[Federal Register Volume 64, Number 110 (Wednesday, June 9, 1999)]
[Proposed Rules]
[Pages 31074-31090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14640]



[[Page 31073]]

_______________________________________________________________________

Part VI





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 799



Proposed Test Rule for In Vitro Dermal Absorption Rate Testing of 
Certain Chemicals of Interest to Occupational Safety and Health 
Administration; Proposed Rule

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

[[Page 31074]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 799

[OPPTS-42196; FRL-5760-3]
RIN 2070-AB07


Proposed Test Rule for In Vitro Dermal Absorption Rate Testing of 
Certain Chemicals of Interest to Occupational Safety and Health 
Administration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is proposing a test rule under section 4(a) of the Toxic 
Substances Control Act (TSCA) to require manufacturers, importers, and 
processors of 47 chemical substances of interest to the Occupational 
Safety and Health Administration (OSHA) to conduct in vitro dermal 
absorption rate testing. These chemicals, and others, were designated 
for in vitro dermal absorption rate testing in the 31st, 32nd, and 35th 
Reports of the TSCA Section 4(e) Interagency Testing Committee (ITC) to 
the EPA Administrator. The dermal absorption rate data obtained under 
this testing program would be used to support OSHA's development of 
``skin designations'' for the chemical substances included in this 
proposed rule. Skin designations are used by OSHA to provide specific 
guidance to employers concerning whether changes should be made to 
processes involving chemical substances in order to reduce the hazard 
of systemic toxicity from dermal absorption of these chemicals. Changes 
to a process might include changes in engineering controls or changes 
in the use of or type of personal protective equipment. Skin 
designations alert industrial hygienists, employers, and workers to 
potential adverse health effects resulting from dermal exposure to 
chemicals in the workplace. Persons who export or intend to export any 
chemical substance included in the final rule based on this proposed 
rule will be subject to the export notification requirements in TSCA 
section 12(b)(1).

DATES: Comments, identified by docket control number OPPTS-42196, must 
be received by EPA on or before August 9, 1999. Your request to present 
oral comments must be in writing and must be received by EPA on or 
before July 9, 1999.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Follow the detailed instructions for each method as provided in 
Unit I.C. of the ``SUPPLEMENTARY INFORMATION'' section of this 
preamble. To ensure proper receipt by EPA, your comments must identify 
docket control number OPPTS-42196 in the subject line on the first page 
of your response.

FOR FURTHER INFORMATION CONTACT: For general information: Christine 
Augustyniak, Associate Director, Environmental Assistance Division 
(7408), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone 
number: (202) 554-1404; TDD: (202) 554-0551; e-mail address: TSCA-
H[email protected].
    For technical information: Keith Cronin, Project Manager, Chemical 
Control Division (7405), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; 
telephone number: (202) 260-8157; fax number: (202) 260-1096; e-mail 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does This Action Apply To Me?

    You may be affected by this action, if you manufacture (defined by 
statute to include import) or process any of the chemical substances 
that are listed in Table 2 of this unit. Use of the term 
``manufacture'' in this preamble will encompass ``import,'' unless 
otherwise stated. In addition, as described in Unit VI. of this 
preamble, once the Agency issues the final rule, any person who 
exports, or intends to export, one of these chemical substances will be 
subject to the export notification requirements in 40 CFR part 707, 
subpart D. The export notification requirements do not apply until the 
Agency issues a final test rule, and then, only apply to exports of the 
chemical substances that are contained in the final test rule. 
Therefore, entities potentially affected by this proposed rule may 
include, but are not limited to:


                  Table 1.-- Entities Potentially Affected by the Proposed Testing Requirements
----------------------------------------------------------------------------------------------------------------
                                                                                         Examples of potentially
           Type of entity                       SIC                     NAICS               affected entities
----------------------------------------------------------------------------------------------------------------
Chemical manufacturers and importers  28, 2911                 325, 32411               Persons who manufacture
                                                                                         (defined by statute to
                                                                                         include import) one or
                                                                                         more of the subject
                                                                                         chemical substances
-------------------------------------
Chemical processors                   28, 2911                 325, 32411               Persons who process one
                                                                                         or more of the subject
                                                                                         chemical substances.
----------------------------------------------------------------------------------------------------------------


    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in Table 1 of this unit 
could also be affected. The Standard Industrial Classification (SIC) 
codes and the North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business is affected by this action, you should 
carefully examine the applicability provisions in Unit V.C. of this 
preamble entitled ``Would I Be Required To Test Under This Rule?'' and 
consult the proposed regulatory text in Sec. 799.5115. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the technical person listed in ``FOR FURTHER 
INFORMATION CONTACT'' at the beginning of the preamble.
    If you are an entity identified in Table 1 of this unit, you would 
only be subject to the testing requirements contained in this proposed 
rule if you manufacture or process any of the 47 chemical substances 
that are listed in Table 2 of this unit.


       Table 2.--List of Chemical Substances Proposed for Testing
------------------------------------------------------------------------
                 CAS No.                         Chemical substance
------------------------------------------------------------------------
60-29-7                                    Ethyl ether
74-96-4                                     Ethyl bromide
75-05-8                                    Acetonitrile
75-15-0                                    Carbon disulfide
75-35-4                                    Vinylidene chloride
77-73-6                                     Dicyclopentadiene
77-78-1                                     Dimethyl sulfate
78-59-1                                     Isophorone
78-83-1                                     Isobutyl alcohol
78-87-5                                     Propylene dichloride
78-92-2                                    sec-Butyl alcohol
79-20-9                                     Methyl acetate
79-46-9                                     2-Nitropropane
91-20-3                                     Naphthalene

[[Page 31075]]

 
92-52-4                                     Biphenyl
95-49-8                                     o-Chlorotoluene
95-50-1                                    o-Dichlorobenzene
97-77-8                                     Disulfiram
98-29-3                                     tert-Butylcatechol
99-99-0                                    p-Nitrotoluene
100-00-5                                   p-Nitrochlorobenzene
100-01-6                                   p-Nitroaniline
100-44-7                                    Benzyl chloride
106-42-3                                    p-Xylene
106-46-7                                    p-Dichlorobenzene
107-06-2                                    Ethylene dichloride
107-31-3                                    Methyl formate
108-03-2                                    1-Nitropropane
108-90-7                                    Chlorobenzene
108-93-0                                    Cyclohexanol
109-66-0                                    Pentane
109-99-9                                    Tetrahydrofuran
110-12-3                                    Methyl isoamyl ketone
111-84-2                                    Nonane
120-80-9                                    Catechol
121-69-7                                    Dimethylaniline
122-39-4                                    Diphenylamine
123-42-2                                    Diacetone alcohol
126-99-8                                    beta-Chloroprene
127-19-5                                    Dimethyl acetamide
142-82-5                                   n-Heptane
150-76-5                                    p-Methoxyphenol
528-29-0                                   o-Dinitrobenzene
628-63-7                                    n-Amyl acetate
768-52-5                                   N-Isopropylaniline
25013-15-4                                  Vinyl toluene
34590-94-8                                  Dipropylene glycol methyl
                                            ether
------------------------------------------------------------------------


B. How Can I Get Additional Information or Copies of This Document or 
Other Documents?

    1. Electronically. You may obtain electronic copies of this 
document and other documents from the EPA Internet EPA Home Page at 
http://www.epa.gov/. On the Home Page select ``Law and Regulations'' 
and then look up the entry for this document under ``Federal Register--
Environmental Documents.'' You can also go directly to the Federal 
Register listings at http://www.epa.gov/fedrgstr/.
    2. In person . The official record for this proposed rule, which 
includes the public version, has been established under docket control 
number OPPTS-42196. The official record consists of the documents 
referenced in this preamble (see Unit VIII. of this preamble), as well 
as the public comments that will be received during the comment period, 
and other information related to this rulemaking, including information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as all documents that are referenced in those 
documents. The public version of the offical record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments that may be submitted as described in Unit I.C. and D. of this 
preamble, is available for inspection in the TSCA Nonconfidential 
Information Center, Rm. NE B-607, 401 M St., SW., Washington, DC. The 
Center is open from 12 noon to 4 p.m., Monday through Friday, excluding 
legal holidays. The telephone number of the Center is (202) 260-7099.

C. How and To Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, your comments must 
identify docket control number OPPTS-42196 in the subject line on the 
first page of your response.
    1. By mail. Submit comments to: Document Control Office (7407), 
Office of Pollution Prevention and Toxics, Environmental Protection 
Agency, 401 M St., SW., East Tower, Rm. G-099, Washington, DC 20460.
    2. In person or by courier. Deliver comments to: Document Control 
Office, Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 401 M St., SW., East Tower, Rm. G-099, Washington, 
DC. The telephone number for the OPPT Document Control Office is (202) 
260-7093.
    3. Electronically. Submit your comments electronically by e-mail 
to: [email protected], or you may mail or deliver your computer disk to 
the addresses identified in Units I.C.1. or 2. of this preamble. Do not 
submit any information electronically that you consider to be CBI. 
Submit comments as an ASCII file, avoiding the use of special 
characters and any form of encryption. Comments will also be accepted 
on standard disks in WordPerfect 5.1/6.1 or ASCII file format. All 
copies of electronic comments must be identified by docket control 
number OPPTS-42196. Electronic comments may be filed online at many 
Federal Depository Libraries.

D. How Should I Handle CBI Information That I Want To Submit To The 
Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit in response to this 
document as CBI by marking any part or all of that information as CBI. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comments that include any information claimed as CBI, a 
copy of the comments that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record by EPA without prior 
notice. If you have any questions about CBI or the procedures for 
claiming CBI, consult the technical person identified in ``FOR FURTHER 
INFORMATION CONTACT''at the beginning of this preamble.

E. Can I Request An Opportunity To Present Oral Comments To The Agency?

    You may submit a request for an opportunity to present oral 
comments. This request must be in writing. If such a request is 
received on or before July 9, 1999, EPA will hold a public meeting on 
this proposed rule in Washington, DC. This written request must be 
submitted to the address provided in Unit I.C. of this preamble. If 
such a request is received, EPA will announce the scheduling of the 
public meeting in a subsequent Federal Register document. If a public 
meeting is announced, and if you are interested in attending or 
presenting oral and/or written comments at the public meeting, you 
should follow the instructions provided in the subsequent Federal 
Register document announcing the public meeting.

F. What Should I Consider as I Prepare My Comments For EPA?

    We invite you to provide your views on the various options we 
propose, new approaches we have not considered, the potential impacts 
of the various options (including possible unintended consequences), 
and any data or information that you would like the Agency to consider 
during the development of the final rule. You may find the following 
suggestions helpful for preparing your comments:
      Explain your views as clearly as possible.
      Describe any assumptions that you used.
      Provide copies of any technical information and/or data 
you used that support your views.
      If you estimate potential burden or costs, explain how 
you arrived at the estimate.
      Provide specific examples to illustrate your concerns.
      Offer alternative ways to improve the rule or collection 
activity.

[[Page 31076]]

      Make sure to submit your comments by the deadline in this 
document.
      At the beginning of your comments, be sure to properly 
identify the document you are commenting on. To ensure proper receipt 
by EPA, your comments must identify the docket control number assigned 
to this action in the subject line on the first page of your response. 
You may also provide the name, date, and Federal Register citation.

G. Are There Issues On Which EPA Is Particularly Interested In 
Receiving Comment?

    EPA invites comment on any aspect of this proposed rule. EPA is 
particularly interested in specific comments on the approach discussed 
in Unit V.C. of this preamble, entitled ``Would I Be Required To Test 
Under This Rule?''

II. Authority

    This document proposes a test rule under TSCA section 4(a) (15 
U.S.C 2603(a)) that would require an in vitro dermal absorption rate 
test for 47 of the chemical substances designated by the ITC for this 
testing.
    Section 2(b)(1) of TSCA (15 U.S.C. 2601(b)(1)) states that it is 
the policy of the United States that ``adequate data should be 
developed with respect to the effect of chemical substances and 
mixtures on health and the environment and that the development of such 
data should be the responsibility of those who manufacture and those 
who process such chemical substances and mixtures [.]'' To implement 
this policy, TSCA section 4(a) mandates that EPA require by rule that 
manufacturers and processors of chemical substances and mixtures 
conduct testing if the Administrator finds that:

    (1)(A)(i) the manufacture, distribution in commerce, processing, 
use, or disposal of a chemical substance or mixture, or that any 
combination of such activities, may present an unreasonable risk of 
injury to health or the environment,
    (ii) there are insufficient data and experience upon which the 
effects of such manufacture, distribution in commerce, processing, 
use, or disposal of such substance or mixture or of any combination 
of such activities on health or the environment can reasonably be 
determined or predicted, and
    (iii) testing of such substance or mixture with respect to such 
effects is necessary to develop such data; or
    (B)(i) a chemical substance or mixture is or will be produced in 
substantial quantities, and (I) it enters or may reasonably be 
anticipated to enter the environment in substantial quantities or 
(II) there is or may be significant or substantial human exposure to 
such substance or mixture,
    (ii) there are insufficient data and experience upon which the 
effects of the manufacture, distribution in commerce, processing, 
use, or disposal of such substance or mixture or of any combination 
of such activities on health or the environment can reasonably be 
determined or predicted, and
    (iii) testing of such substance or mixture with respect to such 
effects is necessary to develop such data [.]

    If EPA makes these findings for a chemical substance or mixture, 
the Administrator must require by rule that testing be conducted on 
that chemical substance or mixture. The purpose of the testing would be 
to develop data about the substance or mixture's health and 
environmental effects for which there is an insufficiency of data and 
experience, and which are relevant to a determination that the 
manufacture, distribution in commerce, processing, use, or disposal of 
the substance or mixture, or any combination of such activities, does 
or does not present an unreasonable risk of injury to health or the 
environment.
    Once the Administrator has made a finding under TSCA section 
4(a)(1)(A)(i) (i.e., a finding that a chemical substance may present an 
unreasonable risk of injury to health or the environment) or a finding 
under TSCA section 4(a)(1)(B)(i) (i.e., a finding that a chemical 
substance is or will be produced in substantial quantities and either 
it may enter the environment in substantial quantities or there may be 
significant or substantial human exposure to the chemical substance), 
EPA may require any type of health or environmental effects testing 
necessary to address unanswered questions about the effects of the 
chemical substance. EPA need not limit the scope of testing required to 
the factual basis for the TSCA section 4(a)(1)(A)(i) or (B)(i) 
findings, as long as EPA also finds that there are insufficient data 
and experience upon which the effects of the manufacture, distribution 
in commerce, processing, use, or disposal of such substance or mixture 
or of any combination of such activities on health or the environment 
can reasonably be determined or predicted, and that testing is 
necessary to develop such data. This approach is explained in more 
detail in EPA's statement of policy for making findings under TSCA 
section 4(a)(1)(B) (frequently described as the ``B'' policy) in the 
Federal Register of May 14, 1993 (58 FR 28736, 28738-28739).
    In this proposed rule, EPA intends to use its broad TSCA section 
4(a) authority to obtain dermal absorption rate data necessary to 
support OSHA's development of ``skin designations'' (see Unit III.C. of 
this preamble) for the 47 chemical substances included in the proposed 
rule. EPA has made preliminary findings for these chemicals under TSCA 
section 4(a)(1)(B) that: They are produced in substantial quantities; 
there is or may be substantial human exposure to them; existing data 
are insufficient to determine or predict their health effects; and 
testing is necessary to develop such data.
    Under TSCA section 10(b), EPA is responsible, through an 
interagency committee, for collecting data and disseminating the data 
to other Federal agencies, such as OSHA, as the Agency is proposing in 
this document. EPA has used its TSCA section 4(a) authority in the past 
to support regulatory programs of other EPA offices as well as other 
Federal agencies needing health and/or environmental effects test data. 
See, e.g., the final test rule for the Office of Water Chemicals (58 FR 
59667, 59673 November 10, 1993).

III. Background

A. Why Is EPA Proposing To Take This Action?

    Under TSCA section 4(e)(1), the ITC is responsible for recommending 
chemical substances and mixtures to the EPA Administrator for priority 
testing consideration. The chemical substances and mixtures so 
designated by the ITC comprise a list called the Priority Testing List. 
OSHA nominated 658 chemical substances and mixtures for ITC review in 
September 1991. The results of the ITC's review were published in the 
Federal Register issues of May 5, 1993 (58 FR 26898, 26900) and July 
16, 1993 (58 FR 38490, 38492-38493). OSHA requested that the ITC assess 
the availability of data relevant to dermal absorption for these 
chemical substances and mixtures and determine the need for further 
testing (58 FR 26898, 26900, May 5, 1993). OSHA indicated to the ITC 
that it needed quantitative measures of dermal absorption to evaluate 
the potential hazard of these chemicals to workers (58 FR 38490, 38492, 
July 16, 1993). These quantitative measures are expressed as the dermal 
absorption rate for a particular chemical (59 FR 35720, 35725, July 13, 
1994).
    In its 31st, 32nd, and 35th ITC Reports to the EPA Administrator 
(58 FR 26898, May 5, 1993; 58 FR 38490, July 16, 1993; and 59 FR 67596, 
December 29, 1994, respectively), the ITC designated for in vitro 
dermal absorption rate testing a total of 83 of the chemical substances 
nominated by OSHA. In reducing OSHA's list of 658 chemicals to 83 
chemicals, the ITC

[[Page 31077]]

grouped the nominated chemicals into categories as a means of 
prioritizing the chemicals for consideration. Chemicals that were 
assigned to categories such as polymers, pesticides, and 
chloroflurocarbons were eliminated from consideration by the ITC. They 
were eliminated because, among other reasons, they are regulated under 
other Federal authorities or because EPA, under TSCA, does not have the 
authority to require the testing of certain chemicals (58 FR 26898, 
26900-26902 and 58 FR 38490, 38493). The remaining chemicals were then 
grouped by production volume, and literature searches were performed.
    The ITC performed searches for data relating to the chemicals on 
the following data bases: RTECS (Registry of Toxic Effects of Chemical 
Substances), TOXLINE (TOXicology information onLINE), MEDLINE (MEDlars 
onLINE), TOXLIT (TOXicology LITerature from special sources), CECATS 
(OPPT/Risk Assessment Division/Chemical Screening Branch's Existing 
Chemical Assessment Tracking System), TSCATS (Toxic Substances Control 
Act Test Submissions), and INDEX MEDICUS. The search strategy was 
designed to identify any toxicological tests that used the dermal route 
of exposure. The information from the searches was collected and the 
chemicals were subcategorized based on the number of postings (58 FR 
38490, 38493).
    The 83 chemicals designated by the ITC were identified as follows: 
The ITC first ascertained those chemicals having no dermal information 
postings in any of the data bases searched, and, in its 31st ITC 
Report, the ITC designated this group of 24 chemicals for priority 
testing consideration (58 FR 26898, 26900). A second group of chemicals 
with limited dermal toxicity or dermal absorption data (as determined 
by the searches described in this unit) from which dermal absorption 
rate could not be estimated was then identified by the ITC, which 
designated this group of 34 chemicals in its 32nd ITC Report (Ref. 1) 
(58 FR 38490, 38492, 38494). Another 25 chemicals were designated in 
the 35th ITC Report, after the ITC reviewed the dermal data of 63 high 
production volume chemicals with slightly larger information bases (59 
FR 67596, 67598). These data were insufficient to estimate dermal 
absorption rate because dermal absorption rate could not be calculated 
on the basis of the dermal absorption data which were available to the 
ITC.
    The ITC then reviewed data from TSCA section 8(a) and 8(d) rules 
which were promulgated by EPA for these 83 chemical substances included 
in the 31st, 32nd, and 35th ITC Reports (40 CFR 712.30(e) (58 FR 68311, 
December 27, 1993; 59 FR 5956, February 9, 1994; 60 FR 34879, July 5, 
1995)). These rules required the reporting to EPA of certain 
production, use and exposure-related information, and unpublished 
health and safety data concerning these 83 chemicals.
    In reviewing the available data relating to these 83 chemicals, the 
ITC determined that the dermal absorption rate data for methyl 
methacrylate (Ref. 2), diethyl phthalate (Ref. 3), and cyclohexanone 
(Ref. 4) would meet OSHA's data needs for the chemicals (59 FR 35720, 
35722, July 13, 1994; 60 FR 42982, 42985, August 17, 1995). 
Accordingly, the ITC withdrew its designation for these 3 chemicals: 
Methyl methacrylate and diethyl phthalate in the 34th ITC Report (59 FR 
35720, 35725, July 13, 1994), and cyclohexanone in the 36th ITC Report 
(60 FR 42982, 42987, August 17, 1995).
    Eighty of the chemical substances nominated by OSHA are thus 
currently designated by the ITC for in vitro dermal absorption rate 
testing under TSCA. In the Federal Register notices containing the 
31st, 32nd, and 35th ITC Reports, EPA additionally solicited proposals 
for TSCA section 4 enforceable consent agreements (ECAs) for dermal 
absorption rate testing of the 80 chemical substances. EPA received no 
proposals for ECAs for dermal absorption rate testing in response to 
these solicitations.
    On April 3, 1996 (61 FR 14773), EPA again solicited interested 
parties to submit proposals for ECAs. On June 26, 1996, EPA received a 
proposal for the development of an ECA for tert-butyl alcohol from the 
ARCO Chemical Company (ARCO). On March 26, 1998, EPA received a study 
entitled ``[14C]-t-Butyl Alcohol: Topical Application: 
Dermal Absorption Study in the Male Rat,'' from ARCO (Ref. 5). This 
study was reviewed and found acceptable as a means of determining the 
dermal absorption rate for tert-butyl alcohol (Ref. 6). Accordingly, 
this action does not propose testing of tert-butyl alcohol.
    In this action, EPA is proposing in vitro dermal absorption rate 
testing of 47 chemical substances of interest to OSHA. These chemical 
substances are listed in Table 2 of Unit I.A. of this preamble, 
entitled ``List of Chemical Substances Proposed for Testing,'' and in 
Table 2 of Sec. 799.5115(i) of the proposed regulatory text, entitled 
``Required Testing: Chemical Substances Designated for In Vitro Dermal 
Absorption Rate Testing.'' EPA has selected these 47 chemicals for 
testing because the Agency believes that the production volumes of 
these chemicals are higher than the production volumes of the 32 
chemicals remaining out of the 80 chemicals currently designated by the 
ITC. Testing of the latter chemicals for dermal absorption rate will be 
addressed at a later date.

B. How Was the Test Standard Developed For EPA's Use in This Proposed 
Rule?

    In the solicitations discussed in Unit III.A. of this preamble, EPA 
referenced an in vitro dermal absorption rate test protocol for review 
by potential submitters in developing their proposed protocols (Ref. 
7). The draft protocol was developed by a group of scientists from EPA 
in conjunction with ITC member and liaison agencies (Consumer Product 
Safety Commission (CPSC), Department of Defense (DoD), Food and Drug 
Administration (FDA), National Institute for Occupational Safety and 
Health (NIOSH), and OSHA) and consisted of the methods of Bronaugh and 
Collier (Ref. 7). EPA received public comments on the proposed protocol 
and entered them, along with the protocol itself, into the dockets for 
the 31st, 32nd, and 35th ITC Reports, as appropriate (docket control 
numbers OPPTS-41038, OPPTS-41039, and OPPTS-41042, respectively). In 
addition, the Chemical Manufacturers Association (CMA) submitted a 
proposed protocol outlining an alternative method (Ref. 8). Scientists 
from EPA and other Federal agencies represented on the ITC (including 
OSHA) reviewed the public comments and the CMA proposal. Based on their 
review of the Bronaugh and Collier protocol, public comments, and the 
CMA proposal, EPA and ITC scientists developed the in vitro dermal 
absorption rate test method which is the test standard used in this 
proposed rule.

C. How Will The Data Developed Under This Test Rule Be Used?

    This proposed rule would require the development of quantitative 
measures of dermal absorption rate to assist in evaluating the 
potential contribution of dermal absorption of the chemical substances 
proposed for testing to total exposures to workers from chemicals in 
the workplace. The dermal absorption rate data obtained under this 
testing program would be used to support OSHA's development of ``skin 
designations'' for the chemical substances included in this proposed 
rule.
    OSHA assigns a skin designation to a chemical if it determines that 
cutaneous exposure (through the skin, eyes, and mucous membranes) to 
the chemical may result in systemic toxicity. Skin

[[Page 31078]]

designations are used by OSHA to provide specific guidance to employers 
concerning whether changes should be made to processes involving 
chemical substances in order to reduce the hazard of systemic toxicity 
from dermal absorption of these chemicals. Changes to a process might 
include changes in engineering controls or changes in the use or type 
of personal protective equipment. Skin designations alert industrial 
hygienists, employers, and workers to potential adverse health effects 
resulting from dermal exposure to chemicals in the workplace.
    The information that would be developed under this test rule would 
not only support OSHA's activities, but also would support chemical 
risk assessment activities at EPA as well as at other Federal agencies. 
In particular, these data would provide input for chemical risk 
assessments involving environmental exposure scenarios which include 
intentional or incidental skin contact.

IV. EPA Findings

A. What Is The Basis For EPA's Proposal To Test These Chemical 
Substances?

    As indicated in Unit II. of this preamble, in order to develop a 
rule under TSCA section 4(a) requiring the testing of chemical 
substances or mixtures, EPA must make certain findings for those 
chemicals regarding either:
    1. Hazard (TSCA section 4(a)(1)(A)(i)); or
    2. Production and either chemical release or human exposure (TSCA 
section 4(a)(1)(B)(i)).
EPA is proposing to require testing of the chemical substances included 
in this test rule based on its findings under TSCA section 
4(a)(1)(B)(i) relating to ``substantial'' production and ``substantial 
human exposure,'' as well as findings under TSCA sections 
4(a)(1)(B)(ii) and (iii).
    In EPA's ``B'' policy, discussed in Unit II. of this preamble, 
``substantial'' production of a chemical substance or mixture is 
generally interpreted to be aggregate production (including import) 
volume equaling or exceeding one million pounds (lbs) per year of that 
chemical substance or mixture (58 FR 28736, 28746, May 14, 1993). The 
``B'' policy sets out the numeric threshold for ``substantial human 
exposure'' of workers to a chemical substance or mixture of 1,000 
workers annually being exposed to that chemical substance or mixture. 
Id. See EPA's ``B'' policy (58 FR 28736, May 14, 1993) for further 
discussion on how EPA makes decisions under TSCA section 4(a)(1)(B)(i).
    EPA has found preliminarily that, under TSCA section 4(a)(1)(B)(i), 
each of the 47 chemical substances proposed for dermal absorption rate 
testing is produced in ``substantial quantities'' and there is or may 
be ``substantial human exposure'' to each chemical substance. In 
addition, under TSCA section 4(a)(1)(B)(ii), EPA believes that there 
are insufficient data and experience to reasonably determine or predict 
the effects of the manufacturing, processing, or use of these chemical 
substances, or of any combination of such activities, on human health. 
In particular, as discussed in Unit IV.D. of this preamble, EPA has 
determined that there are insufficient data relating to dermal 
absorption rate resulting from human exposure to these chemicals. EPA 
also finds that testing the substances identified in this document is 
necessary to develop such data (TSCA section 4(a)(1)(B)(iii)). EPA has 
not identified any ``additional factors'' as discussed in the ``B'' 
policy (58 FR 28736, 28746, May 14, 1993) to cause the Agency to use 
decisionmaking criteria other than those described in the policy.
    The specific chemical substances included in this proposed test 
rule are listed in Table 2 of Unit I.A. of this preamble, and in 
Sec. 799.5115(i) of the proposed regulatory text.

B. Are These Chemical Substances Produced in Substantial Quantities?

    Each of the chemical substances included in this proposal is 
produced in an amount equal to or greater than one million lbs per year 
(Ref. 9), based on information gathered pursuant to the 1994 TSCA 
section 8(a) Inventory Update Rule (40 CFR part 710) and contained in 
the TSCA Chemical Update System. Their production volumes range from 
over one million to well over one billion lbs annually. Assuming the 
continued accuracy of these figures, EPA believes that these annual 
production volumes are ``substantial'' as that term is used with 
reference to production in TSCA section 4(a)(1)(B)(i). See 58 FR 28736, 
28746, May 14, 1993.

C. Are a Substantial Number Of Workers Exposed To These Chemicals?

    EPA finds that the manufacturing, processing, and use of the 
chemical substances included in this document result or may result in 
exposure of a substantial number of workers. Table 3, entitled 
``Exposure Information for Chemical Substances Included in This 
Proposed Test Rule,'' in Unit IV.C. of this preamble contains an 
estimate of the actual and potential worker exposure to these chemical 
substances (Ref. 10). These chemical substances are used in a wide 
variety of applications as industrial solvents, which result in 
potential exposures of workers as described in the exposure support 
document for this proposed rule (Ref. 10). EPA believes that the 
exposure to each chemical substance of 1,000 workers or more (Table 3 
of this unit) is or may be ``substantial'' as that term is used with 
reference to ``human exposure'' in TSCA section 4(a)(1)(B)(i). See 58 
FR 28376, 28746, May 14, 1993.


 Table 3.--Exposure Information for Chemical Substances Included in This
                           Proposed Test Rule
------------------------------------------------------------------------
                                                       Number of workers
             CAS No.                Chemical name         exposed\1\
------------------------------------------------------------------------
60-29-7                          Ethyl ether           272,746
74-96-4                          Ethyl bromide         12,285
75-05-8                          Acetonitrile          31,341
75-15-0                           Carbon disulfide    45,761
75-35-4                          Vinylidene chloride  2,679
77-73-6                           Dicyclopentadiene    6,247
77-78-1                          Dimethyl sulfate     10,482
78-59-1                          Isophorone           47,097
78-83-1                          Isobutyl alcohol     256,975
78-87-5                          Propylene            2,944
                                  dichloride
78-92-2                          sec-Butyl alcohol    126,200
79-20-9                          Methyl acetate       20,455
79-46-9                          2-Nitropropane        9,817
91-20-3                          Naphthalene          112,695
92-52-4                          Biphenyl             32,000

[[Page 31079]]

 
95-49-8                          o-Chlorotoluene      11,617
95-50-1                           o-Dichlorobenzene   92,248
97-77-8                           Disulfiram           53,525
98-29-3                          tert-Butylcatechol    27,528
99-99-0                           p-Nitrotoluene       4,354
100-00-5                          p-                   2,949
                                  Nitrochlorobenzene
100-01-6                          p-Nitroaniline       1,448
100-44-7                          Benzyl chloride      41,075
106-42-3                          p-Xylene             20,367
106-46-7                         p-Dichlorobenzene     33,980
107-06-2                          Ethylene             83,245
                                  dichloride
107-31-3                          Methyl formate       7,739
108-03-2                          1-Nitropropane       21,535
108-90-7                          Chlorobenzene        18,049
108-93-0                          Cyclohexanol         112,366
109-66-0                          Pentane              38,464
109-99-9                          Tetrahydrofuran      356,041
110-12-3                          Methyl isoamyl       18,835
                                  ketone
111-84-2                          Nonane               7,277
120-80-9                          Catechol             13,517
121-69-7                          Dimethylaniline      30,479
122-39-4                          Diphenylamine        155,673
123-42-2                         Diacetone alcohol     264,660
126-99-8                         beta-Chloroprene      17,752
127-19-5                          Dimethyl acetamide   28,944
142-82-5                          n-Heptane            449,487
150-76-5                         p-Methoxyphenol       250,088
528-29-0                          o-Dinitrobenzene     1,358
628-63-7                         n-Amyl acetate        265,435
768-52-5                         N-Isopropylaniline   >1,000\2\
25013-15-4                        Vinyl toluene        25,353
34590-94-8                        Dipropylene glycol   210,735
                                  methyl ether
------------------------------------------------------------------------
\1\National Occupational Exposure Survey (NOES) conducted by the NIOSH
  (1981-1983), unless otherwise indicated. These data are the most
  recent available to the Agency (Ref. 10).
\2\Not listed in NOES data base. The exposure analysis for this chemical
  is attached to Reference 10.


D. Do Sufficient Data Exist For These Chemical Substances?

    As discussed in this preamble, dermal absorption rate is an 
important factor in ascertaining the effects of the 47 chemicals in 
this proposed rule on human health. EPA has determined that there are 
no dermal absorption rate data for the chemicals in this proposed rule 
and, therefore, existing data are insufficient to reasonably determine 
or predict the human health effects relating to dermal absorption rate 
that result from manufacturing, processing, or use of the subject 
chemical substances. This finding is based on the review and analysis 
of relevant data by the ITC (which included EPA participation), as 
described in Unit III.A. of this preamble.

E. Is Testing Necessary For These Chemical Substances?

    EPA believes that the proposed testing of the 47 subject chemical 
substances is necessary to develop dermal absorption rate data. This 
testing is needed to determine if the manufacturing, processing, or use 
of these chemical substances presents an unreasonable risk of injury to 
human health.

V. Proposed Rule

A. How Would the Studies Proposed Under This Test Rule Be Conducted?

    EPA is proposing specific testing and reporting requirements for 
the chemical substances specified in Table 2 in Sec. 799.5115(i) of the 
proposed regulatory text according to the in vitro dermal absorption 
rate test standard set forth at Sec. 799.5115(h) of the proposed 
regulatory text.
    The test standard that would be required under this rule was 
developed as described in Unit III.B. of this preamble. This standard 
describes the procedures for measuring a permeability constant (Kp) and 
a short-term absorption rate for chemicals in liquid form. Measurement 
of short-term absorption rates is only required when a Kp cannot be 
obtained using this test standard. For most chemicals, a Kp is useful 
in estimating skin permeation. However, for ``harsh'' chemicals, i.e., 
those that may damage the skin more severely with prolonged contact, it 
is more appropriate to obtain a short-term absorption rate measurement.
    This test standard utilizes established in vitro diffusion cell 
techniques that allow absorption rate studies to be conducted using 
human skin (see the proposed regulatory text at Sec. 799.5115(h)). The 
in vitro approach was chosen for practical considerations because it is 
efficient in terms of labor and materials and can be performed easily 
by a variety of laboratories. In addition, in vitro diffusion cell 
studies are necessary for measuring a Kp (Ref. 7).
    The in vitro dermal absorption rate test standard allows use of 
cadaver skin and static diffusion cells to maintain the viability of 
the skin, thus more closely simulating in vivo conditions. This test 
method also requires the use of radiolabelled chemical substances 
unless the test sponsor can demonstrate that alternative, non-
radiolabelled methods provide sensitivity sufficient to detect the 
parent chemical (and its major metabolites in those cases in which skin 
viability is maintained). The first six parameters that are discussed 
(choice of membrane, preparation of membrane, diffusion cell design, 
temperature, testing hydrophobic chemicals, and vehicle) are similar 
for determination of either of the two percutaneous absorption rate 
values. In

[[Page 31080]]

contrast, the remaining two parameters (i.e., dose and study duration) 
are different for the two percutaneous absorption rate values.
    Testing under this proposed rule must be conducted in accordance 
with TSCA Good Laboratory Practice (GLP) Standards (40 CFR part 792).

B. What Substances Would Be Tested Under This Rule?

    EPA is proposing that the chemical substances listed in Table 2 in 
Sec. 799.5115(i) of the proposed regulatory text be tested at a purity 
of at least 99%.

C. Would I Be Required To Test Under This Rule?

    Under TSCA section 4(a)(1)(B), EPA has made preliminary findings 
that there are insufficient data and experience to reasonably determine 
or predict health effects resulting from the manufacturing, processing, 
or use of the chemical substances listed in this proposed rule. As a 
result, under TSCA section 4(b)(3)(B), manufacturers and processors of 
these substances would be subject to the rule with regard to those 
listed chemicals which they manufacture or process.
    1. Would I be subject to this rule? You would be subject to this 
rule and may be required to test if you manufacture (which is defined 
by statute to include import) or process, or intend to manufacture or 
process, one or more chemical substances listed in this proposed rule 
during the time period discussed in Unit V.C.2. of this preamble, 
entitled ``When would my manufacturing or processing (or my intent to 
do so) cause me to be subject to this rule?'' However, if you do not 
know or cannot reasonably ascertain that you manufacture or process a 
listed test substance (based on all information in your possession or 
control, as well as all information that a reasonable person similarly 
situated might be expected to possess, control, or know, or could 
obtain without unreasonable burden), you would not be subject to the 
rule.
    2. When would my manufacturing or processing (or my intent to do 
so) cause me to be subject to this rule? You would be subject to this 
rule if you manufacture or process, or intend to manufacture or 
process, a substance listed in the rule at any time from the effective 
date of the final test rule to the end of the test data reimbursement 
period.
    The term reimbursement period is defined at 40 CFR 791.3(h) and may 
vary in length for each substance to be tested under a final TSCA 
section 4(a) test rule, depending on what testing is required and when 
testing is completed. See Unit V.C.4. of this preamble, entitled ``How 
do the reimbursement procedures work?''
    3. Would I be required to test if I were subject to the rule? It 
depends on the nature of your activities. All persons who would be 
subject to this TSCA section 4(a) test rule, which incorporates EPA's 
generic procedures applicable to TSCA section 4(a) test rules 
(contained within 40 CFR part 790), would fall into one of two groups, 
designated here as Tier 1 and Tier 2. Persons in Tier 1 (those who 
would have to initially comply with the rule) must either: Submit to 
EPA letters of intent to conduct testing, conduct this testing, and 
submit the test data to EPA or apply to and obtain from EPA exemptions 
from testing. Persons in Tier 2 (those who would not have to initially 
comply with the rule) need not take any action unless they are notified 
by EPA that they are required to do so, as described in Unit V.C.3.d. 
of this preamble, entitled ``What would my obligations be if I were in 
Tier 2?'' Note that persons in Tier 1 who obtain exemptions and persons 
in Tier 2 would nonetheless be subject to providing reimbursement to 
persons who do actually conduct the testing, as described in Unit 
V.C.4. of this preamble, entitled ``How do the reimbursement procedures 
work?''
    a. Who would be in Tier 1 and Tier 2? All persons subject to this 
rule would be considered to be in Tier 1 unless they fall within Tier 
2. The following table describes who is in Tier 1 and Tier 2.


  Table 4.-- Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
 Tier 1 (Persons initially required to    Tier 2 (Persons not initially
                comply)                        required to comply)
------------------------------------------------------------------------
Persons that manufacture (as     Persons that
 defined at TSCA section 3(7)), or        manufacture (as defined at
 intend to manufacture, a test rule       TSCA section 3(7)) or intend
 substance who are not listed under       to manufacture a test rule
 Tier 2                                   substance solely as one or
                                          more of the following:
                                         --As a byproduct (as defined at
                                          40 CFR 791.3(c));
                                         --As an impurity (as defined at
                                          40 CFR 790.3);
                                         --As a naturally occurring
                                          substance (as defined at 40
                                          CFR 710.4(b));
                                         --As a non-isolated
                                          intermediate (as defined at 40
                                          CFR 704.3);
                                         --As a component of a Class 2
                                          substance (as described at 40
                                          CFR 720.45(a)(1)(i));
                                         --In amounts of less than 500
                                          kilograms (kg) (1,100 lbs)
                                          annually (as described at 40
                                          CFR 790.42(a)(4)); or
                                         --In small quantities solely
                                          for research and development
                                          (as described at 40 CFR
                                          790.42(a)(5)).
                                         Persons that process
                                          (as defined at TSCA section
                                          3(10)) or intend to process a
                                          test rule substance (see 40
                                          CFR 790.42(a)(2))
------------------------------------------------------------------------


    b. When would it be appropriate for a person in Tier 1 to apply for 
an exemption rather than to submit a letter of intent to conduct 
testing? You may apply for an exemption if you believe that the 
required testing will be performed by another person (or a consortium 
of persons formed under TSCA section 4(b)(3)(A)) in Tier 1. You can 
find procedures relating to exemptions in 40 CFR 790.80 through 790.99, 
and in the proposed regulatory text at Sec. 799.5115(c)(2), (c)(5), and 
(c)(7). In this rule, EPA would not require equivalence data (i.e., 
data demonstrating that your substance is equivalent to the substance 
actually being tested) as a condition for approval of your exemption. 
EPA is interested in evaluating the effects attributable to each listed 
substance itself and has specified almost pure substances for testing.
    c. What would happen if I were in Tier 1 and I submitted an 
exemption application? EPA believes that requiring the collection of 
duplicative data is unnecessarily burdensome. As a result, if EPA has 
received a letter of intent to test from another source or has received 
(or expects to receive) the test data that would be required under this 
rule, the Agency would conditionally approve your exemption application 
under 40 CFR 790.87. The Agency would

[[Page 31081]]

terminate conditional exemptions, if a problem occurs with the 
initiation, conduct, or completion of the required testing or the 
submission of the required data to EPA. EPA may then require you to 
submit a notice of intent to test or an exemption application. See 40 
CFR 790.93 and the proposed regulatory text at Sec. 799.5115(c)(6). 
Persons in Tier 1 who obtain exemptions and persons in Tier 2 would 
nonetheless be subject to providing reimbursement to persons who do 
actually conduct the testing, as described in Unit V.C.4. of this 
preamble, entitled ``How do the reimbursement procedures work?.''
    d. What would my obligations be if I were in Tier 2? If you are in 
Tier 2, you would be subject to the rule and you would be responsible 
for providing reimbursement to persons in Tier 1, as described in Unit 
V.C.4. of this preamble. You are considered to have an automatic 
conditional exemption. You would not need to take any action unless you 
are notified by EPA that you are required to do so.
    If a problem occurs with the initiation, conduct, or completion of 
the required testing, or the submission of the required data to EPA, 
the Agency may require you to submit a notice of intent to test or an 
exemption application. See 40 CFR 790.93 and the proposed regulatory 
text at Sec. 799.5115(c)(6).
    In addition, you would need to submit a notice of intent to test or 
an exemption application if:
    i. No manufacturer in Tier 1 has notified EPA of its intent to 
conduct testing and
    ii. EPA has published a Federal Register document directing all 
persons in Tier 2 to submit to EPA letters of intent to conduct testing 
or exemption applications. See 40 CFR 790.48(b) and the proposed 
regulatory text at Sec. 799.5115(c)(4) and (c)(5).
The Agency would conditionally approve an exemption application under 
40 CFR 790.87, if EPA has received a letter of intent to test or has 
received (or expects to receive) the test data required under this 
rule.
     e.  How did EPA decide who would be in Tier 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(a) test rules in 40 CFR part 790. 
For purposes of this proposed rule, EPA is proposing to set forth 
certain requirements that differ from those under 40 CFR part 790.
     Under 40 CFR part 790, in TSCA section 4(a) test rules EPA 
traditionally has treated the following persons as being in Tier 2. 
(These rules are found at 40 CFR part 799, subparts B and D).
    Processors (40 CFR 790.42(a)(2));
    Manufacturers of less than 500 kg (1,100 lbs) per year 
(``small-volume manufacturers'') (40 CFR 790.42(a)(4)); and
     Manufacturers of small quantities for research and 
development (``R&D manufacturers'') (40 CFR 790.42(a)(5)).
     EPA has historically placed processors in Tier 2 because the 
Agency ``expected that, in most cases, testing will be performed by the 
manufacturers and that part of the cost of testing will be passed on to 
processors through the pricing mechanism, thereby enabling them to 
share in the costs of testing'' (50 FR 20652, 20654, May 17, 1985). In 
addition, ``[t]here are so many processors that it would be difficult 
to include them all in the technical decisions about the tests and in 
the financial decisions about how to allocate the costs'' (48 FR 31786, 
31789, July 11, 1983).
     EPA has historically placed small-volume manufacturers and R&D 
manufacturers in Tier 2 because this type of manufacturing ``normally 
represents a small percentage of the overall production volume [and] 
test sponsors are not expected to expend the administrative resources 
to recover the small proportional amounts of the testing costs from 
these manufacturers'' (55 FR 18881, May 7, 1990).
     In this proposed test rule, EPA has reconfigured the tiers in 40 
CFR 790.42. EPA has added the following persons to Tier 2: Byproduct 
manufacturers; impurity manufacturers; manufacturers of naturally 
occurring substances; manufacturers of non-isolated intermediates; and 
manufacturers of components of Class 2 substances. The Agency took 
administrative burden and complexity into account in determining who 
was to be in Tier 1 in this proposed rule. EPA believes that those 
persons in Tier 1 who would conduct testing under this rule, when 
finalized, would generally be large chemical manufacturers who, in the 
experience of the Agency, have traditionally conducted testing or 
participated in testing consortia under previous TSCA section 4(a) test 
rules.
     The Agency also believes that byproduct manufacturers, impurity 
manufacturers, manufacturers of naturally occurring substances, 
manufacturers of non-isolated intermediates, and manufacturers of 
components of Class 2 substances have not themselves historically 
participated in testing or contributed to reimbursement of those 
persons who have conducted testing. EPA understands that these may 
include persons for whom the marginal transaction costs involved in 
negotiating and administering testing arrangements are deemed likely to 
raise the expense and burden of testing to a level that is 
disproportional to the additional benefits of including these persons 
in Tier 1. Therefore, EPA does not believe that the likelihood of the 
persons proposed to be added to Tier 2 actually doing the testing is 
sufficiently high to justify burdening these persons with Tier 1 
requirements (e.g., submitting requests for exemptions). Nevertheless, 
these persons, along with all other persons in Tier 2, would be subject 
to providing reimbursement to persons who do actually conduct the 
testing, as described in Unit V.C.4. of this preamble, entitled ``How 
do the reimbursement procedures work?''
     Section 4(b)(3)(B) of TSCA requires all manufacturers and 
processors of a chemical substance to test that chemical substance if 
EPA has made findings for that chemical substance, and therefore issued 
a TSCA section 4(a) test rule requiring testing. However, practicality 
must be a factor in determining who is subject to a particular test 
rule. Thus, persons who do not know or cannot reasonably ascertain that 
they are manufacturing or processing the substances subject to this 
proposed rule, e.g., manufacturers or processors of the substances as 
trace contaminants who are not aware of these activities, would not be 
subject to the rule. See Unit V.C.1 of this preamble and 
Sec. 799.5115(b)(2) of the proposed regulatory text.
     EPA is soliciting comment on who should be included in Tier 1 and 
Tier 2. The Agency may define these categories differently in response 
to comments received. EPA is also soliciting comment on who should not 
be subject to the rule. The latter persons are described at Unit V.C.1 
of this preamble and Sec. 799.5115(b)(2) of the proposed regulatory 
text.
    f. Should EPA prioritize which persons in Tier 2 would be required 
to perform testing? EPA is considering subdividing Tier 2 to enable the 
Agency to prioritize which persons in Tier 2 would be required to 
perform testing, if needed. This would involve subdividing Tier 2 into:
    i. Tier 2A. 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.

[[Page 31082]]

    ii. Tier 2B. Those who process, or intend to process, a test rule 
substance.
If the Agency needed testing from persons in Tier 2, EPA would seek 
testing from persons in Tier 2A before proceeding to Tier 2B. EPA 
believes that, if the Agency were to subdivide Tier 2, persons in Tier 
2A should be required to submit letters of intent to test or exemption 
applications before processors are called upon because testing costs 
are traditionally passed by manufacturers along to processors.
    EPA is soliciting comment on whether this subtiering scheme should 
be applied in the final rule.
    4. How do the reimbursement procedures work? In the past, persons 
subject to test rules have independently worked out among themselves 
their respective financial contributions to those persons who have 
actually conducted the testing. However, if persons are unable to agree 
privately on reimbursement, they may take advantage of EPA's 
reimbursement procedures at 40 CFR part 791, promulgated under the 
authority of TSCA section 4(c). These procedures include: The 
opportunity for a hearing with the American Arbitration Association; 
publication by EPA of a Federal Register document concerning the 
request for a hearing; and the appointment of a hearing officer to 
propose an order for fair and equitable reimbursement. The hearing 
officer may base his or her proposed order on the production volume 
formula set out at 40 CFR 791.48, but is not obligated to do so. Under 
this proposed rule, amounts manufactured as impurities would be 
included in production volume (40 CFR 791.48(b)), subject to the 
discretion of the hearing officer (40 CFR 791.40(a)). The hearing 
officer's proposed order may become the Agency's final order, which is 
reviewable in Federal court (40 CFR 791.60).

D. What Are the Reporting Requirements Proposed Under This Test Rule?

    You would be required to submit interim progress reports for each 
test every 6 months, beginning 6 months after the effective date of the 
final rule. You would be required to submit a final report for a 
specific test by the deadline indicated as the number of months after 
the effective date that would be shown in Table 2 in Sec. 799.5115(i) 
of the proposed regulatory text.

E. Would There Be Sufficient Test Facilities and Personnel To Undertake 
the Testing in This Test Rule?

    EPA has conducted a study to assess the availability of test 
facilities and personnel to handle the additional demand for testing 
services created by TSCA section 4(a) test rules and has found that 
test facilities and personnel would adequately accommodate the testing 
specified in this proposed rule (Ref. 11).

F. Might EPA Seek Further Testing of the Chemicals in This Proposed 
Test Rule?

    If EPA determines that it needs additional data regarding any of 
the chemical substances included in this proposed rule, the Agency 
might seek further health and/or environmental effects testing for 
these chemicals. Should the Agency decide to seek such additional 
testing, EPA would initiate a separate action for this purpose.

VI. Export Notification

    Any person who exports, or intends to export, one of the chemical 
substances contained in this proposed rule in any form will be subject 
to the export notification requirements in TSCA section 12(b)(1) and 40 
CFR part 707, subpart D, but only after the final rule is issued and 
only if the chemical is contained in the final rule. However, 
notification of export would generally not be required for articles, as 
provided by 40 CFR 707.60(b).

VII. Materials in the Official Record

    The official record for this proposed rule has been established 
under docket control number OPPTS-42196. The following is a listing of 
the documents that have already been placed in the official record for 
this proposed rule:

A. Supporting Documentation

    1. Federal Register documents:
    a. Notice containing the 31st ITC Report to the EPA Administrator 
(58 FR 26898, May 5, 1993 (FRL-4583-4)).
    b. Notice containing the TSCA section 4(a)(1)(B) Final Statement of 
Policy (58 FR 28736, May 14, 1993 (FRL-4059-9)).
    c. Notice containing the 32nd ITC Report to the EPA Administrator 
(58 FR 38490, July 16, 1993 (FRL-4630-2)).
    d. TSCA Sections 8(a) and 8(d) Final Rules for Chemicals Contained 
in the 31st ITC Report to the EPA Administrator (58 FR 68311, December 
27, 1993 (FRL-4644-1)).
    e. TSCA Sections 8(a) and 8(d) Final Rules for Chemicals Contained 
in the 32nd ITC Report to the EPA Administrator (59 FR 5956, February 
9, 1994 (FRL-4745-5)).
    f. Notice containing the 34th ITC Report to the EPA Administrator 
(59 FR 35720, July 13, 1994 (FRL-4870-4)).
    g. Notice containing the 35th ITC Report to the EPA Administrator 
(59 FR 67596, December 29, 1994 (FRL-4923-2)).
    h. TSCA Sections 8(a) and 8(d) Final Rules for Chemicals Contained 
in the 35th ITC Report to the EPA Administrator (60 FR 34879, July 5, 
1995 (FRL-4954-9)).
    i. Notice containing the 36th ITC Report to the EPA Administrator 
(60 FR 42982, August 17, 1995 (FRL-4965-6)).
    j. Small Business Size Standards; Final Rule, issued by the Small 
Business Administration (SBA) (61 FR 3280, January 31, 1996).
    k. Notice containing EPA's Solicitation of Interested Parties for 
Proposals for Enforceable Consent Agreements for Testing of 80 
Chemicals of Interest to OSHA (61 FR 14773, April 3, 1996 (FRL-5359-
3)).
    2. Correspondence:
    a. ARCO Chemical Company. Letter to Charles M. Auer, USEPA. 
Proposal for Development of ECA for Tert-Butyl Alcohol (June 26, 1996).
    b. ARCO Chemical Company. Letter to Keith Cronin, USEPA. Letter 
transmitting a Dermal Absorption Rate Study in the Male Rat for Tert-
Butyl Alcohol (March 23, 1998).
    3. Other support documentation:
    EPA. ``EPA Interim Guidance for Implementing the Small Business 
Regulatory Enforcement Fairness Act and Related Provisions of the 
Regulatory Flexibility Act.'' EPA SBREFA Task Force (February 5, 1997).

B. References

    1. ITC. Chemicals Under Consideration for the 32nd ITC Report; 
Summary of Skin Absorption Data on OSHA Tier 2 Chemicals (September 22, 
1993).
    2. Zeneca. Methyl Methacrylate: In Vitro Absorption through Human 
Epidermis. Zeneca Central Toxicology Report No. CTL/P/4025 provided by 
the Methacrylate Producers Association, Washington, D.C. (1993).
    3. Scott, R.C., Dugard, P.H., Ramsey, J.D., and Rhodes, C. In Vitro 
Absorption of Some o-Phthalate Diesters through Human and Rat Skin. 
Environmental Health Perspectives. 74:223-227 (1987).
    4. Mraz, J., Galova, E., Nohova, H., and Vitkova, D. Uptake, 
Metabolism and Elimination of Cyclohexanone in Humans. International 
Archives of Occupational Environmental Health. 66:203-208 (1994).
    5. ARCO Chemical Company. [14C]-t-Butyl Alcohol: Topical 
Application: Dermal Absorption Study in the Male Rat. Huntington Life 
Sciences (January 7, 1998).
    6. OSHA. Review of [14C]-t-Butyl Alcohol: Topical 
Application: Dermal Absorption Study in the Male Rat. (June 24, 1998).

[[Page 31083]]

    7. Bronaugh, R.L., and Collier, S.W. Protocol for In Vitro 
Percutaneous Absorption Studies. In Vitro Percutaneous Absorption: 
Principles, Fundamentals, and Applications. R.L. Bronaugh and H.I. 
Maibach, Eds. CRC Press, Boca Raton, FL. pp. 237-241 (1991).
    8. Chemical Manufacturers Association (CMA). Letter to Charles M. 
Auer, USEPA. (October 21, 1994).
    9. EPA. Economic Impact Analysis and Small Entity Impact Analysis 
of Proposed TSCA Section 4(a) Test Rule for 47 Chemicals Targeted for 
In Vitro Dermal Absorption Rate Testing. OPPT/EETD/EPAB, Washington, DC 
(May 5, 1999).
    10. EPA. CEB Support to the OSHA Chemicals Test Rule--Number of 
Workers Exposed and TRI Release Data. OPPT/EETD/CEB, Washington, DC 
(March 1998).
    11. EPA. EPA Census of TSCA Testing Laboratories. Washington, DC 
(October 10, 1996).
    12. EPA. Laboratory Cost Estimate for In Vitro Dermal Absorption 
Rate Testing. OPPT/EETD/EPAB, Washington, DC (April 14, 1999).
    13. EPA. ``Treatment of 12(b) Export Notification Unit Costs for 
Section 4 Test Rule Analyses.'' OPPT/EETD/EPAB, Washington, DC (April 
1, 1999).
    14. EPA. ``Economic Analysis in Support of the TSCA 12(b) 
Information Collection Request.'' OPPT/EETD/EPAB, Washington, DC 
(October 30, 1998).

VIII. Regulatory Assessment Requirements

A. Executive Order 12866

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), this is not a ``significant 
regulatory action'' subject to review by the Office of Management and 
Budget (OMB), because this action is not likely to result in a rule 
that meets any of the criteria for a ``significant regulatory action'' 
provided in section 3(f) of the Executive Order.
    EPA has prepared an economic analysis of the potential impact of 
this proposed rule, which is contained in a document entitled 
``Economic Impact Analysis and Small Entity Impact Analysis of Proposed 
TSCA Section 4(a) Test Rule for 47 Chemicals Targeted for In Vitro 
Dermal Absorption Rate Testing'' (Ref. 9). This document is available 
as a part of the public version of the official record for this action 
(instructions for accessing this document are contained in Unit I.B. of 
this preamble), and is briefly summarized here. The costs developed in 
the economic impact analysis are based on laboratory test cost 
estimates that have been placed in the docket for this proposed rule 
(Ref. 12).
    While legally subject to this test rule, processors of a subject 
chemical would only be required to comply with the requirements of the 
rule if they are directed to do so by EPA as described in 
Sec. 799.5115(c)(5) and (c)(6) of the proposed regulatory text. EPA 
would only require processors to test if no person in Tier 1 has 
submitted a notice of its intent to conduct testing, or if, under 40 
CFR 790.93, a problem occurs with the initiation, conduct, or 
completion of the required testing, or the submission of the required 
data to EPA. Because EPA has identified at least one manufacturer in 
Tier 1 for each subject chemical, the Agency assumes that, for each 
chemical in this proposed rule, at least one such person will submit a 
letter of intent to conduct the required testing and that that person 
will conduct such testing and will submit the test data to EPA. Because 
processors would not need to comply with the rule initially, the 
economic analysis does not address processors.
    To evaluate the potential economic impact of testing on 
manufacturers of the chemical substances in this proposed rule, EPA 
estimated the impact of testing requirements as a percentage of each 
chemical's sale price. This measure compares the annualized testing 
costs per pound (based on the conservative assumption that all 
chemicals are produced in volumes of one million lbs), to the price per 
pound for each chemical. First, annualized testing costs (including 
laboratory and administrative expenditures) are calculated by 
converting the total testing costs in the first year into an equivalent 
series of expenditures over 15 years using a 7% discount rate. Second, 
annualized testing costs are divided by one million lbs (the assumed 
production volume per chemical) to derive the annualized unit (per 
pound) testing cost. The price impacts--testing costs as a percentage 
of each chemical's price--are calculated by dividing the annualized 
unit testing cost by each unit price and multiplying by 100. The 
Agency's estimated total costs of testing (including both laboratory 
and administrative costs), annualized testing cost, price impacts, and 
public reporting burden hours for the chemicals are presented in the 
economic analysis (Ref. 9).
    Based on the economic analysis, the total one-time cost of this 
action, if finalized as proposed, is estimated to be $1.55 million. 
When this cost is annualized over 15 years using a 7% discount rate, 
the total annualized cost is estimated to be $170,576, with an 
estimated annualized cost of $3,628 per chemical. In addition, the 
estimated cost of the TSCA section 12(b)(1) export notification, which, 
in the final rule, would be required for the first export to a 
particular country of a chemical subject to the rule, is estimated to 
be $83.38 for the first time that an exporter must comply with TSCA 
section 12(b)(1) export notification requirements, and $19.08 for each 
subsequent export notification submitted by that exporter (Ref. 9, 13, 
and 14).
    The economic impacts of the testing, expressed as a percentage of 
each chemical's sale price, range from 0.09% to 3.3%, with an average 
impact of 0.64%. EPA estimates that 5 of the 35 chemicals for which 
price data are available will experience an adverse impact of 1% or 
greater under the assumption that production volumes for these 
chemicals are one million lbs. In fact, these chemicals are all 
manufactured or imported in excess of 10 million lbs, reducing the 
estimated impact by a factor of 10 to less than 1%. For the remaining 
12 chemicals without price data, EPA estimates that with annualized 
testing costs of $3,628 per chemical and one million lbs production 
volumes each, an economic impact of 1% or greater would occur only at a 
sales price below $0.36 per lb. Given that the average price for the 
other 35 chemicals is $0.97 per lb (prices range from $0.11 to $3.96 
per lb), that the unavailability of price data for these 12 chemicals 
may indicate that they are higher priced specialty chemicals, and that 
their production volumes are likely to be higher than the one million 
lbs minimum, the likelihood of an adverse impact is low.

B. Executive Order 12898

    This proposed rule does not involve special considerations of 
environmental-justice related issues pursuant to Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

C. Executive Order 13045

    Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997), does not apply to this proposed rule, because it is not 
``economically significant'' as defined under Executive Order 12866; 
and does not concern an

[[Page 31084]]

environmental health or safety risk that may have a disproportionate 
effect on children. This proposed rule would require the development of 
quantitative measures of dermal absorption rate to assist in evaluating 
the potential contribution of the chemical substances proposed for 
testing to total exposures to adult workers. The public is invited, 
however, to submit or identify peer-reviewed studies and data, of which 
EPA may not be aware, that assess results of early life exposure to the 
47 chemicals proposed for testing in this document.

D. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 
5 U.S.C. 601 et seq., the Agency hereby certifies that this rule, if 
promulgated as proposed, will not have a significant economic impact on 
a substantial number of small entities. The factual basis for the 
Agency's determination is presented in the small entity impact analysis 
prepared as part of the economic analysis for this proposed rule (Ref. 
9), and is briefly summarized here. The costs developed in the small 
entity impact analysis are based on the laboratory test cost estimates 
that have been placed in the docket for this proposed rule (Ref. 12).
    For the purpose of analyzing potential impacts on small entities, 
EPA used the RFA definition of small entities in RFA section 601(6). 
Under this section, a small entity may be a small government, a small 
non-profit organization, or a small business. Because EPA does not 
believe that governments or non-profit organizations are likely to be 
burdened by testing requirements under this proposed rule, EPA's 
analysis presents only the estimated potential impacts on small 
businesses.
    Section 601(3) of the RFA establishes as the default definition of 
small business the definition used in section 3 of the Small Business 
Act (15 U.S.C. 632) under which the SBA establishes small business size 
standards (13 CFR 121.201). For this proposed rule, EPA has analyzed 
the potential small business impacts using the size standards 
established under the RFA section 601(3) definition.
    In addition, in analyzing potential impacts, the RFA recognizes 
that it may be appropriate at times for Federal agencies to use an 
alternate definition of small business. As such, RFA section 601(3) 
also provides that an agency may establish a different definition of 
small business after consultation with the SBA Office of Advocacy and 
after notice and an opportunity for public comment. Even though the 
Agency has used the default SBA definition of small business to conduct 
its analysis of potential small entity impacts for this proposed rule, 
EPA does not believe that the SBA size standards are generally the best 
size standards to use in assessing potential small entity impacts with 
regard to TSCA section 4(a) test rules.
    The SBA size standards, which are primarily intended to define 
whether a business entity is eligible for Federal government programs 
and preferences reserved for small businesses (13 CFR 121.101), ``seek 
to ensure that a concern that meets a specific size standard is not 
dominant in its field of operation'' (13 CFR 121.102(b)). See section 
632(a)(1) of the Small Business Act. The SBA size standard is generally 
based on the number of employees an entity in a particular industrial 
sector may have. For example, in the chemical manufacturing industrial 
sector (i.e., SIC 28 and SIC 29), approximately 98% of the industries 
would be classified as small businesses under the default SBA 
definition. The SBA size standard for 75% of this industry sector is 
500 employees, and the size standards for 23% of this industry sector 
are 750, 1,000, or 1,500 employees. As a result, when assessing the 
potential impacts of test rules on chemical manufacturers, EPA believes 
that a standard based on total annual sales may provide a more 
appropriate means to judge the ability of a chemical manufacturing firm 
to support chemical testing without significant costs or burdens.
    EPA is currently determining what level of annual sales would 
provide the most appropriate size cutoff with regard to various 
segments of the chemical industry usually impacted by TSCA section 4(a) 
test rules, but has not yet reached a determination. As stated in this 
unit, therefore, the factual basis for the RFA determination for this 
proposed rule is based on an analysis using the default SBA size 
standards. Although EPA is not proposing to establish an alternate 
small business definition in the small entity impact analysis conducted 
for this proposed rule, the analysis includes the results of 
calculations using a size standard based on total annual sales. EPA is 
interested in receiving comments on whether the Agency should consider 
establishing an alternate small business definition to use in the small 
entity impact analyses for future TSCA section 4(a) test rules, and 
what size cutoff may be appropriate.
    Based on the Agency's estimated total costs for this proposed rule, 
which are summarized in Unit VIII.A. of this preamble, EPA estimates 
that the annualized cost for the testing in this proposed rule will be 
$3,628 per chemical. As discussed previously, EPA was unable to obtain 
any price information on 12 of the 47 chemicals in this proposed test 
rule. Nevertheless, EPA provides an estimate of the price of these 
chemicals in the economic analysis, and concludes that the total cost 
of testing these 47 chemicals as proposed, will not result in a 
significant impact on the chemical manufacturers subject to the 
proposed rule, regardless of their size. EPA identified a total of 102 
ultimate corporate entities (UCEs) that would be potentially impacted 
by the proposed test rule. None of these manufacturers would experience 
a significant impact as a result of the rule.
    In addition, the estimated cost of the TSCA section 12(b)(1) export 
notification, which, as a result of the final rule, would be required 
for the first export to a particular country of a chemical subject to 
the rule, is estimated to be $83.38 for the first time that an exporter 
must comply with TSCA section 12(b)(1) export notification 
requirements, and $19.08 for each subsequent export notification 
submitted by that exporter (Ref. 9, 13, and 14). EPA has concluded that 
the costs of TSCA section 12(b)(1) export notification would have a 
negligible impact on exporters of the chemicals in the final rule, 
regardless of the size of the exporter.
    The Agency has also examined the standard practices that industry 
uses in carrying out chemical testing in response to test rules, such 
as this one. Based on that examination, EPA believes that:
    1. Small businesses do not perform the testing themselves, nor do 
they participate in the organization of the testing effort, because 
health effects testing of chemical substances is generally carried out 
by consortia of the large manufacturers or importers of the chemical 
substances;
    2. A small business would experience only very minor costs, if any, 
in securing an exemption from testing requirements, because exemption 
request requirements, described generally at 40 CFR 790.80 through 
790.99 and the proposed regulatory text at Sec. 799.5115(c)(2), (c)(5), 
and (c)(7), are minimal and EPA does not charge a fee for filing such a 
request; and
    3. Small businesses are unlikely to be affected by the 
reimbursement requirements because under the reimbursement provisions 
described in 40 CFR part 791, manufacturers and importers with a 
significant share of production or importation are the entities that 
will likely pay the highest share of testing costs, and the marginal

[[Page 31085]]

benefit of securing reimbursement from small contributors may not be 
worth the cost.
    Information relating to this determination has been included in the 
public version of the official record for the proposed rule. This 
information will also be provided to the SBA Chief Counsel for Advocacy 
upon request. Any comments regarding the impacts that this action may 
impose on small entities, or regarding whether the Agency should 
consider establishing an alternate definition of small business to be 
used for analytical purposes for future test rules and what size cutoff 
may be appropriate, should be submitted to the Agency in the manner 
specified in Unit I.C. of this preamble.

E. Paperwork Reduction Act

    Pursuant to the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et 
seq.), an Agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information that is subject to 
approval under the PRA, unless it displays a currently valid OMB 
control number. The OMB control numbers for EPA's regulations, after 
appearing in the preamble of the final rule, are listed in 40 CFR part 
9, and included on the related collection instrument. The information 
collection activities related to chemical testing under TSCA section 
4(a) have already been approved under OMB control number 2070-0033 (EPA 
ICR# 1139), and the information collection activities related to export 
notification under TSCA section 12(b)(1) are already approved under OMB 
control number 2070-0030 (EPA ICR# 0795). Since this proposed rule does 
not contain any new information collection activities, additional 
review and approval of these activities by OMB under the PRA is not 
necessary.
    Although the information collection activities contained in this 
proposed rule have already been approved by OMB, the total burden hours 
currently approved for the information collection activities related to 
chemical testing in general include an average burden estimate to cover 
future test rules. As described in the information collection 
instrument for chemical testing, the Agency's total burden estimate 
specifically accounts for the potential issuance of approximately 7 
final test rules during the approval period, with an estimated burden 
of less than 20,000 burden hours each. EPA believes that the existing 
approval includes a sufficient burden hour allocation to cover the 
estimated burden related to this proposed rule, if finalized as 
proposed. When the final rule is issued, EPA will verify that the 
approved burden hours will cover the estimated burden for the final 
rule, or request that the total approved burden hour allocation be 
increased accordingly.
    The standard chemical testing program involves the submission of 
letters of intent to test (or exemption applications), study plans, 
semi-annual progress reports, and test results. For this proposed rule, 
EPA estimates that the information collection activities related to 
chemical testing would result in 105.4 burden hours for each chemical, 
for a total estimated burden increase of 4,954 hours (Ref. 9). The 
estimated burden of the information collection activities related to 
export notification is 0.5-1.5 burden hours for each chemical/country 
combination (Ref. 9). In estimating the total burden hours approved for 
the information collection activities related to export notification, 
the Agency has included sufficient burden hours to accommodate any 
export notifications that may be required by the Agency's issuance of 
final chemical test rules (Ref. 9, 13, and 14). As such, EPA does not 
expect to need to request an increase in the total burden hours 
approved by OMB for export notifications.
    As defined by the PRA and 5 CFR 1320.3(b), burden means the total 
time, effort, or financial resources expended by persons to generate, 
maintain, retain, or disclose or provide information to or for a 
Federal agency. This includes the time needed to review instructions; 
develop, acquire, install, and utilize technology and systems for the 
purposes of collecting, validating, and verifying information, 
processing and maintaining information, and disclosing and providing 
information; adjust the existing ways to comply with any previously 
applicable instructions and requirements; train personnel to be able to 
respond to a collection of information; search data sources; complete 
and review the collection of information; and transmit or otherwise 
disclose the information.
    Comments are requested on the Agency's need for this information, 
the accuracy of the provided burden estimates, and any suggested 
methods for minimizing respondent burden, including through the use of 
automated collection techniques. Send comments to EPA as part of your 
overall comments on this proposed action in the manner specified in 
Unit I.C. of this preamble. In the final rule, the Agency will address 
any comments received regarding the information collection requirements 
contained in this proposal.

F. Unfunded Mandates Reform Act

    Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA), Pub. L. 104-4, EPA has determined that this proposed rule does 
not contain a Federal mandate that may result in expenditures of $100 
million or more for State, local, and tribal governments, in the 
aggregate, or the private sector in any 1 year. It is estimated that 
the total one-time cost of the rule, which is summarized in Unit 
VIII.A. of this preamble, is $1.55 million, with the total annualized 
cost estimated to be $170,576, and the estimated annual cost per 
chemical to be $3,628. In addition, EPA has determined that this 
proposed rule does not significantly or uniquely affect small 
governments. Accordingly, today's proposed rule is not subject to the 
requirements of UMRA sections 202, 203, 204, or 205.

 G. Executive Order 12875

     Under Executive Order 12875, entitled  Enhancing the 
Intergovernmental Partnership  (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local, or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments, or EPA consults with those 
governments. If EPA complies by consulting, Executive Order 12875 
requires EPA to provide to OMB a description of the extent of EPA's 
prior consultation with representatives of affected State, local, and 
tribal governments, the nature of their concerns, any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
     EPA does not believe the today's proposed rule under TSCA section 
4(a) creates a Federal mandate on State, local, or tribal governments, 
and thus, EPA does not believe that the requirements of section 1(a) of 
Executive Order 12875 apply to this rule. The Agency does not know of 
any State, local, or tribal governments that would be subject to the 
requirements of the rule if it were promulgated as proposed. In the 
history of the TSCA section 4(a) testing program, the Agency has never 
received a letter of intent to

[[Page 31086]]

test or an exemption application from a State, local, or tribal 
government. EPA is requesting comment on whether any State, local, or 
tribal government would be subject to the requirements of the proposed 
rule. If, on the basis of these comments, EPA determines that the rule 
would create a Federal mandate, the Agency will consult with 
representatives of affected State, local, or tribal governments in 
accordance with the Executive Order prior to promulgating the final 
rule.

H. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA has 
determined that this proposed rule does not significantly or uniquely 
affect the communities of Indian tribal governments. This determination 
is based on the Agency's belief that, as a practical matter, the burden 
of chemical testing under TSCA section 4(a) rules has traditionally 
fallen on large, private sector manufacturers rather than on tribal 
governments. Accordingly, the requirements of section 3(b) of Executive 
Order 13084 do not apply to this proposed rule.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note), directs EPA to use voluntary 
consensus standards in its regulatory activities unless to do so would 
be inconsistent with applicable law or otherwise impractical. Voluntary 
consensus standards are technical standards (e.g., materials 
specifications, test methods, sampling procedures, and business 
practices) that are developed or adopted by voluntary consensus 
standards bodies. The NTTAA directs EPA to provide Congress, through 
OMB, explanations when the Agency decides not to use available and 
applicable voluntary consensus standards.
    If the Agency has made findings under TSCA section 4(a), EPA is 
required by TSCA section 4(b) to include specific standards for the 
development of data in test rules. The testing that would be required 
under this rule would be conducted according to the enforceable in 
vitro dermal absorption rate test standard proposed in this document. 
This test standard was developed by EPA in conjunction with ITC member 
and liaison agencies (CPSC, DoD, FDA, NIOSH, and OSHA). It was based on 
the methods of Bronaugh and Collier (Bronaugh, R.L., and Collier, S.W., 
Protocol for In Vitro Percutaneous Absorption Studies, In Vitro 
Percutaneous Absorption: Principles, Fundamentals, and Applications. 
R.L. Bronaugh and H.I. Maibach, Eds. CRC Press, Boca Raton, FL. pp. 
237-241 (1991)) (Ref. 7) , and modified in response to public comments. 
The group of scientists that developed this test standard did so based 
on their experience with the methodologies available for conducting 
this type of testing. As a result of their collective expertise in 
these methodologies, they considered the method developed for this 
testing program to be an effective and efficient method for testing a 
large number of chemicals to determine an in vitro dermal absorption 
rate using human cadaver skin.
    EPA is not aware of any potentially applicable voluntary consensus 
standards which needed to be considered in lieu of the in vitro dermal 
absorption rate test standard included in this proposed rule. The 
Agency invites comment on the potential use of voluntary consensus 
standards in this proposed rule, and, specifically, invites the public 
to identify potentially applicable voluntary consensus standard(s) and 
to explain why such standard(s) should be used here.

List of Subjects in 40 CFR Part 799

     Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements, Laboratories.

    Dated: June 1, 1999.

Susan H. Wayland,

Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
    Therefore, it is proposed that 40 CFR chapter I, subchapter R, be 
amended as follows:

PART 799--[AMENDED]

    1. The authority citation for part 799 would continue to read as 
follows:

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

    2. By adding Sec. 799.5115 to subpart D to read as follows:


 Sec. 799.5115  Chemical testing requirements for certain chemicals of 
interest to the Occupational Safety and Health Administration.

    (a) What substances will be tested under this section? Table 2 in 
paragraph (i) of this section identifies the chemical substances that 
must be tested under this section. The purity of each test substance 
must be 99% or greater unless otherwise specified in this section.
    (b) Am 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 of paragraph (i) of this section 
at any time from the effective date specified in Table 2 of paragraph 
(i) of this section to the end of the test data reimbursement period as 
defined in 40 CFR 791.3(h), you are subject to this section with 
respect to that chemical substance.
    (2) If you do not know or cannot reasonably ascertain that you 
manufacture or process a chemical substance listed in Table 2 of 
paragraph (i) of this section during the time period described in 
paragraph (b)(1) of this section (based on all information in your 
possession or control, as well as all information that a reasonable 
person similarly situated might be expected to possess, control, or 
know, or could obtain without unreasonable burden), you are not subject 
to this section with respect to that chemical substance.
    (c) If 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.

[[Page 31087]]



   Table 1.--Persons Subject to the Rule: Persons in Tier 1 and Tier 2
------------------------------------------------------------------------
 Persons initially required to comply  Persons not initially required to
      with this section (Tier 1)       comply with this section (Tier 2)
------------------------------------------------------------------------
Persons not otherwise          Persons that manufacture
 specified in column 2 of this table    (as defined at TSCA section
 that manufacture (as defined at TSCA   3(7)) or intend to manufacture a
 section 3(7)) or intend to             chemical substance included in
 manufacture a chemical substance       this section solely as one or
 included in this section.              more of the following:
                                       --As a byproduct (as defined at
                                        40 CFR 791.3(c));
                                       --As an impurity (as defined at
                                        40 CFR 790.3);
                                       --As a naturally occurring
                                        substance (as defined at 40 CFR
                                        710.4(b));
                                       --As a non-isolated intermediate
                                        (as defined at 40 CFR 704.3);
                                       --As a component of a Class 2
                                        substance (as described at 40
                                        CFR 720.45(a)(1)(i));
                                       --In amounts of less than 500
                                        kilograms (kg) (1,100 lbs)
                                        annually (as described at 40 CFR
                                        790.42(a)(4)); or
                                       --For research and development
                                        (as described at 40 CFR
                                        790.42(a)(5)).
                                       Persons that process (as
                                        defined at TSCA section 3(10))
                                        or intend to process a chemical
                                        substance included in this
                                        section (see 40 CFR
                                        790.42(a)(2)).
------------------------------------------------------------------------


    (ii) Table 1 of paragraph (c)(1)(i) of this section expands the 
list of persons specified in Sec. 790.42(a)(2), (a)(4), and (a)(5) of 
this chapter, who, while legally subject to this section, must comply 
with the requirements of this section only if directed to do so by EPA 
under the circumstances set forth in paragraphs (c)(4) and (c)(5) of 
this section.
    (2) If you are in Tier 1 with respect to a chemical substance 
listed in Table 2 of paragraph (i) of this section, you will be 
required to comply with this section with regard to that chemical 
substance, as described in paragraph (d) of this section, no later than 
30 days after the effective date specified in Table 2 of paragraph (i) 
of this section for that chemical substance. Sections 790.45(a) and 
790.80(b)(1) of this chapter do not apply to this section.
    (3) If you are in Tier 2 with respect to a chemical substance 
listed in Table 2 of paragraph (i) of this section, you are considered 
to have an automatic conditional exemption and you will be required to 
comply with this section with regard to that chemical substance only if 
directed to do so by EPA under paragraphs (c)(5) or (c)(6) of this 
section.
    (4) If no person in Tier 1 has notified EPA of its intent to 
conduct one or more of the tests required by this section on any 
chemical substance listed in Table 2 of paragraph (i) of this section 
within 30 days after the effective date in Table 2 of paragraph (i) of 
this section, EPA will publish a Federal Register document that will 
specify the test and the chemical substance for which no letter of 
intent has been submitted. Section 790.48(b)(2) of this chapter does 
not apply to this section.
    (5) If you are in Tier 2 with respect to a chemical substance 
listed in Table 2 of paragraph (i) of this section, and if you 
manufacture or process this chemical as of the effective date specified 
in Table 2 of paragraph (i) of this section, or within 30 days after 
publication of the Federal Register document described in paragraph 
(c)(4) of this section, you must do the following: For each test on 
that chemical specified in the Federal Register document described in 
paragraph (c)(4) of this section, either notify EPA by letter of your 
intent to test or submit to EPA an exemption application. You must 
comply within 30 days after the date of publication of the Federal 
Register document described in paragraph (c)(4) of this section. 
Sections 790.48(b)(3), and 790.80(a)(2) and (b)(1) of this chapter do 
not apply to this section.
    (6) If a problem occurs with the initiation, conduct, or completion 
of the required testing or the submission of the required data with 
respect to a chemical substance listed in Table 2 of paragraph (i) of 
this section, under the procedures in 40 CFR 790.93 and 790.97, EPA 
will terminate all testing exemptions with respect to that substance 
and may notify persons in Tier 1 and Tier 2 that they are required to 
submit letters of intent to test or exemption applications within a 
specified period of time. A notification will be given by certified 
letter or by publication of a Federal Register document.
    (7) If you are required to comply with this section, but your 
manufacturing or processing of a chemical substance listed in Table 2 
of paragraph (i) of this section begins after the applicable compliance 
date referred to in paragraphs (c)(2), (c)(5) or (c)(6) of this 
section, you must comply by submitting a letter of intent to test or an 
exemption application as of the day you begin manufacturing or 
processing. Sections 790.45(d)(1) and (d)(2), and 790.80(b)(2) and 
(b)(3) of this chapter do not apply to this section.
    (d) What must I do to comply with this section? (1) To comply with 
this section you must either:
    (i) Submit to EPA a letter of intent to test, conduct the testing 
specified in Table 2 of paragraph (i) of this section, and submit the 
test data to EPA; or
    (ii) Apply to and obtain from EPA an exemption from testing.
    (2) You must also comply with the procedures governing test rule 
requirements in part 790 of this chapter, including the submission of 
letters of intent to test or exemption applications, the conduct of 
testing, and the submission of data; part 792 of this chapter; and this 
section.
    (e) If 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. Sections 790.45(e) and (f) of this chapter do not apply 
to this section.
    (f) How are EPA's data reimbursement procedures affected for 
purposes of this section? If persons subject to this section are unable 
to agree on the amount or method of reimbursement for test data 
development for one or more chemical substances included in this 
section, any person may request a hearing as described in 40 CFR part 
791. In the determination of fair reimbursement shares under this 
section, if the hearing officer chooses to use a formula based on 
production volume, the total production volume amount will include 
amounts of a chemical substance produced as an impurity.
    (g) Who must comply with the export notification requirements? Any 
person who exports, or intends to export, a chemical substance listed 
in Table 2 of paragraph (i) of this section is subject to part 707, 
subpart D, of this chapter.
    (h) What test standard must I follow? The chemical substances 
identified by Chemical Abstract Service (CAS) registry number and 
chemical name in Table 2 of paragraph (i) of this section must be 
tested as follows:

[[Page 31088]]

    (1) Applicability. This in vitro dermal absorption rate test 
standard must be used for all testing conducted under this section.
    (2) Source. The source used to develop this test standard is the 
``Protocol for In Vitro Percutaneous Absorption Studies,'' (Referenced 
in paragraph (h)(8)(i)(A) of this section).
    (3) Purpose. In the assessment and evaluation of the 
characteristics of a chemical substance or mixture (test substance), 
determination of the rate of absorption of the chemical substance where 
dermal exposure to the chemical substance in the workplace may result 
in systemic toxicity is important. This test standard is designed to 
develop data on the rate at which chemicals are absorbed through the 
skin so that the body burden of chemical resulting from dermal exposure 
in the workplace can be better evaluated.
    (4) Principles of the test method. This test standard describes 
procedures for measuring a permeability constant (Kp) and a short-term 
in vitro absorption rate for chemical substances in liquid form. The 
test standard utilizes in vitro diffusion cell techniques which allow 
absorption studies to be conducted with human skin. In vitro diffusion 
studies are necessary for measuring a Kp. This test standard specifies 
the use of cadaver skin and static diffusion cells to maintain the 
viability of the skin, thus, more closely simulating in vivo 
conditions. It also requires the use of radiolabeled test chemicals 
unless it can be demonstrated that procedures utilizing a non-
radiolabeled test substance are able to measure the substance with a 
sensitivity equivalent to the radiolabeled method.
    (5) Test procedure--(i) Choice of membrane--(A) Skin selection. 
Human cadaver skin must be used in all testing conducted under this 
test standard. The most accurate absorption-rate data for regulatory 
concerns related to human health would be obtained with live human 
skin. Because this test standard requires the use of static diffusion 
cells, maintenance of skin viability is not necessary. However, the 
time elapsed between death and harvest of the tissue must be reported.
    (B) Number of samples. Data from a total of at least six samples 
obtained from at least three human subjects must be averaged to allow 
for biological variation among subjects.
    (C) Anatomical region. In order to minimize the variability in skin 
absorption measurements for these tests, samples of human skin must be 
obtained from the abdominal region of human subjects of known source 
and disease state. Variability in skin permeation is well known to 
occur in different anatomical regions. The trunk and its extremities 
have reasonably similar barrier properties (less than 2-fold 
differences). Enhanced absorption can be observed in regions of the 
face (4-fold) and the scrotum (20-fold). Small differences in regional 
absorption may not be significant compared to intersubject variability
    (D) Validation of human skin barrier. Barrier properties of human 
skin must be pretested with a standard compound such as tritiated water 
prior to conducting an experiment with the test chemical because 
barrier alteration can result from surgery or topical scrubbing, as 
discussed in the reference in paragraph (h)(8)(i)(B) of this section.
    (ii) Preparation of membrane. Full thickness skin must not be used. 
Because chemicals are taken up by blood vessels directly beneath the 
epidermis in vivo, this in vitro test standard must be conducted using 
a membrane with most of the dermis removed. This is particularly 
important for hydrophobic chemicals that diffuse slowly through the 
dermis. A suitable membrane must be prepared from skin with a dermatome 
at a thickness of 200 to 500 millimeters (mm). The microtomed skin 
samples can be stored frozen for up to 2 weeks, if necessary, provided 
that they are frozen quickly and the barrier properties of the samples 
are confirmed.
    (iii) Diffusion cell design. Static diffusion cells must be used in 
these studies. The testing laboratory must verify that the difference 
in the concentration of the test compound across the skin membrane does 
not decrease by more than 10% during the experiment. This will ensure 
that the test compound concentration in the receptor fluid does not 
alter the penetration rate. Concentration of the neat liquid must be 
taken as the density of the compound.
    (iv) Temperature. Skin must be maintained at a physiological 
temperature of 32 deg. Celsius.
    (v) Testing hydrophobic chemicals. Chemicals with water solubility 
less than about 10 milligrams/liter do not freely partition from skin 
into aqueous receptor fluid. To increase the water solubility of such 
hydrophobic chemicals, polyethoxyoleate (polyethylene glycol (PEG) 20 
oleyl ether) must be added to the receptor fluid at a concentration of 
6%. To ensure that an increase in concentration of the chemical in the 
receptor fluid does not alter penetration rate, the concentration 
difference across the membrane must not decrease by more than 10% 
during the experiment.
    (vi) Vehicle. If the test chemical is a liquid at room temperature 
and does not damage the skin during the determination of Kp, it must be 
applied neat. If the chemical cannot be applied neat because it is a 
solid at room temperature or because it damages the skin when applied 
neat, it must be dissolved in water. If the concentration of a 
hydrophobic chemical in water is not high enough so that a steady-state 
absorption can be obtained, the chemical must be dissolved in isopropyl 
myristate. A sufficient volume of liquid must be used to completely 
cover the skin and provide the amount of test chemical needed as 
described in paragraph (h)(5)(vii) of this section.
    (vii) Dose--(A) Kp. An ``infinite dose'' of the test chemical must 
be applied to the skin to achieve the steady-state rate of absorption 
necessary for calculation of a Kp. The actual concentration required to 
give an undepletable reservoir on the surface of the skin depends on 
the rate of penetration of the test chemical. Preliminary studies may 
be necessary to determine this concentration. The diffusion cell tops 
must be covered with a stopper or with parafilm 7 to ensure that 
significant evaporation of the vehicle or test chemical does not occur. 
The skin barrier integrity must be verified at the end of the 
experiment by measuring the absorption of a standard compound such as 
tritiated water, as discussed in the reference in paragraph 
(h)(8)(i)(B) of this section.
    (B) Short-term absorption rate. Short-term absorption rates must be 
determined for all test chemicals. The dose of test chemical applied to 
the skin must be sufficient to completely cover the exposed skin 
surface. A minimum of four to six diffusion cells must be set up using 
skin from a single subject and two to three of these shall be 
terminated at 10 and 60 minutes. Skin absorption at each sampling time 
is the sum of the receptor-fluid levels and the absorbed chemical that 
remains in the skin, as discussed in the reference in paragraph 
(h)(8)(i)(C) of this section. Unabsorbed chemical must be removed from 
the skin surface by washing gently with soap and water. This procedure 
must be repeated with skin from two additional subjects. In order to 
ensure reliable short-term absorption rates, the diffusion cell tops 
must be covered with a stopper or with parafilm 7 to prevent 
evaporation of the test chemical.
    (viii) Study duration--(A) Kp. This in vitro dermal absorption rate 
test must be performed until at least four absorption measurements are 
obtained during the steady state absorption portion of the procedure. A 
preliminary study may be

[[Page 31089]]

useful to establish time points for sampling. The required absorption 
measurements can be accomplished in an hour or two with fast-
penetrating chemicals but require 24 hours or longer for slow-
penetrating chemicals. Unabsorbed material need not be removed from the 
surface of the skin.
    (B) Short-term exposure rate. The test chemical must be applied to 
skin for durations of at least 10 and 60 minutes. At the end of the 
study, the unabsorbed material must be removed from the surface of the 
skin with soap and water and the amount absorbed into the skin and 
receptor fluid must be determined, as discussed in the reference in 
paragraph (h)(8)(i)(C) of this section.
    (6) Results--(i) Kp. The Kp must be calculated by dividing the 
steady-state rate of penetration (measured in micrograms x 
hr-1 x centimeters (cm)-2) by the concentration 
of the test chemical (measured in micrograms x cm-3) applied 
to the skin. For example, if the steady-state rate is 1 microgram x 
hr-1 x cm-2 and the concentration applied to the 
skin is 1,000 micrograms x cm-3, then the Kp value is 
calculated to be 0.001 cm x hr-1.
    (ii) Short-term exposure rate. The rates of penetration (micrograms 
x hr-1 x cm-2 ) must be determined from the total 
amount of test chemical found in the receptor fluid and skin after the 
10- and 60-minute exposures.
    (7) Test reports. In addition to compliance with the TSCA Good 
Laboratory Practice (GLP) Standards at 40 CFR part 792, the following 
specific information must be collected and reported under paragraph (i) 
of this section:
    (i) Test systems and test methods. (A) A description of the date, 
time, and location of the test, the name(s) of the person(s) conducting 
the test, the location of records pertaining to the test, as well as a 
GLP statement. These statements must be certified by the signatures of 
the individuals performing the work and their supervisors.
    (B) A description of the source, identity, and purity of the test 
chemical and the source, identity, and handling of the test skin. There 
must be a detailed description of the test procedure and all materials, 
devices used and doses tested, as well as a detailed description and 
illustration of flow-cell design. There must also be a description of 
the skin preparation method including measurements of the skin membrane 
thickness.
    (C) A description of the analytical techniques to be used, 
including their accuracy, precision, and detection limits (in 
particular for non-radiolabeled tests), and, if a radiolabel is used, 
there must be a description of the radiolabel (e.g., type, location of, 
and radiochemical purity of the label).
    (D) All data must be clearly identified as to dose and specimen. 
Derived values (means, permeability coefficient, graphs, charts, etc.) 
are not sufficient.
    (ii) Conduct of study. Data must be collected and reported on the 
following:
    (A) Monitoring of testing parameters.
    (B) Temperature of chamber.
    (C) Receptor fluid pH.
    (D) Barrier property validation.
    (E) Analysis of receptor fluid for radioactivity or test chemical.
    (iii) Results. The Kp or short-term absorption rate must be 
presented. In addition, all raw data from each individual diffusion 
cell must be maintained to support the calculations of Kp and short-
term exposure rates. When radiolabeled compounds are used, a full 
balance of the radioactivity must be presented, including cell rinsing 
and stability of the test substance in the donor compartment.
    (8) References. (i) For background information on this test 
standard, the following references should be consulted. These 
references are available at the TSCA Nonconfidential Information 
Center, Rm. NE B-607, Environmental Protection Agency, 401 M St., SW., 
Washington, DC, 12 noon to 4 p.m., Monday through Friday, except legal 
holidays.
    (A) Bronaugh, R.L., and Collier, S.W. Protocol for In Vitro 
Percutaneous Absorption Studies. In Vitro Percutaneous Absorption: 
Principles, Fundamental, and Applications. R.L. Bronaugh and H.I. 
Maibach, Eds. CRC Press, Boca Raton, FL. pp. 237-241 (1991).
    (B) Bronaugh, R.L., Stewart, R.F., and Simon, M. Methods for In 
Vitro Percutaneous Absorption VII: Use of Excised Human Skin. Journal 
of Pharmaceutical Sciences. Vol. 75, pp. 1094-1097 (1986).
    (C) Bronaugh, R.L., Stewart, R.F., and Storm, J.E. Extent of 
Cutaneous Metabolism during Percutaneous Absorption of Xenobiotics. 
Toxicology and Applied Pharmacology. Vol. 99, pp. 534-543 (1989).
    (ii) Two additional documents consulted in developing this test 
standard are:
    (A)Walker, J.D., Whittaker, C. and McDougal, J.N. Role of the TSCA 
Interagency Testing Committee in Meeting the U.S. Government Data 
Needs: Designating Chemicals for Percutaneous Absorption Rate Testing. 
Dermatoxicology. F. Marzulli and H. Maibach, Eds. Taylor & Francis, 
Washington, DC. pp. 371-381 (1996).
    (B) Bronaugh, R.L. Stewart, R.F. Methods for In Vitro Percutaneous 
Absorption Studies IV: The Flow-Through Diffusion Cell. Journal of 
Pharmaceutical Sciences. Vol. 74, pp. 64-67 (1985).
    (i) Reporting requirements. The reports submitted under this 
section must include the information specified in paragraph (h)(7) of 
this section. Interim progress reports for each test must be submitted 
every 6 months, beginning 6 months after the effective date of any 
specific test listed in Table 2 of this paragraph. A final report for a 
specific test must be submitted by the deadline indicated as the number 
of months after the effective date shown in Table 2 of this paragraph.


     Table 2.--Required Testing: Chemical Substances Designated for In Vitro Dermal Absorption Rate Testing
----------------------------------------------------------------------------------------------------------------
                                                                           Number of Interim
             CAS No.                 Chemical name    Deadline for final   (6 month) reports    Effective date
                                                            report             required
----------------------------------------------------------------------------------------------------------------
60-29-7                            Ethyl ether                 9                   1
74-96-4                            Ethyl bromide               9                   1
75-05-8                            Acetonitrile                9                   1
75-15-0                            Carbon disulfide            9                   1
75-35-4                            Vinylidene                  9                   1
                                   chloride
77-73-6                           Dicyclopentadiene            9                   1
77-78-1                            Dimethyl sulfate            9                   1
78-59-1                            Isophorone                  9                   1
78-83-1                            Isobutyl alcohol            9                   1
78-87-5                            Propylene                   9                   1
                                   dichloride
78-92-2                            sec-Butyl alcohol           9                   1

[[Page 31090]]

 
79-20-9                            Methyl acetate              9                   1
79-46-9                            2-Nitropropane              9                   1
91-20-3                            Naphthalene                 9                   1
92-52-4                           Biphenyl                     9                   1
95-49-8                            o-Chlorotoluene             9                   1
95-50-1                            o-Dichlorobenzene           9                   1
97-77-8                            Disulfiram                  9                   1
98-29-3                            tert-                       9                   1
                                   Butylcatechol
99-99-0                           p-Nitrotoluene               9                   1
100-00-5                          p-                           9                   1
                                   Nitrochlorobenzen
                                   e
100-01-6                          p-Nitroaniline               9                   1
100-44-7                          Benzyl chloride              9                   1
106-42-3                           p-Xylene                    9                   1
106-46-7                           p-Dichlorobenzene           9                   1
107-06-2                          Ethylene                     9                   1
                                   dichloride
107-31-3                           Methyl formate              9                   1
108-03-2                           1-Nitropropane              9                   1
108-90-7                           Chlorobenzene               9                   1
108-93-0                           Cyclohexanol                9                   1
109-66-0                           Pentane                     9                   1
109-99-9                           Tetrahydrofuran             9                   1
110-12-3                           Methyl isoamyl              9                   1
                                   ketone
111-84-2                           Nonane                      9                   1
120-80-9                           Catechol                    9                   1
121-69-7                           Dimethylaniline             9                   1
122-39-4                           Diphenylamine               9                   1
123-42-2                          Diacetone alcohol            9                   1
126-99-8                          beta-Chloroprene             9                   1
127-19-5                          Dimethyl acetamide           9                   1
142-82-5                          n-Heptane                    9                   1
150-76-5                          p-Methoxyphenol              9                   1
528-29-0                           o-Dinitrobenzene            9                   1
628-63-7                          n-Amyl acetate               9                   1
768-52-5                          N-Isopropylaniline           9                   1
25013-15-4                        Vinyl toluene                9                   1
34590-94-8                         Dipropylene                 9                   1
                                   glycol methyl
                                   ether
----------------------------------------------------------------------------------------------------------------


[FR Doc. 99-14640 Filed 6-8-99; 8:45 am]
BILLING CODE 6560-50-F