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Federal Register/Vol. 69, No. 80/Monday, April 26, 2004/Rules and Regulations

4.3 Exception

[Revise 4.3 to read as follows:]

Some parcels may be successfully

processed on BMC parcel sorters even

though they do not conform to the

general machinability criteria in 4.1.

The manager, BMC Operations, USPS

Headquarters (see G043 for address)

may authorize a mailer to enter such

parcels as machinable parcels rather

than irregular parcels if the parcels are

tested on BMC parcel sorters and prove

to be machinable. Mailers who wish to

have parcels tested for machinability on

USPS parcel sorting machines must:

a. Submit a written request to BMC

Operations. The request must list

mailpiece characteristics for every

shape, weight, and size to be

considered. If the letter requesting

testing describes a mailpiece that falls

within the specifications of pieces that

were tested previously, the mailpiece

will not be tested.

b. Describe mailpiece construction,

parcel weight(s), estimated number of

parcels to be mailed in the coming year,

and preparation level (e.g., destination

BMC pallets).

c. Send 100 samples to the test facility

designated by the manger, BMC

Operations, at least 6 weeks prior to the

first mailing date. The manager, BMC

Operations, will recommend changes, to

ensure machinability, of parcels that do

not qualify.

6.0 OUTSIDE PARCEL

(NONMACHINABLE)

[Revise the first sentence to read as follows:]

An outside parcel is a parcel that

exceeds any of the maximum

dimensions for a machinable parcel.

G General Information

GO00 The USPS and Mailing

Standards

G040 Information Resources

G043 Address List for Correspondence

[Add the following address:] BMC

Operations, US Postal Service, 475

L'Enfant PLZ, SW., RM 7631,

Washington, DC 20260-2806.

We will publish an appropriate

amendment to 39 CFR part 111 to reflect

these changes.

Neva R. Watson,

Attorney, Legislative.

[FR Dec. 04-9414 Filed 4-23-04; 8:45 am]

BILLING CODE 7710-12-P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 9 and 799

[OPPT-2003-0006; FRL-7312-2]

RIN 2070-AD42

In Vitro Dermal Absorption Rate

Testing of Certain Chemicals of

Interest to the Occupational Safety and

Health Administration

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is promulgating a final

rule under the Toxic Substances Control

Act (TSCA) that requires manufacturers

(including importers) and processors of

34 chemicals to conduct in vitro dermal

absorption rate testing. These chemicals

are of interest to the Occupational

Safety and Health Administration

(OSHA) of the Department of Labor, and

the data obtained under this testing

program will be used by OSHA to

evaluate the need for "skin

designations" for these chemicals. Skin

designations are used by OSHA to alert

industrial hygienists, employers, and

workers to the potentially significant

contribution to the overall exposure to

certain chemicals which can occur by

the cutaneous route. Thus, skin

designations encourage employers to

consider whether changes should be

made to processes involving such

chemical substances in order to reduce

the potential for systemic toxicity from

dermal absorption of these chemicals.

Persons who export or intend to export

any chemical substance included in this

final rule are subject to the export

notification requirements in TSCA

section 12(b).

DATES: This final rule is effective on

May 26, 2004. For purposes of judicial

review, this final rule shall be

promulgated at 1 p.m. eastern daylight/

standard time on May 10, 2004.

ADDRESSES: EPA has established a

docket for this action under docket

identification (ID) number OPPT-2003-

0006. All documents in the docket are

listed in the EDOCKET index at http:/

/www.epa.gov/edocket/. Although listed

in the index, some information is not

publicly available, i.e., Confidential

Business Information (CBI) or other

information whose disclosure is

restricted by statute. Certain other

material, such as copyrighted material,

will not be placed on the Internet and

will be publicly available only in hard

copy form. Publicly available docket

materials are available either

electronically in EDOCKET or in hard

copy at the Office of Pollution

Prevention and Toxics (OPPT) Docket,

EPA Docket Center (EPA/DC), EPA

West, Room B102, 1301 Constitution

Ave., NW., Washington, DC. The Public

Reading Room is open from 8:30 a.m. to

4:30 p.m., Monday through Friday,

excluding legal holidays. The EPA

Docket Center Reading Room telephone

number is (202) 566-1744, and the

telephone number for the OPPT Docket,

which is located in EPA Docket Center,

is (202) 566-0280.

FOR FURTHER INFORMATION CONTACT: For

general information contact: Colby

Lintner, Regulatory Coordinator,

Environmental Assistance Division

(7408M), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460-0001; telephone

number: (202) 554-1404; e-mail address:

TSCA-Hotline@epa.gov.

For technical information contact:

Keith Cronin or Catherine Roman,

Chemical Control Division (7405M),

Office of Pollution Prevention and

Toxics, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460-0001; telephone

number: (202) 564-8157 or (202) 564-

8172; e-mail address:

cronin.keith@epa.gov or

roman. catherine@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you manufacture (defined by statute to

include import) or process any of the

chemical substances that are listed in

§ 799.5115(j) of the regulatory text. Any

use of the term "manufacture" in this

document will encompass "import,"

unless otherwise stated. In addition, as

described in Unit VI., any person who

exports or intends to export any of the

chemical substances in this final rule is

subject to the export notification

requirements in 40 CFR part 707,

subpart D. Entities that could be subject

to the requirements in this final rule

may include, but are not limited to:

* Manufacturers (defined by statute

to include importers) of one or more of

the 34 subject chemical substances

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(NAICS 325 and 324110), e.g., chemical

manufacturing and petroleum refineries.

* Processors of one or more of the 34

subject chemical substances (NAICS 325

and 324110), e.g., chemical

manufacturing and petroleum refineries.

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 this unit could also

be affected. The North American

Industry 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 may be affected by this action,

you should carefully examine the

applicability provisions in Unit V.E. and

consult the regulatory text at 40 CFR

799.5115(b). If you have any questions

regarding the applicability of this action

to a particular entity, consult one of the

technical persons listed under FOR

FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies

of this Document and Other Related

Information?

In addition to EDOCKET (http://

www.epa.gov/edocket/), you may access

this Federal Register document

electronically through the EPA Internet

under the "Federal Register" listings at

http://www.epa.gov/fedrgstr/. A

frequently updated electronic version of

40 CFR part 9 and part 799 is available

on E-CFR Beta Site Two at http://

www.gpoaccess.gov/ecfr/.

II. Background

A. What Action is the Agency Taking?

In this action, EPA is promulgating a

test rule under TSCA section 4 (15

U.S.C. 2603) which responds to

recommendations of the Interagency

Testing Committee (ITC). Under TSCA

section 4(e)(1), the ITC is responsible for

recommending chemical substances and

mixtures to the EPA Administrator for

priority testing consideration. In

September 1991, the ITC received a

nomination from OSHA of 658 chemical

substances and mixtures for ITC review.

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 (Ref. 1).

OSHA indicated to the ITC that it

needed quantitative measures of dermal

absorption to evaluate the potential

hazard of these chemicals to workers

(Ref. 2). These quantitative measures are

expressed as the dermal absorption rate

for a particular chemical (Ref. 3, p.

35725). The results of the ITC's review

were published in the Federal Register

(Ref. 1, p. 26900 and Ref. 2, pp. 38492-

38493).

In the 31 st, 3 2nd, and 3 5th ITC Reports

to the EPA Administrator (Refs. 1, 2,

and 4), the ITC designated for in vitro

dermal absorption rate testing a total of

83 of the 658 chemical substances

nominated by OSHA. A summary of the

process by which the ITC selected the

83 chemical substances was presented

in the proposal to this action (Ref. 5, p.

31077). The data reviewed by the ITC

included data obtained from TSCA

section 8(a) and 8(d) rules (Refs. 6, 7,

and 8) which were promulgated by EPA

for the 83 chemical substances included

in the 3 1 st, 3 2 nd, and 3 5 th ITC Reports

(Refs. 1, 2, and 4). These rules required

the reporting to EPA of certain

production, use and exposure-related

information, and unpublished health

and safety data concerning the 83

chemical substances.

In reviewing the available data, the

ITC determined that the data for methyl

methacrylate, diethyl phthalate, and

cyclohexanone would meet OSHA's

data needs for these three chemicals.

Accordingly, the ITC withdrew its

designation for these three chemicals:

Methyl methacrylate and diethyl

phthalate in the 34 th ITC Report (Ref. 3),

and cyclohexanone in the 36th ITC

Report (Ref. 9).

Eighty of the chemical substances

originally 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 31st, 32nd, and

3 5 th ITC Reports (Refs. 1, 2, and 4), EPA

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, EPA again solicited

interested parties to submit proposals

for ECAs (Ref. 10). On June 26, 1996,

EPA received a proposal from the ARCO

Chemical Company (ARCO) (Ref. 11) for

tert-butyl alcohol. On March 26, 1998,

EPA received a study from ARCO

entitled [14C]-t-Butyl Alcohol: Topical

Application: Dermal Absorption Study

in the Male Rat (Refs. 12 and 12a.). This

study was reviewed and found

acceptable as a means of determining

the dermal absorption rate for tert-butyl

alcohol. Accordingly, EPA did not

propose testing of tert-butyl alcohol.

On June 9, 1999, EPA responded to

the ITC's designation of the remaining

79 chemicals by issuing a proposed test

rule under TSCA section 4 (Ref. 5)

which would require that 47 of these

chemical substances be tested with

respect to in vitro dermal absorption

rate. The Agency selected the 47

chemicals for testing because, at the

time of the proposal, EPA believed that

their production volumes were the

highest among the 80 chemicals

designated by the ITC. At the time of the

proposed rule, the most current

information available to EPA indicated

that each of the 47 chemicals was

produced in "substantial quantities,"

meaning that their annual production

volumes ranged from one million to

more than one billion pounds. These

chemical substances were being used in

a wide variety of applications, which

resulted in potential exposures of 1,000

or more workers to each chemical

substance. Based upon EPA's review of

more recent production volume data,

exposure data, and dermal absorption

rate data, which became available after

the proposal to this rule was published,

EPA is now requiring testing for 34 of

the 47 chemicals that had been included

in the proposed rule. The rationale for

EPA's decision not to finalize testing

requirements for the other 13 chemicals,

which were originally proposed for

testing, is described in Unit VII.A.

through I.

EPA is requiring that the 34 chemicals

be tested according to the in vitro

dermal absorption rate test standard set

forth in § 799.5115(h) of the regulatory

text. EPA has also specified reporting

requirements in § 799.5115(i) of the

regulatory text. EPA may pursue testing

of the remaining 32 chemicals based on

further analysis.

In the solicitations discussed in this

unit (Refs. 1, 2, 4, and 10), EPA

referenced an in vitro dermal absorption

rate test method for review by potential

submitters in developing their proposed

protocols (Ref. 10, p. 14776). This

method was based on the peer reviewed

method of Bronaugh and Collier (Ref.

13). Some refinements of the method

were made by a panel of Federal

scientists from ITC member and liaison

agencies (including, for example,

Consumer Product Safety Commission

(CPSC), Department of Defense (DoD),

EPA, Food and Drug Administration

(FDA), National Institute for

Occupational Safety and Health

(NIOSH), and OSHA). EPA received

public comments on the method and

entered them, along with the method

itself, into the dockets for the 3 1

s

t, 3 2 nd,

and 35th ITC Reports (docket control

numbers OPPTS-41038, OPPTS-41039,

and OPPTS-41042, respectively). In

addition, the American Chemistry

Council (ACC, formerly the Chemical

Manufacturers Association (CMA))

submitted a proposed protocol outlining

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an alternative method (Refs. 14 and

14a.). Scientists from the Federal

Agencies represented on the ITC

(including EPA and OSHA) reviewed

the public comments and the ACC

proposal. As a result of this review, the

ITC and EPA scientists further refined

the in vitro dermal absorption rate test

method of Bronaugh and Collier which

EPA then proposed to be the test

standard required by this final rule (Ref.

5).

The test standard that will be required

under this final rule describes the

procedures for measuring a permeability

constant (Kp) and two short-term

absorption rates (10 minutes and 60

minutes) for chemical substances in

liquid form. A Kp is useful in estimating

skin permeation when contact with the

chemical is prolonged (hours) and

steady state is achieved, while a shortterm absorption rate measurement is

more relevant when the contact is shortterm (minutes). Both measurements are

required by the test standard.

This test standard makes use of

established in vitro diffusion cell

techniques that allow absorption rate

studies to be conducted using human

cadaver skin and either flow-through or

static diffusion cells (see § 799.5115(h)

in the regulatory text). This test

standard also requires the use of

radiolabeled chemical substances unless

the test sponsor can demonstrate that

procedures utilizing a non-radiolabeled

test substance are able to measure the

substance with equivalent sensitivity.

The first six parameters that are

discussed under test procedures in

§ 799.5115(h)(5) of the regulatory text

(i.e., choice of membrane, preparation of

membrane, diffusion cell design,

temperature, testing of hydrophobic

chemicals, and vehicle) are similar for

the determination of either of the two

percutaneous absorption rate values (Kp

and short-term absorption rate). In

contrast, the remaining two parameters

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

different for the two percutaneous

absorption rate values.

The in vitro approach was chosen not

only for the practical considerations that

it makes efficient use of labor and

materials and can easily be performed

by a variety of laboratories, but also

because in vitro diffusion cell studies

are necessary for measuring a Kp.

Although the in vitro method in

§ 799.5115(h) of the regulatory text will

satisfy OSHA's data needs to support its

skin designations, EPA does not believe

the method is an adequate substitute for

all dermal absorption rate testing

methods.

B. What is the Agency's Authority for

Taking this Action?

This final rule is being promulgated

under TSCA section 4 (15 U.S.C. 2603),

which authorizes EPA to require the

development of data relevant to

assessing the risk to health and the

environment posed by exposure to

chemical substances and mixtures

(chemicals).

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

2603(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/or 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 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 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 [.]

The purpose of this testing is to

develop data about the substance's or

mixture's health or 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 enters or may reasonably be

anticipated to enter the environment in

substantial quantities or there is or may

be significant or substantial human

exposure to the chemical substance),

EPA may require any type of health or

environmental effect 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 to reasonably

predict the effects of the manufacture,

distribution in commerce, processing,

use, or disposal of such substance or

mixture or any combination of such

activities on health or the environment,

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) (Ref. 55, pp. 28738-28739).

In this final rule, EPA is using its

broad TSCA section 4(a) authority to

obtain dermal absorption rate data

necessary for OSHA to evaluate the

need for "skin designations" (see Unit

III.B.3.) for the 34 chemical substances

specified in Table 2 in § 799.5115(j) of

the regulatory text. Following

consideration of the public comments

received by EPA on the proposed test

rule (Ref. 5), EPA is making the

following findings for these chemicals

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

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

(Ref. 68, p. 59673).

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III. Response to Public Comments

A. Summary

EPA received comments on the

proposed rule (Ref. 5) from ACC,

Monsanto Company, First Chemical

Corporation, American Forest and Paper

Association (AFPA), American

Petroleum Institute (API), Biphenyl

Work Group, Diethyl Ether Producers

Association (DEPA), Synthetic Organic

Chemical Manufacturers Association

(SOCMA), Acetonitrile Task Force,

Dupont Dow Elastomers, Fragranced

Products Information Network,

Association of Veterinarians for Animal

Rights, People for the Ethical Treatment

of Animals, Animal Protection Institute

Midwest Regional Office, Humane

Society of the United States, Doris Day

Animal League, Chlorobenzene

Producers Association, Tetrahydrofuran

Task Force (THFTF), a private citizen,

and Union Carbide Corporation (Refs.

15-33).

ACC's Naphthalene Panel, Propylene

Glycol Ethers Panel, Olefins Panel

(ACC/O), Hydrocarbon Solvents Panel,

Ketones Panel and Oxo Process Panel

(ACC/KO), and Carbon Disulfide Panel,

generally supported the comments by

ACC (Refs. 34-39). The Chlorobenzene

Producers Association, Biphenyl Work

Group, and the Acetonitrile Task Force,

also endorsed the comments submitted

by ACC. Comments by ACC and those

comments generally supportive of

ACC's comments are collectively

referred to as "ACC's" hereinafter in

this document. Comments submitted by

these groups that are specific to a

chemical are addressed, as appropriate,

in Unit III.F. and in Unit VII.

A summary of the comments received

by EPA on the Proposed Test Rule for

In Vitro Dermal Absorption Rate Testing

of Certain Chemicals of Interest to

Occupational Safety and Health

Administration is included in this unit,

along with EPA's responses to those

comments. The comments are available

in the public docket for this rulemaking

(see ADDRESSES).

B. TSCA Section 4 Findings

1. "Substantial" human exposure,

TSCA section 4(a)(1)(B)(i)(II)-a. "B"

policy. ACC commented that EPA has

not provided a sufficient basis for its

finding of "substantial" human

exposure under TSCA section

4(a)(1)(B)(i)(II), (15 U.S.C.

2603(a)(1)(B)(i)(II)), with its approach in

this final rule which is based solely on

numbers of people exposed (more

specifically, the number of workers

exposed) to each chemical. ACC asserts

that a substantial human exposure

finding must additionally be based on

information such as each chemical's

physical, chemical, and biological

properties; the manner of use and

release; exposure concentrations; and

duration and frequency of exposure.

ACC states that neither OSHA's

objective of developing skin

designations, nor EPA's objectives

under TSCA, are served by requiring

dermal testing in circumstances where

dermal exposures are at low

concentrations, or are so infrequent that

harm is not likely to occur.

EPA disagrees with ACC's assertion

that EPA has not provided a sufficient

rationale for its finding that there is or

may be "substantial" human exposure

to the chemical substances that are

subject to this final rule as required

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

EPA also disagrees with ACC's

contention that EPA must consider

chemical-specific factors to make a "substantial" human exposure finding.

In its policy statement that explains

how EPA generally makes findings

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

"B" policy), EPA articulated

quantitative thresholds to serve as

guidance in making findings of

"substantial" production, release, and

human exposure. (Ref. 55) These

quantitative thresholds are based on the

Agency's belief that it is reasonable to

interpret the word "substantial" to

mean exposure to large numbers of

people. Therefore, EPA believes that, in

the case of this final rule, where, based

on information available to EPA (Refs. 5

and 56), 1,000 or more workers are

potentially exposed to each chemical for

which the final rule would require

testing, it is reasonable to require the

testing of each chemical. In other words,

EPA's policy (as articulated in its final

"B" policy statement (Ref. 55)) is that

quantitative data alone can justify EPA's

finding that production, potential

release, or the number of people

potentially exposed to a chemical are "substantial." This is consistent with

TSCA's goals of ensuring that, given the

exposure of humans and the

environment to a large number of

chemical substances and mixtures with

potentially harmful effects, there is

effective regulation of commerce in such

substances (15 U.S.C. 2601(a)), that

adequate data 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 these substances (15 U.S.C.

2601(b)). Affected entities had the

opportunity to comment on the

proposed rule and submit current

employee information, readily available

to them, to refute EPA's finding that a

substantial number of employees is

exposed. In those instances when EPA

agreed with information submitted by

commenters which demonstrated that

fewer than 1,000 employees were

exposed to a chemical, that chemical

was not included in this final rule (see

Unit VIID., E., and G.)

A "substantial" human exposure

finding under TSCA section

4(a)(1)(B)(i)(II) requires no hazard or risk

analysis (Ref. 55, p. 28742). Given the

statutory framework, the legislative

history, and the case law interpreting

the TSCA section 4 testing provisions,

EPA does not believe that it is required

to consider each of the types of

information described by ACC in order

to make a TSCA section 4(a)(1)(B)(i)(II) "substantial" human exposure finding

(Ref. 55, p. 28742).

Although EPA is not required to

consider the factors mentioned by ACC

in making its "substantial" human

exposure findings, information of the

sort described by ACC is nevertheless

relevant to other decisions leading to a

determination as to whether to require

testing under TSCA section 4. As stated

in the Agency's "B" policy:

[f] or each substance-specific rulemaking

under section 4, EPA must determine

whether there are sufficient 'data and

experience' upon which to 'reasonably

determine or predict' the health and

environmental effects of a chemical

substance, and whether testing of such

substance is 'necessary to develop such data.'

In making these determinations, the Agency

has always, and will continue to examine all

available and relevant information

concerning the substance in question,

including the physical and biological

properties of the substance, the manner of its

use and release, the level, frequency, and

duration of exposure, and any available

relevant exposure and toxicity data. It is the

responsibility of interested parties to provide

any information they believe may be relevant

to the Agency's determination to require

testing of a particular chemical substance

under TSCA section 4.

(Ref. 55, p. 28743).

In those instances where interested

parties provided such relevant

information on chemical substances

prior to the publication of this final test

rule, EPA and OSHA carefully reviewed

the information and, based on that

review, EPA in some cases decided not

to require testing for those chemical

substances. (See Unit VII.A. through G.).

b. The National Occupational

Exposure Survey (NOES). ACC

commented that EPA has continued to

rely on the NOES database to support its

findings of "substantial" human

exposure, a data base which ACC

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believes to be unrepresentative,

incomplete, and outdated. ACC states

that the NOES estimates are greatly

overstated and should not be relied

upon by EPA in making its findings.

ACC provided a critique of the NOES

(Ref. 40) as support for its statements

and added that EPA should evaluate the

level, frequency, and duration of

exposure to each chemical to determine

if it is "substantial."

EPA disagrees with the commenter's

statements regarding the adequacy of

the NOES for supporting a finding of

"substantial" human exposure under

TSCA section 4(a)(1)(B)(i)(II). This

database contains, among other things,

useful information on the approximate

number of workers potentially exposed

to a chemical substance specified in the

database. That is to say, while the

survey does not provide meaningful

information on the level, frequency, or

duration of exposure, it is useful for

providing an estimate of the potential

number of workers exposed to a

chemical. As noted in Unit III.B.1.a.,

EPA also does not agree with the

comment that EPA should undertake an

exhaustive analysis of exposure (i.e.,

level, frequency, and duration) to a

chemical substance to find that there is

or may be "substantial" human

exposure.

For each of the chemicals for which

testing is required in this final rule,

estimates of the number of exposed

workers were identified in the NOES.

The NOES was a nationwide data

gathering project conducted by NIOSH,

which was designed to develop national

estimates for the number of workers

potentially exposed to various chemical,

physical, and biological agents and

describe the distribution of those

potential exposures. Initiated in 1980

and completed in 1983, the survey

involved a walkthrough investigation by

trained surveyors of 4,490 facilities in

523 different types of industries.

Surveyors recorded potential exposures

when a chemical agent was likely to

enter or contact a worker's body for a

minimum duration. These potential

exposures could be observed or inferred.

Information from these representative

facilities was extrapolated to generate

national estimates of potentially

exposed workers for more than 10,000

different chemicals (Ref. 41). The NOES

survey is the most recent and

comprehensive source of this kind of

information.

In the critique of the NOES cited by

ACC, a general conclusion of the

authors was:

We conclude from reviewing the survey

design that, despite some flaws, it represents

one of the soundest approaches possible,

within the limited budget, for attaining

national estimates of the number of workers

in the proximity of potentially hazardous

agents.

(Ref. 40).

EPA agrees with this conclusion and

believes that it is reasonable to use

information provided in the NOES

database to support a finding of

"substantial" human exposure for a

chemical substance contained within

that database.

In addition, EPA agrees with the

authors of the critique, Buell et al (Ref.

40), that the survey results, while

potentially useful for making broad,

national estimates of the number of

persons in workplaces where potentially

hazardous agents are also present,

should not be used to gauge actual

worker exposure to these agents,

particularly to individual chemicals in

individual industry sectors. This

information was not collected in the

survey. EPA has relied only on the

information in the NOES database

regarding the approximate number of

potentially exposed workers in support

of its finding of "substantial" human

exposure.

Because some time has passed since

the NOES was completed, EPA

acknowledges that there may be

instances where changes in various

industrial sectors (i.e., market demand,

advances in technology, and other

mitigating factors) have led to a decrease

in the number of workers potentially

exposed to certain chemical substances.

EPA's proposed test rule asked

interested parties to provide any

information they believed relevant to

the Agency's determination to require

testing of a particular chemical

substance under TSCA section 4. EPA

has received additional exposure

information on certain chemical

substances for which testing was

proposed. This information has been

fully considered, and for those chemical

substances for which EPA believes it

cannot make the "substantial" human

exposure finding in light of such

information, the Agency is not finalizing

testing requirements. (See Units VIID.,

E., and G.).

c. The Toxic Release Inventory (TRI).

ACC stated that it is unclear what role

the TRI data played in making the TSCA

section 4 findings in the proposed rule,

and that EPA should clarify how

environmental releases factor into a

determination of occupational dermal

exposures. ACC notes that TSCA section

4(a)(1)(B), makes no mention of

"release," but refers to whether a

substance "enters" the environment.

ACC asserts that in the context of TSCA

section 4, the word "enter" connotes

presence in the environment.

Accordingly, ACC argues that "release"

of a chemical in excess of one million

pounds per year is not necessarily

evidence that the compound "enters"

the environment in "substantial"

quantities. For example, if a substance

is dispersed, degraded, or reacted

rapidly upon release from

manufacturing and processing facilities

and is never present in significant

concentrations in air, water, or soil,

ACC asserts that it has not "entered" the

environment in "substantial" quantities.

Moreover, ACC contends that

environmental release, such as that

reported under section 313 of the

Emergency Planning and Community

Right-to-Know Act (EPCRA), does not

correlate well with dermal exposure in

the workplace. ACC notes that TRI

reports do not indicate the

concentrations of listed substances in

environmental media or the extent of

their distribution in the environment.

Accordingly, ACC asserts that the

release quantities reported under

section 313 of EPCRA are not an

adequate basis to support a TSCA

section 4(a)(1)(B)(i)(I) finding in the

context of this final rule, and they

should not be combined with other data

on the number of workers potentially

exposed to support such a finding.

Although EPA reviewed information

contained in the TRI database to

identify additional support material for

the test rule (Ref. 56), EPA did not find

it necessary to use TRI release data in

developing its exposure findings for this

final rule.

d. TSCA sections 8(a) and 8(d). API

commented that EPA does not present

results of data gathering in the 1993,

1994, and 1995 TSCA section 8(a) and

8(d) rules (Refs. 6-8) for the proposed

test rule chemicals. API objects to EPA's

issuing data gathering rules and then

not using the data gathered for the

purposes of the test rule, particularly

given that it is 10 years more current

than the data that EPA used to make its

TSCA section 4(a)(1)(B)(i)(II) finding

i.e., NOES data (Ref. 19).

Following the EPA Administrator's

receipt of the ITC Reports (Refs. 1, 2,

and 4) which designated 83 chemicals

for priority testing, the EPA's Office of

Pollution Prevention and Toxics (OPPT)

promulgated TSCA section 8(a)

Preliminary Assessment Information

Reporting (PAIR) and TSCA section 8(d)

Health and Safety Data rules (Refs. 6-8)

for the 83 chemicals designated for

testing by the ITC. The TSCA section

8(a) rule required manufacturers and

importers of chemicals designated for

testing by the ITC to submit production

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and exposure reports. The TSCA section

8(d) rule required manufacturers

(including importers), and processors of

chemicals designated for testing by the

ITC to submit unpublished health and

safety studies. These rules are

automatically promulgated by EPA

unless the ITC requests that EPA not do

SO.

The ITC reviews the TSCA section

8(a) PAIR reports, TSCA section 8(d)

studies, and "other information" that

become available after the ITC adds

chemicals to the Priority Testing List.

"Other information" includes TSCA

section 4(a) studies, TSCA section 8(c)

submissions, TSCA 8(e) "substantial

risk" notices, "For Your Information"

(FYI) submissions, ITC-FYI voluntary

submissions, unpublished data

submitted to U.S. Government

organizations represented on the ITC,

published papers, as well as use,

exposure, effects, and persistence data

that are voluntarily submitted to the ITC

by manufacturers, importers, processors,

and users of chemicals recommended by

the ITC. The submissions are indexed

and maintained by EPA. After the ITC

reviews this information it determines if

data needs should be revised, if

chemicals should be removed from the

Priority Testing List, or if

recommendations should be changed to

designations.

EPA disagrees with the comment that

data gathered under TSCA section 8(a)

and 8(d) rules were not considered in

preparing the proposal. In fact, the

proposed rule described the ITC's use of

the data from the TSCA section 8(d)

rules to support withdrawing its

designation for three chemicals. As

described in the proposal (Ref. 5, p.

31077), the ITC received dermal

absorption rate data for three chemicals

after EPA had promulgated TSCA

section 8(d) rules for these chemicals.

The ITC determined that the dermal

absorption rate data for these three

chemicals would meet OSHA's data

needs, and accordingly, the ITC

withdrew its designation for these three

chemicals: Methyl methacrylate and

diethyl phthalate in the 34th ITC Report

(Ref. 3, p. 35725), and cyclohexanone in

the 3 6 th ITC Report (Ref. 9, p. 42987).

Furthermore, the ITC's review of the

data gathered under TSCA sections 8(a)

and 8(d) for the 80 remaining designated

chemicals did not provide a sufficient

rationale for the ITC to make a

determination that the specified data

needs should be revised or that its

designation of chemicals for in vitro

dermal absorption rate testing should be

withdrawn and those chemicals

removed from its Priority Testing List.

The proposed rule also described

EPA's use of production data as a basis

for its decision to pursue rulemaking on

only 47 of the remaining 80 designated

chemicals because of their greater

production volumes, data which were

reported under the TSCA section 8(a)

rules (Ref. 5, p. 31077). Although EPA

considered the information on employee

exposure at manufacturing sites

provided in the TSCA section 8(a)

submissions, EPA also relied on NOES

data as they indicate what additional

employee exposure may occur at

processing facilities.

Finally, for those remaining 32

chemicals designated for in vitro dermal

absorption rate testing by the ITC which

are not addressed by this final rule, EPA

will present any determinations

regarding data gathered from TSCA

section 8(a) and 8(d), as well as any

other available data in any future

proposal for those chemicals.

2. "Data are insufficient," TSCA

4(a)(1)(B)(ii). DEPA (Ref. 21), the

Chlorobenzene Producers Association

(Ref. 31), and the Union Carbide

Corporation (Ref. 47) challenged the

Agency's finding that data are

insufficient to determine a dermal

absorption rate for ethyl ether, odichlorobenzene, and n-amyl acetate,

respectively. These commenters

provided studies to support their claims

that available data are sufficient to

determine dermal absorption rates. ACC

(Ref. 15) commented that isobutyl

alcohol and sec-butyl alcohol are

structurally similar to other alcohols for

which data have been generated and

that a structure-activity relationship

(SAR) approach could be used to predict

the dermal absorption rates of these two

chemicals. EPA reviewed the submitted

studies and agreed that the available

data are sufficient at this time to

adequately determine or predict dermal

absorption rates for these five

chemicals. See Unit VII.A. through C.

and F. for a description of the submitted

studies and the basis for EPA's decision

not to pursue rulemaking on these five

chemicals.

3. "Testing is necessary," TSCA

section 4(a)(1)(B)(iii). ACC commented

that EPA failed to demonstrate that the

proposed testing is necessary to develop

data to predict the effects of the

chemicals on human health and the

environment (Ref. 15). ACC also stated

that the Agency has provided no

information on the need for dermal

absorption data to "support chemical

risk assessments at EPA as well as at

other Federal agencies." As a general

matter, ACC believes that EPA should

not require testing when the Agency has

not determined how the data will be

used, and indeed cannot conclude that

testing is necessary in such a case.

Similarly, API and THFTF (Refs. 19 and

32) requested that EPA explain how the

Agency (or other Federal Agencies)

might use the dermal test data.

EPA believes it has adequately

demonstrated a need for the testing that

will be conducted under this final rule.

As discussed in the preamble to the

proposed rule (Ref. 5, pp. 31076-31078)

and in the 3 1 st, 3 2 nd, and 3 5 th ITC

Reports to the Administrator (Refs. 1, 2,

and 4, respectively), OSHA has found

that for many toxic substances to which

workers are exposed via multiple routes,

and specifically for the chemical

substances for which testing will be

required under this final rule, very little

knowledge exists of the contribution of

dermal exposure to the total body

burden of the substance.

Dermal absorption rate data for toxic

substances encountered in industrial

and occupational settings are

quantitative estimates of the rate

(amount per specified period of time) at

which substances pass through the

layers of the skin to enter the systemic

circulation. 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. In order to assign

a skin designation for a chemical

substance, OSHA requires dermal

absorption rate data. OSHA requested

(Refs. 1, 2, and 4) that the ITC help

identify chemicals which lack sufficient

data for OSHA to develop skin

designations and to use its authority to

recommend chemicals for priority

testing consideration by EPA to obtain

these data.

As described in the proposed rule, the

ITC performed searches for data relating

to the chemicals on the following

databases: RTECS (Registry of Toxic

Effects of Chemical Substances),

TOXLINE (TOXicology of 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 (Ref. 2, p. 38493).

Also as described in the proposed

rule, in addition to these literature

searches, the ITC reviewed data from

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TSCA section 8(a) and 8(d) rules (Refs.

6 through 8) which were promulgated

by EPA for the chemical substances

included in the 31st, 3 2 nd, and 3 5th ITC

Reports (Refs. 1, 2, and 4). These rules

required the reporting to EPA of certain

production, use and exposure-related

information, and unpublished health

and safety data concerning these

chemicals. For the 34 chemicals for

which in vitro dermal absorption rate

testing is required under this final rule,

there was either no dermal absorption

rate information available or available

data were insufficient to derive a dermal

absorption rate.

Testing of the 34 subject chemical

substances is necessary to develop

dermal absorption rate data. Dermal

absorption rate data derived from testing

these 34 chemical substances are

needed by OSHA to estimate the

amount of the chemical substance

absorbed after contact with the skin.

Only when dermal absorption is

considered along with inhalation

exposure data can a more complete and

accurate quantitative assessment of

body burden be estimated. Accurate

estimates of body burden are necessary

to develop assessments of risk to worker

health posed by exposures to toxic

substances in the workplace. This

testing is needed to determine if the

manufacturing, processing, or use of

these 34 chemical substances presents

an unreasonable risk of injury to human

health.

In addition to playing an important

role in assessing body burden, dermal

absorption rate data can generate useful

quantitative information for making

recommendations or decisions

concerning engineering controls or

employee use of personal protective

clothing to prevent exposure by the

dermal route. Such information, when

considered in conjunction with

toxicologic and health effects data, can

be used by industrial hygienists, other

occupational health professionals,

employers, and workers. Dermal

absorption information is useful for

hazard communication and right-toknow purposes, including Material

Safety Data Sheets, and product labels.

Additionally, dermal absorption rate

data for chemicals used or produced in

particular work sites are useful in

developing comprehensive safety and

health programs at those facilities.

OSHA standards, including skin

designations, are widely applied and

referenced. Local, State, and county

governments, and other Federal

Agencies rely on OSHA's occupational

standards, as do other national

governments. It is both appropriate and

necessary to require dermal absorption

rate testing of these industrial

chemicals.

Although OSHA is the primary

agency requesting the data that will be

developed under this final rule, OSHA

is not the only Federal Agency that will

use the data. NIOSH is also very

interested in method-related issues

associated with characterizing dermal

exposure and advancing improvements

in occupational exposure assessments.

EPA is also interested in data that

may be gathered on these chemicals.

The information obtained by the testing

required in this final rule may be used

to inform the Agency's decisionmaking

process by providing data which can be

used in a preliminary estimate of the

potential health risk of certain chemical

exposures. The 34 chemicals for which

testing is required under this final rule

are part of other ongoing Agency efforts.

For example, all 34 chemicals are

included in EPA's High Production

Volume (HPV) Initiative (http://

www.epa.gov/chemrtk.htm.) In addition,

EPA's Voluntary Children's Chemical

Evaluation Program (VCCEP) (Ref. 43) is

designed to provide data to enable the

public to better understand the potential

health risks to children associated with

certain chemical exposures. Four of the

34 chemicals are included in EPA's

VCCEP: Vinylidene chloride (Chemical

Abstract Service Registry Number (CAS

No.) 75-35-4); p-dichlorobenzene (CAS

No. 106-46-7); ethylene dichloride

(CAS No. 107-06-2); and chlorobenzene

(CAS No. 108-90-7). (See http://

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

While in vitro dermal absorption rate

data are not being developed under

either of these Agency efforts, the data

may be of benefit in preliminary risk

screening, which is the purpose of data

gathering in the HPV Initiative. Dermal

absorption rate data may also be

beneficial in further consideration of

chemicals to which children may be

exposed. Thus, EPA may use data

obtained under this test rule in

preliminary risk screenings to support

its HPV Initiative and VCCEP, or for

other Agency efforts to protect human

health and the environment from

unreasonable risks resulting from the

manufacture, processing, or use of

chemicals.

In summary, the data developed

under this test rule will assist the

Agency and others in evaluating these

chemical substances for potential health

or safety risk concerns. Although it is

not an independent basis for supporting

this final rule, as an additional benefit,

the data will be publicly available, and

thus will serve to further the Agency's

goal of identifying and controlling

human health and environmental risks

by providing greater knowledge to the

public.

C. Categories

ACC (Ref. 15) believes that EPA

should consider a category approach to

dermal absorption rate testing. In

reviewing the list of 79 ITC-designated

chemicals, ACC concludes that a great

majority can be grouped into categories

of similar chemical structure and that

selected chemicals from each category

could be tested for the purpose of

obtaining sufficient data that would

allow an accurate prediction of dermal

absorption rate for other members of the

structural group through a combination

of modeling and quantitative structure

activity relationship (QSAR) analysis.

ACC states that for the designated

chemicals, these categories would

include aliphatic alcohols, ketones,

aliphatic hydrocarbons, nitroaliphatics,

halogenated hydrocarbons, aliphatic

esters, aromatic hydrocarbons,

nitroaromatics, halogenated aromatics,

amides, aromatic amines, and phenols/

phenol ethers. ACC suggests that the

data generated from testing chemicals

within categories could then be

combined with existing data on other

category members (including those in

the larger group of 658 workplace

chemicals that were originally

nominated for testing by OSHA) to

attempt to correlate chemical structure

with dermal absorption rates.

EPA disagrees with the category

approach suggested by ACC as an

alternative to the approach proposed by

EPA for testing these chemicals. ACC

has not provided specifics on the

number of chemicals in each category

that would need to be tested and the

reason certain chemicals would be

representative so that reliable structure

activity predictions could be made.

Twelve different structural classes were

mentioned as potential categories by

ACC, but additional classes would

likely be needed to categorize within the

group of 79 chemicals that have been

designated for testing by the ITC. EPA

remains unconvinced that the approach

suggested by ACC will either minimize

the testing burden or more efficiently

develop data on the chemicals of

interest. However, the results from the

dermal absorption rate testing of the

chemicals in this final rule could, in

appropriate cases, provide additional

data for more thorough QSAR analysis

and better validated models for future

predictions.

D. Use of Calculated Kps to Screen and

Prioritize Chemicals

ACC commented that adequate data

already exist to "reasonably determine

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or predict adverse effects," according to

TSCA 4(a)(1)(B), for most if not all of the

chemicals included in the proposed test

rule (Ref. 15). It is ACC's understanding

that the ITC calculated dermal

penetration rates (Kps) for all of the

chemicals covered by the test rule. ACC

also notes that in 1992, EPA published

guidance for estimating Kps for organic

chemicals (see Ref. 42). The guidance

document included calculated Kps for

11 of the 47 chemicals proposed for

testing. In addition, ACC indicates that

EPA's 1992 methodology has been

largely validated, as the calculated Kps

closely approximate available

experimentally determined penetration

rates. As such, ACC asserts that Kps,

estimated using the suggested

methodology, would be of sufficient

quality to be used in screening-level

assessments to determine the likely

influence of dermal exposure on total

worker exposure (i.e., the need for

OSHA skin designations).

ACC states that EPA should consider

giving industry the option of using

calculated Kp values in lieu of testing,

and together with industry and OSHA,

assess the feasibility of using such data

before the final rule is promulgated.

ACC also states that, at a minimum, EPA

should consider using calculated Kp

data in order to screen and prioritize the

chemicals for the proposed dermal

absorption rate testing (Ref. 15). To do

this, ACC states that prior to requiring

testing the available calculated Kp data

should be used to screen chemicals for

their potential to cause systemic toxicity

as a result of dermal exposure by

assessing the potential contribution of

dermal exposures to total occupational

exposures, and that this assessment

should be used to prioritize testing

needs. ACC believes that the dermal

absorption rate testing should be

reserved for those chemicals for which

screening-level assessments indicate the

dermal pathway may be of concern.

ACC comments that neither OSHA nor

EPA has attempted to prioritize

chemicals using published EPA dermal

exposure assessment guidance,

including published estimated dermal

penetration rates.

EPA disagrees that adequate data exist

to "reasonably determine or predict

adverse effects," according to TSCA

4(a)(1)(B), for the chemicals included in

the final test rule. As an initial matter,

EPA believes that measured Kps (i.e.,

those determined through well designed

and conducted in vitro or in vivo testing

experiments) are generally more reliable

than calculated Kps, and measured Kps

are not available for the 34 chemicals

subject to this final rule. EPA further

believes that calculated Kp data may not

be sufficiently reliable to be used in lieu

of testing or in screening-level

assessments to prioritize testing needs

when the most relevant worker

exposures involve exposure to neat

compounds or compounds dissolved in

organic solvents. With respect to the

chemicals for which measured Kps are

presented in Table 5-8 in EPA's 1992

guidance document (Ref. 42), the Kps

were measured exclusively for the

chemicals when they were in aqueous

solutions; the table presents no

measured Kps for neat liquids or

chemicals in organic solvents, both of

which are generally expected to be more

relevant to the workplace (Ref. 62).

Thus, these data are not adequate to

provide the information needed for

OSHA's intended purpose (Ref. 62).

However, the in vitro testing required by

this final rule, in addition to developing

data needed to assess the potential risk

of the 34 subject chemicals, will expand

the existing data base and allow more

thorough comparisons of measured Kps

with calculated Kps relevant to

occupational exposures.

E. Comments on Proposed In Vitro Test

Standard

1. General. EPA received comments

supporting use of the proposed test

standard from several groups and

individuals (Refs. 25-30). Many of these

comments were similar in that they

supported the standard as a means of

gathering data without utilizing

laboratory animals.

EPA agrees that there are instances,

such as utilizing the test standard

articulated in this final rule, in which

sufficient data on the dermal absorption

rate of a chemical substance may be

gathered without using live laboratory

animals. EPA considers many factors in

relying upon specific test methods in its

proposals under TSCA section 4. In

specifying the standard for this

rulemaking, the ITC and EPA

considered the views of the public

commenters, Federal scientists, and

laboratories capable of conducting such

testing. The standard articulated in this

rulemaking makes efficient use of labor

and materials and can be performed in

a consistent, economical, and timely

manner by different laboratories. The

specification of the in vitro method as

the test standard for this final rule also

reflects EPA efforts to reduce the use of

animals, where appropriate, in its

testing programs. However, as noted

previously in Unit II.A., although this in

vitro method will satisfy OSHA's data

needs to support its skin designations,

EPA does not believe the method is an

adequate substitute for all dermal

absorption rate testing methods.

2. Technical. In addition to the

general comments received by EPA on

the proposed test standard, EPA also

received technical comments from ACC,

API, THFTF, DEPA, and a private

citizen. In general, commenters argue

that the proposed test standard was

unnecessarily rigid and that several

improvements would provide greater

flexibility and reduce the cost of testing.

EPA and OSHA agree with a number of

the changes recommended by ACC,

API, and THFTF, and have revised the

test standard accordingly, as described

in this unit.

a. ACC, API, and THFTF commented

that both static and flow-through in vitro

cells have been found acceptable in

estimating dermal penetration of

compounds. EPA agrees. Both static and

flow-through in vitro cells, as described

by the commenters and in the

international Organization for Economic

Co-operation and Development (OECD)

draft guidance document (Ref. 44), are

acceptable for estimating dermal

penetration of compounds (Ref. 62).

EPA has modified the test standard at

paragraph (h)(5)(iii) to read: "Either

static or flow-through diffusion cells

must be used in these studies."

b. EPA received a comment from a

private citizen (Ref. 33) who believes

that more scientifically valid dermal

absorption rates would be obtained by

using the technologically more

advanced flow-through type cells and

viable human skin instead of the older

method using static diffusion cells and

cadaver skin.

EPA agrees that in some instances it

may be preferable to utilize flowthrough cell types and viable human

skin to generate dermal absorption rate

data. Based on this comment and

similar comments by ACC, API, and

THFTF, EPA has modified the test

standard to allow the use of either flowthrough cells or static diffusion cells in

developing the data required under this

final rule (See § 799.5115(h)(5)(iii) of the

regulatory text). However, although EPA

agrees that utilizing viable human skin

could provide more reliable data, EPA is

requiring that human cadaver skin be

utilized for all testing required in this

action. EPA's rationale for this decision

is described in Unit III.E.2.o.ix.

c. ACC commented that heat

treatment to separate epidermis from

dermis is an acceptable alternative to

dermatome slicing for preparing

epidermal membranes. EPA agrees. The

use of a dermatome prepared skin

membrane of a thickness of 200 to 500

micrometers (um) is but one

scientifically acceptable method of

preparation. Peeling the epidermis from

the dermis after heat treatment at 600 C

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for 45 seconds, as recommended by

ACC (Ref. 15), or 1 to 2 minutes, as

specified in the draft OECD guidance

document (Ref. 44), is also a

scientifically accepted means of

preparing the test membrane (Ref. 62).

In response to this comment, EPA

specified a time range of 45 seconds to

2 minutes as the time for heat treatment

to include the two recommended

treatment times in the ACC and OECD

methods (45 seconds and 1 to 2

minutes, respectively). EPA modified

the required test standard

§ 799.5115(h)(5)(ii) to read:

A suitable membrane must be prepared

from skin either with a dermatome at a thickness of 200 to 500 micrometers (um), or with heat separation by treating the skin at

60' C for 45 seconds to 2 minutes after which

the epidermis can be peeled from the dermis.

d. ACC and THFTF commented that

the requirement that barrier properties

of human cadaver skin must be

pretested with a standard compound

such as tritiated water prior to

conducting the study should be

expanded to include suitable

alternatives to the use of tritiated water.

(See Howes, et al., Methods for

Assessing Absorption, in ECVAM

Workshop Report 13, J.H. Fentem, ed.,

European Center for the Validation of

Alternative Methods, 94-95 (Ispra, Italy

1996)). EPA agrees. Membrane integrity

checks conducted with transepidermal

water loss (TEWL) or electrical

resistance, as described by the

commenters and in the OECD guidance

document (Ref. 44), are acceptable

alternatives to dermal penetration of

tritiated water for the evaluation of

human cadaver skin integrity (Ref. 62).

EPA has modified the test standard in

§ 799.5115(h)(5)(i)(D) to read:

Prior to conducting an experiment with the

test substance, barrier properties of human

cadaver skin must be pretested either by:

(1) measuring the movement of a standard

compound such as tritiated water as

discussed, for example, in the reference in

§ 799.5115(h)(8)(i),

(2) determining an electrical resistance to an alternating current, at up to two volts, or (3) measuring trans-epidermal water loss

from the stratum corneum.

e. API, THFTF, and ACC commented

that human cadaver skin samples can be

stored frozen for periods longer than 2

weeks, as proposed by EPA. Frozen

storage, even for longer periods of time,

does not adversely affect the integrity of

the dermal barrier (see Ref. 45).

EPA agrees that for purposes of this

test rule, the human cadaver skin

samples can be stored frozen for periods

longer than 2 weeks. However, EPA

does not agree with ACC that skin

samples can be frozen for up to 18

months without changes in penetration

rates for standard compounds. EPA does

not believe that a single report (Ref. 45)

of acceptable skin penetration using a

single substance (water) with

membranes frozen for 466 days justifies

extending the standard storage period to

18 months. Most of the chemicals

designated for testing in this final rule

are organic chemicals with chemical

properties quite different from water.

EPA believes it is reasonable to extend

the maximum period of time during

which human cadaver skin samples can

be stored frozen (-20' C) to 3 months

(Ref. 62). This period of time is

consistent with OECD guidance (Ref.

44). In response to these comments, EPA

has modified the test standard in

§ 799.5115(h)(5)(ii) to read:

These epidermal membranes can be

stored frozen (-20' C) for up to 3

months, if necessary, if they are frozen

quickly and the barrier properties of the

samples are confirmed immediately

prior to commencement of the

experiment.

f. THFTF commented that EPA should

allow a longer, though unspecified,

amount of time for study completion.

THFTF cited three circumstances which

would make more time necessary:

* The practical ability of companies

to test multiple materials.

* The availability of contract

facilities to conduct the testing.

* The extra time needed to

synthesize radiolabeled material.

EPA agrees. Circumstances may arise

where the proposed 9 months would be

an insufficient amount of time to

complete testing. Therefore, EPA is

extending the period of time provided to

complete the required testing from 9

months to 13 months which EPA

believes should accommodate the

circumstances cited by THFTF.

g. ACC and THFTF noted that the test

standard requires a full balance sheet to

demonstrate recovery of radioactivity.

(A "full balance" refers to a

determination of where the radiolabel is

present at the conclusion of the

experiment (i.e., in the receptor fluid,

skin sample, test vehicle, or diffusion

cell) and that the recovery of

radioactivity in the test system is nearly

100%). Commenters stated that it is

unclear whether this requirement

applies to Kp studies, to studies to

measure short-term absorption rates, or

both. They assert that full balance sheets

are not necessary for studies in which

Kp is being determined. Additionally,

they commented that small losses of the

test article do not affect the outcome of

the studies because the study is, by

definition, conducted with an infinite

dose. (Infinite dose is the amount of test

preparation applied to the skin where a

maximum absorption rate is achieved

and maintained because such a volume

ensures continuous excess of test

preparation in the donor chamber.) (Ref.

44). Commenters requested that EPA

clarify how accounting for losses affects

Kp values.

EPA believes the test standard should

require that a full balance of

radioactivity be presented for both Kp

and short-term absorption rate studies,

as proposed. While EPA agrees that

small losses of test compound are

tolerable in the infinite dose design, it

is, nevertheless, considered good

laboratory procedure and does not

require excessive effort to assess

recovery in experiments using

radiolabeled compound (Ref. 62).

h. ACC and API (Refs. 15 and 19)

commented that the use of isopropyl

myristate (IPM) as a solvent in the

proposed test standard is inappropriate.

ACC and API stated that IPM, although

frequently used as a vehicle in various

dermatological formulations, has

questionable applicability in an

occupational environment to the

chemicals subject to this test rule. ACC

and API also stated that IPM may not

mimic workplace conditions and if

used, some corrective factor should be

applied to determine the rate of

percutaneous absorption.

EPA disagrees. IPM is an appropriate

all-purpose solvent for the rare

instances in which certain water

insoluble substances capable of

damaging skin are being tested (Ref. 62).

ACC has not provided evidence to

suggest that use of IPM will generate

distorted Kp values unrepresentative of

occupational settings. If such evidence

exists, EPA is willing to consider, via

the procedures specified at 40 CFR

790.55, in vitro percutaneous absorption

experiments with other vehicles for

specific test chemicals, if the test

sponsor demonstrates that their vehicle

is more representative of relevant

occupational exposure than IPM. EPA

will not speculate on what, if any,

adjustments might be made to Kp values

determined by the test standard in order

"to reflect realistic exposure scenarios"

or to account for differences in regional

absorption for skin.

i. ACC noted that the preamble to the

proposed rule indicates that the parent

chemical and its major metabolites are

to be detected in certain cases, and

requested clarification as to which of

the major metabolites of the chemicals

this requirement applies.

In the proposal to this action, EPA

mentioned that the measurement of

major metabolites in the receptor fluid

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is done when viable skin is used and

significant dermal metabolism is

anticipated. However, EPA did not

propose nor is EPA requiring that live

skin be used and skin viability be

maintained during performance of the

required tests. Therefore, EPA is also

not requiring measurement of major

metabolites in the receptor fluid. (See

Unit III.E.2.o.ix.).

j. ACC was unsure whether EPA's

proposed test standard would require

the use of 6 or 18 human cadaver skin

samples per chemical. EPA is requiring

a minimum of 18 human cadaver skin

samples per chemical. EPA has

modified the test standard at

§ 799.5115(h)(5)(i)(B) to clarify that data

must be obtained from a minimum of

six samples for each of the

determinations, i.e., Kp, 10-minute

short-term absorption rate, and 60-

minute short-term absorption rate. Also,

the samples used for the testing of a

given chemical must come from at least

three different human subjects, with two

samples from each subject being used

for each determination to allow for

biological variation among subjects. (See

§ 799.5115(h)(5)(i)(B) of the regulatory

text).

k. ACC commented that in

§ 799.5115(h)(5)(v) of the proposed

regulatory text it is unclear whether it

is necessary to demonstrate that the

concentration of a test substance in the

donor chamber has remained at greater

than 90% of its original value, or that

the concentration of the test substance

in the receptor fluid is less than 10% of

the initial test substance concentration

in the donor chamber. Similarly, THFTF

commented that § 799.5115(h)(5)(v) of

the proposed regulatory text should be

revised to state that physicochemical

data or experimental results should be

used to show that about 10 times the

concentration in the receptor fluid is

achievable under experimental

conditions. This will ensure that back

diffusion is not significant. See the

OECD Guideline 1999 (Ref. 44).

EPA has removed the language in

question in § 799.5115(h)(5)(v) of the

regulatory text, and has inserted related

text in the test standard at

§ 799.5115(h)(5)(iii) to read:

To ensure that an increase in concentration

of the test substance in the receptor fluid

does not alter penetration rate, the testing

laboratory must verify that the concentration

of the test substance in the receptor fluid is

less than 10% of the initial concentration in

the donor chamber.

This requirement applies to all

chemicals to be tested, including

hydrophobic chemicals.

1. ACC commented that there is some

confusion created by inconsistencies

between statements in the proposed rule

preamble and requirements in the

proposed test standard. ACC points out

that the preamble states that "the

measurement of a short-term absorption

rate is only required when a Kp cannot

be obtained using this standard,"

whereas § 799.5115(h)(5)(vii)(B) of the

proposed regulatory text states that

"Short-term absorption rates must be

determined for all chemicals." It is not

clear to ACC why short-term absorption

rates must be determined for all test

chemicals. ACC believes that if a

chemical affects the skin and a Kp value

cannot be determined, determining a Kp

rate is moot. Knowledge of the shortterm rate is not useful in determining

Kp values. API similarly commented

that it is not clear why determining the

short-term absorption rate for each test

rule chemical is necessary.

EPA is requiring the measurement of

short-term absorption rates for all

chemicals included in this final rule.

The panel of Federal scientists that

refined the method of Bronaugh and

Collier (Ref. 13) recommended that all

chemicals be tested for short-term

absorption in order to obtain in vitro

dermal absorption rate measurements

for brief dermal exposures that

commonly occur in occupational

settings, such as spills or splashes. EPA

believes that the panel's rationale

supporting the testing of all chemicals

for short-term absorption is reasonable.

m. ACC and THFTF commented that

the correct unit of measurement is

micrometers, not millimeters, as stated

in § 799.5115(h)(5)(ii) of the proposed

regulatory text. EPA agrees that the

correct unit of measurement is

micrometers, not millimeters. EPA has

corrected the test standard in

§ 799.5115(h)(5)(ii) of the regulatory text

to reflect this.

n. DEPA argues that the proposed test

standard is unacceptable for measuring

very volatile liquids, such as ethyl ether,

because efforts to prevent evaporation

would lead to unrealistically high

pressures, leakage of material from the

cell, damage to the skin membrane, and

other substantial technical difficulties.

EPA disagrees. DEPA did not provide

any evidence to suggest, nor is EPA

aware, that any such problems have ever

been reported. However, in those

instances where a test sponsor can

document that closed (i.e., occluded)

conditions lead to leakage of material or

damage to the skin membrane or similar

technical difficulties, in vitro

percutaneous dermal absorption rate

experiments with the skin surfaces

uncovered (unoccluded) may be

substituted, via the provisions in 40

CFR 790.55, if EPA agrees that

conducting the study in such a manner

is more technically feasible and

appropriate.

o. THFTF suggested numerous minor

changes to the test standard that EPA

believes go against either the

recommendations of the ITC expert

panel or TSCA Good Laboratory Practice

Standards (GLPS) at 40 CFR part 792,

and do not enhance the validity or

acceptability of the method. The

suggested changes include:

i. Removing the requirement that the

time elapsed between the death and

harvest of human skin specimens be

reported. EPA believes that all

experimental parameters should be

reported in accordance with TSCA

GLPS, and has retained this requirement

in the final rule.

ii. Removing the requirement that the

thickness of the skin membrane be

reported. EPA believes that all

experimental parameters should be

reported in accordance with TSCA

GLPS, and has retained this requirement

in the final rule.

iii. Requiring solids to be applied

directly to the skin and determining

percentage absorbed rather than

dissolving solids in a vehicle and

determining Kp. EPA disagrees.

Although there may be instances where

some of the test rule chemicals that are

solids at room temperature have dermal

exposures limited to the chemical in

solid form, it is also possible based on

common industrial practices, that there

will be occupational exposures to these

chemicals when they are dissolved or

suspended in an aqueous or solvent

medium. In addition, test solutions are

more suitable for determining Kp values

for chemicals that are solids at room

temperature. This is because solutions

in contact with the skin are uniform and

have known concentrations, which is

not necessarily the case with solids in

contact with skin (Ref. 63). Therefore,

EPA is generally requiring, as proposed,

that chemicals that are solids at room

temperature be dissolved in water. If the

chemical is hydrophobic and its

concentration in water is not high

enough to obtain a steady-state

absorption, the chemical must be

dissolved in isopropyl myristate.

However, in those instances where a test

sponsor can document that occupational

exposure is limited to a chemical in

solid form, development of

percutaneous dermal absorption rate

experiments with solid material may be

substituted, via the provisions

contained in 40 CFR 790.55, if EPA

agrees that conducting the study in such

a manner is more appropriate.

iv. Specifying fixed amounts of test

chemical, 10 milligrams per centimeter

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squared (mg/cm2) for dry solid or 10

microliters per centimeter squared (ul/

cm2) for liquids, be used in short-term

absorption rate experiments rather than

simply requiring the use of sufficient

test chemical to cover the skin and

reporting the quantity used. EPA

disagrees. It is not necessary to specify

that all substances be tested at the same

fixed volume per skin area. The size of

the diffusion chamber will partially

determine the volume of required test

material. The important issue is that

sufficient test chemical is available to

completely cover the skin. This is

because the absorption rate of a

chemical is reported per square

centimeter of skin, thus, it is necessary

to precisely ascertain the area of skin

contacted (Ref. 63).

v. Requiring three rather than four

absorption measurements for

determination of Kp. EPA disagrees. The

panel of Federal scientists that refined

the Bronaugh and Collier method (Ref.

13) for use as the test standard in this

final rule believes that three

measurements during the steady state

absorption period are inadequate to

accurately determine the Kp and that an

additional measurement is necessary for

this purpose (Ref. 62). As a result, EPA

is retaining the requirement in this final

rule that four absorption measurements

be taken for the determination of a Kp.

vi. Specifying that exposure time

should be up to 8 hours for estimating

dermal absorption of finite doses. EPA

disagrees. EPA does not believe that it

will be necessary to test each of the

chemicals for as long as 8 hours. In fact

in many instances, the study can be

completed in an hour. However, there

may be chemicals for which the study

could require up to 24 hours to

complete. Therefore, EPA believes that

specifying a study duration of up to 8

hours is inappropriate (Ref. 63).

However, if a test sponsor provides EPA

with documentation that an alternate

exposure time for a specific chemical is

more relevant than the exposure time

specified in this final rule, EPA may

provide for the substitution of other

exposure durations for the development

of in vitro percutaneous dermal

absorption rate experiments, via the

provisions contained in 40 CFR 790.55,

if EPA agrees that conducting the study

in such a manner is more appropriate.

vii. Allowing 1:1 ethanol:water to be

used as receptor fluid for hydrophobic

chemicals in addition to 6%

polyethylene glycol (PEG) in water. EPA

agrees that a 1:1 ratio of ethanol to water

is a suitable receptor fluid for

hydrophobic chemicals. However, EPA

is specifying that the PEG receptor

solvent at a concentration of 6% be used

for testing of hydrophobic chemicals.

EPA believes that specifying the use of

the single PEG receptor solvent for these

chemicals should ensure more uniform

and consistent results. Specifying that a

single receptor fluid be used for all

hydrophobic chemicals will enhance

the interpretability of test results for

these chemicals (Ref. 63).

viii. Not expressing short-term finite

absorption as a rate, i.e., micrograms per

hour per centimeter squared (ug/h/cm2),

because the true absorption rate is likely

to change over the time interval during

which absorption is being measured.

This is to be distinguished from Kp

determinations at steady state

conditions under which there is little

change in an absorption rate over time.

The commenter suggests that

cumulative amount absorbed per area,

i.e., micrograms per centimeter squared (ug/cm2) is a more appropriate way to

express the data.

EPA disagrees. EPA is aware of the

distinctions between a short-term

absorption rate measured under nonsteady state conditions and a Kp value

based on a steady state absorption rate.

(See § 799.5115(h)(5)(vii)(A) of the

regulatory text which states that an

infinite dose must be applied to the skin

to achieve a steady-state rate of

absorption for calculation of a Kp.)

Concerning the units to be used for

short-term absorption rates, EPA does

not agree that expressing short-term

absorption data as cumulative amount

per area rather than a rate provides any

interpretive advantage. A short-term

absorption rate represents the average

absorption over the time interval during

which it is measured. The true rate will

usually be greater than the average rate

early in the time interval and less than

the average rate later in the time

interval. A determination of cumulative

amount absorbed per unit of area

provides only end of the experiment

information rather than information

about the average rate during the course

of the test. EPA is requiring that the

results be expressed as a rate (ug/h/

cm2), rather than as an amount per area (ug/cm2) in order to be consistent with

rate units used to calculate Kp (Ref. 63).

ix. Allowing the use of human skin

obtained from cosmetic surgery (breast

and/or abdominal skin) as an alternative

to human cadaver skin for testing. In

refining the test method, the ITC and

EPA considered the collective views of

commenters, Federal scientists, and

laboratories capable of conducting such

testing. The test standard specifies the

use of human cadaver skin which EPA

believes makes efficient use of labor and

materials and can easily be performed

by many different laboratories. EPA

believes that the use of this human

cadaver skin will provide the desired

results in an economical and timely

manner. Although EPA agrees that a

method utilizing viable human skin

could provide more reliable Kps for

compounds in which skin metabolism

influences dermal penetration, EPA

does not believe that extensive

metabolism is likely, based on the

physical chemical properties, for the 34

chemicals subject to this final rule.

Based on the public comments received

and discussions with Federal scientists

and laboratories capable of conducting

such testing, EPA believes that

performing the study with skin from

cosmetic surgery could increase test

costs. As a result, the final test standard

requires the use of human cadaver skin.

x. Not requiring the use of

radiolabeled materials in the required

testing because many chemicals subject

to the final rule are unlikely to be

readily available in radiolabeled form.

Thus, it will take additional time to

prepare an adequate supply of

radiolabeled chemicals, potentially

adversely affecting industry's ability to

meet the regulatory deadlines

established for completing the testing

and submitting the test results.

EPA disagrees. This comment was in

reference to a single chemical

(tetrahydrofuran) and was the only

comment which indicated that

radiolabeled materials are not available

off-the-shelt EPA believes that

radiolabeled materials are likely to be

available for at least some of the other

chemicals included in this final rule. In

those instances where radiolabeled

materials are not currently available and

must be synthesized, EPA believes that

the additional amount of time provided

in this final rule (see Unit III.E.2.f.) is

sufficient both to prepare such materials

and complete the testing. Also,

radiolabeling is not an uncommon

analytical procedure and there are many

different laboratories (Ref. 46) in the

United States that are capable of

preparing radiolabeled materials.

Finally, the test itself is short-term,

generally taking no longer than 24 hours

to complete. The Agency has provided

test sponsors with 13 months to

complete the requirements established

under this final rule. To the extent that

a test sponsor does require additional

time to comply with the final rule, an

extension from EPA may be requested

utilizing the procedures at 40 CFR

790.55.

xi. Deleting the word "live" as used

in § 799.5115(h)(5)(i)(A) of the proposed

regulatory text which states "the most

accurate absorption rate data for

regulatory concerns related to human

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health would be obtained with live

human skin." In the course of

developing the final test rule, EPA

deleted this statement from the test

standard primarily for the reasons

presented in Unit III.E.2.o.ix.

F. Chemical Specific Comments

Chemical specific comments on ethyl

ether (CAS No. 60-29-7), isobutyl

alcohol (CAS No. 78-83-1), sec-butyl

alcohol (CAS No. 78-92-2), odichlorobenzene (CAS No. 95-50-1), pnitrotoluene (CAS No. 99-99-0), betachloroprene (CAS No. 126-99-8), namyl acetate (CAS No. 628-63-7), Nisopropylaniline (CAS No. 768-52-5),

and o-dinitrobenzene (CAS No. 528-29-

0) are addressed in Unit VII.

1. Acetonitrile. The Acetronitrile Task

Force commented that the total number

of workers associated with acetonitrile

(CAS No. 75-05-8) production in the

United States is on the order of 500 (Ref.

23). The Task Force believes that EPA

has included laboratory personnel in its

larger estimate as the Agency's figure far

exceeds the number of personnel

involved in manufacturing the

chemical. The Task Force notes that

analytical laboratory personnel are well

trained in safely handling hazardous

materials of this type, and that these

workers typically handle small volumes

of acetonitrile.

EPA reviewed the Acetonitrile Task

Force's estimate of the number of

workers exposed to acetonitrile at

manufacturing sites, but did not find

that the information provided sufficient

basis to conclude that there are not

substantial numbers of workers

potentially exposed to acetonitrile

during manufacturing, processing, and

use. Although EPA requested the

Acetonitrile Task Force to provide

documentation for its estimate of the

number of workers exposed to

acetonitrile, EPA did not receive any

further information from the Task Force

in support of its estimate. Also, the

NOES data used by EPA did include

laboratory personnel and EPA believes

it is appropriate to include them

because they are potentially exposed.

EPA believes that employee training

does not assure that exposure will not

occur and is no basis for the assertion

that laboratory employees will have no

exposure. EPA also believes that the

Task Force's estimate that 500

employees are potentially exposed may

be low if it did not include laboratory

personnel. Absent specific data

indicating otherwise, EPA believes the

NOES database should be used to

estimate worker exposure because it is

the most recent and comprehensive

source of this kind of information.

Therefore, EPA is requiring the testing

of acetonitrile to determine an in vitro

dermal absorption rate.

2. Carbon disulfide. ACC's Carbon

Disulfide Panel cited three studies

summarized in an Agency for Toxic

Substances and Disease Registry

(ATSDR) document (Toxicological

Profile for Carbon Disulfide (August

1996), p. 65-66) as a supporting

rationale for its assertion that sufficient

data exist for carbon disulfide (CAS No.

75-15-0) and that testing of carbon

disulfide is therefore, unnecessary (Ref.

39). One 30-year-old study estimated

dermal absorption by measuring very

small changes in carbon disulfide

solution before and after immersion of

the hand (T. Dutkiewicz and B.

Baranowska. 1967. The significance of

absorption of carbon disulfide through

the skin in the evaluation of exposure.

Toxicology of Carbon Disulfide.

Proceedings of a Symposium, Prague,

1966, pp. 50-51). EPA reviewed this

study and considered the methodology

flawed due to its indirect measurement

and potential failure to control for

volatilization. In the other two studies

cited by the Carbon Disulfide Panel

(A.E. Cohen, et al. 1958. Skin absorption

of carbon disulfide vapor in rabbits. I.

Associated changes in blood protein and

zinc. AMA Archives of Industrial

Health, 17:164-169; and H. Drexler, et

al. 1995. Carbon disulfide. 2.

Investigations on the uptake of CS 2 and

the excretion of its metabolite 2-

thiothiazolidine-4-carboxylic acid after

occupational exposure. International

Archives of Occupational

Environmental Health, 67:5-10), EPA

notes that a dermal absorption rate was

not determined and could not be

derived using the data gathered (Ref.

62).

The Carbon Disulfide Panel also cited

a dermal absorption rate calculated by

EPA for carbon disulfide in composted

sludge at a level of 0.59 milligrams per

kilogram (mg/kg) soil. EPA notes that

the dermal absorption rate was not

experimentally determined, but was

estimated from low environmental

levels in composted sludge rather than

the potentially higher worker exposure

to the undiluted liquid (Ref. 62). EPA

and OSHA do not consider the data

cited by the Carbon Disulfide Panel to

be sufficient to determine a useful and

reliable dermal absorption rate (Ref. 62).

The Carbon Disulfide Panel also cited

ATSDR's statement that "carbon

disulfide partitions immediately to the

air when released to the environment,

and does not therefore expose humans

to carbon disulfide through oral or

dermal contact" (Toxicological Profile

for Carbon Disulfide (August 1996), pp.

134-141). EPA notes that this statement

refers to dermal contact with

environmental media that had been

contaminated with carbon disulfide, not

to occupational exposure (Ref. 62). In

fact, the same document makes it clear

that the main way workers are exposed

to carbon disulfide is through the

inhalation of vapors and dermal contact

(Toxicological Profile for Carbon

Disulfide (August 1996), pp. 9 and 63).

Therefore, EPA is requiring the testing

of carbon disulfide to determine an in

vitro dermal absorption rate in this final

rule.

3. Naphthalene. ACC's Naphthalene

Panel commented that dermal toxicity

data generated under the Federal

Insecticide, Fungicide and Rodenticide

Act (FIFRA) makes the [proposed] test

rule unnecessary [with respect to

naphthalene] (Ref. 34). The Naphthalene

Panel comments summarize four

unpublished studies submitted under

FIFRA to support the registration of

naphthalene (CAS No. 91-20-3) as an

active ingredient in moth repellants.

One study reports the simulated amount

of naphthalene that would be deposited

on the hands of a homeowner handling

mothballs. However, the study did not

simulate occupational exposure and a

dermal absorption rate was not

measured. The other three studies were

toxicity investigations in which the test

compound was topically applied to

animals, but none of the studies

measured the rate of absorption. The

toxicity endpoints examined (mortality,

body/organ weights, hematology, gross

tissue examination, skin lesions) related

to only dermal irritation or advanced

systemic effects (Ref. 62). EPA and

OSHA do not consider the data cited by

the Naphthalene Panel to be sufficient

to determine a dermal absorption rate.

Therefore, EPA is requiring the testing

of naphthalene to determine an in vitro

dermal absorption rate in this final rule.

The Naphthalene Panel also

commented that EPA's proposed test

rule for certain Hazardous Air

Pollutants (Ref. 48) estimated that

23,092 workers are exposed to

naphthalene, yet, the proposal to this

final rule estimated that 112,695

workers are exposed to naphthalene. In

both proposals, EPA cited the NOES as

the basis for the estimates. The

Naphthalene Panel argued that neither

figure is correct and that an informal

survey of Naphthalene Panel members,

which comprise the major

manufacturers and importers of

naphthalene, showed that only

approximately 263 workers are

potentially exposed during naphthalene

manufacturing activities in the United

States. The Naphthalene Panel also

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argued that the NOES did not obtain

information on the frequency,

concentration, nor duration of worker

exposure to naphthalene, and therefore

EPA should not rely on the NOES to

find "substantial" or "significant"

worker exposure. Furthermore, although

the criteria stated in EPA's "B" policy

for finding "substantial" human

exposure may be met (Ref. 55, p. 28746),

the Naphthalene Panel believes NOES

does not show worker exposure to

naphthalene at levels that may cause

health concerns. Moreover, the

Naphthalene Panel indicated (without

providing further specific information)

that NOES does not reflect current

workplace conditions or naphthalene

exposure levels.

EPA acknowledges that different

estimates for the numbers of workers

exposed to naphthalene were cited in

the two proposed test rules indicated by

the commenter and that these estimates

were both from the NOES. The estimate

of 23,092 workers in the Hazardous Air

Pollutants proposal (Ref. 48) was based

on an interim report (Ref. 49) compiled

in March of 1989. The NOES database

was still being updated after that time

until June 1990, when the final update

was completed and trade name product

resolution ceased. The estimate of

112,695 potentially exposed workers

cited in the proposal to this final rule

was based on the final update of the

NOES. The figure is still the most upto-date NOES information EPA has

related to potential worker exposure to

naphthalene, which includes employee

exposure information on both

manufacturing and processing sites.

EPA considered the results of the

Naphthalene Panel's survey of its

members which found that 263 workers

were potentially exposed at their

manufacturing sites. However, that

number does not include an estimate of

the number of employees potentially

exposed to naphthalene at processing

sites.

As stated in Unit III.B.1.a., it is EPA's

belief that the "substantial" human

exposure finding in TSCA section

4(a)(1)(B)(i)(II) was intended to address

situations in which large numbers of

people, in this instance, large numbers

of workers, may be potentially exposed

to a chemical substance. EPA is not

required to make a finding that a

chemical substance would pose an

unreasonable risk of injury at some

hypothetical level of toxicity and

exposure in order to require testing

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

Chemical Manufacturers Association v.

EPA, 899 F.2d 344, 354-55 (5 th Cir.

1990). EPA has made the necessary

findings under TSCA section 4(a)(1)(B),

and EPA is therefore requiring the

testing of naphthalene to determine an

in vitro dermal absorption rate in this

final rule.

4. Biphenyl. The Biphenyl Work

Group (BWG) commented that biphenyl

(CAS No. 92-52-4) currently has two

primary uses. Both uses are in closed

systems either as a chemical

intermediate or as a component of

thermal fluids in highly specialized,

closed industrial heat transfer systems

(Ref. 20). The BWG states that previous

industrial uses of biphenyl in fruit

wrappings and as a dye carrier have

been phased out. Therefore they state

that any exposure to biphenyl is

unlikely. The BWG asserts that only

very low airborne exposures of biphenyl

are found in manufacturing facilities

and facilities using heat transfer fluids.

They state that, with reference to the

biphenyl occupational exposure limit of

200 parts per billion (ppb) (29 CFR

1910.1000(a), Table Z-1), occupational

airborne exposures are very low. The

BWG estimated that at present, no more

than 100 workers are involved in U.S.

biphenyl production (including

maintenance and laboratory personnel)

and fewer than 100 workers have

potential dermal exposure in heat

transfer uses.

EPA reviewed the BWG's estimate of

number of workers exposed to biphenyl,

but did not agree that the information

provided sufficient basis to conclude

that there are not substantial numbers of

workers potentially exposed to biphenyl

(Ref. 67). Although EPA requested the

BWG to provide documentation for its

estimate of the number of workers

exposed to biphenyl, EPA did not

receive any further information from the

BWG to support its estimate. Absent

specific data indicating otherwise, EPA

believes the NOES database should be

used to estimate worker exposure

because it is the most recent and

comprehensive source of this kind of

information. Therefore, EPA is requiring

the testing of biphenyl to determine an

in vitro dermal absorption rate.

5. p-Xylene, pentane, nonane, and nheptane. The Hydrocarbon Solvents

Panel states that EPA should be able to

reliably determine dermal absorption

rates for untested members of a

chemical category by comparing the

logarithms of their octanol-water

partition coefficients (log Kow) to those

of structurally similar category members

which have data on dermal absorption

rates (Ref. 37).

The Hydrocarbon Solvents Panel did

not provide sufficient detail to evaluate

its case for a category approach with

these four chemicals. The Hydrocarbon

Solvents Panel also did not provide any

data, nor is EPA aware of any data,

which would provide EPA with a

reliable estimate of the dermal

absorption rate for p-xylene, pentane,

nonane, and n-heptane. Therefore, EPA

is requiring testing of p-xylene, pentane,

nonane, and n-heptane.

6. p-Dichlorobenzene and

chlorobenzene. The Chlorobenzene

Producers Association cited a number of

acute dermal toxicity studies for pdichlorobenzene (CAS No.106-46-7)

and chlorobenzene (CAS No. 108-90-7)

to support its position that testing of

these chemicals is unnecessary (Ref. 31).

In addition, the Association cited EPA's

Dermal Exposure Assessment:

Principles and Applications (Ref. 42),

which described calculated Kps for

chlorobenzene and p-dichlorobenzene.

EPA disagrees with the comment that

testing chlorobenzene and pdichlorobenzene is unnecessary because

existing data on dermal toxicity or

calculated Kp values are sufficient to

reasonably predict the human health

effects of dermal exposure to these

chemicals. None of the studies cited by

the Chlorobenzene Producers

Association for chlorobenzene or pdichlorobenzene specifically measure

the dermal absorption rate of these

chemicals or provide data by which

dermal absorption rate can be

determined. The Kp values cited in the

1992 EPA Dermal Exposure Assessment

Report for the two chemicals are

estimated from empirical models and

not experimental data and, therefore, do

not meet OSHA needs. Therefore, EPA

is requiring testing of chlorobenzene

and p-dichlorobenzene to determine an

in vitro dermal absorption rate.

7. Tetrahydrofuran. THFTF

commented that quantitative dermal

absorption data for tetrahydrofuran

(CAS No. 109-99-9) are not needed by

OSHA to establish its skin designations

because OSHA has established skin

designations in the past without such

data. THFTF also commented that

"current MSDS warnings and product

stewardship efforts" are adequately

protective against harmful dermal

exposure to tetrahydrofuran in the

workplace (Ref. 32).

OSHA's current skin designations (29

CFR 1910.1000, Table Z-1) were

originally recommendations made by

the Threshold Limit Value (TLV)

Committee of the American Conference

of Governmental Industrial Hygienists

(ACGIH) in 1970 or prior to 1970, and

adopted without reservation by OSHA

in 1971. It is true that OSHA was able

to set the original "skin designations"

without quantitative dermal absorption

data. However, OSHA currently believes

that now and in the future when a skin

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designation is included in a standard

that limits occupational exposure, it

should be supported by a scientific

determination of the ability or speed of

the substance to be absorbed through

the skin after dermal contact. Because

methods are now available to provide

this information for human skin, OSHA

is seeking such testing.

Regarding "current MSDS warnings

and product stewardship efforts," EPA

agrees with THFTF that these vehicles

have been important in reducing worker

exposures, but they are only as good as

the scientific data on which they are

based. To ensure that the exposure

limits endorsed by MSDSs are

sufficiently protective, dermal

absorption rate information is needed to

better understand the contribution to

total exposure from the dermal route.

8. Dipropylene glycol methyl ether.

ACC's Propylene Glycol Ethers Panel

cited a number of acute, subacute, and

subchronic toxicity studies on

dipropylene glycol methyl ether (CAS

No. 34590-94-8), including studies via

the dermal route, to support the position

that testing this chemical is unnecessary

(Ref. 35). None of the studies described

in the Panel's comments specifically

measure the dermal absorption rate of

dipropylene glycol methyl ether nor can

dermal absorption rates be derived from

the data provided in those studies (Ref.

64). Therefore, EPA is requiring testing

of dipropylene glycol methyl ether to

determine an in vitro dermal absorption

rate.

G. Laboratory Capacity

API and THFTF commented that EPA

should consider ongoing demands for

laboratory services. API noted that

government and industry are currently

involved in many testing projects,

including the voluntary HPV Challenge

Program (Ref. 51). API suggested that

EPA evaluate laboratory capacity and

the combined demand that multiple

testing programs will create. Likewise,

THFTF warned of the possibility that

available laboratory expertise will be

overwhelmed by the testing required in

this final rule.

In specifying the in vitro dermal

absorption rate test standard for this

rulemaking, EPA concluded that the test

standard uses labor and materials

efficiently and can be performed in the

manner described by a variety of

laboratories. The Agency has conducted,

in addition to the analysis (Ref. 52)

described in the proposal to this

rulemaking (Ref. 5), two more recent

studies (Refs. 46 and 53) of laboratory

capacity associated with its other

chemical testing programs. These two

studies provided further support to

EPA's belief that there is sufficient

laboratory capacity to accommodate the

testing which is required by this final

rule.

The testing required under this

rulemaking is not very complicated. The

in vitro tests are of short duration,

generally taking no longer than 24 hours

to complete. The Agency has provided

test sponsors with 13 months to

complete the requirements established

under this final rule. EPA does not

believe that the relatively modest

amount of new testing required (a total

of three tests on each of 34 chemicals)

will exceed the available laboratory

capacity, particularly given the shortterm nature of the testing, the relatively

low cost of the tests, and the long time

period allowed for completing the

studies. Furthermore, based on the

analyses developed by EPA (Refs. 46,

52, and 53), EPA does not believe the

cumulative impacts associated with a

variety of its existing chemical testing

programs is likely to overwhelm the

available laboratory expertise as

suggested by API and THFTF.

H. Export Notification

Several issues raised in comments

relate to EPA's implementation of TSCA

section 12(b) (15 U.S.C. 2611(b)) export

notification requirements for chemicals

for which the submission of data is

required under TSCA section 4. Section

12(b) of TSCA states, in part, that any

person who exports or intends to export

to a foreign country a chemical

substance or mixture for which the

submission of data is required under

TSCA section 4 must notify the EPA

Administrator of such export or intent

to export. The Administrator in turn

will notify the government of the

importing country of EPA's regulatory

action with respect to the substance.

EPA's regulations implementing TSCA

section 12(b) are at 40 CFR part 707,

subpart D.

As a general matter, comments on the

scope of EPA's regulations under TSCA

section 12(b) are beyond the scope of

this rulemaking. However, three

comments associated with the

requirements under TSCA section 12(b)

do merit some discussion in this

preamble.

1. Application to chemical in any

form. ACC commented that EPA's

statement in its proposed rule that

export notification requirements would

apply to exporters of the chemical

substances subject to the final rule

regardless of the form (e.g., byproduct,

impurity) in which they are exported

constitutes an unprecedented expansion

of the TSCA section 12(b) notification

requirements.

EPA disagrees with this comment.

TSCA section 12(b) and the

implementing regulations at 40 CFR part

707 apply, in part, to the export or

intended export of a chemical substance

for which the submission of data is

required under TSCA section 4. Neither

the statutory nor the regulatory language

restricts this requirement to exporters of

chemical substances and mixtures in

particular forms, but instead generally

extends export notification

requirements to exporters of chemical

substances and mixtures without regard

to the form in which the chemical

substances and mixtures are being or

will be exported. The language in the

proposed rule and in this final rule are

not an expansion of the TSCA section

12(b) notification requirements. It is

noted, however, that the Agency did not

intend to change the current export

notification provisions affecting articles

which specify that no export

notification is required for articles,

except polychlorinated biphenyl

articles, unless required in specific

section 5, 6, or 7 rules. See 40 CFR

707.60(b).

2. Exporters subject to notification

requirement. ACC states that TSCA

section 12(b) limits the imposition of

export notification requirements related

to TSCA section 4 actions to persons

who actually have testing obligations

under TSCA section 4. EPA disagrees.

TSCA section 12(b)(1) and the

implementing regulations at 40 CFR part

707, subpart D apply to any person who

"exports or intends to export to a

foreign country a chemical substance or

mixture for which the submission of

data is required under [TSCA section

4]." (15 U.S.C. 2611(b)(1)). Under 40

CFR 707.65(a)(2)(ii), exporters must

notify EPA of their first export or

intended export to a particular country

when data are required under TSCA

section 4. EPA believes the language

unambiguously requires notification of

export by exporters of substances which

are the subject of TSCA section 4

actions regardless of whether the

exporters themselves are also subject to

the underlying TSCA section 4 rules.

Thus, exporters of a chemical substance

that is covered by data submission

requirements under TSCA section 4,

including persons who are not

otherwise subject to the TSCA section 4

rule itself as manufacturers and/or

processors, are subject to export

notification requirements under TSCA

section 12(b).

3. Information collection request

(ICR). API suggests that, because this

final rule will result in the requirement

that export notifications are submitted

to EPA for exports or intended exports

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of the substances covered by the final

rule, this is a new information

collection activity that requires OMB

review (Ref. 19). Furthermore, API

believes that EPA's cost estimates for

TSCA section 12(b) notification ignores

the biggest costs associated with export

notification, which are the internal

training and systems necessary to

identify exports against the export

notification list, tracking of what

notifications have already been

submitted and to what countries, and so

forth. These system costs are magnified

when business operations change (e.g.,

sales, acquisitions, and so forth) and

export notification systems need to be

adjusted accordingly.

EPA disagrees that this action is a

new collection of information requiring

OMB review. The information collection

activities related to export notification

under TSCA section 12(b)(1) are

approved under OMB control number

2070-0030 (EPA ICR No. 0795). The

methodologies, assumptions, and

estimates developed by EPA for

implementation of TSCA section 12(b)

have been reviewed under notice and

comment procedures during the

development of the ICR. EPA believes it

would be more appropriate to address

API's burden concerns in the context of

the ICR renewal process and therefore

will not respond to them in the context

of this final rule.

L Persons Required to Test

EPA stated in the proposed rule that

manufacturers and processors of the

chemical substances included in the

final rule would be subject to the final

rule. As in the past, under the

procedures set forth at 40 CFR part 790,

the persons subject to the final rule fall

into one of two groups, designated here

as Tier 1 and Tier 2. Persons in Tier 1

(those who would initially have to

comply with the final rule) would be

obligated either to: Submit to EPA

letters of intent to conduct testing,

conduct this testing, and submit the test

data to EPA or apply to and obtain from

EPA exemptions from testing. Persons

in Tier 2 (those who would not have to

initially comply with the final rule)

would not need to take any action

unless they are notified by EPA that

they are required to do so. Persons in

Tier 1 who obtain exemptions and

persons in Tier 2 would nonetheless be

subject to providing reimbursement to

persons who actually conduct the

testing.

Under 40 CFR part 790, EPA

traditionally has treated the following

persons as being in Tier 2 in TSCA

section 4(a) test rules:

* Processors (40 CFR 790.42(a)(2)).

* Manufacturers of less than 500 kg

(1,100 lbs) per year ("small-volume

manufacturers") (40 CFR 790.42(a)(4)).

* Manufacturers of small quantities

for research and development

("Research and Development (R&D)

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

In the proposed test rule, EPA

reconfigured the tiers in 40 CFR 790.42

by adding 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 also proposed that persons who

do not know or cannot reasonably

ascertain that they are manufacturing or

processing the chemical substances

included in the final rule would not be

subject to the final rule.

EPA's proposed approach to the

"persons required to test" portion of

this test rule was intended to clarify

subject entities' obligations under the

final rule and focus the testing

requirements initially on those entities

whom EPA believes would be most

likely to conduct testing (Ref. 5, pp.

31080-31082). EPA solicited comment

on this new approach to the "persons

required to test" portion of the test rule,

and received a number of comments.

After considering these comments, EPA

has decided to finalize the approach as

proposed, with the addition of

provisions related to the "subtiering" of

Tier 2 entities (see Ref. 5, pp. 31081-

31082, and Unit 111.1.3.).

1. General agreement with EPA's

"persons required to test" approach. All

the commenters on the new approach to

the "persons required to test" section of

the proposed rule agreed that

manufacturers of byproducts and

impurities and processors are

appropriately placed in Tier 2. These

commenters also agreed that the persons

EPA has put in Tier 1 are appropriately

placed in Tier 1. API stated that the

approach in the proposed rule

"appropriately focuses the rule, will

reduce burden and complexity, and will

facilitate timely accomplishment of

testing." API also agreed with the

Agency's rationales for tiering. AFPA

stated that the new "persons required to

test" approach would provide greater

certainty to people about what they

must do under the final rule.

ACC/O and ACC/KO additionally

agreed with the inclusion of

manufacturers of components of Class 2

substances in Tier 2. API agreed with

the exclusion of manufacturers or

processors who do not know or cannot

reasonably ascertain that they are

manufacturing or processing a test rule

substance.

2. EPA should retain the ability to

move Tier 2 groups to Tier 1. AFPA,

ACC/0, and ACC commented that EPA

should retain the flexibility to move

Tier 2 groups to Tier 1 on a case-by-case

basis. For example, if certain processing

activities cause special risks, then

processors could be brought into Tier 1

upfront in the proposed rule. If casespecific justifications exist for moving

Tier 2 entities to Tier 1, EPA should

state these justifications publicly.

EPA agrees that the Agency should

retain the ability to elevate Tier 2

entities to Tier 1 on a case-specific basis

in future test rules, and where the

Agency takes such an action, it will

state its justification(s) for doing so. For

example, if EPA is able to determine

that a chemical is manufactured solely

or primarily in the form of a byproduct,

EPA may propose to include persons

who manufacture that chemical as a byproduct in Tier 1, even though

byproduct manufacturers of other

chemicals listed in the same proposed

rule might otherwise be included in Tier

2. EPA does not agree, however, that

risk should be a basis for moving

entities from Tier 2 to Tier 1 (see Unit

111.1.4.).

EPA will continue to retain flexibility

over the status of entities covered by

Tier 2 consistent with EPA's flexibility

over the narrower group of entities that

have been included in Tier 2 in

previous test rules; processors, smallquantity manufacturers (i.e.,

manufacturers of less than 500 kg (1,100

lbs.) of a test rule chemical), and R&D

manufacturers (40 CFR 790.42(a)(2),

(a)(4), and (a)(5), respectively). In the

final rule which established the general

Tier 2 status of small-quantity and R&D

manufacturers and processors in test

rules, EPA stated that it "reserves the

right to differ from the general

procedure in this final rule by proposing

in a specific TSCA section 4 test rule to

require R&D manufacturers and/or

small-quantity manufacturers to submit

exemption applications" (Ref. 69, p.

18882). EPA will also continue to retain

the ability to elevate, on a case-specific

basis, R&D manufacturers, smallquantity manufacturers, and processors,

from Tier 2 to Tier 1. The concept that

flexibility can be built into test rules in

general is suggested by 40 CFR 790.2,

which states in part that "the

procedures for test rules are applicable

to each test rule in part 799 of this

chapter unless otherwise stated in

specific test rules in part 799 of this

chapter."

The Agency does not intend to

specifically identify all individual Tier

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2 entities. Rather, these entities would

self-identify via the submission of

letters of intent to test or exemption

applications. EPA expects that, similar

to the arrangements typically developed

when Tier 1 entities are under an

obligation to conduct testing, if Tier 2

entities are required to conduct testing,

it would generally be to their benefit to

reach agreement on who will actually

conduct the testing. The Agency

believes that it is unlikely that Tier 2

entities will be required to conduct

testing under this final test rule, a view

that is shared by ACC which stated that:

[AC] is not aware of any substance

covered by the testing proposal for which

there is likely to be no Tier 1 producer who comes forward [to conduct testing]. Indeed,

ACC is not aware of any instance in the past

where not a single person initially required

to comply with a test rule came forward,

such that EPA was required to notify other

persons of their obligations under the test

rule.

EPA intends to follow the procedures

laid out in the regulatory text if it

becomes necessary for EPA to call upon

persons in Tier 2 to conduct testing. In

other words, if EPA does not receive a

letter of intent to test from any Tier 1

entities, the Agency will publish a

Federal Register notice to alert Tier 2

entities to the requirement that they

submit letters of intent to test or

exemption applications.

3. Do not subdivide Tier 2 as a general

matter, instead subdivide Tier 2 on a

case-by-case basis. In the proposed rule,

EPA solicited comments on subdividing

Tier 2 to enable the Agency to prioritize

which persons in Tier 2 would be

required to perform testing, if needed.

ACC and API suggested that EPA should

not subdivide Tier 2 entities as a general

matter, for all test rules. They

commented that, if EPA considers

requiring Tier 2 entities to conduct

testing, the Agency should first

determine whether in fact there are no

Tier 1 entities, and reevaluate whether

the proposed testing is still necessary. If

Tier 1 manufacturers do not conduct

testing and the testing is still necessary,

then EPA should identify upfront which

persons in Tier 2 will be required to

test. ACC suggests that subtiering the

Tier 2 entities could be done on a caseby-case basis as needed, based on the

activities that give rise to the need for

testing. API argues that there is no basis

for distinguishing processors from the

various types of manufacturers included

in Tier 2, therefore there is no

justification for subtiering the Tier 2

entities.

Despite these comments, and

although EPA does not anticipate a need

for Tier 2 entities to conduct testing

under this final rule, EPA has decided

to subdivide the Tier 2 entities upfront

in this final rule (see Unit V.E.3.e.).

Subdividing Tier 2 upfront in test rules

may facilitate compliance by requiring

Tier 2 manufacturers, when required to

comply, to submit letters of intent to test

or exemption applications before

processors are called upon to do so. The

Agency's expectation is that it may

generally be less administratively

complex for manufacturers to conduct

the testing (including coordinating

efforts to determine who will actually

conduct testing) than for processors to

do so. This is because there are

generally fewer manufacturers (even as

byproducts, impurities, etc.) than

processors. EPA also believes that

testing costs have traditionally been

passed by manufacturers along to

processors, and has not received

evidence to the contrary. The Agency

does not believe at this time that it can

justify a subdivision of Tier 2 entities

other than between Tier 2

manufacturers and processors. For

example, EPA does not believe it would

be appropriate to base a subdivision on

the activities that give rise to the need

for testing (see, e.g., Unit 111.1. 7.).

4. Persons who solely manufacture

and/or process non-isolated

intermediates or naturally occurring

substances should not be subject to

rules under TSCA section 4.

Commenters provided several reasons

for completely exempting these

manufacturers from test rule coverage.

Certain commenters believe that these

entities have never been covered by test

rules in the past, and were specifically

excluded under the amended proposed

rule for hazardous air pollutant (HAP)

chemicals (Ref. 70). These commenters

pointed out that non-isolated

intermediates are exempt from

Premanufacture Notification (PMN), the

Inventory Update Rule (IUR), PAIR, and

general TSCA section 8(a) requirements.

One commenter indicated that

production of non-isolated

intermediates does not contribute to the

need for testing or present the same

concerns as do other substances

introduced into commerce, thus

manufacturers of non-isolated

intermediates should not be considered

subject to test rules. Another commenter

suggested that EPA has discretion under

TSCA section 4 to specify the classes of

persons subject to or exempt from a test

rule based on its rationale for requiring

testing. The comments suggest,

however, that where EPA has casespecific justification(s) (for example,

chemical-specific hazard or exposure

concerns related to the manufacture of

non-isolated intermediates or naturally

occurring substances are demonstrated),

these categories of manufacturers could

be appropriately included as subject to

a rule.

EPA does not believe that it would be

appropriate to fully exempt

manufacturers and processors of nonisolated intermediates and naturally

occurring substances from rules under

TSCA section 4. Instead, it is generally

appropriate to include such entities as

persons subject to TSCA section 4 test

rules because they are considered

manufacturers and processors under

TSCA and should be included among

those responsible for conducting testing

or providing fair and equitable

reimbursement to those who have

conducted testing. As a general matter,

however, EPA intends to place

manufacturers of non-isolated

intermediates and naturally occurring

substances in Tier 2 in test rules unless,

for example, the Agency believes such

manufacturers are responsible for a

disproportionate share of the production

volume of a test rule substance, in

which case EPA may place them in Tier

1.

The plain language of the statute

indicates that testing responsibilities

under TSCA section 4(b)(3)(B) are not

restricted to those who manufacture or

process a test rule chemical for limited

uses. Nor is EPA required to

demonstrate that particular types of

manufacturing or processing contribute

to the need for testing (i.e., that a

particular type of manufacture plays a

direct role in increasing risk, in the case

of a rule based on a TSCA section

4(a)(1)(A) finding, or in increasing

exposure, in the case of a rule based on

a TSCA section 4(a)(1)(B) finding). See

TSCA section 4(a). The statute indicates

that if EPA finds that the effects

associated with manufacture,

distribution in commerce, processing,

use, or disposal cannot reasonably be

determined or predicted (see TSCA

section 4(a)(1)(A)(ii) and 4(a)(1)(B)(ii)),

then manufacturers and/or processors

are generally required to test (see TSCA

section 4(b)(3)(B)). For example, the

final TSCA section 4 rule for biphenyl

(Ref. 77, pp. 37184-37185) stated that

TSCA section 4 testing responsibilities

are not restricted to only those who

manufacture or process a test rule

chemical for certain uses. Rather, the

persons who manufacture and/or

process (depending on the findings

made) a test rule chemical are generally

subject to the requirements of a final test

rule.

In order to ensure that reimbursement

of the entity(ies) conducting testing is

equitable, as a general matter, EPA does

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not believe that it is appropriate for

classes of entities otherwise potentially

subject to a rule to be dropped from all

rule-related obligations (with the

exception of persons who do not know

or cannot reasonably ascertain that they

manufacture or process a test rule

substance). There may be

circumstances, not present here, when it

would be equitable to exempt additional

entities from all test rule obligations, but

that determination would need to be

made on a case-by-case basis.

Persons who solely manufacture a

chemical in the form of a non-isolated

intermediate are generally exempt from

the TSCA section 5 PMN regulations (40

CFR 720.30(h)(8)), the TSCA section 8(a)

IUR (40 CFR 710.30(c)), the TSCA

section 8(a) PAIR (40 CFR 712.25(d)(2)),

and the general TSCA section 8(a)

regulations (40 CFR 704.5(d)) for

reasons particular to those regulations.

However, this does not preclude EPA

from treating these persons as

manufacturers of chemical substances

for purposes of other provisions of

TSCA, including TSCA section 4. For

example, EPA has stated that:

chemical substances [which are not

intentionally removed from the equipment in

which they were manufactured] are considered to be manufactured or processed

for a commercial purpose for the purposes of

section 8 of the Act.

(Ref. 71, p. 64588).

EPA believes it is generally appropriate

to include manufacturers of nonisolated intermediates and naturally

occurring substances as persons subject

to TSCA section 4 test rules in order to

ensure that reimbursement of those who

paid the costs of testing is equitable.

TSCA section 4(c)(3)(A) requires EPA to

order "fair and equitable"

reimbursement for test costs under the

Agency's reimbursement regulations.

Consistent with this purpose, EPA's

current "persons required to test"

approach distributes the burden of

testing and reimbursement equitably

among the persons who manufacture

and/or process test rule substances, with

an exemption for persons who do not

know or cannot reasonably ascertain

that they manufacture or process a test

rule substance.

Even if it were relevant to the

question of who is subject to a TSCA

section 4 test rule, EPA disagrees with

the assertion that the manufacture of

non-isolated intermediates does not

present any exposure-related concerns.

While the amount of chemical substance

released as a result of this type of

production may generally be expected

to be less than is released as a result of

other production, manufacturing or

processing a chemical as an

intermediate does not preclude

exposure to that chemical. See Office of

Solid Waste final test rule (Ref. 72, p.

22305). The production of non-isolated

intermediates presents concerns related

to acute exposures, from, e.g., spills,

leaks or transfers. In addition, as EPA

stated in the test rule for Office of Solid

Waste chemicals:

It is common experience that process waste

streams and reactor vessel residues will

contain "intermediates." In many instances,

these chemicals are released to the

environment as fugitive emissions, liquid or

solid wastes, and as unreacted feedstock

(impurities) in finished products. As such, "intermediates" typically exist as chemicals

to which there is potential for human

exposure.

(Ref. 72, p. 22305).

EPA believes that, although a person's

manufacture of a chemical in the form

of a non-isolated intermediate may

provide a lesser exposure concern than

the manufacture by other persons of the

same chemical in other forms, an

appropriate accounting of responsibility

is provided for in the determination of

fair and equitable reimbursement under

TSCA, when necessary. TSCA section

4(c)(3)(A) states that "all relevant

factors" must be considered by EPA in

the promulgation of rules for the

determination of reimbursement.

Pursuant to this provision, EPA

established mechanisms in its general

reimbursement rule to allow, as needed,

for the case-specific consideration of

factors such as exposure to a chemical

as a result of each subject person's

manufacturing and/or processing

activities. See 40 CFR 791.40(a).

Finally, manufacturers and processors

of non-isolated intermediates and

naturally occurring substances have

been subject to test rules in the past,

except as proposed in the amended

proposals for the testing of certain

hazardous air pollutants (HAPs). (Ref.

73, pp. 19696, 19699 and Ref. 70, pp.

67470, 67481). EPA is not adopting the

approach taken in the HAPs proposals

for this final rule and, as described in

Unit V.E., is taking a different position

here. TSCA section 4(a) requires testing

if findings have been made with regard

to certain activities involving chemical

substances or mixtures, and, under

TSCA section 4(b)(3)(B), manufacturers

and/or processors must conduct such

testing if findings have been made.

TSCA does not distinguish among

manufacturers and processors of

different forms/production types of a

chemical substance or mixture; all are

generally subject to the requirements of

TSCA section 4.

5. "Manufacturers of test substances

as components of Class 2 substances"

should not be included among the

persons subject to the final rule. In the

proposed rule, EPA stated that

manufacturers of test substances as

components of Class 2 substances

would be among those entities that

would be subject to the final rule, but

not initially required to comply (i.e.,

Tier 2). Class 2 substances are chemical

substances having a chemical

composition that cannot be represented

by a specific, complete chemical

structure diagram, because such a

substance generally contains two or

more different chemical species (not

including impurities) (see 40 CFR

720.45(a)(1)(i)). The Agency received a

number of comments debating the

appropriateness of the proposed Tier 2

status of manufacturers of components

of Class 2 substances.

a. ACC and API (Refs. 15 and 19)

commented that components of Class 2

substances are not considered under

TSCA to have been "manufactured" in

their own right unless they have been

separated from the Class 2 substance.

EPA disagrees. The Agency considers

a substance to be manufactured for

purposes of TSCA section 4 even if it is

manufactured as a component of

another chemical substance, and

regardless of its isolation from other

components of the combination. EPA

maintains that to be regulated under a

TSCA section 4 action (for which

findings have been made that allow EPA

to cover manufacturers), a manufacturer

must be a "manufacturer" as defined by

TSCA section 3, and manufacture a

chemical substance (or mixture) that is

subject to a test rule. Under TSCA

section 3(7):

[t]he term 'manufacture' means to import

into the Customs territory of the United

States (as defined in general headnote 2 of

the Tariff Schedules of the United States),

produce, or manufacture.

There are no limitations in the

definition of "manufacture" or in TSCA

section 4 to suggest that if a person

imports, produces, or manufactures a

test rule substance as part of a complex

combination of substances (i.e., a Class

2 substance), as opposed to an isolated

component, then the person is not a

manufacturer of that test rule substance.

Therefore, EPA considers a chemical

substance to be manufactured and

subject to coverage under TSCA section

4 even if it is manufactured as a

component of another chemical

substance, and regardless of its isolation

from other components of the

combination.

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EPA has used the term "Class 2

substance" as a way to describe variable

composition substances and complex

combinations of substances which can

separately be considered "chemical

substances" under TSCA. If a Class 2

substance is a chemical substance as

defined by section 3(2)(A) of TSCA,

then EPA may regulate the Class 2

substance itself. Neither the designation

of a particular substance as a Class 2

substance, nor EPA's authority to

regulate it as a distinct chemical

substance under the Act, changes the

fact that it may contain any number of

individual components which may also

be "chemical substances" as defined by

TSCA, and therefore, also be subject to

EPA's regulatory authority under the

Act. See, especially, TSCA section

3(2)(A), which identifies among the set

of substances that are "chemical

substances":

... any organic or inorganic substance of

a particular molecular identity, including any

combination of such substances occurring in

whole or in part as a result of a chemical

reaction or occurring in nature..

Thus, if appropriate TSCA section

4(a)(1) findings are made with regard to

manufacturing, distribution in

commerce, use, and/or disposal

activities for a chemical substance, then

manufacturers of that substance are

subject to the test rule according to

TSCA section 4(b)(3), regardless of

whether they manufacture the substance

as a component of a Class 2 substance

or in some other manner.

This is consistent with the position

set forth in the proposed

methylcyclopentane (MCP) and

commercial hexane test rule, stating

that:

.. manufacturers and processors of MCP

or commercial hexane who do so in the

course of producing gasoline or other motor

or heating fuels are subject to this rule

because the Agency's.. .findings are based on

the manufacture, processing, and use of MCP

and commercial hexane.

(Ref. 75, p. 17864-17865).

Gasoline is a Class 2 substance;

commercial hexane is a Class 2

component of gasoline and MCP is one

of its C6 isomer components. In the final

rule, EPA dropped the testing

requirement for MCP, but kept the

requirement for manufacturers of

commercial hexane, stating that "[i]f

health effects are positive for

commercial hexane, then EPA may

consider testing the C6 components

individually" (Ref. 76, pp. 3387-3388).

The Agency acknowledges that it has

not explicitly required persons who

manufacture test substances as

components of Class 2 substances to

comply with certain test rules in the

past. However, the Agency does believe

that these persons are manufacturers for

purposes of TSCA section 4, and hence

are subject to test rules where

appropriate findings are made under

TSCA sections 4(a)(1) and in accordance

with TSCA section 4(b)(3).

b. ACC (Ref. 15) commented that EPA

should clarify that it will continue to

treat Class 2 substances as distinct

chemical substances (with components

that are not regulated under the PMN

and other TSCA regulations) regardless

of the "persons required to test"

approaches taken in the OSHA dermal

and HAPs proposed rules.

The approach to the identification of

"persons required to test" that is being

adopted in this final test rule, and

which may be applied in other, future

test rules, is not intended to modify the

status of any chemical substance or

entity under other existing TSCA

regulations.

c. API (Ref. 19) commented that Tier

2 should include "manufacturers of

Class 2 substances that contain a test

rule substance" rather than

"manufacturers of components of Class

2 substances."

EPA disagrees with this suggested

change, and has not implemented it in

this final rule. The Agency believes it

has the authority under TSCA section 4

to regulate both manufacturers of Class

2 substances themselves (for example,

by requiring the testing of a Class 2

substance by manufacturers of that Class

2 substance) and manufacturers of test

substances as components of Class 2

substances (for example, by requiring

the testing of a chemical substance by

manufacturers that produce or import

that chemical substance as a component

of a Class 2 substance). In this final test

rule, persons in the former group are

included in Tier 1 of the grouping of

persons required to test, whereas

persons in the latter group are included

in Tier 2.

d. API (Ref. 19) commented that

manufacturers of Class 2 substances

should not be considered manufacturers

of the myriad components in the Class

2 substances unless they isolate a

component chemical, for a number of

reasons:

* Class 2 substances are distinct

chemical substances that are complex

and variable in composition, and the

Class 2 nomenclature is accurate and

useful for representing them.

* A Class 2 stream may contain a

substance as a component at some times

but not at others.

* Applying TSCA rules to Class 2

substances, rather than to their

individual components, does not

compromise protection of human health

and the environment.

* Because many components of

Class 2 substances do not add

commercial value to the products,

manufacturers of Class 2 substances

may not be aware of the presence of test

rule substances as components.

As stated in Unit III.I.5.a., EPA does

not agree that manufacturers of

components of Class 2 substances

should only be regulated under TSCA

section 4 if they isolate a component

substance that is subject to the test rule.

TSCA section 4(b)(3)(B) generally

provides the authority for the Agency to

include all manufacturers and/or

processors in the scope of test rules,

regardless of whether they isolate a test

rule substance from a Class 2 substance.

The inclusion of manufacturers of test

substances as components of Class 2

substances as persons subject to this

final test rule is not intended to reflect

any finding, or determination on the

part of EPA that there is a direct

connection between a specific

manufacturing activity and the potential

human health and/or environmental

hazards or risks that may be associated

with the test rule substance. See also

biphenyl final test rule (Ref. 77, pp.

37184-37185). Their inclusion as

persons subject to the rule is intended

to facilitate the fair and equitable

distribution of burden of testing and

reimbursement among the persons who

manufacture and process test rule

substances. For example, there may be

cases where large quantities of a

component of a Class 2 substance are

manufactured, such that the quantity of

a particular non-isolated component

(that is the subject of a TSCA section 4

test rule) is far greater than the quantity

of the same chemical substance

manufactured in isolated form by other

persons.

The concern that "because many

components of Class 2 substances do

not add commercial value to the

products, manufacturers of Class 2

substances may not be aware of the

presence of test rule substances as

components" is addressed by the

provision in this final test rule which

exempts persons from testing

obligations where their status as

manufacturers or processors of a

particular substance is not "known to or

reasonably ascertainable by" them.

In response to the comment noting

that persons may be aware of the

presence of a component of a Class 2

substance in a stream at some times but

not others, EPA believes that the

reimbursement process under TSCA

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section 4 and the implementing

regulations at 40 CFR part 791 address

the concern; under these provisions, if

utilized, persons would be required to

provide fair and equitable contributions

to test costs. The circumstance of a

substance that is known to be produced

at only certain times and not others may

be a consideration under that process.

e. API (Ref. 19) commented that

requiring manufacturers of Class 2

substances to test components of Class

2 substances that are also test

substances would be a departure from

past regulatory practice under TSCA

section 4.

EPA disagrees with the commenter's

statement that requiring manufacturers

of Class 2 substances to test components

that are also test substances that the

person manufactures would be a

departure from past regulatory practice

under TSCA section 4. EPA

acknowledges that in general its past

practice has not been to impose explicit

obligations under TSCA section 4 on

persons who manufacture a test

substance as a component of a Class 2

substance, unless that person isolates

the test substance from the Class 2

substance, although as discussed in Unit

III.I.5.a., there have been exceptions.

However, EPA did not explicitly

require testing by manufacturers of test

substances as components of Class 2

substances in certain previous test rules

in part because EPA had determined in

light of comments received on the

proposals that testing of the Class 2

substance itself would be more

appropriate than requiring testing on the

individual components of Class 2

substances. See the discussion of the

commercial hexane test rule (Ref. 76) in

Unit III.I.5.a. In another case, EPA

declined to require testing by

manufacturers of components of Class 2

substances in a final test rule because it

believed that it had provided

insufficient notice that such

manufacturers would be subject to the

test rule. See the clarification to the

final test rule covering certain "Office of

Water chemicals" (Ref. 78).

As discussed previously, however,

TSCA sections 4(c)(3)(A) and 4(c)(4)(A)

require EPA to order, where necessary,

"fair and equitable" reimbursement

from manufacturers and processors for

test costs incurred by those who are

developing, or who have submitted the

required test data. EPA believes that

fairness and equity can be best

facilitated by including within the pool

of persons from whom reimbursement

can potentially be sought all persons

who can be considered manufacturers or

processors under TSCA, subject to

narrow, clear exemptions. EPA believes

that persons who manufacture test

substances as components of Class 2

substances are "manufacturers" under

TSCA section 4, and generally should

not be exempt from inclusion among

those from whom reimbursement could

potentially be sought.

6. Create a de minimis exemption.

API suggests that EPA provide a de

minimis exemption like the exemption

provided in the amended proposed

HAPs rules (Ref. 70, pp. 67470, 67481

and Ref. 73, pp. 19696, 19699) for

manufacturers and processors who

solely manufacture or process test rule

chemicals in amounts less than 1% in

a mixture.

EPA is not adopting this suggestion in

this final rule. The final rule contains an

exemption from all responsibilities

associated with the final rule for

persons who do not know or cannot

reasonably ascertain that they

manufacture or process a test rule

substance. The final rule also provides

Tier 2 status to manufacturers of smallquantities (less than 500 kg/1,100 lb per

year or solely for R&D), those who

manufacture the test substance as a

byproduct, impurity, naturally

occurring substance, non-isolated

intermediate, or component of a Class 2

substance, and all processors. With

respect to manufacturers of small

quantities who manufacture the test

substance as a component of a Class 2

substance, the 500 kg/1,100 lb cutoff

applies to the manufacture of the test

substance, not the Class 2 substance.

EPA believes that these provisions

supply sufficient relief from test rule

requirements to lower volume

manufacturers and processors. These

groups are still subject to

reimbursement, however, and they

would also potentially be subject to

testing.

To the extent that persons who

manufacture a test rule chemical in

amounts less than 1% in a mixture are

not covered by the "known to or

reasonably ascertainable by" exemption,

and are not otherwise included in Tier

2, they are initially required to comply

with the final test rule. EPA believes

that Tier 1 status is appropriate for these

manufacturers, who produce or import

at least 500 kg/1,100 lb of a test rule

chemical each year, and who know (or

who could reasonably ascertain) that

they are manufacturing the chemical.

7. In determining who is responsible

for conducting testing, EPA should

consider the data needs the rule is

intended to fill and the role of specific

manufacturing and processing activities

in creating the exposure scenarios the

rule is intended to evaluate. ACC

commented that under TSCA section

4(b)(3)(B), responsibility for conducting

testing may be imposed on those

manufacturers and/or processors

engaged in activities for which EPA has

determined that available data and

experience are insufficient under TSCA

section 4(a). Thus, EPA's approach to

the "persons required to test" section in

a given test rule should depend on the

data needs the rule is intended to fill,

and the role of the specific

manufacturing and processing activities

in creating the particular human or

environmental exposure scenarios

which the rule is intended to evaluate.

TSCA does not limit the persons

subject to a test rule solely to specific

classes of manufacturers and/or

processors based on the data needs the

rule is intended to fill, or based on the

role of the specific manufacturing and

processing activities in creating

particular exposures. Rather, persons

who manufacture and/or process

(depending on the findings made) a test

rule chemical are generally subject to

the requirements of the test rule. TSCA

section 4(b)(3)(B). See also biphenyl

final test rule (Ref. 77, pp. 37184-

37185), which states that testing

responsibilities under TSCA section 4

are not restricted to only those who

manufacture or process a test rule

chemical for certain uses.

EPA agrees that certain limited

exemptions for persons who would

otherwise be subject to test rules may be

appropriate. However, in order to fully

exempt a group of persons otherwise

covered by a test rule from

responsibilities under the test rule,

EPA's view is that there must be an

adequate justification for doing so that

is consistent with the intent of the

statute, and that is applicable only to

those persons who it is proposing to

exempt, and not any others. For

example, in this final rule EPA is

exempting manufacturers and

processors who "do not know or cannot

reasonably ascertain" that they are

manufacturing or processing a test rule

chemical (see § 799.5115(b)(2) of the

regulatory text).

Exempting individual entities or

classes of entities from test rule

requirements on the basis of a

determination that their activities do not

relate in some direct way to the data

needs the rule is intended to fill or to

the exposure scenarios addressed by the

rule is not consistent with the intent of

the statute. Such exemptions would

likely result in the need for multiphase

rulemaking, and may in most cases not

be possible from a practical standpoint

given that EPA often would not have

enough information to make such

determinations. In addition, exempting

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certain individual entities or classes of

entities from test rule requirements

increases the potential that the burden

of testing and reimbursement would be

distributed in an inequitable manner

among the persons who manufacture

and process test rule substances. The

Agency believes it is appropriate to

generally require manufacturers and/or

processors of a test rule chemical to be

subject to a rule, rather than to fully

exempt individual manufacturers or

processors or certain classes of

manufacturers or processors from test

rule responsibilities.

8. Tier 2 should not be subject to

reimbursement. AFPA, API, ACC/O,

ACC/KO, and ACC commented that

subjecting Tier 2 entities to

reimbursement would, in large part,

eliminate the benefit associated with

having a tiered approach. EPA should

only require Tier 2 entities to reimburse

if they are required to conduct testing in

the absence of testing commitments

from Tier 1 entities.

EPA does not agree. In order to ensure

that test sponsors have the ability to

seek equitable reimbursement, Tier 2

entities are subject to reimbursement

regardless of whether the entities

included in Tier 1 complete the testing

required under the rule. EPA addressed

this issue in the context of its May 7,

1990 rule amending the testing

procedural rule by adding certain

groups of manufacturers to Tier 2. EPA

stated the following in the final rule:

Some commenters suggested that

chemicals produced solely for R&D [research

and development] purposes should be

excluded altogether from TSCA section 4

rules. Thus, rather than placing R&D

manufacturers in a "second tier," they would

not be legally subject unless specified in a particular test rule... EPA does not believe

that it should grant a total exemption to R&D

manufacturers. TSCA section 4 gives EPA

authority to require testing of chemicals

manufactured for R&D. Congress did not

exempt R&D manufacturers from being

subject to TSCA section 4, as in the case of

[rules under] sections 5 or 8 of TSCA. In this

rule, EPA has lifted the procedural burden

imposed on R&D manufacturers by test rules,

recognizing that test sponsors would rarely,

if ever, seek reimbursement from R&D

manufacturers. By maintaining legal

authority over R&D manufacturers, however,

EPA has reserved the right of a test sponsor

to seek reimbursement from all persons

legally subject to a test rule.

(Ref. 69, p. 18883).

The final rule amending the testing

procedural rule indicates that persons in

Tier 2 are subject to the requirement to

conduct testing under a test rule during

the period from the effective date of the

test rule to the end of the

reimbursement period, but will not

generally be required to submit letters of

intent to test or exemption applications

unless no other manufacturer of the

chemical submits a letter of intent to

test (Ref. 69, p. 18882). In addition,

persons in Tier 2 will be required to

submit letters of intent to test or

exemption applications 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

included in the test rule.

However, although Tier 2 entities are

subject to providing reimbursement,

EPA's experience under previous test

rules has been that persons who

manufacture the largest quantities of a

test rule substance have generally found

it to be in their best interest to develop

cost-sharing arrangements (which

typically do not include all persons

subject to providing reimbursement) to

cover the costs of testing, rather than

attempting to reach an agreement

regarding reimbursement among the

broader group made up of all persons

potentially subject to providing

reimbursement, or soliciting the

involvement of the Agency under the

reimbursement regulations at 40 CFR

part 791 in developing a reimbursement

arrangement. The development of such

private cost-sharing arrangements

appears to avoid possible difficulties

that could be associated with

coordinating the larger group of all

persons potentially subject to

reimbursement under a test rule, and

provides flexibility to the parties to the

arrangement because it may take any

form they choose. If the parties are

unable to agree upon a cost-sharing

arrangement, they may contact EPA and

initiate formal reimbursement

procedures under 40 CFR part 791.

These procedures would include all

persons subject to the rule, i.e., all

entities from both Tier 1 and Tier 2.

Other comments related to the issue

of reimbursement by Tier 2 entities are

listed below:

a. Persons not initially required to

comply with a test rule have never been

required to reimburse before (ACC,

ACC/O, API). EPA disagrees. Since

1990, EPA has included processors,

small-quantity manufacturers (i.e.,

manufacturers of less than 500 kg (1,100

lbs.) of a test rule chemical), and R&D

manufacturers in Tier 2 (See 40 CFR

790.42(a)(2), 40 CFR 790.42(a)(4), and

40 CFR 790.42(a)(5), respectively). As a

result, for the last decade these entities

have been considered subject to test

rules, but not initially required to

comply with the requirement that letters

of intent to test or exemption

applications be submitted to EPA.

Shifting groups of manufacturers and/or

processors to Tier 2 does not "change

the legal rights and obligations of

persons subject to TSCA section 4 test

rules, but would only eliminate some of

the paperwork burden associated with

compliance." (Ref. 69, p. 18882). In fact,

persons included in Tier 2 "would still

be subject to test rules (and export

notification requirements as specified in

TSCA section 12(b)), and would not be

exempt from reimbursement claims."

(Ref. 69, p. 18882).

The Agency shifted R&D and smallquantity manufacturers to Tier 2 based

on its recognition that, in practice, the

administrative costs of seeking

reimbursement from these entities

would likely exceed the reimbursement

that might be gained by their

participation. Therefore, the filing of

exemption applications by R&D and

small-quantity manufacturers serves no

practical purpose (i.e., there is no need

for them to self-identify by submitting

exemption applications). As discussed

in the proposed rule, processors were

originally put in Tier 2 for another

reason, i.e., manufacturers would not

likely seek reimbursement directly from

them, but would rather pass their costs

on to processors indirectly via the

market. In addition, the large numbers

of processors would create

administrative difficulties in making

testing decisions (Ref. 5, p. 31081).

Persons who are subject to a test rule,

but who are not initially required to

comply with the test rule have always

been potentially subject to

reimbursement under the formal

reimbursement procedures at 40 CFR

part 791. For example, see the interim

final rule amending the procedural rule

at 40 CFR part 790 (Ref. 74, p. 20654),

which states that, where manufacturers

and processors are subject to a test rule,

processors will automatically be given a

conditional exemption from the

requirement that letters of intent to test

or exemption applications be submitted

to EPA. This exemption is conditional

because it would be lifted if none of the

persons initially required to comply

with the rule (i.e., manufacturers)

submit a letter of intent to test. In

addition, processors may be required to

provide reimbursement directly to those

sponsoring the testing.

Although Tier 2 entities are subject to

reimbursement under this final test rule

and have been subject under past test

rules (see final rule amending the

testing procedural rule at 40 CFR part

790 (Ref. 69), EPA believes that they

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sharing arrangements that did not

require their involvement.

b. Tier 1 manufacturers should be

those persons who undertake the

activities that, for the most part, give

rise to the need for testing. As a result,

they should be the only ones

responsible for reimbursement. EPA

should identify upfront in a rule the

persons whose activities warrant their

contribution to the cost of testing. All of

these persons should be included in

Tier 1, and reimbursement should only

apply to those Tier 1 persons (unless

EPA has to resort to requiring entities in

Tier 2 to submit letters of intent to test/

exemption applications, and then Tier 2

would have to reimburse also) (API).

Entities in Tier 1 that obtain an

exemption in lieu of testing should

generally be the only persons

responsible for reimbursing. EPA should

retain flexibility to impose costs on Tier

2 entities when circumstances warrant

(ACC, ACC/O).

Under TSCA section 4(b)(3)(B), once

EPA has made the requisite regulatory

findings with respect to a chemical, "each person" who manufactures (or

intends to manufacture) and/or

processes (or intends to process) the

chemical "shall" be required to conduct

tests and submit data. Tier 2 entities

have "automatic conditional

exemptions" from the requirement that

they conduct testing (see

§ 799.5115(c)(3) of the regulatory text).

TSCA sections 4(c)(3) and 4(c)(4)

indicate that persons granted

exemptions from the requirement that

testing be conducted and data submitted

may be required to reimburse the costs

of testing under reimbursement

regulations promulgated by the Agency

if the persons subject to the rule do not

otherwise agree on the amount and

method of reimbursement. As a result,

although EPA initially exempts Tier 2

entities from requirements associated

with testing and the submission of data,

these entities are not exempt from the

requirement that they reimburse the

costs of testing.

EPA does not believe TSCA provides

flexibility to impose reimbursement

obligations on Tier 2 entities only when

it makes a determination that the

circumstances warrant it, or based on

determinations as to whether particular

manufacturers/processors or specific

groups of such entities undertake

activities that relate directly to the

rationale for requiring testing. TSCA

section 4 indicates that testing

responsibilities are not restricted to

those who manufacture or process a test

rule chemical in certain forms (such as

restricting the requirements of the rule

only to Tier 1 entities). Rather, persons

who manufacture and/or process

(depending on the findings made) a test

rule chemical are generally subject to

the requirements of a final test rule.

TSCA section 4(b)(3)(B). See also

biphenyl final test rule (Ref. 77, pp.

37184-37185). EPA has created an

exception to this general approach

solely for persons who do not know or

who cannot reasonably ascertain that

they manufacture and/or process a test

rule chemical.

c. Reimbursement requirements

should only apply to persons who may

be required to conduct tests and submit

data, i.e., Tier 1 (ACC).

All persons included in either Tier 1

or Tier 2 may be required to reimburse

the costs of testing because all

manufacturers and processors of the

chemical substances included in this

final test rule are subject to the final test

rule. As the reimbursement regulations

(promulgated pursuant to TSCA section

4(c)(3)(A)) provide: "[p]ersons subject to

a test rule have an obligation ... either

to test or to obtain an exemption and

pay reimbursement" (40 CFR 791.2(a)).

Tier 2 entities have automatic

conditional exemptions from testing

requirements, as discussed earlier.

Although Tier 2 entities are not as likely

to be required to conduct testing as Tier

1 entities, both groups are responsible

for reimbursing the person(s) who

actually conduct testing.

d. EPA's proposed extension of

reimbursement obligations to Tier 2

entities might complicate future efforts

to conduct testing under ECAs (ACC,

ACC/O).

EPA is not significantly changing the

status quo with regard to reimbursement

obligations established under previous

TSCA section 4 regulations. Persons in

Tier 2 under previous test rules have

been subject to providing

reimbursement. See the final rule

amending the testing procedural rule at

40 CFR part 790 (Ref. 69). The primary

effect of the approach to "persons

required to test" that was proposed and

is being adopted in this final rule is to

better focus the set of persons included

in Tier 1, and to expand and clarify the

set of persons included in Tier 2. EPA

is unaware of any reason to believe that

this approach to "persons required to

test" will make it more difficult to

develop ECAs.

e. EPA has said that manufacturers of

impurities, byproducts, and components

of Class 2 substances have not

historically participated in testing or

reimbursement. This is true of all other

entities included in Tier 2 under this

final rule. Extending reimbursement to

Tier 2 disregards this experience (ACC,

ACC/O).

EPA agrees that manufacturers of

impurities, byproducts, components of

Class 2 substances, and all other entities

included in Tier 2 under this final rule

have probably not historically

participated in testing or

reimbursement. However, the likely

reason they have not participated is

because the costs of testing under test

rules promulgated to date have been

contributed to by a smaller group of

entities subject to the rule (the larger

manufacturers of each test rule

substance), without the need for EPA's

involvement. EPA anticipates that

similar cost-sharing arrangements

would continue to occur under this final

rule and other rules using this revised

approach to "persons required to test,"

as they offer significant advantages to

the persons subject to the rule. If EPA

were to become involved in

reimbursement via the reimbursement

procedures at 40 CFR part 791, then all

Tier 1 and Tier 2 manufacturers and

processors would be included in those

proceedings.

9. EPA should clarify that the

approaches to the "persons required to

test" sections in the OSHA dermal and

HAPs proposed rules will not affect the

applicability of requirements under

TSCA programs outside those

implementing TSCA section 4. ACC/O

and ACC commented that where a

particular group (e.g., manufacturers of

non-commercial byproducts) is

currently exempt under certain TSCA

regulations, it should continue to be

exempt under those regulations

regardless of the "persons required to

test" approach taken in test rules under

TSCA section 4.

The approach the Agency takes in the

"persons required to test" portion of any

given test rule is not intended to affect

the status of persons under regulations

other than those relevant to the given

test rule.

J. Economic Impact Analysis

API noted that EPA's Economic

Impact Analysis estimates

administrative costs only for companies

initially required to comply with the

final test rule (companies in Tier 1). API

believes that this analysis is

inappropriate if EPA pursues imposing

reimbursement obligations on Tier 2

entities. If reimbursement obligations

are imposed on Tier 2 companies, API

asserts there will be associated

administrative, negotiation, and other

costs that EPA should include in its

analysis.

EPA disagrees with this comment.

Although Tier 2 entities are subject to

reimbursement, EPA's experience under

past test rules has been that Tier 1

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persons have found it to be in their best

interest to develop cost-sharing

arrangements among themselves to

cover the cost of testing. The

development of such private costsharing arrangements appears to avoid

possible difficulties that could be

associated with coordinating a larger

group of persons subject to

reimbursement under a test rule, and

provides maximum flexibility to the

parties to the arrangement. Because

manufacturers in Tier 1 have been

identified for each subject chemical (see

discussion of economic analysis in Unit

VIII. (Ref. 57)), EPA expects that at least

one such person will comply with the

testing requirements. EPA is not aware

of any circumstances in which Tier 1

entities have sought reimbursement

from Tier 2 entities either through

private agreements or by soliciting the

involvement of the Agency under the

reimbursement regulations at 40 CFR

part 791. Given this consistent

experience with previous TSCA testing

actions, EPA does not believe that there

will be any administrative, negotiation,

or any other costs associated with

seeking reimbursement from Tier 2

companies.

K. Definition of Small Business

In the preamble of the proposal to this

rule (Ref. 5), EPA requested comment on

whether the Agency should establish an

alternative 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.

SOCMA commented that the most

appropriate definition to use in

conducting small entity analyses for

TSCA section 4(a) test rules is the

employee-based definition established

by the U.S. Small Business

Administration (SBA), which for most

industries classifies firms as small based

on the number of employees in the firm.

The SBA set the numerical threshold for

what is considered small on an

industry-by-industry basis. SOCMA

believes that this definition provides

EPA with a straightforward and

appropriate distinction between small

and large companies that are closely

related to a company's total annual

sales. SOCMA also commented that it

does not believe that an alternative

approach, such as the small business

definition from TSCA section 8 would

be appropriate for conducting impact

analyses for TSCA section 4(a) test

rules. However, SOCMA believes if EPA

were to pursue a sales volume-based

definition of "small business," an

appropriate level would be, at a

minimum, a total annual sales of $100

million.

EPA did use SBA's size criteria,

which SOCMA stated it prefers, in its

economic analysis for this final rule.

Based on the SBA definitions, EPA has

concluded that there are no significant

impacts on small entities (Ref. 57).

Regarding SOCMA's second comment,

EPA notes that SOCMA did not provide

its reasoning as to why it considers a

definition of small business based on a

combination of revenue and production

volume inappropriate, nor did it

provide any research or justification as

to why an appropriate level of annual

sales used in such a definition should

be set at a minimum of $100 million.

As a more general matter, EPA

disagrees with SOCMA's position that

the SBA small business size standards

are the most appropriate to use in

analyzing the impacts of TSCA section

4 testing rules. The Regulatory

Flexibility Act (RFA) of 1980, as

amended by the Small Business

Regulatory Enforcement Act (SBREFA)

of 1996, requires that special

consideration be given to small

businesses affected by proposed Federal

regulations. The SBA size standards,

which are primarily intended to

determine whether a business entity is

eligible for government programs and

preferences reserved for small

businesses (13 CFR 121.101), "seek to

ensure that a concern that meets a

specific size standard is not dominant in

its field of operation." (13 CFR

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

Small Business Act. Section 601(3) of

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 for each industrial sector

using an employment threshold that

entities in that sector may not exceed to

be classified as small. (13 CFR 121.201).

RFA recognizes that it may be

appropriate at times to use an alternate

definition of small business for the

purpose of analyzing potential

regulatory impacts. As such, section

601(3) of RFA provides that an agency

may establish a different definition of

small business after consultation with

the SBA Office of Advocacy and after

notice and an opportunity for public

comment.

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

incurring significant costs or burdens.

Therefore, EPA is currently determining

what levels 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. EPA may

propose, following conclusion of its

analysis, that an alternative definition

based on sales be established in

accordance with section 601(3) of the

RFA.

IV. Findings

A. What is the Basis for EPA's Final

Rule to Test These Chemical

Substances?

As indicated in Unit II.B., in order to

promulgate a rule under TSCA section

4(a) requiring testing of chemical

substances or mixtures, EPA must make

certain findings for those chemical

substances or mixtures regarding either

hazard (TSCA section 4(a)(1)(A)(i)); or

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

EPA is requiring testing of the chemical

substances included in this final 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). The chemical

substances included in this final rule

are listed in § 799.5115(j) of the

regulatory text along with their CAS

numbers.

In EPA's policy for making findings

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

the "B" policy), "substantial

production" of a chemical substance or

mixture is generally interpreted to be

aggregate production (including import)

volume equaling or exceeding one

million pounds per year (Ref. 55, p.

28746). The general "B" policy

threshold for "substantial human

exposure" of workers is the exposure of

1,000 workers annually to a chemical

substance or mixture (Ref. 55, p. 28746).

See EPA's "B" policy (Ref. 55) for

further discussion on how EPA

generally makes decisions under TSCA

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

EPA finds that, under TSCA section

4(a)(1)(B)(i), each of the 34 chemical

substances included in this final rule is

produced in "substantial quantities"

and there is or may be "substantial

human exposure" to each chemical

substance (Ref. 56). In addition, under

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

believes that there are insufficient data

and experience to reasonably determine

or predict the effects of the manufacture,

processing, or use of these chemical

substances, or of any combination of

such activities, on human health or the

environment. In particular, as discussed

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in Unit IV.D., EPA has determined that

there are insufficient in vitro dermal

absorption rate data on these chemicals.

EPA also finds that testing of the 34

chemical substances is necessary to

develop such data (TSCA section

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

not identified any "additional factors"

as discussed in the "B" policy (Ref. 55,

p. 28746) to cause the Agency to use

decision making criteria other than the

general thresholds described in the

policy with respect to the chemicals

included in this final rule.

B. Are These Chemical Substances

Produced and/or Imported in

Substantial Quantities?

Each of the chemical substances

included in this final rule is produced

and/or imported in an amount equal to

or greater than one million pounds per

year (Ref. 57), based on information

gathered pursuant to the 2002 TSCA

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

IUR is the most recently available

compilation of TSCA Inventory data,

and is contained in the TSCA Chemical

Update System. 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) (Ref. 55).

C. Are a Substantial Number of Workers

Exposed to These Chemicals?

EPA finds that the manufacture,

processing, and use of the chemical

substances included in this action result

or may result in exposure to a

substantial number of workers. These

chemical substances are used in a wide

variety of industrial applications which

result in potential exposures to workers,

as described in the exposure support

document for this final rule (Ref. 56).

EPA defines human exposure as the

contact with a chemical or agent at the

visible exterior of a person (i.e., skin

and openings into the body such as

mouth and nostrils) (Ref. 58, p. 22891).

Worker exposure is the human exposure

to a chemical or agent that occurs while

a person is working. Worker exposure

may have various causes, with chemical

releases being a common cause of

exposure. Chemical manufacturing and

processing plants can release chemicals

from pumps as fugitive emissions, from

reactor and condenser vents as stack

emissions, in the form of a vapor and/

or as a particulate. Diffusion and air

currents may carry a chemical

throughout the plant and workers may

breathe air containing the chemical,

resulting in exposures. Certain human

activities such as manually transferring

a chemical from one container to

another may also cause exposures.

Each of the chemicals in this final

rule was identified in the NOES as

having a total worker exposure of 1,000

workers or more (Ref. 56). EPA believes

that an exposure of 1,000 workers or

more to a chemical substance is or may

be "substantial" as that term is used

with reference to "human exposure" in

TSCA section 4(a)(1)(B)(i) (Ref. 55).

D. Do Sufficient Data Exist for These

Chemical Substances?

As discussed in this preamble, dermal

absorption rate is an important factor in

ascertaining the health effects of the 34

chemicals in this final rule. EPA has

determined that for the 34 chemicals for

which in vitro dermal absorption rate

testing is required under this final rule,

there is either no dermal absorption rate

information available or where there is

some information, these data are

insufficient to estimate dermal

absorption rate. Therefore, existing data

are insufficient to reasonably determine

or predict the human health effects that

may result from dermal exposures to the

chemical substances included in this

final rule during the 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 II.A.

E. Is Testing Necessary for These

Chemical Substances?

EPA believes that the testing of these

34 subject chemical substances is

necessary to determine if the

manufacturing, processing, or use of

these chemical substances may present

an unreasonable risk of injury to human

health. In particular, the testing required

by this final rule will provide dermal

absorption rate data which OSHA can

consider together with toxicity data to

evaluate the need for skin designations

which are used to protect against

potential health risks associated with

exposures to these chemicals in the

workplace. See Unit III.B.3. for a

detailed description of this and other

data needs that will be filled by the

testing required by this final rule.

V. Final Rule

A. What Testing is Required by this

Action?

EPA is specifying testing and

reporting requirements for the chemical

substances listed in Table 2 in

§ 799.5115(j) of the regulatory text

according to the in vitro dermal

absorption rate test standard set forth in

§ 799.5115(h) of the regulatory text.

The test standard that will be used

under this final rule was refined as

described in Unit III.B. of the proposed

rule (Ref. 5). In addition, certain

modifications which added flexibility to

the test standard have been made in

response to comments submitted to EPA

and addressed in Unit III.E.2. of this

final rule.

B. When Will the Testing Imposed by

this Final Rule Begin?

Once this final rule is effective, which

will be 30 days after its publication in

the Federal Register, the required

testing must be initiated at a time

sufficient to allow the final report to be

submitted by the deadline indicated in

§ 799.5115(i) of the regulatory text, i.e.,

13 months after the effective date of the

final rule.

C. How Must the Studies Required

Under this Test Rule be Conducted?

Persons required to comply with this

final rule must conduct the necessary

testing in accordance with the testing

and reporting requirements described in

the regulatory text, and with the TSCA

Good Laboratory Practice Standards

(GLPS) (40 CFR part 792). Clarification

was provided in the test standard

concerning how data should be

reported. The clarification indicates that

means and standard deviations must be

used when reporting the required

determinations. Although the test

standard in the proposed rule would

have required three separate

determinations for each chemical (i.e.,

one each for Kp, 10-minute, and 60-

minute short-term dermal absorption

rates), reporting each as a mean and

standard deviation was not specified.

However, good scientific practice would

suggest that the determinations be

reported in this way, and EPA believes

that this clarification does not

substantively change the reporting

requirements or their burden and costs

(Ref. 57).

D. What Substances Will be Tested

Under this Final Rule?

The "Class 1" chemical substances

listed in Table 2 in § 799.5115(j) of the

regulatory text (i.e., 32 of the 34

chemical substances included in this

final rule) must be tested at a purity of

at least 99%. The term Class 1 chemical

substance refers to a chemical substance

having a chemical composition that

consists of a single chemical species

(not including impurities) that can be

represented by a specific, complete

structure diagram. In those instances in

which the test sponsor(s) believes that a

99% level of purity is unattainable for

a given chemical, the sponsor may

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request a modification under the

procedures described in 40 CFR 790.55.

For the "Class 2" chemical substances

listed in Table 2 in § 799.5115(j) of the

regulatory text (i.e., 2 of the 34 chemical

substances included in this final rule),

EPA is requiring that the substance to be

tested be any representative form of the

chemical substance.

In providing a different approach for

identifying the substance to be tested

with regard to Class 2 substances, EPA

recognizes two characteristics which

further distinguish Class 2 from Class 1

chemical substances. First, unlike Class

1 substances, knowledge of the

composition of commercial Class 2

substances can vary in quality and

specificity from substance to substance.

The composition of the chemical

species which comprise a Class 2

substance may be:

* Well characterized in terms of

molecular formulae, structural

diagrams, and compositional

percentages of all species present (for

example, methyl phenol);

* Less well-characterized, for

example, characterized only by

molecular formulae, nonspecific

structural diagrams, and/or by

incomplete or unknown compositional

percentages of the species present (for

example C12 -C 14 tert-alkyl amines); or

* Poorly characterized because all

that is known is the identity of only

some of the chemical species present

and their percentages of composition, or

of only the feedstock and method used

to manufacture the substance (for

example, nut shell liquors of cashews).

Second, the composition of some

Class 2 substances may vary from one

manufacturer to another, or, for a single

manufacturer, from production run to

production run, because of small

variations in feedstock, manufacturing

methods, or other production variables.

A "Class 2" designation most frequently

applies to a substance consisting of a

combination of different chemical

species that are either structurally

similar or related by being formed

together when a certain chemical

reaction or process is carried out on a

certain chemical feedstock. Small

variations in the feedstock or in

chemical production methods or

conditions can account for the types of

small variations in composition

typically allowable within a given Class

2 Inventory listing. By contrast, a "Class

1" designation generally applies to a

substance which is an individual

chemical whose only variables are its

impurities and byproducts.

EPA believes that, for purposes of this

final rule which would require the

determination of a Kp and two in vitro

short-term dermal absorption rates, the

testing of any representative form of a

subject Class 2 substance would be

relevant to a determination of whether

the chemical substance would or would

not present an unreasonable risk to

human health. However, EPA would

encourage the selection of

representative forms of the test

substances that meet industry or

consensus standards, where they exist.

In accordance with TSCA GLPS at 40

CFR part 792, the final study report

must include test substance

identification information, including

name, CAS No., strength, purity, and

composition, or other appropriate

characteristics. (See 40 CFR 792.185).

E. Am I Required to Test Under this

Final Rule?

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

finds that there are insufficient data and

experience to reasonably determine or

predict health effects resulting from the

manufacture, processing, or use of the

chemical substances listed in this

rulemaking. As a result, under TSCA

section 4(b)(3)(B), manufacturers and

processors of these substances are

subject to the final rule with regard to

those listed chemicals which they

manufacture or process.

1. Am I subject to this final rule? You

are subject to this final 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 Table 2 in

§ 799.5115(j) of the regulatory text

during the time period discussed in

Unit V.E.2. 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 an unreasonable

burden), you are not subject to the final

rule for that listed substance.

2. When will my manufacture or

processing (or my intent to do so) cause

me to be subject to this final rule? You

are subject to this final rule if you

manufacture or process, or intend to

manufacture or process, a substance

listed in Table 2 in § 799.5115(j) of the

regulatory text at any time from the

effective date of the final test rule to the

end of the test cost reimbursement

period.

The term reimbursement period is

defined at 40 CFR 791.3(h) and may

vary in length for each substance to be

tested under a final TSCA section 4(a)

test rule, depending on what testing is

required and when testing is completed.

(See Unit V.E.4.).

3. Will I be required to test if I am

subject to the final rule? It depends on

the nature of your activities. All persons

who are subject to this TSCA section

4(a) test rule, which, unless otherwise

noted in the regulatory text,

incorporates EPA's generic procedures

applicable to TSCA section 4(a) test

rules (contained within 40 CFR part

790), fall into one of two groups,

designated here as Tier 1 and Tier 2.

Persons in Tier 1 (those who must

initially comply with the final rule)

must either: Submit to EPA letters of

intent to conduct testing, conduct this

testing, and submit the test data to EPA

or apply to and obtain from EPA

exemptions from testing. Persons in Tier

2 (those who do not have to initially

comply with the final rule) need not

take any action unless they are notified

by EPA that they are required to do so,

as described in Unit V.E.3.d. Note that

persons in Tier 1 who obtain

exemptions and persons in Tier 2 are

nonetheless subject to providing

reimbursement to persons who actually

conduct the testing, as described in Unit

V.E.4.

a. Who is in Tier i and Tier 2? All

persons subject to this final rule are

considered to be in Tier 1 unless they

fall within Tier 2. The following table

describes who is in Tier 1 and Tier 2.

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

b. When is it appropriate for a person

required to comply with the rule 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)). You can find procedures

relating to exemptions in 40 CFR 790.80

through 790.99, and § 799.5115(c)(2),

(c)(5), (c)(7), and (c)(11) of the regulatory

text. In this final rule, EPA will not

require the submission of 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. Therefore,

40 CFR 790.82(e)(1) and 40 CFR 790.85

do not apply to this final test rule.

c. What will happen if I submit an

exemption application? EPA believes

that requiring the collection of

duplicative data is unnecessarily

burdensome. As a result, if EPA receives

a letter of intent to test from another

source or has received (or expects to

receive) the test data that are required

under this final rule, the Agency will

conditionally approve your exemption

application under 40 CFR 790.87. The

Agency will terminate conditional

exemptions if a problem occurs with the

initiation, conduct, or completion of the

required testing, or with the submission

of the required data to EPA. EPA may

then require you to submit a letter of

intent to test or an exemption

application. See 40 CFR 790.93 and

§ 799.5115(c)(10) of the regulatory text.

Persons who obtain exemptions or

receive them automatically will

nonetheless be subject to providing

reimbursement to persons who actually

conduct the testing, as described in Unit

V.E.4.

d. What are my obligations if I am in

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

subject to the final rule and you are

responsible for providing

reimbursement to persons in Tier 1, as

described in Unit V.E.4. You are

considered to have an automatic

conditional exemption. You do not need

to submit a letter of intent to test or an

exemption application 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 letter of

intent to test or an exemption

application. See 40 CFR 790.93 and

§ 799.5115(c)(10) of the regulatory text.

In addition, you will need to submit a

letter of intent to test or an exemption

application if:

* No manufacturer in Tier 1 has

notified EPA of its intent to conduct

testing.

* EPA has published a Federal

Register document directing persons in

Tier 2 to submit to EPA letters of intent

to conduct testing or exemption

applications. (See § 799.5115(c)(4),

(c)(5), (c)(6), and (c)(7) of the regulatory

text.)

The Agency will 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 final rule.

e. Subdivision of Tier 2 entities. In the

proposed rule that preceded this final

rule, EPA solicited comment on the

issue of whether the Agency should

prioritize which persons in Tier 2

would be required to perform testing, if

needed (Ref. 5, p. 31082). Specifically,

the Agency suggested that it could

subdivide Tier 2 entities into:

* Tier 2A. Tier 2 manufacturers, i.e.,

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 non-isolated

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.

* Tier 2B. Tier 2 processors, i.e.,

those who process, or intend to process,

a test rule substance (in any form). The

terms "process" and "processor" are

defined by TSCA section 3(10) and (11),

respectively.

After consideration of comments

received by the Agency (see Unit

111.1.3.), EPA has decided that it will

subdivide Tier 2 in the suggested

manner, and the final rule regulatory

text is structured to reflect this. If the

Agency needs testing from persons in

Tier 2, EPA will seek testing from

persons in Tier 2A before proceeding to

Tier 2B. It is appropriate to require

manufacturers in Tier 2A to submit

letters of intent to test or exemption

applications before processors are called

upon because the Agency believes that

testing costs are traditionally passed by

manufacturers along to processors,

enabling them to share in the costs of

testing (Ref. 74, p. 20654). In addition,

"[t]here are [typically] so many

processors [of a given test rule chemical]

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" (Ref.

79, p. 31789).

f. 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 test rules in 40 CFR part

790. For the purposes of this final rule,

EPA is setting forth certain requirements

Persons who manufacture (as defined at TSCA Tier 2A

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

test rule substance who are not listed under rule substance solely as one or more of the following:

Tier 2 -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 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))

Tier 2B

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

substance (see 40 CFR 790.42(a)(2))

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that differ from those under 40 CFR part

790.

In this 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 rule. EPA

believes that those persons in Tier 1

who will conduct testing under this

final rule will 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

historically have not themselves

participated in testing or contributed to

the reimbursement of those persons who

have conducted testing. EPA

understands that these manufacturers

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 disproportionate to the

additional benefits of including these

persons in Tier 1. Therefore, EPA does

not believe that the likelihood of the

persons who are being added to Tier 2

actually conducting 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, are subject to reimbursement

obligations to persons who actually

conduct the testing, as described in Unit

V.E.4.

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

manufacturers and processors of a

chemical substance to test that chemical

substance if EPA has made findings for

that chemical substance, and therefore

issued a TSCA section 4(a) test rule

requiring testing. However, practicality

must be a factor in determining who is

subject to a particular test rule. Thus,

persons who do not know or cannot

reasonably ascertain that they are

manufacturing or processing the

substances subject to this final rule, e.g.,

manufacturers or processors of the

substances as trace contaminants who

are not aware of these activities, are not

subject to the final rule. (See Unit V.E.1.

and § 799.5115(b)(2) of the regulatory

text.)

4. How do the reimbursement

procedures work? In the past, persons

subject to test rules have independently

worked out among themselves their

respective financial contributions to

those persons who have actually

conducted the testing. However, if

persons are unable to agree privately on

reimbursement, they may take

advantage of EPA's reimbursement

procedures at 40 CFR part 791,

promulgated under the authority of

TSCA section 4(c). These procedures

include:

* The opportunity for a hearing

with the American Arbitration

Association.

* Publication by EPA of a Federal

Register document concerning the

request for a hearing.

* 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 final rule, amounts

manufactured as impurities will be

included in production volume (40 CFR

791.48(b)), subject to the discretion of

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

The hearing officer's proposed order

may become the Agency's final order,

which is reviewable in Federal court (40

CFR 791.60).

F. What are the Reporting Requirements

Under this Final Rule?

A final report must be submitted for

each chemical 13 months after the

effective date of the final rule, i.e., by

the deadline indicated in § 799.5115(i)

of the regulatory text. Although EPA

originally proposed a deadline of 9

months after the effective date, EPA

extended the reporting deadline to 13

months after the effective date in

response to public comments. (See Unit

III.E.2.f.). EPA is not requiring the

submission of interim progress reports

for the in vitro dermal absorption rate

testing required in this final rule. For

the short-term studies required by this

final rule, interim progress reports

would likely yield little useful

information. Furthermore, by not

requiring interim progress reports for

these short-term studies, the overall

burden of the final rule will be

somewhat reduced.

G. What Would I Need to Do if I Cannot

Complete the Testing?

A company that submits a letter of

intent to test under this final rule and

that subsequently anticipates difficulties

in completing the testing by the

deadline may submit a request to the

Agency to modify the test schedule,

pursuant to 40 CFR 790.55. EPA will

determine whether modification of the

test schedule is appropriate, and may

first seek public comment on the

modification.

H. Will There be Sufficient Test

Facilities and Personnel to Undertake

the Testing in this Test Rule?

Various surveys of the availability of

test facilities and personnel to handle

the additional demand for testing

services created by TSCA section 4(a)

test rules indicate that available test

facilities and personnel will adequately

accommodate the testing specified in

this final rule (Refs. 46, 52, and 53) (see

also Unit III.G.).

L Might EPA Seek Further Testing of the

Chemicals in this Final Rule?

If EPA determines that it needs

additional data regarding any of the

chemical substances included in this

final rule, the Agency might seek further

health and/or environmental effects

testing for these chemical substances.

Should the Agency decide to seek such

additional testing, EPA would initiate a

separate action under TSCA section 4

for that purpose.

VI. Export Notification

Any person who exports, or who

intends to export, one of the chemical

substances contained in this final rule

in any form is subject to the export

notification requirements in TSCA

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

subpart D. However, export notification

is generally not required for articles, as

provided by 40 CFR 707.60(b).

VII. Decision to Terminate Rulemaking

EPA is withdrawing the in vitro

dermal absorption rate testing proposed

on June 9, 1999 (64 FR 31074) for 13

chemicals: Ethyl ether, isobutyl alcohol,

sec-butyl alcohol, o-dichlorobenzene, pnitrotoluene, beta-chloroprene, n-amyl

acetate, N-isopropylaniline, odinitrobenzene, ethyl bromide, ochlorotoluene, disulfiram, and NNdimethylaniline. The rationale for the

decision to withdraw this proposed

testing is presented in this unit.

A. Ethyl Ether

DEPA commented that ethyl ether

(CAS No. 60-29-7) should be removed

from the rule, in part, because dermal

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absorption rate data had previously

been developed and because the high

volatility of ethyl ether would not allow

a dermal absorption rate to be

adequately determined under the

proposed standard (Ref. 21).

EPA and OSHA have reviewed the

dermal absorption rate study by Blank et

al., 1967 (Journal of Investigative

Dermatology. 49:582-589), submitted by

DEPA as an attachment to its comments

(Ref. 21). The study measured a Kp for

an aqueous solution of ethyl ether

through a human abdominal epidermal

membrane using an in vitro static

diffusion cell. Barrier function was

maintained as verified by measuring

penetration of tritiated water. Most

other experimental parameters

conformed with the standard proposed

by EPA for determining an in vitro

dermal absorption rate. A sensitive gas

chromatographic method was used to

analyze the receptor fluid in place of

radiolabeled compound. It is unclear

whether absorption was determined

under occluded or unoccluded

conditions, but the Kp values are close

to theoretical calculations, indicating

that ethyl ether evaporation likely did

not confound absorption measurements

under these experimental conditions.

Skin penetration of the neat liquid was

not reported, but EPA and OSHA

believe this can be estimated using the

aqueous Kp value and data on water

solubility and liquid density. Therefore,

EPA and OSHA believe that this study

provides sufficient data for an adequate

determination of the dermal absorption

rate information sought in this

rulemaking and testing of ethyl ether is

not required at this time (Ref. 62).

B. Isobutyl Alcohol and Sec-Butyl

Alcohol

ACC, in its comment proposing a

category approach when testing

chemical substances to determine in

vitro dermal absorption rates, noted that

in its suggested aliphatic alcohol

category, three of the four possible

isomers for butyl alcohol were included

in the proposed rule (Ref. 15). ACC

stated that given their same molecular

weight and functionality, and taking

into consideration the likelihood of

there being existing dermal absorption

rate data for other three-, four-, and fivecarbon alcohols, evaluating the three

isomers using a structure activity

relationship (SAR) approach would

appear reasonable, in lieu of testing

three chemicals under this rule.

The three butyl alcohols referred to by

ACC are isobutyl alcohol (CAS No. 78-

83-1), sec-butyl alcohol (CAS No. 78-

92-2), and tert-butyl alcohol (CAS No.

75-65-0). The first two were included

in the proposed rule. The third

substance, tert-butyl alcohol was cited

in the proposed rule (Ref. 5) as a

chemical substance that was removed

from the test list as a result of a 1998

study. The fourth butyl alcohol, not

included in the proposed test rule, is nbutyl alcohol (CAS No. 71-36-3) which

the ITC found to have sufficient dermal

absorption rate data.

EPA agrees with ACC that sufficient

data on in vitro dermal absorption rates

have been generated on three, four, and

five carbon aliphatic alcohols to

adequately predict Kps for isobutyl

alcohol and sec-butyl alcohol (Ref. 62).

In vitro dermal absorption rates and Kps

using human skin have already been

measured for a series of homologous

two [ethanol], three [propanol], four [nbutanol], and five [pentanol] carbon

aliphatic alcohols (Ref. 65). This

provides adequate structure activity

information to predict the dermal

absorption rates for the closely related

branched chain alcohols, isobutyl

alcohol and sec-butyl alcohol, with

reasonable accuracy. Therefore, EPA is

not requiring the testing of isobutyl

alcohol and sec-butyl alcohol under this

final rule.

C. o-Dichlorobenzene

The Chlorobenzene Producers

Association cited two documents to

support its position that testing of odichlorobenzene (CAS No. 95-50-1) is

unnecessary (Ref. 31). The Association

cited EPA's Dermal Exposure

Assessment: Principles and

Applications (Ref. 42), which described

a calculated Kp for o-dichlorobenzene.

The Association also noted that a study

conducted at the North Carolina State

University at Raleigh entitled

Percutaneous Absorption of Volatile

Compounds (Ref. 50) analyzed the

relative absorption and penetration of odichlorobenzene on the skin surface in

the context of evaluating volatile

organic compounds.

The Kp value for o-dichlorobenzene

cited in the 1992 EPA Report on dermal

exposure assessment is estimated from

empirical models rather than

experimental data and, therefore, does

not meet OSHA needs. However, the

data developed for o-dichlorobenzene in

the context of evaluating percutaneous

absorption of volatile organic

compounds does provide a measure of

the dermal absorption rate of odichlorobenzene. Therefore, testing of odichlorobenzene is not required in this

final rule.

D. p-Nitrotoluene

First Chemical Corporation provided

EPA with biological monitoring

information (Ref. 17a.), toxicity studies

(Ref. 17b.), and specific information on

the numbers of workers exposed to pnitrotoluene (CAS No. 99-99-0) (Ref.

17). First Chemical Corporation

concluded from the submitted

information that p-nitrotoluene does not

present a significant hazard from dermal

contact and proposed that this chemical

be removed from the test list. One study

(Ref. 17a.) discussed biological

monitoring in workers but did not

measure dermal absorption. An acute

toxicity study with short-term dermal

administration to experimental animals

was negative (Ref. 17b.). This study also

did not attempt to measure dermal

absorption, and, therefore is not

adequate to eliminate the testing

requirement. A submission under

section 8(d) of TSCA "found no

evidence of skin absorption when a

dermal dose of 1.0 g/kg was applied to

rabbits" (Ref. 17) but further review by

EPA finds no mention of the

methodology or data that support this

statement in the submission. EPA does

not consider the data cited by First

Chemical Corporation to be sufficient to

determine a dermal absorption rate for

p-nitrotoluene (Ref. 62).

First Chemical Corporation also

submitted data relevant to EPA's finding

of substantial human exposure. First

Chemical Corporation is the only

domestic manufacturer of p-nitrotoluene

and accounts for the vast majority of the

total quantity on the U.S. market. The

company provided information on

handling procedures, onsite operations,

and a summary of the number of

workers with potential exposure to the

chemical. This summary was based on

a survey of onsite operations and

inquiries to each offsite company

known to handle p-nitrotoluene. EPA

has reviewed these data and agrees with

First Chemical Corporation that the

number of workers exposed to pnitrotoluene at its facilities and those of

its customers (processors) do not meet

the general worker threshold for

substantial human exposure that EPA

has established to require testing under

TSCA section 4(a)(1)(B). EPA has also

reviewed the information submitted in

response to the TSCA section 8(a) PAIR

for p-nitrotoluene (Ref. 8). PAIR

information for 1994 revealed that

another company in the p-nitrotoluene

market did not use p-nitrotoluene in its

processes, sell it to its customers, or

report any worker exposure, thus

making the number of exposed workers

reported by First Chemical Corp. the

total of the reported worker exposures

in the United States. Therefore, EPA is

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not requiring testing of p-nitrotoluene

under this final rule.

E. beta-Chloroprene

DuPont Dow Elastomers (DDE)

provided EPA with specific information

on production and worker exposure to

beta-chloroprene (CAS No. 126-99-8)

during production and use (Ref. 24).

According to DDE, domestic production

of beta-chloroprene occurs only at

DDE's facility in LaPlace, Louisiana.

DDE also states that no beta-chloroprene

is imported. DDE acknowledges that

beta-chloroprene is manufactured in

quantities in excess of one million

pounds per year which satisfies the

"substantial production" TSCA section

4(a)(1)(B) finding. However, the

company maintains that the number of

workers exposed to beta-chloroprene

does not meet the general "substantial

human exposure" TSCA section

4(a)(1)(B) finding.

According to DDE, more than 90% of

beta-chloroprene produced annually is

used for the production of dry

polychloroprene. Most of the remaining

beta-choloroprene is used to produce

polychloroprene latex, a colloidal

suspension of polychloroprene in water.

A small portion is used to manufacture

a comonomer, subsequently

incorporated in polychloroprene

polymerization. DDE states that polymer

manufacture is the only commercial use

of beta-chloroprene. From its sole betachloroprene production facility in

Louisiana, DDE produces betachloroprene monomer to supply its

polychloroprene manufacturing

operations. DDE, the only domestic

producer of beta-chloroprene or

polychloroprene, handles betachloroprene at only two of its facilities

and the total number of DDE employees

at these sites is approximately 500. DDE

states that the actual number of the

workers exposed via the dermal route is

significantly less than the total number

of DDE employees at the two facilities

that manufacture or handle betachloroprene. DDE has determined that

the total number of workers potentially

exposed to beta-chloroprene vapor is

less than 200. Due to the nature of the

beta-chloroprene and polychloroprene

manufacturing processes, the number of

workers with potential exposure to

liquid beta-chloroprene is apparently

significantly less than those potentially

exposed to beta-chloroprene vapor.

EPA has reviewed the production and

worker exposure information submitted

by DDE and concurs with DDE in its

assessment of the potential number of

workers exposed to beta-chloroprene.

Because the potential number of

workers exposed to beta-chloroprene

does not appear to meet the threshold

that EPA generally relies upon in

making the TSCA section 4(a)(1)(B) "substantial human exposure" finding

on the basis of worker exposure, testing

of beta-chloroprene is not required

under this final rule.

F. n-Amy] acetate

EPA and OSHA have reviewed a

dermal absorption study for n-amyl

acetate (CAS No. 628-63-7) submitted

by Union Carbide Corporation (Ref. 47).

A Kp and 6-24 hours dermal absorption

rates for n-amyl acetate were

determined. Absorption data were also

collected at earlier time points of 10

minutes and 1 hour. The method used

an in vitro static diffusion cell technique

with human cadaver skin and was

similar, but not identical, to the test

standard for the study required in this

final rule. The test substance was a

mixed isomer of primary amyl acetate

applied neat (65% n-amyl acetate)

rather than as a pure compound. A

sensitive (non-radiolabeled) gas

chromatographic technique specific to

n-amyl acetate was used as a detection

method. The anatomical region of the

skin and membrane thickness were not

stated, although variability in the results

and the method of epidermal membrane

preparation were found to be

acceptable. The receptor fluid was

ethanol in water instead of the PEG

solution required in the test standard for

this final rule; however, it is unlikely

that this influenced the results of the

study because ethanol in water, as

stated previously in Unit III.E.2.o.vii., is

generally a suitable receptor fluid. This

is the case despite the fact that under

this final rule EPA is requiring the use

of a PEG solution as the receptor fluid

for all hydrophobic chemicals for

purposes of consistency. Therefore, EPA

and OSHA believe that this study

provides sufficient data for an adequate

determination of dermal absorption rate

and further testing of n-amyl acetate is

not required under this final rule (Ref.

64).

G. N-Isopropylaniline

Monsanto Company provided EPA

with specific information on production

and worker exposure to Nisopropylaniline (CAS No. 768-52-5)

during production and use (Ref. 16).

Monsanto Company stated that Nisopropylaniline is an intermediate in

the production of the pesticide

propachlor, the active ingredient in

Ramrod branded herbicides, and is

produced and consumed at the

Monsanto plant in Muscatine, Iowa. No

N-isopropylaniline is sold or used

domestically for any other purpose.

Propachlor, which was introduced on

the market in 1965, is nearing the end

of its commercial life cycle and

production of N-isopropylaniline has

fallen accordingly. Thus, it is

anticipated that N-isopropylaniline will

be produced in amounts far less than

the Agency's general "substantial

production" threshold of one million

pounds per year.

Monsanto Company also provided

EPA with a detailed description of the

number of workers exposed to Nisopropylaniline during production and

use. N-isopropylaniline is produced and

consumed in enclosed systems.

Monsanto Company projected a

maximum of 35 workers are potentially

exposed to N-isopropylaniline.

EPA has reviewed the production and

worker exposure information submitted

by Monsanto Company for Nisopropylaniline. EPA has confirmed,

via 1998 and 2002 IUR data (see 40 CFR

part 710), that manufacture (including

import) of N-isopropylaniline is below

the one million pounds per year

threshold which EPA generally relies

upon as "substantial production" under

TSCA section 4(a)(1)(B). In addition, the

potential number of workers exposed to

N-isopropylaniline does not appear to

meet the "substantial human exposure"

threshold of exposure equal to or greater

than 1,000 workers which EPA

generally relies upon in making the

TSCA section 4(a)(1)(B) "substantial

human exposure" finding on the basis

of worker exposure. As a result, testing

of N-isopropylaniline is not required

under this final rule.

H. o-Dinitrobenzene

EPA received no comments in

response to its proposal to require that

o-dinitrobenzene (CAS No. 528-29-0)

be tested to determine an in vitro dermal

absorption rate. In developing a finding

for the final rule of "substantial

production" under TSCA section

4(a)(1)(B) for this chemical, EPA found

that according to 1998 IUR data (see 40

CFR part 710), o-dinitrobenzene is no

longer produced or imported in

amounts equal to or greater than one

million pounds per year. The 1998 IUR

data became available after the

publication of the proposed rule, which

made a finding for substantial

production based on 1994 IUR data.

Also, there were no 2002 IUR data

reported for o-dinitrobenzene. Because

the 1998 IUR data and the lack of 2002

IUR data do not support a finding of

substantial production as required

under TSCA section 4(a)(1)(B)(i), testing

of o-dinitrobenzene to determine an in

vitro absorption rate is not required at

this time.

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L Ethyl Bromide, o-Chlorotoluene,

Disulfiram, and NN-Dimethylaniline

In developing findings for the final

rule of "substantial production" under

TSCA section 4(a)(1)(B) for ethyl

bromide (CAS. No. 74-96-4), ochlorotoluene (CAS No. 95-49-8),

disulfiram (CAS No. 97-77-8), and NNdimethylaniline (CAS No. 121-69-7),

EPA found that according to 2002 IUR

data (see 40 CFR part 710), these four

chemical substances are no longer

manufactured or imported in amounts

equal to or greater than one million

pounds per year. Because the 2002 IUR

data show manufacture (including

import) below the one million pounds

per year threshold which EPA generally

relies upon as "substantial production"

under TSCA section 4(a)(1)(B)(i), testing

of ethyl bromide, o-chlorotoluene,

disulfiram, and NN-dimethylaniline to

determine in vitro dermal absorption

rates is not required at this time.

VIII. Economic Impacts

EPA has prepared an economic

assessment entitled Economic Impact

Analysis and Small Entity Impact

Analysis of the TSCA Section 4(a) Test

Rule for 34 Chemicals Targeted for In

Vitro Dermal Absorption Rate Testing

(Ref. 57), a copy of which has been

placed in the official public docket. This

economic assessment evaluates the

potential for significant economic

impacts as a result of the testing that

would be required by this final rule. The

total cost of providing test data on the

34 chemicals that were evaluated in this

economic analysis is estimated to be a

total of $1.16 million for all 34

chemicals, or $33,987 per chemical (Ref.

57).

While legally subject to this test rule,

Tier 2 manufacturers and all processors

of a subject chemical would only be

required to comply with the

requirements of the final rule if they are

directed to do so by EPA as described

in § 799.5115(c)(5), (c)(7) and (c)(10) of

the regulatory text. EPA would require

Tier 2 manufacturers or processors to

test only if no Tier 1 manufacturer has

submitted a letter 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 expects that, for each chemical

in this final rule, at least one such

person will submit a letter of intent to

conduct the required testing and that

person will conduct such testing and

will submit the test data to EPA. EPA

believes, therefore, that there will not be

any costs to Tier 2 manufacturers or

processors for conducting the testing

required by the final rule. In addition,

as explained in Unit III.J., EPA is not

aware of any circumstances in which

Tier 1 entities have sought

reimbursement from Tier 2 entities

either through private agreements or by

soliciting the involvement of the Agency

under the reimbursement regulations at

40 CFR part 791. Given this consistent

experience with previous test rules, EPA

does not believe that there will be any

administrative, negotiation, or any other

costs associated with seeking

reimbursement from Tier 2 companies.

To evaluate the potential for an

adverse economic impact of testing on

manufacturers of the chemical

substances in this final rule, EPA

employed a screening approach that

compares the annual revenues from the

sale of a chemical to the annualized

testing costs for that chemical and

expresses the testing costs as a percent

of revenues generated from each

chemical. Annualized testing costs

divide testing expenditures into an

equivalent, constant yearly expenditure

over a longer period of time. To

calculate the percent price impact,

testing costs (including laboratory and

administrative expenditures) are

annualized over 15 years using a 7%

discount rate. Annualized testing costs

are then divided by the estimated

annual revenue of the chemical to

derive the cost-to-sales ratio.

EPA estimates the annualized cost of

testing the 34 chemicals evaluated in

the economic analysis to be $3,732 per

chemical or a total annualized cost of

$126,888 for all 34 chemicals (34 x

$3,732) (Ref. 57). In addition, the TSCA

section 12(b) export notification that is

required for the first export to a

particular country of a chemical subject

to the final rule, is estimated to be

$61.31 for the first time that an exporter

must comply with TSCA section 12(b)

export notification requirements, and

$18.07 for each subsequent export

notification submitted by an exporter

(Ref. 57). The Agency's estimated total

costs of testing (including both

laboratory and administrative costs),

annualized testing costs, price impacts,

and public reporting burden hours for

this final rule are presented in the

economic impact analysis (Ref. 57).

Price data were available for 26 of the

34 chemicals, with an average cost of

$.88 per pound for those 26 chemicals.

The price impact of the test costs is a

function of the chemical's price per

pound and the production volume. For

21 of the 26 chemicals (80.8%) for

which price data were available, the

price impact is less than 1.0% when the

production volume for each chemical is

assumed to be one million pounds,

which is the threshold for substantial

production. The average test cost impact

for all 26 chemicals with price data was

0.68%. This means that the testing costs

represent, on average, 0.68% of

revenues generated from each chemical.

The actual impacts are likely to be

lower, however, because all of the

subject chemicals are produced in

volumes of at least one million pounds

per year. With a price impact of less

than 1.0%, EPA concludes that for these

21 chemicals the potential for adverse

economic impacts is low.

For five of the twenty-six chemicals

(19.2%) with price data, the price

impact is in excess of 1.0%. The average

price impact for these five chemicals is

1.96% and the maximum is 3.7%.

Again, these impacts occur when the

production volumes are assumed to be

one million pounds. The actual impacts

decline in direct proportion to a

chemical's actual production volume

above one million pounds. Thus, if the

actual production volume is two million

pounds, the impact is reduced by 50%.

The Agency verified production

volumes for these five chemicals based

on the 2002 reports to the TSCA

Chemical Update System Database, and

has found that the actual production

volume in each case exceeds 10 million

pounds per year. Therefore, the Agency

believes that the impact for all five of

these chemicals is below 1.0%.

The Agency computed "critical

prices" for the remaining eight

chemicals for which price data were not

available. The "critical price" is the

price per pound below which there

would be an impact of 1.0% or greater.

Assuming a minimum production

volume of one million pounds per year

and annualized testing costs of $3,732

per chemical, the critical price is $0.37

per pound. Below that price, the testing

costs would represent more than 1.0%

of the revenues from the chemical at a

one million pound production volume

level. The average price for the 26

chemicals with actual price data

available is $0.88 per pound. Thus, the

critical price is substantially below this

average. While it cannot be shown

conclusively that the price impacts will

be less than or greater than 1.0% of the

sales for these chemicals, the Agency

believes that adverse impacts are

unlikely, given that both the chemicals'

prices would have to be below $.37 per

pound, and the production volume

would have to meet the worst-case

assumption of one million pounds per

year.

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On the basis of these calculations,

EPA believes that the required chemical

testing presents a low potential for

adverse economic impact for the

majority of the chemicals subject to the

final rule. Because the subject chemical

substances have relatively large

production volumes, the annualized

costs of testing, expressed as a

percentage of annual revenues, are very

small for most chemicals. There are,

however, eight chemicals for which it

cannot conclusively be shown that the

price impact will be below 1.0% of the

revenue for these chemicals. For these

eight chemicals, companies may choose

to use revenue sources other than profits

from the individual chemicals to pay for

testing. To account for this, the Agency

also compared the costs of compliance

to company sales data. These

calculations were made as part of the

Agency's small entity impact analysis

(Ref. 57), conducted in accordance with

the requirements of the Regulatory

Flexibility Act, as amended by the

Small Business Regulatory Enforcement

Fairness Act. These results are

presented in Unit X.B.

IX. Materials in the Docket

An official docket was established

under docket ID number OPPT-2003-

0006. The official public docket

includes information considered by EPA

in developing this final rule, such as the

documents specifically referenced in

this action, any public comments

received, and other information related

to this action. In addition, interested

parties should consult documents that

are referenced in the documents that

EPA has placed in the docket, regardless

of whether these referenced documents

are physically located in the docket. For

assistance in locating documents that

are referenced in documents that EPA

has placed in the docket, but that are

not physically located in the docket,

please consult one of the technical

persons listed under FOR FURTHER

INFORMATION CONTACT. The official

public docket is available for review as

specified in ADDRESSES. The following

is a listing of the documents referenced

in this preamble that have been placed

in the official docket for this final rule:

A. Supporting Documentation

1. U.S. Census Bureau. Bridge

between NAICS and SIC. 1997

Economic Census. Core Business

Statistics Series. Issued June 2000.

2. United States Environmental

Protection Agency (USEPA). Laboratory

Cost Estimate for In Vitro Dermal

Absorption Rate Testing-Short-term

Absorption Rate. Prepared by Economic

and Policy Analysis Branch (EPAB),

Economics, Exposure and Technology

Division (EETD), OPPT. February 20,

2003.

3. USEPA. Laboratory Cost Estimate

for In Vitro Dermal Absorption Rate

Testing-Long-term Absorption Rate.

Prepared by EPAB, EETD, OPPT. March

26, 2003.

4. Background information listed in

§ 799.5115(h)(8) of the regulatory text:

a. Bronaugh, R.L., Stewart, R.F., and

Simon, M. Methods for in vitro

Percutaneous Absorption Studies VII:

Use of Excised Human Skin. Journal of

Pharmaceutical Sciences. 75:1094-

1097. 1986.

b. Bronaugh, R.L. and Stewart, R.F.

Methods for in vitro Percutaneous

Absorption Studies IV: The FlowThrough Diffusion Cell. Journal of

Pharmaceutical Sciences. 74:64-67.

1985.

c. Bronaugh, R.L., Stewart, R.F., and

Storm, J.E. Extent of Cutaneous

Metabolism During Percutaneous

Absorption of Xenobiotics. Toxicology

and Applied Pharmacology. 99:534-

543. 1989.

d. 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.

Dermatotoxicology. F. Marzulli and H.

Maibach, Eds. Taylor & Francis,

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

e. 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.

B. References

1. Interagency Testing Committee

(ITC). Thirty-First Report of the TSCA

Interagency Testing Committee to the

Administrator; Receipt of Report,

Request for Comments, Opportunity to

Initiate Negotiations for TSCA Section 4

Testing Consent Agreements. Federal

Register (58 FR 26898, May 5, 1993)

(FRL-4583-4).

2. ITC. Thirty-Second Report of the

TSCA Interagency Testing Committee to

the Administrator; Receipt of Report,

Request for Comments, Notice of

Opportunity to Initiate Negotiations for

TSCA section 4 Testing Consent

Agreements. Federal Register (58 FR

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

3. ITC. Thirty-Fourth Report of the

TSCA Interagency Testing Committee to

the Administrator; Receipt of Report

and Request for Comments. Federal

Register (59 FR 35720, July 13, 1994)

(FRL-4870-4).

4. ITC. Thirty-Fifth Report of the

TSCA Interagency Testing Committee to

the Administrator; Receipt of Report,

Request for Comments, Solicitation of

Interested Parties in Developing Testing

Consent Agreement. Federal Register

(59 FR 67596, December 29, 1994)

(FRL-4923-2).

5. USEPA. Proposed Test Rule for In

Vitro Dermal Absorption Rate Testing of

Certain Chemicals of Interest to

Occupational Safety and Health

Administration. Federal Register (64 FR

31074, June 9, 1999) (FRL-5760-3).

6. USEPA. Preliminary Assessment

Information and Health and Safety Data

Reporting; Addition of Chemicals.

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

Rules for Chemicals contained in the

ITC's 31st Report to the EPA

Administrator). Federal Register (58 FR

68311, December 27, 1993) (FRL-4644-

1).

7. USEPA. Preliminary Assessment

Information and Health and Safety Data

Reporting; Addition of Chemicals.

(TSCA sections 8(a) and 8(d) Final Rules

for Chemicals contained in the ITC's

32nd Report to the EPA Administrator).

Federal Register (59 FR 5956, February

9, 1994) (FRL-4745-5).

8. USEPA. Preliminary Assessment

Information and Health and Safety Data

Reporting; Addition of Chemicals.

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

Rules for Chemicals contained in the

ITC's 3 5 th Report to the EPA

Administrator). Federal Register (60 FR

34879, July 5, 1995) (FRL-4954-9).

9. USEPA. Thirty-Sixth Report of the

TSCA Interagency Testing Committee to

the Administrator; Receipt of Report,

Request for Comments, Solicitation of

Use and Exposure Data. Federal

Register (60 FR 42982, August 17, 1995)

(FRL-4965-6).

10. USEPA. Request for Proposals for

Enforceable Consent Agreements;

Dermal Absorption Rate Testing of

Eighty OSHA Chemicals; Solicitation of

Interested Parties; Text of Test Protocol.

Federal Register (61 FR 14773, April 3,

1996) (FRL-5359-3).

11. ARCO Chemical Company.

Proposal to conduct in vivo dermal

absorption rate testing for tert-butyl

alcohol under an enforceable consent

agreement (ECA). Letter from Joan

McCuen to Charles M. Auer, OPPT,

USEPA. June 26, 1996.

12. ARCO Chemical Company. A

letter from Joan McCuen to Keith

Cronin, OPPT, USEPA transmitting a

dermal absorption rate study (Ref. 12a.).

March 23, 1998.

12a. Huntington Life Sciences Ltd.,

Suffolk, England. [14C]-t-Butyl Alcohol:

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Topical Application: Dermal Absorption

Study in the Male Rat; Final Report.

Prepared for ARCO Chemical Company.

January 7, 1998.

13. 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. Chapter 19, pp.

237-241. 1991.

14. Chemical Manufacturers

Association (CMA). Comments on ITC

proposal for dermal penetration testing

and protocol (Ref. 14a.) proposed by

CMA. Letter from Sarah Doelp to

Charles M. Auer, USEPA. October 21,

1994.

14a. CMA, Existing Chemicals Testing

Task Group. Proposed Protocol for In

Vitro Percutaneous Absorption Studies.

October 4, 1994.

15. ACC. Comments on EPA's TSCA

section 4(a)(1)(B) Proposed Test Rule for

In Vitro Dermal Absorption Rate Testing

of Certain Chemicals of Interest to

OSHA submitted to the TSCA Public

Docket Office, USEPA. August 10, 1999.

16. Monsanto Company. Comments

on EPA's TSCA section 4(a)(1)(B)

Proposed Test Rule for In Vitro Dermal

Absorption Rate Testing of Certain

Chemicals of Interest to OSHA

submitted to the TSCA Public Docket

Office, USEPA. July 19, 1999.

17. First Chemical Company.

Comments on EPA's TSCA section

4(a)(1)(B) Proposed Test Rule for In

Vitro Dermal Absorption Rate Testing of

Certain Chemicals of Interest to OSHA

submitted to the TSCA Public Docket

Office, USEPA. August 4, 1999.

17a. Linch, A.L. Biological monitoring

for industrial exposure to cyanogenic

aromatic nitro and amino compounds.

American Industrial Hygiene

Association Journal. 35:426-432. 1974.

17b. Kinkead, E.R., MacEwen, J.D.,

Haun, C.C., Vernot, E.H., and Dacre, J.C.

Toxic hazards evaluation of five

atmospheric pollutants from Army

ammunition plants. Prepared by

University of California, Irvine for

Aerospace Medical Research Laboratory,

Wright-Patterson Air Force Base, OH.

Report number AMRL-TR-77-25. June

1977.

18. American Forest & Paper

Association. Comments on EPA's TSCA

section 4(a)(1)(B) Proposed Test Rule for

In Vitro Dermal Absorption Rate Testing

of Certain Chemicals of Interest to

OSHA submitted to the TSCA Public

Docket Office, USEPA. August 9, 1999.

19. American Petroleum Institute.

Comments on EPA's TSCA section

4(a)(1)(B) Proposed Test Rule for In

Vitro Dermal Absorption Rate Testing of

Certain Chemicals of Interest to OSHA

submitted to the TSCA Public Docket

Office, USEPA. August 9, 1999.

20. Biphenyl Work Group,

Washington, DC. Comments on EPA's

TSCA section 4(a)(1)(B) Proposed Test

Rule for In Vitro Dermal Absorption

Rate Testing of Certain Chemicals of

Interest to OSHA submitted to the TSCA

Public Docket Office, USEPA. August 6,

1999.

21. Diethyl Ether Producers

Association, Inc. Comments on EPA's

TSCA section 4(a)(1)(B) Proposed Test

Rule for In Vitro Dermal Absorption

Rate Testing of Certain Chemicals of

Interest to OSHA submitted to the TSCA

Public Docket Office, USEPA. August 9,

1999.

22. Synthetic Organic Chemical

Manufacturers Association, Inc.

Comments on EPA's TSCA section

4(a)(1)(B) Proposed Test Rule for In

Vitro Dermal Absorption Rate Testing of

Certain Chemicals of Interest to OSHA

submitted to the TSCA Public Docket

Office, USEPA. August 9, 1999.

23. Acetonitrile Task Force.

Comments on EPA's TSCA section

4(a)(1)(B) Proposed Test Rule for In

Vitro Dermal Absorption Rate Testing of

Certain Chemicals of Interest to OSHA

submitted to the TSCA Public Docket

Office, USEPA. August 9, 1999.

24. DuPont Dow Elastomers.

Comments on EPA's TSCA section

4(a)(1)(B) Proposed Test Rule for In

Vitro Dermal Absorption Rate Testing of

Certain Chemicals of Interest to OSHA

submitted to the TSCA Public Docket

Office, USEPA. August 9, 1999.

25. Fragranced Products Information

Network. Comments on EPA's TSCA

section 4(a)(1)(B) Proposed Test Rule for

In Vitro Dermal Absorption Rate Testing

of Certain Chemicals of Interest to

OSHA submitted to the TSCA Public

Docket Office, USEPA. July 6, 1999.

26. Association of Veterinarians for

Animal Rights. Comments on EPA's

TSCA section 4(a)(1)(B) Proposed Test

Rule for In Vitro Dermal Absorption

Rate Testing of Certain Chemicals of

Interest to OSHA submitted to the TSCA

Public Docket Office, USEPA. July 17,

1999.

27. People for the Ethical Treatment

of Animals. Comments on EPA's TSCA

section 4(a)(1)(B) Proposed Test Rule for

In Vitro Dermal Absorption Rate Testing

of Certain Chemicals of Interest to

OSHA submitted to the TSCA Public

Docket Office, USEPA. July 30, 1999.

28. Animal Protection Institute,

Midwest Regional Office. Comments on

EPA's TSCA section 4(a)(1)(B) Proposed

Test Rule for In Vitro Dermal

Absorption Rate Testing of Certain

Chemicals of Interest to OSHA

submitted to the TSCA Public Docket

Office, USEPA. August 4, 1999.

29. Humane Society of the United

States. Comments on EPA's TSCA

section 4(a)(1)(B) Proposed Test Rule for

In Vitro Dermal Absorption Rate Testing

of Certain Chemicals of Interest to

OSHA submitted to the TSCA Public

Docket Office, USEPA. August 9, 1999.

30. Doris Day Animal League.

Comments on EPA's TSCA section

4(a)(1)(B) Proposed Test Rule for In

Vitro Dermal Absorption Rate Testing of

Certain Chemicals of Interest to OSHA

submitted to the TSCA Public Docket

Office, USEPA. August 9, 1999.

31. Chlorobenzene Producers

Association. Comments on EPA's TSCA

section 4(a)(1)(B) Proposed Test Rule for

In Vitro Dermal Absorption Rate Testing

of Certain Chemicals of Interest to

OSHA submitted to the TSCA Public

Docket Office, USEPA. August 9, 1999.

32. Tetrahydrofuran Task Force.

Comments on EPA's TSCA section

4(a)(1)(B) Proposed Test Rule for In

Vitro Dermal Absorption Rate Testing of

Certain Chemicals of Interest to OSHA

submitted to the TSCA Public Docket

Office, USEPA. August 9, 1999.

33. Private Citizen. Comments on

EPA's TSCA section 4(a)(1)(B) Proposed

Test Rule for In Vitro Dermal

Absorption Rate Testing of Certain

Chemicals of Interest to OSHA

submitted to the TSCA Public Docket

Office, USEPA. June 15, 1999.

34. ACC Naphthalene Panel.

Comments on EPA's TSCA section

4(a)(1)(B) Proposed Test Rule for In

Vitro Dermal Absorption Rate Testing of

Certain Chemicals of Interest to OSHA

submitted to the TSCA Public Docket

Office, USEPA. August 9, 1999.

35. ACC Propylene Glycol Ethers

Panel. Comments on EPA's TSCA

section 4(a)(1)(B) Proposed Test Rule for

In Vitro Dermal Absorption Rate Testing

of Certain Chemicals of Interest to

OSHA submitted to the TSCA Public

Docket Office, USEPA. August 6, 1999.

36. ACC Olefins Panel. Comments on

EPA's TSCA section 4(a)(1)(B) Proposed

Test Rule for In Vitro Dermal

Absorption Rate Testing of Certain

Chemicals of Interest to OSHA

submitted to the TSCA Public Docket

Office, USEPA. August 9, 1999.

37. ACC Hydrocarbon Solvents Panel.

Comments on EPA's TSCA section

4(a)(1)(B) Proposed Test Rule for In

Vitro Dermal Absorption Rate Testing of

Certain Chemicals of Interest to OSHA

submitted to the TSCA Public Docket

Office, USEPA. August 9, 1999.

38. ACC Ketones Panel and Oxo

Process Panel. Comments on EPA's

TSCA section 4(a)(1)(B) Proposed Test

Rule for In Vitro Dermal Absorption

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Rate Testing of Certain Chemicals of

Interest to OSHA submitted to the TSCA

Public Docket Office, USEPA. August 9,

1999.

39. ACC Carbon Disulfide Panel.

Comments on EPA's TSCA section

4(a)(1)(B) Proposed Test Rule for In

Vitro Dermal Absorption Rate Testing of

Certain Chemicals of Interest to OSHA

submitted to the TSCA Public Docket

Office, USEPA. August 9, 1999.

40. Buell, D.A., Blaustein, M.B., and

Lynch, J.R. An Assessment of the

National Occupational Exposure

Survey. Prepared by Temple, Barker &

Sloane, Inc. and Exxon Corp. Undated.

41. Seta, J.A., Sundin, D.S., and

Pedersen, D.H. National Occupational

Exposure Survey Field Guidelines.

National Institute for Occupational

Safety and Health, Cincinnati, OH.

DHHS (NIOSH) Publication No. 88-106.

1988.

42. USEPA, Office of Research and

Development. Dermal Exposure

Assessment: Principles and

Applications. EPA/600/8-91/011B.

January 1992.

43. USEPA. Voluntary Children's

Chemical Evaluation Program. Federal

Register (65 FR 81699, December 26,

2000) (FRL-6758-5).

44. OECD, Paris. Guidance Document

for the Conduct of In Vitro Skin

Absorption Studies. (Draft). April 1999.

45. Harrison, S.M., Barry, B.W., and

Dugard, P.H. Effects of freezing on

human skin permeability. Journal of

Pharmacy and Pharmacology. 36: 261.

1984.

46. USEPA. Laboratory Capacity and

the HPV Challenge Program. OPPT/

EETD/EPAB, Washington, DC. October

14, 1999.

47. Union Carbide Corporation (now

Dow Corporation). A letter from Dr.

Imogene Treble to Frank Kover, USEPA

transmitting a study entitled Primary

Amy] Acetate, Mixed Isomers: In Vitro

Percutaneous Absorption Study in

Human Skin. July 5, 2000.

48. USEPA. Proposed Test Rule for

Hazardous Air Pollutants. Federal

Register (61 FR 33178, June 26, 1996)

(FRL-4869-1).

49. National Institute for

Occupational Safety and Health.

National Occupational Exposure

Survey. March 29, 1989.

50. Riviere, J.E., Brooks, J.D., Qiao,

G.L., and Monteiro-Riviere, N.A.

Percutaneous Absorption of Volatile

Chemicals. Prepared by North Carolina

State University, Raleigh, NC for

AFSOR/NL, Bolling AFB, Washington,

DC. NTIS number ADA332910.

November 1997.

51. USEPA. Data Collection and

Development on High Production

Volume (HPV) Chemicals. Federal

Register (65 FR 81686, December 26,

2000) (FRL-6754-6).

52. USEPA. EPA Census of TSCA

Testing Laboratories. Prepared by OPPT,

EETD, EPAB, Washington, DC. October

10, 1996.

53. USEPA. Analysis of U.S.

Laboratory Capacity for Developmental

and Reproductive Toxicity Testing and

the Impact of Expanded TSCA Test

Rules. Prepared by OPPT/EETD/EPAB,

Washington, DC. May 28, 1999.

54. USEPA. ChemRTK, HPV

Challenge Program Chemical List.

Prepared by OPPT. (This list is updated

periodically, and is available

electronically at http://www.epa.govchemrtk/hpvchmlt.htm)

55. USEPA. TSCA section 4(a)(1)(B)

Final Statement of Policy.Federal

Register (58 FR 28736, May 14, 1993)

(FRL-4059-9).

56. USEPA. Information on OSHA

Dermal Test Rule Chemicals: TRI

Release Data and Number of Workers

Exposed. Prepared by OPPT/EETD/

Chemical Engineering Branch (CEB),

Washington, DC. April 24, 2001 and

March 1998.

57. USEPA. Economic Impact

Analysis and Small Entity Impact

Analysis of the TSCA Section 4(a) Test

Rule for 34 Chemicals Targeted for In

Vitro Dermal Absorption Rate Testing.

Prepared by OPPT/EETD/EPAB,

Washington, DC. February 3, 2004.

58. USEPA. Guidelines for Exposure

Assessment. Federal Register (57 FR

22888, May 29, 1992) (FRL-4129-5).

59. Small Business Administration,

Office of Size Standards. Small Business

Size Standards matched to North

American Industry Classification

System (NAICS). On website: http://

www.sba.gov/size/sizetable2002.html.

60. USEPA. Treatment of 12(b) Export

Notification Unit Costs for section 4

Test Rule Analyses. Prepared by Lynne

Blake-Hedges OPPT/EETD/EPAB,

Washington, DC. April 1, 1999.

61. USEPA. Economic Analysis in

Support of the TSCA 12(b) Information

Collection Request. Prepared by Joseph

Callahan OPPT/EETD/EPAB,

Washington, DC. October 30, 1998.

62. OSHA. OSHA dermal test rule.

Electronic mail from Val Schaeffer to

Keith Cronin, USEPA. May 22, 2000.

63. OSHA. Dermal rule. Electronic

mail from Val Schaeffer to Keith Cronin,

USEPA. March 20, 2002.

64. OSHA. Dermal rule. Electronic

mail from Val Schaeffer to Keith Cronin,

USEPA. August 25, 2000.

65. Scheuplein, R.J. and Blank, I.H.

Mechanism of percutaneous absorption.

IV. Penetration of nonelectrolytes

(alcohols) from aqueous solutions and

from pure liquids. Journal of

Investigative Dermatology. 60:286-296.

1973.

66. USEPA. Wage Rates for Economic

Analysis of the Toxics Release Inventory

Program. Prepared by Cody Rice,

Analytical Support Branch,

Environmental Analysis Division, Office

of Environmental Information. April 11,

2002.

67. USEPA. Review of comments

received on proposed dermal absorption

test rule. Memorandum from Greg

Macek, CEB to Keith Cronin, Chemical

Control Division. October 8, 1999.

68. USEPA. Office of Water

Chemicals; Final Test Rule.Federal

Register (58 FR 59667, November 10,

1993) (FRL-4047-2).

69. USEPA. Testing Consent

Agreements and Test Rules; Final

Rule.Federal Register (55 FR 18881,

May 7, 1990) (FRL-3687-6).

70. USEPA. Amended Proposed Test

Rule for Hazardous Air Pollutants;

Extension of Comment Period. Federal

Register (62 FR 67465, December 24,

1997) (FRL-5742-2).

71. USEPA. Inventory Reporting

Requirements; Final Rule. Federal

Register (42 FR 64571, December 23,

1977) (FRL-817-1).

72. USEPA. Office of Solid Waste

Chemicals; Final Test Rule.Federal

Register (53 FR 22300, June 15, 1988)

(FRL-3396-8).

73. USEPA. Amended Proposed Test

Rule for Hazardous Air Pollutants;

Extension of Comment Period. Federal

Register (63 FR 19694, April 21, 1998)

(FRL-5780-6).

74. USEPA. Toxic Substances; Test

Rule Development and Exemption

Procedures. Federal Register (50 FR

20652, May 17, 1985) (FRL-2809-7).

75. USEPA. Methylcyclopentane and

Commercial Hexane; Proposed Test

Rule. Federal Register (51 FR 17854,

May 15, 1986) (FRL-3008-8).

76. USEPA. Commercial Hexane and

Methylcyclopentane; Final Test Rule.

Federal Register (53 FR 3382, February

5, 1988) (FRL-3325-1).

77. USEPA. Toxic Substances;

Biphenyl; Final Test Rule.Federal

Register (50 FR 37182, September 12,

1985) (FRL-2871-5).

78. USEPA. Office of Water

Chemicals, Final Test Rule;

Clarification. Federal Register (59 FR

45629, September 2, 1994) (FRL-4047-

2).

79. USEPA. Toxic Substances Control

Act; Data Reimbursement.Federal

Register (48 FR 31785 July 11, 1983)

(FRL-2349-8).

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X. Statutory and Executive Order

Reviews

A. Paperwork Reduction Act

The information collection

requirements contained in TSCA section

4 test rules have already been approved

by OMB under the provisions of the

Paperwork Reduction Act, 44 U.S.C.

3501 et seq., and have been assigned

OMB control number 2070-0033 (EPA

ICR No. 1139). The information

collection activities related to export

notification under TSCA section

12(b)(1) are already approved under

OMB control number 2070-0030 (EPA

ICR No. 0795). This final rule does not

contain any new or amended

requirements that would require

additional review and/or approval by

OMB.

The standard chemical testing

program involves the submission of

letters of intent to test (or exemption

applications), study plans, progress

reports, and test results. EPA estimates

that the information collection activities

related to chemical testing for all

chemicals in this final rule (representing

the submission of letters of intent or

exemption applications, study plans,

and the final reports; progress reports

are not required by this final rule

because testing will be completed

within about 1 year) would result in an

annual public reporting burden of 165

hours per chemical or a total of 5,610

hours for the 34 chemicals (Ref. 57).

The annual public reporting burden

related to export notification is

estimated to be 0.5 to 1.5 burden hours

for each chemical/country combination

(Ref. 57). 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 (Refs. 57, 60,

and 61).

For each manufacturer of the 34

chemicals identified in the economic

analysis, the parent company (ultimate

corporate entity, or UCE) was also

identified. The economic analysis

identified a total of 84 UCEs that EPA

believes would be the likely

respondents to the final rule. The public

reporting burden for this collection of

information is estimated to average 165

hours per chemical. Multiplying by 34

chemicals (34 x 165 = 5,610 hours total),

and dividing by 84 UCEs, results in a

per respondent estimated burden of 66.8

hours. This burden estimate includes

time for reviewing instructions,

searching existing data sources,

gathering and maintaining the data

needed, and completing and reviewing

the collection of information.

As defined by 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 which have subsequently

changed; 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.

Under PRA, an agency may not

conduct or sponsor, and a person is not

required to respond to, an information

collection request unless it displays a

currently valid OMB control number.

The OMB control numbers for EPA's

regulations are listed in 40 CFR part 9

and included on the related collection

instrument. EPA is amending the table

in 40 CFR part 9 to list the OMB

approval number for the information

collection requirements contained in

this final rule. This listing of the OMB

control numbers and their subsequent

codification in the CFR satisfies the

display requirements of PRA and OMB's

implementing regulations at 5 CFR part

1320. This ICR was previously subject to

public notice and comment prior to

OMB approval, and given the technical

nature of the table, EPA finds that

further notice and comment to amend it

is unnecessary. As a result, EPA finds

that there is "good cause" under section

553(b)(1)(B) of the Administrative

Procedure Act, 5 U.S.C. 553(b)(1)(B), to

amend this table without further notice

and comment.

B. Regulatory Flexibility Act (RFA)

Pursuant to section 605(b) of the

Regulatory Flexibility Act (RFA), 5

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

certifies that this final rule will not have

a significant adverse 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 final rule (Ref. 57), and

is briefly summarized here.

Three factors are examined in EPA's

small entity assessment (Ref. 57) in

order to characterize the potential small

entity impacts of this final rule:

* The size of the adverse impact

(measured as the ratio of the cost to

sales or revenue).

* The total number of small entities

that experience the adverse impact.

* The percentage of the total number

of small entities that experience the

adverse impact.

Section 601(3) of 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 for each

industry sector. (13 CFR 121.201). For

this final rule, EPA has analyzed the

potential small business impacts using

the size standards established under this

default definition. The SBA size

standards, which are primarily intended

to determine whether a business entity

is eligible for government programs and

preferences reserved for small

businesses (13 CFR 121.101), "seek to

ensure that a concern that meets a

specific size standard is not dominant in

its field of operation." (13 CFR

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

Small Business Act. Industrial sectors

are identified by a NAICS code. In most

cases, SBA has specified an employee

size standard (100; 500; 750; 1,000; or

1,500 employees) or, in some cases, a

sales-based, or other industry-specific

indicator, cut-off below which an entity

in that particular NAICS code would be

considered small (Ref. 59).

The SBA employee size standards that

apply to most of the NAICS codes that

are potentially impacted (Ref. 57) by

this final rule range from 500 to 1,500

employees. Size standards for three

potentially affected non-manufacturing

NAICS are defined in terms of sales, and

in each case the standards are $5

million in annual sales, while the

standards for the set of possible NAICS

where another entity is likely to fall, are

expressed in terms of electricity

generating capacity (4 million megawatt

hours).

Sales and employment data were

obtained for the 84 UCEs that

manufacture the 34 chemicals subject to

this final rule to identify those UCEs

that qualify for "small business" status,

where data were available. Based on the

SBA size standards for the NAICS codes

that applied to those UCEs, 25 of the 84

UCEs (30%) were identified as small.

The significance of this final rule's

impact on these small businesses was

analyzed by examining the number of

small entities that experienced different

levels of costs as a percentage of their

sales. In such an analysis, small

businesses are placed in the following

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categories on the basis of cost-to-sales

ratios: less than 1.0%, 1.0% but less

than 3.0%, and 3.0% or greater. Of the

25 companies that qualified for small

business status according to the SBA

size standards, none had a cost-to-sales

ratio that exceeded 1.0%. Given these

results, EPA concludes that there is not

a significant economic impact on these

small entities as a result of this final

rule.

There were an additional seven UCEs

for which the NAICS code, sales, and

employment data were not available.

Because of this, EPA could not

determine whether they are small

businesses or assess the potential

impacts of the test rule on them.

However, it is very unlikely that all

seven of these UCEs are small entities.

Moreover, given the Agency's analysis

for the identified small businesses,

which concluded that there is not a

significant economic impact on any of

them, EPA believes it is reasonable to

conclude that even if some of these

seven UCEs are small entities, they will

not experience a significant economic

impact. Consequently, EPA concludes

that there will not be a significant

economic impact on a substantial

number of small entities as a result of

this final rule.

In analyzing potential impacts on

small entities, RFA recognizes that it

may be appropriate at times to use an

alternate definition of small business.

As such, section 601(3) of RFA provides

that an agency may establish a different

definition of small business after

consultation with the SBA Office of

Advocacy and after notice and an

opportunity for public comment. Even

though the Agency has used the default

SBA definition of small business to

conduct its analysis of potential small

entity impacts for this final rule, EPA

does not believe that the SBA size

standards are generally the best

standards to use in assessing potential

impacts of TSCA section 4(a) test rules

on small entities. EPA believes that a

standard based on total annual sales,

such as the definition found in TSCA

(40 CFR 704.3), may provide a more

appropriate means to determine the

ability of a chemical manufacturing firm

to support testing without significant

costs or burdens. EPA is 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. Therefore,

as previously stated in this unit, the

RFA determination for this final rule is

based on an analysis using the default

SBA size standards. In the proposal to

this rule, EPA requested comment on

whether the Agency should establish an

alternate small business definition to

use in small entity impact analyses for

future TSCA section 4(a) test rules, and

what size cutoff may be appropriate.

The comment received on this subject

and the Agency's response are in Unit

III.K.

Although EPA has not yet pursued the

establishment of an alternate definition

for use in the analysis conducted for

this final rule, the analysis does present

the results of calculations using a

standard based on total annual sales.

Under the TSCA definition at 40 CFR

704.3, a firm is classified as small if it

has either total annual sales below $40

million and annual production or

importation volume less than or equal to

100,000 pounds, or, annual sales below

$4 million. Of the 84 UCEs subject to

the final rule, a maximum of 9 can be

classified as small under the TSCA

definition, with data unavailable for an

additional 7 firms. None of those 9 firms

will be affected at the level of 1.0% or

greater. Impacts could not be

determined for the 7 firms whose size

was unknown, but as with the analysis

conducted using the SBA size

standards, the Agency believes it is

reasonable to conclude that under the

referenced TSCA definition of small, the

7 UCEs will not experience significant

economic impacts as a result of the final

rule.

The estimated costs of the TSCA

section 12(b) export notification, which,

as a result of this final rule, would be

required for the first export to a

particular country of a chemical subject

to the rule, is estimated to be $61.31 for

the first time that an exporter must

comply with TSCA section 12(b) export

notification requirements, and $18.07

for each subsequent export notification

submitted by that exporter (Refs. 57, 60,

and 61). EPA has concluded that the

costs of TSCA section 12(b) export

notification would have a negligible

impact on exporters of the chemicals in

this final rule, regardless of the size of

the exporter.

Therefore, the Agency certifies that

this final rule will not have a significant

adverse economic impact on a

substantial number of small entities.

C. Unfunded Mandates Reform Act

Pursuant to Title II of the Unfunded

Mandates Reform Act of 1995 (Public

Law 104-4), EPA has determined that

this regulatory action 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 for the private sector

in any 1 year. The analysis of the costs

associated with this action are described

in Unit VIII. In addition, since EPA does

not have any information to indicate

that any State, local, or tribal

government manufactures or processes

the chemicals covered by this action

such that this final rule would apply

directly to State, local, or tribal

governments, EPA has determined that

this final rule does not significantly or

uniquely affect small governments.

Accordingly, this final rule is not

subject to the requirements of sections

202, 203, 204, and 205 of UMRA.

D. Executive Order 13132

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999), requires EPA to develop an

accountable process to ensure 'meaningful and timely input by State

and local officials in the development of

regulatory policies that have federalism

implications." "Policies that have

federalism implications" is defined in

the Executive order to include

regulations that have "substantial direct

effects on the States, on the relationship

between the national government and

the States, or on the distribution of

power and responsibilities among the

various levels of government."

This final rule does not have

federalism implications. It will not have

substantial direct effects on the States,

on the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132. This final rule

establishes testing and recordkeeping

requirements that apply to

manufacturers (including importers)

and processors of certain chemicals.

Because EPA has no information to

indicate that any State or local

government manufactures or processes

the chemical substances covered by this

action, this final rule does not apply

directly to States and localities and will

not affect State and local governments.

Thus, Executive Order 13132 does not

apply to this final rule. Although

Executive Order 13132 was not yet in

effect when EPA developed the

proposed rule, its predecessor,

Executive Order 12875, was and EPA's

conclusions under Executive Order

13132 are consistent with EPA's

considerations under Executive Order

12875.

E. Executive Order 13175

Under Executive Order 13175,

entitled Consultation and Coordination

with Indian Tribal Governments (65 FR

67249, November 6, 2000), this final

rule does not have tribal implications

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because it will not have substantial

direct effects on tribal governments, on

the relationship between the Federal

Government and the Indian tribes, or on

the distribution of power and

responsibilities between the Federal

Government and Indian tribes, as

specified in the Order. As indicated

above, EPA has no information to

indicate that any tribal government

manufactures or processes the chemical

substances covered by this action. Thus,

Executive Order 13175 does not apply

to this final rule. Although Executive

Order 13175 was not yet in effect when

EPA developed the proposed rule, its

predecessor, Executive Order 13084,

was and EPA's conclusions under

Executive Order 13175 are consistent

with EPA's considerations under

Executive Order 13084.

F. Executive Order 13045

This final rule does not require

special consideration pursuant to the

terms of Executive Order 13045, entitled

Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997),

because it is not likely to have an

annual effect on the economy of $100

million or more and it does not have a

potential effect or impact on children.

This final rule establishes testing and

recordkeeping requirements that apply

to manufacturers (including importers)

and processors of certain chemicals, and

will result in the production of

information that will assist the Agency

and others in determining whether the

chemical substances in this final rule

present potential risks, allowing the

Agency and others to take appropriate

action to investigate and mitigate those

risks.

G. Executive Order 13211

This final rule is not a "significant

energy action" as defined in Executive

Order 13211, Actions Concerning

Regulations That Significantly Affect

Energy Supply, Distribution, or Use (66

FR 28355, May 22, 2001) because it is

not likely to have a significant adverse

effect on the supply, distribution, or use

of energy. As such, the Agency has

concluded that this final rule is not

likely to have adverse energy effects.

H. National Technology Transfer and

Advancement Act

As noted in the proposed rule, section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104-113 section

12(d) (15 U.S.C 272 note) directs EPA to

use voluntary consensus standards in its

regulatory activities unless to do so

would be inconsistent with applicable

law or otherwise impractical. Voluntary

consensus standards are technical

standards (e.g., materials specifications,

test methods, sampling procedures, and

business practices) that are developed or

adopted by voluntary consensus

standards bodies. The NTTAA directs

EPA to provide Congress, through OMB,

explanations when the Agency decides

not to use available and applicable

voluntary consensus standards.

Because this final rule involves

technical standards, the Agency

conducted a search to identify

potentially applicable voluntary

consensus standards. No such standards

were identified and none were brought

to the Agency's attention in comments.

Therefore, EPA has decided to use the

in vitro dermal absorption rate test

standard finalized in this document.

This standard was based on the peer

reviewed method of Bronaugh and

Collier which was published in 1991

(Ref. 13) and refined by a panel of

Federal scientists from ITC member and

liaison agencies (including, for example,

CPSC, DoD, EPA, FDA, NIOSH, and

OSHA). The method was further refined

by this panel in response to public

comments.

L Executive Order 12898

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), the Agency has considered

environmental justice-related issues

with regard to the potential impacts of

this action on the environmental and

health conditions in minority and lowincome populations. The Agency

believes that the information collected

under this final rule will assist EPA and

others in determining the hazards and

risks associated with the chemicals

covered by the final rule. Although not

directly impacting environmental

justice-related concerns, this

information will better enable the

Agency to protect human health and the

environment.

J. Congressional Review Act

The Congressional Review Act, 5

U.S.C. 801 et seq., generally provides

that before a rule may take effect, the

Agency promulgating the rule must

submit a rule report to each House of

the Congress and the Comptroller

General of the United States. EPA will

submit a report containing this rule and

other required information to the U.S.

Senate, the U.S. House of

Representatives, and the Comptroller

General of the United States prior to

publication of the rule in the Federal

Register. This rule is not a "major rule"

as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

Environmental protection, Reporting

and recordkeeping requirements.

40 CFR Part 799

Environmental protection, Chemicals,

Hazardous substances, Laboratories,

Reporting and recordkeeping

requirements.

Dated: April 4, 2004.

Susan B. Hazen,

Acting Assistant Administrator, Office of

Prevention, Pesticides and Toxic Substances.

* Therefore, 40 CFR chapter I is

amended as follows:

m 1. By amending part 9 as follows:

PART 9-[AMENDED]

* a. The authority citation for part 9

continues to read as follows:

Authority: 7 U.S.C. 135 et seq., 136-136y;

15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671;

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,

1321, 1326, 1330, 1342, 1344, 1345 (d) and

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,

1971-1975 Comp. p. 973; 42 U.S.C. 241,

242b, 243, 246, 300f, 300g, 300g-1, 300g-2,

300g-3, 300g-4, 300g-5, 300g-6, 300j-1,

300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq.,

6901-6992k, 7401-7671q, 7542, 9601-9657,

11023, 11048.

* b. In § 9.1, the table is amended by

adding an entry for § 799.5115 in

numerical order under the indicated

heading to read as follows:

§9.1 OMB approvals under the Paperwork

Reduction Act.

40 CFR citation OMB control No.

Identification of Specific Chemical Substance

and Mixture Testing Requirements

799.5115 ............................... 2070-0033

* 2. By amending part 799 as follows:

PART 799-[AMENDED]

* a. The authority citation for part 799

continues to read as follows:

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

* b. By adding § 799.5115 to subpart D

to read as follows:

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§ 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

(j) of this section identifies the chemical

substances that must be tested under

this section. For the chemical

substances identified as "Class 1"

substances in Table 2 in paragraph (j) of

this section, the purity of each chemical

substance must be 99% or greater,

unless otherwise specified in this

section. For the chemical substances

identified as "Class 2" substances in

Table 2 in paragraph (j) of this section,

a representative form of each chemical

substance must be tested.

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

you manufacture (including import) or

intend to manufacture, or process or

intend to process, any chemical

substance listed in Table 2 in paragraph

(j) of this section at any time from May

26, 2004, to the end of the test data

reimbursement period as defined in 40

CFR 791.3(h), you are subject to this

section with respect to that chemical

substance.

(2) If you do not know or cannot

reasonably ascertain that you

manufacture or process a chemical

substance listed in Table 2 in paragraph

(j) 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 an unreasonable

burden), you are not subject to this

section with respect to that chemical

substance.

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

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

subject to this section are divided into

two groups, as set forth in Table 1 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.

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

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

section (Tier 1)

Persons not otherwise specified in column 2 of A. Persons who manufacture (as defined at TSCA section 3(7)) or intend to manufacture a

this table that manufacture (as defined at chemical substance included in this section solely as one or more of the following:

TSCA section 3(7)) or intend to manufacture -As a byproduct (as defined at 40 CFR 791.3(c));

a chemical substance included in this sec- -As an impurity (as defined at 40 CFR 790.3);

tion. -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)).

B. Persons who 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 in 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) through (c)(7) and

(c)(10) of this section.

(2) If you are in Tier 1 with respect

to a chemical substance listed in Table

2 in paragraph (j) of this section, you

must, for each test required under this

section for that chemical substance,

either submit to EPA a letter of intent

to test or apply to EPA for an exemption

from testing. The letter of intent to test

or the exemption application must be

received by EPA no later than June 25,

2004.

(3) If you are in Tier 2 with respect

to a chemical substance listed in Table

2 in paragraph (j) 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), (c)(7), or (c)(10) of this

section.

(4) If no person in Tier 1 has notified

EPA of its intent to conduct one or more

of the tests required by this section on

any chemical substance listed in Table

2 in paragraph (j) of this section by June

25, 2004, EPA will publish a Federal

Register document that would specify

the test(s) and the chemical substance(s)

for which no letter of intent has been

submitted, and notify manufacturers in

Tier 2A of their obligation to submit a

letter of intent to test or to apply for an

exemption from testing.

(5) If you are in Tier 2A with respect

to a chemical substance listed in Table

2 in paragraph (j) of this section, and if

you manufacture this chemical

substance as of May 26, 2004, or within

30 days after publication of the Federal

Register document described in

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

must, for each test specified for that

chemical substance in the document

described in paragraph (c)(4) of this

section, either submit to EPA a letter of

intent to test or apply to EPA for an

exemption from testing. The letter of

intent to test or the exemption

application must be received by EPA no

later than 30 days after publication of

the document described in paragraph

(c)(4) of this section.

(6) If no manufacturer in Tier 1 or Tier

2A has notified EPA of its intent to

conduct one or more of the tests

required by this section on any chemical

substance listed in Table 2 in paragraph

(j) of this section within 30 days after

the publication of the Federal Register

document described in paragraph (c)(4)

of this section, EPA will publish another

Federal Register document that would

specify the test(s) and the chemical

substance(s) for which no letter of intent

has been submitted, and notify

processors in Tier 2B of their obligation

to submit a letter of intent to test or to

apply for an exemption from testing.

(7) If you are in Tier 2B with respect

to a chemical substance listed in Table

2 in paragraph (j) of this section, and if

you process this chemical substance as

of May 26, 2004, or within 30 days after

publication of the Federal Register

document described in paragraph (c)(6)

of this section, you must, for each test

specified for that chemical substance in

the document described in paragraph

(c)(6) of this section, either submit to

EPA a letter of intent to test or apply to

EPA for an exemption from testing. The

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letter of intent to test or the exemption

application must be received by EPA no

later than 30 days after publication of

the document described in paragraph

(c)(6) of this section.

(8) If no manufacturer or processor

has notified EPA of its intent to conduct

one or more of the tests required by this

section for any of the chemical

substances listed in Table 2 in

paragraph (j) of this section within 30

days after the publication of the Federal

Register document described in

paragraph (c)(6) of this section, EPA will

notify all manufacturers and processors

of those chemical substances of this fact

by certified letter or by publishing a

Federal Register document specifying

the test(s) for which no letter of intent

has been submitted. This letter or

Federal Register document will

additionally notify all manufacturers

and processors that all exemption

applications concerning the test(s) have

been denied, and will give the

manufacturers and processors of the

chemical substance(s) an opportunity to

take corrective action.

(9) If no manufacturer or processor

has notified EPA of its intent to conduct

one or more of the tests required by this

section for any of the chemical

substances listed in Table 2 in

paragraph (j) of this section within 30

days after receipt of the certified letter

or publication of the Federal Register

document described in paragraph (c)(8)

of this section, all manufacturers and

processors subject to this section with

respect to that chemical substance who

are not already in violation of this

section will be in violation of this

section.

(10) If a problem occurs with the

initiation, conduct, or completion of the

required testing or the submission of the

required data with respect to a chemical

substance listed in Table 2 in paragraph

(j) of this section, under the procedures

in § § 790.93 and 790.97 of this chapter,

EPA may initiate termination

proceedings for all testing exemptions

with respect to that chemical 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.

(11) If you are required to comply

with this section, but your

manufacturing or processing of a

chemical substance listed in Table 2 in

paragraph (j) of this section begins after

the applicable compliance date referred

to in paragraphs (c)(2), (c)(5), (c)(7), or

(c)(10) of this section, you must either

submit a letter of intent to test or apply

to EPA for an exemption. The letter of

intent to test or the exemption

application must be received by EPA no

later than the day you begin

manufacturing or processing.

(d) What must I do to comply with

this section? (1) To comply with this

section you must either submit to EPA

a letter of intent to test, or apply to and

obtain from EPA an exemption from

testing.

(2) For each test with respect to which

you submit to EPA a letter of intent to

test, you must conduct the testing

specified in paragraph (h) of this section

and submit the test data to EPA.

(3) You must also comply with the

procedures governing test rule

requirements in part 790 of this chapter,

as modified by this section, including

the submission of letters of intent to test

or exemption applications, the conduct

of testing, and the submission of data;

Part 792-Good Laboratory Practice

Standards of this chapter; and this

section. The following provisions of 40

CFR part 790 do not apply to this

section: Paragraphs (a), (d), (e), and (f)

of § 790.45; paragraph (a)(2) and

paragraph (b) of § 790.80; and § 790.48.

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

when will I be considered in violation of

it? You will be considered in violation

of this section as of 1 day after the date

by which you are required to comply

with this section.

(f) How are EPA's data reimbursement

procedures affected for purposes of this

section? If persons subject to this section

are unable to agree on the amount or

method of reimbursement for test data

development for one or more chemical

substances included in this section, any

person may request a hearing as

described in 40 CFR part 791. In the

determination of fair reimbursement

shares under this section, if the hearing

officer chooses to use a formula based

on production volume, the total

production volume amount will include

amounts of a chemical substance

produced as an impurity.

(g) Who must comply with the export

notification requirements? Any person

who exports, or intends to export, a

chemical substance listed in Table 2 in

paragraph (j) of this section is subject to

part 707, subpart D, of this chapter.

(h) How must I conduct my testing?

The chemical substances identified by

Chemical Abstract Service Registry

Number (CAS No.) and chemical name

in Table 2 in paragraph (j) of this section

must be tested as follows:

(1) Applicability. This in vitro dermal

absorption rate test standard must be

used for all testing conducted under this

section. In certain instances,

modifications to the test standard may

be considered. The procedures for

applying for a modification to the test

standard are specified in 40 CFR 790.55.

(2) Source. The test standard is based

on the Protocol for In Vitro

Percutaneous Absorption Rate Studies,

referenced in paragraph (h)(8)(v) of this

section.

(3) Purpose. In the assessment and

evaluation of the characteristics of a

chemical substance or mixture for

which testing is required under this

section (test substance), it is important

to determine the rate of absorption of

the test substance in cases where dermal

exposure to the test substance in the

workplace may result in systemic

toxicity. This test standard is designed

to develop data that describe the rate at

which test substances are absorbed

through the skin so that the body

burden of a test substance resulting from

dermal exposure in the workplace can

be better evaluated.

(4) Principles of the test standard.

This test standard describes procedures

for measuring a permeability constant

(Kp) and two short-term dermal

absorption rates for test substances in

liquid form. The test standard utilizes in

vitro diffusion cell techniques which

allow absorption studies to be

conducted with human cadaver skin. In

vitro diffusion studies are necessary for

measuring a Kp. This test standard

specifies the use of static or flowthrough diffusion cells and non-viable

human cadaver skin. It also requires the

use of radiolabeled test substances

unless it can be demonstrated that

procedures utilizing a non-radiolabeled

test substance are able to measure the

test 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. This

test standard does not require use of live

skin, or the maintenance of skin

viability during the course of the

experiment. However, the time elapsed

between death and harvest of tissue

must be reported.

(B) Number of skin samples. Data for

the determination of a Kp must be

obtained from a minimum of six skin

samples and the skin samples must

come from at least three different

human subjects (two skin samples from

each subject) in order to allow for

biological variation between subjects.

Data for the determination of each shortterm (i.e., 10 minute and 60 minute)

absorption rate must be obtained from a

minimum of six skin samples and the

skin samples must come from at least

three different human subjects (two skin

samples from each subject).

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(C) Anatomical region. In order to

minimize the variability in skin

absorption measurements for these tests,

samples of human cadaver skin must be

obtained from the abdominal region of

human subjects of known source and

disease state.

(D) Validation of human cadaver skin

barrier. Prior to conducting an

experiment with the test substance,

barrier properties of human cadaver

skin must be pretested either by:

(1) Measuring the absorption of a

standard compound such as tritiated

water as discussed, for example, in the

reference in paragraph (h)(8)(i) of this

section;

(2) Determining an electrical

resistance to an alternating current, at

up to two volts; or

(3) Measuring trans-epidermal water

loss from the stratum corneum.

(ii) Preparation of membrane. Full

thickness skin must not be used. A

suitable membrane must be prepared

from skin either with a dermatome at a

thickness of 200 to 500 micrometers

(um), or with heat separation by treating

the skin at 600 C for 45 seconds to 2

minutes after which the epidermis can

be peeled from the dermis. These

epidermal membranes can be stored

frozen (-20' C) for up to 3 months, if

necessary, if they are frozen quickly and

the barrier properties of the samples are

confirmed immediately prior to

commencement of the experiment.

(iii) Diffusion cell design. Either static

or flow-through diffusion cells must be

used in these studies. To ensure that an

increase in concentration of the test

substance in the receptor fluid does not

alter penetration rate, the testing

laboratory must verify that the

concentration of the test substance in

the receptor fluid is less than 10% of the

initial concentration in the donor

chamber. Concentration of the neat (i.e.,

undiluted) liquid must be taken as the

density of the test substance.

(iv) Temperature. Skin must be

maintained at a physiological

temperature of 320 C during the test.

(v) Testing hydrophobic chemicals.

When testing hydrophobic chemicals,

polyethoxyoleate (polyethylene glycol

(PEG) 20 oleyl ether) must be added to

the receptor fluid at a concentration of

6%.

(vi) Vehicle. If the test substance is a

liquid at room temperature and does not

damage the skin during the

determination of Kp, it must be applied

neat. If the test substance 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 test substance in water

is not high enough so that a steady-state

absorption can be obtained, the test

substance 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 substance as described in

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

(vii) Dose-(A) Kp. A Kp must be

determined for each test chemical. An

"infinite dose" of the test substance

must be applied to the skin to achieve

the steady-state rate of absorption

necessary for calculation of a Kp.

Infinite dose is defined as the

concentration of a test substance

required to give an undepletable

reservoir on the surface of the skin. The

actual concentration required to give an

undepletable reservoir on the surface of

the skin depends on the rate of

penetration of the test substance.

Preliminary studies may be necessary to

determine this concentration.

Percutaneous absorption must be

determined under occluded (i.e.,

covered) conditions unless it is

demonstrated that such conditions

cause leakage of material or damage to

the skin membrane as a result of

unrealistically high pressures or

excessive hydration. Skin barrier

integrity must be verified at the end of

the experiment by the methods

discussed in paragraph (h)(5)(i)(D) of

this section.

(B) Short-term absorption rates. 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 diffusion cells must be set up using

skin from a single subject. Two

diffusion cells must be terminated at 10

minutes. The remaining two diffusion

cells must be terminated at 60 minutes.

Skin absorption at each sampling time

is the sum of the receptor fluid levels

and the absorbed test substance that

remains in the skin, as discussed, for

example, in the reference in paragraph

(h)(8)(iii) of this section. Unabsorbed

chemical must be removed from the

skin surface by washing gently with

soap and water. This experiment must

be repeated with skin from two

additional subjects. In order to ensure

reliable short-term absorption rates,

percutaneous absorption must be

determined under occluded conditions

unless it is demonstrated that such

conditions cause leakage of material or

damage to the skin membrane as a result

of unrealistically high pressures or

excessive hydration.

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

vitro dermal absorption rate test must be

performed until at least four absorption

measurements per diffusion cell

experiment are obtained during the

steady-state absorption portion of the

experiment. A preliminary study may be

useful to establish time points for

sampling. The required absorption

measurements can be accomplished in

an hour or two with fast-penetrating

chemicals but may require 24 hours or

longer for slow-penetrating chemicals.

Unabsorbed test substance need not be

removed from the surface of the skin

after each experiment.

(B) Short-term absorption rates. The

test substance must be applied to skin

for durations of 10 and 60 minutes. At

the end of the study, the unabsorbed test

substance 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, for example, in the

reference in paragraph (h)(8)(iii) of this

section.

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

calculated by dividing the steady-state

rate of absorption (measured in

micrograms (ug) x hr -1 x centimeters

(cm) -

2) by the concentration of the test

substance (measured in ug x cm -

3)

applied to the skin. (For example, if the

steady-state rate is 1 microgram x hr1 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-1.) The mean and standard

deviation of the calculated Kp values for

all diffusion cell experiments must be

determined.

(ii) Short-term absorption rate. The

absorption rates (ug x hr- x cm -

2) must

be determined from the total amount of

test substance found in the receptor

fluid and skin after the 10-minute and

60-minute exposures for each diffusion

cell experiment. The mean and standard

deviation of 10-minute short-term

absorption rates from all experiments

must be calculated. The mean and

standard deviation of 60-minute shortterm absorption rates from all

experiments must also be calculated.

(7) Test report. In addition to

compliance with the TSCA Good

Laboratory Practice Standards (GLPS) at

40 CFR part 792, the following specific

information must be collected and

reported by the date in 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 GLPS statement. These

statements must be certified by the

signatures of the individuals performing

the work and their supervisors.

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(B) A description of the source,

identity, and purity of the test substance

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 static or flow-through

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 mean Kp and mean

short-term absorption rates must be

presented along with their standard

deviations and the number of diffusion

cell experiments. In addition, all raw

data from each individual diffusion cell

must be retained to support the

calculations of permeability constants

and short-term absorption rates. When a

radiolabeled test substance is 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. For background

information on this test standard, the

following references may be consulted.

These references are available under

docket ID number OPPT-2003-0006 at

the EPA Docket Center, Rm. B102-

Reading Room, EPA West, 1301

Constitution Ave., NW., Washington,

DC, from 8:30 a.m. to 4:30 p.m., Monday

through Friday, excluding legal

holidays.

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

Simon, M. Methods for In Vitro

Percutaneous Absorption Studies VII:

Use of Excised Human Skin. Journal of

Pharmaceutical Sciences. 75:1094-

1097. 1986.

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

Methods for In Vitro Percutaneous

Absorption Studies IV: The FlowThrough Diffusion Cell. Journal of

Pharmaceutical Sciences. 74:64-67.

1985.

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

Storm, J.E. Extent of Cutaneous

Metabolism During Percutaneous

Absorption of Xenobiotics. Toxicology

and Applied Pharmacology. 99:534-

543. 1989.

(iv) 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.

Dermatotoxicology. F. Marzulli and H.

Maibach, Eds. Taylor & Francis,

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

(v) 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.

(i) Reporting requirements. The

reports submitted under this section

must include the information specified

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

final report for each chemical substance

must be received by EPA by June 27,

2005, unless an extension is granted in

writing pursuant to 40 CFR 790.55.

(j) Designation of specific chemical

substances for testing. The chemical

substances identified by chemical name,

CAS No., and class in Table 2 of this

paragraph must be tested in accordance

with the testing requirements in

paragraph (h) of this section and the

requirements described in 40 CFR part

792.

TABLE 2.-CHEMICAL SUBSTANCES DESIGNATED FOR TESTING

CAS No. Chemical name Class

75-05-8 Acetonitrile 1

75-15-0 Carbon disulfide 1

75-35-4 Vinylidene chloride 1

77-73-6 Dicyclopentadiene 1

77-78-1 Dimethyl sulfate 1

78-59-1 Isophorone 1

78-87-5 Propylene dichloride 1

79-20-9 Methyl acetate 1

79-46-9 2-Nitropropane 1

91-20-3 Naphthalene 1

92-52-4 Biphenyl 1

98-29-3 tert-Butylcatechol 1

100-00-5 p-Nitrochlorobenzene 1

100-01-6 p-Nitroaniline 1

100-44-7 Benzyl chloride 1

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TABLE 2.-CHEMICAL SUBSTANCES DESIGNATED FOR TESTING-Continued

CAS No. Chemical name Class

106-42-3 p-Xylene 1

106-46-7 p-Dichlorobenzene 1

107-06-2 Ethylene dichloride 1

107-31-3 Methyl formate 1

108-03-2 1 -Nitropropane 1

108-90-7 Chlorobenzene 1

108-93-0 Cyclohexanol 1

109-66-0 Pentane 1

109-99-9 Tetrahydrofuran 1

110-12-3 Methyl isoamyl ketone 1

111-84-2 Nonane 1

120-80-9 Catechol 1

122-39-4 Diphenylamine 1

123-42-2 Diacetone alcohol 1

127-19-5 Dimethyl acetamide 1

142-82-5 n-Heptane 1

150-76-5 p-Methoxyphenol 1

25013-15-4 Vinyl toluene 2

34590-94-8 Dipropylene glycol methyl ether 2

(k) Effective date This section is

effective on May 26, 2004.

[FR Doc. 04-9409 Filed 4-23-04; 8:45 am]

BILLING CODE 6560-50-S

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[CA 083-0436a; FRL-7650-4]

Revisions to the California State

Implementation Plan, San Joaquin

Valley Unified Air Pollution Control

District

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: EPA is taking direct final

action to approve revisions to the San

Joaquin Valley Unified Air Pollution

Control District (SJVUAPCD) portion of

the California State Implementation

Plan (SIP). The revisions concern stack

monitoring, source sampling, and the

emission of volatile organic compounds

from bakery ovens. We are approving

local rules that are administrative or

regulate this emission source under the

Clean Air Act as amended in 1990 (CAA

or the Act).

DATES: This rule is effective on June 25,

2004 without further notice, unless EPA

receives adverse comments by May 26,

2004. If we receive such comments, we

will publish a timely withdrawal in the

Federal Register to notify the public

that this rule will not take effect.

ADDRESSES: Send comments to Andy

Steckel, Rulemaking Office Chief (AIR4), U.S. Environmental Protection

Agency, Region IX, 75 Hawthorne

Street, San Francisco, CA 94105, or email to steckel.andrew@epa.gov, or

submit comments at http://

www.regulations.gov.

You can inspect a copy of the

submitted rule or rule revisions and

EPA's technical support document

(TSD) at our Region IX office during

normal business hours. You may also

see a copy of the submitted rule or rule

revisions and TSD at the following

locations:

Environmental Protection Agency, Air

Docket (6102), Ariel Rios Building,

1200 Pennsylvania Avenue, NW.,

Washington DC 20460

California Air Resources Board,

Stationary Source Division, Rule

Evaluation Section, 1001 "I" Street,

Sacramento, CA 95814

San Joaquin Valley Unified Air

Pollution Control District, 1990 East

Gettysburg Street, Fresno, CA 93726

A copy of the rule may also be

available via the Internet at http://

www.arb.ca.gov/drdb/drdbltxt.htm.

Please be advised that this is not an EPA

Web site and may not contain the same

version of the rule that was submitted

to EPA.

FOR FURTHER INFORMATION CONTACT: Al

Petersen, Rulemaking Office (AIR-4),

U.S. Environmental Protection Agency,

Region IX, (415) 947-4118,

petersen.alfred@epa.gov.

SUPPLEMENTARY INFORMATION:

Throughout this document, "we," "us"

and "our" refer to EPA.

Table of Contents

I. The State's Submittal

A. What rules did the State submit?

B. Are there other versions of these rules?

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