[Federal Register Volume 86, Number 103 (Tuesday, June 1, 2021)]
[Proposed Rules]
[Pages 29212-29216]
[FR Doc No: 2021-11376]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 86, No. 103 / Tuesday, June 1, 2021 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0379; Project Identifier MCAI-2021-00068-R]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2016-12-51, which applies to all Airbus Helicopters Model AS332L2 and
Model EC225LP helicopters. AD 2016-12-51 prohibits all further flight
of Model AS332L2 and Model EC225LP helicopters. AD 2016-12-51 was
prompted by an accident in which the main rotor hub detached from the
main gearbox (MGB). Since the FAA issued AD 2016-12-51, the design
approval holder has developed procedures that address failure of the
main rotor system. This proposed AD would require replacing certain
second stage planet gear assemblies, removing certain epicyclic
modules, installing a full flow magnetic plug (FFMP), revising the
existing rotorcraft flight manual (RFM) for your helicopter,
repetitively inspecting the MGB particle detectors, repetitively
inspecting the MGB oil filter and oil cooler, and corrective action if
necessary, as specified in a European Union Aviation Safety Agency
(EASA) AD, which is proposed for incorporation by reference (IBR). The
actions specified in the proposed AD would terminate the flight
prohibition. The FAA is proposing this AD to address the unsafe
condition on these products.

DATES: The FAA must receive comments on this proposed AD by July 16,
2021.

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 https://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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For material that is proposed for IBR in this AD, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999
000; email<EMAIL_ADDRESS>internet www.easa.europa.eu. You may
find this IBR material on the EASA website at https://ad.easa.europa.eu. You may view this material at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2021-0379.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0379; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Mahmood Shah, Aviation Safety
Engineer, Fort Worth ACO Branch, FAA, 10101 Hillwood Pkwy., Fort Worth,
TX 76177; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0379; Project Identifier
MCAI-2021-00068-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this proposal.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Mahmood Shah, Aviation Safety Engineer, Fort Worth ACO Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Any commentary that the FAA receives that
is not specifically designated as CBI will be placed in the public
docket for this rulemaking.

Discussion

    The FAA issued AD 2016-12-51, Amendment 39-18578 (81 FR 43479, July
5, 2016) (AD 2016-12-51), which applies to all Airbus Helicopters Model
AS332L2 and EC225LP helicopters. AD 2016-12-51 prohibits all further
flight of Airbus Helicopters Model AS332L

and EC225LP helicopters. The FAA issued AD 2016-12-51 to address an
accident involving an EC225LP helicopter in which the main rotor hub
detached from the MGB. The Airbus Helicopters Model AS332L2 helicopter
has a similar design to the affected Model EC225LP helicopter,
therefore, this model may be subject to the unsafe condition revealed
on the Model EC225LP helicopter.

Actions Since AD 2016-12-51 Was Issued

    Since the FAA issued AD 2016-12-51, the design approval holder has
developed procedures that address failure of the main rotor system.
These procedures terminate the flight prohibition required by AD 2016-
12-51. In addition, after AD 2016-12-51 was issued, the FAA issued an
Alternate Means of Compliance (AMOC) letter dated September 7, 2017,
which addressed the flight prohibition required by paragraph (e) of AD
2016-12-51. The AMOC letter lifted the flight prohibition and allowed
operation of the affected helicopter models provided the conditions
specified in the AMOC letter were followed, which include repetitive
inspections that have no terminating action. This proposed AD includes
terminating action for certain repetitive inspections.
    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2017-0134R2, dated April 16, 2020
(EASA AD 2017-0134R2) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for all Airbus Helicopters Model AS332L2 and EC225LP helicopters.
    This proposed AD was prompted by an accident involving a Model
EC225LP helicopter in which the main rotor hub detached from the MGB.
The FAA is proposing this AD to address failure of the main rotor
system, which would result in loss of control of the helicopter. See
the MCAI for additional background information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2017-0134R2 references procedures for replacing certain
second stage planet gear assemblies with serviceable parts; removing
certain epicyclic modules from service; modifying the helicopter by
installing an FFMP; revising the RFM to prohibit MGB particle burning
in-flight; repetitively inspecting the FFMP and MGB particle detectors
for metal particles, analyzing any metal particles that are found, and
corrective action; and repetitively inspecting the MGB oil filter and
oil cooler for particles and corrective action. The corrective actions
include replacing an affected MGB with a serviceable MGB. EASA AD 2017-
0134R2 also provides terminating action for certain repetitive
inspections.
    Airbus Helicopters has issued Emergency Alert Service Bulletin
EC225 05A049, Revision 6, dated July 25, 2017; and Emergency Alert
Service Bulletin AS 332 05.01.07, Revision 6, dated July 27, 2017. The
service information specifies procedures for, among other things,
replacing the MGB.
    This material 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.

FAA's Determination and Requirements of This Proposed AD

    These products have been approved by the aviation authority of
another country, and are approved for operation in the United States.
Pursuant to the bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD after evaluating all the
relevant information and determining the unsafe condition described
previously is likely to exist or develop in other products of these
same type designs.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2017-0134R2 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD and except as discussed under ``Differences
Between this Proposed AD and the MCAI.''

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2017-
0134R2 will be incorporated by reference in the FAA final rule. This
proposed AD would, therefore, require compliance with EASA AD 2017-
0134R2 in its entirety, through that incorporation, except for any
differences identified as exceptions in the regulatory text of this
proposed AD. Using common terms that are the same as the heading of a
particular section in the EASA AD does not mean that operators need
comply only with that section. For example, where the AD requirement
refers to ``all required actions and compliance times,'' compliance
with this AD requirement is not limited to the section titled
``Required Action(s) and Compliance Time(s)'' in the EASA AD. Service
information specified in EASA AD 2017-0134R2 that is required for
compliance with EASA AD 2017-0134R2 will be available on the internet
at https://www.regulations.gov by searching for and locating Docket No.
FAA-2021-0379 after the FAA final rule is published.

Differences Between This Proposed AD and the MCAI

    Although the service information referenced in EASA AD 2017-0134R2
specifies to return affected planetary gear assemblies to the
manufacturer for module overhaul, this proposed AD does not include
that requirement.
    Although the service information referenced in EASA AD 2017-0134R2
specifies that retrofit of the planet gear of the MGB can only be done
by Airbus Helicopters or Airbus Helicopters approved repair centers,
this proposed AD does not include that requirement.
    EASA AD 2017-0134R2 requires operators to ``inform all flight
crews'' of revisions to the RFM, and thereafter to ``operate the
helicopter accordingly.'' However, this AD would not specifically
require those actions.
    FAA regulations require pilots to follow the procedures in the
existing RFM including all updates. 14 CFR 91.9 requires that no person
may operate a civil aircraft without complying with the operating
limitations specified in the RFM. Therefore, including a requirement in
this AD to operate the airplane according to the revised RFM would be
redundant and unnecessary. Further, compliance with such a requirement
in an AD would be impracticable to demonstrate or track on an ongoing
basis; therefore, a requirement to operate the airplane in such a
manner would be unenforceable.

Interim Action

    The FAA considers this proposed AD interim action. If final action
is later identified, the FAA might consider further rulemaking then.

Costs of Compliance

    The FAA estimates that this proposed AD affects 28 helicopters of
U.S. registry. The FAA estimates the

following costs to comply with this proposed AD:

                                     Estimated Costs for Required Actions *
----------------------------------------------------------------------------------------------------------------
            Action                  Labor cost       Parts cost      Cost per product     Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
New proposed actions..........  Up to 6 work-                  $0  Up to $510..........  Up to $14,280.
                                 hours x $85 per
                                 hour = $510.
----------------------------------------------------------------------------------------------------------------
* Table does not include estimated costs for reporting.

    The FAA estimates that it would take about 1 work-hour per product
to comply with the proposed reporting requirement in this proposed AD.
The average labor rate is $85 per hour. Based on these figures, the FAA
estimates the cost of reporting the inspection results on U.S.
operators to be $2,380, or $85 per product.
    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of any
required actions. The FAA has no way of determining the number of
helicopters that might need these on-condition actions:

                 Estimated Costs of On-Condition Actions
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
40 work-hours x $85 per hour = $3,400.        $295,000         $298,400
------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators. The FAA does not control warranty
coverage for affected operators. As a result, the FAA has included all
known costs in the cost estimate.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this proposed AD
is 2120-0056. The paperwork cost associated with this proposed AD has
been detailed in the Costs of Compliance section of this document and
includes time for reviewing instructions, as well as completing and
reviewing the collection of information. Therefore, all reporting
associated with this proposed AD is mandatory. Comments concerning the
accuracy of this burden and suggestions for reducing the burden should
be directed to Information Collection Clearance Officer, Federal
Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-
1524.

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.
    The FAA is 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

    The FAA 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) Would not affect intrastate aviation in Alaska, and
    (3) Would 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:
0
a. Removing Airworthiness Directive 2016-12-51, Amendment 39-18578 (81
FR 43479, July 5, 2016); and
0
b. Adding the following new airworthiness directive:

Airbus Helicopters: Docket No. FAA-2021-0379; Project Identifier
MCAI-2021-00068-R.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by July 16, 2021.

(b) Affected ADs

    This AD replaces AD 2016-12-51, Amendment 39-18578 (81 FR 43479,
July 5, 2016 (AD 2016-12-51)).

(c) Applicability

    This AD applies to all Airbus Helicopters Model AS332L2 and
EC225LP helicopters, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 6320, Main Rotor
Gearbox.

(e) Reason

    This AD was prompted by an accident involving a Model EC225LP
helicopter in which the main rotor hub detached from the main
gearbox. The FAA is issuing this AD to address failure of the main
rotor system, which would result in loss of control of the
helicopter.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2017-0134R2, dated April 16, 2020 (EASA AD 2017-0134R2).

(h) Exceptions to EASA AD 2017-0134R2

    (1) Where EASA AD 2017-0134R2 refers to the effective dates
specified in paragraphs (h)(1)(i) through (v) of this AD, this AD
requires using the effective date of this AD.
    (i) The effective date of EASA AD 2017-0134R2.
    (ii) October 13, 2016 (the effective date of EASA AD 2016-0199,
dated October 7, 2016).
    (iii) March 20, 2017 (the effective date of EASA AD 2017-0050-E,
dated March 17, 2017).
    (iv) June 30, 2017 (the effective date of EASA AD 2017-0111,
dated June 23, 2017).
    (v) August 1, 2017 (the effective date of EASA AD 2017-0134,
dated July 27, 2017).
    (2) The ``Remarks'' section of EASA AD 2017-0134R2 does not
apply to this AD.
    (3) Where any service information referred to in EASA AD 2017-
0134R2 specifies to discard certain parts after they have been
removed from the helicopter, this AD requires removing those parts
from service.
    (4) Where paragraph (2) of EASA AD 2017-0134R2 specifies to
replace a part before exceeding the applicable ``new service life
limit,'' this AD requires removing that part from service.
    (5) Where any service information referred to in EASA AD 2017-
0134R2 specifies to return certain parts to the manufacturer,
including for overhaul, after they have been removed from the
helicopter, this AD does not include that requirement.
    (6) Where EASA AD 2017-0134R2 refers to flight hours (FH), this
AD requires using hours time-in-service.
    (7) Where any service information referred to in EASA AD 2017-
0134R2 specifies to perform a metallurgical analysis and contact the
manufacturer if unsure about the characterization of the particles
collected, this AD does require characterization of the particles
collected, however this AD does not require contacting the
manufacturer to determine the characterization of the particles
collected.
    (8) Where EASA AD 2017-0134R2 requires actions during each
``after last flight'' of the day (ALF) inspection, this AD requires
those actions before the first flight of each day.
    (9) Where any service information referred to in EASA AD 2017-
0134R2 specifies to do the actions identified in paragraphs
(h)(9)(i) through (iv) of this AD, this AD does not include those
requirements.
    (i) Watch a video for removing the grease from the full flow
magnetic plug (FFMP), using a cleaning agent, and collecting
particles.
    (ii) Return affected planetary gear assembly to the manufacturer
for module overhaul.
    (iii) Contact the approved repair station/Airbus Helicopters if
the reason for a repair to an epicyclic module is unknown and
inform/contact Airbus Helicopters.
    (iv) Contact the approved repair station/Airbus Helicopters
depending on who performed the last overhaul (RG) to determine if a
repair has been done on the second stage planet gears since new.
    (10) Where any service information referred to in EASA AD 2017-
0134R2 specifies that retrofit of the planet gear of the main
gearbox (MGB) can only be done by Airbus Helicopters or Airbus
Helicopters approved repair centers, this AD does not require that
the retrofit of the planet gear be done only by Airbus Helicopters
or Airbus Helicopters approved repair centers. For this AD the
retrofit can also be done by an FAA-approved repair station.
    (11) Where paragraph (5) of EASA AD 2017-0134R2 specifies
accomplishing the FFMP additional work within 3 months after August
1, 2017, this AD requires accomplishing the FFMP additional work
within 4 months after the effective date of this AD.
    (12) Where paragraph (6) of EASA AD 2017-0134R2 specifies to
``inform all flight crews and, thereafter, operate the helicopter
accordingly,'' this AD does not require those actions.
    (13) Where any service information referred to in EASA AD 2017-
0134R2 specifies that if any 16NCD13 particles are found you are to
take a 1-liter sample of oil and send it to the manufacturer, this
AD does not require those actions.
    (14) Where any service information referred to in EASA AD 2017-
0134R2 specifies ``Do not resume flights until corrective action(s)
are agreed by Airbus Helicopters,'' or to contact Airbus Helicopters
before resuming flights ``if further particles are collected during
the close monitoring period,'' for this AD, you must repair before
further flight using a method specified in paragraph (h)(14)(i) or
(ii) of this AD.
    (i) In accordance with FAA approved procedures.
    (ii) In accordance with the procedures specified in Appendix
4.A., Particle Analysis, of Airbus Helicopters Emergency Alert
Service Bulletin EC225 05A049, Revision 6, dated July 25, 2017; or
Emergency Alert Service Bulletin AS 332 05.01.07, Revision 6, dated
July 27, 2017, as applicable, except as required by paragraphs
(h)(5), (7), and (13) of this AD.
    (15) Where the service information identified in EASA AD 2017-
0134R2 specifies to report inspection results to Airbus Helicopters,
for this AD, report the inspection results at the applicable time
specified in paragraph (h)(15)(i) or (ii) of this AD.
    (i) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after the date of the
inspection.
    (ii) If the inspection was done before the effective date of
this AD: Submit the report within 30 days after the effective date
of this AD.

(i) Credit for Previous Actions

    (1) This paragraph provides credit for the actions specified in
paragraph (4) of EASA AD 2017-0134R2, if those actions were
performed before the effective date of this AD using Airbus
Helicopters Emergency Alert Service Bulletin AS332 ASB 63.00.83 or
EC225 ASB 63A030, both Revision 1, both dated October 7, 2016.
    (2) Corrective action(s) for the inspections required by
paragraphs (8) and (10) of EASA AD 2017-0134R2 accomplished on a
helicopter before the effective date of this AD, in accordance with
Paragraph 3.B. and Appendix 4.A. of the Accomplishment Instructions
of the applicable Airbus Helicopters service information specified
in paragraphs (i)(2)(i) through (viii) of this AD, as applicable,
are acceptable to comply with the requirements of paragraph (11) of
EASA AD 2017-0134R2 for that helicopter, but only for the corrective
actions for the inspections required by paragraphs (8) and (10) of
EASA AD 2017-0134R2.
    (i) Emergency Alert Service Bulletin AS332 ASB 05.01.07,
Revision 2, dated October 7, 2016.
    (ii) Emergency Alert Service Bulletin AS332 ASB 05.01.07,
Revision 3, dated February 25, 2017.
    (iii) Emergency Alert Service Bulletin AS332 ASB 05.01.07,
Revision 4, dated March 17, 2017.
    (iv) Emergency Alert Service Bulletin AS332 ASB 05.01.07,
Revision 5, dated June 23, 2017.
    (v) Emergency Alert Service Bulletin EC225 05A049, Revision 2,
dated October 7, 2016.
    (vi) Emergency Alert Service Bulletin EC225 05A049, Revision 3,
dated February 25, 2017.
    (vii) Emergency Alert Service Bulletin EC225 05A049, Revision 4,
dated March 17, 2017.
    (viii) Emergency Alert Service Bulletin EC225 05A049, Revision
5, dated June 23, 2017.

(j) Special Flight Permit

    Special flight permits, as described in 14 CFR 21.197 and
21.199, are prohibited.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, 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 manager of the International Validation

Branch, send it to the attention of the person identified in
paragraph (l)(2) of this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) 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.

(l) Related Information

    (1) For EASA AD 2017-1034R2, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu. You may
view this material at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX
76177. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. This material may be found in the AD docket
on the internet at https://www.regulations.gov by searching for and
locating Docket No. FAA-2021-0379.
    (2) For more information about this AD, contact Mahmood Shah,
Aviation Safety Engineer, Fort Worth ACO Branch, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
    Issued on May 21, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-11376 Filed 5-28-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: July 31, 2006 (Volume 71, Number 146)]
[Notices]
[Page 43150-43154]
[DOCID:fr31jy06-67]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2006-0597; FRL-8204-5]

Proposed Approval of the Advanced Mixed Waste Treatment Project's
Transuranic Waste Characterization Program at Idaho National Laboratory

AGENCY: Environmental Protection Agency.

ACTION: Notice of availability; opening of public comment period.

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

SUMMARY: The Environmental Protection Agency (``EPA'' or ``we'') is
announcing the availability of, and soliciting public comments for 45
days on, the proposed approval of the radioactive, transuranic
(``TRU'') waste characterization program implemented by the Advanced
Mixed Waste Treatment Project (``AMWTP'') at Idaho National Laboratory
(``INL''). This waste is intended for disposal at the Waste Isolation
Pilot Plant (``WIPP'') in New Mexico. In accordance with the WIPP
Compliance Criteria, EPA evaluated the AMWTP/INL's characterization of
TRU debris and solid waste from AMWTP/INL during an inspection
conducted March 27-March 31, 2006. Using the systems and processes
developed as part of the Department of Energy's (``DOE's'') Carlsbad
Field Office (``CBFO''), EPA verified whether DOE could adequately
characterize TRU waste consistent with the Compliance Criteria. The
results of EPA's evaluation of the AMWTP/INL program and the proposed
approval are described in EPA's inspection report, which is available
for review in the public dockets listed in ADDRESSES. We will consider
public comments received on or before the due date mentioned in DATES.
    This notice summarizes the waste characterization processes
evaluated by EPA and EPA's proposed approval. As required by 40 CFR
194.8, at the end of a 45-day comment period, EPA will evaluate public
comments received, finalize the report responding to the relevant
public comments, and issue the final report and an approval letter to
DOE's CBFO. Based on previous EPA inspections and approvals, AMWTP/INL
is currently approved to dispose of debris and solid waste at WIPP.
AMWTP/INL is permitted to continue waste characterization and disposal
in accordance with prior site approvals

while EPA establishes a baseline approval.

DATES: Comments must be received on or before September 14, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2006-0597, by one of the following methods:
     http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
     E-mail: to<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>
     Mail: Air and Radiation Docket and Information Center,
Environmental Protection Agency, Mailcode: 6102T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
    Instructions: Direct your comments to Attn: Docket ID No. EPA-HQ-
OAR-2006-0597. The Agency's policy is that all comments received will
be included in the public docket without change and may be made
available online at http://www.regulations.gov, including any personal

information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through
http://www.regulations.gov or e-mail. The www.regulations.gov Web site is an

``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be

automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm
.

    Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some

information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
at http://www.regulations.gov or in hard copy at the Air and Radiation Docket

in the EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301
Constitution Ave., NW., Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the Air and
Radiation Docket is<PHONE_NUMBER>. These documents are also available
for review in hard-copy form at the following three EPA WIPP
informational docket locations in New Mexico: In Carlsbad at the
Municipal Library, Hours: Monday-Thursday, 10 a.m.-9 p.m., Friday-
Saturday, 10 a.m.- 6 p.m., and Sunday, 1 p.m.-5 p.m., phone number:
505-885-0731; in Albuquerque at the Government Publications Department,
Zimmerman Library, University of New Mexico, Hours: Vary by semester,
phone number:<PHONE_NUMBER>; and in Santa Fe at the New Mexico State
Library, Hours: Monday-Friday, 9 a.m.-5 p.m., phone number: 505-476-
9700. As provided in EPA's regulations at 40 CFR Part 2, and in
accordance with normal EPA docket procedures, if copies of any docket
materials are requested, a reasonable fee may be charged for
photocopying.

FOR FURTHER INFORMATION CONTACT: Rajani Joglekar, Radiation Protection
Division, Center for Federal Regulations, Mail Code 6608J, U.S.
Environmental Protection Agency, 1200 Pennsylvania Avenue, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

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

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the

information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

II. Background

    DOE is developing the WIPP near Carlsbad in southeastern New Mexico
as a deep geologic repository for disposal of TRU radioactive waste. As
defined by the WIPP Land Withdrawal Act (LWA) of 1992 (Pub. L. 102-
579), as amended (Pub. L. 104-201), TRU waste consists of materials
containing processes having atomic numbers greater than 92 (with half-
lives greater than twenty years), in concentrations greater than 100
nanocuries of alpha-emitting TRU isotopes per gram of waste. Much of
the existing TRU waste consists of items contaminated during the
production of nuclear weapons, such as rags, equipment, tools, and
sludges.
    On May 13, 1998, EPA announced its final compliance certification
decision to the Secretary of Energy (published May 18, 1998, 63 FR
27354). This decision stated that the WIPP will comply with EPA's
radioactive waste disposal regulations at 40 CFR part 191, Subparts B
and C.
    The final WIPP certification decision includes conditions that (1)
prohibit shipment of TRU waste for disposal at WIPP from any site other
than the Los Alamos National Laboratories (LANL) until the EPA
determines that the site has established and executed a quality

assurance program, in accordance with Sec. Sec.  194.22(a)(2)(i),
194.24(c)(3), and 194.24(c)(5) for waste characterization activities
and assumptions (Condition 2 of Appendix A to 40 CFR part 194); and (2)
(with the exception of specific, limited waste streams and equipment at
LANL) prohibit shipment of TRU waste for disposal at WIPP (from LANL or
any other site) until EPA has approved the procedures developed to
comply with the waste characterization requirements of Sec.
194.22(c)(4) (Condition 3 of Appendix A to 40 CFR part 194). The EPA's
approval process for waste generator sites is described in Sec.  194.8.
    In July 2004, EPA promulgated changes to the ``Criteria for the
Certification and Recertification of the Waste Isolation Pilot Plant's
Compliance with Disposal Regulations'' (69 FR 42571-42583, July 16,
2004). These changes went into effect October 14, 2004, which modified
the EPA approval of waste characterization (``WC'') programs at DOE's
TRU waste sites. These revisions provide equivalent or improved
oversight and better prioritization of technical issues in EPA
inspections to evaluate WC activities at DOE WIPP waste generator
sites, and also offer more direct public input into the Agency's
decisions about what waste can be disposed of at WIPP. They do not
modify the technical approach that EPA has employed since the 1998 WIPP
Certification Decision.
    Condition 3 of the WIPP Certification Decision requires that EPA
conduct independent inspections at DOE's waste generator/storage sites
of their TRU waste characterization capabilities before approving their
program and the waste for disposal at the WIPP. The revised inspection
and approval process gives EPA greater (a) discretion in establishing
technical priorities, (b) ability to accommodate variation in the
site's waste characterization capabilities, and (c) flexibility in
scheduling site WC inspections. The Sec.  194.8 changes require that
EPA conduct a baseline inspection at every previously approved TRU site
(such as AMWTP/INL). EPA expects that within two years after the
effective date of October 2004 most of the previously approved TRU
sites (such as Hanford, Los Alamos CCP, and Savannah River Site CCP)
will undergo EPA baseline inspections. Following these inspections, the
Agency will issue a new baseline compliance decision for these sites.
    As part of the baseline inspection, EPA must evaluate each WC
process component (equipment, procedures, and personnel training/
experience) for its adequacy and appropriateness in characterizing TRU
waste destined for the disposal at WIPP. During the inspection, the
site demonstrates its capabilities to characterize TRU waste(s) and its
ability to comply with the regulatory limits and tracking requirements
under Sec.  194.24. The baseline inspection can result in approval with
limitations/conditions or may require follow-up inspection(s) before
approval. The approval must specify what subsequent WC program changes
or expansion should be reported to EPA. The Agency is required to
assign Tier 1 (``TI'') and Tier 2 (``T2'') to the reportable changes
depending on their potential impact on data quality. A T1 designation
requires that the site must notify EPA of proposed changes to the
approved components of an individual WC process (such as radioassay
equipment or personnel), and EPA must also approve the change before it
can be implemented. A WC element with a T2 designation allows the site
to implement changes to the approved components of individual WC
processes (such as visual examination procedures) but requires EPA
notification. The Agency may choose to inspect the site to evaluate
technical adequacy before approval. EPA inspections conducted to
evaluate T1 or T2 changes are follow-up inspections under the authority
of Sec.  194.24(h). In addition to the follow-up inspections, if
warranted, EPA may opt to conduct continued compliance inspections at
TRU waste sites with a baseline approval under the authority of Sec.
194.24(h).
    The revisions to the site inspection and approval process outlined
in Sec.  194.8 require EPA to issue a Federal Register notice proposing
the baseline compliance decision, docket the inspection report for
public review, and seek public comment on the proposed decision for a
period of 45 days. The report must describe the WC processes EPA
inspected at the site, as well as their compliance with Sec.  194.24
requirements.

III. Proposed Baseline Compliance Decision

    From March 27--March 31, 2006, EPA performed a baseline inspection
of TRU waste characterization activities of DOE's AMWTP at INL (EPA
Inspection No. EPA-AMWTP-03.06-8).
    The purpose of EPA's inspection was to verify that AMWTP is
characterizing CH TRU retrievably-stored debris waste (S5000) and solid
waste (S3000), as well as CH TRU newly-generated debris waste (S5000),
from INL properly and in compliance with the regulatory requirements at
40 CFR 194.24. During the inspection, EPA also evaluated AMWTP's use of
the WIPP Waste Information System (``WWIS'') for tracking the contents
of CH TRU waste containers destined for disposal at WIPP. This tracking
ensures that the volume emplaced in the WIPP repository and
characteristics of the emplaced wastes conform to the requirements of
the WIPP LWA and the specific conditions of the WIPP Certification
Decision.
    During the inspection, EPA evaluated the adequacy, implementation,
and effectiveness of AMWTP/INL's waste characterization activities. The
Agency's evaluation focused on the individual components--equipment,
procedures, and personnel training/experience of the following waste
characterization processes: acceptable knowledge (``AK''),
nondestructive assay (``NDA''), visual examination techniques
(``VET''), visual examination/real-time radiography (``VE/RTR''), load
management, and the WWIS. The overall program adequacy and
effectiveness of AMWTP/INL was based on DOE-provided upper-tier
documents.
    EPA evaluated the waste characterization processes at AMWTP/INL for
specific CH TRU waste categories, as follows:
     Acceptable knowledge (AK) and load management for CH
retrievably-stored and newly-generated TRU debris waste (S5000) and
retrievably-stored solids (S3000)
     Visual examination technique (VET) for CH newly-generated
debris waste (S5000)
     Visual examination (VE) as quality control (QC) check of
real-time radiography (RTR) and VE in lieu of RTR for CH retrievably-
stored TRU debris waste (S5000) and solids (S3000)
     RTR for CH retrievably-stored TRU debris waste (S5000) and
solids (S3000)
     Nondestructive assay (NDA) and the WIPP Waste Information
System (WWIS) for CH retrievably-stored and newly-generated TRU debris
waste (S5000) and retrievably-stored solids (S3000) for Integrated
Waste Assay System (IWAS) units Z-211-102 and -103, and CH retrievably-
stored and newly-generated TRU debris waste (S5000) only for IWAS units
Z-390-100 and -101
     Debris waste that has been removed from standard waste
boxes and damaged 55-gallon drums, repackaged in 55-gallon drums for
supercompaction
    Four NDA IWAS units were evaluated. IWAS units Z-211-102 and -103
were evaluated for characterizing debris (S5000) and solid (S3000)
wastes. IWAS units Z-390-100 and 101 were

evaluated for characterizing debris (S5000) only.
    In addition to reviewing individual components (namely, procedures,
and equipment) of each of the WC processes (AK, NDA, VET, VE/RTR, load
management, and the WWIS), the Agency interviewed and reviewed training
records of personnel responsible for compiling data, analyzing waste
contents, operating equipment, and preparing data for WWIS tracking.
EPA also required radioassay replicate analysis on selected containers
from the population of previously analyzed waste containers on the same
system or instrument for the two different waste categories. The
purpose of this replicate testing is to provide EPA with an independent
means to verify that the radioassay equipment being assessed for
approval can provide consistent, reproducible results for the
determination of the quantity of 10 WIPP-tracked radionuclides (241Am,
137Cs, 238Pu, 239Pu, 240Pu, 242Pu, 90Sr, 233U, 234U, and 238U) as well
as TRU alpha concentration. The results of the replicate analysis help
EPA to determine whether:
     The instrument produces results consistent with the
reported total measurement uncertainty (``TMU'') by comparing the
sample standard deviation for a number of replicate measurements taken
over several hours or days to the reported TMU.
     The instrument provides reproducible results over longer
periods of time, such as weeks or months, by comparing the results of
the replicate measurement(s) to the original reported values.
    EPA's inspection team did not identify any findings or concerns
during the inspection, and determined that AMWTP/INL's WC program
activities were technically adequate. EPA is proposing to approve the
AMWTP--INL WC program in the configuration observed during this
inspection and described in this report and in the checklists in
Attachment A. This proposed approval includes the following waste
characterization activities:
    (1) The AK and load management process for CH retrievably-stored
TRU debris and solids.
    (2) Two NDA systems (IWAS units Z-211-102 and Z-211-103) for
assaying CH retrievably-stored or newly-generated debris and solid
wastes in both 55- and 85-gallon containers.
    (3) Two NDA systems (IWAS units Z-390-100 and Z-390-101) for
assaying only CH retrievably-stored or newly-generated debris wastes in
55-gallon containers.
    (4) VE as a QC check of the RTR process for retrievably-stored
debris and solid wastes, including VE performed in lieu of RTR.
    (5) The VET process for newly-generated debris wastes.
    (6) RTR for retrievably-stored S5000 debris and S4000 solid wastes.
    (7) The WWIS for the purpose of data transfer and tracking waste
contents of debris and solid wastes including 100-gallon overpack
containers.
    As required by the new Sec.  194.8 revisions, EPA has assigned
specific requirements for reporting changes to an approved waste
characterization program. As seen from the table below, Tier 1 changes
require EPA approval prior to implementation of the change and may
require EPA inspection to determine technical adequacy. Tier 2 changes
may be implemented prior to EPA approval; however, this type of change
must be reported to EPA quarterly. Any changes to WC activities from
the date of the baseline inspection must be reported to and, if
applicable, approved by EPA, according to the following table:

                       Table 1.--Proposed Tiering of TRU WC Processes Implemented by AMWTP
                                [Based on March 28-30, 2006, Baseline Inspection]
----------------------------------------------------------------------------------------------------------------
                                   AMWTP WC process specific      AMWTP WC process          AMWTP general T2
       WC process  elements                T1 changes           specific T2 changes*            changes*
----------------------------------------------------------------------------------------------------------------
AK including Load Management.....  Any new waste category...  Waste Stream Profile      Changes to site
                                   Changes to WWIS             Forms, including          procedures requiring
                                    algorithms specific to     updates or additions to   approvals by the
                                    load management.           waste stream(s) within    Carlsbad Field Office
                                                               an approved waste         (CBFO) and other
                                                               category (see Section     changes as discussed in
                                                               8.1).                     Section 8.1 of this
                                                              Changes in load            report.
                                                               management status of
                                                               approved waste
                                                               stream(s).
NDA..............................  New equipment or physical  Changes to software for   Changes to site
                                    modifications to           approved equipment (see   procedures requiring
                                    approved equipment.**      Section 8.2).             CBFO approvals and
                                   Changes to approved        Changes to operating       other changes as
                                    calibration range for      range(s) upon CBFO        discussed in Section
                                    approved equipment (see    approval.                 8.2 of this report.
                                    Section 8.2)..
RTR..............................  N/A......................  New equipment or changes  Changes to site
                                                               to approved equipment.    procedures requiring
                                                                                CBFO approvals and
                                                                                other changes as
                                                                                discussed in Section
                                                                                8.3 of this report.
VE and VET.......................  Changes in vendor          Addition of new waste     Changes to site
                                    performing VE and/or VET.  category.                 procedures requiring
                                                              Addition of new            CBFO approvals and
                                                               procedure or site         other changes as
                                                               equipment identifier.     discussed in Section
                                                                                8.4 of this report.
WWIS.............................  N/A......................  N/A.....................  Changes to site
                                                                                procedures requiring
                                                                                CBFO approvals and
                                                                                other changes as
                                                                                discussed in Section
                                                                                8.5 of this report.
----------------------------------------------------------------------------------------------------------------
* Upon receiving EPA approval, AMWTP will report all T2 changes to EPA every three months.
** Modifications to approved equipment include all changes with the potential to affect NDA data relative to
  waste isolation, and exclude minor changes such as the addition of safety-related equipment.

    EPA will notify the public of its evaluation results for proposed
Tier 1 (T1) and Tier 2 (T2) changes on the EPA Web site and by sending
e-mails to the WIPP-NEWS list (see Section 2.0, below, for a brief
discussion of tiering).

All T1 changes that are submitted for approval before their
implementation will be evaluated by EPA and, upon approval, EPA will
post the evaluation results on the EPA Web site and the WIPP-NEWS list,
as described above. EPA will post T2 changes approximately every three
months beginning with the date of EPA's approval of the TRU WC program
implemented at AMWTP/INL. EPA expects the first report of T2 changes at
AMWTP/INL approximately three months from the FR notice accompanying
this report.
    The scope of the AMWTP baseline is based on EPA's inspection of the
WC system of controls. EPA will not approve any changes to the AMWTP
program until after EPA issues the baseline approval. AMWTP is
currently approved to dispose of retrievably-stored and newly-generated
debris (S5000) and retrievably-stored solid (S3000) wastes at the WIPP,
and AMWTP is permitted to continue WC and disposal in accordance with
prior site approvals during the period before EPA approves the final
baseline.

IV. Availability of the Baseline Inspection Report for Public Comment

    EPA has placed the report discussing the results of EPA's
inspection of AMWTP at INL in the public docket as described in
ADDRESSES. In accordance with 40 CFR 194.8, EPA is providing the public
45 days to comment on these documents. The Agency requests comments on
the tiering designations and the proposed approval decision. EPA will
accept public comment on this notice and supplemental information as
described in Section 1.B. above. The EPA will not make a determination
of compliance before the 45-day comment period ends. At the end of the
public comment period, EPA will evaluate all relevant public comment
and revise the inspection report as necessary. The Agency will then
issue an approval letter and the final inspection report, both of which
will be posted on the WIPP Web site. The letter of approval will allow
AMWTP to use the approved TRU waste characterization processes to
characterize waste at INL.
    Information on the certification decision is filed in the official
EPA Air Docket, Docket No. A-93-02 and is available for review in
Washington, DC, and at the three EPA WIPP informational docket
locations in New Mexico (as listed in ADDRESSES). The dockets in New
Mexico contain only major items from the official Air Docket in
Washington, DC, plus those documents added to the official Air Docket
since the October 1992 enactment of the WIPP LWA.

    Dated: July 11, 2006.
Barnes Johnson,
Acting Director, Office of Radiation and Indoor Air.
[FR Doc. E6-12215 Filed 7-28-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 40 (Tuesday, March 1, 2022)]
[Notices]
[Pages 11425-11426]
[FR Doc No: 2022-04210]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2003-0073; FRL9343-01-OLEM]

Proposed Information Collection Request; Comment Request:
Distribution of Offsite Consequence Analysis Information Under the
Clean Air Act (CAA), as Amended, EPA ICR 1981.08, OMB Control Number
2050-0172

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), Distribution of Offsite
Consequence Analysis Information under section 112(r)(7)(H) of the
Clean Air Act (CAA), as amended (EPA No. 1981.08, OMB Control Number
2050-0172), to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. Before doing
so, EPA is soliciting public comments on specific aspects of the
proposed information collection as described in Supplementary
Information. This is a proposed extension of the ICR, which is
currently approved through November 30, 2022. An agency may not conduct
or sponsor and a person is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

DATES: Comments must be submitted on or before May 2, 2022.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2006-0073, to: EPA online using www.regulations.gov (our preferred
method), or by mail to: EPA Docket Center, Environmental Protection
Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC
20460, and (2) OMB via email to [email protected]. Address
comments to OMB Desk Officer for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Wendy Hoffman, Office of Emergency
Management, Mail Code 5104A, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202)
564-8794; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that EPA will be collecting are available in the public
docket for this ICR. The docket can be viewed online at http://www.regulations.gov. Out of an abundance of caution for members of the
public and our staff, the EPA Docket Center and Reading Room is closed
to the public, with limited exceptions, to reduce the risk of
transmitting COVID-19. Our Docket Center staff will continue to provide
remote customer service via email, phone, and webform. For further
information about the EPA's public docket, Docket Center services and
the current status, please visit us online at https://www.epa.gov/dockets. The telephone number for the Docket Center is<PHONE_NUMBER>.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate the accuracy of
the Agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: This ICR is the renewal of the ICR developed for the
final rule, Accidental Release Prevention Requirements; Risk Management
Programs Under the Clean Air Act Section 112(r)(7); Distribution of
Off-Site Consequence Analysis Information. CAA section 112(r)(7)
required EPA to promulgate reasonable regulations and appropriate
guidance to provide for the prevention and detection of accidental
releases and for responses to such releases. The regulations include
requirements for submittal of a risk management plan (RMP) to EPA. The
RMP includes information on offsite consequence analyses (OCA) as well
as other elements of the risk management program.
    On August 5, 1999, the President signed the Chemical Safety
Information, Site Security, and Fuels Regulatory Relief Act
(CSISSFRRA). The Act required the President to promulgate regulations
on the distribution of OCA information (CAA section 112(r)(7)(H)(ii)).
The President delegated to EPA and the Department of Justice (DOJ) the
responsibility to promulgate regulations to govern the dissemination of
OCA information to the public. The final rule was published on August
4, 2000 (65 FR 48108). The regulations imposed minimal information and
recordkeeping requirements.
    In accordance with the final rule, the Federal Government
established 55 reading rooms at Federal facilities geographically
distributed across the United States and its territories. At these
reading rooms, members of the public are able to read, but not
mechanically copy or remove, paper copies of OCA information for up to
10 stationary sources per calendar month. At these reading rooms, the
members of the public may also have access to OCA information that the
Local Emergency Planning Committee (LEPC) in whose jurisdiction the
person lives or works is authorized to provide.
    The final rule also authorizes and encourages state and local
government officials to have access to OCA information for their
official use, and to provide members of the public with read-only
access to OCA sections of RMPs for sources located within the
jurisdiction of the LEPC where the person lives or works and for any
other stationary sources with vulnerability zones extending into the
LEPC's jurisdiction.
    EPA also established a Vulnerable Zone Indicator System (VZIS) that
informs any person located in any state whether an address specified by
that person might be within the vulnerable zone of one or more
stationary sources, according to the data reported in RMPs. The VZIS is
available on the internet. Members of the public who do not have access
to the internet are able to obtain the same information by regular mail
request to the EPA.
    The burden estimates, numbers and types of respondents, wage rates
and unit and total costs for this ICR renewal will be revised and
updated, if needed, during the 60-day comment period while the ICR
Supporting Statement is undergoing review at OMB.

    Form Numbers: None.
    Respondents/affected entities: State and local agencies and the
public.
    Respondent's obligation to respond: Required to obtain or retain a
benefit (40 CFR 1400).
    Estimated number of respondents: 315 (total).
    Frequency of response: As necessary.
    Total estimated burden: 367 hours (per year). Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $16,252 (per year), includes $23 annualized
capital or operation & maintenance costs.
    Changes in the Estimates: Any change in burden or cost resulting
from the 60-day OMB review period will be described and explained in
this section when the updated ICR Supporting Statement is completed.

Donna Salyer,
Director, Office of Emergency Management.
[FR Doc. 2022-04210 Filed 2-28-22; 8:45 am]
BILLING CODE 6560-50-P


Meeting Minutes June 24, 2004 On June 24, 2004 the 2,4 DB Task Force met with the Agency's Special Review and Reregistration Division. The Task Force is comprised of Aceto Agricultural Chemicals Company,

A. H. Marks & Company Ltd., and Atanor S. A. ( Albaugh Inc). The primary function of the meeting was to introduce the Task Force to the reregistration managers. Additional discussion covered clarification of technical registrants and technical questions from the Task Force. The Task Force expressed interest in meeting again in early August, when 2,4 DB would be in Phase 3 of the reregistration process.

Meeting Minutes August 4, 2004 On August 4, 2004 members of the 2,4 DB Task Force met with managers and scientists from the Agency. A representative from Nufarm, Inc. also attended the meeting. Agency attendees involved with the reregistration of 2,4 DB included members from the following divisions: Special Review and Reregistration, Health Effects, Environmental Fate and Effects, and Registration. The Agency's contact from the USDA was also present at the meeting. Discussion topics included comments from the Task Force on the preliminary risk assessment, USDA expression of need, possible study waiver requests, status of registration is the European Union,

and potential expanded use for the chemical.


1. Gowan Company

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

(7/1/2004)

EPA Registration Division contact: James A. Tompkins,<PHONE_NUMBER>

INSTRUCTIONS:  Please utilize this outline in preparing tolerance
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PP2F6429

Summary of Petitions

	EPA has received a pesticide petition (PP2F6429) from Gowan Company,
370 S. Main Street proposing, pursuant to section 408(d) of the Federal
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR
part 180 by establishing a tolerance for residues of

halosulfuron-methyl:methyl 5-{[(4,6-dimethoxy-2-pyrimidinyl)amino]
carbonyl aminosulfonyl}-

3-chloro-l-methyl-l H-pyrazole-4-carboxylate] in or on the raw
agricultural commodity alfalfa, forage at 1 parts per million (ppm) and
alfalfa, hay at 2 parts per million (ppm). EPA has determined that the
petition contains data or information regarding the elements set forth
in section 408(d)(2) of the FFDCA; however, EPA has not fully evaluated
the sufficiency of the submitted data at this time or whether the data
supports granting of the petition.  Additional data may be needed before
EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The metabolism of halosulfuron-methyl as well as
the nature of the residues in plants is adequately understood for
purposes of this tolerance. Metabolism studies were

conducted in three crops, viz.; field com, sugarcane and soybeans.
Metabolism depends on the mode of application. Preemergent applications
result in rapid soil degradation halosulfuron-methyl followed by crop
uptake of the resulting pyrazole moiety. The pyrimidine ring binds
tightly to soil and is eventually converted to carbon dioxide by
microbial degradation. In postemergent applications, little metabolism
and translocation take place resulting in unmetabolized parent compound
as the major residue on the directly treated Joliar surfaces. Very low
residue levels of the metabolite
3-chloro-I-methyl-5-sulfamoylpyrazole-4-carboxylic acid (3-CSA) are
found in the grain.

	2. Analytical method. A practical analytical method, gas chromatography
with a nitrogen

specific detector (TSD) which detects and measures residues
halosulfuron-methyl, is

available for enforcement purposes with a limit of detection that allows
monitoring of food with

residues at or above the levels set in these tolerances. This
enforcement method has been

submitted to the Food and Drug Administration for publication in the
Pesticide Analytical

Manual (PAM II). It has undergone independent laboratory validation and
validation at the

Beltsville laboratory. The Analytical Chemistry Section of the EPA
concluded that the method is

adequate for enforcement. The analytical method is also available for
analyzing meat by products,

which also underwent successful independent laboratory and Beltsville
laboratory

validations.

	3. Magnitude of residues. In alfalfa, maximum forage and hay residues
were approximately 0.6 and 1.1 ppm with a 14 day PHI, respectively.

B. Toxicological Profile

	1. Acute toxicity.  Acute toxicological studies placed the
technical-grade halosulfuron-methyl in Toxicity Category III. A 90-day
feeding study in rats resulted in a lowest-observed-adverse-
effect-level (LOAEL) of 497 milligrams/kilograms/day (mg/kg/day) in
males and 640 mg/kg/day in females, and a no-observed-effect-level
(NOAEL) of 116 mg/kg/day in males and 147

mg/kg/day in females.

	2. Genotoxicty.  Bacterial/mammalian microsomal mutagenicity assays
were performed and found not to be mutagenic. Two mutagenicity studies
were performed to test gene mutation and

found to produce no chromosomal aberrations or gene mutations in
cultured Chinese hamster

ovary cells. An in vivo mouse micronucleus assay did not cause a
significant increase in the

frequency of micronucleated polychromatic erythrocytes in bone marrow
cells. A mutagenicity

study was performed on rats and found not to induce unscheduled DNA
synthesis in primary

rat hepatocytes.

	3. Reproductive and developmental toxicity.  A developmental toxicity
study in rats resulted in a developmental LOAEL of 750 mg/kg/day, based
on decreases in mean litter size and fetal bodyweight, and increases in
resorptions, resorptions/dam, post-implantation loss and in fetal and
litter incidences or soft tissue and skeletal variations, and a
developmental NOAEL of 250

kg/kg/day. Maternal LOAEL was 750 mg/kg/day based on increased incidence
of clinical

observations, reduced body weight gains, and reduced food consumption
and food efficiency.

The maternal NOAEL was 250 mg/kg/day.  A developmental toxicity study in
rabbits resulted in a developmental LOAEL of 150 mg/kg/day, based on
decreased mean litter size and increases in resorptions, resorptions/dam
and postimplantation loss, and a developmental NOAEL of 50 mg/kg/day.
The maternal LOAEL was 150 mg/kg/day based on reduced body weight gain
and reduced food consumption and food efficiency. The maternal NOAEL was
50 mg/kg/day.

A dietary 2-generation reproduction study in rats resulted in parental
toxicity at 223.2 mg/kg/day

in males and 261.4 mg/kg/day in females in the form of decreased body
weights, decreased body

weight gains, and reduced food consumption during the premating period.
Very light effects

were noted in body weight of the offspring at this dose. This effect was
considered to be

developmental toxicity (developmental delay) rather than a reproductive
effect. No effects were

noted on reproductive or other developmental toxicity parameters. The
systemic/ developmental

toxicity LOAEL was 223.2 mg/kg/day in males and 261.4 mg/kg/day in
females; the

systemic/ developmental toxicity NOAEL was 50.4 mg/kg/day in males and
58.7 mg/kg/day in

females. The reproductive LOAEL was greater than 223.2 mg/kg/day in
males and 261.4

mglkg/day in females; the reproductive NOAEL was equal to or greater
than 223.2 mg/kg/day in

males and 261.4 mg/kg/day in females.

	4. Subchronic toxicity.  A 21-day dermal toxicity study in rats
resulted in a NOAEL of 100

mg/kg/day in males and greater than 1,000 mg/kg/day in females. The only
treatment-related

effect was a decrease in body weight gain of the 1,000mg/kglday group in
males.

	5. Chronic toxicity. A 1-year chronic oral study in dogs resulted in a
LOAEL of 40 mg/kg/day based on decreased weight gain and a NOAEL of 10
mg/kg/day for systemic toxicity. A 78-week carcinogenicity study was
performed on mice. Males in the 971.6 mg/kg/day group had

decreased body weight gains and an increased incidence of
microconcretion/mineralization in the

testis and epididymis. No treatment-related effects were noted in
females. Based on these results,

a LOAEL of971.9 mg/kg/day was established in males and NOAELs of 410
mg/kg/day in males

and 1,214.6 mg/kg/day in females were established. The study showed no
evidence of

carcinogenicity. A combined chronic toxicity/carcinogenicity study in
rats resulted in a LOAEL

of 225.2 mg/kg/day in males and 138.6 mg/kg/day in females based on
decreased body weight

gains, and a NOAEL of 108.3 mg/kg/day in males and 56.3 mg/kg/day in
females. The study

showed no evidence of carcinogenicity.

	6. Animal metabolism. EPA stated that the nature of the residue in
ruminants was determined to be adequately understood. In the tissues and
milk of goats, the major extractable residue was the unmetabolized
parent compound. Based on the low residues of the parent compound in
corn grain and the low transfer of residues in the metabolism study,
tolerances on poultry products were not required. In the rat metabolism
study, parent compound was absorbed rapidly but incompletely. Excretion
was relatively rapid at all doses tested with majority of radioactivity
eliminated in the urine and feces by 72 hours. Fecal elimination of
parent was apparently the result of unabsorbed parent.

	7. Metabolite toxicology. The toxicology studies listed below were
conducted with the 3-CSA metabolite. Based on the toxicological data of
the 3-CSA metabolite, EPA concluded that it has

lower toxicity compared to the parent compound and that it should not be
included in the

tolerance expression. The residue of concern is the parent compound
only.

i. A 90-day rat feeding study resulted in a LOAEL in males of >20,000
ppm and a NOAEL of

20,000 ppm (1,400 mg/kg/day). In females, the LOAEL is 10,000ppm (772.8
mg/kg/day) based

on decreased body weight gains and a NOAEL of 1,000ppm (75.8 mg/kg/day).

ii. A developmental toxicity resulted in a LOEL for maternal toxicity
of> 1.000 mg/kg/day based

on the absence of systemic toxicity, a NOAEL of 1,000 mg/kg/day. The
developmental LOEL is

>1,000 mg/kg/day and the NOAEL is 1,000mg/kg/day.

iii. The microbial reverse gene mutation did not produce any mutagenic
effect while the

mammalian cell gene mutation/Chinese hamster ovary cells did not show a
clear evidence of

mutagenic effect in the Chinese hamster ovary cells.

iv. The mouse micronucleus assay did not show any clastogenic or
aneugenic effect.

	8. Endocrine disruption.  No specific tests have been conducted with
halosulfuron-methyl to determine whether the chemical may have an effect
in humans that is similar to an effect produced by a naturally occurring
estrogen or other endocrine effects. However, there were no

significant findings in other relevant toxicity tests, i.e., teratology
and multi-generation

reproduction studies, which would suggest that halosulfuron-methyl
produces effects characteristic of the disruption of the estrogenic
hormone.

C. Aggregate Exposure

	1. Dietary exposure. Tolerances have been established (40 CFR 180.479)
for residues of

halosulfuron-methyl in or on a variety of plant and animal RACs
including field corn at 0.05

ppm, grain sorghum (milo) at 0.05 ppm, sweet com (kernel + cobs with
husks removed) at 0.05

ppm), pop corn grain at 0.05 ppm, sugarcane cane at 0.05 ppm, tree nuts
nutmeat at 0.05 ppm,

pistachio nuts nutmeat at 0.05 ppm, cotton undelinted seed at 0.05 ppm,
rice grain al 0.05 ppm,

melons at 0.1 ppm, and cucurbits at 0.5 ppm; and secondary tolerances in
meat and meat

byproducts at 0.1 ppm (cattle, goats, hogs, horses, and sheep).
Additional tolerances are pending

for fruiting vegetables crop group 8 and beans (dry and snap) at 0.05
ppm, and for asparagus at

0.8 ppm. Tolerances are also established for corn forage and fodder at
0.2 ppm and 0.8 ppm,

respectively, sorghum fodder/stover at 0.1 ppm and rice straw at 0.2
ppm. Additional tolerances

for alfalfa forage and hay of 1 ppm and 2 ppm are being requested with
this petition.

	i. Food.  a. Acute exposure. For purposes of assessing the potential
dietary exposure from food under existing and proposed tolerances,
aggregate exposure is based on the Theoretical

Maximum Residue Contribution (TMRC) which is an estimate of the level of
residues consumed

daily if each food item contained pesticide residues equal to the
tolerance. The calculated TMRC

value using the 99.9111 percentile consumption data was 0.003367 mg/kg
body weight/day for the general US population. This value utilizes only
0.67% of the acute Reference Dose (ARfD) for

all established and proposed tolerances for halosulfuron-methyl. TMRC is
obtained by

multiplying the tolerance levels for each commodity by the daily
consumption of the food forms

of that commodity eaten by the U.S. population and various population
subgroups. In conducting

this exposure assessment, conservative assumptions were made, e.g., 100%
of all commodities

will contain halosulfuron-methyl residues and those residues would be at
the level of their

respective tolerances. This results in a large overestimate of human
exposure. Food consumption

data from DEEM software (Novigen Sciences, Inc.) were used in the
calculation. Field corn and

sorghum forage and fodder are fed to animals, thus exposure of humans to
residues from these

commodities might result if such residues are transferred to meat, milk,
poultry or eggs.

However, based on the results of animal metabolism and the amount of
halosulfuron-methyl

expected in animal feeds, it can be concluded that there is no
reasonable expectation that residues

of halosulfuron-methyl will exceed existing tolerances in meat.

b. Chronic exposure. The chronic Reference Dose (CRID)is 0.1 mg/kg/day.
The calculated

TMRC value using 99.91hpercentile consumption data was 0.000779 mg/kg
body weight/day for

children 1-6 years, the most exposed subpopulation group. This value
utilizes only 0.8% of the

CRfD for all established and proposed tolerances for
halosulfuron-methyl.

c. Short- and intermediate- term exposure. The short-term NOAEL for
females 13+ years and

infants and children is 50 mg/kg/day. Comparing the NOAEL with the
chronic food exposure

from DEEM analysis of 0.000365 mg/kg/day for females 13+ and 0.000779
mg/kg/day for

infants and children results in food MOEs of 136,986 and 61,184
respectively. The

intermediate-term NOAEL is 10mg/kg/day, comparing the NOAEL with the
chronic food

exposure from DEEM analysis of 0.000779 mg/kg/day for children (1-6
years old) results in a

food MOE of 12,836.

d. Chronic risk-carcinogenic. Halosulfuron-methyl has been classified as
a Group E chemical

'based upon the lack of evidence of carcinogenicity in mice and rat, and
has been classified as a not likely human carcinogen.]

	ii. Drinking water. There is no Maximum Contaminant Level (MCL)
established for residues of halosulfuron-methy1. It is not listed for
MCL development or drinking water monitoring under the Safe Drinking
Water Act nor is it a target of EPA's National Survey of Wells for
Pesticides. Gowan is not aware of any halosulfuron-methyl detections in
any wells, ponds, lakes or streams resulting from its use in the United
States. The estimated drinking water environmental concentrations (DWEC)
in ground water (acute and chronic) is 0.008 µg/L. The estimated DWECs
(acute and chronic) for surface water are 4.3 µg/L and 1.1 µg/L,
respectively. These estimates are based on a maximum application rate of
0.063 lbs active per acre, which may be  applied twice per season.

a. Acute exposure and risk. Acute DWLOCs have been calculated for
exposure to halosulfuron-methyl in drinking water for the relevant
population subgroups of females 13+ years and infants and children. The
acute DWLOC is 15,000 µg/L for females 13+ years and 5,000 µg/L for
infants and children. The calculated DWLOCs are significantly higher
than the DWECs for ground water (0.008 µg/L)and surface water (4.3
µg/L).

b. Chronic exposure and risk. Chronic DWLOCs have been calculated for
exposure to

halosulfuron-methyl in drinking water for the US population (48 states)
and the relevant

subgroups of females 13+ years and infants and children. The chronic
DWLOC is 3,500 µg/L

for the U.S. population, 3,000 µ g/L for females 13+ years, and 1,000
µg/L for infants and

children. The calculated DWLOCs are significantly higher than the DWECs
for ground water (0.008 µg/L) and surface water (1.1 µg/L).

c. Short and intermediate term exposure and risk. Short-tern and
intermediate-term DWLOCs

have been calculated for exposure to halosulfuron-methyl in drinking
water for the relevant

population subgroups. The short-term DWLOC is 10,000 µg/L for females
13+ years and 3,700

µg/L for infants and children. The intermediate-term DWLOC is 590 µg/L
for adult males, 57

µg/L for females 13+ years, and 160 µg/L for infants and children. The
calculated intermediate-term DWLOCs are significantly higher than the
chronic DWECs for surface water (1.1 µg/L).

The calculated short-term DWLOCs are significantly higher than the acute
DWECs for ground

water (0.008 µg/L) and surface water (4.3 µg/L).

d. Conclusion. EPA has concluded that potential levels of
halosulfuron-methyl in soil and water

do not appear to have significant toxicological effects on humans or
animals and presents a

negligible risk. Based on the very low level of mammalian toxicity, lack
of other toxicological

concerns and low use rates, there is reasonable certainty that no harm
will result from exposure

to halosulfuron-methyl via drinking water sources.]

	2. Non-dietary exposure. [Halosulfuron-methyl is labeled for use on
commercial and residential turf and other non-crop sites. For
residential applicators, short- and intermediate exposure may occur.
Chronic exposure(>6 months of continuous exposure) are not expected.

a. Acute exposure and risk. There is potential for exposure to
halosulfuron-methyl by

homeowner. However, since endpoints for acute dermal or inhalation were
not identified, the

use of halosulfuron-methyl on residential non-food sites is not expected
to pose an unacceptable

acute risk.

b. Chronic exposure and risk. Chronic exposures for residential use of
halosulfuron-methyl are

not expected and a chronic non-dietary endpoint was not identified,
therefore the use on

residential non-food sites is not expected to pose an unacceptable
chronic risk.

c. Short- and intermediate-term exposure and risk. There is potential
for short- or intermediate-term dermal exposure to residential handlers,
therefore residential exposure assessments were conducted to assess the
following post-application exposure scenarios: (a) dermal exposure to

residues on turf; (b) children's incidental non-dietary ingestion of
residues on residential lawn

from hand-to-mouth transfer; (c) children's ingestion of
pesticide-treated turfgrass.

The short-term dermal MOE for residential handlers is 4,200 which is
significantly greater than

the minimum acceptable MOE of 100.

The short-term dermal MOE for exposure from treated lawns for adult
males, adult females, and

children are 390, 330, and 420, respectively, which are significantly
greater than the minimum

acceptable MOE of 100.The intermediate-term dermal MOE for exposure from
treated lawns for

adult males, adult females, and children are 120, 100, and 130,
respectively, which are

significantly greater than the minimum acceptable MOE of 100. Therefore
the use of

halosulfuron-methyl on residential non-food sites is not expected to
pose an unacceptable short or

intermediate-term risk.  The short-and intermediate-term oral MOE for
hand-to-mouth transfer for children are 4,900 and 1,500, respectively,
which are significantly greater than the minimum acceptable MOE of 100.
Therefore the use of halosulfuron-methyl on residential non-food sites
is not expected to

pose an unacceptable short- or intermediate- term risk. The short- and
intermediate- term oral MOE for incidental ingestion by children are
210,000 and 66,000, respectively, which are significantly greater than
the minimum acceptable MOE of 100. Therefore the use on residential
non-food sites is not expected to pose an unacceptable short- or
intermediate- term risk.

D. Cumulative Effects

	Halosulfuron-methyl belongs to the sulfonyl urea class of chemistry.
The mode of action of

halosulfuron-methyl is the inhibition of the plant enzyme acetolactase
synthetase (ALS), which

is essential for the production of required amino acid in plants.
Although other registered sulfonyl ureas may have similar herbicidal
mode of action, there is no information available to suggest that these
compounds exhibit a similar toxicity profile in the mammalian system
that would be cumulative with halosulfuron-methy1.Thus, consideration of
a common mechanism of toxicity is not appropriate at this time. Gowan is
considering only the potential risks of halosulfuron-methyl in its
aggregate exposure assessment.

E. Safety Determination

	1. U.S. population.

i. Acute risk. Aggregate exposure risk includes exposure from food and
water. The risk from acute "food only" exposure is ≤ 1% of the RfD for
all population groups which is less than the EPA's level of concern. The
lowest DWLOC calculated was 5,000 µg/L for infants and children. The
calculated DWLOC for females (13+ years) was 15,000 µg/L. For both
subgroups, the DWLOC is significantly higher than the DWEC for acute
ground water (0.008 µg/L) and surface water (4.3 µg/L), therefore, the
risk from aggregate exposure to halosulfuron-methyl residues from all
anticipated dietary exposure routes does not pose appreciable risks to
human health.

ii. Chronic risk. Aggregate chronic exposure to halosulfuron-methyl from
"food only" utilities

less than 0.8% of the RfD for the most sensitive subgroup, children (1-6
years). The lowest

DWLOC calculated was 1,000 µg/L for infants and children, which is
significantly higher than

the DWEC for chronic ground water (0.008 µg/L) and surface water (1.1
µg/L). Therefore, the

aggregate risk from chronic exposure to halosulfuron-methyl residues
from all anticipated

dietary exposures does not pose appreciable risks to human health.

iii. Short- and intermediate- term risk-

a. Short-term aggregate exposure takes into account

chronic dietary food and water plus short-term residential exposure. For
halosulfuron-methyl,

the EPA has determined that it is appropriate to aggregate exposure via
oral exposure route (food

and water) with those via oral and dermal exposure routes from
residential uses. The MOEs for

"food only" and residential exposure routes are 13,859 and 310 for
females 13+ years. Short-term

DWLOC for females 13+ is 10,000 µg/L, which is substantially higher
than the DWEC for

acute surface water (4.3 µg/L).The food only and residential (oral and
dermal) MOEs are well

above the acceptable short-term aggregate MOE of 100. Therefore,
exposure to halosulfuron-methyl residues resulting from current and
proposed uses does not pose a short-term aggregate

risk.

b. Intermediate-term aggregate exposure takes into account chronic
dietary food and water plus

intermediate-term residential exposure. The MOEs for "food only" and
residential exposure

routes are 29,069 and 120 for adult males, and 28,985 and 102 for
females 13+ years. The

intermediate-term DWLOCs are 590 µg/L and 57 µg/L, respectively, for
adult males and

females 13+. Intermediate-term DWLOCs are substantially higher than the
DWEC for chronic

surface water (1.1 µg/L).The food only and residential (dermal) MOEs
are above the acceptable

short-term aggregate MOE of 100. Therefore, exposure to
halosulfuron-methyl residues

resulting from current and proposed uses does not pose a
intermediate-term aggregate risk.

iv. Aggregate cancer risk. Halosulfuron-methyl has been classified as a
Group E chemical based

upon the lack of evidence of carcinogenicity in mice and rats, and has
been classified as a not

likely human carcinogen.

v. Conclusion. Based upon these risk assessments, Gowan concluded that
there is a reasonable

certainty that no harm will result from aggregate exposure to
halosulfuron-methyl residues

resulting from current and proposed uses.]

	2. Infants and children.  Aggregate Risks for Infants and Chi1dren-

i. Safety factor. FFDCA section 408 provides that EPA may apply an
additional safety factor (up to 10) in the case of threshold effects for
infants and children to account for pre- and post-natal toxicity and the
completeness or the database. Except for the pending request for a
developmental neurotoxicity study, the toxicity data base is complete
for halosulfuron-methyl. Based upon reliable toxicity data, the use or
an additional 10x safety factor is not warranted. Dietary assessments do
not indicate a level of concern for potential risks to infants and
children based upon the low use rates of halosulfuron-methyl and that
the results of field and animal RAC studies conclude that detectable
residues are not expected in human foods.

ii. Acute risk. The acute RfD was determined to be 0.5 mg/kg/day based
upon the

developmental rabbit study. The percent of the RfD occupied is 0.67% for
the U.S. population,

0.72% for females 13+ years, and 1.03% for children 1-6 year, which was
the subpopulation with

the highest exposure. The drinking water level of comparison (DWLOC) for
acute exposure for

infants and children is 5,000 µg/L and is significantly greater than
the maximum concentration of

halosulfuron-methyl in drinking water (0.008 µg/L in ground water and
4.3 µg/L in surface

water).

iii. Chronic risk. The chronic RfD was determined to be 0.1 mg/kg/day
based upon the chronic

dog study. The percent of RfD occupied is 0.8% for the most sensitive
subgroup, children (1-6

years old). The DWLOC for chronic exposure for infants and children is
1,000 µg/L and is

significantly greater than the maximum concentration of
halosulfuron-methyl in drinking water

(0.008 µg/L in ground water and 1.1 µg/L in surface water).

iv. Short- and intermediate- term risk. An aggregate exposure estimate
and risk assessment was

calculated for post-application exposure to halosulfuron-methyl from
treated lawns. Short- term

MOEs for food, residential oral, and residential dermal are 61,184,
4,900, and 420, respectively,

for infants and children. Intermediate-term MOEs for food, residential
oral, and residential

dermal are 12,836, 1,500, and 130, respectively, for children and
infants. The short- and

intermediate- term DWLOCs for infants and children were 3,700 and 160
µg/L, respectively,

which are substantially higher than the DWECs for acute surface water
(4.3 µg/L) and chronic

surface water (1.1 µg/L).

v. Conclusion. Therefore, based on complete and reliable toxicity data
and the conservative

exposure assessment, Gowan concludes that there is reasonable certainty
that no harm will result

to infants and children from aggregate exposure to halosulfuron-methyl
residues with respect to

the proposed new uses on the fruiting vegetable (except cucurbits) crop
group.]

F. International Tolerances

	Maximum residue levels have not been established for residues of
halosulfuron-methyl on alfalfa forage and hay by Canada, Mexico or the
Codex Alimentarius Commission.

 PAGE  2


[Federal Register: March 31, 2010 (Volume 75, Number 61)]
[Rules and Regulations]
[Page 15992-15993]
[DOCID:fr31mr10-2]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 73

[Docket No. FAA-2009-0921; Airspace Docket No. 09-AWA-3]
RIN 2120-AA66

Revision of Prohibited Area P-49; Crawford, TX

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Prohibited Area 49 (P-49) Crawford, TX.
While the United States Secret Service (USSS) recognizes the ongoing
security

requirement for this prohibited area, it considers reducing prohibited
airspace area appropriate at this time. This action restores previously
prohibited airspace to public use within the National Airspace System.

DATES: Effective date 0901 UTC, June 3, 2010.

FOR FURTHER INFORMATION CONTACT: Colby Abbott, Airspace and Rules
Group, Office of System Operations Airspace and AIM, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On October 5, 2009, the Department of the Treasury, USSS, notified
the FAA that while the security requirements for establishing P-49
Crawford, TX (66 FR 16391) remain valid, consideration of a
modification of the existing prohibited area was appropriate. After a
six-month security review of P-49, the USSS determined the dimensions
(boundary and altitude) of the prohibited area could be reduced. This
action responds to that notification.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 73 by revising the legal description for P-49 Crawford, TX. After
conducting a security review of P-49, the USSS notified the FAA to
reduce the boundary and altitude dimensions of the prohibited area.
This action reduces the boundary from a 3 NM radius to a 2 NM radius of
lat. 31[deg]34'45'' N., 97[deg]32'00'' W., and lowers the designated
altitude from ``Surface to but not including 5,000 feet MSL'' to
``Surface to but not including 2,000 feet MSL.''
    Because this action restores previously prohibited airspace to
public use, I find that notice and public procedures under 5 U.S.C.
553(b) are unnecessary as it would only delay the return of the
airspace to public use.
    Section 73.89 of Title 14 CFR part 73 was republished in FAA Order
7400.8S, effective February 16, 2010.
    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.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under Department of Transportation (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, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    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 the
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 amends prohibited airspace in Crawford, Texas.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with paragraph 311c, FAA Order 1050.1E, Environmental Impacts: Policies
and Procedures. This airspace action is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exist that warrant preparation of an environmental
assessment.

List of Subjects in 14 CFR Part 73

    Airspace, Prohibited areas, Restricted areas.

Adoption of Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 73 as follows:

PART 73--SPECIAL USE AIRSPACE

0
1. The authority citation for part 73 continues to read as follows:

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

Sec.  73.89  [Amended]

0
2. Sec.  73.89 is amended as follows:

* * * * *

P-49 Crawford, TX [Revised]

    Boundaries. That airspace within a 2 NM radius of lat.
31[deg]34'45'' N., long. 97[deg]32'00'' W.
    Designated altitudes. Surface to 2,000 feet MSL.
    Time of designation. Continuous.
    Using agency. United States Secret Service, Washington, DC.

    Issued in Washington, DC, on March 25, 2010.
Kelly Neubecker,
Acting Manager, Airspace and Rules Group.
[FR Doc. 2010-7242 Filed 3-30-10; 8:45 am]
BILLING CODE 4910-13-P