of 6%. To

ensure that an increase in concentration

of the chemical in the receptor fluid

does not alter penetration rate, the

concentration difference across the

membrane must not decrease by more

than 10% during the experiment.

(vi) Vehicle. If the test chemical is a

liquid at room temperature and does not

damage the skin during the

determination of Kp, it must be applied

neat. If the chemical cannot be applied

neat because it is a solid at room

temperature or because it damages the

skin when applied neat, it must be

dissolved in water. If the concentration

of a hydrophobic chemical in water is

not high enough so that a steady-state

absorption can be obtained, the

chemical must be dissolved in isopropyl

myristate. A sufficient volume of liquid

must be used to completely cover the

skin and provide the amount of test

chemical needed as described in

paragraph (h)(5)(vii) of this section.

(vii) Dose--(A) Kp. An "infinite dose"

of the test chemical must be applied to

the skin to achieve the steady-state rate

of absorption necessary for calculation

of a Kp. The actual concentration

required to give an undepletable

reservoir on the surface of the skin

depends on the rate of penetration of the

test chemical. Preliminary studies may

be necessary to determine this

concentration. The diffusion cell tops

must be covered with a stopper or with

parafilm 7 to ensure that significant

evaporation of the vehicle or test

chemical does not occur. The skin

barrier integrity must be verified at the

end of the experiment by measuring the

absorption of a standard compound

such as tritiated water, as discussed in

the reference in paragraph (h)(8)(i)(B) of

this section.

(B) Short-term absorption rate. Shortterm absorption rates must be

determined for all test chemicals. The

dose of test chemical applied to the skin

must be sufficient to completely cover

the exposed skin surface. A minimum of

four to six diffusion cells must be set up

using skin from a single subject and two

to three of these shall be terminated at

10 and 60 minutes. Skin absorption at

each sampling time is the sum of the

receptor-fluid levels and the absorbed

chemical that remains in the skin, as

discussed in the reference in paragraph

(h)(8)(i)(C) of this section. Unabsorbed

chemical must be removed from the

skin surface by washing gently with

soap and water. This procedure must be

repeated with skin from two additional

subjects. In order to ensure reliable

short-term absorption rates, the

diffusion cell tops must be covered with

a stopper or with parafilm 7 to prevent

evaporation of the test chemical.

(viii) Study duration-(A) Kp. This in

vitro dermal absorption rate test must be

performed until at least four absorption

measurements are obtained during the

steady state absorption portion of the

procedure. A preliminary study may be

31088
Federal Register/Vol. 64, No. 110/Wednesday, June 9, 1999/Proposed Rules

useful to establish time points for

sampling. The required absorption

measurements can be accomplished in

an hour or two with fast-penetrating

chemicals but require 24 hours or longer

for slow-penetrating chemicals.

Unabsorbed material need not be

removed from the surface of the skin.

(B) Short-term exposure rate. The test

chemical must be applied to skin for

durations of at least 10 and 60 minutes.

At the end of the study, the unabsorbed

material must be removed from the

surface of the skin with soap and water

and the amount absorbed into the skin

and receptor fluid must be determined,

as discussed in the reference in

paragraph (h)(8)(i)(C) of this section.

( 6 ) Results--(i) Kp. The Kp must be

calculated by dividing the steady-state

rate of penetration (measured in

micrograms x hr - 1 x centimeters (cm) -

2)

by the concentration of the test chemical

(measured in micrograms x cm -

3)

applied to the skin. For example, if the

steady-state rate is 1 microgram x hr - 1 x

cm -

2 and the concentration applied to

the skin is 1,000 micrograms x cm -3 ,

then the Kp value is calculated to be

0.001 cm x hr-.

(ii) Short-term exposure rate. The

rates of penetration (micrograms x hr - 1

x cm - 2 ) must be determined from the

total amount of test chemical found in

the receptor fluid and skin after the 10-

and 60-minute exposures.

(7) Test reports. In addition to

compliance with the TSCA Good

Laboratory Practice (GLP) Standards at

40 CFR part 792, the following specific

information must be collected and

reported under paragraph (i) of this

section:

(i) Test systems and test methods. (A)

A description of the date, time, and

location of the test, the name(s) of the

person(s) conducting the test, the

location of records pertaining to the test,

as well as a GLP statement. These

statements must be certified by the

signatures of the individuals performing

the work and their supervisors.

(B) A description of the source,

identity, and purity of the test chemical

and the source, identity, and handling

of the test skin. There must be a detailed

description of the test procedure and all

materials, devices used and doses

tested, as well as a detailed description

and illustration of flow-cell design.

There must also be a description of the

skin preparation method including

measurements of the skin membrane

thickness.

(C) A description of the analytical

techniques to be used, including their

accuracy, precision, and detection limits

(in particular for non-radiolabeled tests),

and, if a radiolabel is used, there must

be a description of the radiolabel (e.g.,

type, location of, and radiochemical

purity of the label).

(D) All data must be clearly identified

as to dose and specimen. Derived values

(means, permeability coefficient, graphs,

charts, etc.) are not sufficient.

(ii) Conduct of study. Data must be

collected and reported on the following:

(A) Monitoring of testing parameters.

(B) Temperature of chamber.

(C) Receptor fluid pH.

(D) Barrier property validation.

(E) Analysis of receptor fluid for

radioactivity or test chemical.

(iii) Results. The Kp or short-term

absorption rate must be presented. In

addition, all raw data from each

individual diffusion cell must be

maintained to support the calculations

of Kp and short-term exposure rates.

When radiolabeled compounds are

used, a full balance of the radioactivity

must be presented, including cell

rinsing and stability of the test

substance in the donor compartment.

(8) References. (i) For background

information on this test standard, the

following references should be

consulted. These references are

available at the TSCA Nonconfidential

Information Center, Rm. NE B-607,

Environmental Protection Agency, 401

M St., SW., Washington, DC, 12 noon to

4 p.m., Monday through Friday, except

legal holidays.

(A) Bronaugh, R.L., and Collier, S.W.

Protocol for In Vitro Percutaneous

Absorption Studies. In Vitro

Percutaneous Absorption: Principles,

Fundamental, and Applications. R.L.

Bronaugh and H.I. Maibach, Eds. CRC

Press, Boca Raton, FL. pp. 237-241

(1991).

(B) Bronaugh, R.L., Stewart, R.F., and

Simon, M. Methods for In Vitro

Percutaneous Absorption VII: Use of

Excised Human Skin. Journal of

Pharmaceutical Sciences. Vol. 75, pp.

1094-1097 (1986).

(C) Bronaugh, R.L., Stewart, R.F., and

Storm, J.E. Extent of Cutaneous

Metabolism during Percutaneous

Absorption of Xenobiotics. Toxicology

and Applied Pharmacology. Vol. 99, pp.

534-543 (1989).

(ii) Two additional documents

consulted in developing this test

standard are:

(A)Walker, J.D., Whittaker, C. and

McDougal, J.N. Role of the TSCA

Interagency Testing Committee in

Meeting the U.S. Government Data

Needs: Designating Chemicals for

Percutaneous Absorption Rate Testing.

Dermatoxicology. F. Marzulli and H.

Maibach, Eds. Taylor &Francis,

Washington, DC. pp. 371-381 (1996).

(B) Bronaugh, R.L. Stewart, R.F.

Methods for In Vitro Percutaneous

Absorption Studies IV: The FlowThrough Diffusion Cell. Journal of

Pharmaceutical Sciences. Vol. 74, pp.

64-67 (1985).

(i) Reporting requirements. The

reports submitted under this section

must include the information specified

in paragraph (h)(7) of this section.

Interim progress reports for each test

must be submitted every 6 months,

beginning 6 months after the effective

date of any specific test listed in Table

2 of this paragraph. A final report for a

specific test must be submitted by the

deadline indicated as the number of

months after the effective date shown in

Table 2 of this paragraph.

TABLE 2.-REQUIRED TESTING: CHEMICAL SUBSTANCES DESIGNATED FOR IN VITRO DERMAL ABSORPTION RATE TESTING

Deadline for final Number of Interim (6 CAS No. Chemical name report month) reports re- Effective date quired

Ethyl ether

Ethyl bromide

Acetonitrile

Carbon disulfide

Vinylidene chloride

Dicyclopentadiene

Dimethyl sulfate

Isophorone

Isobutyl alcohol

Propylene dichloride

sec-Butyl alcohol

31089

60-29-7

74-96-4

75-05-8

75-15-0

75-35-4

77-73-6

77-78-1

78-59-1

78-83-1

78-87-5

78-92-2
31090 Federal Register/Vol. 64, No. 110/Wednesday, June 9, 1999/Proposed Rules

TABLE 2.-REQUIRED TESTING: CHEMICAL SUBSTANCES DESIGNATED FOR IN VITRO DERMAL ABSORPTION RATE

TESTING-Continued

Deadline for final Number of Interim (6

CAS No. Chemical name report month) reports re- Effective date

quired

79-20-9 Methyl acetate 9 1

79-46-9 2-Nitropropane 9 1

91-20-3 Naphthalene 9 1

92-52-4 Biphenyl 9 1

95-49-8 o-Chlorotoluene 9 1

95-50-1 o-Dichlorobenzene 9 1

97-77-8 Disulfiram 9 1

98-29-3 tert-Butylcatechol 9 1

99-99-0 p-Nitrotoluene 9 1

100-00-5 p-Nitrochlorobenzene 9 1

100-01-6 p-Nitroaniline 9 1

100-44-7 Benzyl chloride 9 1

106-42-3 p-Xylene 9 1

106-46-7 p-Dichlorobenzene 9 1

107-06-2 Ethylene dichloride 9 1

107-31-3 Methyl formate 9 1

108-03-2 1 -Nitropropane 9 1

108-90-7 Chlorobenzene 9 1

108-93-0 Cyclohexanol 9 1

109-66-0 Pentane 9 1

109-99-9 Tetrahydrofuran 9 1

110-12-3 Methyl isoamyl ketone 9 1

111-84-2 Nonane 9 1

120-80-9 Catechol 9 1

121-69-7 Dimethylaniline 9 1

122-39-4 Diphenylamine 9 1

123-42-2 Diacetone alcohol 9 1

126-99-8 beta-Chloroprene 9 1

127-19-5 Dimethyl acetamide 9 1

142-82-5 n-Heptane 9 1

150-76-5 p-Methoxyphenol 9 1

528-29-0 o-Dinitrobenzene 9 1

628-63-7 n-Amyl acetate 9 1

768-52-5 N-Isopropylaniline 9 1

25013-15-4 Vinyl toluene 9 1

34590-94-8 Dipropylene glycol methyl ether 9 1

[ER Doc. 99 14640 Filed 6 8 99; 8:45 am]

BILLING CODE 6560-50-F