[Federal Register Volume 81, Number 124 (Tuesday, June 28, 2016)]
[Proposed Rules]
[Pages 41886-41889]
[FR Doc No: 2016-14969]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0831; Directorate Identifier 2014-NM-061-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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SUMMARY: We are revising an earlier proposed airworthiness directive
(AD) for all Airbus Model A318 and A319 series airplanes, A320-211, -
212, -214, -231, -232, and -233 airplanes, and A321 series airplanes.
The NPRM proposed to require an inspection to identify the part number
and serial number of the main landing gear (MLG) sliding tubes
installed on the airplane; and inspection of affected chromium plates
for damage; an inspection of affected sliding tube axles for damage;
and replacement of the sliding tube if necessary. The NPRM was prompted
by a report of a rupture of a MLG sliding tube axle. This action
revises the NPRM by removing certain service information that does not
adequately address the identified unsafe condition and revising the
compliance method. We are proposing this supplemental NPRM (SNPRM) to
detect and correct cracks in the axle and (partial) detachment of the
axle and wheel from the sliding tube, which could result in failure of
an MLG. Since these actions impose an additional burden over those
proposed in the NPRM, we are reopening the comment period to allow the
public the chance to comment on these proposed changes.

DATES: We must receive comments on this SNPRM by August 12, 2016.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this SNPRM, contact Airbus,
Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte, 31707
Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44
51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
425-227-1221.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0831; 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 proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (telephone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-0831;
Directorate Identifier 2014-NM-061-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on 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 proposed AD.

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all Airbus Model A318 and
A319 series airplanes, A320-211, -212, -214, -231, -232, and -233
airplanes, and A321 series airplanes. The NPRM published in the Federal
Register on April 24, 2015 (80 FR 22939) (``the NPRM''). The NPRM was
prompted by a report of a rupture of a MLG sliding tube axle. The NPRM
proposed to require an inspection to identify the part number and
serial number of the MLG sliding tubes installed on the airplane; and
an inspection of the axle on certain MLG sliding tubes for damage, and
replacement of the sliding tube if necessary.

Actions Since Previous NPRM Was Issued

    Since we issued the NPRM, we have determined that Messier-Bugatti-
Dowty Service Bulletin 200-32-313, dated February 25, 2013, including
Appendices A, B, and C, dated February 25, 2013; and Service Bulletin
201-32-62, including Appendices A, B, and C, dated February 25, 2013;
do not adequately address the identified unsafe condition because this
service information does not include all Required for Compliance steps
required in Airbus Service Bulletin A320-32-1416, including Appendix
01, dated March 10, 2014. Therefore, this SNPRM proposes revising the
service information specified for accomplishing the proposed actions.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2014-0058, dated March 11, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Airbus Model A318
and A319 series airplanes, A320-211, -212, -214, -231, -232, and -233
airplanes, and A321 series airplanes. The MCAI states:

    A main landing gear (MLG) sliding tube axle rupture occurred in
service. Investigation of the affected part showed that

this failure was due to an abnormal grinding operation during
overhaul by a certain maintenance and repair organization located in
Singapore. A population of MLG sliding tubes was subsequently
identified whose axles may have been subject to this grinding
operation, which may have resulted in areas of residual stress on
the axles on the MLG sliding tubes. In addition, the MSN
[manufacturer serial number] of the aeroplanes which are known to
have had the affected parts installed have been identified.
    This condition, if not detected and corrected, could lead to
cracks in the axle and (partial) detachment of axle and wheel from
the sliding tube, possibly resulting in failure of a MLG with
consequent damage to the aeroplane and injury to occupants.
    To address this potential unsafe condition, Messier-Bugatti-
Dowty, the MLG gear manufacturer, issued Service Bulletin (SB) 200-
32-313 and SB 201-32-62 [both dated February 25, 2013], providing
inspection instructions and criteria for removal from service of the
affected MLG sliding tubes.
    For the reasons described above, this [EASA] AD requires a one-
time Special Detailed Inspection (SDI) of the axle on the affected
MLG sliding tubes and, depending on findings, replacement of the MLG
sliding tube.

    The SDI includes a detailed visual inspection of the chromium plate
for damage, and a Barkhausen noise inspection of the sliding tube axles
for damage.
    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
0831.

Related Service Information Under 1 CFR Part 51

    Airbus has issued Service Bulletin A320-32-1416, dated March 10,
2014, including Appendix 01, dated March 10, 2014. This service
information describes procedures for inspecting MLG axles and brake
flanges by doing a detailed visual inspection of the chromium plates
for damage, and a Barkhausen noise inspection of the sliding tube axles
for damage, and replacement of affected parts if necessary. This
service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Comments

    We gave the public the opportunity to participate in developing
this proposed AD. We considered the comments received.

Request To Revise Parts Installation Limitation

    American Airlines requested that we revise paragraphs (l)(1) and
(l)(2) of the proposed AD (in the NPRM) to allow installation of
serviceable MLG sliding tubes that have passed the inspection required
by paragraph (i) of the proposed AD (in the NPRM). American Airlines
stated that it believes that this is the intent of the MCAI.
    We agree with the commenter's request and have revised paragraphs
(l)(1) and (l)(2) of this proposed AD accordingly.

Additional Changes to This SNPRM

    We have removed Messier-Bugatti-Dowty Service Bulletin 200-32-313,
including Appendices A, B, and C, dated February 25, 2013; and Service
Bulletin 201-32-62, including Appendices A, B, and C, dated February
25, 2013; as sources of service information in this SNPRM. We have
specified Airbus Service Bulletin A320-32-1416, including Appendix 01,
dated March 10, 2014, as the appropriate source of service information
for accomplishing the proposed actions.

FAA's Determination and Requirements of This SNPRM

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.
    Certain changes described above expand the scope of the NPRM. As a
result, we have determined that it is necessary to reopen the comment
period to provide additional opportunity for the public to comment on
this SNPRM.

Differences Between This SNPRM and the MCAI or Service Information

    The effectivity in Airbus Service Bulletin A320-32-1416, including
Appendix 01, dated March 10, 2014, does not include Model A318 series
airplanes. This SNPRM specifies using the procedures specified for
Model A319 series airplanes in Airbus Service Bulletin A320-32-1416,
including Appendix 01, dated March 10, 2014, for accomplishing the
proposed actions on Model A318 series airplanes.

Costs of Compliance

    We estimate that this SNPRM affects 3 airplanes of U.S. registry.
    We also estimate that it would take about 18 work-hours per product
to comply with the basic requirements of this SNPRM. The average labor
rate is $85 per work-hour. Based on these figures, we estimate the cost
of this SNPRM on U.S. operators to be $4,590, or $1,530 per product.
    In addition, we estimate that any necessary on-condition actions
would take about 3 work-hours, for a cost of $255 per product. We have
received no definitive data that would enable us to provide part cost
estimates for the on-condition actions specified in this SNPRM. We have
no way of determining the number of aircraft that might need these
actions.

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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 proposed
regulation:
    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);
    3. Will not affect intrastate aviation in Alaska; and
    4. 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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 airworthiness
directive (AD):

Airbus: Docket No. FAA-2015-0831; Directorate Identifier 2014-NM-
061-AD.

(a) Comments Due Date

    We must receive comments by August 12, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the Airbus airplanes identified in paragraphs
(c)(1) through (c)(4) of this AD, certificated in any category, all
manufacturer serial numbers.
    (1) Airbus Model A318-111, -112, -121, and -122 airplanes.
    (2) Airbus Model A319-111, -112, -113, -114, -115, -131, -132,
and -133 airplanes.
    (3) Airbus Model A320-211, -212, -214, -231, -232, and -233
airplanes.
    (4) Airbus Model A321-111, -112, -131, -211, -212, -213, -231,
and -232 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
gear.

(e) Reason

    This AD was prompted by a report of a rupture of a main landing
gear (MLG) sliding tube axle. We are issuing this AD to detect and
correct cracks in the axle and (partial) detachment of the axle and
wheel from the sliding tube, which could result in failure of an
MLG.

 (f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) MLG Sliding Tube Part Number and Serial Number Identification

    Within 3 months after the effective date of this AD: Do an
inspection to identify the part number and serial number of the MLG
sliding tubes installed on the airplane. A review of airplane
maintenance records is acceptable in lieu of this inspection if the
part number and serial number of the MLG sliding tubes can be
conclusively determined from that review.

(h) Identification of Airplanes Not Affected by the Requirements of
Paragraph (i) of This AD

    An airplane with a manufacturer serial number (MSN) not listed
in figure 1 to paragraph (h) of this AD is not affected by the
requirements of paragraph (i) of this AD, provided it can be
determined that no MLG sliding tube having a part number and serial
number listed in table 1 to paragraphs (h), (i), (k)(1), (k)(2),
(l)(1), and (l)(2) of this AD has been installed on that airplane
since first flight of the airplane.

                                      Figure 1 to Paragraph (h) of This AD
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                        Affected Airplanes Listed by MSN
----------------------------------------------------------------------------------------------------------------
           0179               0214               0296               0412               0558               0604
           0607               0668               0704               0720               0726               0731
           0754               0771               0799               0828               0841               0855
           0909               0914               0925               0939               0986               1028
           1030               1041               1070               1083               1093               1098
           1108               1148               1294               1356               2713               2831
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  Table 1 to Paragraphs (h), (i), (k)(1), (k)(2), (l)(1), and (l)(2) of
                   This AD--Affected MLG Sliding Tubes
------------------------------------------------------------------------
                 Part No.                            Serial No.
------------------------------------------------------------------------
201160302................................  78B
201160302................................  1016B11
201160302................................  1144B
201371302................................  B4493
201371302................................  B4513
201371302................................  SS4359
201371302................................  B4530
201371302................................  B4517
201371302................................  B4568
201371302................................  B4498
201371302................................  4490B
201371302................................  B202-4598
201371302................................  B165-4623
201371302................................  B244-4766
201371302................................  B267-4794
201371302................................  B272-4813
201160302................................  1108B
201371304................................  B041-4871
201371304................................  B045-4869
201371304................................  B001-4781
201371304................................  B051-4892
201371304................................  B110-1952
201371304................................  B054-4891
201371304................................  B063-4921
201371304................................  B071-4911
201371304................................  B071-4917
201371304................................  B080-1933
201371304................................  B117-5010
201371304................................  B120-4989
201371304................................  B132-2023
201371304................................  B114-1956
201371304................................  B208-2009
201371304................................  B133-1947
201371304................................  B154-5037
201371304................................  B89 4952
201371304................................  B129-1964
201371304................................  B227-2010
201371304................................  B170-5031
201371304................................  B182-5047
201371304................................  B239-2053
201371304................................  B1401-2856
201371304................................  B1813-3142
201371304................................  B116-5004
201522353................................  B011-149
201522350................................  B014-25
201522350................................  B019-56
201522350................................  B019-57
201522350................................  B021-69
201522350................................  B022-60
201522353................................  B03-111
201522353................................  B03-110
201522353................................  B112-317
201522353................................  B174-351
201522353................................  B179-392
201383350................................  4377B
201383350................................  4393B
201383350................................  B1831
201383350................................  B1832
201383350................................  SS4355B
201383350................................  SS4400B
------------------------------------------------------------------------

(i) Inspections

    For each MLG sliding tube, identified as required by paragraph
(g) of this AD, having a part number and serial number listed in
table 1 to paragraphs (h), (i), (k)(1), (k)(2), (l)(1), and (l)(2)
of this AD: Within 3 months after the effective date of this AD,
inspect affected MLG axles and brake flanges by doing a detailed
visual inspection of the chromium plates for damage, and a
Barkhausen noise inspection of the sliding tube axles for damage, in
accordance with the Accomplishment Instructions of Airbus Service
Bulletin A320-32-1416, including

Appendix 01, dated March 10, 2014. For Model A318 series airplanes,
use the procedures specified for Model A319 series airplanes in
Airbus Service Bulletin A320-32-1416, including Appendix 01, dated
March 10, 2014.

(j) Corrective Action

    If, during any inspection required by paragraph (i) of this AD,
any damage is detected: Before further flight, replace the MLG
sliding tube with a serviceable tube, in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A320-32-1416,
including Appendix 01, dated March 10, 2014. For Model A318 series
airplanes, use the procedures specified for Model A319 series
airplanes in Airbus Service Bulletin A320-32-1416, including
Appendix 01, dated March 10, 2014.

(k) Definition of Serviceable Sliding Tube

    For the purpose of this AD, a serviceable sliding tube is
defined as a sliding tube that meets the criterion in either
paragraph (k)(1) or (k)(2) of this AD.
    (1) A sliding tube having a part number and serial number not
listed in table 1 to paragraphs (h), (i), (k)(1), (k)(2), (l)(1),
and (l)(2) of this AD.
    (2) A sliding tube having a part number and serial number listed
in table 1 to paragraphs (h), (i), (k)(1), (k)(2), (l)(1), and
(l)(2) of this AD that has passed the inspections required by
paragraph (i) of this AD.

(l) Parts Installation Prohibitions

    (1) For airplanes that have an MLG sliding tube installed that
has a part number and serial number listed in table 1 to paragraphs
(h), (i), (k)(1), (k)(2), (l)(1), and (l)(2) of this AD: After an
airplane is returned to service following accomplishment of the
actions required by paragraphs (g), (h), and (i) of this AD, no
person may install on any airplane an MLG sliding tube having a part
number and serial number listed in table 1 to paragraphs (h), (i),
(k)(1), (k)(2), (l)(1), and (l)(2) of this AD unless that sliding
tube has passed the inspection required by paragraph (i) of this AD.
    (2) For airplanes that, as of the effective date of this AD, do
not have an MLG sliding tube installed that has a part number and
serial number listed in table 1 to paragraphs (h), (i), (k)(1),
(k)(2), (l)(1), and (l)(2) of this AD: No person may install on any
airplane an MLG sliding tube having a part number and serial number
listed in table 1 to paragraphs (h), (i), (k)(1), (k)(2), (l)(1),
and (l)(2) of this AD unless that sliding tube has passed the
inspection required by paragraph (i) of this AD.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Required for Compliance (RC): If any service information
contains procedures or tests that are identified as RC, those
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.
    (3) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or Airbus's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(n) Special Flight Permits

    Special flight permits may be issued in accordance with sections
21.197 and 21.199 of the Federal Aviation Regulations (14 CFR 21.197
and 21.199) to operate the airplane to a location where the airplane
can be modified (if the operator elects to do so), provided the MLG
remains extended throughout the flight.

(o) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2014-0058, dated March 11, 2014,
for related information. This MCAI may be found in the AD docket on
the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-
2015-0831-0003.
    (2) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Renton, Washington, on June 16, 2016.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-14969 Filed 6-27-16; 8:45 am]
 BILLING CODE 4910-13-P


Burden Estimates for the Enforceable Consent Agreement for Ethylene Dichloride DRAFT   DOES NOT CONTAIN TSCA CBI

Prepared by:

Economic and Policy Analysis Branch Economics, Exposure and Technology Division Office of Pollution Prevention and Toxics U. S. ENVIRONMENTAL PROTECTION AGENCY 401 M STREET S. W. WASHINGTON, D. C. 20460 January 31, 2002 RECEIVED OPPT NCIC 2003 MAR11 5: 03PM OPPT 2003 0010 0020 Burden Estimates for the Enforceable Consent Agreement for Ethylene Dichloride Introduction The enforceable consent agreement ( ECA) for ethylene dichioride requires named manufacturers to undertake a tiered testing program. The testing requirements are outlined in the ECA, particularly Table 1 and several appendices of the ECA. This memo presents estimates of the burden associated with meeting the requirements of the ECA, i. e., performing the required testing and associated modeling, as explained below.

In general, the ECA requires the named manufacturers to conduct testing for a series of endpoints in the P344 rat. All testing will be conducted via the oral route. The ECA then requires that data obtained from the testing program be run through a physiological basedpharmacokinetic ( PBPK) model, to extrapolate results from the oral route to the inhalation route. In addition, a series of studies, specified in Appendix C. 1 ( Pharmacokinetic Studies for F344 Rats) of the ECA, must also be performed to generate supporting data for the PBPK modeling effort. The specific requirements of the ECA are listed in Table 1 of this report.

Methodology for Calculating Burden The burden associated with the requirements of the ECA includes the administrative burden associated with conducting the required toxicological testing in addition to the burden associated with running a required pharmacokinetic ( PBPK) model, The administrative burden of testing includes time devoted to arrange for, monitor, and report the test results. To develop estimates of administrative burden, EPA uses a methodology for converting testing costs to administrative burden. This methodology is similar to the approach used in the Economic Assessmentfor the Amended Proposed TSCA Section 4( a) TestRule for 21 Hazardous Air Pollutants ( HAPs EA) as well as the TSCA Section 4 Information Collection Request. The approach can be summarized as follows:

a. Administrative burden is calculated from an estimate of administrative costs. Administrative costs are assumed to be proportional to the laboratory cost. EPA's Economics and Policy Analysis Branch assumes that administrative costs are 25% of laboratory costs, meaning that for every $ 100 of laboratory testing costs incurred, $ 25 in administrative costs will also be incurred. b. Administrative costs are then converted to administrative burden using the weighted average labor rate of $ 69.28 per hour ($ 2001) ( EPAB 2001). This rate is based on the assumption that the administrative burden reflects a 20/ 60/ 20 mix of managerial, technical, and clerical time. The estimated wage rate for managerial time is $ 98.34 ($ 2001), for technical time it is $ 72.89 ($ 2001), and for clerical time is $ 29.39 ($ 2001). Therefore, the average labor rate is calculated as ( 898.34*. 2)+($ 72.89*, 6)+($ 29.39*. 2) $ 69.28. Administrative costs are divided by $ 69.28 to estimate administrative burden associated with the testing activity. The costs are then used to develop an estimate of the administrative burden associated with meeting the testing conditions of the ECA.

Those subject to the ECA are also expected to incur burden associated with the PBPK modeling itself. It is assumed that those subject to the ECA will utilize an existing computer based model that incorporates the logic and procedures shown in Appendix C. 5 of the ECA ( PBPK Mode! Description and Coding). It is further assumed that this model has been compiled into a userfriendly form. Under Tier I requirements of the ECA, the model will be validated using acute and subchronic toxicity data also developed in that tier. The model validation is estimated to require 24 burden hours.

Once validated, the model will be used to extrapolate oral data developed in Tier II to inhalation. Running the model will entail drawing the necessary input data from the studies and tests conducted, instructing the model to perform the extrapolations, and generating or recording the output. These activities are estimated to require a total of two hours of labor ( burden) time for each model run. Table 1. Enforceable Consent Agreement Requirements for Ethylene Dichloride Tier I FLAPs Testing A. Acute toxicity ( inhalation) based on 799.9135 B. Acute neurotoxicty ( inhalation) based on 799.9620 C. Developmental toxicitya Program Review Testing D. PKIMECH data to support model validation and verification oforal to inhalation extrapolation for the following data needs in the F344 rat a) subchronic toxicity, b) subchronic neurotoxicity, and c) reproductive toxicity. ( Requires 4 separate studies).

E. PBPK model simulations to validate model Tier II Testing and/ or Extrapolations F. Subchronic toxicity, extrapolation of extant data ( Daniel et al. 1994) from oral to inhalation route.

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U. Subchronic neurotoxicity ( oral), based on 799.9620 H. Subchronic neurotoxicity extrapolation of oral data to inhalation I. Reproductive toxicity ( oral), based on 799.9380 J. Reproductive toxicity extrapolation oforal data from study to inhalation K. Reproductive toxicity extrapolation ofextant literature data to inhalation a Data from existing studies Payan etal. ( 1995) and Rao et al. ( 1980) deemed adequate to fulfill this requirement. No new testing is required.

Step 1. Estimate Administrative Costs To estimate the testing costs, the following approach was used: ° For testing required to obtain necessary endpoint data, cost estimates for the testing protocols specified in the ECA were used. These were obtained from a database of test cost information maintained by EPAB. All test costs have been updated to Q4 $ 2001 using the Bureau of Labor Statistics Employment Cost Index. In some cases test costs were available for tests conducted via a different route from that required in the ECA ( e. g., gavage instead of drinking water). In such cases, the costs for the route most similar to that required in the ECA were used. Inmost cases this likely results in a higher estimate of costs compared to the actual route required in the ECA. To the extent this is true, the costs ofthe required tests may be overstated. Because administrative burden is calculated as a function ofadministrative costs, it is possible that the burdens too, are overstated.

° For testing required to support the PBPK modeling ( i. e., the five studies specified in Appendix C. I of the ECA), an expert toxicologist reviewed the study procedure and developed a best professional estimate of the laboratory cost of performing the testing ( EPAB 2000). These costs are shown in Table 2. Table 2. Pharmacokinetic Studies for Ethy~ neDichioride Study Species Cost Range ($ 2001)

Best Low High Study I Demonstration of periodicity following repeated inhalation exposure Rats $ 43,290 $ 34,727 $ 52,523 Study 2 Demonstration of periodicity following repeated oral exposures to ethylene dichloride by corn oil gavage Rats $ 12,335 $ 9,037 $ 15,725 Study 3 Demonstration of periodicity following repeated oral exposure to ethylene dichloride by aqueous gavage Rats $ 12,335 $ 9,037 $ 15,725 Study 5 Determination of partition coefficients Rat brain, kidney, testes, ovarya $ 6,152 $ 5,173 $ 7,213 Total Costs $ 74,112 $ 57,974 $ 91,186 a Based on costs estimated for obtaining partition coefficients formouse blood, rat brain, rat spleendeveloped for the ECA for l. l. 2 TCE ( EPAB 2000). Source: EPAB ( 2000).

The estimated costs of testing are presented in Table 3. The paragraphs that follow provide explanatory detail on the cost estimate methodology for each component of the tiered testing requirements for ethylene dichioride.

Tier IHAPs Testing A. Acute toxicity ( inhalation) based on 799.9135, as annotated in Appendix D. 1 of the ECA.

Costs for this test are based on existing costs for 799.9135 for rats via inhalation. The best estimate of the cost for this testing element is $ 93,889.

B. Acute neurotoxicity ( inhalation) based on 799.9620, as annotated in Appendix D. 2 of the ECA Costs for this test are based on existing costs for 799.9620 for rats via inhalation. The best estimate of the cost for this testing element is $ 103,108.

C. Developmental toxicity. The ECA indicates that extant data reported in Payan et al. ( 1980) in rats and Rao et al. ( 1980) in rabbits fulfills the testing requirement. See Appendix E. 3 of the ECA. There are no additional costs.

4 Tier I Program Review Testing D. PKIMECH data to support model validation and verification of oral to inhalation extrapolation for the following data needs in the F344 rat: a) subchronic toxicity, b) subchronic neurotoxicity, c) reproductive toxicity.

Costs for this component of the testing requirements are represented by the costs for Appendix C. 1 ( ofthe ECA) studies 1 through 4 for rats. The costs for these tests are based on costs developed for the ECA for 1,1 ,2 Trichloroethane ( EPAB 2000). The best estimate of the cost for this testing element is $ 74,111.

E. PBPK model simulations.

It has been assumed that the burden associated with model simulations and development will be 24 hours.

Tier II Testing and/ or Extrapolation Reporting F. Subchronic toxicity, extrapolation of extant oral data to inhalation, based on Appendix C. 2 and C. 6 oftheECA.

This requirement relates to extrapolation of testing results from existing data contained in Daniels et al. ( 1984). The extrapolation of data generated from oral route testing to obtain inhalation data is done via the PBPK model. Collecting the necessary data, calculating the model, and generating or recording the output are estimated to require a total of two hours of labor time. This labor time will involve a 20/ 60/ 20 mix of managerial, technical, and clerical time, hence the two hours of labor time has been valued at the weighted average labor rate for these three categories of labor, which is $ 69.28 per hour ($ 2001). The cost ofthis requirement is estimated to be $ 139.

G. Subchronic neurotoxicity ( oral), based on 799.9620, as annotated in Appendix D. 2 of the ECA.

The cost estimate for this testing are based on costs for 799.9620 reported in the HAPs Economic Analysis ( EA). As noted in the EA, the costs are based on costs for the similar 870.6200 protocol ( Neurotoxicity Screening Battery, Subchronic). Costs for that protocol, however, were available for the dietary route only. These costs are probably somewhat higher than the costs for the oral route, which is specified in Appendix D. 2 of the ECA as drinking water. The best estimate of the costs for 799.9620 ( subchronic) via the oral route is $ 145,373.

5 H. Subchronic neurotoxicity, extrapolation of oral data to inhalation, as annotated in Appendix C of the ECA.

See explanation of costs for testing elementG above. The cost of this requirement is estimated to be $ 139.

I. Reproductive toxicity ( oral), based on 799.9380, as annotated in Appendix D. 3 of the ECA.

The cost estimate for this testing was based on costs for 799.9380 reported in the HAPs EA. As noted in the EA, the costs are based on costs for the similar 870.3800 protocol ( Reproduction/ Fertility Effects). Costs for that protocol, however, were available for the gavage route only. These costs are probably somewhat higher than the costs for the oral route, which is specified in Appendix D. 3 of the ECA as drinking water. The best estimate ofthe costs for 799.9380 via the oral route at $ 506,837.

J. Reproductive toxicity extrapolation of oral data to inhalation, as annotated in Appendix C of the ECA.

See explanation of costs for testing element G above. This element requires extrapolation of the oral data obtained under I above. The cost of this requirement is estimated to be$ 139.

K. Reproductive toxicity extrapolation of oral data to inhalation, as annotated in Appendix C of the ECA.

See explanation of costs for testing element G above. This element requires extrapolation of extant literature data from the oral to inhalation route. The cost of this requirement is estimated to be $ 139.

Step 2. Estimate Burden Administrative burden associated with the tests conducted is calculated by multiplying the cost of testing by 25 percent and then dividing this cost by the weighted average labor rate of $ 69.28. These estimates are shown in Table 3.

Additional burden is estimated to occur as a result ofthe development and execution of the PBPK model ( see item D. in Table 1 ofthis report). It is estimated to take 24 hours to run PBPK model simulations and to refine the PBPK model. Once the model is developed, each run of the model to extrapolate from oral to inhalation data is estimated to take 2 hours ( items F, H, 3, and K in Table 1 of this report).

6 Table 3. Summary of Costs and Burdens for ECA for Ethylene Dichloride Testing Segment I Required testing Cost ($ 2001) Admin. Burden ( Hrs) Other Burden ( Hrs)

HAPs Testing A. Acute toxicity ( inhalation) based on 799.9135 $ 93,889 339

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B. Acute neurotoxicity ( inhalation) based on 799.9620 $ 103,108 372

C. Developmental toxicitya Subtotal $ 196,997 711 Program Review Testing D. PK/ MECH data to support model validation and verification of oral to inhalation extrapolation for the following data needs in the P344: ( a) subchronic toxicity, ( b) subchronic neurotoxicity, and ( c) reproductive toxicity. $ 74,111 267 E. PBPK model simulations to validate model $ 1,632  24 Subtotal $ 145,020 291 Tier II Testing and/ or Extrapolation Reporting F. Subchronic neurotoxicity, extrapolation of extant data $ 139  2 .

G. Subchronic neurotoxicity ( oral), based on 799.9620 $ 145,373 525 H. Subchronic neurotoxicity extrapolation oforal data to inhalation $ 139  2 I. Reproductive toxicity ( oral), based on 799.9380 $ 506,837 1,829 3. Reproductive toxicity extrapolation of oral data from I. above to inhalation $ 139  2 K. Reproductive toxicity extrapolation of extant data to inhalation $ 139  2 Subtotal $ 652,766 2,362 TOTAL ( may not add due to rounding) $ 994,783 3,364 a Data from existing studies Payan et al. ( 1995) and Rao et al. ( 1980) deemed adequate to fulfill this requirement. No new testing is required.

7 Results The total estimated burden for the ECA is 3,364 hours.

References EPAB 1997. Economics and Policy Analysis Branch. Economic Assessment for the Amended PrOposed TSCA Section 4( a) Test Rule for 21 Hazardous Air Pollutants. EPA/ OPPT/ EETD/ EPAB, November 14, 1997.

EPAB 2000. Economics and Policy Analysis Branch. Burden Estimates for Enforceable Consent Agreement for 1,1,2 trichloroethane. EPA/ OPPT/ EETD/ EPAB, February 14, 2000.

EPAB 2001. Economics and Policy Analysis Branch. Economic Analysis for Renewed Infromation Collection Request for the TESSCA Section 5( a)( 2) Significant New Use Rule. EPAJOPPT/ EETD/ EPAB, September 2001.

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