[Federal Register: February 27, 2008 (Volume 73, Number 39)]
[Rules and Regulations]
[Page 10396-10398]
[DOCID:fr27fe08-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0182; FRL-8341-4]

Dibasic Esters (DBE); Exemption from the Requirement of a
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of
a tolerance for residues of dibasic esters (DBE; CAS Reg. No. 95481-62-
2) when used as an inert ingredient solvent and/or anti-freeze
microencapsulated at 10% weight/weight (W/W) or less in pesticide
formulations with the active ingredient cyfluthrin. Whitmire Micro-Gen
Research Laboratories, Inc. submitted a pesticide petition 5E4442 to
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA) requesting
exemptions from the requirement of a tolerance. EPA published in the
Federal Register on August 29, 2007 (72 FR 49689) a proposed rule for
this petition in order to provide the public with an opportunity to
comment on data that submitted to the Agency after the publication of
the petition's Notice of Filing.

DATES: This regulation is effective February 27, 2008. Objections and
requests for hearings must be received on or before April 28, 2008, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0182. 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. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the OPP
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The Docket Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Tracy Ward, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. 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 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. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2007-0182 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before April 28, 2008.

    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0182, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of December 23, 1998 (63 FR 71126) (FRL-
6047-7), EPA issued a notice pursuant to section 408 of the FFDCA, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP 5E4442)
by Whitmire Micro-Gen Research Laboratories, Inc., 3568 Tree Court
Industrial Blvd., St. Louis, MO 63122-6682. The petition requested that
40 CFR 180.910 and 180.930 be amended by establishing an exemption from
the requirement of a tolerance for residues of dibasic esters (DBE).
EPA received a significant number of new studies as a result of an
enforceable consent agreement issued under Section 4 of the Toxic
Substance Control Act (TSCA) (Federal Register, August 5, 1999, 64 FR
42692) (FRL-6090-6). EPA published in the Federal Register on August
29, 2007 (72 FR 49689) (FRL-8143-3) a proposed rule for this petition
in order to provide the public with an opportunity to comment on the
new data.

III. EPA's Determination on Proposed Rule

    One comment was received on the proposed rule. The commenter
expressed a general concern over test results: ``The test results show
a real tendency to harm i do not think this product should ever be sold
or manufactured ever.'' The Agency has addressed the results of the
studies in the proposed rule and its decision document. The full
decision document for this action is available on EPA's Electronic
Docket at http://www.regulations.gov/ under docket number EPA-HQ-OPP-
2007-0182. Given the non-specificity of the comment EPA cannot respond
further.
    Accordingly, based on the reasons set forth in the proposed rule
and the decision document, EPA concludes that there is a reasonable
certainty of no harm to the general population, including infants and
children, from aggregate exposure to residues of dibasic esters (DBE;
CAS Reg. No. 95481-62-2) when used as an inert ingredient in pesticide
formulations. Accordingly, EPA finds that the tolerance exemptions
described in Unit II. for residues of dibasic esters will be safe.
    The Agency is granting the requested exemptions from the
requirement of a tolerance for residues of dibasic esters when used as
an inert ingredient solvent and/or anti-freeze microencapsulated at 10%
weight/weight (W/W) or less in pesticide formulations with the active
ingredient cyfluthrin.

IV. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section
408(d) of FFDCA in response to a petition submitted to the Agency. The
Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). Because this rule
has been exempted from review under Executive Order 12866, this rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This 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., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency hereby certifies that this proposed action will not
have significant negative economic impact on a substantial number of
small entities. Establishing a pesticide tolerance or an exemption from
the requirement of a pesticide tolerance is, in effect, the removal of
a regulatory restriction on pesticide residues in food and thus such an
action will not have any negative economic impact on any entities,
including small entities. This final rule directly regulates growers,
food processors, food handlers and food retailers, not States or
tribes, nor does this action alter the relationships or distribution of
power and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. As such, the Agency has
determined that this action will not have a substantial direct effect
on States or tribal governments, on the relationship between the
national government and the States or tribal governments, or on the
distribution of power and responsibilities among the various levels of
government or between the Federal Government and Indian tribes. Thus,
the Agency has determined that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175,
entitled Consultation and Coordination with Indian Tribal Governments
(65 FR 67249, November 6, 2000) do not apply to this rule. In addition,
This rule 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).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to 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).

V. 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 this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: February 6, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.1277 is added to subpart D to read as follows:

Sec.  180.1277  Dibasic esters; exemption from the requirement of a
tolerance.

    Dibasic esters (CAS Reg. No. 95481-62-2) is exempted from the
requirement of a tolerance for residues when used as an inert
ingredient (solvent and/or anti-freeze) at 10% W/W or less in
microencapsulated pesticide formulations with the active ingredient
cyfluthrin.
[FR Doc. E8-3492 Filed 2-26-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 81, Number 133 (Tuesday, July 12, 2016)]
[Rules and Regulations]
[Pages 45020-45022]
[FR Doc No: 2016-16226]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-1057]
RIN 1625-AA09

Drawbridge Operation Regulation; Norwalk River, Norwalk, CT

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is modifying the operating schedule that
governs the Metro-North WALK Bridge across the Norwalk River, mile 0.1,
at Norwalk, Connecticut. The bridge owner submitted a request to
require a greater advance notice for bridge openings and to increase
time periods the bridge remains in the closed position during the
weekday morning and evening rush hours. It is expected that this change
to the regulations will create efficiency in drawbridge operations
while continuing to meet the reasonable needs of navigation.

DATES: This rule is effective August 11, 2016.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type ``USCG-
2014-1057'' in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Christopher J. Bisignano, Supervisory Bridge
Management Specialist, First Coast Guard District, Coast Guard;
telephone<PHONE_NUMBER> or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
E.O. Executive Order
FR Federal Register
NPRM Notice of proposed rulemaking
SNPRM Supplemental notice of proposed rulemaking
Pub. L. Public Law
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard twice published a notice of proposed rulemaking to
adjust when the draw of the Metro-North WALK Bridge will be available
to open Monday through Friday, excluding holidays. In response to
comments received to the notice of proposed rulemaking (NPRM),
published in August 2015 (80 FR 52423), the Coast Guard conducted
further review of tidal data, bridge logs and train schedules.
    On April 4, 2016, we published a supplemental notice of proposed
rulemaking (SNPRM) entitled Drawbridge Operation Regulation; Norwalk
River, Norwalk, CT, in the Federal Register (81 FR 19094), soliciting
comments on the proposed rule through May 4, 2016. In addition,
Commander (dpb), First Coast Guard District published Public Notice 1-
150 dated April 4, 2016. We received two

comments on the proposed rule, which will be addressed in Section IV,
below.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
499.
    The Metro-North WALK Bridge, mile 0.1, across the Norwalk River at
Norwalk, CT, has a vertical clearance in the closed position of 16 feet
at mean high water and 23 feet at mean low water. The drawbridge
operation regulations are listed at 33 CFR 117.217(b). The waterway
users are seasonal recreational vessels and commercial vessels of
various sizes. The owner of the bridge, Connecticut Department of
Transportation (CDOT), requested a change to the Drawbridge Operation
Regulations because the volume of train traffic across the bridge
during the peak commuting hours makes bridge openings impractical under
the current schedule. As a result, bridge openings that occur during
peak commuter train hours cause significant delays to commuter rail
traffic.
    The Coast Guard believes these final changes balance the needs of
rail and vessel traffic. The proposed changes enhance rail traffic
without significantly impacting vessel traffic.

IV. Discussion of Comments, Changes and the Final Rule

    We received two submissions commenting on the SNPRM. One comment
requested that any modification to the existing rule should not be
extended past the initiation of construction of a new replacement
bridge. The Coast Guard disagrees. A replacement bridge is only in the
planning stage at CDOT. Design and construction of a replacement
project for a bridge of this scale typically takes several years. As
the timeline of a potential bridge replacement is uncertain, the Coast
Guard cannot consider it within this rulemaking.
    One comment suggested the Coast Guard consider revising the AM peak
window to end at 8:45 a.m. and revising the PM peak window to begin at
4:15 p.m. and end at 8:20 p.m. to better accommodate commuters. The
Coast Guard believes that the proposed rule offers greater
consideration to peak commuter train traffic by restricting bridge
openings until 9:45 a.m. The Coast Guard also believes that the PM peak
revision of the proposed rule more adequately addresses the concerns in
the comment by offering an additional 15 minutes on the front end by
restricting bridge openings starting at 4 p.m. In addition, while the
train schedules do adjust twice annually, only one train crosses the
bridge between 8 p.m. and 8:20 p.m. Therefore, the Coast Guard believes
ending the restriction to bridge openings at 8 p.m. is sufficient. The
proposed changes balance the needs of rail and vessel traffic,
enhancing rail traffic without significant adverse impact to vessel
traffic.
    The Coast Guard amends 33 CFR 117.217(b) as proposed in the SNPRM
of April 4, 2016.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders (E.O.s) related to rulemaking. Below we summarize our
analyses based on a number of these statutes and E.O.s, and we discuss
First Amendment rights of protesters.

A. Regulatory Planning and Review

    E.O.s 12866 and 13563 direct agencies to assess the costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits.
E.O. 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has not been designated a ``significant
regulatory action,'' under E.O. 12866. Accordingly, it has not been
reviewed by the Office of Management and Budget.
    This regulatory action determination is based on the ability that
vessels can still transit the bridge given advanced notice. The
vertical clearance under the bridge in the closed position is
relatively high enough to accommodate most vessel traffic during the
time periods the draw is closed during the morning and evening commuter
rush hours.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rule. The Coast Guard certifies under 5 U.S.C.
605(b) that this rule will not have a significant economic impact on a
substantial number of small entities. While some owners or operators of
vessels intending to transit the bridge may be small entities, for the
reasons stated in section V.A above this final rule would not have a
significant economic impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Government

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the 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. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in E.O. 13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a
determination that this action is one of a category of actions which do
not individually or cumulatively have a significant effect on the human
environment. This rule simply promulgates the operating regulations or
procedures for drawbridges. This action is categorically excluded from
further review, under figure 2-1, paragraph (32)(e), of the
Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority:  33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. Revise Sec.  117.217, paragraph (b), to read as follows:

Sec.  117.217  Norwalk River.

* * * * *
    (b) The draw of the Metro-North ``WALK'' Bridge, mile 0.1, at
Norwalk, shall operate as follows:
    (1) The draw shall open on signal between 4:30 a.m. and 9 p.m.
after at least a two hour advance notice is given; except that, from
5:45 a.m. through 9:45 a.m. and from 4 p.m. through 8 p.m., Monday
through Friday excluding holidays, the draw need not open for the
passage of vessel traffic unless an emergency exists.
    (2) From 9 p.m. through 4:30 a.m. the draw shall open on signal
after at least a four hour advance notice is given.
    (3) A delay in opening the draw not to exceed 10 minutes may occur
when a train scheduled to cross the bridge without stopping has entered
the drawbridge lock.
    (4) Requests for bridge openings may be made by calling the bridge
via marine radio VHF FM Channel 13 or the telephone number posted at
the bridge.

    Dated: June 23, 2016.
S.D. Poulin,
Rear Admiral, U.S. Coast Guard Commander, First Coast Guard District.
[FR Doc. 2016-16226 Filed 7-11-16; 8:45 am]
 BILLING CODE 9110-04-P


Friday October 5, 2001 Part IV Environmental Protection Agency Forty Eighth Report of the TSCA Interagency Testing Committee to the Administrator, Receipt of Report and Request for Comments; Notice VerDate 11< MAY> 2000 17: 07 Oct 04, 2001 Jkt 197001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\ FR\ FM\ 05OCN3. SGM pfrm01 PsN: 05OCN3 RECEIVED OPPT NCIC 2003 MAR27 2: 53PM OPPT 2002 0061 0002 51276 Federal Register / Vol. 66, No. 194 / Friday October 5, 2001 / Notices ENVIRONMENTAL PROTECTION AGENCY [ OPPTS   41056; FRL   6786   7]

Forty Eighth Report of the TSCA Interagency Testing Committee to the Administrator; Receipt of Report and Request for Comments AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: The Toxic Substances Control Act ( TSCA) Interagency Testing Committee ( ITC) transmitted its Forty Eighth Report to the Administrator of the EPA on May 15, 2001. In the 48th ITC Report, which is included with this notice, the ITC adds 5 `` chlorinated trihalomethyl pyridines,'' 2 `` trihaloethylidene bisbenzenes,'' 3 chlorotrifluralin, and 4 `` trichlorophenyldihydropyrazols'' to its Priority Testing List and solicits voluntary information for these chemicals under the ITC's Voluntary Information Submissions Policy ( VISP). This action is part of the ITC's ongoing effort to evaluate chemicals with potential to persist and bioconcentrate, and with suspicions of toxicity and few data. In this Report, the ITC also removes 22 alkylphenols and ethoxylates, methylal, and ethyl silicate from its Priority Testing List and requests that EPA promulgate TSCA section 8( d) health and safety data reporting rules for 3 amino 5 mercapto 1,2,4 triazole and glycoluril. DATES: Comments, identified by docket control number OPPTS   41056, must be received on or before November 5, 2001. ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS   41056 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Acting Director, Environmental Assistance Division ( 7408), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone numbers: ( 202) 554   1404; e mail address: TSCA Hotline@ epa. gov. For technical information contact: John D. Walker, ITC Executive Director ( 7401), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 202) 564   7527; fax: ( 202) 564   7528; e mail address: walker. johnd@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? This notice is directed to the public in general. It may, however, be of particular interest to you if you manufacture ( defined by statute to include import) and/ or process TSCAcovered chemicals and you may be identified by the North American Industrial Classification System ( NAICS) codes 325 and 32411. Because this notice is directed to the general public and other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. 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 Get Additional Information, Including Copies of this Document or Other Related Documents? 1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations,'' `` Regulations and Proposed Rules,'' and then look up the entry for this document under the `` Federal Register   Environmental Documents.'' You can also go directly to the Federal Register listings at http:// www. epa. gov/ fedrgstr/. You may also access additional information about the ITC and the TSCA testing program through the web site for the Office of Prevention, Pesticides and Toxic Substances ( OPPTS) at http:// www. epa. gov/ opptsfrs/ home/ opptsim. htm/, or go directly to the ITC home page at http:// www. epa. gov/ opptintr/ itc/. 2. In person. The Agency has established an official record for this action under docket control number OPPTS   41056. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B   607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Center is ( 202) 260   7099.

C. How and to Whom Do I Submit Comments? You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPPTS   41056 in the subject line on the first page of your response. 1. By mail. Submit your comments to: Document Control Office ( 7407), Office of Pollution Prevention and Toxics ( OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 2. In person or by courier. Deliver your comments to: OPPT Document Control Office ( DCO) in East Tower Rm. G   099, Waterside Mall, 401 M St., SW., Washington, DC. 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) 260   7093. 3. Electronically. You may submit your comments electronically by e mail to: oppt. ncic@ epa. gov, or mail your computer disk to the address identified above. Do not submit any information electronically that you consider to be CBI. Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on standard disks in WordPerfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPPTS   41056. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI Information that I Want to Submit to the Agency? Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

VerDate 11< MAY> 2000 17: 07 Oct 04, 2001 Jkt 197001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4703 E:\ FR\ FM\ 05OCN3. SGM pfrm01 PsN: 05OCN3 51277 Federal Register / Vol. 66, No. 194 / Friday October 5, 2001 / Notices In addition to one complete version of the comment that includes any 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 version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

We invite you to provide your views and comments on the ITC's 48th Report. You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. Provide specific examples to illustrate your concerns. 5. Offer alternatives for improvement. 6. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. Background TSCA ( 15 U. S. C. 2601 et seq.) authorizes the Administrator of the EPA to promulgate regulations under section 4( a) of TSCA requiring testing of chemicals and chemical groups in order to develop data relevant to determining the risks that such chemicals and chemical groups may present to health or the environment. Section 4( e) of TSCA established the ITC to recommend chemicals and chemical groups to the Administrator of the EPA for priority testing consideration. Section 4( e) of TSCA directs the ITC to revise the TSCA section 4( e) Priority Testing List at least every 6 months. A. The 48th ITC Report The 48th ITC Report was transmitted to the EPA's Administrator on May 15, 2001, and is included in this notice. In the 48th ITC Report, the ITC: 1. Adds 5 `` chlorinated trihalomethyl pyridines,'' 2 `` trihaloethylidene bisbenzenes,'' 3 chlorotrifluralin, and 4 `` trichlorophenyldihydropyrazols'' to its Priority Testing List and solicits voluntary information for these chemicals under the ITC's VISP. This action is part of the ITC's ongoing effort to evaluate chemicals with potential to persist and bioconcentrate, and with suspicions of toxicity and few data. 2. Removes 22 alkylphenols and ethoxylates, methylal, and ethyl silicate from its Priority Testing List. 3. Requests that EPA promulgate TSCA section 8( d) health and safety data reporting rules for 3 amino 5 mercapto 1,2,4 triazole and glycoluril.

B. Status of the Priority Testing List The current TSCA 4( e) Priority Testing List as of May 2001 can be found in Table 1 of the 48th ITC's Report which is included in this notice.

List of Subjects Environmental protection, Chemicals, Hazardous substances.

Dated: September 26, 2001. Charles M. Auer, Director, Chemical Control Division, Office of Pollution Prevention and Toxics.

Forty Eighth Report of the TSCA Interagency Testing Committee to the Administrator, U. S. Environmental Protection Agency Table of Contents Summary I. Background II. TSCA Section 8 Reporting A. TSCA Section 8 Reporting Rules B. ITC's Use of TSCA Section 8 and Other Information C. Promoting More Efficient Use of Information Submission Resources D. Coordinating Information Requests E. Requests to Promulgate TSCA Section 8( a) PAIR and Section 8( d) HaSD Reporting Rules III. ITC's Activities During this Reporting Period ( November 2000 to April 2001) IV. Revisions to the TSCA Section 4( e) Priority Testing List A. Chemicals Added to the Priority Testing List 1. Chlorinated trihalomethyl pyridines 2. Trihaloethylidene bisbenzenes 3. 3 Chlorotrifluralin 4. Trichlorophenyldihydropyrazols B. Chemicals Removed From the Priority Testing List 1. Alkylphenols and alkylphenol ethoxylates 2. Methylal 3. Ethyl silicate V. References VI. TSCA Interagency Testing Committee SUMMARY This is the 48th Report of the TSCA Interagency Testing Committee ( ITC) to the Administrator of the U. S. Environmental Protection Agency ( USEPA). In this Report, the ITC is adding 5 chlorinated trihalomethyl pyridines, 2 trihaloethylidene bisbenzenes, 3 chlorotrifluralin, and 4 trichlorophenyldihydropyrazols to its Priority Testing List and soliciting voluntary information for these chemicals under the ITC's Voluntary Information Submissions Policy ( VISP). This action is part of the ITC's ongoing effort to evaluate chemicals with suspicions of toxicity and few data and potential to persist and bioconcentrate. In this Report, the ITC is removing 22 alkylphenols and ethoxylates and methylal and ethyl silicate from its Priority Testing List. The ITC is removing 22 alkylphenols and ethoxylates from its Priority Testing List because domestic production or importation volumes were not reported to the USEPA in response to 1986, 1990, 1994, and 1998 TSCA section 8( a) Information Update Rules ( IURs) and in response to the TSCA section 8( a) Preliminary Assessment Information Reporting ( PAIR) rule published in the Federal Register of July 5, 2000 ( 65 FR 41371) ( FRL   6589   1). The ITC is removing methylal and ethyl silicate from its Priority Testing List because data are being developed under the USEPA's High Production Volume ( HPV) Challenge Program. The revised TSCA section 4( e) Priority Testing List follows as Table 1.

TABLE 1.   THE TSCA SECTION 4( E) PRIORITY TESTING LIST ( MAY 2001)

Report Date Chemical/ group Action 28 ................ May 1991 ................ Chemicals with Low Confidence Reference Dose ( RfD) ............................................ Designated Acetone Thiophenol 30 ................ May 1992 ................ 5 Siloxanes .................................................................................................................. Recommended 31 ................ January 1993 .......... 13 Chemicals with insufficient dermal absorption rate data ....................................... Designated VerDate 11< MAY> 2000 17: 07 Oct 04, 2001 Jkt 197001 PO 00000 Frm 00003 Fmt 4701 Sfmt 4703 E:\ FR\ FM\ 05OCN3. SGM pfrm01 PsN: 05OCN3 51278 Federal Register / Vol. 66, No. 194 / Friday October 5, 2001 / Notices TABLE 1.   THE TSCA SECTION 4( E) PRIORITY TESTING LIST ( MAY 2001)   Continued Report Date Chemical/ group Action 32 ................ May 1993 ................ 16 Chemicals with insufficient dermal absorption rate data ....................................... Designated 35 ................ November 1994 ...... 4 Chemicals with insufficient dermal absorption rate data ......................................... Designated 37 ................ November 1995 ...... 12 Alkylphenols and alkylphenol ethoxylates ............................................................. Recommended 39 ................ November 1996 ...... 8 Nonylphenol ethoxylates .......................................................................................... Recommended 41 ................ November 1997 ...... 7 Alkylphenols and alkylphenol ethoxylates ............................................................... Recommended 42 ................ May 1998 ................ 3 Amino 5 mercapto 1,2,4 triazole .............................................................................. Recommended 42 ................ May 1998 ................ Glycoluril ...................................................................................................................... Recommended 46 ................ May 2000 ................ 8 Nonylphenol polyethoxylate degradation products .................................................. Recommended 47 ................ November 2000 ...... 37 Indium chemicals ................................................................................................... Recommended 47 ................ November 2000 ...... Pentachlorothiophenol ................................................................................................. Recommended 47 ................ November 2000 ...... Tetrachloropyrocatechol .............................................................................................. Recommended 47 ................ November 2000 ...... p Toluidine, 5 chloro. alpha.,. alpha.,. alpha. trifluoro 2 nitro N phenyl ........................ Recommended 47 ................ November 2000 ...... Benzoic acid, 3[ 2 chloro 4 ( trifluoromethyl) phenoxy], 2 ethoxy 1 methyl 2 oxoethyl ester. Recommended 47 ................ November 2000 ...... 3 Chloroalkenes .......................................................................................................... Recommended 48 ................ May 2001 ................ 5 Chlorinated trihalomethyl pyridines .......................................................................... Recommended 48 ................ May 2001 ................ 2 Trihaloethylidene bisbenzenes ................................................................................. Recommended 48 ................ May 2001 ................ 3 Chlorotrifluralin ......................................................................................................... Recommended 48 ................ May 2001 ................ 4 Trichlorophenyldihydropyrazols ................................................................................ Recommended I. Background The ITC was established by section 4( e) of the Toxic Substances Control Act ( TSCA) `` to make recommendations to the Administrator respecting the chemical substances and mixtures to which the Administrator should give priority consideration for the promulgation of a rule for testing under section 4( a).... At least every six months..., the Committee shall make such revisions to the Priority Testing List as it determines to be necessary and transmit them to the Administrator together with the Committee's reasons for the revisions'' ( Public Law 94   469, 90 Stat. 2003 et seq., 15 U. S. C. 2601 et seq.). Since its creation in 1976, the ITC has submitted 47 semi annual ( May and November) Reports to the EPA Administrator transmitting the Priority Testing List and its revisions. ITC Reports are available from the ITC's web site ( http:// www. epa. gov/ opptintr/ itc) within a few days of submission to the Administrator and from http:// www. epa. gov/ fedrgstr after publication in the Federal Register. The ITC meets monthly and produces its revisions to the Priority Testing List with administrative and technical support from the ITC Staff, ITC Members, and their U. S. Government organizations and contract support provided by EPA. ITC Members and Staff are listed at the end of this Report.

II. TSCA Section 8 Reporting A. TSCA Section 8 Reporting Rules Following receipt of the ITC's Report ( and the revised Priority Testing List) by the USEPA Administrator, the USEPA's Office of Pollution Prevention and Toxics ( OPPT) promulgates TSCA section 8( a) PAIR and TSCA section 8( d) Health and Safety Data ( HaSD) reporting rules for chemicals added to the Priority Testing List. The PAIR rule requires producers and importers of CASnumbered chemicals added to the Priority Testing List to submit production and exposure reports under TSCA section 8( a). The HaSD reporting rule requires producers, importers, and processors of all chemicals ( including those with no CAS numbers) added to the Priority Testing List to submit unpublished health and safety studies under TSCA section 8( d) that must be in compliance with the revised HaSD reporting rule published in the Federal Register of April 1, 1998 ( 63 FR 15765) ( FRL   5750   4). All submissions must be received by the USEPA within 90 days of the reporting rules' Federal Register publication date. The reporting rules are automatically promulgated by OPPT unless otherwise requested by the ITC. It is an ITC policy, for most chemicals that are added to the Priority Testing List, to delay automatic promulgation of HaSD reporting rules to allow voluntary submission of studies of specific interest ( see Unit II. C. of this Report for further details).

B. ITC's Use of TSCA Section 8 and Other Information The ITC reviews the TSCA section 8( a) PAIR reports, TSCA section 8( d) HaSD reporting studies and `` other information'' that becomes available after the ITC adds chemicals to the Priority Testing List. `` Other information'' includes TSCA section 4( a) and 4( d) studies, TSCA section 8( c) submissions, TSCA section 8( e) `` substantial risk'' notices, `` For Your Information'' ( FYI) submissions, ITC voluntary submissions, unpublished data submitted to and from U. S. Government organizations represented on the ITC, published papers, as well as use, exposure, effects, and persistence data that are voluntarily submitted to the ITC by manufacturers, importers, processors, and users of chemicals recommended by the ITC. The ITC reviews this information and determines if data needs should be revised, if chemicals should be removed from the Priority Testing List, or if recommendations should be changed to designations.

C. Promoting More Efficient Use of Information Submission Resources To promote more efficient use of information submission resources, the ITC developed VISP. VISP provides examples of data needed by ITC Member U. S. Government organizations, examples of studies that should not be submitted, the milestones for submitting information, guidelines for using the TSCA Electronic HaSD Reporting Form, and instructions for electronically submitting full studies. The TSCA Electronic HaSD Reporting Form can be used to provide information electronically on ITC voluntary submissions, TSCA section 8( d) studies, FYI submissions, and TSCA section 8( e) studies. VISP is described in the ITC's 41st Report published in the Federal Register of April 9, 1998 ( 63 FR 17658) ( FRL   5773   5) and is accessible through the world wide web ( http:// www. epa. gov/ opptintr/ itc/ visp. htm ). To facilitate the implementation of VISP, the ITC developed the Voluntary Information Submissions Innovative Online Network ( VISION). VISION is described in the ITC's 42nd Report VerDate 11< MAY> 2000 17: 07 Oct 04, 2001 Jkt 197001 PO 00000 Frm 00004 Fmt 4701 Sfmt 4703 E:\ FR\ FM\ 05OCN3. SGM pfrm01 PsN: 05OCN3 51279 Federal Register / Vol. 66, No. 194 / Friday October 5, 2001 / Notices published in the Federal Register of August 7, 1998 ( 63 FR 42554) ( FRL   5797   8) and is accessible through the world wide web ( http:// www. epa. gov/ opptintr/ itc/ vision. htm). VISION includes the VISP and links to the TSCA Electronic HaSD Reporting Form ( http:/ / www. epa. gov/ opptintr/. er/ hasd. htm) including revised section 3.2 of the TSCA Electronic HaSD Reporting Form to provide more use and exposure information ( see the ITC's 46th Report published in the Federal Register of December 1, 2000 ( 65 FR 75552) ( FRL   6594   7) for details. The ITC requests that chemical producers, importers, processors, and users provide information electronically via VISION on chemicals for which the ITC is soliciting voluntary information. To enhance visibility, the ITC will be adding all chemicals to the Priority Testing List for which it is soliciting voluntary information. If the ITC does not receive voluntary information submissions to meet its data needs according to the procedures in VISP, the ITC may then request that EPA promulgate the appropriate TSCA sections 8( a) and 8( d) reporting rules to determine if there are unpublished data to meet those needs. The ITC requests that those companies responding to a TSCA section 8( d) HaSD reporting rule provide data by using the TSCA Electronic HaSD Reporting Form.

D. Coordinating Information Requests To avoid duplicate reporting, the ITC carefully coordinates its information solicitations and reporting requirements with other national and international testing programs, e. g., the National Toxicology Program, the Organization for Economic Cooperation and Development ( OECD) Screening Information Data Set ( SIDS) Program, and the USEPA's HPV Challenge Program. The ITC is currently focusing its efforts on persistent non HPV chemicals that have exposure potential, but few, if any, publicly available ecological or health effects data. The ITC is working with the USEPA's workgroups, such as the Persistent Bioaccumulative Toxics ( PBT), Endocrine Disruption, and perfluoroctylsulfonate chemicals workgroups to develop data that will complement the objectives of those programs.

E. Requests to Promulgate TSCA Section 8( a) PAIR and Section 8( d) HaSD Reporting Rules The ITC has not received any submissions on the chloroalkenes, chlorinated trihalomethyl pyridines, trihaloethylidene bisbenzenes, trifluralins and trichlorophenyldihydropyrazols in response to its solicitation for use and exposure information in the ITC's 45th Report. Therefore, the ITC is asking the EPA to promulgate a TSCA section 8( a) PAIR rule for the 3 chloroalkenes added to the Priority Testing List in the ITC's 47th Report published in the Federal Register of April 3, 2001 ( 66 FR 17768) ( FRL   6763   6) and 5 chlorinated trihalomethyl pyridines, 2 trihaloethylidene bisbenzenes, 3 chlorotrifluralin, and 4 trichlorophenyldihydropyrazols added to the Priority Testing List in this 48th ITC Report. The PAIR data will provide production and exposure information and aid in the selection of chemicals for potential TSCA section 8( d) HaSD reporting rules. The ITC is asking the USEPA not to promulgate TSCA section 8( d) HaSD reporting rules for the alkylphenols and alkylphenol ethoxylates that were added to the Priority Testing List in the ITC's 39th Report published in the Federal Register of February 25, 1997 ( 62 FR 8578) ( FRL   5580   9) and in the ITC's 41st Report because of a need to further review the data. The TSCA section 8( d) HaSD reporting rule for methylal that was added to the Priority Testing List in the ITC's 42nd Report is no longer needed since this chemical is being removed from the Priority Testing List in this Report ( see Unit IV. B. 2. of this Report). At this time, the ITC is requesting that EPA not promulgate TSCA section 8( d) HaSD reporting rules for the 5 chlorinated trihalomethyl pyridines, 2 trihaloethylidene bisbenzenes, 3 chlorotrifluralin, and 4 trichlorophenyldihydropyrazols added to the Priority Testing List in this ITC Report, to allow producers, importers, processors, and users an opportunity to voluntarily provide the requested information ( see Unit IV. of this Report). After review of the information provided in the TSCA section 8( a) PAIR rule published in the Federal Register of July 24, 2000 ( 65 FR 45535) ( FRL   6589   1), the ITC is requesting that the USEPA promulgate TSCA section 8( d) HaSD reporting rules for 3 amino 5 mercapto 1,2,4 triazole ( CAS No. 16691   43   3) and glycoluril ( CAS No. 496   46   8). These TSCA section 8( d) HaSD reporting rules will require the submission of pharmacokinetics, subchronic toxicity, immunotoxicity, genotoxicity, carcinogenicity, reproductive and developmental effects, and ecological effects studies. The chemical purity of 3 amino 5 mercapto 1,2,4 triazole and glycoluril in these studies should exceed 90%. III. ITC's Activities During this Reporting Period ( November 2000 to April 2001) In its 45th and 46th ITC Reports, the ITC discussed its strategies to screen and evaluate chemicals for persistence and bioconcentration potential. These strategies are referred to as Degradation Effects Bioconcentration Information Testing Strategies ( DEBITS). DEBITS provides a means to prioritize chemicals based on degradation, ecological or human health effects, and bioconcentration information. In its 45th ITC Report, the ITC added several chemicals to its web site to solicit measured bioconcentration data and use and exposure information. To avoid duplicate reporting requirements, the ITC is removing the USEPA's HPV Challenge Program chemicals ( http:// www. epa. gov/ opptintr/ chemrtk/ hpvchmlt. htm) and European Union's HPVCs ( http:// ecb. ei. jrc. it/ existingchemicals from its web site. In its 46th ITC Report, the ITC initiated efforts to implement DEBITS by focusing its efforts on structural classes of chemicals from a subset of 42 moderate production volume ( MPV) chemicals ( production/ importation volumes between 100,000 and 1,000,000 pounds) with estimated or measured bioconcentration factors ( BCFs) > 250 and about 70 structurally related non MPV chemicals ( also with BCFs > 250). In its 47th ITC Report, the ITC added more of these chemicals from its DEBITS prioritization to its Priority Testing List. Other chemical groups such as nitro musks, polycyclic musks, and tertiary butyl peroxyl chemicals were reviewed but not added to the Priority Testing List. During this reporting period, the ITC continued to focus its efforts on structural classes of MPV chemicals by adding 5 chlorinated trihalomethyl pyridines, 2 trihaloethylidene bisbenzenes, 4 trichlorophenyldihydropyrazols, and 3 chlorotrifluralin to its Priority Testing List and soliciting voluntary health and ecological effects information for these chemicals under the ITC's VISP. The ITC evaluated several chlorinated pyridines, and azo bis ( alpha nitriles) and decided not to add them to the Priority Testing List at this time.

IV. Revisions to the TSCA Section 4( e) Priority Testing List A. Chemicals Added to the Priority Testing List 1. Chlorinated trihalomethyl pyridines   i. Recommendation. Five non HPV chlorinated trihalomethyl pyridines are being added to the Priority Testing List to obtain information on VerDate 11< MAY> 2000 17: 07 Oct 04, 2001 Jkt 197001 PO 00000 Frm 00005 Fmt 4701 Sfmt 4703 E:\ FR\ FM\ 05OCN3. SGM pfrm01 PsN: 05OCN3 51280 Federal Register / Vol. 66, No. 194 / Friday October 5, 2001 / Notices uses, exposures, environmental releases, pharmacokinetics, subchronic toxicity, mutagenicity, reproductive and developmental effects, carcinogenicity, and ecological effects as well as the percent by weight of any of the 5 unreacted chlorinated trihalomethyl pyridines in formulated products. The 5 non HPV chlorinated trihalomethyl pyridines are 3,5 dichloro 2 ( trichloromethyl) pyridine ( CAS No. 1128   16   1), 2,3,4,5 tetrachloro 6 ( trichloromethyl) pyridine ( CAS No. 1134   04   9), 3,4,5 trichloro 2 ( trichloromethyl) pyridine ( CAS No. 1201   30   5), 2,6 dichloro 3 ( trichloromethyl) pyridine ( CAS No. 55366   30   8), and 2,3 dichloro 5 ( trichloromethyl) pyridine ( CAS No. 69045   84   7). See Table 2 below.

TABLE 2.   CHLORINATED TRIHALOMETHYL PYRIDINES IDENTIFIED BY DEBITS CAS No. Chlorinated trihalomethyl pyridine HPV BCF Fish LC50 001128   16   1 ..... 3,5 Dichloro 2( trichloromethyl) pyridine ............................................. No ..................... 238 .................... 3.5 001134   04   9 ..... 2,3,4,5 Tetrachloro 6( trichloromethyl) pyridine .................................. No ..................... 2343 .................. 0.1 001201   30   5 ..... 3,4,5 Trichloro 2( trichloromethyl) pyridine ......................................... No ..................... 747 .................... 2.7 001817   13   6 ..... 3,6 Dichloro 2( trichloromethyl) pyridine ............................................. Yes ................... 238 .................... 3.5 001929   82   4 ..... 2 Chloro 6( trichloromethyl) pyridine ................................................... Yes ................... 84 ...................... 9.3 055366   30   8 ..... 2,6 Dichloro 3( trichloromethyl) pyridine ............................................. No ..................... 238 .................... 3.1 069045   78   9 ..... 2 Chloro 5( trichloromethyl) pyridine ................................................... Yes ................... 76 ...................... 7.6 069045   83   6 ..... 2,3 Dichloro 5( trichloromethyl) pyridine ............................................. Yes ................... 238 .................... 3.2 069045   84   7 ..... 2,3 Dichloro 5( trifluoromethyl) pyridine .............................................. No ..................... 45 ...................... 12.2 ii. Rationale for recommendation. The 5 non HPV chlorinated trihalomethyl pyridines are predicted to persist in the environment. They present suspicions of toxicity based on fish LC50 values and mutagenicity based on data from structurally related compounds. Several of these non HPV chlorinated trihalomethyl pyridines are produced/ imported in substantial amounts (> 100,000 pounds) and have potential to bioconcentrate. iii. Supporting information. The ITC used DEBITS to identify 9 chlorinated trihalomethyl pyridines ( Table 2 of this unit). Four of these chlorinated trihalomethyl pyridines are in the USEPA's HPV Challenge Program, including the registered pesticide, nitrapyrin ( CAS No. 1929   82   4). The ITC is not soliciting information on the HPV chemicals but did review the available toxicity and ecological effects information on these compounds to better evaluate the data needs for the non HPV chlorinated trihalomethyl pyridines. The trichloro and tetrachloro trichloromethyl pyridines have estimated bioconcentration factors ( BCFs) > 250 while 2 of 3 dichloro trichloromethyl pyridines have estimated BCFs very close to this threshold ( i. e., BCFs of 238). All five chloro trihalomethyl pyridines have fish LC50 values about 10 milligram/ Liter ( mg/ L) or less, indicating that they have potential to cause acute effects in fish. The fish LC50 values are based on measured or estimated values for fathead minnows. The predicted mode of toxic action ( based on fathead minnow models described by Russom et al., 1997) for 4 of 5 chlorinated trihalomethyl pyridines is narcosis. The tetrachloro trichloromethyl pyridine ( CAS No. 1134   04   9) with the lowest fish LC50 value and highest BCF is predicted to have a mode of toxic action based on uncoupling of oxidative phosphorylation. There were no health effects data available for the 5 chlorinated trihalomethyl pyridines being added to the Priority Testing List. However, there were some available health effects data for the two HPV monochloro substituted trichloromethyl pyridines ( CAS Nos. 1929   82   4 and 69045   78   9) and a HPV dichloro trichloromethyl pyridine ( CAS No. 69045   83   6). Subchronic and mutagenicity data were available for 2 chloro 5 ( trichloromethyl) pyridine ( CAS No. 69045   78   9). Mice exposed to 10 parts per million ( ppm) of 2 chloro 5 ( trichloromethyl) pyridine died after 4 days. Histologic examination of these animals revealed hepatic necrosis and vacuolization. No treatment related effects were observed at 0, 0.1, or 1.0 ppm exposure levels ( Dow Chemical Co., 1991). In a dermal irritation study with rats, a dose of 500 mg/( kilogram) kg/ day [ for 21 days ( 18 hours per day)] 2 chloro 5( trichloromethyl) pyridine produced a well defined systemic toxic response characterized by hepatic necrosis and a disturbance of lipid metabolism. As a result of topical irritation among the rats in the 100 mg/ kg/ day group, the no observed adverseeffect level ( NOAEL) was 20 mg/ kg/ day ( Hazelton Laboratories, 1992). In a number of mutagenicity test systems, 2 chloro 5 ( trichloromethyl) pyridine was found to be mutagenic ( Confidential, 1984a; Confidential 1984b; and Confidential 1984c). Subchronic data were available for 2,3 dichloro 5( trichloromethyl) pyridine ( CAS No. 69045   83   6). Degenerative lesions occurred in the nasal turbinates of rats and mice exposed to 0.5 ppm 2,3 dichloro 5( trichloromethyl) pyridine for 2 weeks ( Confidential, 1986). Numerous health effects data were available for 2 chloro 6 ( trichloromethyl) pyridine or nitrapyrin ( CAS No. 1929   82   4). Nitrapyrin was well absorbed by dogs when administered using the oral route ( Redemann et al., 1966). Oral administration of nitrapyrin at doses of 30 to 50 mg/ kg/ day and greater in pregnant rats and rabbits caused maternal and fetal toxicity ( Berdasco et al., 1988). Nitrapyrin is also reported to be mutagenic in the reverse mutation assay in Salmonella typhimurium under most conditions ( Zeiger et al., 1988). Hepatotoxicity occurred in rats dermally exposed to 500 mg/ kg/ day of 2 chloro 5 ( trichloromethyl) pyridine for 3 weeks ( Hazelton Laboratory, 1992). iv. Information needs. For the 5 non HPV chlorinated trihalomethyl pyridines in Table 2 of this unit, the ITC needs: a. Use information, including percentages of production or importation that are associated with different uses; b. Identification of the chlorinated trihalomethyl pyridines that are intermediates and the final products in which they are contained; c. Weight percent of chlorinated trihalomethyl pyridines in commercial formulated products; and d. Pharmacokinetics, subchronic toxicity, mutagenicity, reproductive and developmental effects, carcinogenicity, and ecological effects data. 2. Trihaloethylidene bisbenzenes   i. Recommendation. Two non HPV trihaloethylidene bisbenzenes are being added to the Priority Testing List to obtain information on uses, exposures,

VerDate 11< MAY> 2000 17: 07 Oct 04, 2001 Jkt 197001 PO 00000 Frm 00006 Fmt 4701 Sfmt 4703 E:\ FR\ FM\ 05OCN3. SGM pfrm01 PsN: 05OCN3 51281 Federal Register / Vol. 66, No. 194 / Friday October 5, 2001 / Notices environmental releases, pharmacokinetics, subchronic toxicity, mutagenicity, reproductive and developmental effects, carcinogenicity, and ecological effects. The 2 non HPV trihaloethylidene bisbenzenes are hexafluoroisopropylidenebis ( 4 hydroxybenzene) and benzene, 1,1' ( 2,2,2 trichloroethylidene) bis. See Table 3 below.

TABLE 3.   TRIHALOETHYLIDENE BISBENZENES IDENTIFIED BY DEBITS CAS No. Trihaloethylidene bisbenzene BCF 000072   43   5 ....................... Methoxychlor ( 2,2 bis( p methoxyphenyl) 1,1,1 trichloroethane) ................................................. 8128 001478   61   1 ....................... Hexafluoroisopropylidenebis ( 4 hydroxybenzene) ...................................................................... 556 002971   22   4 ....................... Benzene, 1,1'( 2,2,2 trichloroethylidene) bis ............................................................................... 1122 ii. Rationale for recommendation. The 2 non HPV trihaloethylidene bisbenzenes have been produced/ imported in substantial amounts (> 100,000 pounds) and are predicted to persist and bioconcentrate in the environment. Benzene, 1,1'( 2,2,2 trichloroethylidene) bis ( CAS No. 2971   22   4) is structurally related to the insecticide methoxychlor, which has estrogenic activity and has been shown to alter hormone levels, decrease fertility, damage reproductive organs, and retard reproductive development in experimental animals. iii. Supporting information. The ITC used DEBITS to identify 3 trihaloethylidene bisbenzenes ( Table 3 of this unit). All are MPV chemicals that have estimated BCFs well over 250 ( Table 3 of this unit). One of the trihaloethylidene bisbenzenes is the well studied insecticide, methoxychlor ( CAS No. 72   43   5), that is not being added to the Priority Testing List but which is currently regulated by a number of international, Federal, and State agencies because of its potential to cause adverse effects in humans. Methoxychlor is included in the USEPA's Toxics Release Inventory ( TRI) PBT rule published in the Federal Register of November 4, 1999 ( 64 FR 60194) ( FRL   6097   7) and is a candidate for regulatory action under the USEPA's PBT Initiative. The Agency for Toxic Substances and Disease Registry ( ATSDR) has recently completed a Toxicological Profile for methoxychlor which summarizes available health effects data ( ATSDR, 2000). Among the effects that are relevant to predicting the effects of hexafluoroisopropylidenebis ( 4 hydroxybenzene) and benzene, 1,1' ( 2,2,2 trichloroethylidene) bis are those related to alteration of hormone levels, including increasing levels of prolactin, follicle stimulating hormone ( FSH), and thyroid stimulating hormone ( TSH) in the pituitary of male rats ( Goldman et al. 1986; Gray et al. 1989). In addition to the ATSDR Toxicological Profile that summarizes the health effects of methoxychlor, a Pesticide Information Profile that summarizes the ecological effects of methoxychlor is available on the web ( http:// ace. orst. edu/ cgi bin/ mfs/ 01/ pips/ methoxyc. htm). Methoxychlor is slightly toxic to bird species, with reported acute oral LD50 values of greater than 2,000 mg/ kg in the mallard duck, sharp tailed grouse, and California quail ( Hudson et al., 1984). In contrast, methoxychlor is highly toxic to fish; 96 hour LD50 values for the technical grade 90% pure chemical are less than 20 ug/ L for cutthroat trout, atlantic salmon, brook trout, lake trout, northern pike, and large mouth bass ( Johnson and Finley, 1980). There are some health effects data for hexafluoroisopropylidenebis( 4 hydroxybenzene) and benzene, 1,1' ( 2,2,2 trichloroethylidene) bis. In an in vitro study evaluating endocrine disruption, hexafluoroisopropylidenebis( 4 hydroxybenzene) was found to be estrogenic in MCF 7 cells, promoting cell proliferation and increasing protein synthesis ( Olea Serrano, 1998; Perez et al., 1998). Benzene, 1,1'( 2,2,2 trichloroethylidene) bis had estrogenic activity at doses as low as 1 mg/ rat ( Bitman and Cecil, 1970). No other health or ecological effect studies were available for these two trihaloethylidene bisbenzenes. iv. Information needs. The ITC needs information on uses, exposures, environmental releases, pharmacokinetics, subchronic toxicity, mutagenicity, reproductive and developmental effects, carcinogenicity, and ecological effects. 3. 3 Chlorotrifluralin   i. Recommendation. 3 Chlorotrifluralin ( CAS No. 29091   20   1) is being added to the Priority Testing List to obtain information on uses, exposures, environmental releases, pharmacokinetics, subchronic toxicity, mutagenicity, reproductive and developmental effects, carcinogenicity, and ecological effects. ii. Rationale for Recommendation. 3 Chlorotrifluralin is a non HPV chemical that has been produced/ imported in substantial amounts (> 100,000 pounds) and is predicted to persist and bioconcentrate in the environment. It is a chlorinated analog of the herbicide, trifluralin ( CAS No. 1582   09   8). Trifluralin causes adverse effects in experimental animals and is considered to be a possible human carcinogen by the USEPA. 3 Chlorotrifluralin has limited toxicity data even though its potential to persist and bioconcentrate in the environment may be greater than trifluralin. iii. Supporting Information. 3 Chlorotrifluralin meets the DEBITS criteria and has an estimated BCF of 7,700. There are no available subchronic toxicity studies or ecological effects data on this compound. The LD50 in mice was determined to be 2,744 mg/ kg ( Industrial Bio Test Laboratories, 1992). The structurally related trifluralin caused adverse liver and kidney effects in rodents and dogs as a result of subchronic and chronic feeding studies. Trifluralin induced urinary tract tumors ( renal pelvis carcinomas and urinary bladder papillomas) and thyroid tumors ( adenomas/ carcinomas combined) in one animal species ( Fisher 344 rats) in one study ( USEPA, 2000). Trifluralin is included in the USEPA's TRI PBT rule and is a candidate for regulatory action under the USEPA's PBT Program. iv. Information Needs. The ITC needs information on uses, exposures, environmental releases, pharmacokinetics, subchronic toxicity, mutagenicity, reproductive and developmental effects, carcinogenicity, and ecological effects.

4. Trichlorophenyldihydropyrazols   i. Recommendation. Four trichlorophenyldihydropyrazols are being added to the Priority Testing List to obtain information on uses, exposures, environmental releases, pharmacokinetics, subchronic toxicity, mutagenicity, reproductive and developmental effects, carcinogenicity, and ecological effects ( Table 4 of this unit).

VerDate 11< MAY> 2000 17: 07 Oct 04, 2001 Jkt 197001 PO 00000 Frm 00007 Fmt 4701 Sfmt 4703 E:\ FR\ FM\ 05OCN3. SGM pfrm01 PsN: 05OCN3 51282 Federal Register / Vol. 66, No. 194 / Friday October 5, 2001 / Notices TABLE 4.   TRICHLOROPHENYLDIHYDROPYRAZOLS IDENTIFIED BY DEBITS CAS No. Trichlorophenyldihydropyrazol BCF 030707   68   7 ...................... 3H Pyrazol 3 one, 5[( 2 chloro 5 nitrophenyl) amino] 2,4 dihydro 2( 2,4,6 trichlorophenyl) ....... 2230 040567   18   8 ...................... Benzamide, 3 amino N[ 4,5 dihydro 5 oxo 1( 2,4,6 trichlorophenyl) 1H pyrazol 3 yl] ............... 92 053411   33   9 ...................... 3H Pyrazol 3 one, 5[( 5 amino 2 chlorophenyl) amino] 2,4 dihydro 2( 2,4,6 trichlorophenyl) ..... 44 063134   25   8 ...................... Benzamide, N[ 4,5 dihydro 5 oxo 1( 2,4,6 trichlorophenyl) 1H pyrazol 3 yl] 3 nitro .................. 338 ii. Rationale for recommendation. The 4 trichlorophenyldihydropyrazols are predicted to persist in the environment. Two of these trichlorophenyldihydropyrazols ( CAS Nos. 30707   68   7 and 63134   25   8) are produced/ imported in substantial amounts (> 100,000 pounds) and have potential to bioconcentrate. iii. Supporting information. Two of the four trichlorophenyldihydropyrazols have estimated BCFs > 250 ( Table 4 of this unit). The other two chemicals are structurally related but are predicted to have lower bioconcentration potential. There are no available health or ecological effects studies for any of the trichlorophenyldihydropyrazols. iv. Information needs. The ITC needs information on uses, exposures, environmental releases, pharmacokinetics, subchronic toxicity, mutagenicity, reproductive and developmental effects, carcinogenicity, and ecological effects.

B. Chemicals Removed From the Priority Testing List 1. Alkylphenols and alkylphenol ethoxylates. In this Report, the ITC is removing 22 alkylphenols and alkylphenol ethoxylates that were added to the Priority Testing List in the ITC's 41st Report published in the Federal Register of April 9, 1998 ( 63 FR 17658) ( FRL   5773   5). The 22 alkylphenols and alkylphenol ethoxylates are being removed from the Priority Testing List because: i. No domestic production or importation volumes were reported to the USEPA in response to 1986, 1990, 1994, and 1998 IURs ( indicating that volumes were less than 10,000 pounds per site in 1985, 1989, 1993, and 1997) and ii. No domestic production or importation volumes were reported to the USEPA in response to the PAIR rule published in the Federal Register of July 5, 2000 ( 65 FR 41371) ( FRL   6589   1) ( indicating that volumes were less than 1,000 pounds per site in 1999). The 22 alkylphenols and alkylphenol ethoxylates being removed from the Priority Testing List are listed in Table 5 of this unit.

TABLE 5.   ALKYLPHENOLS AND ALKYLPHENOL ETHOXYLATES BEING REMOVED FROM THE PRIORITY TESTING LIST CAS No. Chemical 000136   81   2 ....................... Phenol, 2 pentyl 002446   69   7 ....................... Phenol, 4 hexyl 002589   78   8 ....................... Phenol, 4 hexadecyl 003279   27   4 ....................... Phenol, 2( 1,1 dimethylpropyl) 009004   87   9 ....................... Poly( oxy 1,2 ethanediyl),  ( iso octylphenyl)   hydroxy 009063   89   2 ....................... Poly( oxy 1,2 ethanediyl),   ( octylphenyl)   hydroxy 025401   86   9 ....................... Phenol, 2 hexadecyl 025735   67   5 ....................... Phenol, 4 sec pentyl 026401   47   8 ....................... Poly( oxy 1,2 ethanediyl),  ( 4 dodecylphenyl)   hydroxy 026401   74   1 ....................... Phenol, 2 sec pentyl 027157   66   0 ....................... Phenol, decyl 059911   95   4 ....................... Poly( oxy 1,2 ethanediyl),  ( 4 hexadecylphenyl)   hydroxy 061723   87   3 ....................... Poly( oxy 1,2 ethanediyl),  ( tridecylphenyl)   hydroxy 068081   86   7 ....................... Phenol, nonyl derivs. 068784   24   7 ....................... Phenol, C18   30 alkyl derivs. 068891   67   8 ....................... Phenol, polypropene derivs. 068954   70   1 ....................... Phenol, polyethylene derivs. 070682   80   3 ....................... Phenol, tetradecyl 071902   25   5 ....................... Phenol, octenylated 084605   25   4 ....................... Phenol, 1 methylhexyl derivs. 091672   41   2 ....................... Phenol, 2 nonyl, branched 112375   89   0 ....................... Phenol, poly( 2,4,4 trimethylpentene) derivs.

2. Methylal. Methylal ( CAS No. 109   87   5) was added to the Priority Testing List in the ITC's 42nd Report and recommended for information reporting to meet U. S. Government data needs. In response to that recommendation, the USEPA added methylal to the PAIR rule published in the Federal Register of July 24, 2000 ( 65 FR 45535) ( FRL   6589   1). The ITC reviewed the data submitted in response to the PAIR rule. These data indicated that in 1999, 10,000 to 500,000 pounds of methylal were produced under controlled release and enclosed conditions, involving < 10 and 10   100 workers, respectively. Methylal's manufacture was associated with industrial products. The ITC is removing methylal from the Priority Testing List because it is being sponsored for testing under the USEPA's HPV Challenge Program. Test plans and data developed under the challenge program may be reviewed to determine if they meet the needs of the U. S. Government. 3. Ethyl silicate. Ethyl silicate ( CAS No. 78   10   4) was also added to the Priority Testing List in the ITC's 42nd Report and recommended for information reporting to meet U. S. Government data needs. In response to that recommendation, the USEPA added ethyl silicate to the PAIR rule published in the Federal Register of July 24, 2000 ( 65 FR 45535) ( FRL   6589   1) and the VerDate 11< MAY> 2000 17: 07 Oct 04, 2001 Jkt 197001 PO 00000 Frm 00008 Fmt 4701 Sfmt 4703 E:\ FR\ FM\ 05OCN3. SGM pfrm01 PsN: 05OCN3 51283 Federal Register / Vol. 66, No. 194 / Friday October 5, 2001 / Notices ITC received voluntary use and toxicity data from the Silicones Environmental Health and Safety Council ( SEHSC). Data submitted in response to the PAIR rule indicated that in 1999, 10,000 to 500,000 pounds of ethyl silicate were produced under enclosed conditions, that 10   100 workers were involved in the production of ethyl silicate under those conditions and that ethyl silicate's manufacture and customer uses were associated with industrial products. SEHSC's voluntary submissions confirmed that ethyl silicate is used as an industrial, not consumer chemical. Toxicity data voluntarily submitted by SEHSC indicated that: i. Ethyl silicate's rat oral LD50 was 5,920 mg/ kg ( Smyth et al., 1949); ii. No deaths occurred when rats, mice, guinea pigs, and rabbits were exposed to 50 and 88 ppm ethyl silicate for 90 days and the only significant observation was a depression in kidney weights in the mice exposed to 88 ppm ethyl silicate ( Pozzani and Carpenter, 1951); iii. The mutagenic potential of ethyl silicate was evaluated using the Chinese Hamster Ovary ( CHO), Sister Chromatid Exchange ( SCE), and Unscheduled DNA Synthesis ( UDS) assays; the only significant mutagenic effect was seen in the UDS assay ( Slesinski et al., 1981). The ITC is removing ethyl silicate from the Priority Testing List because it is being sponsored for testing under the USEPA's HPV Challenge Program. Test plans and data developed under the challenge program may be reviewed to determine if they meet the needs of the U. S. Government.

V. References 1. ATSDR. 2000. Toxicological Profile for Methoxychlor. Update   DRAFT FOR PUBLIC COMMENT edition. Agency for Toxic Substances and Disease Registry, Atlanta, GA. 2. Berdasco, N., Lomax, L., Zimmer, M., and Hanley, T. 1988. Teratologic evaluation of orally administered nitrapyrin in rats and rabbits. Fundamentals of Applied Toxicology. 11( 3): 464   471. 3. Bitman, J. and Cecil, H. C. 1970. Estrogenic activity of DDT analogs and polychlorinated biphenyls. Journal of Agricultural Food Chemistry. 18: 1108   12. 4. Confidential. 1984a. Summary of results from several genotoxicity studies with 2 chloro 5 trichloromethyl pyridine; EPA Document No. 88   8500683; Fiche No. OTS0509740. 5. Confidential. 1984b. The mutagenicity evaluation of 2 chloro 5 trichloromethyl pyridine in the Ames test with cover letter dated 121284; EPA Document No. 88   85704; Fiche No. OTS0509740. 6. Confidential. 1984c. Substance H. 109345: a cytogenetic study in human lymphocytes ( in vitro) and an evaluation in the Salmonella mutagenicity assay with cover letter dated 122684; EPA Document No. 88   8500713; Fiche No. OTS0509740. 7. Confidential. 1986. Two week inhalation toxicity study in Fischer 344 rats and B6C3F1 mice ( company sanitized) with cover letter dated 101686; EPA Document No. FYI OTS 1086 0473; Fiche No. OTS0000473_ 1. 8. Dow Chemical Co. 1991. Initial submission: 2 chloro 5 trichloromethyl pyridine: two week inhalation toxicity study in b6c3f1 mice ( final report) with attachment and cover letter ( sanitized). EPA Document No. 88   920000186S; Fiche No. OTS0534636. 9. Goldman, J. M., Cooper, R. L., and Rehnberg, G. L., et al. 1986. Effects of low subchronic doses of methoxychlor on the rat hypothalamic pituitary reproductive axis. Toxicology and Applied Pharmacology. 86: 474   483. 10. Gray, L. E., Otsby, J. S., and Ferrell, J. M., et al. 1989. A dose response analysis of methoxychlor induced alterations of reproductive development and function in the rat. Fundamentals of Applied Toxicology. 12: 92 108. 11. Hazelton Laboratories. 1992. Initial submission: three week dermal toxicity study in the rat with cover letter. EPA Document No. 88   920007444; Fiche No. OTS0545698. 12. Hudson, R. H., Tucker, R. K., and Haegele, M. A. 1984. Handbook of Acute Toxicity of Pesticides to Wildlife, Resource Publication 153. U. S. Department of Interior, Fish and Wildlife Service, Washington, DC. pp. 6   54. 13. Johnson, W. W. and Finley, M. T. 1980. Handbook of Acute Toxicity of Chemicals to Fish and Aquatic Invertebrates, Resource Publication 137. U. S. Department of Interior, Fish and Wildlife Service, Washington, DC. pp. 6   56. 14. Olea Serrano, M. F., Pulgar, R., Perez, P., Metzler, M., Pedraza, V., and Olea, N. 1998. Bisphenols: in vitro effects. Hormonal Active Agents Food, Symposium. 1998: 161   180. 15. Perez, P., Pulgar, R., Olea Serrano, F., Villalobos, M., Rivas, A., Metzler, M., Pedraza, V., and Olea, N. 1998. The estrogenicity of bisphenol A related diphenylalkanes with various substituents at the central carbon and the hydroxy groups. Environmental Health Perspectives. 106( 3): 167   174. 16. Pozzani, U. C. and Carpenter, C. P. 1951. Response of Rodents to Repeated Inhalation of Vapors of Tetraethyl Orthosilicate. Archives of Industrial Hygiene and Occupational Medicine. 4: 465   468. 17. Redemann, C., Williams, E., Clark, H., and Kaku, J. 1966. The excretion of n 6 chloropicolinoyl glycine by the dog fed 2 chloro 6 ( trichloromethyl) pyridine. Journal of Agricultural Food Chemistry. 14( 5): 530   532. 18. Russom, C. L., Bradbury S. P., Braiders S. J., Hammermeister D. E., and Drummond R. A. 1997. Predicting modes of toxic action from chemical structure: Acute toxicity in the fathead minnow ( Pimephales Promelas). Environmental Toxicology and Chemistry. 16( 5): 948   967. 19. Slesinski, R. S., Guzzie, P. J., Hengler, W. C., and Wagner, K. J. 1981. TetraethylOrthosilicate In Vitro Mutagenesis Studies 3 Test Battery. Export, PA: Bushy Run Research Center, Project Report 44   68, June 1981. 20. Smyth, H. F., Jr., Carpenter, C. P., and Weil, C. S. 1949. Range Finding Toxicity Data, List III. Journal of Industrial Hygiene and Toxicology. 31: 60   62. 21. USEPA. 2000. Integrated Risk Information System ( IRIS): Trifluralin, oral RfD last revised 7/ 89, cancer assessment updated 10/ 93. Online chemical toxicity database, available at www. epa. gov/ iris, accessed 12/ 00. 22. Zeiger, E., Anderson, B., Haworth, S., Lawlor, T., and Mortelmans, K. 1988. Salmonella mutagenicity tests: IV. Results from the testing of 300 chemical. Environmental Molecular Mutagenesis. 11( s12): 1   158.

VI. TSCA Interagency Testing Committee Statutory Organizations and Their Representatives Council on Environmental Quality Vacant Department of Commerce National Institute of Standards and Technology Robert Huie, Member Barbara C. Levin, Alternate National Oceanographic and Atmospheric Administration Vacant Environmental Protection Agency Paul Campanella, Member David R. Williams, Alternate National Cancer Institute Alan Poland, Member National Institute of Environmental Health Sciences Scott Masten, Member, Chair William Eastin, Alternate VerDate 11< MAY> 2000 17: 07 Oct 04, 2001 Jkt 197001 PO 00000 Frm 00009 Fmt 4701 Sfmt 4703 E:\ FR\ FM\ 05OCN3. SGM pfrm01 PsN: 05OCN3 51284 Federal Register / Vol. 66, No. 194 / Friday October 5, 2001 / Notices National Institute for Occupational Safety and Health Albert E. Munson, Member Mark Toraason, Alternate National Science Foundation A. Frederick Thompson, Member Marge Cavanaugh, Alternate Occupational Safety and Health Administration Val H. Schaeffer, Member, Vice Chair Lyn Penniman, Alternate Liaison Organizations and Their Representatives Agency for Toxic Substances and Disease Registry William Cibulas, Member Stephanie Miles Richardson, Alternate Consumer Product Safety Commission Jacqueline Ferrante, Member Treye Thomas, Alternate Department of Agriculture Clifford P. Rice, Member Laurau L. McConnell, Alternate Department of Defense Barbara Larcom, Member Kenneth Still, Alternate Jose ´ Centeno, Alternate Department of the Interior Barnett A. Rattner, Member Food and Drug Administration David Hatten, Alternate National Library of Medicine Vera W. Hudson, Member National Toxicology Program NIEHS, FDA, and NIOSH Members Counsel Scott Sherlock, OPPT, EPA Technical Support Contractor Syracuse Research Corporation ITC Staff John D. Walker, Executive Director Norma S. L. Williams, Executive Assistant TSCA Interagency Testing Committee, Office of Pollution Prevention and Toxics ( 7401), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone: ( 202) 564   7527; fax: ( 202) 564   7528; e mail address: williams. norma@ epa. gov; url: http:// www. epa. gov/ opptintr/ itc.

[ FR Doc. 01   25046 Filed 10   4   01; 8: 45 am]

BILLING CODE 6560   50   S VerDate 11< MAY> 2000 17: 07 Oct 04, 2001 Jkt 197001 PO 00000 Frm 00010 Fmt 4701 Sfmt 4703 E:\ FR\ FM\ 05OCN3. SGM pfrm01 PsN: 05OCN3


[Federal Register: November 4, 2008 (Volume 73, Number 214)]
[Rules and Regulations]
[Page 65509-65511]
[DOCID:fr04no08-7]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0841; Directorate Identifier 2008-NE-23-AD;
Amendment 39-15720; AD 2008-22-23]
RIN 2120-AA64

Airworthiness Directives; Thielert Aircraft Engines GmbH (TAE)
Model TAE 125-02-99 Reciprocating Engines

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for the
product listed above. This AD results from mandatory continuing
airworthiness information (MCAI) issued by an aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    In-flight engine shutdown incidents have been reported on
aircraft equipped with TAE 125-02-99 engines. Preliminary
investigations showed that it was mainly the result of cracked disc
springs in the clutch.

This AD requires actions that are intended to address the unsafe
condition described in the MCAI, which could result in engine in-flight
shutdown and the subsequent loss of control of the airplane.

DATES: This AD becomes November 19, 2008. The Director of the Federal
Register approved the incorporation by reference of TAE Service
Bulletin TM TAE 125-1006 P1, Revision 1, dated May 30, 2008, listed in
the AD as of November 19, 2008.
    We must receive comments on this AD by December 4, 2008.

ADDRESSES:  You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: U.S. Department of Transportation, 1200 New Jersey
Avenue, SE., West Building Ground Floor, Room W12-140, Washington, DC
20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is the same as
the Mail address provided in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Jason Yang, Aerospace Engineer, Engine
Certification Office, FAA, Engine and Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2008-0106-E, dated May 30, 2008 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    In-flight engine shutdown incidents have been reported on
aircraft equipped with TAE 125-02-99 engines. Preliminary
investigations showed that it was mainly the result of cracked disc
springs in the clutch. This condition, if not corrected, could
result in further cases of engine in-flight shutdown and the
consequent loss of control of the aircraft.
    To address this unsafe condition, AD 2008-0100-E was published
to mandate repetitive inspections until a new clutch P/N 05-7211-
K006001 is installed.
    Since that publication, data collected from the performed
inspections revealed that only the clutch assembly P/N 05-7211-
K000304 was subject to failure.
    For the reasons stated above, this EASA AD supersedes AD 2008-
0100-E and requires the removal of the affected clutch

assemblies P/N 05-7211-K000304 on all TAE 125-02-99 engines and
their replacement by new clutches of an improved design.

    You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Thielert Aircraft Engines GmbH has issued Service Bulletin TM TAE
125-1006 P1, Revision 1, dated May 30, 2008. The actions described in
this service information are intended to correct the unsafe condition
identified in the MCAI.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of
Germany, and is approved for operation in the United States. Pursuant
to our bilateral agreement with Germany, they have notified us of the
unsafe condition described in the MCAI and service information
referenced above. We are issuing this AD because we evaluated all the
information provided by Germany and determined the unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because of
the short time to comply with this rule. Therefore, we determined that
notice and opportunity for public comment before issuing this AD are
impracticable and that good cause exists for making this amendment
effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2008-0841; Directorate
Identifier 2008-NE-23-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD because of
those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the 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.
    For the reasons discussed above, I certify this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-22-23 Thielert Aircraft Engines GmbH: Amendment 39-15720.;
Docket No. FAA-2008-0841; Directorate Identifier 2008-NE-23-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective November
19, 2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Thielert Aircraft Engines GmbH (TAE)
model TAE 125-02-99 reciprocating engines with clutch, part number
(P/N) 05-7211-K000304, installed. These engines are installed on,
but not limited to, Cessna 172 and (Reims-built) F172 series (STC
No. SA01303WI); and Diamond DA42 airplanes.

Reason

    ``(d) In-flight engine shutdown incidents have been reported on
aircraft equipped with TAE 125-02-99 engines. Preliminary
investigations showed that it was mainly the result of cracked disc
springs in the clutch. This condition, if not corrected, could
result in further cases of engine in-flight shutdown and the
consequent loss of control of the aircraft.''

    We are issuing this AD to prevent engine in-flight shutdown and
the subsequent loss of control of the airplane.

Actions and Compliance

    (e) Unless already done, do the following actions.
    (1) For engines that have accumulated, on the effective date of
this AD, less than 50 flight hours (FH) since installing clutch, P/N
05-7211-K000304: Upon the accumulation of 50 FH since installing
clutch, P/N 05-7211-K000304, replace the clutch as specified in TAE
SB TM TAE 125-1006 P1, Revision 1, dated May 30, 2008.
    (2) For engines that have accumulated, on the effective date of
this AD, 50 or more FH since installing clutch, P/N 05-7211-K000304:
Before further flight, replace the clutch as specified in TAE SB TM
TAE 125-1006 P1, Revision 1, dated May 30, 2008.

FAA AD Differences

    (f) We have further clarified the corrective action by
specifying the P/N of each affected clutch, and timing the
compliance period from when the clutch was installed instead of when
it was last inspected.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Engine Certification

Office, FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19.
    (2) Special Flight Permits: We are limiting special flight
permits to one ferry flight to a maintenance station to replace the
engine clutch. The maximum flight duration must not exceed 2 hours
and is limited to VFR conditions.

Related Information

    (h) Refer to MCAI EASA Airworthiness Directive 2008-0106-E,
dated May 30, 2008, for related information.
    (i) Contact Jason Yang, Aerospace Engineer, Engine Certification
Office, FAA, Engine and Propeller Directorate, 12 New England
Executive Park, Burlington, MA 01803; e-mail<EMAIL_ADDRESS>
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>, for more information
about this AD.

Material Incorporated by Reference

    (j) You must use Thielert Aircraft Engines GmbH Service Bulletin
TM TAE 125-1006 P1, Revision 1, dated May 30, 2008, to do the
actions required by this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Thielert Aircraft Engines GmbH, Platanenstrasse 14 D-09350,
Lichtenstein, Germany, telephone: +49-37204-696-0; fax: +49-37204-
696-55; e-mail<EMAIL_ADDRESS>    (3) You may review copies at the FAA, New England Region, 12 New
England Executive Park, Burlington, MA; or at the National Archives
and Records Administration (NARA). For information on the
availability of this material at NARA, call<PHONE_NUMBER>, or go
to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Burlington, Massachusetts, on October 23, 2008.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
 [FR Doc. E8-25892 Filed 11-3-08; 8:45 am]

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