[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the listed substances to report unpublished health and safety data to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unpublished health and safety data, and manufacturers and importers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
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* * * * * * *
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
* * * * * * *
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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
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* * * * * * *
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
