[Federal Register Volume 60, Number 128 (Wednesday, July 5, 1995)]
[Rules and Regulations]
[Pages 34879-34885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16425]
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40 CFR Part 180
40 CFR Parts 712 and 716
[OPPTS-82046; FRL-4954-9]
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 35th Report to
EPA revised the Toxic Substances Control Act (TSCA) Section 4(e)
Priority List by designating for testing 25 chemical substances. The
ITC recommendations must be given priority consideration by EPA in
promulgating test rules. EPA is adding certain of 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substances to report unpublished health and safety data to EPA.
DATES: This rule will become effective on August 4, 1995.
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 24 chemical substances to the
PAIR and 12 chemical substances to 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chemicals will be required to report unpublished health and safety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.
[[Page 34880]]
Because the ITC has expressed no need for ecological effects
information for the 12 substances being added to the section 8(d) rule
under the category designated ``OSHA Chemicals in Need of Dermal
Absorption Testing,'' EPA is exempting from ecological effects data
reporting these substances under the section 8(d) rule. Also, for
substances being added to the 8(d) rule by this action, EPA is
exempting certain studies on mixtures containing 8(d)-listed substances
at levels below 1 percent of the mixture. For further information on
these exemptions, see Unit III. of this preamble.
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 3, 1994, EPA announced the receipt of the 35th Report
of the ITC, and it was then published in the Federal Register of
December 29, 1994 (59 FR 67596). The 35th report revises the
Committee's priority list of chemicals by designating for testing 25
chemical substances to the section 4(e) priority list.
This rule adds 24 substances to the the section 8(a) Preliminary
Assessment Information Reporting Rule and 12 substances to 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 rules provide for the automatic addition of ITC priority list
chemicals. Whenever EPA announces the receipt of an ITC report, EPA
may, without further notice and comment, amend the model information-
gathering rule by adding the recommended (or designated) chemicals. The
amendment adding these chemicals to the PAIR and Health and Safety Data
Reporting Rule becomes effective 30 days after publication in the
Federal Register.
II. Chemicals To Be Added
In its 35th Report to EPA, the ITC designated 25 chemical
substances for dermal absorption testing. EPA is adding 24 substances
to the section 8(a) PAIR and 12 substances to the section 8(d) Health
and Safety Data Reporting Rule. EPA is not adding cyclohexanone (CAS
No. 108-94-1) to section 8(a) or section 8(d) because of the ITC's
decision to remove this chemical substance from the testing priority
list in its 36th report. EPA is not adding to the section 8(d) model
rule 12 of the substances listed in the ITC report because the
substances were previously listed on the section 8(d) rule and are
currently subject to reporting or have recently ended the 10-year
reporting period. These 12 substances are listed below.
------------------------------------------------------------------------
Substance CAS No. FR Cite
------------------------------------------------------------------------
Acetonitrile 75-05-8 47 FR 38791, September
2, 1982
Benzene, 1,2-dichloro- 95-50-1 47 FR 38791, September
2, 1982
Benzene, 1,4-dichloro- 106-46-7 47 FR 38791, September
2, 1982
1,1'-Biphenyl 92-52-4 48 FR 13178, March 30,
1983
Dipropylene glycol 34590-94-8 54 FR 8484, February
monomethyl ether 28, 1989
Ethane, 1,2-dichloro- 107-06-2 52 FR 16022, May 1,
1987
Formamide 75-12-7 47 FR 38791, September
2, 1982
Isophorone 78-59-1 47 FR 38791, September
2, 1982
Naphthalene 91-20-3 52 FR 16022, May 1,
1987
Propane, 1,2-dichloro- 78-87-5 47 FR 38791, September
2, 1982
Propane, 1,2,3- 96-18-4 47 FR 38791, September
trichloro- 2, 1982
1-Propanol, 2-methyl- 78-83-1 51 FR 2890, January
22, 1986
------------------------------------------------------------------------
For a complete listing of the substances being added to the section
8(d) model rule and the PAIR, see the regulatory text section of this
document.
III. Exemptions
For the 12 substances being added to the section 8(d) rule, EPA is
exempting certain types of studies from the 8(d) rule reporting
requirements of 40 CFR part 716 because no ITC member has indicated a
current need for the specific study types. The study types being
specially exempted in this action include: (1) Ecological effects data
and (2) studies conducted on mixtures (e.g., formulated products)
containing a subject substance at a level below 1 percent of the
mixture, unless a purpose of the study includes the investigation of
the effects of an 8(d) rule-listed substance at levels below 1 percent.
EPA may later require the reporting of the types of studies being
exempted at this time, via an amendment to this rule using notice and
comment procedures,
[[Page 34881]]
if circumstances indicate a need for the data.
IV. 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 October 3, 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).
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 PAIR or 8(d) Reporting).
D. Removal of Chemical Substances from the Rules
Any person who believes that section 8(a) and/or 8(d) reporting
required by this action is unwarranted, should promptly submit to EPA
in detail the reasons for that belief. EPA, in its discretion, may
remove the substance from the rule(s) 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.
V. Economic Analysis
A. Preliminary Assessment Information Rule
EPA estimates the PAIR reporting cost of this rule is $234,752. To
calculate this figure, EPA searched the Chemical Update System (CUS) to
determine the manufacturers and importers of the 24 chemicals. This
search identified 115 firms manufacturing or importing the 24 chemicals
at a total of 131 sites. Manufacturing and or importing sites were
identified for all the chemicals. An unknown number of the business
affected by the addition of the chemicals to the Priority List may
quality 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 115 to generate a total of 131 reports (some
sites produce more than one of the 24 chemicals).
Reporting Costs (dollars)
(a) 131 reports estimated at $941 per report = $123,271
(b) 131 sites at $851 per site = $111,481
Total Cost = $234,752
Mean cost per site = $234,752/131 sites = $1,792
Mean cost per firm = $234,752/115 firms = $2,041
Reporting Burden (hours)
(a) Rule familiarization: 18 hrs/site x 131 sites = 2,358
(b) Reporting: 16 hrs/report x 131 reports = 2,096
Total burden hours = 4,454
Average burden per site = 4,454 hours/131 sites = 34
Average burden per firm = 4,454 hours/115 firms = 39
EPA Costs (dollars)
It is estimated that the annual cost to the Federal Government will
be 1.774 FTEs (or 3,690 hours annually). At an estimated $64,477 per
FTE, the total of 1.774 FTEs will cost EPA $114,382.
B. Health and Safety Data Reporting Rule
EPA estimates the total reporting costs for establishing section
8(d) reporting requirements for 12 chemicals will be $68,630. 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.
[[Page 34882]]
The estimated reporting costs are broken down as follows:
Initial corporate review $ 18,217
Site identification 7,626
File searches at site 17,289
Photocopying existing studies 2,589
Title listing 790
Managerial review for CBI 15,534
Reporting on newly-initiated studies 324
Submissions after initial reporting period 5,931.36
Total $ 68,630
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-82046). 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-fifth 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 5 hours per
response 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, Recordkeeping and reporting requirements.
Dated: June 26, 1995.
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]
2. 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 by adding 24 chemicals in CAS
number sequence, to the category ``OSHA Chemicals in Need of Dermal
Absorption Testing,'' to read as follows:
Sec. 712.30 Chemical lists and reporting periods.
* * * * *
(e) * * *
------------------------------------------------------------------------
CAS No. Substance Effective date Reporting date
------------------------------------------------------------------------
* * * * * * *
OSHA Chemicals
in Need of
Dermal
Absorption
Testing
* * * * * * *
75-05-8 Acetonitrile 8/4/95 10/3/95
* * * * * * *
75-12-7 Formamide 8/4/95 10/3/95
[[Page 34883]]
* * * * * * *
75-35-4 Vinylidene 8/4/95 10/3/95
chloride
* * * * * * *
77-73-6 Dicyclopentadien 8/4/95 10/3/95
e
* * * * * * *
78-59-1 Isophorone 8/4/95 8/4/95
78-83-1 Isobutyl alcohol 8/4/95 8/4/95
* * * * * * *
78-87-5 Propylene 8/4/95 10/3/95
dichloride
* * * * * * *
91-20-3 Naphthalene 8/4/95 10/3/95
* * * * * * *
92-52-4 Biphenyl 8/4/95 10/3/95
* * * * * * *
95-50-1 o- 8/4/95 10/3/95
Dichlorobenzene
* * * * * * *
96-18-4 1,2,3- 8/4/95 10/3/95
Trichloropropan
e
* * * * * * *
98-29-3 t-Butylcatechol 8/4/95 10/3/95
* * * * * * *
99-08-1 m-Nitrotoluene 8/4/95 10/3/95
* * * * * * *
99-99-0 p-Nitrotoluene 8/4/95 10/3/95
* * * * * * *
106-46-7 p- 8/4/95 10/3/95
Dichlorobenzene
* * * * * * *
107-06-2 Ethylene 8/4/95 10/3/95
dichloride
* * * * * * *
108-93-0 Cyclohexanol 8/4/95 10/3/95
* * * * * * *
110-12-3 Methyl isoamyl 8/4/95 10/3/95
ketone
* * * * * * *
120-80-9 Catechol 8/4/95 10/3/95
* * * * * * *
121-69-7 Dimethylaniline 8/4/95 10/3/95
* * * * * * *
123-42-2 Diacetone 8/4/95 10/3/95
alcohol
[[Page 34884]]
* * * * * * *
127-19-5 Dimethyl 8/4/95 10/3/95
acetamide
* * * * * * *
542-92-7 Cyclopentadiene 8/4/95 10/3/95
* * * * * * *
34590-94-8 Dipropylene 8/4/95 10/3/95
glycol methyl
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 716.20 is amended by adding paragraph (b)(4) to read as
follows:
Sec. 716.20 Studies not subject to the reporting requirements.
* * * * *
(b) * * *
(4) For the chemicals listed at Sec. 716.120 with a special
exemption referencing this paragraph, studies on mixtures containing
the listed substance at levels below 1 percent of the mixture, except
when a purpose of the study includes the investigation of the effects
of the listed substance at levels below 1 percent.
c. Section 716.120(d) is amended by adding 12 chemicals
alphabetically to the category ``OSHA Chemicals in Need of Dermal
Absorption Testing.''
Sec. 716.120 Substances and listed mixtures to which this subpart
applies.
* * * * *
(d) * * *
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CAS No. Substance Special exemptions Effective date Sunset date
----------------------------------------------------------------------------------------------------------------
* * * * * * *
OSHA Chemicals in Need
of Dermal Absorption
Testing
t-Butylcatechol 98-29-3 Sec. 716.20(b)(3) and 8/4/95 8/4/05
(b)(4) apply
* * * * * * *
Catechol 120-80-9 Sec. 716.20(b)(3) and 8/4/95 8/4/05
(b)(4) apply
Cyclohexanol 108-93-0 Sec. 716.20(b)(3) and 8/4/95 8/4/05
(b)(4) apply
* * * * * * *
Cyclopentadiene 542-92-7 Sec. 716.20(b)(3) and 8/4/95 8/4/05
(b)(4) apply
* * * * * * *
Diacetone alcohol 123-42-2 Sec. 716.20(b)(3) and 8/4/95 8/4/05
(b)(4) apply
[[Page 34885]]
* * * * * * *
Dicylcopentadiene 77-73-6 Sec. 716.20(b)(3) and 8/4/95 8/4/05
(b)(4) apply
Dimethyl acetamide 127-19-5 Sec. 716.20(b)(3) and 8/4/95 8/4/05
(b)(4) apply
* * * * * * *
Dimethylaniline 121-69-7 Sec. 716.20(b)(3) and 8/4/95 8/4/05
(b)(4) apply
Methyl isoamyl ketone 110-12-3 Sec. 716.20(b)(3) and 8/4/95 8/4/05
(b)(4) apply
m-Nitrotoluene 99-08-1 Sec. 716.20(b)(3) and 8/4/95 8/4/05
(b)(4) apply
p-Nitrotoluene 99-99-0 Sec. 716.20(b)(3) and 8/4/95 8/4/05
(b)(4) apply
Vinylidene chloride 75-35-4 Sec. 716.20(b)(3) and 8/4/95 8/4/05
(b)(4) apply
* * * * * * *
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[FR Doc. 95-16425 Filed 7-3-95; 8:45 am]
BILLING CODE 6560-50-F