Removal of Two Chemical Substances from Preliminary Assessment
Information Reporting and Health and Safety Data Reporting Rules
[Federal Register: April 30, 2007 (Volume 72, Number 82)]
[Rules and Regulations]
[Page 21119-21123]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap07-12]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 712 and 716
[EPA-HQ-OPPT-2005-0014 and EPA-HQ-OPPT-2005-0055; FRL-8124-9]
RIN 2070-AB08 and 2070-AB11
Removal of Two Chemical Substances from Preliminary Assessment
Information Reporting and Health and Safety Data Reporting Rules
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
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SUMMARY: This direct final rule the removes chemical substances
phosphorotrithious acid, tributyl ester, CAS No. 150-50-5, and
phosphorodithioic acid, O,O-diethyl ester, sodium salt, CAS No. 3338-
24-7, which were inadvertently added to the list of voluntary High
Production Volume (HPV) Challenge Program orphan (unsponsored) chemical
substances by EPA. As a result, these chemical substances were
inadvertently added to two final rules: The Preliminary Assessment
Information Reporting (PAIR) rule (Toxic Substances Control Act (TSCA)
section 8(a)) and the Health and Safety Data Reporting rule (TSCA
section 8(d)), both published in the Federal Register issue of August
16, 2006. With this removal action, persons who manufacture (including
import) either of these two chemical substances are no longer subject
to the reporting requirements imposed by these TSCA section 8(a) and
8(d) rules.
DATES: This rule is effective on June 29, 2007 without further notice,
unless EPA receives adverse comment on or before May 30, 2007.
ADDRESSES: Submit your comments, identified by docket identification
(ID) numbers EPA-HQ-OPPT-2005-0014 and EPA-HQ-OPPT-2005-0055, by one of
the following methods:
? Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
? Mail: Document Control Office (7407M), Office of
Pollution Prevention and Toxics (OPPT), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
? Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Numbers EPA-HQ-OPPT-2005-0014 and EPA-HQ-OPPT-
2005-0055. The DCO is open from 8 a.m. to 4 p.m.,
[[Page 21120]]
Monday through Friday, excluding legal holidays. The telephone number
for the DCO is (202) 564-8930. Such deliveries are only accepted during
the DCO's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
Instructions: Direct your comments to docket ID numbers EPA-HQ-
OPPT-2005-0014 and EPA-HQ-OPPT-2005-0055. EPA's policy is that all
comments received will be included in the docket without change and may
be made available on-line at http://www.regulations.gov, including any
personal information provided, unless the comment includes information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Do not submit
information that you consider to be CBI or otherwise protected through
regulations.gov or e-mail. The regulations.gov website is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses. For additional information about EPA's public docket, visit
the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket are listed in the docket index
available in regulations.gov. To access the electronic docket, go to
http://www.regulations.gov, select ``Advanced Search,'' then ``Docket
Search.'' Insert the docket ID number where indicated and select the
``Submit'' button. Follow the instructions on the regulations.gov web
site to view the docket index or access available documents. Although
listed in the index, some information is not publicly available, e.g.,
CBI or other information whose disclosure is restricted by statute.
Certain other material, such as copyrighted material, will be publicly
available only in hard copy. Publicly available docket materials are
available electronically at http://www.regulations.gov, or, if only
available in hard copy, at the OPPT Docket. The OPPT Docket is located
in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding Federal holidays. The telephone number of the EPA/DC Public
Reading Room is (202) 566-1744, and the telephone number for the OPPT
Docket is (202) 566-0280. Docket visitors are required to show
photographic identification, pass through a metal detector, and sign
the EPA visitor log. All visitor bags are processed through an X-ray
machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.
FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address:
TSCA-Hotline@epa.gov.
For technical information contact: Joe Nash, Chemical Control
Division (7405M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (202) 564-8886; fax
number: (202) 564-4765; e-mail address: ccd.citb@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you manufacture
(defined by statute to include import) either of the two chemical
substances listed in this direct final rule. Entities potentially
affected by this action may include, but are not limited to:
? Chemical manufacturers (including importers), (NAICS codes
325, 32411), e.g., persons who manufacture (defined by statute to
include import) 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. 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. If you have any
questions regarding the applicability of this action to a particular
entity, consult the technical person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal Register
document through the electronic docket at http://www.regulations.gov,
you may access this ``Federal Register'' document electronically through
the EPA Internet under the ``Federal Register'' listings at
http://www.epa.gov/fedrgstr. Frequently updated electronic versions
of 40 CFR parts 712 and 716 are available through the Government Printing
Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
C. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and
then identify electronically within the disk or CD-ROM the specific
information that is claimed as CBI. In addition to one complete version
of the comment that includes information claimed as CBI, a copy of the
comment that does not contain the information claimed as CBI must be
submitted for inclusion in the public docket. Information so marked
will not be disclosed except in accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
[[Page 21121]]
vii. Explain your views as clearly as possible, avoiding the use
of profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. What Action is the Agency Taking?
The chemical substances phosphorotrithious acid, tributyl ester,
CAS No. 150-50-5, and phosphorodithioic acid, O,O-diethyl ester, sodium
salt, CAS No. 3338-24-7, are being removed from the table in 40 CFR
712.30(e) of the TSCA section 8(a) PAIR rule published in the Federal
Register of August 16, 2006 (Ref. 1), and the table in 40 CFR
716.120(d) of the TSCA section 8(d) Health and Safety Data Reporting
rule published in the Federal Register of August 16, 2006 (Ref. 2). On
August 16, 2006, EPA published a final PAIR rule under TSCA section
8(a) (40 CFR part 712), which requires manufacturers (including
importers) of chemical substances in the category of voluntary HPV
Challenge Program orphan (unsponsored) chemical substances on the ITC's
TSCA section 4(e) Priority Testing List to submit a one-time report on
general production/importation volume, end use, and exposure-related
information to EPA. Also on August 16, 2006, EPA published a final
Health and Safety Data Reporting rule under TSCA section 8(d) (40 CFR
part 716), which requires manufacturers (including importers) of
chemical substances in this category of voluntary HPV Challenge Program
orphan (unsponsored) chemical substances to submit certain unpublished
health and safety data to EPA. On September 15, 2006, EPA published a
final rule (Ref. 3) that revised the effective date of the two rules
published on August 16, 2006. The effect of this action is that persons
who manufacture (including import) either of the two chemical
substances are not subject to the reporting requirements imposed by the
final TSCA section 8(a) and 8(d) rules published on August 16, 2006,
and the rule published on September 15, 2006 (Ref. 3), that changed the
effective date for these two rules.
B. What is the Agency's Authority for Taking This Action?
EPA promulgated the PAIR rule under TSCA section 8(a) (15 U.S.C.
2607(a)), and it is codified at 40 CFR part 712. This model TSCA
section 8(a) rule establishes standard reporting requirements for
certain manufacturers (including importers) of the chemical substances
listed in the rule at 40 CFR 712.30. The final rule published by EPA on
August 16, 2006, amended the model TSCA section 8(a) rule by adding the
ITC category of certain voluntary HPV Challenge Program orphan
(unsponsored) chemical substances (Ref. 1).
EPA promulgated the model Health and Safety Data Reporting rule
under TSCA section 8(d) (15 U.S.C. 2607(d)), and it is codified at 40
CFR part 716. The TSCA section 8(d) model rule requires past, current,
and prospective manufacturers, importers, and (if specified by EPA in a
particular notice or rule under TSCA section 8(d)) processors of listed
chemical substances to submit to EPA copies and lists of unpublished
health and safety studies on the listed chemical substances that they
manufacture, import, or (if specified by EPA in a particular notice or
rule under TSCA section 8(d)) process. The final rule published by EPA
on August 16, 2006, amended the model TSCA section 8(d) rule by adding
the ITC category of certain voluntary HPV Challenge Program orphan
(unsponsored) chemical substances (Ref. 2).
C. Why is EPA Using a Direct Final Rule?
EPA is publishing this direct final rule without a prior proposed
rule because we view this as a non-controversial action and anticipate
no adverse comment. If EPA receives adverse comment, we will publish a
timely withdrawal in the Federal Register informing the public that the
direct final rule will not take effect. Any parties interested in
commenting must do so on or before May 30, 2007.
D. Why are These Two Chemical Substances Being Removed?
The chemical substances phosphorotrithious acid, tributyl ester,
CAS No. 150-50-5, and phosphorodithioic acid, O,O-diethyl ester, sodium
salt, CAS No. 3338-24-7, were inadvertently added by EPA to the list of
HPV orphan orphan (unsponsored) chemical substances. This list was the
source of the category of ``Voluntary HPV Challenge Program orphan
(unsponsored) chemicals'' that was the subject of the TSCA section 8(a)
PAIR rule and TSCA section 8(d) Health and Safety Data Reporting rule
published in the Federal Register of August 16, 2006 (Refs. 1 and 2).
These two chemicals were originally sponsored in the HPV Challenge
Program by Bayer CropScience on March 15, 1999 (Ref. 4). Subsequently,
in a letter dated December 29, 2003, Bayer CropScience requested that
EPA ``designate the two chemicals as `no longer HPV' on the HPV
Challenge Program Chemical List'' because Bayer CropScience considered
the chemicals to be ``non-isolated intermediates'' (Ref. 5). In a
letter dated December 3, 2004, EPA responded that, based on a review of
the information submitted by Bayer CropScience, EPA had determined that
the two substances were ``isolated intermediates'' and, consequently,
did not meet the `no longer HPV' criteria and that ``they will remain
in the HPV Challenge Program and should continue to be reported'' (Ref.
6). In a letter dated December 15, 2005, Bayer CropScience clarified
the status of the two chemicals (Ref. 7). In that letter, Bayer
``recommit[ed]
to sponsoring'' both chemicals in the HPV Challenge
Program and proposed to include the two chemicals into two categories.
This record demonstrates that Bayer CropScience did not withdraw its
commitment to sponsor these two chemicals in the HPV Challenge Program.
Consequently, EPA is removing these two chemicals from the table in 40
CFR 712.30(e) of the TSCA section 8(a) PAIR rule published in the
Federal Register of August 16, 2006 (Ref. 1), and the table in 40 CFR
716.120(d) of the TSCA section 8(d) Health and Safety Data Reporting
rule published in the Federal Register of August 16, 2006 (Ref. 2).
This action does not preclude the future listing of these two
chemical substances under the TSCA section 8(a) PAIR rule or the TSCA
section 8(d) Health and Safety Data Reporting rule should the
information be reasonably required.
III. Economic Analysis
In the economic analysis conducted for the final TSCA section 8(a)
PAIR rule, the Agency estimated the total reporting cost to industry to
be $644,000 for all 243 chemical substances, or approximately $2,650
per chemical substance (Ref. 1). The Agency is estimated to incur an
additional $248,000 or $1,021 per chemical substance to provide public
support for the TSCA section 8(a) PAIR rule and to process the data
(Ref. 1). The total cost of the TSCA section 8(a) rule, per chemical
substance, is estimated to be approximately $3,671. This direct final
rule removes two chemical substances from the TSCA section 8(a) PAIR
rule. Therefore, costs are estimated to be reduced by $7,342 (two
chemical substances x $3,671 per chemical substance).
Furthermore, this direct final rule will also remove two chemical
substances
[[Page 21122]]
from the TSCA section 8(d) Health and Safety Data Reporting rule. The
economic analysis conducted for the TSCA section 8(d) Health and Safety
Data Reporting rule estimates that the total cost to industry is
$110,000 and to the Agency is $79,000, or $453 and $325 per chemical
substance, respectively, for a total of $778 per chemical substance
(Ref. 2). Because this direct final rule removes two chemical
substances from the TSCA section 8(d) Health and Safety Data Reporting
rule, the costs of the TSCA section 8(d) Health and Safety Data
Reporting rule are estimated to be reduced by $1,556 (two chemical
substances x $778).
Therefore, the removal of two chemical substances from the TSCA
section 8(a) and TSCA section 8(d) rules is estimated to result in a
total reduction in costs of $8,898.
IV. References
The dockets for this direct final rule are the dockets established
for the TSCA section 8(a) PAIR rule (docket ID number EPA-HQ-OPPT-2005-
0014) (Ref. 1) and the TSCA section 8(d) Health and Safety Data
Reporting rule (docket ID number EPA-HQ-OPPT-2005-0055) (Ref. 2). These
dockets are available for review as specified in ADDRESSES. The
following is a listing of the materials referenced in this document
that have been placed in the dockets:
1. EPA. Preliminary Assessment Information Reporting; Addition of
Certain Chemicals. Federal Register (71 FR 47122, August 16, 2006)
(FRL-7764-9). Available on-line at: http://www.epa.gov/fedrgstr.
2. EPA. Health and Safety Data Reporting; Addition of Certain
Chemicals. Federal Register (71 FR 47130, August 16, 2006) (FRL-7764-
7). Available on-line at: http://www.epa.gov/fedrgstr.
3. EPA. Preliminary Assessment Information Reporting Rule and
Health and Safety Data Reporting Rule; Revision of Effective Dates.
Federal Register (71 FR 54434, September 15, 2006) (FRL-8094-8).
Available on-line at: http://www.epa.gov/fedrgstr.
4. Bayer Corporation. Letter from Ron Fuchs (Bayer Corporation) to
Carol Browner (EPA) RE: Sponsorship of chemicals in the HPV Challenge
Program. March 15, 1999.
5. Bayer Corporation. Letter from Janet M. Mostowy (Bayer
Corporation) to Michael Leavitt (EPA) RE: Request to designate
chemicals as `no longer HPV.' December 29, 2003.
6. EPA. Letter from Diane Sheridan (EPA/OPPT) to Janet M. Mostowy
(Bayer Corporation) RE: EPA response to December 29, 2003 letter from
Bayer Corporation. December 3, 2004.
7. Bayer CropScience. Letter from George S. Goodridge to Oscar
Hernandez (EPA/OPPT) RE: Clarification of status of chemicals appearing
on EPA's 9/16/05 orphan list. December 15, 2005.
V. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
The Office of Management and Budget (OMB) has exempted actions
under TSCA sections 8(a) and 8(d) related to the PAIR and Health and
Safety Data Reporting rules from the requirements of Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). In addition, this direct final rule does not impose any new
requirements and will result in a burden and cost reduction; therefore,
it is not subject to OMB review under the Executive order.
B. Paperwork Reduction Act
The information collection requirements contained in TSCA sections
8(a) PAIR and 8(d) Health and Safety Data Reporting rules have already
been approved by OMB under the provisions of the Paperwork Reduction
Act (PRA), 44 U.S.C. 3501 et seq., and OMB control numbers 2070-0054
(EPA ICR No. 0586) and 2070-0004 (EPA ICR No. 0575). The collection
activities in this direct final rule are captured by the existing
approval and do not require additional review and/or approval by OMB.
C. Regulatory Flexibility Act
Because this direct final rule eliminates reporting requirements,
the Agency certifies pursuant to section 605(b) of the Regulatory
Flexibility Act (RFA), 5 U.S.C. 601 et seq., that this action will not
have a significant adverse economic impact on a substantial number of
small entities.
D. Unfunded Mandates Reform Act
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995
(UMRA), Public Law 104-4, EPA has determined that this direct final
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. In addition, EPA
has determined that this direct final rule will not significantly or
uniquely affect small governments. Accordingly, the direct final rule
is not subject to the requirements of UMRA sections 202, 203, 204, or 205.
E. Executive Order 13132: Federalism
This direct final rule has no Federalism implications because it
will not have substantial direct effects on States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999).
F. Executive Order 13175: Consultation and Coordination with Indian
Tribal Governments
This direct final rule has no tribal implications because it will
not have substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, nor
on the distribution of power and responsibilities between the Federal
Government and Indian tribes as specified in Executive Order 13175,
entitled Consultation and Coordination with Indian Tribal Governments
(59 FR 22951, November 6, 2000).
G. Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks
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 direct final rule because this is not
an economically significant regulatory action as defined under
Executive Order 12866, and it does not concern an environmental health
or safety risk that may have a disproportionate effect on children.
H. Executive Order 13211: Actions that Significantly Affect Energy
Supply, Distribution, or Use
This rule is not subject to Executive Order 13211, entitled Actions
that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001), because this action is not expected to affect energy
supply, distribution, or use.
I. National Technology Transfer and Advancement Act
Because this action does not involve any technical standards,
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note), does not apply to this action.
[[Page 21123]]
J. Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations
This action 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).
VI. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of the rule in the Federal Register.
This rule is not a major rule as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Parts 712 and 716
Environmental protection, Chemicals, Hazardous substances, Health
and safety, Reporting and recordkeeping requirements.
Dated: April 23, 2007.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.
? Therefore, 40 CFR chapter I is amended as follows:
PART 712--[AMENDED]
? 1. The authority citation for part 712 continues to read as follows:
Authority: 15 U.S.C. 2607(a).
Sec. 712.30 [Amended]
? 2. In Sec. 712.30, in the table under the heading ``Voluntary HPV
Challenge Program orphan (unsponsored) chemicals'' in paragraph (e),
remove the entries CAS No. 150-50-5, Phosphorotrithious acid, tributyl
ester and CAS No. 3338-24-7, Phosphorodithioic acid, O,O-diethyl ester,
sodium salt.
PART 716--[AMENDED]
? 3. The authority citation for part 716 continues to read as follows:
Authority: 15 U.S.C. 2607(d).
Sec. 716.120 [Amended]
? 4. In Sec. 716.120, in the table under the heading ``Voluntary HPV
Challenge Program orphan (unsponsored) chemicals in paragraph (d),
remove the entries Phosphorotrithious acid, tributyl ester, CAS No.
150-50-5 and Phosphorodithioic acid, O,O-diethyl ester, sodium salt,
CAS No. 3338-24-7.
[FR Doc. 07-2104 Filed 4-27-07; 8:45 am]
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