[Federal Register Volume 59, Number 227 (Monday, November 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29148]


[Federal Register: November 28, 1994]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 712 and 716

[OPPTS-82044; FRL-4914-5]


Preliminary Assessment Information and Health and Safety Data 
Reporting; Addition of Chemicals

Agency: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Interagency Testing Committee (ITC) in its 34th Report to 
EPA revised the Toxic Substances Control Act (TSCA) Section 4(e) 
Priority List by recommending for health effects testing ethyl tert-
butyl ether (ETBE) (CAS No. 637-92-3) and tert-amyl methyl ether (TAME) 
(CAS No. 994-05-8). The ITC recommendations must be given priority 
consideration by EPA in promulgating test rules. EPA is adding these 
two chemical substances to two model information-gathering rules: the 
TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR) and 
the TSCA Section 8(d) Health and Safety Data Reporting Rule. These 
model rules will require: Manufacturers and importers of the substances 
identified herein to report certain production, use, and exposure-
related information, and manufacturers, importers, and processors of 
the listed substances to report unpublished health and safety data to 
EPA.

EFFECTIVE DATE: This rule will become effective on December 28, 1994.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, TSCA 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., 
Rm. E-543, Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202) 
554-0551.

SUPPLEMENTARY INFORMATION: This rule adds ETBE and TAME to the PAIR and 
the section 8(d) Health and Safety Data Reporting Rule. Manufacturers, 
importers, and processors of these chemicals will be required to report 
unpublished health and safety data, and manufacturers and importers 
will be required to report end use, exposure, and production volume 
data to EPA. Because the ITC has expressed no need for ecological 
effects information for the substances being added to the section 8(d) 
rule via this action, EPA is not requiring the reporting of these data 
for the subject substances under the section 8(d) rule.

I. Background

    Section 4(e) of TSCA established the ITC and authorized it to 
recommend to EPA chemical substances and mixtures (chemicals) to be 
given priority consideration in proposing test rules under section 4. 
For some of these chemicals, the ITC may designate that EPA must 
respond to its recommendations within 12 months. In this time, EPA must 
either initiate a rulemaking to test the chemical or publish in the 
Federal Register its reasons for not doing so.
    On May 17, 1994, EPA announced the receipt of the 34th Report of 
the ITC, and it was then published in the Federal Register of July 13, 
1994 (59 FR 35720). The 34th Report revises the Committee's priority 
list of chemicals by recommending ETBE and TAME to the section 4(e) 
priority list.
    This rule adds ETBE and TAME to the PAIR and the section 8(d) 
Health and Safety Data Reporting Rule. These two rules are model 
information gathering rules which assist the ITC in making testing 
recommendations and aid EPA in responding to the ITC recommendations.
    EPA issued the PAIR under section 8(a) of TSCA (15 U.S.C. 2607(a)), 
and it is codified at 40 CFR part 712. This model section 8(a) rule 
establishes standard reporting requirements for manufacturers and 
importers of the chemicals listed in the rule at 40 CFR 712.30. These 
manufacturers and importers are required to submit a one-time report on 
general volume, end use, and exposure-related information using the 
Preliminary Assessment Information Manufacturer's Report (EPA Form 
7710-35).
    EPA uses this model section 8(a) rule to gather current information 
on chemicals of concern quickly. EPA issued the model Health and Safety 
Data Reporting Rule under section 8(d) of TSCA (15 U.S.C. 2607(d)), and 
it is codified at 40 CFR part 716. The section 8(d) model rule requires 
past, current, and prospective manufacturers, importers, and processors 
of listed chemicals to submit to EPA copies and lists of unpublished 
health and safety studies on the listed chemicals that they 
manufacture, import, or process. These studies provide EPA with useful 
information and have provided significant support for EPA's 
decisionmaking under TSCA sections 4, 5, 6, 8, and 9.
    These model rules provide for the automatic addition of ITC 
priority list chemicals. Whenever EPA announces the receipt of an ITC 
report, EPA may, at the same time without further notice and comment, 
amend the two model information-gathering rules by adding the 
recommended chemicals. The amendment adding these chemicals to the PAIR 
and the Health and Safety Data Reporting Rule becomes effective 30 days 
after publication in the Federal Register.
    The reporting of ecological effects data will not be required for 
ETBE and TAME under the section 8(d) rule. Because no member of the ITC 
has expressed a need for these data, EPA believes there is no need to 
collect this information at this time.

II. Chemicals To Be Added

    In its 34th Report to EPA, the ITC recommended ETBE and TAME for 
health effects testing. EPA is adding these two chemical substances to 
the PAIR and the section 8(d) Health and Safety Data Reporting Rule. 
The use of ETBE and TAME to augment or substitute for methyl tert-butyl 
ether (MTBE) (CAS No. 1634-04-4) as fuel oxygenates and the need for 
health effects data for ETBE and TAME are of concern to EPA and the 
ITC. For these reasons, EPA is adding ETBE and TAME to the section 8(d) 
rule to obtain data to support EPA's ongoing assessments of the 
potential hazards/risks posed by these two substances.
    Manufacturers, importers, and processors of the two substances 
being listed on the 8(d) rule by this action will not be required to 
report ecological effects data under the 8(d) rule for those 
substances.

III. Reporting Requirements

A. Preliminary Assessment Information Rule

    All persons who manufactured or imported the chemical substances 
named in this rule during their latest complete corporate fiscal year 
must submit a Preliminary Assessment Information Manufacturer's Report 
(EPA Form No. 7710-35) for each manufacturing or importing site at 
which they manufactured or imported a named substance. A separate form 
must be completed for each substance and submitted to the Agency no 
later than February 27, 1995. Persons who have previously and 
voluntarily submitted a Manufacturer's Report to the ITC or EPA may be 
able to submit a copy of the original Report to EPA or to notify EPA by 
letter of their desire to have this voluntary submission accepted in 
lieu of a current data submission. See Sec. 712.30(a)(3).
    Details of the reporting requirements, the basis for exemptions, 
and a facsimile of the reporting form, are provided in 40 CFR part 712. 
Copies of the form are available from the TSCA Environmental Assistance 
Division at the address listed under FOR FURTHER INFORMATION CONTACT.

B. Health and Safety Data Reporting Rule

    Listed below are the general reporting requirements of the section 
8(d) model rule.
    1. Persons who, in the 10 years preceding the date a substance is 
listed, either have proposed to manufacture, import, or process, or 
have manufactured, imported, or processed, the listed substance must 
submit to EPA: A copy of each health and safety study which is in their 
possession at the time the substance is listed.
    2. Persons who, at the time the substance is listed, propose to 
manufacture, import, or process; or are manufacturing, importing, or 
processing the listed substance must submit to EPA:
    a. A copy of each health and safety study which is in their 
possession at the time the substance is listed.
    b. A list of health and safety studies known to them but not in 
their possession at the time the substance is listed.
    c. A list of health and safety studies that are ongoing at the time 
the substance is listed and are being conducted by or for them.
    d. A list of each health and safety study that is initiated after 
the date the substance is listed and is conducted by or for them.
    e. A copy of each health and safety study that was previously 
listed as ongoing or subsequently initiated and is now complete--
regardless of completion date.
    3. Persons who, after the time the substance is listed, propose to 
manufacture, import, or process the listed substance must submit to 
EPA:
    a. A copy of each health and safety study which is in their 
possession at the time they propose to manufacture, import, or process 
the listed substance.
    b. A list of health and safety studies known to them but not in 
their possession at the time they propose to manufacture, import, or 
process the listed substance.
    c. A list of health and safety studies that are ongoing at the time 
they propose to manufacture, import, or process the listed substance, 
and are being conducted by or for them.
    d. A list of each health and safety study that is initiated after 
the time they propose to manufacture, import, or process the listed 
substance, and is conducted by or for them.
    e. A copy of each health and safety study that was previously 
listed as ongoing or subsequently initiated and is now complete--
regardless of the completion date.
    The bulk of reporting is required at the time the substance is 
listed. Persons described in categories 1 and 2 do all or most of their 
health and safety data reporting at the start of the reporting period. 
The remaining reporting requirements, specifically categories 2(d), 
2(e), and 3, continue prospectively.
    Detailed guidance for reporting unpublished health and safety data 
is provided in the Federal Register of September 15, 1986 (51 FR 
32720). Also found there are explanations of the reporting exemptions.

C. Submission of PAIR Reports and Section 8(d) Studies

    PAIR reports and section 8(d) health and safety studies must be 
sent to:
    TSCA Document Processing Center (7407), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460, ATTN: (insert either PAIR or 8(d) Reporting).

D. Removal of Chemical Substances from the Rules

    Any person who believes that section 8(a) or 8(d) reporting 
required by this rule is unwarranted, should promptly submit to EPA in 
detail the reasons for that belief. EPA, in its discretion, may remove 
the substance from this rule for good cause (40 CFR 712.30 and 
716.105). When withdrawing a substance from the rule, EPA will issue a 
rule amendment for publication in the Federal Register.

IV. Release of Aggregate Data

    EPA will follow procedures for the release of aggregate statistics 
as prescribed in the Federal Register notice of June 13, 1983 (48 FR 
27041). Included in the notice are procedures for requesting exemptions 
from the release of aggregate data. Exemption requests concerning the 
release of aggregate data on any chemical substance must be received by 
EPA no later than February 27, 1995.

V. Economic Analysis

A. Preliminary Assessment Information Rule

    EPA estimates the PAIR reporting cost of this rule is $14,072. To 
calculate this figure, EPA used information from a variety of published 
sources as well as information from OPPTS's Risk Management 1 (RM1) 
reports on similar chemicals to generate a list of five firms that 
manufacture and/or import the two chemicals at a total of eight sites. 
The published sources used include: SRI International's Directory of 
Chemical Producers, Chemical Economics Handbook, and Specialty 
Chemicals; other multi-client studies; the U.S. International Trade 
Commission's Synthetic Organic Chemicals; and company product 
literature. An unknown number of the businesses affected by the 
addition of the chemicals to the Priority List may qualify as a small 
business as defined in 40 CFR 712.25(c). However, for this analysis it 
is assumed that all firms identified will report. Therefore, EPA 
expects five firms to generate a total of eight reports (some sites 
produce both of the chemicals).
                    Reporting Costs (dollars)
(a) 8 reports estimated at $924 per report = $7,392
(b) 8 sites at $835 per site = $6,680
Total Cost = $14,072
Mean cost per site = $14,072/8 sites = $1,759
Mean cost per firm = $14,072/5 firms = $2,814
Mean cost per report = $14,072/8 reports = $1,759
                    Reporting Burden (hours)
(a) Rule familiarization: 18 hours/site x 8 sites = 144
(b) Reporting: 16 hours/report x 8 reports = 128
Total burden hours = 272
Average burden per site = 272 hours/8 sites = 34
Average burden per firm = 272 hours/5 firms = 55
Average burden per firm = 272 hours/8 reports = 34
                    EPA Costs (dollars)
Processing cost = 8 reports x $95/report = $760

B. Health and Safety Data Reporting Rule

    EPA estimates the total reporting costs for establishing section 
8(d) reporting requirements for the two chemicals will be $10,353. This 
cost estimate is high because the Agency is uncertain about the likely 
number of respondents to the rule. Although EPA has used the best 
available data to make its economic projections, much of the 
information is based upon the 1986 TSCA Inventory Update and secondary 
information from industry sources. Therefore, EPA tends to overestimate 
rather than underestimate reporting burden.
    The estimated reporting costs are broken down as follows:

                                                                        
                                                                        
Initial corporate review                                         $ 2,080
                                                                        
Site identification                                                1,248
                                                                        
File searches at site                                              2,829
                                                                        
Photocopying existing studies                                        428
                                                                        
Title listing                                                        129
                                                                        
Managerial review for CBI                                          2,565
                                                                        
Reporting on newly-initiated studies                               54.52
                                                                        
Submissions after initial reporting period                        970.80
                                                                        
Total                                                           $ 10,353

                Reporting Burden (hours)
(a) Initial review: 2 hours/firm x 15 firms = 30 hrs
(b) Reporting: 10.26 hours/firm x 15 firms = 154 hrs
Total reporting burden hours = 184 hrs

VI. Rulemaking Record

    The following documents constitute the record for this rule (docket 
control number OPPTS-82044). All of these documents are available to 
the public in the TSCA Nonconfidential Information Center (NCIC), 
formerly the TSCA Public Docket Office, from 12 noon to 4 p.m., Monday 
through Friday, excluding legal holidays. The NCIC is located at EPA 
Headquarters, Rm. NE-B607, 401 M St., SW., Washington, DC 20460.
    1. This final rule.
    2. The economic analysis for this rule.
    3. The Thirty-fourth Report of the ITC.

VII. Regulatory Assessment Requirements

A. Executive Order 12866

    Under Executive Order l2866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to review by the Office of Management and Budget 
(OMB) and the requirements of the Executive Order. Under section 3(f), 
the order defines a ``significant regulatory action'' as an action that 
is likely to result in a rule (1) having an annual effect on the 
economy of $100 million or more, or adversely and materially affecting 
a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local or tribal 
governments of communities (also referred to as ``economically 
significant''); (2) creating serious inconsistency or otherwise 
interfering with an action taken or planned by another agency; (3) 
materially altering the budgetary impacts of entitlement, grants, user 
fees, or loan programs or the rights and obligations of recipients 
thereof; or (4) raising novel legal or policy issues arising out of 
legal mandates, the President's priorities, or the principles set forth 
in this Executive Order.
    Pursuant to the terms of this Executive Order, it has been 
determined that this rule is not ``significant'' and is therefore not 
subject to OMB review.

B. Paperwork Reduction Act

    The information collection requirements contained in this rule have 
been approved by OMB under the provisions of the Paperwork Reduction 
Act of 1980, 44 U.S.C. 3501 et seq. and have been assigned OMB control 
numbers 2070-0054 for PAIR reporting and 2070-0004 for TSCA section 
8(d) reporting.
    Public reporting burden for this collection of information is 
estimated to average 34 hours for PAIR per response and 8.2 hours for 
section 8(d), including time for reviewing instructions, searching 
existing data sources, gathering and maintaining the data needed, and 
completing and reviewing the collection of information.
    Send comments regarding the burden estimate or any other aspect of 
this collection of information, including suggestions for reducing this 
burden, to Chief, Information Policy Branch, 2131, U.S. Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; and to the 
Office of Information and Regulatory Affairs, Office of Management and 
Budget, Washington, DC 20503, marked ``Attention: Desk Officer for 
EPA.''

List of Subjects in 40 CFR Parts 712 and 716

    Environmental protection, Chemicals, Hazardous substances, Health 
and safety data, Reporting and recordkeeping requirements.

    Dated: November 8, 1994.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
    Therefore, 40 CFR Chapter I is amended as follows:

PART 712--[AMENDED]

    1. In part 712:

    a. The authority citation for part 712 continues to read as 
follows:

    Authority: 15 U.S.C. 2607(a).

    b. Section 712.30(w) is amended by adding in CAS number sequence 
two chemicals to the list to read as follows:


Sec. 712.30   Chemical lists and reporting periods.

* * * * *
    (w) *  *  *

                                                                        
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     CAS No.          Substance       Effective date     Reporting date 
------------------------------------------------------------------------
                                                                        
                              * * * * * * *                             
637-92-3          Ethyl tert-butyl           12/28/94            2/27/95
                   ether                                                
                                                                        
                              * * * * * * *                             
994-05-8          Tert-amyl methyl           12/28/94            2/27/95
                   ether                                                
                                                                        
                              * * * * * * *                             
------------------------------------------------------------------------

* * * * *

PART 716--[AMENDED]

    2. In part 716:
    a. The authority citation for part 716 continues to read as 
follows:

    Authority: 15 U.S.C. 2607(d).

    b. Section 716.120(a) is amended by adding in CAS number sequence 
two chemicals to the list to read as follows:


Sec. 716.120   Substances and listed mixtures to which this subpart 
applies.

* * * * *
    (a)  *  *  *

                                                                                                                
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         CAS No.                 Substance            Special exemptions      Effective date      Sunset date   
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                                                  * * * * * * *                                                 
637-92-3                  Ethyl-tert-butyl ether   Sec. 716.20(b)(3)                 12/28/94           12/28/04
                                                    applies                                                     
                                                                                                                
                                                  * * * * * * *                                                 
994-05-8                  Tert-amyl methyl ether   Sec. 716.20(b)(3)                 12/28/94           12/28/04
                                                    applies                                                     
                                                                                                                
                                                  * * * * * * *                                                 
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[FR Doc. 94-29148 Filed 11-25-94; 8:45 am]
BILLING CODE 6560-50-F