Revocation of TSCA Section 4 Testing Requirements for Certain Chemical Substances, 18650-18654 [06-3491]
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18650
Federal Register / Vol. 71, No. 70 / Wednesday, April 12, 2006 / Rules and Regulations
ZB1b) in/on the following commodities
when present therein as a result of the
application of emamectin to crops listed
in the table in paragraph (a)(1) of this
section:
Commodity
Parts per million
Cattle, fat ........................
Cattle, liver ......................
Cattle, meat ....................
Cattle, meat byproducts,
except liver ..................
Goat, fat ..........................
Goat, liver .......................
Goat, meat ......................
Goat, meat byproducts,
except liver ..................
Horse, fat ........................
Horse, liver .....................
Horse, meat ....................
Horse, meat byproducts,
except liver ..................
Milk .................................
Sheep, fat .......................
Sheep, liver .....................
Sheep, meat ...................
Sheep, meat byproducts,
except liver ..................
0.010
0.050
0.003
0.020
0.010
0.050
0.003
0.020
0.010
0.050
0.003
0.020
0.003
0.010
0.050
0.003
0.020
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect and inadvertant residues.
[Reserved]
[FR Doc. 06–3308 Filed 4–11–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 799
[EPA–HQ–OPPT–2003–0006; FRL–7751–7]
RIN 2070–AD42
Revocation of TSCA Section 4 Testing
Requirements for Certain Chemical
Substances
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
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AGENCY:
SUMMARY: EPA is taking direct final
action to amend the final test rule, ‘‘In
Vitro Dermal Absorption Rate Testing of
Certain Chemicals of Interest to the
Occupational Safety and Health
Administration,’’ promulgated under
section 4 of the Toxic Substances
Control Act (TSCA). This amendment
removes dimethyl sulfate (DMS) from
the list of chemical substances regulated
under the test rule and also removes the
requirement that testing be conducted to
determine a permeability constant (Kp)
for methyl isoamyl ketone (MIAK) and
dipropylene glycol methyl ether
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(DPGME). However, the requirement to
conduct testing to measure short-term
dermal absorption rates remains for
MIAK and DPGME. EPA is basing its
decisions to take these actions on
information it received since
publication of the final rule. Also, upon
the effective date of the revocation of
the TSCA section 4 testing requirements
for DMS, persons who export or intend
to export DMS will no longer be subject
to the TSCA section 12(b) export
notification requirements to the extent
that they were triggered by the testing
requirements being revoked by this
action.
DATES: This direct final rule is effective
June 12, 2006 without further notice,
unless EPA receives adverse comment
in writing, or a request to present
comment orally, on or before May 12,
2006. If EPA receives adverse comment,
or a written request for an opportunity
to present oral comments, EPA will
publish a timely withdrawal in the
Federal Register informing the public
that this direct final rule, or relevant
portions of this direct final rule, will not
take effect. If you write EPA to request
an opportunity to present oral
comments on or before May 12, 2006,
EPA will hold a public meeting on this
direct final rule in Washington, DC. The
announcement of such a meeting would
be published in the Federal Register.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2003–0006, by
one of the following methods:
• https://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, Rm.
6428, 1201 Constitution Ave., NW.,
Washington, DC. Attention: Docket ID
Number EPA–HQ–OPPT–2003–0006.
The DCO is open from 8 a.m. to 4 p.m.,
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 number EPA–HQ–OPPT–
2003–0006. EPA’s policy is that all
comments received will be included in
the public docket without change and
may be made available on-line at https://
www.regulations.gov, including any
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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 email. 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 public 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 https://
www.epa.gov/epahome/docket.htm.
Docket: All documents in the docket
are listed in the regulations.gov index.
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
either electronically at https://
www.regulations.gov or in hard copy at
the OPPT Docket, EPA Docket Center
(EPA/DC), EPA West, Rm. B102, 1301
Constitution Ave., NW., Washington,
DC. The EPA Docket Public Reading
Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number
for the Public Reading Room is (202)
566–1744, and the telephone number for
the OPPT Docket is (202) 566–0280.
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.
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For technical information contact:
John Schaeffer or Catherine Roman,
Chemical Control Division (7405M),
Office of Pollution Prevention and
Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: (202) 564–8173 or (202) 564–
8172; e-mail address:
schaeffer.john@epa.gov or
roman.catherine@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
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A. Does this Action Apply to Me?
This action is directed to the public
in general, and may be of particular
interest to those persons who
manufacture (defined by statute to
include import) or process DMS,
DPGME, or MIAK. Also, persons that
export or intend to export DMS may
have an interest in this action, as, upon
the effective date of the revocation of
the TSCA section 4 testing requirements
for DMS, persons who export or intend
to export DMS will no longer be subject
to the TSCA section 12(b) export
notification requirements to the extent
that they were triggered by the testing
requirements being revoked by this
action. Because other persons may also
be interested, the Agency has not
attempted to describe all the specific
persons that may be affected by this
action. If you have any questions
regarding the applicability of this action
to a particular person, consult the
persons listed under FOR FURTHER
INFORMATION CONTACT.
B. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit CBI
to EPA through regulations.gov or email. 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 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. Requesting an opportunity to
present oral comments to the Agency.
When you submit a request for an
opportunity to present oral comments,
this request must be in writing. If such
a request is received on or before May
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12, 2006, EPA will hold a public
meeting on this direct final rule in
Washington, DC. This written request
must be submitted to the Document
Control Office (7407M), Office of
Pollution Prevention and Toxics
(OPPT), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001. If such a
request is received, EPA will announce
the scheduling of the public meeting in
a subsequent Federal Register
document. If a public meeting is
announced, and if you are interested in
attending or presenting oral and/or
written comments and data at the public
meeting, you should follow the
instructions provided in the subsequent
Federal Register document announcing
the public meeting.
3. 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.
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?
Pursuant to section 4 of TSCA, EPA
promulgated and published in the
Federal Register a test rule on April 26,
2004 (OSHA dermal test rule) requiring
that manufactures (including importers)
and processors of 34 chemical
substances of interest to the
Occupational Safety and Health
Administration (OSHA) conduct in vitro
dermal absorption rate testing (Ref. 1).
OSHA intends to use the data from
these studies to evaluate the need to
develop ‘‘skin designations’’ for these
chemicals. Skin designations are used
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by OSHA to alert industrial hygienists,
employers, and workers to the
potentially significant contribution of a
particular chemical to an individual’s
total workplace exposure to chemicals
which can occur by the cutaneous route.
Skin designations encourage employers
to consider whether changes should be
made to processes involving such
chemical substances in order to reduce
the potential for systemic toxicity from
dermal absorption of these chemicals.
EPA recently received dermal
absorption data on 3 of the 34 chemical
substances listed in the final rule. These
data have persuaded EPA to fully
withdraw the testing requirements set
forth in the final rule for dimethyl
sulfate (DMS; Chemical Abstracts
Service Number (CAS No.): 77–78–1,
Chemical Abstracts (CA) Index Name:
Sulfuric acid, dimethyl ester), and to
partially withdraw such requirements
for methyl isoamyl ketone (MIAK; CAS
No.: 110–12–3, CA Index Name: 2Hexanone, 5-methoxy-) and dipropylene
glycol methyl ether (DPGME; CAS No.:
34590–94–8, CA Index Name: Propanol,
1(or 2)-(2-methoxymethylethoxy)-).
On November 2, 2004, DuPont
Chemical Solutions Enterprise (DCSE)
submitted results of an exploratory skin
absorption study entitled Dimethyl
Sulfate: An In Vitro Assay for
Assessment of Dermal Corrosivity Using
Transcutaneous Electrical Impedance
(Refs. 2 and 3). This study clearly
showed that DMS is corrosive (Ref. 3).
While the test rule requires that if a
chemical ‘‘damages the skin when
applied neat, it must be dissolved in
water’’ (40 CFR 799.5115(h)(5)(vi)),
DMS is also rapidly hydrolyzed in
water, and would not be available as the
test substance, even for the required
short-term testing (Refs. 1, 2, and 4).
These factors, considered together,
render the in vitro dermal absorption
testing of DMS which is required in the
test rule technically infeasible (Ref. 5).
Furthermore, EPA neither has, nor
knows of, any test standard which could
successfully obtain the dermal
absorption testing data for DMS as
described in the OSHA dermal test rule.
Therefore, for the dermal absorption
testing requirements for DMS, EPA can
no longer meet the TSCA requirement
under section 4(b)(1)(B) of TSCA
regarding the inclusion of standards for
development of test data. Therefore,
EPA, in this direct final rule, is revoking
the testing requirements for DMS by
removing it from the list of chemical
substances in 40 CFR 799.5115(j) for
which in vitro dermal absorption rate
testing is required (Ref. 1).
EPA also received dermal absorption
studies on MIAK and DPGME, which
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were conducted prior to issuance of the
final test rule. On June 22, 2005, the
Eastman Chemical Company submitted
a study entitled Methyl Isoamyl Ketone:
Measurement of the In Vitro Rate of
Percutaneous Absorption through
Human Skin (Refs. 6 and 7). The study
determined an absorption rate for MIAK
of 0.215 ± 0.15 milligrams/centimeter
squared/hour (mg/cm2/h) yielding a Kp
(permeability constant) of 0.000261 cm/
h (Ref. 7). On September 29, 2004, EPA
received a request from the American
Chemistry Council to review a recently
published study by Venier, et al. (2004)
on the dermal absorption of five glycol
ethers, including DPGME (Ref. 8). This
study determined an absorption rate for
DPGME of 0.106 ± 0.038 mg/cm2/h
yielding a Kp of 0.00011 cm/h (Ref. 9).
EPA and OSHA have reviewed the
studies submitted for MIAK and DPGME
and have concluded that the studies are
reliable and provide sufficient data for
EPA to reasonably determine the Kp for
these two chemical substances (Refs. 10,
11, and 12). Therefore, this direct final
rule revokes the requirement to conduct
testing to determine the Kp for MIAK
and DPGME. However, the test data
provided did not include a
determination of short-term dermal
absorption rates. Therefore, EPA is not
revoking the short-term testing
requirement for MIAK and DPGME. EPA
has already granted an extension of the
testing deadline for the short-term
testing for these two substances to allow
for the completion of this testing, which
was suspended by the test sponsors
pending review by EPA and OSHA of
the submitted studies (Refs. 11 and 12).
B. What is the Agency’s Authority for
Taking this Action?
The final rule requiring in vitro
dermal absorption rate testing for DMS,
DPGME, and MIAK (Ref. 1) was
promulgated under section 4 of TSCA
(15 U.S.C. 2603), which mandates that
EPA require that manufacturers and/or
processors of chemical substances and
mixtures conduct testing if certain
findings are made by EPA (see section
4(a) of TSCA). Section 4(b)(5) of TSCA
authorizes EPA to amend or repeal test
rules issued under section 4(a) of TSCA.
One of the findings that EPA made in
promulgating the OSHA dermal test rule
was a determination that testing was
necessary in order to determine both a
Kp and short-term absorption rates for
all of the chemicals included in the rule
(see section 4(a)(1)(B)(iii) of TSCA; see
also Ref. 1).
In this direct final rule, EPA is
withdrawing the testing required by the
final test rule for DMS, and partially
withdrawing the testing required for
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DPGME and MIAK. The test rule
requirements for DMS are being
withdrawn because the extreme
corrosiveness of DMS and its rapid rate
of hydrolysis preclude obtaining a
relevant rate of absorption, and thus
make it infeasible to conduct in vitro
dermal absorption rate testing for this
chemical. The test requirement to
determine a Kp for DPGME and MIAK
is being withdrawn because EPA has
concluded the data recently submitted
to EPA on June 22, 2005, and September
29, 2004, are sufficient to determine this
value for these chemicals for the
purposes identified in the test rule.
Therefore, EPA finds that testing to
determine a Kp for DPGME and MIAK
is no longer necessary.
III. Economic Analysis
In the economic analysis conducted
for the final rule, the Agency estimated
the total cost of the testing to be $1.16
million for all 34 chemicals, or $33,987
per chemical (Ref. 13). This total
included an average $10,425 per
chemical for the short-term dermal
absorption rate testing, $16,765 for the
Kp testing, and an additional 25%
($6,797) in administrative costs. This
direct final rule would have the effect of
reducing the total testing cost by an
estimated $75,899, or approximately
7%, by eliminating the Kp testing for
three chemicals and the short-term
dermal absorption rate testing for one
chemical. In addition, the 25%
administrative cost would be eliminated
for those tests. The new total cost of the
testing is estimated to be $1.08 million
(i.e., $1.16 million minus $75,899). The
annualized cost per chemical calculated
in the economic analysis, based on a
15–year amortization period and a 7%
discount rate, was $3,732. For DPGME
and MIAK, which will no longer be
required to undergo the Kp testing, the
annualized cost is estimated to be
reduced to $2,301 as a result of the
direct final rule.
IV. Export Notification
Upon the effective date of the
revocation of the TSCA section 4 testing
requirements for DMS, persons who
export or intend to export DMS will no
longer be subject to the TSCA section
12(b) export notification requirements to
the extent that they were triggered by
the testing requirements being revoked
by this action. For all of the other
chemicals, including MIAK and
DPGME, listed as subject to the
requirements of the OSHA dermal test
rule (Ref. 1), the export notification
requirements remain the same.
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V. Direct Final Rule Procedures
EPA is publishing this direct final
rule without prior proposal because the
Agency views this as a noncontroversial
amendment and anticipates no adverse
comment as this action simply revokes
testing for which EPA already has
adequate data or for which such testing
is not feasible. This direct final rule is
effective June 12, 2006 without further
notice, unless EPA receives adverse
comment or a written request for an
opportunity to present oral comments
on or before May 12, 2006. If EPA
receives adverse comment or a request
for an opportunity to present oral
comments on one or more distinct
amendments, paragraphs, or sections of
this direcct final rule, the Agency will
publish a timely withdrawal in the
Federal Register indicating which
provisions will become effective and
which provisions are being withdrawn
due to adverse comment. Any distinct
amendment, paragraph, or section of
this direct final rule for which the
Agency does not receive adverse
comment or a request for an opportunity
to present oral comments will become
effective June 12, 2006, notwithstanding
any adverse comment or request on any
other distinct amendment, paragraph, or
section of this direct final rule. For any
distinct amendment, paragraph, or
section of this direct final rule that is
withdrawn due to adverse comment or
a request for an opportunity to present
oral comments, EPA will publish a
notice of proposed rulemaking in a
future edition of the Federal Register.
The Agency will address the comment
or request for an opportunity to present
oral comments on any such distinct
amendment, paragraph, or section as
part of that notice of proposed
rulemaking.
VI. References
1. EPA. Final Test Rule for In Vitro
Dermal Absorption Rate Testing of
Certain Chemicals of Interest to the
Occupational Safety and Health
Administration. Federal Register (69 FR
22402, April 26, 2004) (FRL–7312–2).
Available on-line at: https://
www.epa.gov/fedrgstr/EPA-TOX/2004/
April/Day-26/t9409.htm.
2. DCSE. Letter from Robert W.
Freerksen, PhD to EPA Re: In Vitro
Dermal Absorption Test rule (69 FR
22402 (4/26/04; OPPT–2003–0006)) 40
CFR 799.5115 Dimethyl Sulfate (CAS
No.77–78–1) Request for Modification of
Test Standard. November 2, 2004.
3. Fasano, W.J. Dimethyl Sulfate: An
In Vitro Assay for Assessment of Dermal
Corrosivity Using Transcutaneous
Electrical Impedance. E.I. du Pont de
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Nemours and Company. Haskell
Laboratory for Health and
Environmental Sciences. October 15,
2004.
4. EPA. E-mail from Andrew
Mamantov, PhD to Greg Schweer Re:
Hydrolysis rate for Dimethyl Sulfate.
March 9, 2005.
5. EPA. Note from Leonard Keifer to
Greg Schweer Re: Technical Feasibility
of Performing an In Vitro Dermal
Absorption Study with Dimethyl
Sulfate. March 10, 2005.
6. Eastman Chemical Company. Letter
from Marc G. Schurger to Catherine
Roman Re: In vitro dermal absorption
testing on methyl isoamyl ketone (CAS
No. 110–12–3) under TSCA Section 4
Test Rule (OPPT–2003–0006). June 22,
2004.
7. Hill, T.S. and Taylor, L. Methyl
isoamyl ketone: measurement of the in
vitro rate of percutaneous absorption
through human skin. Final Report:
Toxicological Sciences Laboratory,
Health and Environment Laboratories,
Eastman Kodak Company. January 29,
2001.
8. ACC. Communication (e-mail) from
Susan Lewis to Catherine Roman.
Directing EPA’s attention to a recent
publication (2004) on dermal absorption
of dipropylene glycol methyl ether
(DPGME). September 29, 2004.
9. Venier, M., Adami, G., Larese, F.,
and Renzi, N. Percutaneous absorption
of 5 glycol ethers through human skin
in vitro. Toxicology In Vitro 18:665–671.
2004.
10. OSHA, Department of Labor.
Letter from William G. Perry, CIH to
Catherine Roman dated January 26,
2005.
11. EPA. Letter from Charles M. Auer
to Marc G. Shurger Re: USEPA and
OSHA review of the dermal absorption
rate study sponsored by the Eastman
Chemical Company and conducted by
Toxicological Sciences Laboratory. May
26, 2005. (OPPT–2003–0006–0270).
12. EPA. Letter from Charles M. Auer
to Susan Anderson Lewis, Ph.D. Re:
USEPA review of a recently published
dermal absorption rate study on
dipropylene glycol methyl ether. May
26, 2005. (OPPT–2003–0006–0272).
13. EPA. Economic Impact Analysis
and Small Entity Impact Analysis for
the TSCA Section 4(a) Test Rule for 34
Chemicals Targeted for In Vitro Dermal
Absorption Rate Testing. Prepared by
OPPT/Economics, Exposure, and
Technology Division (EETD)/Economic
and Policy Analysis Branch (EPAB).
Washington, DC. February 3, 2004.
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VII. Statutory and Executive Order
Reviews
A. Executive Order 12866: Regulatory
Planning and Review
This direct final rule implements
changes to 40 CFR 799.5115 resulting in
a burden and cost reduction. Since this
direct final rule does not impose any
new requirements, it is not subject to
review by the Office of Management and
Budget (OMB) under Executive Order
12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act
This direct final rule does not contain
any information collections subject to
OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq.
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
revocation of certain requirements
under section 4 of TSCA will not have
a significant economic impact on a
substantial number of small entities.
D. Unfunded Mandates Reform Act
This action does not impose any
enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public
Law 104–4).
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 (65 FR
67249, November 6, 2000).
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18653
G. Executive Order 13045: Protection of
Children from Environmental Health
Risks and Safety Risks
This action is not subject to Executive
Order 13045, entitled Protection of
Children from Environmental Health
Risks and Safety Risks (62 FR 19885,
April 23, 1997), because this is not an
economically significant regulatory
action as defined under Executive Order
12866, and it does not address
environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This direct final rule is not subject to
Executive Order 13211, entitled Actions
Concerning Regulations 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
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.
VIII. 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, which includes a
copy of the rule, to each House of the
Congress and 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 Part 799
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: April 3, 2006.
Susan B. Hazen,
Acting Assistant Administrator, Office of
Prevention, Pesticides and Toxic Substances.
Therefore, 40 CFR chapter I is
amended as follows:
I
E:\FR\FM\12APR1.SGM
12APR1
18654
Federal Register / Vol. 71, No. 70 / Wednesday, April 12, 2006 / Rules and Regulations
PART 799—AMENDED
1. The authority citation for part 799
continues to read as follows:
I
Authority: 15 U.S.C. 2603, 2611, 2625.
2. Amend §799.5115 by revising the
first sentence of paragraph (h)(5)(vii)(A)
in § 799.5115 to read as follows and by
removing the entry ‘‘CAS No. 77–78–1
Dimethyl sulfate’’ in Table 2 of
paragraph (j) in § 799.5115.
I
§ 799.5115 Chemical testing requirements
for certain chemicals of interest to the
Occupational Safety and Health
Administration.
*
*
*
*
*
(h) * * *
(5) * * *
(vii) * * *
(A) Kp. A Kp must be determined for
each test chemical, except for methyl
isoamyl ketone (MIAK; CAS No.: 110–
12–3, Chemical Abstracts (CA) Index
Name: 2-Hexanone, 5-methoxy-) and
dipropylene glycol methyl ether
(DPGME; CAS No.: 34590–94–8, CA
Index Name: Propanol, 1(or 2)-(2methoxymethylethoxy)-). * * *
*
*
*
*
*
[FR Doc. 06–3491 Filed 4–11–06; 8:45 am]
BILLING CODE 6560–50–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 412 and 413
[CMS–1531–IFC]
RIN 0938–AO35
Medicare Program; Medicare Graduate
Medical Education Affiliation
Provisions for Teaching Hospitals in
Certain Emergency Situations
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment
period.
cprice-sewell on PROD1PC66 with RULES
AGENCY:
SUMMARY: This interim final rule with
comment period will modify the current
Graduate Medical Education (GME)
regulations as they apply to Medicare
GME affiliations to provide for greater
flexibility during times of disaster.
Specifically, this rule will implement
the emergency Medicare GME affiliated
group provisions that will address
issues that may be faced by certain
teaching hospitals in the event that
residents who would otherwise have
trained at a hospital in an emergency
area (as that term is defined in section
VerDate Aug<31>2005
15:11 Apr 11, 2006
Jkt 208001
1135(g) of the Social Security Act (the
Act)) are relocated to alternate training
sites.
DATES: This interim final rule is
effective as of August 29, 2005.
Comment date: To be assured
consideration, comments must be
received at one of the addresses
provided below, no later than 5 p.m. on
June 12, 2006.
ADDRESSES: In commenting, please refer
to file code CMS–1531–IFC. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (no duplicates, please):
1. Electronically. You may submit
electronic comments on specific issues
in this regulation to https://
www.cms.hhs.gov/eRulemaking. Click
on the link ‘‘Submit electronic
comments on CMS regulations with an
open comment period.’’ (Attachments
should be in Microsoft Word,
WordPerfect, or Excel; however, we
prefer Microsoft Word.)
2. By regular mail. You may mail
written comments (one original and two
copies) to the following address only:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–1531–
IFC, P.O. Box 8011, Baltimore, MD
21244–8011.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments (one
original and two copies) to the following
address only:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–1531–
IFC, Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments (one original
and two copies) before the close of the
comment period to one of the following
addresses. If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
9994 in advance to schedule your
arrival with one of our staff members.
Room 445–G, Hubert H. Humphrey
Building, 200 Independence Avenue,
SW., Washington, DC 20201; or 7500
Security Boulevard, Baltimore, MD
21244–1850.
(Because access to the interior of the
HHH Building is not readily available to
persons without Federal Government
identification, commenters are
encouraged to leave their comments in
the CMS drop slots located in the main
PO 00000
Frm 00066
Fmt 4700
Sfmt 4700
lobby of the building. A stamp-in clock
is available for persons wishing to retain
a proof of filing by stamping in and
retaining an extra copy of the comments
being filed.)
Comments mailed to the addresses
indicated as appropriate for hand or
courier delivery may be delayed and
received after the comment period.
Submission of comments on
paperwork requirements. You may
submit comments on this document’s
paperwork requirements by mailing
your comments to the addresses
provided at the end of the ‘‘Collection
of Information Requirements’’ section in
this document.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Truong, (410) 786–6005.
Renate Rockwell, (410) 786–4645.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome
comments from the public on all issues
set forth in this rule to assist us in fully
considering issues and developing
policies. You can assist us by
referencing the file code CMS–1531–IFC
and the specific ‘‘issue identifier’’ that
precedes the section on which you
choose to comment.
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://www.cms.hhs.gov/
eRulemaking. Click on the link
‘‘Electronic Comments on CMS
Regulations’’ on that Web site to view
public comments.
Comments received timely will be
also available for public inspection as
they are received, generally beginning
approximately three weeks after
publication of a document, at the
headquarters of the Centers for Medicare
& Medicaid Services, 7500 Security
Boulevard, Baltimore, Maryland 21244,
Monday through Friday of each week
from 8:30 a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
I. Background
[If you choose to comment on issues
in this section, please include the
caption ‘‘BACKGROUND’’ at the
beginning of your comments.]
E:\FR\FM\12APR1.SGM
12APR1
Agencies
[Federal Register Volume 71, Number 70 (Wednesday, April 12, 2006)]
[Rules and Regulations]
[Pages 18650-18654]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-3491]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 799
[EPA-HQ-OPPT-2003-0006; FRL-7751-7]
RIN 2070-AD42
Revocation of TSCA Section 4 Testing Requirements for Certain
Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is taking direct final action to amend the final test
rule, ``In Vitro Dermal Absorption Rate Testing of Certain Chemicals of
Interest to the Occupational Safety and Health Administration,''
promulgated under section 4 of the Toxic Substances Control Act (TSCA).
This amendment removes dimethyl sulfate (DMS) from the list of chemical
substances regulated under the test rule and also removes the
requirement that testing be conducted to determine a permeability
constant (Kp) for methyl isoamyl ketone (MIAK) and dipropylene glycol
methyl ether (DPGME). However, the requirement to conduct testing to
measure short-term dermal absorption rates remains for MIAK and DPGME.
EPA is basing its decisions to take these actions on information it
received since publication of the final rule. Also, upon the effective
date of the revocation of the TSCA section 4 testing requirements for
DMS, persons who export or intend to export DMS will no longer be
subject to the TSCA section 12(b) export notification requirements to
the extent that they were triggered by the testing requirements being
revoked by this action.
DATES: This direct final rule is effective June 12, 2006 without
further notice, unless EPA receives adverse comment in writing, or a
request to present comment orally, on or before May 12, 2006. If EPA
receives adverse comment, or a written request for an opportunity to
present oral comments, EPA will publish a timely withdrawal in the
Federal Register informing the public that this direct final rule, or
relevant portions of this direct final rule, will not take effect. If
you write EPA to request an opportunity to present oral comments on or
before May 12, 2006, EPA will hold a public meeting on this direct
final rule in Washington, DC. The announcement of such a meeting would
be published in the Federal Register.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2003-0006, by one of the following methods:
https://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, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention:
Docket ID Number EPA-HQ-OPPT-2003-0006. The DCO is open from 8 a.m. to
4 p.m., 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 number EPA-HQ-OPPT-
2003-0006. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at https://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 public 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 https://www.epa.gov/epahome/docket.htm.
Docket: All documents in the docket are listed in the
regulations.gov index. 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 either electronically
at https://www.regulations.gov or in hard copy at the OPPT Docket, EPA
Docket Center (EPA/DC), EPA West, Rm. B102, 1301 Constitution Ave.,
NW., Washington, DC. The EPA Docket Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280.
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.
[[Page 18651]]
For technical information contact: John Schaeffer or Catherine
Roman, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-8173 or (202) 564-8172; e-mail address:
schaeffer.john@epa.gov or roman.catherine@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general, and may be of
particular interest to those persons who manufacture (defined by
statute to include import) or process DMS, DPGME, or MIAK. Also,
persons that export or intend to export DMS may have an interest in
this action, as, upon the effective date of the revocation of the TSCA
section 4 testing requirements for DMS, persons who export or intend to
export DMS will no longer be subject to the TSCA section 12(b) export
notification requirements to the extent that they were triggered by the
testing requirements being revoked by this action. Because other
persons may also be interested, the Agency has not attempted to
describe all the specific persons that may be affected by this action.
If you have any questions regarding the applicability of this action to
a particular person, consult the persons listed under FOR FURTHER
INFORMATION CONTACT.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit CBI 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 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. Requesting an opportunity to present oral comments to the
Agency. When you submit a request for an opportunity to present oral
comments, this request must be in writing. If such a request is
received on or before May 12, 2006, EPA will hold a public meeting on
this direct final rule in Washington, DC. This written request must be
submitted to the Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001. If such a request is
received, EPA will announce the scheduling of the public meeting in a
subsequent Federal Register document. If a public meeting is announced,
and if you are interested in attending or presenting oral and/or
written comments and data at the public meeting, you should follow the
instructions provided in the subsequent Federal Register document
announcing the public meeting.
3. 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.
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?
Pursuant to section 4 of TSCA, EPA promulgated and published in the
Federal Register a test rule on April 26, 2004 (OSHA dermal test rule)
requiring that manufactures (including importers) and processors of 34
chemical substances of interest to the Occupational Safety and Health
Administration (OSHA) conduct in vitro dermal absorption rate testing
(Ref. 1). OSHA intends to use the data from these studies to evaluate
the need to develop ``skin designations'' for these chemicals. Skin
designations are used by OSHA to alert industrial hygienists,
employers, and workers to the potentially significant contribution of a
particular chemical to an individual's total workplace exposure to
chemicals which can occur by the cutaneous route. Skin designations
encourage employers to consider whether changes should be made to
processes involving such chemical substances in order to reduce the
potential for systemic toxicity from dermal absorption of these
chemicals.
EPA recently received dermal absorption data on 3 of the 34
chemical substances listed in the final rule. These data have persuaded
EPA to fully withdraw the testing requirements set forth in the final
rule for dimethyl sulfate (DMS; Chemical Abstracts Service Number (CAS
No.): 77-78-1, Chemical Abstracts (CA) Index Name: Sulfuric acid,
dimethyl ester), and to partially withdraw such requirements for methyl
isoamyl ketone (MIAK; CAS No.: 110-12-3, CA Index Name: 2-Hexanone, 5-
methoxy-) and dipropylene glycol methyl ether (DPGME; CAS No.: 34590-
94-8, CA Index Name: Propanol, 1(or 2)-(2-methoxymethylethoxy)-).
On November 2, 2004, DuPont Chemical Solutions Enterprise (DCSE)
submitted results of an exploratory skin absorption study entitled
Dimethyl Sulfate: An In Vitro Assay for Assessment of Dermal
Corrosivity Using Transcutaneous Electrical Impedance (Refs. 2 and 3).
This study clearly showed that DMS is corrosive (Ref. 3). While the
test rule requires that if a chemical ``damages the skin when applied
neat, it must be dissolved in water'' (40 CFR 799.5115(h)(5)(vi)), DMS
is also rapidly hydrolyzed in water, and would not be available as the
test substance, even for the required short-term testing (Refs. 1, 2,
and 4). These factors, considered together, render the in vitro dermal
absorption testing of DMS which is required in the test rule
technically infeasible (Ref. 5). Furthermore, EPA neither has, nor
knows of, any test standard which could successfully obtain the dermal
absorption testing data for DMS as described in the OSHA dermal test
rule. Therefore, for the dermal absorption testing requirements for
DMS, EPA can no longer meet the TSCA requirement under section
4(b)(1)(B) of TSCA regarding the inclusion of standards for development
of test data. Therefore, EPA, in this direct final rule, is revoking
the testing requirements for DMS by removing it from the list of
chemical substances in 40 CFR 799.5115(j) for which in vitro dermal
absorption rate testing is required (Ref. 1).
EPA also received dermal absorption studies on MIAK and DPGME,
which
[[Page 18652]]
were conducted prior to issuance of the final test rule. On June 22,
2005, the Eastman Chemical Company submitted a study entitled Methyl
Isoamyl Ketone: Measurement of the In Vitro Rate of Percutaneous
Absorption through Human Skin (Refs. 6 and 7). The study determined an
absorption rate for MIAK of 0.215 0.15 milligrams/
centimeter squared/hour (mg/cm\2\/h) yielding a Kp (permeability
constant) of 0.000261 cm/h (Ref. 7). On September 29, 2004, EPA
received a request from the American Chemistry Council to review a
recently published study by Venier, et al. (2004) on the dermal
absorption of five glycol ethers, including DPGME (Ref. 8). This study
determined an absorption rate for DPGME of 0.106 0.038 mg/
cm\2\/h yielding a Kp of 0.00011 cm/h (Ref. 9).
EPA and OSHA have reviewed the studies submitted for MIAK and DPGME
and have concluded that the studies are reliable and provide sufficient
data for EPA to reasonably determine the Kp for these two chemical
substances (Refs. 10, 11, and 12). Therefore, this direct final rule
revokes the requirement to conduct testing to determine the Kp for MIAK
and DPGME. However, the test data provided did not include a
determination of short-term dermal absorption rates. Therefore, EPA is
not revoking the short-term testing requirement for MIAK and DPGME. EPA
has already granted an extension of the testing deadline for the short-
term testing for these two substances to allow for the completion of
this testing, which was suspended by the test sponsors pending review
by EPA and OSHA of the submitted studies (Refs. 11 and 12).
B. What is the Agency's Authority for Taking this Action?
The final rule requiring in vitro dermal absorption rate testing
for DMS, DPGME, and MIAK (Ref. 1) was promulgated under section 4 of
TSCA (15 U.S.C. 2603), which mandates that EPA require that
manufacturers and/or processors of chemical substances and mixtures
conduct testing if certain findings are made by EPA (see section 4(a)
of TSCA). Section 4(b)(5) of TSCA authorizes EPA to amend or repeal
test rules issued under section 4(a) of TSCA. One of the findings that
EPA made in promulgating the OSHA dermal test rule was a determination
that testing was necessary in order to determine both a Kp and short-
term absorption rates for all of the chemicals included in the rule
(see section 4(a)(1)(B)(iii) of TSCA; see also Ref. 1).
In this direct final rule, EPA is withdrawing the testing required
by the final test rule for DMS, and partially withdrawing the testing
required for DPGME and MIAK. The test rule requirements for DMS are
being withdrawn because the extreme corrosiveness of DMS and its rapid
rate of hydrolysis preclude obtaining a relevant rate of absorption,
and thus make it infeasible to conduct in vitro dermal absorption rate
testing for this chemical. The test requirement to determine a Kp for
DPGME and MIAK is being withdrawn because EPA has concluded the data
recently submitted to EPA on June 22, 2005, and September 29, 2004, are
sufficient to determine this value for these chemicals for the purposes
identified in the test rule. Therefore, EPA finds that testing to
determine a Kp for DPGME and MIAK is no longer necessary.
III. Economic Analysis
In the economic analysis conducted for the final rule, the Agency
estimated the total cost of the testing to be $1.16 million for all 34
chemicals, or $33,987 per chemical (Ref. 13). This total included an
average $10,425 per chemical for the short-term dermal absorption rate
testing, $16,765 for the Kp testing, and an additional 25% ($6,797) in
administrative costs. This direct final rule would have the effect of
reducing the total testing cost by an estimated $75,899, or
approximately 7%, by eliminating the Kp testing for three chemicals and
the short-term dermal absorption rate testing for one chemical. In
addition, the 25% administrative cost would be eliminated for those
tests. The new total cost of the testing is estimated to be $1.08
million (i.e., $1.16 million minus $75,899). The annualized cost per
chemical calculated in the economic analysis, based on a 15-year
amortization period and a 7% discount rate, was $3,732. For DPGME and
MIAK, which will no longer be required to undergo the Kp testing, the
annualized cost is estimated to be reduced to $2,301 as a result of the
direct final rule.
IV. Export Notification
Upon the effective date of the revocation of the TSCA section 4
testing requirements for DMS, persons who export or intend to export
DMS will no longer be subject to the TSCA section 12(b) export
notification requirements to the extent that they were triggered by the
testing requirements being revoked by this action. For all of the other
chemicals, including MIAK and DPGME, listed as subject to the
requirements of the OSHA dermal test rule (Ref. 1), the export
notification requirements remain the same.
V. Direct Final Rule Procedures
EPA is publishing this direct final rule without prior proposal
because the Agency views this as a noncontroversial amendment and
anticipates no adverse comment as this action simply revokes testing
for which EPA already has adequate data or for which such testing is
not feasible. This direct final rule is effective June 12, 2006 without
further notice, unless EPA receives adverse comment or a written
request for an opportunity to present oral comments on or before May
12, 2006. If EPA receives adverse comment or a request for an
opportunity to present oral comments on one or more distinct
amendments, paragraphs, or sections of this direcct final rule, the
Agency will publish a timely withdrawal in the Federal Register
indicating which provisions will become effective and which provisions
are being withdrawn due to adverse comment. Any distinct amendment,
paragraph, or section of this direct final rule for which the Agency
does not receive adverse comment or a request for an opportunity to
present oral comments will become effective June 12, 2006,
notwithstanding any adverse comment or request on any other distinct
amendment, paragraph, or section of this direct final rule. For any
distinct amendment, paragraph, or section of this direct final rule
that is withdrawn due to adverse comment or a request for an
opportunity to present oral comments, EPA will publish a notice of
proposed rulemaking in a future edition of the Federal Register. The
Agency will address the comment or request for an opportunity to
present oral comments on any such distinct amendment, paragraph, or
section as part of that notice of proposed rulemaking.
VI. References
1. EPA. Final Test Rule for In Vitro Dermal Absorption Rate Testing
of Certain Chemicals of Interest to the Occupational Safety and Health
Administration. Federal Register (69 FR 22402, April 26, 2004) (FRL-
7312-2). Available on-line at: https://www.epa.gov/fedrgstr/EPA-TOX/
2004/April/Day-26/t9409.htm.
2. DCSE. Letter from Robert W. Freerksen, PhD to EPA Re: In Vitro
Dermal Absorption Test rule (69 FR 22402 (4/26/04; OPPT-2003-0006)) 40
CFR 799.5115 Dimethyl Sulfate (CAS No.77-78-1) Request for Modification
of Test Standard. November 2, 2004.
3. Fasano, W.J. Dimethyl Sulfate: An In Vitro Assay for Assessment
of Dermal Corrosivity Using Transcutaneous Electrical Impedance. E.I.
du Pont de
[[Page 18653]]
Nemours and Company. Haskell Laboratory for Health and Environmental
Sciences. October 15, 2004.
4. EPA. E-mail from Andrew Mamantov, PhD to Greg Schweer Re:
Hydrolysis rate for Dimethyl Sulfate. March 9, 2005.
5. EPA. Note from Leonard Keifer to Greg Schweer Re: Technical
Feasibility of Performing an In Vitro Dermal Absorption Study with
Dimethyl Sulfate. March 10, 2005.
6. Eastman Chemical Company. Letter from Marc G. Schurger to
Catherine Roman Re: In vitro dermal absorption testing on methyl
isoamyl ketone (CAS No. 110-12-3) under TSCA Section 4 Test Rule (OPPT-
2003-0006). June 22, 2004.
7. Hill, T.S. and Taylor, L. Methyl isoamyl ketone: measurement of
the in vitro rate of percutaneous absorption through human skin. Final
Report: Toxicological Sciences Laboratory, Health and Environment
Laboratories, Eastman Kodak Company. January 29, 2001.
8. ACC. Communication (e-mail) from Susan Lewis to Catherine Roman.
Directing EPA's attention to a recent publication (2004) on dermal
absorption of dipropylene glycol methyl ether (DPGME). September 29,
2004.
9. Venier, M., Adami, G., Larese, F., and Renzi, N. Percutaneous
absorption of 5 glycol ethers through human skin in vitro. Toxicology
In Vitro 18:665-671. 2004.
10. OSHA, Department of Labor. Letter from William G. Perry, CIH to
Catherine Roman dated January 26, 2005.
11. EPA. Letter from Charles M. Auer to Marc G. Shurger Re: USEPA
and OSHA review of the dermal absorption rate study sponsored by the
Eastman Chemical Company and conducted by Toxicological Sciences
Laboratory. May 26, 2005. (OPPT-2003-0006-0270).
12. EPA. Letter from Charles M. Auer to Susan Anderson Lewis, Ph.D.
Re: USEPA review of a recently published dermal absorption rate study
on dipropylene glycol methyl ether. May 26, 2005. (OPPT-2003-0006-
0272).
13. EPA. Economic Impact Analysis and Small Entity Impact Analysis
for the TSCA Section 4(a) Test Rule for 34 Chemicals Targeted for In
Vitro Dermal Absorption Rate Testing. Prepared by OPPT/Economics,
Exposure, and Technology Division (EETD)/Economic and Policy Analysis
Branch (EPAB). Washington, DC. February 3, 2004.
VII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
This direct final rule implements changes to 40 CFR 799.5115
resulting in a burden and cost reduction. Since this direct final rule
does not impose any new requirements, it is not subject to review by
the Office of Management and Budget (OMB) under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
B. Paperwork Reduction Act
This direct final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq.
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 revocation of
certain requirements under section 4 of TSCA will not have a
significant economic impact on a substantial number of small entities.
D. Unfunded Mandates Reform Act
This action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
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
(65 FR 67249, November 6, 2000).
G. Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined under Executive Order 12866,
and it does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This direct final rule is not subject to Executive Order 13211,
entitled Actions Concerning Regulations 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 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.
VIII. 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, which includes a copy of the rule,
to each House of the Congress and 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 Part 799
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: April 3, 2006.
Susan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and
Toxic Substances.
0
Therefore, 40 CFR chapter I is amended as follows:
[[Page 18654]]
PART 799--AMENDED
0
1. The authority citation for part 799 continues to read as follows:
Authority: 15 U.S.C. 2603, 2611, 2625.
0
2. Amend Sec. 799.5115 by revising the first sentence of paragraph
(h)(5)(vii)(A) in Sec. 799.5115 to read as follows and by removing the
entry ``CAS No. 77-78-1 Dimethyl sulfate'' in Table 2 of paragraph (j)
in Sec. 799.5115.
Sec. 799.5115 Chemical testing requirements for certain chemicals of
interest to the Occupational Safety and Health Administration.
* * * * *
(h) * * *
(5) * * *
(vii) * * *
(A) Kp. A Kp must be determined for each test chemical, except for
methyl isoamyl ketone (MIAK; CAS No.: 110-12-3, Chemical Abstracts (CA)
Index Name: 2-Hexanone, 5-methoxy-) and dipropylene glycol methyl ether
(DPGME; CAS No.: 34590-94-8, CA Index Name: Propanol, 1(or 2)-(2-
methoxymethylethoxy)-). * * *
* * * * *
[FR Doc. 06-3491 Filed 4-11-06; 8:45 am]
BILLING CODE 6560-50-S