[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Rules and Regulations]
[Pages 66158-66160]
[FR Doc No: 2018-27795]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 555

[Docket No. NHTSA-2018-0103]
RIN 2127-AL97

Temporary Exemption From Motor Vehicle Safety and Bumper
Standards

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Final rule.

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SUMMARY: This document amends NHTSA's regulation on temporary exemption
from the Federal motor vehicle safety standards (FMVSS) and bumper
standards to expedite the publishing of notices soliciting public
comment on exemption petitions. It does so by eliminating the provision
calling for the Agency to determine that a petition is complete before
the Agency publishes a notice summarizing the petition and soliciting
public comments on it. As amended, the regulation continues to provide
that the Agency will, as it does now, determine whether a petition
contains adequate justification in deciding whether to grant or deny
the petition. The intended effect of these changes is to enable the
Agency to solicit public comments more quickly.

DATES: This final rule is effective on January 25, 2019.
    Petitions for reconsideration of this final rule must be received
not later than February 11, 2019.

ADDRESSES: Petitions for reconsideration of this final rule must refer
to the docket and notice number set forth above and be submitted to the
Administrator, National Highway Traffic Safety Administration, 1200 New
Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: For questions concerning this final
rule, contact Stephen Wood, NCC-200, Assistant Chief Counsel for
Vehicle Rulemaking and Harmonization, National Highway Traffic Safety
Administration, 1200 New Jersey Avenue SE, Washington, DC 20590;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The National Traffic and Motor Vehicle Safety Act, as amended,
authorizes the Secretary of Transportation to exempt, on a temporary
basis, under specified circumstances, and on terms the Secretary deems
appropriate, motor vehicles from a FMVSS or bumper standard. This
authority is set forth at 49 U.S.C. 30113. The Secretary has delegated
the authority for implementing this section to NHTSA.\1\
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    \1\ 49 CFR 1.94.
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    The exercise of NHTSA's authority to grant, in whole or in part, a
temporary exemption to a vehicle manufacturer is conditioned upon the
Agency's making specified findings. The Agency must comprehensively
evaluate the request for exemption and find that the exemption is
consistent with the public interest and with the objectives of the
Vehicle Safety Act.\2\ In addition, the Agency must make one of the
following more focused findings:
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    \2\ 49 U.S.C. 30113(b)(3)(A).

    (i) compliance with the standard[s] [from which exemption is
sought] would cause substantial economic hardship to a manufacturer
that has tried to comply with the standard[s] in good faith;
    (ii) the exemption would make easier the development or field
evaluation of a new motor vehicle safety feature providing a safety
level at least equal to the safety level of the standard;
    (iii) the exemption would make the development or field
evaluation of a low-emission motor vehicle easier and would not
unreasonably lower the safety level of that vehicle; or
    (iv) compliance with the standard would prevent the manufacturer
from selling a motor vehicle with an overall safety level at least
equal to the overall safety level of nonexempt vehicles.\3\
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    \3\ 49 U.S.C. 30113(b)(3)(B).

    To provide procedures for implementing these statutory provisions
concerning temporary exemptions, NHTSA established 49 CFR part 555,
Temporary Exemption from Motor Vehicle Safety and Bumper Standards. The
requirements in 49 CFR 555.5 state that a petitioner must set forth the
basis of its petition by providing the information required under 49
CFR 555.6, and explaining why the exemption would be in the public
interest and consistent with the objectives of the Safety Act. In
addition, the petitioner must submit data and analysis supporting the
making of one of the four findings specified above.
    Section 555.7 describes the steps that NHTSA is to take after it
receives an exemption petition. If the Agency determines that a
petition is complete, it publishes a notice in the Federal Register
summarizing the petition and inviting public comment on whether it
should be granted or denied.\4\ However, if NHTSA finds that a petition
does not

contain some of types of the information required by part 555, it so
informs the applicant, pointing out the areas of insufficiency and
stating that the petition will not receive further consideration until
the required information is submitted.\5\ If the petitioner submits
sufficient additional information and analysis to eliminate the ``areas
of insufficiency,'' the Agency publishes the notice requesting public
comment.
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    \4\ 49 CFR 555.7(a).
    \5\ Ibid.
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    If, after considering the petition and the public comments, NHTSA
determines that the petition does not contain ``adequate
justification,'' the Administrator denies it and notifies the
petitioner in writing.\6\ The Administrator also publishes in the
Federal Register a notice of the denial and the reasons for it.
Alternatively, if the Administrator determines that the petition
contains adequate justification, the Administrator grants it, and
notifies the petitioner in writing.\7\ The Administrator also publishes
in the Federal Register a notice of the grant and the reasons for
it.\8\
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    \6\ 49 CFR 555.7(d).
    \7\ 49 CFR 555.7(e).
    \8\ Ibid.
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II. Discussion of the Final Rule

    This document amends NHTSA's regulation on temporary exemption from
Federal motor vehicle safety standards (FMVSS) and bumper standards to
expedite the publishing of notices soliciting public comment on
exemption petitions. It does so by eliminating the provision calling
for the Agency to determine that a petition is complete before
publishing a notice soliciting public comments on the petition.
Especially in the context of complex petitions, the difficulty in
neatly separating ``areas of insufficiency'' from failures to provide
``adequate justification'' leads to delays in processing petitions.
Further, while areas of insufficiency would be considered in deciding
whether to grant or deny petitions, the Vehicle Safety Act does not
require that determinations of insufficiency be made by the Agency
before publishing notices of receipt. As amended, the regulation
continues to provide that the Agency will, as it does now, determine
whether a petition contains adequate justification in deciding whether
to grant or deny the petition.

III. Rulemaking Requirements

A. Executive Order 12866 (Regulatory Planning and Review)

    This rulemaking has been determined to be not significant for
purposes of Executive Order 12866.

B. Executive Order 13771 (Reducing Regulation and Controlling
Regulatory Costs)

    Executive Order 13771 titled ``Reducing Regulation and Controlling
Regulatory Costs,'' directs that, unless prohibited by law, whenever an
executive department or agency publicly proposes for notice and comment
or otherwise promulgates a new regulation, it shall identify at least
two existing regulations to be repealed. In addition, any new
incremental costs associated with new regulations shall, to the extent
permitted by law, be offset by the elimination of existing costs. Only
those rules deemed significant under section 3(f) of Executive Order
12866, ``Regulatory Planning and Review,'' are subject to these
requirements.
    This rule is not an Executive Order 13771 regulatory action because
this rule is not significant under Executive Order 12866.

C. Regulatory Flexibility Act

    Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.),
whenever an agency is required by 5 U.S.C. 553 (or any other law) to
publish a notice of proposed rulemaking (NPRM), the agency must prepare
and make available for public comment an Initial Regulatory Flexibility
Analysis, unless the agency certifies under 5 U.S.C. 605(b) that the
proposed rule, if implemented, will not have a significant economic
impact on a substantial number of small entities. 5 U.S.C. 603, 605.
    As noted above, NHTSA is not required to publish an NPRM in this
rulemaking. Further, the change made by this final rule will not have
not result in a significant economic impact on a substantial number of
small entities.

D. Executive Order 13132 (Federalism)

    NHTSA has analyzed this immediately adopted final rule under the
principles and criteria of Executive Order 13132, ``Federalism.'' The
Agency determined that this action will not have a substantial direct
effect on the States, or the relationship between the Federal
Government and the States, or on the distribution of power and
responsibilities among the various levels of government, and,
therefore, does not have Federalism implications.

E. Congressional Review Act

    This rule is not a ``rule'' as defined in 5 U.S.C. 804(3), because
it falls within the exclusion of ``any rule of agency organization,
procedure, or practice that does not substantially affect the rights or
obligations of non-agency parties.''

F. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(in 1995 dollars) in any one year by State, local, and tribal
governments, in the aggregate, or by the private sector; such a mandate
is deemed to be a ``significant regulatory action.'' The FAA currently
uses an inflation-adjusted value of $155 million in lieu of $100
million.
    This final rule does not contain such a mandate; therefore, the
requirements of Title II of the Act do not apply.

G. National Technology Transfer and Advancement Act

    The requirements of section 12(d) of the National Technology
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not
applicable because this rulemaking does not contain provisions
involving the use of technical standards.
Good Cause for Immediate Adoption
    Section 553(b)(3)(A) of the Administrative Procedure Act (APA) (5
U.S.C.) authorizes agencies to dispense with notice and comment
procedures for rules of agency organization, procedure, or practice,
except when notice or hearing is required by statute. Under this
section, an agency may issue a final rule without seeking comment prior
to the rulemaking.
    Additionally, section 553(b)(3)(B) of the APA authorizes agencies
to dispense with notice and comment procedures for rules when the
agency for ``good cause'' finds that those procedures are
``impracticable, unnecessary, or contrary to the public interest.''
Under this section, an agency, upon finding good cause, may issue a
final rule without seeking comment prior to the rulemaking.
    NHTSA finds that notice and public comment to this immediately
adopted final rule are unnecessary because this rule meets the
exception of section 553(b)(3)(A). The sole purpose of this rule is to
eliminate the provision calling for the Agency to determine that a
petition is complete before the Agency publishes a notice summarizing
the petition and soliciting public comments

on it. This rule does not impose any additional requirements on
exemption applicants or the public. Therefore, NHTSA has determined
that notice and public comment are unnecessary.
    In consideration of the foregoing, NHTSA amends 49 CFR chapter V as
follows:

List of Subjects in 49 CFR Part 555

    Motor vehicle safety, Motor vehicles.

PART 555--TEMPORARY EXEMPTION FROM MOTOR VEHICLE SAFETY AND BUMPER
STANDARDS

0
1. The authority citation for part 555 continues to read as follows:

    Authority: 49 U.S.C. 30113, 32502, Pub. L. 105-277; delegation
of authority at 49 CFR 1.50.

0
2. Paragraph (a) of Sec.  555.7 is revised to read as follows:

Sec.  555.7  Processing of applications.

    (a) The agency publishes a notice of the application in the Federal
Register, affording opportunity for comment.
* * * * *

    Issued in Washington, DC, under authority delegated in 49 CFR
1.95 and 501.5.
Heidi Renate King,
Deputy Administrator.
[FR Doc. 2018-27795 Filed 12-21-18; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Page 13851]
[FR Doc No: 2015-06104]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0805; FRL-9924-52]

EPA Proposal To Improve Corn Rootworm Resistance Management;
Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; extension of comment period.

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SUMMARY: EPA issued a notice in the Federal Register of January 28,
2015, concerning a proposal to improve the corn rootworm insect
resistance management program currently in place for registrations of
plant-incorporated protectants (PIP) derived from Bacillus
thuringiensis (Bt) in corn. This document extends the comment period
for an additional 30 days, from March 16, 2015 to April 15, 2015. A
number of stakeholders have expressed a desire to comment on EPA's
proposal and have requested additional time to review the proposal and
respond.

DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPP-2014-0805, must be received on or before April 15, 2015.

ADDRESSES: Follow the detailed instructions provided under ADDRESSES in
the Federal Register document of January 28, 2015 (80 FR 4564) (FRL-
9920-16).

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; main telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document extends the public comment
period established in the Federal Register document of January 28,
2015. In that document, EPA made available for public comment a
proposal to improve the corn rootworm insect resistance management
program currently in place for registrations of plant-incorporated
protectants (PIP) derived from Bacillus thuringiensis (Bt) in corn. The
Agency is seeking input on the proposal from potentially affected
entities and other stakeholders, including (but not limited to)
registrants of pesticides and PIPs for corn, corn growers, crop
consultants/agronomists, commodity groups, extension entomologists,
independent researchers, and the general public. EPA has received
several requests from stakeholders asking to extend the comment period.
Requests from crop consultants, grower representatives, and academic
researchers indicate that additional time is needed to develop and
submit detailed information addressing various aspects of EPA's
proposal. Therefore, the Agency has decided to extend the comment
period to ensure that all interested stakeholders have an opportunity
to comment. EPA is hereby extending the comment period, which was set
to end on March 16, 2015, to April 15, 2015.
    To submit comments, or access the docket, please follow the
detailed instructions provided under ADDRESSES in the Federal Register
document of January 28, 2015. If you have questions, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

    Authority: 7 U.S.C. 136 et seq.

    Dated: March 11, 2015.
Robert McNally,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. 2015-06104 Filed 3-12-15; 4:15 pm]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Notices]
[Page 14861]
[FR Doc No: 2018-07105]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1324]

Science Board to the Food and Drug Administration Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Science Board to
the Food and Drug Administration. The Science Board provides advice to
the Commissioner of Food and Drugs and other appropriate officials on
specific, complex scientific and technical issues important to FDA and
its mission, including emerging issues within the scientific community.
Additionally, the Science Board advises the Agency on keeping pace with
technical and scientific developments, including in regulatory science;
provides input into the Agency's research agenda; and advises on
upgrading its scientific and research facilities and training
opportunities. It will also provide, where requested, expert review of
Agency sponsored intramural and extramural scientific research
programs. The meeting will be open to the public.

DATES: The meeting will be held on April 23, 2018, from 9 a.m. to 4:30
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring,
MD 20993. For those unable to attend in person, the meeting will also
be webcast. The link for the webcast is available at https://collaboration.fda.gov/scienceboard2018/. Answers to commonly asked
questions including information regarding special accommodations due to
a disability, visitor parking, and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the
Chief Scientist, Office of the Commissioner, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver
Spring, MD 20993,<PHONE_NUMBER>, [email protected], 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: The Science Board will hear a report from the Center for
Biologics Evaluation and Research Program Review Subcommittee; hear
about FDA's Patient Affairs Initiative; and discuss how the Agency can
leverage its existing tools and authorities, and work with
stakeholders, to better address the complex scientific, public health,
and technology challenges it faces today.
    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.
    Procedure: 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
April 18, 2018. Oral presentations from the public will be scheduled
between approximately 3:30 p.m. and 4:30 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 April 13, 2018. 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 April 16, 2018.
    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 Rakesh Raghuwanshi 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: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07105 Filed 4-5-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Rules and Regulations]
[Pages 66173-66177]
[FR Doc No: 2021-25374]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2020-N-1082]

Microbiology Devices; Reclassification of Certain Hepatitis C
Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody
Tests

AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing a final order to reclassify certain hepatitis C virus (HCV)
antibody assay devices intended for the qualitative detection of HCV,
postamendments class III devices (product code MZO) into class II
(general controls and special controls), subject to premarket
notification. FDA is renaming and codifying these devices under the
classification regulation named ``hepatitis C virus (HCV) antibody
tests.'' FDA is also identifying the special controls that the Agency
believes are necessary to provide a reasonable assurance of safety and
effectiveness of these devices.

DATES: This order is effective December 22, 2021.

FOR FURTHER INFORMATION CONTACT: Maria Ines Garcia, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3104, Silver Spring, MD 20993-0002, 301-
796-7017, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended,
establishes a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the FD&C Act (21 U.S.C.
360c) established three classes of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three classes of devices are class I (general
controls), class II (general and special controls), and class III
(general controls and premarket approval).
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f)(1) of the FD&C Act into
class III without any FDA rulemaking process.\1\ Those devices remain
in class III and require premarket approval unless, and until, (1) FDA
reclassifies the device into class I or II, or (2) FDA issues an order
finding the device to be substantially equivalent, in accordance with
section 513(i) of the FD&C Act, to a predicate device that does not
require premarket approval. FDA determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807), subpart E, of the regulations.
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    \1\ HCV antibody assay devices for the qualitative detection of
HCV with intended uses outside the scope of the classification under
21 CFR 866.3169 are considered postamendments devices that are
subject to classification under section 513(f)(1) of the FD&C Act
or, if the relevant requirements are met, under section 513(f)(2) of
the FD&C Act.
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    A postamendments device that has been initially classified in class
III under section 513(f)(1) of the FD&C Act may be reclassified into
class I or II under section 513(f)(3) of the FD&C Act. Section
513(f)(3) of the FD&C Act provides that FDA, acting by administrative
order, can reclassify the device into class I or II on its own
initiative, or in response to a petition from the manufacturer or
importer of the device. To change the classification of the device, the
proposed new class must have sufficient regulatory controls to provide
a reasonable assurance of the safety and effectiveness of the device
for its intended use.
    FDA relies upon ``valid scientific evidence,'' as defined in
section 513(a)(3) of the FD&C Act and

Sec.  860.7(c)(2) (21 CFR 860.7(c)(2)), in the classification process
to determine the level of regulation for devices. To be considered in
the reclassification process, the ``valid scientific evidence'' upon
which the Agency relies must be publicly available (see section 520(c)
of the FD&C Act (21 U.S.C. 360j(c))). Publicly available information
excludes trade secret and/or confidential commercial information, e.g.,
the contents of a pending premarket approval application (PMA) (see
section 520(c) of the FD&C Act).
    FDA published a proposed order in the Federal Register of April 2,
2020 (85 FR 18490), to reclassify these device types from class III
into class II (general controls and special controls), subject to
premarket notification. FDA has considered the information available to
the Agency, including the deliberations of the March 22, 2018,
Microbiology Devices Panel (2018 Panel), and comments from the public
docket to determine that there is sufficient information to establish
special controls to effectively mitigate the risks to the health
identified in section V of the proposed order, and that these special
controls, together with general controls, provide a reasonable
assurance of safety and effectiveness when applied to certain HCV
antibody assay devices intended for the qualitative detection of HCV.
    Therefore, in accordance with section 513(f)(3) of the FD&C Act,
FDA, on its own initiative, is issuing this final order to reclassify
certain HCV antibody assay devices intended for the qualitative
detection of HCV from class III to class II (general and special
controls).\2\
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    \2\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
the Federal Register's (OFR) interpretation of the Federal Register
Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9
and parts 21 and 22) and the Document Drafting Handbook.
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II. Comments on the Proposed Order

    On April 2, 2020, FDA published in the Federal Register a proposed
order (85 FR 18490) to reclassify certain HCV antibody assay devices
intended for the qualitative detection of HCV from class III to class
II, subject to premarket notification. The comment period on the
proposed order closed on June 1, 2020. In response to the proposed
order, FDA received comments from industry, healthcare associations,
public health departments, and individual consumers by the close of the
comment period, some of which contained one or more comments on one or
more issues. We describe and respond to the comments in this section of
the document. Certain comments are grouped based on common themes; we
grouped similar comments together under the same number and listed them
numerically.
    The order of response to the commenters is purely for
organizational purposes and does not signify the comment's value or
importance nor the order in which comments were received. Please note
that in some cases we separated different issues discussed by the same
commenter and designated them as distinct comments for purposes of our
responses.
    (Comment 1) FDA received numerous comments in favor of the proposed
reclassification of certain HCV antibody assay devices intended for the
qualitative detection of HCV from class III to class II with special
controls. Commenters stated they believed that special controls, along
with general controls, could provide a reasonable assurance of the
safety and effectiveness of these devices. In addition, they believed
that the decreased regulatory burden resulting from the
reclassification could encourage further development of, and provide
patients more timely access to, these devices. Overall, there was a
general consensus among the commenters that the proposed special
controls are necessary and sufficient to mitigate the risks to health
of patients presented by these devices and to provide reasonable
assurance of the safety and effectiveness of these devices.
    (Response 1) Based on the evidence considered, comments received in
response to the proposed order and deliberations of the 2018 Panel, FDA
agrees with the commenters that reclassification of certain HCV
antibody assay devices for the qualitative detection of HCV from class
III into class II and that special controls, in addition to general
controls, can provide a reasonable assurance of the safety and
effectiveness of these devices. In addition, FDA expects that the
reclassification of these devices would enable more manufacturers to
develop them such that patients would benefit from increased access to
safe and effective tests.
    (Comment 2) One comment expressed concerns about the proposed
reclassification of these devices from class III into class II. The
commenter suggested that there was not enough justification to
reclassify these devices at this time and asked for clarification on
FDA's justification proposing this reclassification. The commenter also
asked for clarification on whether a high demand of these devices was a
consideration in FDA's proposed reclassification order.
    (Response 2) Based on the evidence considered, comments received in
response to the proposed order and deliberations of the 2018 Panel, FDA
disagrees with this comment and continues to believe that
reclassification of these devices is justified for the reasons
identified in the proposed order (85 FR 18490). FDA's justification for
reclassifying these devices is based on the unanimous recommendation of
the 2018 Panel, FDA's accumulated experience with these devices from
review submissions, and from published peer-reviewed literature. In
addition, FDA believes that the special controls identified in this
final order, in addition to the general controls, will provide a
reasonable assurance of the safety and effectiveness of these devices.
    FDA relies upon ``valid scientific evidence'' as defined in section
513(a)(3) of the FD&C Act and Sec.  860.7(c)(2) in the classification
process to determine the level of regulation for devices. FDA believes
the standard in section 513(a)(1)(B) of the FD&C Act is met as there is
sufficient information to establish special controls, which, in
addition to general controls, will provide reasonable assurance of the
safety and effectiveness of these devices. While FDA expects that the
reclassification of these devices would enable more manufacturers to
develop HCV antibody tests such that patients would benefit from
increased access to safe and effective tests, this is not a
consideration in the Agency's reclassification determination.
    (Comment 3) Several commenters had questions about the scope of the
proposed reclassification order. Several commenters noted that the
proposed reclassification order identified these devices as HCV
antibody tests for prescription use and suggested that the
reclassification order should also include HCV antibody tests intended
for over-the-counter (OTC) use. In addition, one commenter suggested
that FDA's reclassification order should also include HCV antigen
tests, tests for hepatitis A and hepatitis B, and also that the
reclassification should include other specimen types for HCV antibody
tests beyond those identified in the proposed order (e.g., urine or
saliva).
    (Response 3) These comments are beyond the scope of FDA's proposed
reclassification order which applies only to HCV antibody tests that
have been previously approved by FDA. FDA has not approved any HCV
antibody tests intended for OTC use and FDA believes that an HCV
antibody tests

intended for OTC use would be a new type of device not previously
classified based on the criteria at section 513(a)(1) of the FD&C Act
and, as a result, such postamendments devices would be automatically
classified into class III by operation of section 513(f)(1) of the FD&C
Act. FDA believes that an HCV antibody test intended for OTC use may be
a good candidate for the De Novo classification process under section
513(f)(2) of the FD&C Act (Refs. 1 and 2). FDA recommends that device
manufacturers interested in marketing an HCV antibody test for OTC use
submit a Pre-Submission to request FDA feedback on the studies and data
that may be necessary to support a De Novo request (Ref. 3).
    Similarly, to date, FDA has only approved HCV antibody tests
intended for use with human serum or plasma and new specimen types are
beyond the scope of this reclassification order.
    (Comment 4) Several commenters expressed support of FDA's proposal
to rename these devices from ``hepatitis C virus antibody assay
devices'' to ``hepatitis C virus (HCV) antibody tests.'' These
commenters believed that the new name for these devices made clear that
these are diagnostic tests and is consistent with the naming of similar
diagnostic devices. Alternatively, several commenters provided
suggestions on FDA's proposal to rename these devices to ``hepatitis C
virus (HCV) antibody tests.'' One commenter suggested renaming these
devices ``HCV serological tests.'' Another commenter suggested renaming
these devices ``hepatitis C virus (HCV) antibody test devices.''
    (Response 4) FDA believes that the new identification of these
devices as ``hepatitis C virus (HCV) antibody tests'' is both
understandable to consumers and industry and is consistent with the
naming of similar diagnostic devices.
    FDA disagrees with those commenters that proposed renaming these
devices ``HCV serological tests'' or ``hepatitis C virus (HCV) antibody
test devices'' as FDA believes that the identification of these devices
as ``hepatitis C virus (HCV) antibody tests'' adequately identifies the
types of devices that would be affected by this reclassification action
and is clear and consistent with the naming of similar diagnostic
devices.
    (Comment 5) One commenter suggested that HCV antibody tests could
be classified in part 866 (21 CFR part 866) after ``Hepatitis A virus
(HAV) serological reagents'' which are currently classified under 21
CFR 866.3310.
    (Response 5) FDA disagrees with this comment because FDA believes
that the classification of HCV antibody tests under Sec.  866.3169 (21
CFR 866.3169) is appropriate. In addition, FDA has proposed to
reclassify nucleic acid-based HCV ribonucleic acid (RNA) devices
intended for the qualitative or quantitative detection or genotyping of
HCV RNA under Sec.  866.3170 (21 CFR 866.3170) (85 FR 18483). The
classification of HCV antibody tests in Sec.  866.3169 would allow for
these devices to be located next to nucleic acid-based HCV RNA tests in
the Code of Federal Regulations (CFR).
    (Comment 6) One commenter requested that FDA state the time that it
generally takes for FDA to review 510(k) submissions and PMA
applications.
    (Response 6) Review times for a particular device may vary but the
FD&C Act requires manufacturers to submit a 510(k) to FDA at least 90
days before introducing, or before delivering for introduction, a
device into interstate commerce (see section 510(k) of the FD&C Act).
For comparison, FDA has 180 days to review a PMA starting on the date
an application is accepted for filing (see section 515(d) of the FD&C
Act (21 U.S.C. 360e(d)) and 21 CFR 814.40).
    (Comment 7) One comment indicated a patient who was diagnosed with
hepatitis was successfully treated. Another comment requested that FDA
consider reducing the prices of HCV antibody tests as a result of their
reclassification.
    (Response 7) Each of these comments are outside the scope of this
reclassification action.
    (Comment 8) Several comments expressed general support of the
special controls identified in the proposed order and believed they
would provide a reasonable assurance of safety and effectiveness of
these devices. In addition, several commenters suggested that FDA
revise the special controls to include a requirement that the labeling
identify where and when these devices may be used consistent with
infection control standards and FDA guidance documents for infection
control. Additionally, it was suggested that the labeling specify the
special populations of patients for which test performance may be
affected.
    (Response 8) FDA continues to believe that the special controls
identified in the proposed order and finalized in this final order are
sufficient to provide a reasonable assurance of safety and
effectiveness of HCV antibody tests.
    FDA disagrees that a further level of specificity is necessary for
inclusion within the special controls to provide a reasonable assurance
of safety and effectiveness for these devices and wants to ensure that
the special controls remain appropriate and applicable to provide a
reasonable assurance of safety and effectiveness for these devices over
time. Further, performance of these devices may evolve over time for
special populations and any special populations for which performance
of these devices may be affected are required to be included in the
labeling for these devices by the special controls (see Sec.
866.3169(b)(1)(ii)(A)).

III. The Final Order

    Based on the information discussed in the preamble to the proposed
order (85 FR 18490), the comments received for the proposed order, the
2018 Panel deliberations (Ref. 4), and FDA's experiences over the years
in reviewing these device types, FDA concludes that special controls,
in conjunction with general controls, will provide a reasonable
assurance of the safety and effectiveness of HCV antibody tests. FDA is
adopting its findings under section 513(f)(3) of the FD&C Act, as
published in the preamble to the proposed order. FDA is issuing this
final order to reclassify HCV antibody tests intended for the
qualitative detection of HCV from class III to class II, and
establishing special controls by revising part 866. In this final
order, the Agency has identified the special controls under section
513(a)(1)(B) of the FD&C Act that, together with general controls,
provide a reasonable assurance of the safety and effectiveness of these
devices.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. FDA has determined that premarket
notification is necessary to provide a reasonable assurance of the
safety and effectiveness of HCV antibody tests. Therefore, this device
type is not exempt from premarket notification requirements. Persons
who intend to market a new HCV antibody assay device must submit to FDA
a premarket notification, obtain clearance, and demonstrate compliance
with the special controls included in this final order, prior to
marketing the device.
    These devices are assigned the generic name ``HCV antibody tests''
and identified as in vitro diagnostic devices intended for use with
human serum,

plasma, or other matrices as a prescription device that aids in the
diagnosis of HCV infection in persons with signs and symptoms of
hepatitis and in persons at risk for hepatitis C infection. The test is
not intended for screening blood, plasma, cell, or tissue donors.
    Under this final order, HCV antibody tests are identified as
prescription use only devices and as such, HCV antibody tests must
satisfy prescription labeling requirements for in vitro diagnostic
products (see 21 CFR 809.10(a)(4) and (b)(5)(ii)). Under 21 CFR 807.81,
the device continues to be subject to 510(k) requirements.

IV. Codification of Orders

    Prior to the amendments in the Food and Drug Administration Safety
and Innovation Act (Pub. L. 112-144) (FDASIA), section 513(e) of the
FD&C Act provided for FDA to issue regulations to reclassify devices.
Although section 513(e), as amended by FDASIA, requires FDA to issue
final orders rather than regulations, it also provides for FDA to
revoke previously issued regulations by order. FDA will continue to
codify classifications and reclassifications in the CFR. Changes
resulting from final orders will appear in the CFR as changes to
codified classification determinations or as newly codified orders.
Therefore, under section 513(e)(1)(A)(i), as amended by FDASIA, in this
final order, we are proposing to codify the classification of hepatitis
c virus antibody tests in the new Sec.  866.3169, under which HCV
antibody tests would be reclassified into class II.

V. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved FDA collections. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The
collections of information in part 807, subpart E have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR parts 801 and 809 have been approved under OMB control number
0910-0485; and the collections of information in 21 CFR part 820 have
been approved under OMB control number 0910-0073.

VII. References

    The following references are on display at the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852,<PHONE_NUMBER> and are available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they also are available electronically at https://www.regulations.gov.
FDA has verified the website addresses, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.

1. ``De Novo Classification Process (Evaluation of Automatic Class
III Designation)--Guidance for Industry and Food and Drug
Administration Staff,'' issued October 30, 2017 (available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-process-evaluation-automatic-class-iii-designation).
2. ``Acceptance Review for De Novo Classification Requests--Guidance
for Industry and Food and Drug Administration Staff,'' issued
September 9, 2019 (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-classification-requests).
3. ``Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program--Guidance for Industry and
Food and Drug Administration Staff,'' issued May 7, 2019 (available
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program).
4. Transcript of the FDA Microbiology Devices Panel Meeting, March
22, 2018 (available at https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM630139.pdf).

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  866.3169 to subpart D to read as follows:

Sec.  866.3169   Hepatitis C virus antibody tests.

    (a) Identification. A hepatitis C virus (HCV) antibody test is
identified as an in vitro diagnostic device intended for use with human
serum, plasma, or other matrices as a prescription device that aids in
the diagnosis of HCV infection in persons with signs and symptoms of
hepatitis and in persons at risk for hepatitis C infection. The test is
not intended for screening blood, plasma, cell, or tissue donors.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The labeling required under Sec.  809.10(b) of this chapter
must include:
    (i) A prominent statement that the test is not intended for the
screening of blood, plasma, and cell or tissue donors.
    (ii) Limitations, which must be updated to reflect current clinical
practice and disease presentation and management. The limitations must
include, but are not limited to, statements that indicate:
    (A) When appropriate, the performance characteristics of the test
have not been established in populations of immunocompromised or
immunosuppressed patients or, other special populations where test
performance may be affected.
    (B) The detection of HCV antibodies indicates a present or past
infection with hepatitis C virus, but does not differentiate between
acute, chronic, or resolved infection.
    (C) The specimen types for which the device has been cleared, and
that use of the test with specimen types other than those specifically
cleared for this device may result in inaccurate test results.
    (D) Test results are to be interpreted by qualified licensed
healthcare professionals in conjunction with the individual's clinical
presentation, history, and other laboratory results.
    (E) A non-reactive test result may occur early during acute
infection, prior to development of a host antibody response to
infection, or when analyte levels are below the limit of detection of
the test.
    (iii) A detailed explanation of the principles of operation and
procedures for performing the test.
    (2) Design verification and validation must include the following:
    (i) A detailed device description, including all parts that make up
the device, ancillary reagents required but not provided, an
explanation of the device methodology, and design of the antigen(s) and
capture antibody(ies)

sequences, rationale for the selected epitope(s), degree of amino acid
sequence conservation of the target, and the design and nature of all
primary, secondary, and subsequent standards used for calibration.
    (ii) Documentation and characterization (e.g., supplier,
determination of identity, and stability) of all critical reagents
(including description of the antigen(s) and capture antibody(ies)),
and protocols for maintaining product integrity throughout its labeled
shelf life.
    (iii) Risk analysis and management strategies, such as Failure
Modes Effects Analysis and/or Hazard Analysis and Critical Control
Points summaries and their impact on test performance.
    (iv) Final release criteria to be used for manufactured test lots
with appropriate evidence that lots released at the extremes of the
specifications will meet the claimed analytical and clinical
performance characteristics as well as the stability claims.
    (v) Stability studies for reagents must include documentation of an
assessment of real-time stability for multiple reagent lots using the
indicated specimen types and must use acceptance criteria that ensure
that analytical and clinical performance characteristics are met when
stability is assigned based on the extremes of the acceptance range.
    (vi) All stability protocols, including acceptance criteria.
    (vii) Final release test results for each lot used in clinical
studies.
    (viii) Multisite reproducibility study that includes the testing of
three independent production lots.
    (ix) Analytical performance studies and results for determining the
limit of blank (LoB), limit of detection (LoD), cutoff, precision
(reproducibility) including lot-to-lot and/or instrument-to-instrument
precision, interference, cross reactivity, carryover, hook effect,
seroconversion panel testing, matrix equivalency, specimen stability,
reagent stability, and cross-genotype antibody detection sensitivity,
when appropriate.
    (x) Analytical sensitivity of the test is the same or better than
that of other cleared or approved tests.
    (xi) Detailed documentation of clinical performance testing from a
multisite clinical study. Performance must be analyzed relative to an
FDA cleared or approved HCV antibody test, or a comparator that FDA has
determined is appropriate. This study must be conducted using
appropriate patient samples, with an acceptable number of HCV positive
and negative samples in applicable risk categories. Additional relevant
patient groups must be validated as appropriate. The samples may be a
combination of fresh and repository samples, sourced from
geographically diverse areas. The study designs, including number of
samples tested, must be sufficient to meet the following criteria:
    (A) Clinical sensitivity of the test must have a lower bound of the
95 percent confidence interval of greater than or equal to 95 percent.
    (B) Clinical specificity of the test must have a lower bound of the
95 percent confidence interval of greater than or equal to 96 percent.
    (3) For any HCV antibody test intended for Point of Care (PoC) use,
the following special controls, in addition to those listed in
paragraphs (b)(1) and (2) of this section, apply:
    (i) Clinical studies must be conducted at PoC sites.
    (ii) Additional labeling must include a brief summary of the
instructions for use that are appropriate for use in a PoC environment.

    Dated: November 16, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25374 Filed 11-19-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 192 (Monday, October 5, 2015)]
[Rules and Regulations]
[Pages 60033-60040]
[FR Doc No: 2015-25062]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1910, 1926

[Docket Nos. S-016 (OSHA-S016-2006-0646), OSHA-S215-2006-0063]
RIN 1218-AA32, 1218-AB67

Electrical Safety-Related Work Practices; Electric Power
Generation, Transmission, and Distribution; Electrical Protective
Equipment; Corrections

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Correcting amendments.

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

SUMMARY: This document corrects the electrical safety-related work
practices standard for general industry and the electric power
generation, transmission, and distribution standards for general
industry and construction to provide additional clarification regarding
the applicability of the standards to certain operations, including
some tree trimming work that is performed near (but that is not on or
directly associated with) electric power generation, transmission, and
distribution installations. This document also corrects minor errors in
two minimum approach distance tables in the general industry and
construction standards for electric power generation, transmission and
distribution work.

DATES: These correcting amendments are effective on October 5, 2015.

FOR FURTHER INFORMATION CONTACT: General information and press
inquiries: Mr. Frank Meilinger, Office of Communications, Room N3647,
OSHA, U.S. Department of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    Technical information: Mr. William Perry, Directorate of Standards
and Guidance, Room N3718, OSHA, U.S. Department of Labor, 200
Constitution Avenue NW., Washington, DC 20210; telephone<PHONE_NUMBER>
or fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document revises certain language in
OSHA's standards to reflect the Agency's intent about the scope of two
general industry standards. First, this document revises language that
mistakenly could be read as suggesting that the general industry
electric power generation, transmission, and distribution standard
covers certain tree-trimming work that is performed near, but that is
not on or directly associated with, electric power generation,
transmission, and distribution installations. This was never OSHA's
intent; rather, OSHA intended that the general industry electrical
safety-related work practices standard cover such work. Similarly, OSHA
is correcting language in its general industry electrical safety-
related work practices standard to make clear that the standard covers
other work performed by qualified persons that is near, but not on or
directly associated with, both electric power generation, transmission,
and distribution installations and certain other types of
installations.
    This notice also corrects minor errors in two minimum approach
distance tables in the general industry and construction standards for
electric power generation, transmission and distribution work.

Background

    On August 6, 1990, OSHA adopted a standard on electrical safety-
related work practices for general industry (55 FR 31984).\1\ That
standard is contained in Sec. Sec.  1910.331 through 1910.335 in
subpart S of 29 CFR part 1910. According to Sec.  1910.331(a), that
standard contains electrical safety-related work practices for both
qualified persons \2\ (those who have training in avoiding the
electrical hazards of working on or near exposed energized parts) and
unqualified persons (those with little or no such training) working on,
near, or with certain electrical installations (not including electric
power generation, transmission, and distribution installations).
Paragraph (c) of Sec.  1910.331 excludes from the scope of the
electrical safety-related work practices standard work by qualified
persons ``on or directly associated with'' certain installations,
including installations for the generation, transmission, and
distribution of electric energy (Sec.  1910.331(c)(1)).\3\
---------------------------------------------------------------------------

    \1\ The Docket number, as listed on the original final rule, was
S-016. The corresponding Docket ID on Regulations.gov is OSHA-S016-
2006-0646 (http://www.regulations.gov/#!docketBrowser;rpp=50;so=ASC;sb=docId;po=50;D=OSHA-S016-2006-0646).
    \2\ Subpart S, in Sec.  1910.399, defines ``qualified person''
as someone who has received training in and has demonstrated skills
and knowledge in the construction and operation of electric
equipment and installations and the hazards involved. In addition,
Sec. Sec.  1910.332(b)(3) and 1910.333(c)(2) require qualified
persons to have specialized skills and training before OSHA
considers them to be qualified.
    \3\ Paragraph (b) of Sec.  1910.331 provides that the electrical
safety-related work practice requirements in Sec. Sec.  1910.331
through 1910.335 apply to work performed by unqualified persons on,
near, or with the installations listed in paragraph (c).
---------------------------------------------------------------------------

    When the Agency promulgated the electrical safety-related work
practices standard in 1990, OSHA did not define ``work directly
associated with'' generation, transmission, or distribution
installations. However, Note 2 to Sec.  1910.331(c)(1) gave two
examples of such work: line-clearance tree trimming and replacing
utility poles. OSHA defined ``line-clearance tree trimming,'' at 29 CFR
1910.399 in subpart S, as the pruning, trimming, repairing,
maintaining, removing, or clearing of trees or cutting of brush that is
within 305 cm (10 feet) of electric supply lines and equipment.
    On January 31, 1994, OSHA issued a new standard, Sec.  1910.269,
addressing work practices to be used during the operation and
maintenance of electric power generation, transmission, and
distribution lines and equipment, including, specifically, line-
clearance tree-trimming operations (59 FR 4320).\4\ The 1994 final
rule: adopted a definition of ``line-clearance tree trimming'' in Sec.
1910.269(x) that mirrored the definition of that term in Sec.
1910.399, redesignated Note 2 to Sec.  1910.331(c)(1) (which provided
examples of the types of work that are excluded from the electrical
safety-related work practices standard because they are directly
associated with electric power generation, transmission, or
distribution installations) as Note 3, and added a sentence to that
note stating that work within the scope of the note is covered by Sec.
1910.269.\5\
---------------------------------------------------------------------------

    \4\ Paragraph (a)(1)(i) of Sec.  1910.269 states that the
standard covers the operation and maintenance of electric power
generation, control, transformation, transmission, and distribution
lines and equipment. Paragraph (a)(1)(i)(E) lists line-clearance
tree-trimming operations as work to which the standard applies.
    \5\ The Docket number, as listed on the original final rule, was
S-015. The corresponding Docket ID on Regulations.gov is OSHA-S015-
2006-0645 (http://www.regulations.gov/#!docketBrowser;rpp=25;so=ASC;sb=docId;po=0;dct=N%252BFR%252BPR%252BO
%252BSR%252BPS;D=OSHA-S015-2006-0645).
---------------------------------------------------------------------------

    On April 11, 2014, OSHA revised Sec.  1910.269, as well as subpart
V of part 1926, which contains corresponding requirements for the
construction of electric power transmission and distribution lines and
equipment (79 FR 20316). The 2014 final rule revised the definition of
``line-clearance tree trimming'' in Sec.  1910.269(x) to include the
pruning, trimming, repairing, maintaining, removing, or clearing of
trees, or the cutting of brush, that is within the following distance
of electric supply lines and equipment: (1) For voltages to ground of
50 kilovolts or less--3.05 meters (10 feet) and (2) for voltages to
ground of more than 50 kilovolts--3.05 meters (10 feet) plus 0.10
meters (4 inches) for every 10 kilovolts over 50 kilovolts. The
revision expanded the definition to include work on trees and brush
that were farther away from electric power lines and equipment when the
voltage was more than 50 kilovolts. The 2014 final rule also revised
Note 3 to Sec.  1910.331(c)(1) to reference the definition of ``line-
clearance tree trimming'' in Sec.  1910.269(x) and deleted the
corresponding definition from Sec.  1910.399.

Need for Correcting Amendment

    After OSHA promulgated the 2014 revisions to Sec.  1910.269, tree
care industry representatives raised questions that led the Agency to
believe that the industry was unclear about the application of Sec.
1910.269 with respect to certain tree-trimming work. As a result, OSHA
examined the relevant regulatory language in the general industry
standards on electrical safety-related work practices (subpart S) and
on electric power generation, transmission, and distribution work
(Sec.  1910.269). The Agency's review led to two conclusions: (1)
Revisions to Sec.  1910.269 are necessary to clarify that certain types
of tree trimming meeting the definition of ``line-clearance tree
trimming'' are not covered by that standard; and (2) revisions to Sec.
1910.331 (in subpart S) are necessary to clarify that the electrical
safety-related work practices in Sec. Sec.  1910.331 through 1910.335
apply to tree-trimming work that may meet the definition of ``line-
clearance tree trimming'' when that work is not on or directly
associated with electric power generation, transmission, and
distribution or other installations listed in Sec.  1910.331(c) and,
more generally, to work performed by qualified employees when that work
is near, but not on or directly associated with, installations listed
in Sec.  1910.331(c).
    Tree trimming: As noted earlier in this document, when the Agency
adopted the electrical safety-related work practices standard in 1990,
OSHA listed line-clearance tree trimming and replacing utility poles as
examples of types of work that are directly associated with electric
power generation, transmission, and distribution installations and,
therefore, excluded from subpart S when performed by a qualified person
(as ``qualified person'' is defined in Sec.  1910.399). However, OSHA
was imprecise in its description of these examples. Although clearing
trees and brush around power lines and replacing utility poles are
usually tasks that are directly associated with a power line, that is
not always the case. For example, an employee could be trimming trees
away from telephone or cable television lines that happen to be near an
electric power line. This type of tree trimming, which meets the
definition of line-clearance tree trimming in Sec.  1910.269(x), is
work directly associated with communications lines, not electric power
lines, and is covered by Sec.  1910.268, not Sec.  1910.269.\6\
Similarly, a telecommunications firm replacing a utility pole
supporting communications lines is performing work directly associated
with the communications lines, not with any electric power lines that
also happen to be supported by the pole but that are not

transferred to the new pole by the firm. OSHA intended the examples in
Note 3 to Sec.  1910.331(c)(1) to illustrate types of work that
generally (but not always) would be directly associated with electric
power generation, transmission, and distribution lines. The Agency did
not intend for those examples to be dispositive of the question of
whether any particular activity is directly associated with those
installations.
---------------------------------------------------------------------------

    \6\ Under Sec.  1910.331(c)(2), line-clearance tree trimming to
clear space around communications lines is exempt from Sec. Sec.
1910.331 through 1910.335 when performed by qualified persons.
---------------------------------------------------------------------------

    Furthermore, the current definition of ``line-clearance tree
trimming'' in Sec.  1910.269(x) makes the location of the tree or brush
the key determining factor in deciding whether a trimming activity is
line-clearance tree trimming. Consequently, any trimming or other
maintenance of any tree or brush that is within the specified distances
of an electric power line is line-clearance tree trimming, irrespective
of the purpose of the activity or the occupation of the worker.
Notwithstanding this definition, the only line-clearance tree trimming
OSHA intended Sec.  1910.269 to cover is line-clearance tree trimming
performed: (1) For the purpose of clearing space around electric power
generation, transmission, or distribution lines or equipment and (2) on
behalf of an organization that operates, or that controls the operating
procedures for, those lines or equipment. For example, a crew trimming
trees at a residence or commercial facility for aesthetic purposes
would be performing work meeting the current definition of ``line-
clearance tree trimming'' while trimming any tree that is within the
specified distance of a power line. Yet, in most cases, OSHA would
consider this work to be incidental line-clearance tree trimming \7\
that is not directly associated with an electric power generation,
transmission, or distribution line. When initially promulgating the
electrical safety-related work practices standard in 1990, the Agency
did not intend such incidental line-clearance tree trimming to be
included in the exemption in Sec.  1910.331(c)(1). When OSHA adopted
Sec.  1910.269 in 1994, and revised that standard in 2014, the Agency
proceeded on the understanding that such incidental line-clearance tree
trimming was covered by subpart S; thus, OSHA did not intend to cover
that work under Sec.  1910.269, even though it is now apparent that the
definition of ``line-clearance tree trimming'' in Sec.  1910.269(x),
which was adopted in 1994, and revised in 2014, did not make this
intent clear.\8\
---------------------------------------------------------------------------

    \7\ Throughout this preamble, OSHA refers to any tree trimming
activities performed on a tree or brush that is closer to an
electric power generation, transmission, or distribution line or
equipment than the distances specified in the definition of ``line-
clearance tree trimming'' in existing Sec.  1910.269(x) as
``incidental line-clearance tree trimming'' when the tree trimming
activities are not directly associated with the lines or equipment.
    \8\ During the rulemaking that led to the promulgation of the
electrical safety-related work practices standard in Subpart S in
1990, the National Arborist Association expressed concern that the
exemption in Sec.  1910.331(c)(1) for work performed by qualified
employees on or directly associated with electric power generation,
transmission, and distribution installations was not specific
enough. That organization recommended that line-clearance tree
trimming be separated from the ``directly associated with'' electric
power installations test and exempted through a specified exclusion
for tree trimming performed by qualified employees near overhead
power lines (Docket ID OSHA-S016-2006-0646-0084). OSHA rejected that
recommendation and instead adopted the note stating that line-
clearance tree trimming is an example of work directly associated
with electric power generation, transmission, and distribution
installations (55 FR 31997). In discussing the note in the preamble
to the 1990 rule, OSHA rejected an assertion from the National
Arborist Association that the exemption in Sec.  1910.331(c)(1)
would exempt only work performed on behalf of the owner or operator
of the overhead lines (55 FR 31997). OSHA recognizes that this
discussion in the 1990 preamble may have been misleading with
respect to the Agency's intent, which was stated more clearly
elsewhere in the same notice when OSHA noted that line-clearance
tree trimming contractors (usually hired by electric utilities)
would be covered under Sec.  1910.269 and that residential
contractors (usually hired by homeowners or businesses other than
electric utilities) would be covered by the electrical safety-
related work practice requirements in subpart S (55 FR 31997). This
correcting amendment is designed to provide clarification that
should resolve any confusion resulting from imprecision in the 1990
subpart S preamble.
---------------------------------------------------------------------------

    The Agency's economic analyses for the 1994 and 2014 rulemakings
reflect that OSHA did not intend to cover incidental line-clearance
tree trimming under Sec.  1910.269. The regulatory impact assessment
for the 1994 final rule indicated that Sec.  1910.269 ``will cover . .
. contract line-clearance tree trimmers'' (59 FR 4431, emphasis added),
meaning ``contractors [that] perform tree trimming for electric
utilities'' (OSHA-S015-2006-0645-0008 \9\). And OSHA based the 2014
analysis on the continued assumption that the rule would cover contract
line-clearance tree-trimming firms (in other words, contractors that
perform tree trimming on behalf of a utility or other organization that
operates, or controls the operating procedures for, covered electric
power lines and equipment) only. In the 2014 analysis, OSHA relied on
2002 estimates from the National Arborist Association (now known as the
Tree Care Industry Association) that 90 percent of large
establishments, and 2 percent of small establishments, that perform
ornamental shrub and tree services are involved in line-clearance tree
trimming covered by Sec.  1910.269 (79 FR 20564). Thus, the 2014
analysis did not account for a large percentage of establishments that
perform ornamental shrub and tree care services, even though, in all
likelihood, the majority, if not all, of these establishments perform
at least some work meeting the definition of line-clearance tree
trimming.
---------------------------------------------------------------------------

    \9\ This number is the document ID for ``Preparation of an
Economic Impact Study for the Proposed OSHA Regulation Covering
Electric Power Generation, Transmission, and Distribution,'' a
report prepared by Eastern Research Group, Inc. that formed the
basis for OSHA's economic analysis for the 1994 final rule. This
document is available at http://www.regulations.gov.
---------------------------------------------------------------------------

    Thus, OSHA concludes that the language in the existing standards
does not accurately convey the Agency's intent with respect to tree-
trimming activities that meet the definition of ``line-clearance tree
trimming,'' but that are not directly associated with electric power
generation, transmission, or distribution lines or equipment.
    Subpart S coverage of work by qualified employees that is near, but
not on or directly associated with, electric power generation,
transmission, or distribution installations. Paragraph (a) of Sec.
1910.331 describes work by both qualified and unqualified persons that
is covered by the electrical safety-related work practices at
Sec. Sec.  1910.331 through 1910.335. Paragraph (b) of Sec.  1910.331
states that the electrical safety-related work practices at Sec. Sec.
1910.331 through 1910.335 apply to work performed by unqualified
persons on, near, or with certain installations (including electric
power generation, transmission, and distribution installations) listed
in Sec.  1910.331(c)(1) through (c)(4). And the introductory text to
Sec.  1910.331(c) states that the electrical safety-related work
practices at Sec. Sec.  1910.331 through 1910.335 do not apply to work
performed by qualified persons on or directly associated with the
installations (including electric power generation, transmission, and
distribution installations) listed in Sec.  1910.331(c)(1) through
(c)(4). Section 1910.331 does not state explicitly that the electrical
safety-related work practices in subpart S do apply to work performed
by qualified persons near, but not on or directly associated with,
electric power generation, transmission, and distribution
installations, although other parts of the standard make clear that
OSHA intended to cover this type of work in subpart S. For example,
Sec.  1910.333(c)(3)(ii) contains requirements for qualified persons
working in the vicinity of overhead lines. As virtually all overhead
lines at the voltages addressed by this

provision \10\ are electric power generation, transmission, or
distribution lines, it is evident that OSHA intended to cover work by
qualified persons performed near, but not on or directly associated
with, electric power generation, transmission, or distribution
installations.
---------------------------------------------------------------------------

    \10\ Paragraph (c)(3)(ii) of Sec.  1910.333 generally requires
qualified persons to maintain the minimum approach distances shown
in Table S-5 from overhead lines. Table S-5 lists approach distances
for various voltages up to 140 kilovolts. The highest voltage on
electric utilization systems (which are covered by subpart S as
indicated in Notes 1 and 2 to Sec.  1910.331(c)(1)) is generally
about 4 kilovolts.
---------------------------------------------------------------------------

    Therefore, OSHA concludes that the scope provisions in Sec.
1910.331 do not accurately explain the applicability of the electrical
safety-related work practices at Sec. Sec.  1910.331 through 1910.335
to qualified persons performing work near, but not on or directly
associated with, the installations listed in Sec.  1910.331(c)(1)
through (c)(4), including electric power generation, transmission, and
distribution installations.

Description of Correcting Amendment

    To clarify what work is covered by the general industry standards
on electric power generation, transmission, and distribution work and
on electrical safety-related work practices, OSHA is taking the
following actions:
    1. Expressly limiting the scope of Sec.  1910.269 as it relates to
line-clearance tree trimming by revising Sec.  1910.269(a)(1)(i)(E) to
state explicitly that the standard applies to line-clearance tree
trimming only to the extent it is performed for the purpose of clearing
space around electric power generation, transmission, or distribution
lines or equipment and on behalf of an organization that operates, or
that controls the operating procedures for, those lines or equipment.
    2. Adding a note to the definition of ``line-clearance tree
trimming'' in Sec.  1910.269(x), with corresponding revisions to Note 2
to the definition of ``line-clearance tree trimmer,'' to explain that:
(1) The scope of Sec.  1910.269 limits the application of the standard
to line-clearance tree trimming as noted in Sec.  1910.269(a)(1)(i)(E);
and (2) tree trimming that is performed on behalf of a homeowner or
commercial entity other than an organization that operates, or that
controls the operating procedures for, electric power generation,
transmission, or distribution lines or equipment, or that is not for
the purpose of clearing space around electric power generation,
transmission, or distribution lines or equipment, is not directly
associated with an electric power generation, transmission, or
distribution installation and is not covered by Sec.  1910.269.
    3. Revising Appendix A-3 to Sec.  1910.269 to reflect the
clarifications in this correcting amendment.\11\
---------------------------------------------------------------------------

    \11\ In addition, OSHA is moving the note referring to
requirements for manholes and underground vaults at the bottom of
Appendix A-3 to Appendix A-5 (relating to enclosed spaces), which is
the appendix to which that note applies.
---------------------------------------------------------------------------

    4. Replacing terms such as ``line-clearance tree-trimming
operations'' and ``line-clearance tree-trimming work'' wherever they
appear in Sec.  1910.269 and subpart V of part 1926 with ``line-
clearance tree trimming'' and revising Sec.  1926.950(a)(3) to
correspond to the changes to Sec.  1910.269(a)(1)(i)(E), noted
earlier.\12\
---------------------------------------------------------------------------

    \12\ Specifically, OSHA is revising relevant language in Sec.
1926.950(a)(3) to reflect that Sec.  1910.269 applies to line-
clearance tree trimming only to the extent it is performed for the
purpose of clearing space around electric power generation,
transmission, or distribution lines or equipment and on behalf of an
organization that operates, or that controls the operating
procedures for, those lines or equipment.
---------------------------------------------------------------------------

    5. Referencing the scope of Sec.  1910.269 in Note 3 to Sec.
1910.331(c)(1).
    6. In Sec.  1910.331(b), adding language clarifying that the
electrical safety-related work practices in subpart S cover qualified
persons performing work near, but not on or directly associated with,
installations listed in Sec.  1910.331(c)(1) through (c)(4).
    OSHA is also correcting minor errors in Table R-6 of Sec.  1910.269
and in Table V-5 of subpart V of part 1926. Table R-3 of Sec.  1910.269
and Table V-2 of subpart V, which contain equations for employers to
use to establish minimum approach distances from energized parts of
electric circuits, set the minimum approach distance for 50 to 300
volts as ``avoid contact.'' Using the equations in Table R-3 and Table
V-2, Table R-6 and Table V-5 provide default minimum approach distances
for voltage ranges up to 72.5 kilovolts. The latter two tables
erroneously list the first voltage range as 0.50 to 0.300 kilovolts.
The correct voltage range is 0.050 to 0.300 kilovolts. In addition, the
word ``to'' is missing between the voltages in the first voltage range
in Table V-5. Accordingly, OSHA is correcting Table R-6 and Table V-5
in this document.

Exemption From Notice-and-Comment Procedures

    OSHA determined that this correcting amendment is not subject to
the requirements and procedures for public notice and comment specified
in the Administrative Procedure Act (5 U.S.C. 553(b)) and the
Occupational Safety and Health Act of 1970 (29 U.S.C. 655). See 29 CFR
1911.5 (Minor changes in standards). This action does not affect or
change any existing rights or obligations, and no interested party is
likely to object to the minor amendments being made to 29 CFR 1910.269,
29 CFR 1910.331, or 29 CFR part 1926, subpart V. Therefore, the Agency
finds good cause for foregoing public notice and comment.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, 200
Constitution Ave. NW., Washington, DC 20210, authorized the preparation
of this document.
    This action is taken pursuant to sections 3704 et seq., Public Law
107-217, 116 STAT. 1062, (40 U.S.C. 3704 et seq.); sections 4, 6, and
8, Public Law 91-596, 84 STAT. 1590 (29 U.S.C. 653, 655, 657),
Secretary of Labor's Order No. 1-2012 (77 FR 3912 (Jan. 25, 2012)), and
29 CFR part 1911.

    Signed at Washington, DC, on September 28, 2015.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.

    The Occupational Safety and Health Administration amends parts 1910
and 1926 of title 29 of the Code of Federal Regulations as follows:

PART 1910--[AMENDED]

Subpart R--Special Industries

0
1. The authority citation for subpart R of part 1910 continues to read
as follows:

    Authority: 29 U.S.C. 653, 655, 657; Secretary of Labor's Order
No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90
(55 FR 9033), 6-96 (62 FR 111), 5-2007 (72 FR 31159), 4-2010 (75 FR
55355), or 1-2012 (77 FR 3912), as applicable; and 29 CFR part 1911.
* * * * *
0
2. Amend Sec.  1910.269 by:
0
a. Removing the terms ``line-clearance tree-trimming operations,''
``line-clearance tree trimming operations,'' ``line-clearance tree-
trimming work,'' and ``line-clearance tree trimming work'' in
paragraphs (a)(1)(i)(E) introductory text, (a)(1)(i)(E)(1) and (2),
(a)(1)(ii)(A), (b)(1)(i), (r) subject heading and introductory text,
(r)(1)(vi), and in the Note to paragraph (r)(1)(vi), and adding, in
their place the term ``line-clearance tree trimming'';
0
b. Revising paragraph (a)(1)(i)(E);
0
c. In Table R-6, first entry, removing ``0.50'' and adding in its place
``0.050'';

0
d. Revising paragraph (r) introductory text;
0
e. In paragraph (x), revising Note 2 to the definition of ``line-
clearance tree trimmer'' and adding a note to the definition of ``line-
clearance tree trimming''; and
0
f. Revising appendices A-3 and A-5.
    The revisions and addition read as follows:

Sec.  1910.269  Electric power generation, transmission, and
distribution.

    (a) * * *
    (1) * * *
    (i) * * *
    (E) Line-clearance tree trimming performed for the purpose of
clearing space around electric power generation, transmission, or
distribution lines or equipment and on behalf of an organization that
operates, or that controls the operating procedures for, those lines or
equipment, as follows:
    (1) Entire Sec.  1910.269, except paragraph (r)(1) of this section,
applies to line-clearance tree trimming covered by the introductory
text to paragraph (a)(1)(i)(E) of the section when performed by
qualified employees (those who are knowledgeable in the construction
and operation of the electric power generation, transmission, or
distribution equipment involved, along with the associated hazards).
    (2) Paragraphs (a)(2), (a)(3), (b), (c), (g), (k), (p), and (r) of
this section apply to line-clearance tree trimming covered by the
introductory text to paragraph (a)(1)(i)(E) of this section when
performed by line-clearance tree trimmers who are not qualified
employees.
* * * * *
    (r) Line-clearance tree trimming. This paragraph provides
additional requirements for line-clearance tree trimming and for
equipment used in this type of work.
* * * * *
    (x) * * *
    Line-clearance tree trimmer. * * *

    Note 2 to the definition of ``line-clearance tree trimmer'':  A
line-clearance tree trimmer is not considered to be a ``qualified
employee'' under this section unless he or she has the training
required for a qualified employee under paragraph (a)(2)(ii) of this
section. However, under the electrical safety-related work practices
standard in Subpart S of this part, a line-clearance tree trimmer is
considered to be a ``qualified employee.'' Tree trimming performed
by such ``qualified employees'' is not subject to the electrical
safety-related work practice requirements contained in Sec. Sec.
1910.331 through 1910.335 when it is directly associated with
electric power generation, transmission, or distribution lines or
equipment. (See Sec.  1910.331 for requirements on the applicability
of the electrical safety-related work practice requirements
contained in Sec. Sec.  1910.331 through 1910.335 to line-clearance
tree trimming performed by such ``qualified employees,'' and see the
note following Sec.  1910.332(b)(3) for information regarding the
training an employee must have to be considered a qualified employee
under Sec. Sec.  1910.331 through 1910.335.)

    Line-clearance tree trimming. * * *

    Note to the definition of ``line-clearance tree trimming'':
This section applies only to line-clearance tree trimming performed
for the purpose of clearing space around electric power generation,
transmission, or distribution lines or equipment and on behalf of an
organization that operates, or that controls the operating
procedures for, those lines or equipment. See paragraph (a)(1) of
this section. Tree trimming performed on behalf of a homeowner or
commercial entity other than an organization that operates, or that
controls the operating procedures for, electric power generation,
transmission, or distribution lines or equipment is not directly
associated with an electric power generation, transmission, or
distribution installation and is outside the scope of this section.
In addition, tree trimming that is not for the purpose of clearing
space around electric power generation, transmission, or
distribution lines or equipment is not directly associated with an
electric power generation, transmission, or distribution
installation and is outside the scope of this section. Such tree
trimming may be covered by other applicable standards. See, for
example, Sec. Sec.  1910.268 and 1910.331 through 1910.335.

* * * * *

[GRAPHIC] [TIFF OMITTED] TR05OC15.000

[GRAPHIC] [TIFF OMITTED] TR05OC15.001

Subpart S--Electrical

0
3. The authority citation for subpart S of part 1910 continues to read
as follows:

    Authority:  29 U.S.C. 653, 655, 657; Secretary of Labor's Order
No. 8-76 (41 FR 25059), 1-90 (55 FR 9033), 5-2002 (67 FR 65008), 5-
2007 (72 FR 31160), or 1-2012 (77 FR 3912), as applicable; and 29
CFR part 1911.
* * * * *

0
4. Amend Sec.  1910.331 by revising paragraph (b) and Note 3 to
paragraph (c)(1) to read as follows:

Sec.  1910.331  Scope.

* * * * *
    (b) Other covered work. The provisions of Sec. Sec.  1910.331
through 1910.335 also cover:
    (1) Work performed by unqualified persons on, near, or with the
installations listed in paragraphs (c)(1) through (4) of this section;
and
    (2) Work performed by qualified persons near the installations
listed in paragraphs (c)(1) through (c)(4) of this section when that
work is not on or directly associated with those installations.
    (c) * * *
    (1) * * *

    Note 3 to paragraph (c)(1):  Work on or directly associated with
generation, transmission, or distribution installations includes:
    (1) Work performed directly on such installations, such as
repairing overhead or underground distribution lines or repairing a
feed-water pump for the boiler in a generating plant.
    (2) Work directly associated with such installations, such as
line-clearance tree trimming and replacing utility poles, when that
work is covered by Sec.  1910.269 (see Sec.  1910.269(a)(1)(i)(D)
and (E) and the definition of ``line-clearance tree trimming'' in
Sec.  1910.269(x)).
    (3) Work on electric utilization circuits in a generating plant
provided that:
    (A) Such circuits are commingled with installations of power
generation equipment or circuits, and
    (B) The generation equipment or circuits present greater
electrical hazards than those posed by the utilization equipment or
circuits (such as exposure to higher voltages or lack of overcurrent
protection).
    This work is covered by Sec.  1910.269.

* * * * *

PART 1926--[AMENDED]

Subpart V--Electric power transmission and distribution

0
5. The authority citation for subpart V of part 1926 continues to read
as follows:

    Authority:  40 U.S.C. 3701 et seq.; 29 U.S.C. 653, 655, 657;
Secretary of Labor's Order No. 1-2012 (77 FR 3912); and 29 CFR part
1911.

0
6. In Sec.  1926.950, revise paragraph (a)(3) to read as follows:

Sec.  1926.950  General.

    (a) * * *
    (3) Applicable part 1910 requirements. (i) Line-clearance tree
trimming performed for the purpose of clearing space around electric
power generation, transmission, or distribution lines or equipment and
on behalf of an organization that operates, or that controls the
operating procedures for, those lines or equipment shall comply with
Sec.  1910.269 of this chapter.
    (ii) Work involving electric power generation installations shall
comply with Sec.  1910.269 of this chapter.
* * * * *

Sec.  1926.960  [Amended]

0
7. In Sec.  1926.960, in Table V-5, first entry, remove ``0.50'' and
add in its place ``0.050 to''.

[FR Doc. 2015-25062 Filed 10-2-15; 8:45 am]
 BILLING CODE 4510-26-P