[Federal Register Volume 61, Number 40 (Wednesday, February 28, 1996)]
[Rules and Regulations]
[Pages 7421-7425]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4519]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 712 and 716
[OPPTS-82048; FRL-4996-9]
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 37th Report to
EPA revised the Toxic Substances Control Act (TSCA) Section 4(e)
Priority List by recommending for testing 28 chemical substances. The
ITC recommendations must be given priority consideration by EPA in
promulgating test rules. EPA is adding these 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report unpublished health and safety data to EPA. This rule also makes
certain modifications to a final
[[Page 7422]]
rule published in the Federal Register of February 9, 1994; the TSCA
section 8(d) Health and Safety Data Reporting rule.
EFFECTIVE DATE: March 29, 1996.
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, e-mail: TSCA-
H[email protected].
SUPPLEMENTARY INFORMATION: This rule adds 28 chemical substances 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required to report unpublished health and safety data, and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.
This document also modifies TSCA section 8(d) of a final rule
published in the Federal Register of February 9, 1994 (59 FR 5956), to
require submission of ecological effects data for o-sec-butylphenol
(CAS No. 89-72-5).
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 November 22, 1995, EPA announced the receipt of the 37th Report
of the ITC, and it was then published in the Federal Register of
February 2, 1996 (61 FR 4188). The 37th Report revises the Committee's
priority list of chemicals by recommending the addition of 28 chemical
substances for testing to the section 4(e) priority list.
This rule adds 28 substances to the section 8(a) Preliminary
Assessment Information Reporting Rule 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.
II. Chemicals To Be Added
In its 37th Report to EPA, the ITC recommended adding 28
alkylphenols and alkylphenol ethoxylates to the section 8(a) PAIR and
the section 8(d) Health and Safety Data Reporting Rule. While 28
chemical substances are identified in the regulatory text, 34 CAS
numbers are listed. Two chemical substances, branched 4-nonyphenol
(mixed isomers) and (1,1,3,3-tetramethylbutyl)phenol (mixed isomers)
are characterized with multiple CAS numbers.
For a complete listing of the substances being added to the section
8(d) model rule and the PAIR, see the regulatory text of this document.
In response to the data needs of EPA and the Department of
Interior, TSCA section 8(d) reporting requirements for o-sec-
buytlphenol (CAS No. 89-72-5) are being amended to require submission
of ecological effects data (59 FR 5956, February 9, 1994).
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 May 28, 1996. 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.
[[Page 7423]]
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. Economic Analysis
A. Preliminary Assessment Information Rule
The economic analysis for the addition of the 28 chemicals to the
TSCA Section 4(e) Priority List will be based largely on the methods
and data sources developed for the analyses of the original Section
8(a) Preliminary Assessment Information Rule (PAIR). These analyses
are:
1. Economic Impact and Small Business Definition Analysis for TSCA
Section 8(a) Preliminary Assessment Information Rule. Office of
Regulatory Analysis, OTS, U.S. EPA. February 1980.
2. Economic Analysis of the Final Section 8(a) Preliminary
Assessment Information Rule. R.A. Horner, Regulatory Impacts Branch,
OTS, U.S. EPA. November 12, 1981.
The Chemical Update System (CUS) was searched to determine the
manufacturers and importers of the 28 chemicals. This search identified
17 firms manufacturing or importing the 28 chemicals at a total of 14
sites.
Reporting Costs (dollars)
(a) 26 reports estimated at $1,483.73 per report=$38,576.98
(b) 17 sites at $465.99 per site=$7,921.83
Total Cost=$46,498.81
Mean cost per site=$46,499/14 sites=$3,321.36
Mean cost per firm=$46,499/17 firms=$2,735.24
Reporting Burden (hours)
(a) Rule familiarization: 7 hrs/site x 14 sites=98
(b) Reporting: 22 hrs/report x 26 reports=572
Total burden hours=707
Average burden per site=707 hours/14 sites=50.5
Average burden per firm=707 hours/17 firms=41.6
EPA Costs (dollars)
It is estimated that the annual cost to the Federal Government will
be 1.36 FTEs (or 2,828.8 hours annually). At an estimated $69,370 per
FTE, the total of 1.36 FTEs will cost EPA $94,343.
B. Health and Safety Data Reporting Rule
EPA estimates the total reporting costs for establishing section
8(d) reporting requirements for the 11 chemicals will be $84,954. The
methodology used in this economic analysis was derived from the
approach used in the analysis of the original 8(d) reporting: Impact
Analysis for the Health and Safety Data Reporting Rule (Office of Toxic
Substances, U.S. EPA, September 1982). 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.
The estimated reporting costs are broken down as follows:
Initial corporate review.........................................$8,382
Site identification..............................................12,573
File searches at site............................................28,329
Photocopying existing studies.....................................3,208
Title listing.....................................................1,277
Managerial review for CBI........................................18,549
Reporting on newly-initiated studies................................491
Submissions after initial reporting period.......................11,653
Additional costs....................................................492
Total......................................................84,954
Reporting Burden (hours)
(a) Initial review: 108 hrs
(b) Reporting: 953 hrs
Total reporting burden hours=1,061 hrs
V. Rulemaking Record
The following documents constitute the record for this rule (docket
control number OPPTS-82048). 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-seventh Report of the ITC.
VI. Regulatory Assessment Requirements
A. Executive Order 12866
Pursuant to Executive Order 12866 (58 FR 51735, October 4, 1993),
it has been determined that this rule is not ``significant'' because
the Office of Management and Budget (OMB) has waived review of these
types of actions, and is therefore not subject to OMB review.
B. Paperwork Reduction Act
OMB has approved the information collection requirements contained
in this rule under the provisions of the Paperwork Reduction Act of
1980, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2070-
0054 for PAIR reporting and 2070-0004 for TSCA section 8(d) reporting.
Information concerning the collection of
[[Page 7424]]
this information, its use, and estimated costs may be found in Units I.
and IV. of this preamble.
C. Regulatory Flexibility Act
Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.),
the Agency must consider whether a regulatory action will have an
adverse economic impact on small entities. Section 605(b) requires the
Agency to either certify that the regulatory action will not have a
significant economic impact on a substantial number of small entities,
or prepare a regulatory flexibility analysis. EPA has determined that
this regulatory action does not impose any adverse economic impacts on
small entities.
D. Unfunded Mandates Reform Act and Executive Order 12875
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4), EPA has determined that this regulatory action does
not contain any ``unfunded mandates,'' as described by the Act, for
State, local, or tribal governments or the private sector. In addition,
EPA has determined that this action does not result in the expenditure
of $100 million or more by any State, local or tribal governments, or
by anyone in the private sector. The costs associated with this action
are described in the Executive Order 12966 section above.
E. Executive Order 19898
Due to the nature of this action which is confined to information-
gathering activities, it was not necessary for the Agency to consider
environmental justice related issues pursuant to Executive Order 19898
(59 FR 7629, February 16, 1994).
List of Subjects in 40 CFR Parts 712 and 716
Environmental protection, Chemicals, Hazardous substances, Health
and safety data, Reporting and recordkeeping requirements.
Dated: February 22, 1996.
Frank D. Kover,
Acting 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(e) is amended in the table by alphabetically
adding the new category ``Alkylphenols and Alkylphenol Ethoxylates,''
to read as follows:
Sec. 712.30 Chemicals lists and reporting periods.
* * * * *
(e) * * *
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CAS No. Substance Effective date Reporting date
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* * * * * * *
Alkylphenols and Alkylphenol Ethoxylates:
80-46-6...................... 4-tert-Pentylphenol.......................... 3/29/96 5/29/96
88-18-6...................... 2-tert-Butylphenol........................... 3/29/96 5/29/96
94-06-4...................... 4-(1-Methylbutyl)phenol...................... 3/29/96 5/29/96
98-54-4...................... 4-tert-Butylphenol........................... 3/29/96 5/29/96
99-71-8...................... 4-sec-Butylphenol............................ 3/29/96 5/29/96
104-40-5..................... 4-Nonylphenol................................ 3/29/96 5/29/96
104-43-8..................... 4-Dodecylphenol.............................. 3/29/96 5/29/96
949-13-3..................... 2-Octylphenol................................ 3/29/96 5/29/96
1300-16-9.................... Nonylphenol (mixed isomers).................. 3/29/96 5/29/96
1322-69-6.................... (1,1,3,3-Tetramethylbutyl)phenol (mixed 3/29/96 5/29/96
isomers).
1331-57-3.................... Dodecylphenol (mixed isomers)................ 3/29/96 5/29/96
1638-22-8.................... 4-n-Butylphenol.............................. 3/29/96 5/29/96
1806-26-4.................... 4-Octylphenol................................ 3/29/96 5/29/96
2315-66-4.................... Decaethylene glycol 4-isooctylphenyl ether... 3/29/96 5/29/96
2497-58-7.................... Hexaethylene glycol 4-isooctylphenyl ether... 3/29/96 5/29/96
3180-09-4.................... 2-Butylphenol................................ 3/29/96 5/29/96
3884-95-5.................... 2-(1,1,3,3-Tetramethylbutyl)phenol........... 3/29/96 5/29/96
9002-93-1.................... Polyethylene glycol 4-(tert-octyl)phenyl 3/29/96 5/29/96
ether.
9036-19-5.................... Polyethylene glycol mono(octyl)phenyl ether.. 3/29/96 5/29/96
11066-49-2................... Isononylphenol (mixed isomers)............... 3/29/96 5/29/96
14938-35-3................... 4-Pentylphenol............................... 3/29/96 5/29/96
17404-66-9................... 4-(1-Methyloctyl)phenol...................... 3/29/96 5/29/96
25154-52-3................... Nonylphenol (mixed isomers).................. 3/29/96 5/29/96
27178-34-3................... tert-Butylphenol (mixed isomers)............. 3/29/96 5/29/96
27193-28-8................... (1,1,3,3-Tetramethylbutyl)phenol (mixed 3/29/96 5/29/96
isomers).
27193-86-8................... Dodecylphenol (mixed isomers)................ 3/29/96 5/29/96
27985-70-2................... (1-Methylheptyl)phenol (mixed isomers)....... 3/29/96 5/29/96
29932-96-5................... (1,1,3,3-Tetramethylbutyl)phenol (mixed 3/29/96 5/29/96
isomers).
30105-54-5................... (1,1,3,3-Tetramethylbutyl)phenol (mixed 3/29/96 5/29/96
isomers).
31195-95-6................... Isobutylphenol (mixed isomers)............... 3/29/96 5/29/96
54932-78-4................... 4-(2,2,3,3-Tetramethylbutyl)phenol........... 3/29/96 5/29/96
2744-41-6.................... (1,1,3,3-Tetramethylbutyl)phenol (mixed 3/29/96 5/29/96
isomers).
68987-90-6................... Poly(oxy-1,2-ethanediyl), - 3/29/96 5/29/96
(octylphenyl)--hydroxy-, branched.
84852-15-3................... Branched 4-nonylphenol (mixed isomers)....... 3/29/96 5/29/96
* * * * * * *
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[[Page 7425]]
PART 716--[AMENDED]
2. In part 716:
1a. The authority citation for part 716 continues to read as
follows:
Authority: 15 U.S.C. 2607(d).
b. Section 716.120(d) is amended in the table by alphabetically
adding the new category ``Alkylphenols and Alkylphenol Ethoxyates'' and
revising the entry for o-sec-butylphenol under the category ``OSHA
Chemicals in Need of Dermal Absorption Testing'' to read as follows:
Sec. 716.120 Substances and listed mixtures to which this subpart
applies.
* * * * *
(d) * * *
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CAS No.
Category (exemption for Special exemptions Effective date Sunset date
category)
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Alkylphenols and Alkylphenol Ethoxyates:
tert-Butylphenol (mixed isomers)..... 27178-34-3 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
2-Butylphenol........................ 3180-09-4 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
2-tert-Butylphenol................... 88-18-6 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
4-n-Butylphenol...................... 1638-22-8 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
4-sec-Butylphenol.................... 99-71-8 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
4-tert-Butylphenol................... 98-54-4 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
Decaethylene glycol 4-isoctylphenyl 2315-66-4 Sec. 716.20(b)(4) 3/29/96 3/29/06
ether. applies.
4-Dodecylphenol...................... 104-43-8 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
Dodecylphenol (mixed isomers)........ 1331-57-3 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
Dedecylphenol (mixed isomers)........ 27193-86-8 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
Hexaethylene glycol 4-isoctylphenyl 2497-58-7 Sec. 716.20(b)(4) 3/29/96 3/29/06
ether. applies.
Isobutylphenol (mixed isomers)....... 31195-95-6 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
Isononylphenol (mixed isomers)....... 11066-49-2 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
4-(1-Methylbutyl)phenol.............. 94-06-4 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
(1-Methylheptyl)phenol (mixed 27985-70-2 Sec. 716.20(b)(4) 3/29/96 3/29/06
isomers). applies.
4-(1-Methyloctyl)phenol.............. 17404-66-9 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
Nonylphenol (mixed isomers).......... 1300-16-9 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
25154-52-3 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
4-Nonylphenol........................ 104-40-5 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
Branched 4-nonylphenol (mixed 84852-15-3 Sec. 716.20(b)(4) 3/29/96 3/29/06
isomers). applies.
2-Octylphenol........................ 949-13-3 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
4-Octylphenol........................ 1806-26-4 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
4-Pentylphenol....................... 14938-35-3 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
4-tert-Pentylphenol.................. 80-46-6 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
Polyethylene glycol mono(octyl)phenyl 9036-19-5 Sec. 716.20(b)(4) 3/29/96 3/29/06
ether. applies.
Polyethylene glycol 4-(tert- 9002-93-1 Sec. 716.20(b)(4) 3/29/96 3/29/06
octyl)phenyl ether. applies.
Poly(oxy-1,2-ethanediyl), - 48987-90-6 Sec. 716.20(b)(4) 3/29/96 3/29/06
(octylphenyl)--hydroxy-, applies.
branched.
2-(1,1,3,3-Tetramethylbutyl)phenol... 3884-95-5 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
(1,1,3,3-Tetramethylbutyl)phenol 1322-69-6 Sec. 716.20(b)(4) 3/29/96 3/29/06
(mixed isomers). applies.
27193-28-8 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
29932-96-5 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
30105-54-5 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
62744-41-6 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
4-(2,2,3,3-Tetramethylbutyl)phenol... 54932-78-4 Sec. 716.20(b)(4) 3/29/96 3/29/06
applies.
* * * * * * *
OSHA Chemicals in Need of Dermal
Absorption Testing:
o-sec-butylphenol.................... 89-72-5 ..................... 3/11/94 3/11/04
* * * * * * *
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[FR Doc. 96-4519 Filed 2-27-96; 8:45 am]
BILLING CODE 6560-50-M