[Federal Register Volume 84, Number 191 (Wednesday, October 2, 2019)]
[Notices]
[Pages 52513-52514]
[FR Doc No: 2019-21399]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0573]

Blood Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Blood Products
Advisory Committee (BPAC). The general function of the committee is to
provide advice and recommendations to the Agency on FDA's regulatory
issues related to blood and products derived from blood. The committee
will discuss scientific considerations for cold stored platelet
products intended for transfusion. The meeting will be open to the
public.

DATES: The meeting will be held on November 22, 2019, from 8:30 a.m. to
4:45 p.m.

ADDRESSES: Tommy Douglas Conference Center, 10000 New Hampshire Ave.,
Silver Spring, MD 20993. Answers to commonly asked questions about FDA
advisory committee meetings, including information regarding special
accommodations due to a disability, may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Information about the Tommy Douglas Conference Center may be accessed
at: https://www.tommydouglascenter.com/.
    For those unable to attend in person, the meeting will also be
webcast; please see the following link for webcast and other meeting
information: https://www.fda.gov/advisory-committees/blood-products-advisory-committee/2019-meeting-materials-blood-products-advisory-committee.

FOR FURTHER INFORMATION CONTACT: Christina Vert or Joanne Lipkind,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6268, Silver
Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>or
240-402-8106<EMAIL_ADDRESS>respectively, or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's website
at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down
to the appropriate advisory committee meeting link, or call the
advisory committee information line to learn about possible
modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On November 22, 2019, the BPAC will meet in open session to
discuss scientific considerations for cold stored platelet products
intended for transfusion, including product characterization, duration
of storage and clinical indications for use. The committee will hear
presentations on available characterization and

functional studies of cold stored platelets, clinical studies, and the
potential role of cold stored platelets in clinical care in military
and civilian patient populations. The committee will also discuss the
clinical studies needed to support the indications for use of cold
stored platelet products stored beyond 3 days.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link. For those unable to attend in person, the meeting will also be
webcast; please see the following link for webcast and other meeting
information: https://www.fda.gov/advisory-committees/blood-products-advisory-committee/2019-meeting-materials-blood-products-advisory-committee.
    Procedure: On November 22, 2019, from 8:30 a.m. to 4:45 p.m., the
meeting is open to the public. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the committee. Written submissions may be made to the contact person on
or before November 13, 2019. Oral presentations from the public will be
scheduled between approximately 2:35 p.m. and 3:35 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
November 4, 2019. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by November 5,
2019.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Christina Vert (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-21399 Filed 10-1-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 16 (Monday, January 26, 2015)]
[Proposed Rules]
[Pages 3933-3935]
[FR Doc No: 2015-01333]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2014-0483]
RIN 1625-AA09

Drawbridge Operation Regulation; Chincoteague Channel,
Chincoteague, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to change the operating schedule that
governs the SR 175 Bridge across Lewis Channel and Black Narrows, mile
3.5 at Chincoteague, VA. The proposed change would eliminate the need
for the current special operating schedule and return the bridge to
open on demand. The proposed change does not include the last
consecutive Wednesday and Thursday in July for the annual Pony swim.

DATES: Comments and related material must reach the Coast Guard on or
before March 12, 2015.

ADDRESSES: You may submit comments identified by docket number USCG-
2014-0483 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments. To avoid duplication, please use only one of these
methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Ms. Kashanda Booker, Bridge Specialist; telephone
757-398-6227; email<EMAIL_ADDRESS>If you have questions
on viewing or submitting material to the docket, call Cheryl Collins,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section Symbol
U.S.C. United States Code

A. Public Participation and Request for Comments

    We encourage you to participate in this proposed rulemaking by
submitting comments and related materials. All comments received will
be posted, without change to http://www.regulations.gov and will
include any personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
proposed rulemaking (USCG-2014-0483), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online (http://www.regulations.gov), or by fax, mail or hand
delivery, but please use only one of these means. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand deliver, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an email address, or a phone number in the body of
your document so that we can contact you if we have questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number [USCG-2014-0483] in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit them by mail
and would like to know that they reached the Facility, please enclose a
stamped, self-addressed postcard or envelope. We will consider all
comments and material received during the comment period and may change
the rule based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number (USCG-2014-0483) in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. You may submit a
request for one using one of the methods specified under ADDRESSES.
Please explain why one would be beneficial. If we determine that one
would aid this rulemaking, we will hold one at a time and place
announced by a later notice in the Federal Register .

B. Regulatory History and Information

    On July 14, 2014 the Coast Guard published a test deviation with
request for comments, entitled ``Drawbridge Elizabeth River, Eastern
Branch, VA''. 79 FR 40638. The bridge operated under this NPRM's
proposed schedule from August 4, 2014 to November 3, 2014. No comments
were received.

C. Basis and Purpose

    Virginia Department of Transportation (VDOT), who owns and operates
SR 175 Bridge across Lewis Channel and Black Narrows, mile 3.5, at
Chincoteague, VA has requested to change the existing

bridge regulations, set out at 33 CFR 117.1005. In 2011, the new
single-leaf bascule bridge was constructed on a new alignment replacing
the former swing-type bridge that was located downstream from the
Chincoteague maritime community. The new bridge alignment resulted in
boaters having an improved channel access and the number of necessary
bridge openings reduced.
    The vertical clearance of the new single-span bascule bridge is 15
feet above mean high water in the closed position and unlimited in the
open. The horizontal clearance is 60 feet between fender systems.
    The current operating schedule allows the draw to open on demand
from midnight to 6 a.m., and every one and a half hours from 6 a.m. to
midnight (at 6 a.m., 7:30 a.m., 9 a.m., 10:30 a.m., 12 p.m., 1:30 p.m.,
3 p.m., 4:30 p.m., 6 p.m., 7:30 p.m., 9 p.m., 10:30 p.m., and
midnight); except from 7 a.m., to 5 p.m. on the last consecutive
Wednesday and Thursday in July, the draw need not be opened. This has
been the regular operating schedule since November, 16, 2006.
    Based on the decrease amount of vessel openings, the Chincoteague
maritime community and the Accomack County Board of Supervisors favored
a less restrictive opening schedule by proposing a test deviation from
scheduled openings to an ``on demand'' schedule while still balancing
the needs of marine and vehicular traffic. The monthly vessel openings
at the SR 175 Bridge submitted by VDOT are as follows:

                                                                  Bridge Opening Counts
--------------------------------------------------------------------------------------------------------------------------------------------------------
 APR  2013   MAY  2013  JUNE  2013   JUL  2013   AUG 2013   SEPT  2013   OCT  2013   NOV  2013   DEC  2013   JAN  2014   FEB  2014  MAR  2014  APR  2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
       1           4           7           7           7           6           7           3           2           0           0           0          3
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The bridge logs revealed that from April 2013 to April 2014, the SR
175 Bridge had experienced only 47 total vessel openings.
    The SR 175 Bridge is the only vehicular connection between the
mainland and Eastern Shore of Virginia and Chincoteague Island. Tourism
is a dominant industry of Chincoteague Island with activities taking
place in the Town of Chincoteague, Chincoteague Island and Assateague
Island.

D. Discussion of Proposed Rule

    This proposed change in the rule will allow for a less restrictive
operating schedule while still balancing the needs of the marine and
vehicular traffic. The draw of the SR 175 Bridge will open on demand
except: from 7 a.m. to 5 p.m. on the last consecutive Wednesday and
Thursday in July, the draw need not be opened for the annual Pony swim.
    From August 4, 2014, to November 3, 2014, the draw of the SR 175
Bridge, mile 3.5, at Chincoteague, opened on signal in accordance with
the general operating regulations set out at 33 CFR 117.5. During this
test deviation, VDOT gathered data on vessel openings in hopes of
eliminating the current operating schedule for vessel passage.
    The monthly vessel openings at the SR 175 Bridge submitted by VDOT
are as follows:

                          Bridge Opening Counts
------------------------------------------------------------------------
     September 2014            October 2014            November 2014
------------------------------------------------------------------------
                 3                        5                        1
------------------------------------------------------------------------

E. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on these statutes or executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a ``significant regulatory action'' under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Order 12866 or under
section 1 of Executive Order 13563. The Office of Management and Budget
has not reviewed it under those Orders.
    The proposed change is expected to have minimal impact on mariners
due to the limited number of requests requiring openings for the past
two years and no anticipated change to vessel traffic.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    This proposed rule will not affect or have a significant economic
impact on a substantial number of small entities for the following
reasons. There have been only 47 openings in the past two years.
Vessels that can safely transit under the bridge (with a mast height
less than 15 feet) may do so at any time.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above. The Coast Guard will not retaliate against small
entities that

question or complain about this proposed rule or any policy or action
of the Coast Guard.

4. Collection of Information

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

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this proposed rule under that Order and
have determined that it does not have implications for federalism.

6. Protest Activities

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

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

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

List of Subjects in 33 CFR Part 117

    Bridges.

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

PART 117--DRAWBRIDGE OPERATION REGULATIONS

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

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

0
2. Revise Sec.  117.1005 to read as follows:

Sec.  117.1005  Chincoteague Channel.

    The draw of the SR 175 Bridge, mile 3.5, at Chincoteague shall open
on demand; except from 7 a.m. to 5 p.m. on the last consecutive
Wednesday and Thursday in July the bridge need not open.

    Dated: January 8, 2015.
Stephen P. Metruck,
Rear Admiral, United States Coast Guard, Commander, Fifth Coast Guard
District.
[FR Doc. 2015-01333 Filed 1-23-15; 8:45 am]
BILLING CODE 9110-04-P


Retrospective Analysis & Guidance for Waiving Acute Dermal Toxicity Tests for Pesticide Formulations

  Introduction

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes EPA to register pesticides and require supporting studies to meet statutory safety standards as stipulated under 40 Code of Federal Regulations (CFR) Part 158.  There is flexibility, however, in implementing Part 158. Additional data can be required (§158.75), alternative approaches can be accepted, and studies can be waived (§158.45).  The 2007 NAS report on Toxicity Testing in the 21[st] Century describes a new vision for toxicity testing.  EPA's Office of Pesticide Programs has developed a Strategic Direction for New Pesticide Testing and Assessment Approaches (http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/strategic-vision-adopting-21st-century-science) which describes OPP's approach to implementing the NAS vision.  One component of OPP's strategic vision describes the need for improved approaches to more traditional toxicity tests to minimize the number of animals used while expanding the amount of information obtained.  OPP's document on Guiding Principles for Data Requirements notes the importance of only requiring data that inform regulatory decision making and avoid unnecessary use of time and resources, data generation costs, and animal testing (http://www2.epa.gov/sites/production/files/2015-04/documents/data-require-guide-principle.pdf).  Waiving studies, when such data offer little or no additional scientific information or public health protection, is an important component of the guiding principles for data requirements.  OPP staff can focus on the information most relevant to a particular assessment and still ensure there is sufficient information for regulatory decisions that are protective of public health and the environment.

In 2012, OPP published a "Guidance for Waiving or Bridging of Mammalian Acute Toxicity Tests for Pesticides and Pesticide Products (Acute Oral, Acute Dermal, Acute Inhalation, Primary Eye, Primary Dermal, and Dermal Sensitization)" which consolidated previously existing guidance on waivers for acute toxicity tests.  That 2012 guidance document noted that generally, waivers are considered when data to support a particular endpoint are not relevant to the chemical.  Specifically, data related to dermal acute toxicity for conventional, antimicrobial, and biochemical pesticides may be waived if any of the following criteria are met:
 The test material has been placed in Toxicity Category I for primary dermal irritation.  Such products will be placed in dermal Toxicity Category I on the basis of potential dermal effects.
 The test material is corrosive to skin, or has a pH less than 2 or greater than 11.5. (40 CFR 158.500(e)(3); 40 CFR 158.2050(e)(2); 40 CFR 158. 2083(e)(2); 40 CFR 161.340(b)(2).  Such products will be placed in dermal Toxicity Category I on the basis of potential dermal effects.
 The product design prevents dermal exposure.  Products such as childproof insect baits and rodent bait boxes typically meet these criteria.
The current document expands the potential for data waivers for acute dermal studies for formulated pesticide products.  Several published studies (Creton et al, 2010; Seidle et al., 2011; Moore et al., 2013)  have investigated comparability between oral and dermal acute hazard classifications to assess whether tests for both routes are needed.  Together, these studies suggest that dermal and oral acute studies generally classify chemicals into similar categories, but none suit the needs of OPP since they did not evaluate the EPA OPP categorization scheme and primarily evaluated single agents.  OPP and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) have conducted a retrospective analysis of oral and dermal acute lethality studies that fit the regulatory context relevant for OPP.  This analysis focuses on formulated pesticide products and considers the EPA pesticide categorization scheme which uses acute study results (see 40CFR156.212 and 40CFR156.62).  The OPP/NICEATM analysis is designed to evaluate the relative consistency of the findings of oral and dermal studies (Section 2.0).  The agency has used this analysis to support a draft policy statement in Section 4.0 to waive all acute lethality dermal studies for formulated pesticide products.
Ecological effects assessments often rely on acute studies for the technical active ingredient and are thus needed to ensure the safety to non-human mammals.  As such, this document focuses only on formulated pesticide product testing.  However, many more acute toxicity studies are submitted to OPP annually for formulated pesticide products than are acute studies on active ingredients.  Thus, the potential animal and resource savings from waivers is derived more from formulated pesticide products than single chemical acute toxicity studies.
 Retrospective Analysis
The retrospective analysis conducted by OPP/NICEATM is provided below.
       Dataset for Analysis
The agency developed a dataset of rat acute oral and acute dermal LD50 studies.  The spreadsheet of data used in the analysis is provided in Dermal Data Spreadsheet for 593 Active Pesticide Ingredients.xlxs. Inclusion/exclusion criteria are described below.
		2.1.1. Selection of Studies
Identification of Active Ingredients:  The active ingredients include conventional pesticides, antimicrobials, and biopesticides are included across numerous chemical classes and across Toxicity Categories.  Fumigants and rodenticides were excluded because of their physical forms and the types of exposures that would be anticipated for them.  There are 316 active ingredients in the dataset used in the current analysis (Appendix 1).
Identification of Acute Oral & Dermal Studies:  Searches were conducted from the Office of Pesticide Programs Information Network (OPPIN) database in December 2013-January 2014 which included all available acute studies for formulated pesticide products available for the active ingredients listed in Appendix 1.  Information collected from OPPIN included: Master Record Identification (MRID) number, product registration number, Pesticide Chemical (PC) code, CAS number, formulation name, formulation type, registration status, species (and sex), LD50 value, EPA toxicity category, test acceptability, and study type.  This search yielded thousands of studies across different taxa and different routes/toxicities.  From this initial search, acute oral and dermal studies were identified.  To achieve a dataset that was broadly representative, but manageable in size, the following considerations were used:
 Only rat studies were selected.  To reduce uncertainty associated with comparing results across species, non-rat species were eliminated.
 Focus on studies from last decade.  With changes to approved inerts and revisions to the acute oral guideline, when data on multiple formulation types were available for a particular active ingredient, the study selection focused on newer studies.  This was balanced with the need to have broad representation of formulation type and Toxicity Category.
 Because toxicity (particularly absorption) can be influenced by the nature of the exposure, multiple formulation types.  For each active ingredient in the dataset, generally, one oral-dermal study pair was selected for each formulation type available for that active ingredient.
 Impregnated materials & microencapsulated formulations were excluded.  These types of products were excluded because they tend to have a unique composition which can impact the rate of release from the product.  This uniqueness does not lend itself to an analysis intended for groups of products to be used in a generic approach.
 Formulation intermediates were excluded.  Since there will be limited/no exposure to pesticide handlers & applicators to intermediates, these data are not relevant to the analysis.
From the identified oral & dermal studies, "paired" studies were selected.  `Paired' studies are those which were conducted on the same formulated pesticide product for oral and dermal lethality.  This pairing was achieved by matching the registration number and formulated pesticide product name with consideration of PC code and CAS number.  Data evaluation records (DERs) were collected for paired studies.  From these DERs, the LD50 and Toxicity Category were entered into the spreadsheet.

		2.1.2. Characterization of the Dataset
The dataset of rat acute oral and acute dermal LD50 studies includes 593 formulated pesticide products, representing 316 active ingredients; all four Toxicity Categories; and 13 different formulated pesticide product types (Table 1).  Among the 593 formulations, 272 of these formulations have a single active ingredient, 185 have two, 78 have three, and 58 have four or more.
Table 1.  Formulated pesticide product types in the dataset
                               Formulation Type
                                    Number
Dust
                                      16
Emulsifiable concentrate
                                      143
Flowable concentrate
                                      64
Granular
                                      45
Pellet/tablet
                                       7
Pressurized dust
                                       1
Pressurized liquid
                                      20
Ready to use solution
                                      69
Soluble concentrate
                                      125
Soluble concentrate/solid
                                       8
Water dispersible granule
                                      64
Water soluble package
                                      14
Wettable powder
                                      13
Not available (n/a)
	4

 Comparison of Toxicity Category between oral and dermal studies
As shown in the blue boxes in Table 2 below, for 339 of the 593 formulations, the paired oral and dermal studies provide the same Toxicity Category (blue boxes).  For 224 formulations, the oral study provides a lower (i.e., more potent) Category than the dermal study (light orange boxes).
For 30 formulations, the dermal study provides a lower (i.e., more potent) Category than the oral study (tan and purple boxes).  Two formulations (tan box) have a Toxicity Category II for dermal and Toxicity Category III for oral (i.e., a more potent Category for dermal compared to oral) and 28 formulations in the dataset have a Toxicity Category III for dermal and a Toxicity Category IV for oral (purple box).
One of the most important uses of acute study data in the registration process for pesticides is in making personal protective equipment (PPE) decisions (such as a requirement to wear gloves when using the product).  Therefore, for the 30 formulated pesticide products where the dermal study provides a lower Toxicity Category than the oral study, the agency further investigated additional information used for evaluating dermal worker PPE (see Section 2.3).  The Toxicity Categories are also used for hazard labeling, first aid, and precautionary statements (http://www2.epa.gov/pesticide-registration/label-review-manual).
Table 2.  Results of comparison analysis for oral & dermal formulation acute studies
Rat Dermal Hazard Category (mg/kg)
                       Rat Oral Hazard Category (mg/kg)

                                     EPA I
                                    EPA II
                                    EPA III
                                    EPA IV

                                     <=50
                               >50  -  <=500
                              >500  -  <=5000
                                   >5000
                                     EPA I
                                       1
                                      0
                                      0
                                       0
                                    <=200

                                    EPA II
                                      0
                                      2
                                       2
                                       0
                              >200  -  <=2000

                                    EPA III
                                       0
                                      23
                                     133
                                      28
                             >2000  -  <=5000

                                    EPA IV
                                       0
                                      28
                                      173
                                      203
                                   >5000

                                     Total
                                       1
                                      53
                                      308
                                      231

 Detailed Evaluation of Studies with Lower Dermal Category Compared to Oral
As noted above, for the 30 formulations (purple & tan boxes in Table 2) which showed a lower Toxicity Category from the dermal study compared to the oral, the agency further investigated what information was used for determining dermal PPE to determine if the dermal hazard study was critical to decisions on required protective equipment.
EPA's Label Review Manual provides information on how acute toxicity information is used in pesticide labeling; Table 3 was extracted from Chapter 10 (Worker Protection Labeling).
  Table 3.  Toxicity Category by Route of Exposure of End-Use Product
                               Route of Exposure
    I DANGER
    II WARNING
   III CAUTION
    IV CAUTION
 Dermal Toxicity or Skin Irritation Potential1
 Coveralls worn over long-sleeved shirt and long pants
 Coveralls worn over short-sleeved shirt and short pants
 Long-sleeved shirt and long pants
 Long-sleeved shirt and long pants

 Socks
 Socks
 Socks
 Socks

 Chemical-resistant footwear
 Chemical-resistant footwear
 Shoes
 Shoes

 Chemical-resistant Gloves2
 Chemical-resistant Gloves2
 Chemical-resistant Gloves2
 No minimum4
 Inhalation Toxicity
 Respiratory protection device3
 Respiratory protection device3
 No minimum4
 No minimum4
 Eye Irritation Potential
 Protective eyewear5
 Protective eyewear5
 No minimum4
 No minimum4
 1 If dermal toxicity and skin irritation toxicity categories are different, PPE shall be determined by the more severe toxicity category of the two.  If dermal toxicity or skin irritation is category I or II, refer to Section 2 below to determine if additional PPE is required beyond that specified in Table 1
 2 Refer to Section 3, Table 3 to determine the specific type of chemical-resistant glove.
 3 Refer to Section 4 to determine the specific type of respiratory protection.
 4 Although no minimum PPE is required for these toxicity categories and routes of exposure, the Agency may require PPE on a product-specific basis.
 5 "Protective eyewear" is to be used instead of "goggles" and/or "face shield" and/or "shielded safety glasses" and similar terms to describe eye protection, unless the assessment requires a specific type of eyewear for adequate protection.

Two of the 30 formulations are consumer products for which EPA does not require gloves or any other form of protective clothing (e.g., use of a coverall).
Three of the remaining 28 formulations (FINALE--glufosinate ammonium; SCALA--pyrimethanil; DREXEL SUFFA-8--sulfur) were tested at a limit dose of 4000 mg/kg in the dermal study with no mortalities.  The limit dose to achieve Category IV is 5000 mg/kg.  For these three formulations, the agency believes that a dermal dose of 4000 mg/kg is close in magnitude to 5000 mg/kg and believes the dermal Category III is an artifact of dose selection, not due to toxicity from dermal exposure below 5000 mg/kg.
As noted in Table 3, the dermal irritation study is also used in pesticide labeling.  Of the remaining 25 formulated pesticide products, five of the products have a dermal irritation study which provides a Toxicity Category equal to or lower than the dermal acute Toxicity Category.
For the remaining 20 products, the agency considered the chemical-specific worker protection labeling requirements identified in regulatory assessment documents (Reregistration Eligibility Decision (RED), Registration Review Documents, etc.).  In the pesticide labeling process, label reviews consider not only the product specific labeling defined in the acute toxicity review, but also the chemical-specific worker protection labeling defined by the RED/registration review document and the most current regulatory risk assessment document.  As such, the acute toxicity review is not the only source of information for pesticide labeling.  Table 3 provides the framework for defining personal protective equipment for acute dermal toxicity and dermal irritation studies; however, the framework in Table 3 is pre-empted when the human health risk assessment identifies potential concern for worker risk that requires more PPE than identified by the acute toxicity review.
Information on how pesticide handler exposure assessment is conducted to assess worker dermal risk can be found at:  http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/occupational-pesticide-handler-exposure-data.  This exposure assessment approach specifically considers exposure scenarios for specific type(s) of application equipment, formulation type, job function, and level of PPE.  Calculated exposure values are then compared to toxicology values (e.g., no-observed adverse effects levels, NOAELs) to assess potential worker risk.  These toxicity values are derived from acute or repeat dosing studies in laboratory animals evaluating systemic toxicity, not lethality.  Thus, these toxicity values are more robust and appropriate for assessing worker safety than are acute lethality studies.   As such, the human health risk assessment provides the agency a means to specifically consider whether or not PPE are required to protect against human health effects.
For the remaining 20 pesticide products identified with lower dermal toxicity categories than oral, 11 had active ingredients for which the human health risk assessment indicated PPE was required based on risk concerns.  Risk assessments for the active ingredient in five formulations indicated no dermal risk at `baseline' (baseline scenario means that the analysis is conducted assuming long sleeved shirt, pants and socks and shoes (i.e., without a consideration for use of gloves)), and risk assessments for the active ingredient in four formulations indicated no dermal hazard based on subchronic dermal toxicity studies -- together suggesting that the glove requirement associated with the Toxicity Category III from the acute lethality study over labeled the PPE for these nine.

    Discussion:  Implications of Retrospective Analysis on Utility of Acute Dermal Formulated pesticide product Studies
The overall purpose of this analysis is to address the utility of the acute dermal toxicity study for formulations in pesticide labelling for end use products as described in 40CFR156.212.  To this end, this analysis includes a large number of formulations (593) and active ingredients (316) across numerous classes representing conventional pesticides, antimicrobials, and biopesticides.
For 57% of the 593 formulations, oral and dermal studies provide the same Toxicity Category.  For 38%, the oral study provides a lower (i.e., more conservative) Category.  Thus, for 95% of the formulations in the analysis, the dermal toxicity study was similar or less sensitive than the oral study.  In other words, for 95% of the studies, if the dermal study had not been available and labelling had occurred only from the Toxicity Category for the oral formulation study, the respective labelling would have been equally protective or more protective.  For the remaining 5%, as noted above, the dermal acute toxicity category is not the only source of information for pesticide labelling.  Dermal irritation studies are used in addition to chemical-specific worker protection labeling defined by the RED/registration review document and the most current regulatory risk assessment, where the risk assessments utilize more robust approaches to worker protection.  When all these sources of information are considered together, the dermal acute toxicity study for formulations provides little to no added value in regulatory decision making.

    Waiver Guidance.
The agency believes this retrospective analysis fully supports a conclusion that waivers can be granted of acute dermal toxicity studies for formulations.  The agency will be soliciting public comment on this draft policy.  Registrants may begin submitting waiver requests through existing processes to respective OPP division.

Appendix 1.  List of active ingredients in the retrospective analysis
\s\s\s


[Federal Register: February 14, 2006 (Volume 71, Number 30)]
[Notices]
[Page 7750-7751]
[DOCID:fr14fe06-38]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC06-587-000; FERC Form-587]

Commission Information Collection Activities, Proposed
Collection; Comment Request; Extension

February 7, 2006.
AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice.

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

SUMMARY: In compliance with the requirements of section 3506(c)(2)(a)
of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), the Federal
Energy Regulatory Commission (Commission) is soliciting public comment
on the specific aspects of the information collection described below.

DATES: Comments on the collection of information are due April 14,
2006.

ADDRESSES: A copy of the collection of information accompanies this
notice or can be obtained from the Federal Energy Regulatory
Commission, Attn: Michael Miller, Office of the Executive Director, ED-
34, 888 First Street NE, Washington, DC 20426. Comments may be filed
either in paper format or electronically. Those parties filing
electronically do not need to make a paper filing. For paper filing,
the original and 14 copies of such comments should be submitted to the
Office of the Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426 and refer to Docket No. IC06-
587-000.
    Documents filed electronically via the Internet must be prepared in
WordPerfect, MS Word, Portable Document Format, or ASCII format. To
file the document, access the Commission's Web site at http://www.ferc.govA>

 and click on ``Make an E-filing'', and then follow the

instructions for each screen. First time users will have to establish a
user name and password. The Commission will send an automatic
acknowledgement to the sender's e-mail address upon receipt of
comments.
    All comments may be viewed, printed or downloaded remotely via the
Internet through FERC's homepage using the eLibrary link. For user
assistance, contact<EMAIL_ADDRESS>or toll-free at (866)
208-3676 or for TTY, contact<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Michael Miller may be reached by
telephone at<PHONE_NUMBER>, by fax at

(202) 273-0873, and by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The information collected under the
requirements of FERC Form 587 ``Land Description'' (OMB No. 1902-0145)
is used by the Commission to implement the statutory provisions of
section 24 of the Federal Power Act (FPA), (16 U.S.C. 818).
    Applicants proposing hydropower projects, or changes to existing
projects located on lands owned by the United States are required to
provide a description of the U.S. lands affected, to the Commission and
to the Secretary of Interior. FERC Form 587 consolidates the
information required, and identifies hydropower project boundary maps
associated with lands of the United States. The Commission verifies the
accuracy of the information supplied and coordinates with the Bureau of
Land Management State Offices (BLM) so the U.S. lands can be reserved
as hydropower sites and withdrawn from other uses.
    Action: The Commission is requesting a three-year extension of the
current expiration date, with no changes to the existing collection of
data.
    Burden Statement: Public reporting burden for this collection is
estimated as:

------------------------------------------------------------------------
    Number of          Number of       Average burden
   respondents       responses per        hours per       Total annual
     annually          respondent         response        burden hours
(1)                            (2)                (3)   (1) x (2) x (3)
------------------
            250                  1                  1               250
------------------------------------------------------------------------

    Estimated cost burden to respondents is $13,554. (250 hours/2080
hours per year times $112,767 per year average per employee). The cost
per respondent is $54.
    The reporting burden includes the total time, effort, or financial
resources expended to generate, maintain, retain, disclose, or provide
the information including: (1) Reviewing instructions; (2) developing,
acquiring, installing, and utilizing technology and systems for the
purposes of collecting, validating, verifying, processing, maintaining,
disclosing and providing information; (3) adjusting the existing ways
to comply with any previously applicable instructions and requirements;
(4) training personnel to respond to a collection of information; (5)
searching data sources; (6) completing and reviewing the collection of
information; and (7) transmitting, or otherwise disclosing the
information.
    The estimate of cost for respondents is based upon salaries for
professional and clerical support, as well as direct and indirect
overhead costs. Direct costs include all costs directly attributable to
providing this information, such as administrative costs and the cost
for information technology. Indirect or overhead costs are costs
incurred by an organization in support of its mission. These costs
apply to activities which benefit the whole organization rather than
any one particular function or activity.
    Comments are invited on: (1) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) 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; (3) ways to enhance the quality,
utility and clarity of the information to be collected; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including 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.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-2036 Filed 2-13-06; 8:45 am]

BILLING CODE 6717-01-P


1 Response to OMB Issues Population risk estimates using NATA Estimated NATA Derived Population Cancer Risk Estimated Cancer Risk at Least: 100 in a million 10 in a million 1 in a million All Sources of Perchloroethylene 0 13,649 8,589,338 Area source Perc Dry Cleaners 0 0 963,992 To assess the risks from typical area sources, we first analyzed readily available data. The 1999 National Air Toxics Assessment ( NATA) provides census tract level estimates of inhalation cancer risk and non cancer risk across the entire United States for a subset of the 188 HAP. Using this assessment, we were able to generate a course scale estimate of population risk for PCE by scaling the cancer and non cancer risk for PCE according to the relative contribution of area source dry cleaners to the total emission inventory of PCE. See table xxx below for a summary of these risks from both area source cleaners and all sources of PCE.

This estimate provided a screening level estimate of PCE risk to the general population. In estimating this population level estimate of risk, the assessment makes certain assumptions about personal activity patterns. In doing so, it is somewhat less conservative than an assessment that considers MIR which assumes continuous exposure for 70 years.

Because this screening level assessment suggested potentially high population risk, we decided to pursue a more refined risk assessment.

APEX Assessment To account for the fact that individuals may move through areas ( microenvironments) of differing concentrations during their daily activities, EPA conducted an exposure variability analyses in which it used the Total Risk Integrated Methodology Exposure model ( TRIM. Expo, also known as the Air Pollutant Exposure Model 3, or APEX3). The TRIM. Expo model uses a personal profile approach in which it stochastically simulates exposures for individuals of differing demographic characteristics and associated daily activity patterns. The model output provides a distribution of exposure estimates which are intended to be representative of the study population with respect to their demographically based behavior, in terms of the microenvironments through which they move during a day and throughout a year ( see http:// www. epa. gov/ ttn/ fera for more information regarding the model). To estimate cancer risk, EPA assumes that this one year exposure scenario continues for 70 years. 2 The table below contrasts the ISCST 3 and TRIM estimates of population risk for the worst case major source facility:

Comparison of ISCST 3 Exposure Estimates with Activity patterned/ day, lifetime exposure ( ISC+ TRIM. Expo) Cancer Risk Total Population at Cancer Risk Model > 1E 4 > 1E 5 > 1E 6 Maximum Value ISCST 3 900 14,000 75,000 3.3E 04 ( MIR)

TRIM. Expo 400 9,000 80,000 3.24E 04 APEX provides a more central tendency estimate of risk by accounting for variability in personal exposure. The table above shows that a smaller number of individuals exposed at the higher levels of cancer risk and a slightly larger number of individuals exposed at a cancer risk of at least one in one million. While we performed this analysis for the worst case facility, it is reasonable to infer that the risk distribution above would be similar to the remainder of the major source facilities. One limitation of this analysis is that we assume continuous 70 year exposure when calculating cancer risk, and some individuals are likely to move away from the facility. However, given the large number of dry cleaners nation wide, and the consequent ubiquity of exposure, it is unlikely that individuals moving out of the APEX study area would receive lower exposure than the model estimates.

Co located exposure assumptions To better characterize inhalation cancer risk among residents of apartments co located with area source cleaners, we performed a sensitivity analysis in which it varied the assumed duration of exposure. The table below illustrates the results of this analysis. 3 Estimated Cancer Risk for Residents of Co located Apartments: Exposure Duration Sensitivity Analysis Assumed Exposure Duration 70 Years 50 Years 30 Years 20 Years 10 Years Risk per million ( CalEPA) 11998 8588 5179 3474 1770 Risk per million ( OPPTS) 1444 1034 623 418 213 Hazard Quotient ( ATSDR) 8 5 3 2 1 Risk calculated assuming: ( 1) apartment residents receive exposure at 95th percentile of monitored concentrations from area source cleaners for duration noted; and ( 2) exposure falls to New York urban background ( 11 ug/ m3) for PCE during years in which residents move away from area source cleaner The results above indicate that even when EPA relaxes the 70 year exposure duration to calculate inhalation cancer risk, individual risk remains very high.


[Federal Register Volume 78, Number 187 (Thursday, September 26, 2013)]
[Rules and Regulations]
[Pages 59240-59242]
[FR Doc No: 2013-23100]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2013-0066; FRL-9901-20-Region3]

Approval and Promulgation of Air Quality Implementation Plans;
Maryland; Adoption of Control Techniques Guidelines for Miscellaneous
Metal and Plastic Parts Which Includes Pleasure Craft Coating
Operations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving a State Implementation Plan (SIP) revision
submitted by the State of Maryland. The revision consists of a new
regulation pertaining to control of volatile organic compound (VOC)
emissions from pleasure craft coating operations. EPA is approving the
revision to reduce further VOC emissions from pleasure craft coating
operations in accordance with the requirements of the Clean Air Act
(CAA).

DATES: This final rule is effective on October 28, 2013.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2013-0066. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are

available either electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State
submittal are available at the Maryland Department of the Environment,
1800 Washington Boulevard, Suite 705, Baltimore, Maryland 21230.

FOR FURTHER INFORMATION CONTACT: Gregory Becoat,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On May 16, 2013 (78 FR 28773), EPA published a notice of proposed
rulemaking (NPR) for the State of Maryland. The NPR proposed approval
of Maryland's Regulation .27-1 under COMAR 26.11.19--Volatile Organic
Compounds from Specific Processes. On January 10, 2013, Maryland
submitted the formal SIP revision (12-08) adopting the
requirements as recommended by EPA's control technique guidelines (CTG)
for Miscellaneous Metal Parts and Plastic Coating (MMPPC) operations
and as recommended by trade associations representing the pleasure
craft industry.

II. Summary of SIP Revision

    The SIP revision adds Regulation .27-1 under COMAR 26.11.19 in
order to: (1) Establish applicability for pleasure craft and fiberglass
boat coating operations; (2) establish exemptions; (3) add definitions
and terms to reflect pleasure craft coating operations; (4) incorporate
by reference the standard test method for Specular Gloss; (5) establish
that the least stringent emission limitation is applicable if more than
one emission limitation applies to a specific coating; (6) establish
application methods; and (7) specify VOC limit requirements for
pleasure craft coating operations. EPA received no adverse comments on
the NPR to approve Maryland's SIP revision. A more complete explanation
of the amendments and the rationale for EPA's proposed action is
explained in the technical support document and the NPR in support of
this final rulemaking and will not be restated here.

III. Final Action

    EPA is approving Maryland's SIP revision adopting a new regulation
to control VOC emissions from pleasure craft coating operations.

IV. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 25, 2013. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action approving Maryland's amendments to regulations for
the control of VOCs for MMPPC may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: August 29, 2013.
W.C. Early,
Acting Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

     Authority:  42 U.S.C. 7401 et seq.

Subpart V--Maryland

0
2. In Sec.  52.1070, the table in paragraph (c) is amended by adding an
entry for COMAR <IP_ADDRESS>-1, after the existing entry for COMAR
<IP_ADDRESS>. The added text reads as follows:

Sec.  52.1070  Identification of plan.

* * * * *
    (c) * * *

                 EPA-Approved Regulations, Technical Memoranda, and Statutes in the Maryland SIP
----------------------------------------------------------------------------------------------------------------
       Code of Maryland                                                                 Additional explanation/
  Administrative Regulations      Title/subject         State       EPA-Approval date      citation at 40 CFR
       (COMAR) citation                            effective date                               52.1100
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                           26.11.19 Volatile Organic Compounds From Specific Processes
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
<IP_ADDRESS>-1................  Control of                10/12/12  9/26/13 [Insert     Regulation Added.
                                Volatile Organic                    page number where
                                Compounds from                      the document
                                Pleasure Craft                      begins].
                                Coating
                                Operations.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-23100 Filed 9-25-13; 8:45 am]
BILLING CODE 6560-50-P


PAPERWORK REDUCTION ACT SUBMISSION SAN 4501 Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request U. S. Environmental Protection Agency, Office of Solid Waste & Emergency Response, Office of Solid Waste 2. X OMB control number b. G None 2050 0053 3. Type of information collection ( check one) a. G New collection b. X Revision of a currently approved collection c. G Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. G Three years from approval date b. X Other Specify: 01/ 31/ 2008 7. Title Identification, Listing and Rulemaking Petitions ( Final Rule for Wastewater Treatment Exemptions for Hazardous Waste Mixtures)

8. Agency form number( s) ( If applicable) ICR 1189.17 9. Keywords Environmental protection, Hazardous Waste, Recycling, Waste Treatment and Disposal 10. Abstract The Environmental Protection Agency is finalizing the addition of benzene and 2 ethoxyethanol to the list of solvents whose mixtures with wastewaters are exempted from the definition of hazardous waste under the Resource Conservation and Recovery Act. The scrubber waters derived from the combustion of any of the exempted solvents also are included in the exemption. In addition, the Agency is revising the rule by adding an option to allow generators to directly measure solvent chemical levels at the headworks of the wastewater treatment system to determine whether the wastewater mixture is exempt from the definition of hazardous waste. Finally, the Agency is extending the eligibility for the de minimis exemption to other listed hazardous wastes ( beyond discarded commercial chemical products) and to non manufacturing facilities.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 3,266 b. Total annual responses 3,266 1. Percentage of these responses collected electronically 0 % c. Total annual hours requested 67,972 d. Current OMB inventory 22,074 e. Difference 45,898 f. Explanation of difference 1. Program Change 45,898 2. Adjustment 0 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs $ 66 b. Total annual costs ( O& M) $ 9,471 c. Total annualized cost requested $ 9,537 d. Current OMB inventory $ 980 e. Difference $ 8,557 f. Explanation of difference 1. Program change $ 8,557 2. Adjustment $ 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P_ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. X On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biennually 8. Q Other ( describe) 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Lisa Lauer Phone: 703 308 7418 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement. Signature of Program Office Official Robert Dellinger, Director Hazardous Waste Identification Division Office of Solid Waste Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( i) the reasons the information is planned to be and/ or has been collected; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any 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."

10/ 95


[Federal Register Volume 85, Number 217 (Monday, November 9, 2020)]
[Rules and Regulations]
[Pages 71238-71240]
[FR Doc No: 2020-24641]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0464; Product Identifier 2020-NM-040-AD; Amendment
39-21307; AD 2020-22-11]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

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

ACTION: Final rule.

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

SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2017-18-
17, which applied to all Airbus SAS Model A300 B4-603, A300 B4-620,
A300 B4-622, A300 B4-605R, A300 B4-622R, A300 F4-605R, A300 F4-622R,
and A300 C4-605R Variant F airplanes. AD 2017-18-17 required modifying
certain fuselage frames and a repair on certain modified airplanes.
This AD continues to require the actions in AD 2017-18-17, and also
requires, for certain airplanes, an inspection to determine if rotating
probe inspections were performed prior to oversizing of the open-holes,
and repair if necessary; as specified in a European Union Aviation
Safety Agency (EASA) AD, which is incorporated by reference. This AD
was prompted by a report indicating that the material used to
manufacture the upper frame feet was changed and negatively affected
the fatigue life of the frame feet, and a determination that more work
is required for certain airplanes that were previously modified. The
FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective December 14, 2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of December 14,
2020.

ADDRESSES: For the material incorporated by reference (IBR) in this AD,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
phone: +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 IBR material at the
FAA, Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. 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-2020-0464.

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-2020-
0464; 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 final rule, any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer, Large
Aircraft Section, International Validation Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0051, dated March 11, 2020
(``EASA AD 2020-0051'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Airbus SAS Model A300 B4-603, A300 B4-620, A300 B4-
622, A300 B4-605R, A300 B4-622R, A300 F4-605R, A300 F4-622R, A300 C4-
620, and A300 C4-605R Variant F airplanes. Model A300 C4-620 airplanes
are not certificated by the FAA and are not included on the U.S. type
certificate data sheet; this AD therefore does not include those
airplanes in the applicability.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to supersede AD 2017-18-17, Amendment 39-19026 (82 FR
43160, September 14, 2017) (``AD 2017-18-17''). AD 2017-18-17 applied
to all Airbus SAS Model A300 B4-603, A300 B4-620, A300 B4-622, A300 B4-
605R, A300 B4-622R, A300 F4-605R, A300 F4-622R, and A300 C4-605R
Variant F airplanes. The NPRM published in the Federal Register on June
8, 2020 (85 FR 35016). The NPRM was prompted by a report indicating
that the material used to manufacture the upper frame feet was changed
and negatively affected the fatigue life of the frame feet, and a
determination that more work is

required for certain airplanes that were previously modified. The NPRM
proposed to continue to require the actions in AD 2017-18-17, as
specified in an EASA AD. The NPRM also proposed to require, for certain
airplanes, an inspection to determine if rotating probe inspections
were performed prior to oversizing of the open-holes, and repair if
necessary, as specified in an EASA AD.
    The FAA is issuing this AD to address cracking of the center
section of the fuselage, which could result in a ruptured frame foot
and reduced structural integrity of the airplane. See the MCAI for
additional background information.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The following presents the comment received
on the NPRM and the FAA's response to each comment.

Request for Credit for Using Previous Service Information

    FedEx requested that the FAA provide credit for accomplishing the
required actions using Airbus SAS Service Bulletin A300-53-6178, dated
March 17, 2015, provided the appropriate rotating probe inspection is
performed before oversizing the open holes. FedEx stated that its fleet
is already in compliance with the required actions but used Airbus
Service Bulletin A300-53-6178, dated March 17, 2015, not the current
revision Airbus Service Bulletin A300-53-6178, Revision 01, dated
September 20, 2019.
    The FAA disagrees with the request. This AD incorporated by
reference EASA AD 2020-0051 as the appropriate material to use to
comply with this AD. Paragraph (3) of EASA AD 2020-0051 specifies that,
for airplanes on which the modification specified in Airbus Service
Bulletin A300-53-6178, dated March 17, 2015, was accomplished,
additional work must be done. That additional work consists of
determining whether or not a rotating probe inspection was performed
before oversizing of the open-holes and, depending on findings,
additional corrective actions. Therefore, the credit the commenter
requested is already included in the requirements of this AD. The FAA
has not revised this AD in this regard.

Conclusion

    The FAA reviewed the relevant data, considered the comment
received, and determined that air safety and the public interest
require adopting this final rule as proposed, except for minor
editorial changes. The FAA has determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2020-0051 describes procedures for modifying certain
fuselage frames; a repair on certain modified airplanes; and, for
certain airplanes, an inspection to determine if a rotating probe
inspection was performed prior to oversizing of the open-holes,
contacting the manufacturer for post-modification work instructions,
and repair. 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.

Costs of Compliance

    The FAA estimates that this AD affects 65 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
            Action                   Labor cost              Parts cost        Cost per product     operators
----------------------------------------------------------------------------------------------------------------
Retained actions from AD 2017- Up to 235 work-hours                   $23,000  Up to $42,975...  Up to
 18-17.                         x $85 per hour = Up                                               $2,793,375.
                                to $19,975.
New actions..................  1 work-hour x $85 per                        0  $85.............  $5,525
                                hour = $85.
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data that would enable providing
cost estimates for the on-condition repairs specified in this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2017-18-17, Amendment 39-

19026 (82 FR 43160, September 14, 2017), and
0
b. Adding the following new AD:

2020-22-11 Airbus SAS: Amendment 39-21307; Docket No. FAA-2020-0464;
Product Identifier 2020-NM-040-AD.

(a) Effective Date

    This AD is effective December 14, 2020.

(b) Affected ADs

    This AD replaces AD 2017-18-17, Amendment 39-19026 (82 FR 43160,
September 14, 2017) (``AD 2017-18-17'').

(c) Applicability

    This AD applies to all Airbus SAS Model A300 B4-603, A300 B4-
620, A300 B4-622, A300 B4-605R, A300 B4-622R, A300 F4-605R, A300 F4-
622R, and A300 C4-605R Variant F airplanes, certificated in any
category.

(d) Subject

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

(e) Reason

    This AD was prompted by a report indicating that the material
used to manufacture the upper frame feet was changed and negatively
affected the fatigue life of the frame feet, and a determination
that more work is required for certain airplanes that were
previously modified. The FAA is issuing this AD to address cracking
of the center section of the fuselage, which could result in a
ruptured frame foot and reduced structural integrity of the
airplane.

(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
2020-0051, dated March 11, 2020 (``EASA AD 2020-0051'').

(h) Exceptions to EASA AD 2020-0051

    (1) Where EASA AD 2020-0051 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2020-0051 does not apply
to this AD.
    (3) For airplanes on which the modification specified in Airbus
Service Bulletin A300-53-6178 has been done: Where paragraph (4) of
EASA AD 2020-0051 specifies to do certain actions ``no later than 6
months (estimated by projection of airplane usage) prior to
exceeding 24,500 flight cycles or 42,700 flight hours, whichever
occurs first, after Airbus Service Bulletin A300-53-6178 embodiment
(at any revision),'' this AD requires doing those actions prior to
exceeding 24,100 total flight cycles or 42,000 total flight hours,
whichever occurs first after doing the modification.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, 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 Large Aircraft Section, International Validation
Branch, send it to the attention of the person identified in
paragraph (j) of this AD. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2020-0051 that contains RC procedures and
tests: Except as required by paragraph (i)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified as RC may be
deviated from using accepted methods in accordance with the
operator's maintenance or inspection program without obtaining
approval of an AMOC, provided the procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(j) Related Information

    For more information about this AD, contact Dan Rodina,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; phone and
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2020-0051,
dated March 11, 2020.
    (ii) [Reserved]
    (3) For EASA AD 2020-0051, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; phone: +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.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. 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-2020-0464.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on October 19, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-24641 Filed 11-6-20; 8:45 am]
BILLING CODE 4910-13-P