[Federal Register: December 19, 2008 (Volume 73, Number 245)]
[Notices]
[Page 77724-77725]
[DOCID:fr19de08-109]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0118]

Guidance for Industry on Diabetes Mellitus--Evaluating
Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2
Diabetes; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Diabetes Mellitus--
Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat
Type 2 Diabetes.'' This guidance makes recommendations about how to
demonstrate that a new antidiabetic therapy to treat type 2 diabetes is
not associated with an unacceptable increase in cardiovascular risk. We
are issuing this guidance for immediate implementation to ensure that
relevant issues related to minimizing cardiovascular risk are
considered by all sponsors who have ongoing drug development programs
for type 2 diabetes.

DATES: Submit written or electronic comments on agency guidances at any
time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit

electronic comments to http://www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.

FOR FURTHER INFORMATION CONTACT: Mary Parks, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, rm. 3362, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Diabetes Mellitus--Evaluating Cardiovascular Risk in New
Antidiabetic Therapies to Treat Type 2 Diabetes.'' Diabetes mellitus is
associated with an increased risk of cardiovascular disease. Reducing
long-term cardiovascular complications in patients with diabetes should
be an important goal of disease management. There are compelling data
in patients with type 2 diabetes supporting a reduced risk of
microvascular complications with improved long-term glycemic control.
This guidance makes recommendations about how to demonstrate that a new
antidiabetic therapy to treat type 2 diabetes is not associated with an
unacceptable increase in cardiovascular risk.
    On March 3, 2008, FDA issued the draft guidance for industry
entitled ``Diabetes Mellitus: Developing Drugs and Therapeutic
Biologics for Treatment and Prevention'' (73 FR 11420). On July 1 and
2, 2008, the Endocrinologic and Metabolic Drugs Advisory Committee met
to discuss the role of cardiovascular assessment in the premarketing
and postmarketing settings for drugs and therapeutic biologics
developed for the treatment of type 2 diabetes mellitus. After
considering the discussion at this meeting as well as other available
data and information, we have determined that concerns about
cardiovascular risk should be more thoroughly addressed during drug
development. We are issuing this guidance to ensure that our
recommendations reach all sponsors who may submit applications for
approval of drugs to treat type 2 diabetes mellitus.
    We are issuing this level 1 guidance for immediate implementation,
consistent with FDA's good guidance practices regulation (21 CFR
10.115). FDA is not seeking comment before implementing this guidance
because of the need to immediately notify sponsors with ongoing
development programs of the need to address cardiovascular risk in
ongoing drug development programs. If FDA receives comments on this
guidance, it will consider the comments and incorporate final
recommendations into the final version of the March 2008 draft
guidance.
    This guidance represents the agency's current thinking on
evaluating cardiovascular risk in new antidiabetic therapies to treat
type 2 diabetes. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 312 have been approved under
0910-0014, and the collections of information in 21 CFR part 314 have
been approved under 0910-0001.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/cder/guidance/index.htm or http://
www.regulations.gov.

    Dated: December 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30086 Filed 12-17-08; 11:15 am]

BILLING CODE 4160-01-S


[Federal Register Volume 85, Number 20 (Thursday, January 30, 2020)]
[Proposed Rules]
[Pages 5349-5350]
[FR Doc No: 2020-01589]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-1039; Airspace Docket No. 19-ACE-15]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Coffeyville, KS

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

-----------------------------------------------------------------------

SUMMARY: This action proposes to amend the Class E airspace extending
upward from 700 feet above the surface at Coffeyville Municipal
Airport, Coffeyville, KS. The FAA is proposing this action as the
result of an airspace review caused by the decommissioning of the
Coffeyville non-directional beacon (NDB), which provided navigation
information for the instrument procedures at this airport. The name and
geographic coordinates of the airport would also be updated to coincide
with the FAA's aeronautical database. Airspace redesign is necessary
for the safety and management of instrument flight rules (IFR)
operations at this airport.

DATES: Comments must be received on or before March 16, 2020.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2019-1039/Airspace Docket No. 19-ACE-15 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except federal holidays.
    FAA Order 7400.11D, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend the Class E airspace extending upward from 700 feet
above the surface at Coffeyville Municipal Airport, Coffeyville, KS, to
support IFR operations at this airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking

by submitting such written data, views, or arguments, as they may
desire. Comments that provide the factual basis supporting the views
and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2019-1039/
Airspace Docket No. 19-ACE-15.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11D, Airspace
Designations and Reporting Points, dated August 8, 2019, and effective
September 15, 2019. FAA Order 7400.11D is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11D lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by amending the Class E airspace extending
upward from 700 feet above the surface to within a 6.6-mile radius
(decreased from a 7.6-mile radius) of the Coffeyville Municipal
Airport, Coffeyville, KS; and updating the name (previously
Coffeeyville Municipal Airport) and geographic coordinates of the
airport to coincide with the FAA's aeronautical database.
    This action is necessary due to an airspace review caused by the
decommissioning of the Coffeyville NDB, which provided navigation
information for the instrument procedures at this airport.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11D, dated August 8, 2019, and effective September 15,
2019, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order. FAA Order 7400.11, Airspace Designations and
Reporting Points, is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

     Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ACE KS E5 Coffeyville, KS [Amended]

Coffeyville Municipal Airport, KS
    (Lat. 37[deg]05'38'' N, long. 95[deg]34'19'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of Coffeyville Municipal Airport.

    Issued in Fort Worth, Texas, on January 22, 2020.
Steve Szukala,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2020-01589 Filed 1-29-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 5, 2010 (Volume 75, Number 192)]
[Rules and Regulations]
[Page 61337-61341]
[DOCID:fr05oc10-3]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1069; Directorate Identifier 2009-NM-036-AD;
Amendment 39-16442; AD 2010-20-08]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Model 747-100, 747-
100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400,
747-400D, 747-400F, and 747SR Series Airplanes

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

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The FAA is superseding an existing airworthiness directive
(AD), which applies to all Boeing Model 747-100, 747-100B, 747-100B
SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D, 747-
400F, and 747SR series airplanes. That AD currently requires repetitive
inspections to find cracking of the web, strap, inner chords, and inner
chord angle of the forward edge frame of the number 5 main entry door
cutouts, and repair, if necessary. This new AD requires expanding the
inspection areas to include the frame segment between stringers 16 and
23. This AD reinstates the repetitive inspections specified above for
certain airplanes. This AD also requires repetitive inspections for
cracking of repairs. This AD results from additional reports of cracks
that have been found in the strap and inner chord of the forward edge
frame of the number 5 main entry door cutouts, between stringers 16 and
23. We are issuing this AD to detect and correct such cracks. This
condition, if not corrected, could cause damage to the adjacent body
structure, which could result in depressurization of the airplane in
flight.

DATES: This AD becomes effective November 9, 2010.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of November 9,
2010.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https://www.myboeingfleet.com.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
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 address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Ivan Li, Aerospace Engineer, Airframe
Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind
Avenue, SW., Renton, Washington 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to include an AD to supersede AD 2001-16-02, amendment 39-
12370 (66 FR 41440, August 8, 2001). The existing AD applies to certain
Model 747 series airplanes. That NPRM was published in the Federal
Register on November 20, 2009 (74 FR 60215). That NPRM proposed to
continue to require repetitive inspections to find cracking of the web,
strap, inner chords, and inner chord angle of the forward edge frame of
the number 5 main entry door cutouts between stringers 23 and 31, and
repair, if necessary. The NPRM also proposed to require expanding the
inspection areas to include the frame segment between stringers 16 and
23; reinstating the repetitive inspections specified for certain
airplanes; and adding repetitive inspections for cracking of repairs.

Comments

    We provided the public the opportunity to participate in the
development of this AD. We have considered the comments that have been
received on the NPRM.

Request To Exclude Large Cargo Freighters (LCFs) From the AD
Applicability

    Boeing requests we change the applicability in paragraph (c) of the
NPRM to exclude LCFs. Boeing states that during modification into the
LCF configuration, the 46-section from station 1960 to station 2360 was
removed from the airplane. Boeing also states that this segment of the
airplane

was replaced with a new swing-zone and 47-section.
    We agree with Boeing's request for the reason provided by the
commenter. We have revised paragraph (c) of this AD accordingly.

Request for Clarification of the AD Applicability

    An anonymous commenter requests that we clarify the applicability
of the NPRM. The commenter notes that, in accordance with paragraph (c)
of the NPRM, the proposed AD would be applicable to Boeing Model 747-
400F series airplanes, certificated in any category, as identified in
Boeing Alert Service Bulletin 747-53A2450, Revision 5, dated January
29, 2009. The commenter states that after reviewing this sentence in
light of Revision 5 of the service bulletin, it was discovered that
line number 1399 (i.e. variable number RL534) is not affected by Boeing
Alert Service Bulletin 747-53A2450, Revision 5, dated January 29, 2009,
and therefore is not affected by the proposed AD.
    The commenter also notes that paragraph (j) of the NPRM states,
``For all airplanes: Before the accumulation of 16,000 total flight
cycles * * *'' The commenter states that this sentence is confusing for
airplane line number 1399 (i.e. variable number RL534), since this
airplane is not affected by Boeing Alert Service Bulletin 747-53A2450,
Revision 5, dated January 29, 2009. The commenter states that this
airplane is structurally the same as the other affected airplanes, and
therefore it should be affected by the NPRM.
    We disagree with the commenter's remark that line number 1399 is
not affected by this AD. The ``Effectivity'' paragraph in the Summary
section of Boeing Alert Service Bulletin 747-53A2450, Revision 5, dated
January 29, 2009, specifies ``all 747 airplanes.'' Also, the Note in
paragraph 1.A., ``Effectivity,'' of Boeing Alert Service Bulletin 747-
53A2450, Revision 5, dated January 29, 2009, specifies that ``airplanes
after line number 1397 are also affected by this service bulletin.'' We
acknowledge there may be confusion because the Note in paragraph 1.A.,
``Effectivity,'' of Boeing Alert Service Bulletin 747-53A2450, Revision
5, dated January 29, 2009, also states that ``the effectivity list
shown below is complete for airplanes through line number 1397.''
    We find that clarification of paragraph (c) of this AD is
necessary. All Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-
200C, 747-200F, 747-300, 747-400, 747-400D, 747-400F, and 747SR series
airplanes (line numbers 1 through 1419 inclusive) are affected by this
AD except for the airplanes mentioned in the previous comment,
``Request to Exclude Large Cargo Freighters (LCF) from the
Applicability.'' Line numbers 1420 and subsequent are not affected by
the identified unsafe condition because those line numbers correspond
to Model 747-8 and 747-8F series airplanes, which are still being
certified and have a different configuration than the airplanes
identified in this AD.

Request To Update Delegation of Authority

    Boeing requests that we change Delegation Option Authorization
(DOA) holder to Boeing Commercial Airplanes Organization Designation
Authorization (ODA).
    We agree with Boeing's request to update the delegation of
authority. Boeing Commercial Airplanes has received an Organization
Designation Authorization (ODA), which replaces the previous
designation as a Delegation Option Authorization (DOA) holder. We have
revised paragraph (o)(3) of this AD to add delegation of authority to
Boeing Commercial Airplanes ODA to approve an alternative method of
compliance (AMOC) for any repair required by this AD.
    We also have revised paragraph (l) of this AD to delegate the
authority to approve an alternative method of compliance for any repair
required by this AD to the Boeing Commercial Airplanes ODA rather than
a Designated Engineering Representative.

Request To Do Inspections in Accordance With the Structural Repair
Manual (SRM)

    Boeing requests that for any frame repaired in accordance with the
SRM, the inspections also can be done in accordance with the SRM.
Boeing requests that the following sentence be added to paragraph (n)
of this AD: ``For any frame that is repaired in accordance with the
747-400 SRM 53-60-15, Figure 201, Repair 5, do the inspection,
including the threshold and intervals in accordance with the SRM.''
    Boeing states that the SRM was designed to add reinforcing steel
straps, which will reduce the stress level in the edge frame and
therefore allow an increased threshold of 20,000 flight cycles after
the repair.
    We do not agree with Boeing's request to do the inspections in
accordance with the SRM. We have not been provided with any data to
substantiate such a request, and further evaluation is needed. However,
under the provisions of paragraph (o)(1) of this AD, we may consider
requests for approval of an AMOC if sufficient data are submitted to
substantiate that an alternative inspection plan would provide an
acceptable level of safety. We have not changed the AD regarding this
issue.

Request To Clarify Paragraph (i) of the NPRM

    Northwest Airlines (NWA) requests that we clarify paragraph (i) of
the NPRM. NWA states that it finds paragraph (i) of the NPRM to be
``awkward.'' NWA states that paragraph (g) of the NPRM specifies to use
only Boeing Alert Service Bulletin 747-53A2450, Revision 5, dated
January 29, 2009, after the effective date of the AD. NWA states that
paragraph (i) of the proposed NPRM directs the reader to Figure 1 of
Boeing Alert Service Bulletin 747-53A2450, dated May 4, 2000; or
Revision 1, dated July 6, 2000; and that Figure 1 has been deleted from
Revision 5. NWA recommends that paragraph (i) of the NPRM be revised to
specify: ``Within 3,000 flight cycles after accomplishment of the
inspections previously specified in Figure 1 of Boeing Alert Service
Bulletin 747-53A2450, dated May 4, 2000, or Revision 1, dated July 6,
2000, repeat inspections at intervals not to exceed 3,000 flight cycles
as specified in Table 1 of Boeing Alert Service Bulletin 747-53A2450,
Revision 5, dated January 29, 2009.''
    We disagree with NWA's request to change paragraph (i) of this AD.
For clarification, paragraph (g) of this final rule restates the
inspection requirements of AD 2001-16-02, and paragraph (i) of this
final rule provides the repetitive interval for those inspections. The
compliance times and the repetitive inspection intervals for the
inspections have not changed; therefore, using Figure 1 of the service
bulletin as the reference for the compliance time is correct. We have
not changed the AD in this regard.

Request To Correct Typographical Errors

    All Nippon Airways (ANA) requests that certain part numbers be
corrected in the NPRM. ANA notes that paragraphs (h), (i), (j), and (k)
of the NPRM would require initial and repetitive inspections of the STA
2231 frame, in accordance with Boeing Alert Service Bulletin 747-
53A2450, Revision 5, dated January 29, 2009. ANA states that it found
several typographical errors on the code ``K'' in Figure 7 of this
service bulletin. ANA asserts that the part number of the nut should be
``BACN10JC3CD,'' instead of ``BACB30JC3CD.'' ANA also states that the
part number should be

``BACN10YR3CD,'' instead of ``BACN10YR4CD.'' ANA states that Boeing
concurs with this error and that Boeing will issue a new information
notice with the correct information.
    We agree with ANA's request that the part numbers referenced by the
commenter should be corrected. Since the issuance of the NPRM, Boeing
has issued Service Bulletin Information Notice 747-53A2450 IN 04, dated
May 3, 2010, specifying the correct part numbers. We have added a new
Note 3 to this AD to reference the correct part numbers.

Request To Correct Editorial Error

    Boeing requests that an editorial error be corrected in paragraph
(l) of the NPRM. Boeing states that the first sentence in paragraph (l)
of the NPRM reads: ``* * * required this AD. * * *'' Boeing states that
the word ``by'' should be inserted into the sentence to read: ``* * *
required by this AD. * * *''
    We agree with Boeing and have corrected the editorial error. We
have revised paragraph (l) of this AD in this regard.

Explanation of Change Made to This AD

    We have revised this AD to identify the legal name of the
manufacturer as published in the most recent type certificate data
sheet for the affected airplane models.

Conclusion

    We have carefully reviewed the available data, including the
comments that have been received, and determined that air safety and
the public interest require adopting the AD with the changes described
previously. We have determined that these changes will neither increase
the economic burden on any operator nor increase the scope of the AD.

Explanation of Changes to Costs of Compliance

    Since issuance of the NPRM, we have increased the labor rate used
in the Costs of Compliance from $80 per work-hour to $85 per work-hour.
The Costs of Compliance information, below, reflects this increase in
the specified hourly labor rate.

Costs of Compliance

    There are about 163 airplanes of the affected design in the
worldwide fleet. The following table provides the estimated costs for
U.S. operators to comply with this AD.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of U.S.-
              Action                     Work hours        Average labor         Parts          Cost per airplane     registered         Fleet cost
                                                           rate per hour                                               airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspections (required by AD         16..................             $85  None..............  $1,360 per                       163  $221,680 per
 2001[dash]16[dash]02).                                                                        inspection cycle.                     inspection cycle.
Inspections (new action)..........  28 depending on                   85  None..............  Up to $2,380 per                 163  Up to $387,940 per
                                     airplane                                                  inspection cycle,                     inspection cycle,
                                     configuration.                                            depending on                          depending on
                                                                                airplane                              airplane
                                                                                configuration.                        configuration.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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 have 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under 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. See the ADDRESSES
section for a location to examine the regulatory evaluation.

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 Federal Aviation Administration (FAA) amends Sec.  39.13 by
removing amendment 39-12370 (66 FR 41440, August 8, 2001) and by adding
the following new airworthiness directive (AD):

2010-20-08 The Boeing Company: Amendment 39-16442. Docket No. FAA-
2009-1069; Directorate Identifier 2009-NM-036-AD.

Effective Date

    (a) This AD becomes effective November 9, 2010.

Affected ADs

    (b) This AD supersedes AD 2001-16-02, Amendment 39-12370.

Applicability

    (c) This AD applies to The Boeing Company Model 747-100, 747-
100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400,
747-400D, 747-400F, and 747SR series airplanes, certificated in any
category, having line numbers 1 through 1419 inclusive; except for
Model 747-400 series airplanes that have been modified into

the 747-400 large cargo freighter configuration.

Subject

    (d) Air Transport Association (ATA) of America Code 53:
Fuselage.

Unsafe Condition

    (e) This AD results from additional reports of cracks that have
been found in the strap and inner chord of the forward edge frame of
the number 5 main entry door cutouts, between stringers 16 and 23.
Based on these reports, we have determined that the frame segment
between stringers 16 and 23 is also susceptible to the unsafe
condition. The Federal Aviation Administration is issuing this AD to
detect and correct such cracks. This condition, if not corrected,
could cause damage to the adjacent body structure, which could
result in depressurization of the airplane in flight.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Restatement of Requirements of AD 2001-16-02, With New Service
Information

Repetitive Inspections for Frame Segment Between Stringers 23 and 31
(No Terminating Action)

    (g) For airplanes having line numbers 1 through 1304 inclusive:
Inspect the airplane for cracks between stringers 23 and 31 per
Boeing Alert Service Bulletin 747-53A2450, Revision 2, including
Appendix A, dated January 4, 2001; or Boeing Alert Service Bulletin
747-53A2450, Revision 5, dated January 29, 2009; at the later of the
times specified in either paragraph (h) or (i) of this AD, per Table
1, as follows. After the effective date of this AD, use only
Revision 5 of Boeing Alert Service Bulletin 747-53A2450, to
accomplish the required inspection.

                    Table 1-- Inspection Requirements
------------------------------------------------------------------------
        Type of inspection                     Area to inspect
------------------------------------------------------------------------
(1) Detailed Visual...............  Strap inner chords forward and aft
                                     of the web, and exposed web
                                     adjacent to the inner chords on
                                     station 2231 frame from stringer 23
                                     through 31 per Figure 5 or Figure 6
                                     of the service bulletin, as
                                     applicable.
(2) Surface High Frequency Eddy     Station 2231 inner chord angles at
 Current (HFEC).                     lower main sill interface per
                                     Figure 5 or Figure 6 of the service
                                     bulletin, as applicable.
(3) Open Hole HFEC................  Station 2231 frame fastener
                                     locations per Figures 4 and 7, and
                                     either Figure 5 or 6 of the service
                                     bulletin, as applicable.
(4) Surface HFEC..................  Around fastener locations on station
                                     2231 inner chords from stringer 23
                                     through 31 per Figure 5 or Figure 6
                                     of the service bulletin, as
                                     applicable.
(5) Low Frequency Eddy Current....  Station 2231 frame strap in areas
                                     covered by the reveal per Figure 5
                                     or Figure 6 of the service
                                     bulletin, as applicable.
------------------------------------------------------------------------

     (h) Do the inspections specified in paragraph (g) of this AD at
the applicable times specified in paragraph (h)(1) or (h)(2) of this
AD. Repeat the inspections at intervals not to exceed 3,000 flight
cycles.
    (1) Do the inspections per Table 1 of this AD at the applicable
time specified in the logic diagram in Figure 1 of Boeing Alert
Service Bulletin 747-53A2450, Revision 2, including Appendix A,
dated January 4, 2001. Where the compliance time in the logic
diagram specifies a compliance time beginning, ``from receipt of
this service bulletin,'' this AD requires that the compliance time
begin ``after September 12, 2001 (the effective date of AD 2001-16-
02).''
    (2) After the effective date of this AD, do the inspections per
Table 1 of this AD at the applicable compliance time specified in
paragraph 1.E., ``Compliance'' of the Boeing Alert Service Bulletin
747-53A2450, Revision 5, dated January 29, 2009. Where the
compliance time in Boeing Alert Service Bulletin 747-53A2450,
Revision 2, including Appendix A, dated January 4, 2001, specifies a
compliance time beginning, ``after the date on Revision 2 of this
service bulletin,'' this AD requires that the compliance time begin
``after September 12, 2001 (the effective date of AD 2001-16-02).''
    (i) Within 3,000 flight cycles after accomplishment of the
inspections specified in Figure 1 of Boeing Alert Service Bulletin
747-53A2450, dated May 4, 2000; or Revision 1, dated July 6, 2000;
repeat the inspections specified in paragraph (g) of this AD at
intervals not to exceed 3,000 flight cycles.

    Note 1: There is no terminating action currently available for
the inspections required by paragraph (g) of this AD.

    Note 2: Where there are differences between the AD and Boeing
Alert Service Bulletin 747-53A2450, the AD prevails.

New Requirements of This AD

Additional Repetitive Inspections (For Frame Segment Between Stringers
16 and 23)

    (j) For all airplanes: Before the accumulation of 16,000 total
flight cycles, or within 1,500 flight cycles after the effective
date of this AD, whichever occurs later, do a detailed inspection,
an open hole high frequency eddy current (HFEC) inspection, a
surface HFEC inspection, and a subsurface low frequency eddy current
(LFEC) inspection for cracking of the forward edge frame of the
number 5 main entry door cutouts, at station 2231, between stringers
16 and 23; in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 747-53A2450, Revision 5, dated January
29, 2009. Repeat the inspections thereafter at intervals not to
exceed 3,000 flight cycles.

    Note 3: The part number of the nut for fastener code ``K'' in
Figure 7 of Boeing Alert Service Bulletin 747-53A2450, Revision 5,
dated January 29, 2009, should be ``BACN10JC3CD,'' instead of
``BACB30JC3CD.'' In addition, the part number of the optional nut
for this fastener code should be ``BACN10YR3CD,'' instead of
``BACN10YR4CD.''

Repetitive Inspections for Line Numbers 1305 and On (For Frame Segment
Between Stringers 23 and 31)

    (k) For airplanes having line numbers 1305 and on: Before 16,000
total flight cycles or within 1,500 flight cycles after the
effective date of this AD, whichever occurs later, do a detailed
inspection, an open hole HFEC inspection, a surface HFEC
inspections, and a subsurface LFEC inspection for cracking of the
forward edge frame of the number 5 main entry door cutouts, at
station 2231, between stringers 23 and 31; in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 747-
53A2450, Revision 5, dated January 29, 2009. Repeat the inspections
thereafter at intervals not to exceed 3,000 flight cycles.

Corrective Action

    (l) If any crack is found during any inspection required by this
AD, before further flight, repair the crack in accordance with a
method approved by the Manager, Seattle Aircraft Certification
Office (ACO), FAA; in accordance with data meeting the type
certification basis of the airplane approved by the Boeing
Commercial Airplanes Organization Designation Authorization (ODA)
that has been authorized by the Manager, Seattle ACO, to make those
findings; or in accordance with Boeing Alert Service Bulletin 747-
53A2450, Revision 5, dated January 29, 2009. For a repair method to
be approved by the Manager, Seattle ACO, as required by this
paragraph, the approval letter must specifically reference this AD.
As of the effective date of this AD, repair the crack using a method
approved in

accordance with the procedures specified in paragraph (o) of this
AD.

Post-Repair Inspections

    (m) Except as required by paragraph (n) of this AD, for
airplanes on which the forward edge frame of the number 5 main entry
door cutouts, at station 2231, between stringers 16 and 31, is
repaired in accordance with Boeing Alert Service Bulletin 747-
53A2450: Within 3,000 flight cycles after doing the repair or within
1,500 flight cycles after the effective date of this AD, whichever
occurs later, do the detailed, LFEC, and HFEC inspections of the
repaired area for cracks in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 747-53A2450, Revision
5, dated January 29, 2009. If no cracking is found, repeat the
inspections thereafter at intervals not to exceed 3,000 flight
cycles. If any crack is found, before further flight, repair using a
method approved in accordance with the procedures specified in
paragraph (o) of this AD. Doing the inspections specified in
paragraph (m) of this AD terminates the repetitive inspections
required by paragraphs (g), (h), (i), (j), and (k) of this AD for
the repaired area.
    (n) For any frame that is repaired in accordance with a method
other than the Accomplishment Instructions of Boeing Alert Service
Bulletin 747-53A2450, Revision 5, dated January 29, 2009, do the
inspection in accordance with a method approved in accordance with
the procedures specified in paragraph (o) of this AD.

Alternative Methods of Compliance (AMOCs)

    (o)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. Send information to
Attn: Ivan Li, Aerospace Engineer, Airframe Branch, ANM-120S, FAA,
Seattle Aircraft Certification Office, 1601 Lind Avenue, SW.,
Renton, Washington 98057-3356; telephone<PHONE_NUMBER>; fax (425)
917-6590; Or, e-mail information to 9-ANM-Seattle-ACO-AMOC-
<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) AMOCs approved previously in accordance with AD 2001-16-02,
amendment 39-12370, are approved as AMOCs for the corresponding
provisions of paragraphs (g), (h), (i), and (l) of this AD.

Material Incorporated by Reference

    (p) You must use Boeing Alert Service Bulletin 747-53A2450,
Revision 5, dated January 29, 2009, 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
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference 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/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on September 15, 2010.
Robert D. Breneman,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-23840 Filed 10-4-10; 8:45 am]
BILLING CODE 4910-13-P


Page 1 of 8 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES April 10, 2002 MEMORANDUM SUBJECT: Tolerance Review of Compounds of Group 13, Lignins, Cellulose and Pines as Inert Ingredients in Terrestrial and/ or Aquatic Agricultural and Non Agricultural Uses FROM: Sid Abel, Senior Environmental Scientist Environmental Fate and Effects Division (7507C)

TO: Kathryn Boyle, Inerts Team Lead Registration Division (7505C)

This memorandum transmits the Environmental Fate and Effects Division's (EFED) fate, exposure and ecotoxicity assessment of compounds of the Lignins, Cellulose and Pine compounds and Furfural. The assessment is based on readily available information from the Agency, peer reviewed public literature sources and Structure Activity Relationships (SAR). Information contained in these sources permits EFED to conduct a qualitative assessment of environmental fate, exposures and toxicity of these compounds.

If you should have any questions concerning the information within, please contact me at 305 7346. Page 2 of 8 Conclusions A review of the readily available information and use of Structure Activity Relationships (SAR) on the compounds that make up the ligninsulfonates, cellulose compounds, pinenes and furfural is sufficient to conduct a qualitative assessment of the likely fate, exposures and toxicity associated with their use as pesticide inert ingredients. Environmental loadings will be attributable to anthropogenic (feedstock for chemical syntheses and as a solvent in many consumer and commercial products) and natural sources (plants).

Available data and SARs indicate that the ligninsulfonates, cellulose compounds, pinenes, and furfural will undergo primary biologically mediated degradation in a matter of days to weeks and ultimate degradation (mineralization) in a matter of weeks to months. Transformation and/ or degradation via hydrolysis and direct soil and water photolysis is not expected to occur for any of these compounds. Atmospheric photo oxidation is expected to occur for the pinenes and furfural and represents a very important degradation pathways for these compounds. Reaction rates halflives range from hours to days. With the exception of furfural, this group of compounds are expected to be predominantly found in the sorbed state in water, while furfural will be mainly in dissolution. Where available, literature data is in good agreement with SAR estimates.

Transport to surface water in the sorbed state is expected to dominate the nondegradation pathways of dissipation for all but furfural. Furfural will reach surface water in dissolution based on high water solubility and low sorption coefficients. Groundwater contamination is not likely to be significant for any of these compounds. In water, partitioning to the sediment is likely for all compounds except furfural. Partitioning to air from water surfaces is expected to be high for all compounds based Henry's Law constant and high from dryer surfaces such as soils based on volatility. Bioconcentration is expected to be significant for the pinenes only.

Shallow aquifer ground water contamination of furfural may occur, however, biologically mediated degradation under aerobic conditions will limit loadings, thus, concentrations. Based on the high volatility of these compounds and aeration sequences used in many drinking water treatment utilities, it is unlikely that most of these compounds will be found in treated water at concentrations equivalent to those found in the environment. There are no ambient water quality criteria or drinking water maximum contaminant or health advisory levels for these compounds.

Based on the Agency's toxicity categories the ligninsulfonates and cellulose compounds are classified as practically non toxic to aquatic organisms and the pinenes are classified as highly toxic to very highly toxic to aquatic organisms. Furfural is classified as slightly toxic. Terrestrial organisms toxicity, using mammal data as a surrogate in the absence of avian data, indicate that these compounds may be classified as practically non toxic. Page 3 of 8 LIGNINSULFONATES The available chemical structures, physical chemical properties, environmental fate, and aquatic and terrestrial toxicity of these compounds are somewhat similar, Table 1, with differences mainly attributable to differences in cation group (Ca, Na, NH4 , Mg, P, Zn). Major uses include dispersants, emulsion stabilizer, and chelating agents. One reference indicated sodium lignonsulfonate is used to enhance the biodegradation of PCBs. As a group, the ligninsulfonates are soluble to very highly water soluble depending on the cation. Once in water, dissociation of the cation is expected depending on pH. They are not expected to be mobile in terrestrial environments, moving equally with the water and sediment phase to surface water. Ground water migration is not likely. Once in water, the dissociated cation and anion are likely to remain in dissolution. Volatility from soil and water (Henry's Law Constant) is not expected. Primary microbial mediated degradation may limit transport of parent material to surface and ground water from applications or releases to land. Fugacity modeling predicts approximately 50% of releases will be associated with the water phase and 50% with soils. Predicted volatilization half lives in rivers and lakes is on the order of decades. Therefore, the data suggest that the ligninsulfonates may be persistent in aquatic environment of low microbial activity and much less persistent in environments with ample microbial activity. According to the MSDS (Wesco Technologies, Ltd., 2002), pH of the various compounds range from 4 to 10 for both liquid and powder forms, Table 1. Properties for zinc ligninsulfonate cannot be determined because a representative structure could not be found. MSDS reports the compound's pH as 4 to 5 for both the liquid and powder form.

Estimated ecotoxicity data for aquatic animals are available Table 1. The ecotoxicity estimates indicate that these compounds are practically nontoxic on an acute basis. Estimated acute toxicity is much greater than 1000 mg/ L for freshwater fish, Daphnia magna, and green algae. Chronic toxicity levels are very similar. Terrestrial animal toxicity based on available rat data would indicate that through the oral route, the ligninsulfonates are practically non toxic on an acute basis.

CELLULOSE COMPOUNDS The chemical structures, physical chemical properties, environmental fate behavior, and aquatic and terrestrial toxicity of these compounds is expected to be similar. No compound specific data were found in the readily available information. Structural analyses cannot be conducted without representative structures for one or more of the compounds. Cellulose is a glucose polymer of high molecular weight found in all plants. Glucose units are joined by  1, 4linkages The cellulose compounds are the most abundant compounds found in nature. Whether simple or complex, they play a major role in carbohydrate metabolism of living organisms. As a result, they may be grouped with compounds such as those of the citric acid cycle in terms of importance, environmental behavior and toxicity. Cellulose compounds are polymer compounds with cellulose itself being unbranched. Chemical modification of cellulose produces polymeric materials that are familiar commercial products. Adding carbonyl groups and cations, such as Page 4 of 8 sodium, will tend to increase solubility and reactivity in nature. Carboxymethylcellulose is synthesized when cellulose is reacted with chloroacetate. These compounds are commonly used in detergents. A carboxylic acid, carboxymethylcellulose may be synthesized to the sodium or ether compound listed as inert ingredients. Cellulose compounds are expected to be biodegradable in the environment as primary sources of energy. Volatilization is expected to be minimal. Sorption will be dependent on type and abundance of functional groups, e. g., carbonyl (R C= O).

Terrestrial animal toxicity based on available rat data would indicate cellulose compounds are practically non toxic on an acute basis.

PINENES AND FURFURAL The physical chemical properties, environmental fate behavior, and aquatic and terrestrial toxicity of  pinene,  pinene and furfural are presented in Table 2.  Pinene (turpentine) is naturally occurring in a wide variety of plants and is used as a solvent, fragrance, flavoring and synthetic intermediate.  Pinene will readily volatilize from soil and moving water to the atmosphere within hours and within days from lakes. Once in the atmosphere,  pinene will degrade with photochemically produced hydroxyl radicals with a estimated half life of 4 hours. Reaction with ozone occurs with a half life of approximately 40 minutes. Night time reactions with nitrate radicals occurs with a half life of 6 minutes. Mobility is soil is expected to be low. Biologically mediated primary degradation is expected to occur rapidly in aerobic soils. Complete removal was observed in three different soil slurries from Georgia. Degradation is seawater samples occurred with a half life of approximately 6 8 hours. Bioconcentration in aquatic organisms may occur based on an estimated BFC of 2800.  Pinene has been detected in the Black Warrior River in AL and in sea water from Resurrection Bay, AK. Concentrations were reported in the low parts per billion (< 100 ppb). Based on the above information,  pinene is not expected to persist in the environment.

 Pinene (turpentine) is naturally occurring, with  pinene, but in smaller amounts, in a wide variety of plants used as a solvent, fragrance, flavoring and synthetic intermediate.  Pinene will readily volatilize from soil and moving water to the atmosphere within hours and within days from lakes. Once in the atmosphere,  pinene will degrade with photochemically produced hydroxyl radicals with a estimated half life of 4. 9 hours. Reaction with ozone occurs with a halflife of approximately 22 hours. Night time reactions with nitrate radicals may occur, no relevant information could be located on estimated half lives. Mobility is soil is expected to be low. Biologically mediated primary degradation is expected to occur rapidly in aerobic soils. Bioconcentration in aquatic organisms may occur based on an estimated BFC of 444.  Pinene has been detected in the Black Warrior River in Alabama, concentrations were not reported. Based on the above information,  pinene is not expected to persist in the environment.

Furfural is an aldehyde important as a solvent for certain petrochemical processes and as a raw material for preparation of polymers, plastics, and tetrahydrofuran. Furfural will volatilize Page 5 of 8 from soil and moving water to the atmosphere within days and within months from lakes. Once in the atmosphere, furfural will degrade with photochemically produced hydroxyl radicals with a estimated half life of 3 to 4 hours. Reaction with ozone is uncertain and may not occur. Nighttime reactions with nitrate radicals may be an important degradation pathway, however, data to estimate half lives could not be located. Mobility is soil is expected to be high, with ground and surface contamination likely. Biologically mediated primary degradation is expected to occur in aerobic soils within days and ultimate degradation within weeks. Bioconcentration in aquatic organisms is not expected to occur. Fugacity modeling suggest that approximately 55% of furfural will be found in water and 44 percent on soil. Based on the above information, furfural is not expected to persist in the environment.

Estimated ecotoxicity data for aquatic animals are available Table 2. The ecotoxicity estimates indicate  pine is very highly toxic to aquatic organisms on an acute basis.  Pinene may present an acute concern for marine/ estuarine invertebrates based on documented environmental concentrations near the levels of predicted toxicity. Acute toxicity estimates are 0. 72 mg/ L for freshwater fish, 0. 51 mg/ L for marine/ estuarine fish, 0. 93 mg/ L for Daphnia magna, 0. 042 mg/ L for mysid shrimp, and 0. 66 mg/ L for green algae. Chronic toxicity estimates for freshwater fish is 0. 138 mg/ L. Terrestrial animal toxicity based on available rat data would indicate that  pinene is practically non toxic on an acute basis.

 pine very highly toxic to aquatic organisms on an acute basis.  Pinene may present an acute concern for marine/ estuarine invertebrates based on probable environmental concentrations at or near the levels of predicted toxicity. Acute toxicity estimates are 0.62 mg/ L for freshwater fish, 0. 45 mg/ L for marine/ estuarine fish, 0. 79 mg/ L for Daphnia magna, 0. 034 mg/ L for mysid shrimp, and 0.56 mg/ L for green algae. Chronic toxicity estimates for freshwater fish is 0.117 mg/ L. Terrestrial animal toxicity based on available rat data would indicate that  pinene is practically non toxic on an acute basis.

Furfural is slightly toxic to aquatic organisms on an acute basis. Acute toxicity estimates are 18.8 mg/ L for freshwater fish, 26.3 mg/ L for Daphnia magna, and 518 mg/ L for green algae. Chronic toxicity estimates for freshwater fish is 4 mg/ L. Terrestrial animal toxicity cannot be determine at this time.

References Meylan, William and Philip Howard, 1998. ECOSAR Class Program, Version 0.99d. Syracuse Research Corporation, Syracuse, N. Y. For: U. S. Environmental Protection Agency, Office of Pollution Prevention and Toxics, Washington, D. C.

Meylan, William and Philip Howard, 2000. Estimation Program Interface, Version 3. 10. Syracuse Research Corporation, Syracuse, N. Y. For: U. S. Environmental Protection Agency, Office of Page 6 of 8 Pollution prevention and Toxics, Washington, D. C.

TOXNET 2002. Online Scientific Search Engine, National Library of Medicine, National Institutes of Health. Search results for Lignins, Cellulose Compounds, Pinenes, Furfural http:// toxnet. nlm. nih. gov/.

Wesco Technologies, Ltd, 2002. Material Safety Data Sheets (MSDS) Wesco Technologies, Ltd., San Clemente, CA. Internet search for various ligninsulfonates at: http:// www. wtl. com/ msds/ zl. htm. Page 7 of 8 Table 1.

Available Estimated (E)

and Measured (M)

Chemical Properties and Ecotoxicological Endpoints of Select Lignins Chemical Property Calcium Lignosulfonate Sodium Lignosulfonate Ammonium Lignosulfonate pH 4.5 10 (liquid);

4 10 (powder)

4. 5 10 (liquid and powder)

~4.5 (liquid; ~6. 5 (powder) Vapor Pressure (mmHg)

6.65x10 20 @25 o C (E)

5.92x10 27 @25 o C (E)

2.165.92x10 24 @25 o C (E) Log Kow 0.

33( E)

3. 45 (E)

0. 59 (E) Koc 4.

63x10 4 (E)

1.

85x10 5 (E)

4.

63x10 4 (E) Water Solubility (mg/ L)

236.2 (E)

5.22x10 5 @25 o C (E)

2050 @25 o C (E) Henry's Law Constant atm m 3 /mole 1.96x10 22 (E)

7.

64x10 33 (E)

4.

51x10 33 (E) Hydrolysis/

Photodegradation NA NA NA Biodegradation Ultimate: months; Primary: days to weeks (E)

Ultimate: months; Primary: days to weeks (E)

Ultimate: months; Primary: days to weeks (E) Fish Acute Toxicity (96h LC50 )

FW:

>8000mg/ L (E) >7300 mg/ L (48 h Rainbow trout M)

FW:

>1.7x10 6 mg/ L (E)

FW:

>29300 mg/ L (E) Daphnia Acute Toxicity >1300 mg/ L (48h EC50 )

(E)

>46700 mg/ L (E)

>3130 mg/ L (E) Algae Toxicity (96h EC50 )

>79000 mg/ L (E)

1.

7x10 8 mg/ L (E)

4.

95x10 5 mg/ L (E) Fish Chronic Toxicity (30 day)

>130 mg/ L (E)

2.

92x10 5 mg/ L (E)

>4700 mg/ L (E) Daphnia Chronic Toxicity (21 day)

890 mg/ L (E)

1.

8x10 5 mg/ L (E)

>3100 mg/ L (E) E:

(SAR)

Structure Activity Relationship. NA: Not Available. pH:

Wesco Technologies, LTD, San Clemente, CA,

http:// www. wtl.

com/ msds/ zl.

htm Page 8 of 8 Table 2.

Available Estimated (E)

and Measured (M)

Chemical Properties and Ecotoxicological Endpoints of Select Pinene Compounds Furfural Chemical Property  Pinene  Pinene Furfural Vapor Pressure (mmHg)

4.75 @25 o C (M)

2.93 @25 o C (M)

2.21 @25 o C (M) Log Kow 4.83( M)

4.35 (E)

0.

41 (M) Koc 1204 (E)

1204 (E)

17.7 (E) Water Solubility (mg/ L)

1.

891 @25 o C (M)

4.886 @25 o C (E)

0.5.36x104 @25 o C (E) Henry's Law Constant (atm m 3 /mole)

2.

94x10 1 (M)

9.

2x10 2 (E)

3.

37x10 6 (M) Hydrolysis /Photodegradation Not Expected to Occur Not Expected to Occur NA Biodegradation Ultimate: weeks to months; Primary: days to weeks (E

SAR) Complete removal in 250 hours in 3 different soil slurries from Georgia Ultimate: weeks to months; Primary: days to weeks (E SAR

Ultimate: weeks;

Primary: days (E

SAR) Fish Acute Toxicity (96h LC50 )

FW: 0.72 mg/ L (E) M/ E:

0.51 mg/ L (E)

FW:

0.

62 mg/ L (E) M/ E:

0.45 mg/ L (E)

FW:

18.8mg/ L (E) Daphnia Acute Toxicity 0.93 mg/ L (48h EC50 )

(E)

0.79 mg/ L (48h EC50 )

(E)

26.3 mg/ L (48h EC50 )( E) Mysid Shrimp Toxicity (96h LC50 )

0.

042 mg/ L (E)

0.

034 mg/ L (E)

NA Algae Toxicity (96h EC50 )

0.

66 mg/ L (E)

0.56 mg/ L (E)

517.7 mg/ L Fish Chronic Toxicity (30 day)

0.138 mg/ L (E)

0.

117 mg/ L (E)

4. 0 mg/ L (E)

(32 day) AS:

Activated Sludge.

NA: Not Available. SAR:

Structure Activity Relationship.