22402 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 

G000 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 Doc. 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 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22403

(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 31st, 32nd, and 35th 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 31st, 32nd, and 35th 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 34th 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 

35th 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 31st, 32nd, 

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 

22404 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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). 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22405

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 VII.D., 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 

22406 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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 VII.D., 

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 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22407

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 36th 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 31st, 32nd, and 35th 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 

22408 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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, 32nd, and 35th 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 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22409

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 60° C 

22410 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22411

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. 

l. 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 

22412 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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-shelf. 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 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22413

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 CS2 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 

22414 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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 (5th 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 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22415

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 

22416 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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. 

I. 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 III.I.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/O, 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 

III.I.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 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22417

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:

[ACC] 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 III.I.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 

22418 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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. 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22419

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 

22420 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22421

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 

have not historically participated in 

reimbursement because other 

manufacturers have always created costVerDate jul<14>2003 15:03 Apr 23, 2004 Jkt 203001 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 E:\FR\FM\26APR1.SGM 26APR1
22422 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22423

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 

22424 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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 IV.E.). 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 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22425

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–C14 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 1 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.

22426 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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

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

Persons who manufacture (as defined at TSCA 

section 3(7)), or intend to manufacture, a 

test rule substance who are not listed under 

Tier 2

Tier 2A 

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

rule substance solely as one or more of the following: 

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

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

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

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

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

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

790.42(a)(4)); or 

—In small quantities solely for research and development (as described at 40 CFR 

790.42(a)(5)) 

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)) 

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 

III.I.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 1 and Tier 2 and who would be 

excluded from the rule? Under 40 CFR 

790.2, EPA may establish procedures 

applying to specific test rules that differ 

from the generic procedures governing 

TSCA section 4 test rules in 40 CFR part 

790. For the purposes of this final rule, 

EPA is setting forth certain requirements 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22427

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.). 

I. 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 N,Ndimethylaniline. 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 

22428 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22429

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-Amyl 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. 

22430 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

I. Ethyl Bromide, o-Chlorotoluene, 

Disulfiram, and N,N-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 N,Ndimethylaniline (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 N,N-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. 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22431

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 35th 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: 

22432 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22433

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 

Amyl 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.gov/

chemrtk/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). 

22434 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22435

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 

22436 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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. 

I. 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:

■ 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:

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22437

§ 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 

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

Persons not otherwise specified in column 2 of 

this table that manufacture (as defined at 

TSCA section 3(7)) or intend to manufacture 

a chemical substance included in this section. 

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

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

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

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

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

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

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

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

790.42(a)(4)); or 

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

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 

22438 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

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). 

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22439

(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 60° 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 32° 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 hr-1 x 

cm-2 and the concentration applied to 

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

then the Kp value is calculated to be 

0.001 cm x hr-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-1 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. 

22440 Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 

(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

Federal Register / Vol. 69, No. 80 / Monday, April 26, 2004 / Rules and Regulations 22441

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 (AIR–

4), 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?