Final Rule for 40 CFR Part 158, Subparts U&V:  Data Requirements for
Biochemical and Microbial Pesticides

Response to Comments Summary

The Agency did receive comments that applied to both biochemical and
microbial pesticide data requirements.

The issues are discussed as follows:

1. Endangered species assessments

Summary of comments

Incidental to its proposed data requirements for conventional
pesticides, EPA discussed the possibility of future data and information
needs to develop and/or refine risk assessments for endangered species.
EPA did not propose any data requirements specific to endangered species
but described its current level of information and data usage. EPA
requested comment on the value and utility of location and usage
information, and on additional types of research that might yield
greater refinement in risk assessments for endangered species. One
commenter questioned whether the Agency’s endangered species
discussion in the preamble applies only to biochemical and microbial
pesticides or for conventional pesticides as well. Two commenters
indicated the Agency should require toxicity data for surrogate species,
and in particular reptile and amphibian data.

Response to comments

EPA appreciates the responses it received from the commenter on this
topic. As endangered species data requirements were not proposed, EPA
has not responded to the comment as part of this final rule but will
consider them in the context of its ongoing risk assessments. If EPA
finds that it needs to amend part 158 to normalize endangered species
data requirements, the Agency will consider these comments in the
development of a future proposed rule. The Agency has in the past and
will continue to rely on the avian, fish, and invertebrate testing to
indicate the potential toxicity for other non-target species.

2. Product performance

Summary of comments

Without proposing changes to existing product performance data
requirements (§ 158.640), the Agency augmented language for both
biochemical and microbial pesticide data requirements for product
performance with the regulatory text. One commenter indicated that the
Agency requires data for uses other than for public health pests.
Another comment was that EPA’s language in the proposed preamble
required clarification, indicating some products are not as efficacious
as conventional pesticides. Another commenter indicated that the label
should be supported by the efficacy data provided to the Agency.

Response to comments

The Agency agrees that product performance data are required for all
uses, but are only required to be submitted for review at the time of
registration to support public health claims. These provisions, i.e. new
§§ 158.2070 and 158.2160 for biochemical and microbial pesticides,
respectively, are not replacing the data requirement tables in §
158.640, but only adding additional text for clarifying when submission
of product performance data are typically necessary for biochemical and
microbial pesticides. EPA is finalizing the language as proposed.

EPA agrees with the commenters that the data must be submitted to
support the label claims for registration of these public health
pesticides. EPA did not propose to change the existing data requirements
and neither the existing data table nor the proposed regulating text
would require the applicant to submit data comparing product efficacy.
The Agency agrees with the commenter that there should not have been a
distinction between biochemical and conventional pesticides in their
efficacy, but that the efficacy varies between all pesticides and their
products, and with respect to public health claims, the label should
reflect the efficacy of the product.

3. Addition of passerine species and appropriate nomenclature of test
species within non-target ecological effects data requirements

Summary of comments

The Agency proposed to add another possible test species for the avian
acute oral toxicity study, the red-winged blackbird, a passerine
species. EPA also proposed to continue to include the identification of
other possible avian test species (bobwhite quail and mallards), and for
fish species (rainbow trout and bluegill sunfish). One commenter
requested that EPA revise the word ‘‘songbird’’ to read
‘‘passerine.’’ Another commenter indicated that the Agency
should require historical control data on the red-winged blackbird for
the past 5 years to develop a baseline for future testing on the
species.

Response to comments

The Agency recommends that if the registrant and the Agency deem it
appropriate to test a passerine species, the registrant meet with the
Agency before initiating the study to determine if the passerine species
is appropriate based on the current scientific methodology and use
pattern of the proposed registration. This test species may be required
if the use pattern would result in higher exposure to this order of
avian species. In addition, after reviewing the comments submitted, the
Agency decided to discontinue specific species designation for all
non-target organisms. The test notes in the final rule only indicate
upland game, waterfowl, or passerine species for avian concerns and
coldwater and warmwater fish for fish concerns.

In summary, passerine species data are still conditionally required in
the final rule for both biochemical and microbial pesticides. The
individual test notes indicate when these data would be appropriate.
With respect to developing test data over 5 years, EPA will consider
such protocol concerns when it revises its test guidelines. The Agency
is finalizing the proposed addition of the passerine species.

4. Reptile/amphibian testing

Summary of comments

The Agency did not propose to require separate reptile testing. One
commenter indicated that amphibian testing needed to be included in the
data requirements for evaluating effects to non-target ecological
species.

Response to comments

The Agency has in the past and will continue to rely on avian, fish, and
invertebrate testing to indicate the potential toxicity for other
non-target species. Additional information will be required as needed.

5. New studies providing little or no practical value

Summary of comments

EPA proposed to require a few newly codified studies, i.e.,
applicator/user exposure data to refine data requirements, i.e.,
mutagenicity data requirements. One commenter believed the Agency was
using a ‘‘check box’’ approach to requiring data rather than
regulatory need.

Response to comments

The Agency reviewed the data typically submitted or determined to be
necessary to support registration requests received over 7 years.
EPA’s proposed rule was based on that review. In some cases, EPA
proposed new data requirements to codify existing practices and in other
cases EPA proposed to amend test notes, for example, to clarify existing
data requirements. EPA’s analysis and proposed rule were based on
decisions that the data and the modifications to the tables were
necessary. Without more specific comment, EPA can not further respond to
this comment.

6. Providing adequate guidance when data are required/use pattern

Clarification

Summary of comments

When EPA revised the proposed rule, there was a concerted effort to
provide informative test notes, which would clarify when data are
required. However, a commenter did not provide specific data requirement
issues but indicated the Agency was not clear on the expanded use
patterns. This commenter also indicated that the waiver policy was
unclear.

Response to comments

As indicated in the preamble for the final rule, the Agency provided a
section on ‘‘Consultation with Applicants’’ in the proposal
which the commenter indicated was missing. It is a description of the
pre-submission and post-submission process within the Agency encouraging
the registrant to meet with the Agency as early as possible in the
process in order to minimize delays and avoid unnecessary test costs. In
most cases the numbers of use patterns were actually combined for
transparency, i.e., food use and non-food use. The test notes provided
for biochemical and microbial pesticides are more detailed than in the
current regulation.

7. There are no accepted protocols or guidelines for many data
requirements

Summary of comments

One commenter indicated that the Agency published data requirements
without supporting published guidelines. This commenter cited the
environmental fate guidelines.

Response to comments

The Agency proposed newly codified data requirements guidelines for
applicator/user exposure data; particle size, fiber length, and diameter
distribution; product use information; and companion animal safety.
There were also some new guideline numbers identified for environmental
fate data requirements. All of these data requirements have guidelines
available. At the time of the publication of the proposed rule, the
environmental fate guidelines were not finalized. The Agency did provide
the existing guideline numbers that denoted the test methods at that
time. The environmental fate guidelines (835 series) are anticipated to
be published this year. In the interim, we have provided the current
guideline numbers and the proposed guideline numbers in the data table.
Once the final guidelines are published, the Agency will amend the
guideline references in the data tables, as appropriate. As indicated
previously, the guideline references are provided in part 158 as
information/guidance to applicants. As with existing guidelines, an
applicant is not compelled to use the cited draft guidelines, but may
choose to use an alternative methodology that will provide the
information needed to complete the risk assessment.

8. Codifying existing practice

Summary of comments

EPA made revisions, which included codified, newly codified, or new data
requirements. One commenter stated that the Agency was mistaken in its
distinction between ‘‘new requirements’’ and ‘‘newly
codified requirements.’’ The commenter provided the example that the
immunotoxicity study (guideline 885.3550), is a new requirement, as no
such data requirement previously existed, regardless of whether the
guideline was available.

Response to comments

In developing this rule, the Agency received the data typically
submitted or determined to be necessary to support registration requests
received over the last 7 years. If the data had never been submitted to
support registration, then the data requirement would be considered new.
However, if the data had been submitted or required to support recent
registrations, and were not listed in the 1984 promulgated rule, then
the Agency would classify that data requirement as newly codified.

As for the specific example of immunotoxicity, these data are currently
required and are being submitted to support existing registrations and
is currently required in 40 CFR 158.690. EPA has been requiring or
applicants have been submitting immunotoxicity data based on specific
conditions, consistent with the 880.3550 guideline in more recent years,
so the Agency classified this as a newly codified data requirement as a
Tier II and Tier III data requirement.

9. Animal welfare concerns

Summary of comments

The Agency received comment on individual studies suggesting alternative
approaches to substitute for them. This comment was designed to
recommend reducing the number of animals used in studies.

Response to comments

All new studies required under today’s rule for biochemical and
microbial pesticides were all standard guideline studies that are also
part of the data requirements for conventional pesticides. The EPA’s
Biopesticides and Pollution

Prevention Division (BPPD) uses, where possible, the same studies that
are used for conventional pesticides to allow for similar risk
assessment procedures; to support the validated, time-tried, methods; to
reduce the complexity of studies that testing laboratories must provide;
to avoid excessive expenses for the typically small businesses that
market these biopesticides; and to avoid instituting novel,
non-validated procedures for a relatively small group of pesticides.
The Agency is committed to avoiding unnecessary animal testing, while
taking into consideration principles of sound science and the
requirements of FIFRA to protect humans and the environment. The
complete response to these comments also applies to microbial and
biochemical pesticide data requirements. BPPD will consider test methods
that do not use animals and is working with the rest of the Agency to
move towards these goals. In addition, BPPD will continue to be
available for pre-submission and post-submission meetings to allow an
applicant to submit only those data needed to support that particular
product.


[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)]
[Notices]
[Pages 92822-92832]
[FR Doc No: 2016-30532]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0969]

Authorization of Emergency Use of an In Vitro Diagnostic Device
for Detection of Zika Virus; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of an Emergency Use Authorization (EUA) (the Authorization)
for an in vitro diagnostic device for detection of the Zika virus in
response to the Zika virus outbreak in the Americas. FDA issued this
Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C
Act), as requested by Abbott Molecular, Inc. The Authorization
contains, among other things, conditions on the emergency use of the
authorized in vitro diagnostic device. The Authorization follows the
February 26, 2016, determination by the Secretary of Health and Human
Services (HHS) that there is a significant potential for a public
health emergency that has a significant potential to affect national
security or the health and security of U.S. citizens living abroad and
that involves Zika virus. On the basis of such determination, the
Secretary of HHS declared on February 26, 2016, that circumstances
exist justifying the authorization of emergency use of in vitro
diagnostic tests for detection of Zika virus and/or diagnosis of Zika
virus infection, subject to the terms of any authorization issued under
the FD&C Act. The Authorization, which includes an explanation of the
reasons for issuance, is reprinted in this document.

DATES: The Authorization is effective as of November 21, 2016.

ADDRESSES: Submit written requests for single copies of the EUA to the
Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION
section for electronic access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Carmen Maher, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4347, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. With this EUA authority, FDA can
help assure that medical countermeasures may be used in emergencies to
diagnose, treat, or prevent serious or life-threatening diseases or
conditions caused by biological, chemical, nuclear, or radiological
agents when there are no adequate, approved, and available
alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may
be issued, the Secretary of HHS must declare that circumstances exist
justifying the authorization based on one of the following grounds: (1)
A determination by the Secretary of Homeland Security that there is a
domestic emergency, or a significant potential for a domestic
emergency, involving a heightened risk of attack with a biological,
chemical, radiological, or nuclear agent or agents; (2) a determination
by the Secretary of Defense that there is a military

emergency, or a significant potential for a military emergency,
involving a heightened risk to U.S. military forces of attack with a
biological, chemical, radiological, or nuclear agent or agents; (3) a
determination by the Secretary of HHS that there is a public health
emergency, or a significant potential for a public health emergency,
that affects, or has a significant potential to affect, national
security or the health and security of U.S. citizens living abroad, and
that involves a biological, chemical, radiological, or nuclear agent or
agents, or a disease or condition that may be attributable to such
agent or agents; or (4) the identification of a material threat by the
Secretary of Homeland Security under section 319F-2 of the Public
Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect
national security or the health and security of U.S. citizens living
abroad.
    Once the Secretary of HHS has declared that circumstances exist
justifying an authorization under section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug, device, or biological product if
the Agency concludes that the statutory criteria are satisfied. Under
section 564(h)(1) of the FD&C Act, FDA is required to publish in the
Federal Register a notice of each authorization, and each termination
or revocation of an authorization, and an explanation of the reasons
for the action. Section 564 of the FD&C Act permits FDA to authorize
the introduction into interstate commerce of a drug, device, or
biological product intended for use when the Secretary of HHS has
declared that circumstances exist justifying the authorization of
emergency use. Products appropriate for emergency use may include
products and uses that are not approved, cleared, or licensed under
sections 505, 510(k), or 515 of the FD&C Act (21 U.S.C. 355, 360(k),
and 360e) or section 351 of the PHS Act (42 U.S.C. 262). FDA may issue
an EUA only if, after consultation with the HHS Assistant Secretary for
Preparedness and Response, the Director of the National Institutes of
Health, and the Director of the Centers for Disease Control and
Prevention (to the extent feasible and appropriate given the applicable
circumstances), FDA \1\ concludes: (1) That an agent referred to in a
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of
scientific evidence available to FDA, including data from adequate and
well-controlled clinical trials, if available, it is reasonable to
believe that: (A) The product may be effective in diagnosing, treating,
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under
section 564, approved or cleared under the FD&C Act, or licensed under
section 351 of the PHS Act, for diagnosing, treating, or preventing
such a disease or condition caused by such an agent; and (B) the known
and potential benefits of the product, when used to diagnose, prevent,
or treat such disease or condition, outweigh the known and potential
risks of the product, taking into consideration the material threat
posed by the agent or agents identified in a declaration under section
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no
adequate, approved, and available alternative to the product for
diagnosing, preventing, or treating such disease or condition; and (4)
that such other criteria as may be prescribed by regulation are
satisfied.
---------------------------------------------------------------------------

    \1\ The Secretary of HHS has delegated the authority to issue an
EUA under section 564 of the FD&C Act to the Commissioner of Food
and Drugs.
---------------------------------------------------------------------------

    No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act. Because the statute is self-
executing, regulations or guidance are not required for FDA to
implement the EUA authority.

II. EUA Request for an In Vitro Diagnostic Device for Detection of the
Zika Virus

    On February 26, 2016, the Secretary of HHS determined that there is
a significant potential for a public health emergency that has a
significant potential to affect national security or the health and
security of U.S. citizens living abroad and that involves Zika virus.
On February 26, 2016, under section 564(b)(1) of the FD&C Act, and on
the basis of such determination, the Secretary of HHS declared that
circumstances exist justifying the authorization of emergency use of in
vitro diagnostic tests for detection of Zika virus and/or diagnosis of
Zika virus infection, subject to the terms of any authorization issued
under section 564 of the FD&C Act. Notice of the determination and
declaration of the Secretary was published in the Federal Register on
March 2, 2016 (81 FR 10878). On November 9, 2016, Abbott Molecular,
Inc. requested, and on November 21, 2016, FDA issued, an EUA for the
Abbott Real Time ZIKA assay, subject to the terms of the Authorization.

III. Electronic Access

    An electronic version of this document and the full text of the
Authorization are available on the Internet at https://www.regulations.gov.

IV. The Authorization

    Having concluded that the criteria for issuance of the
Authorization under section 564(c) of the FD&C Act are met, FDA has
authorized the emergency use of an in vitro diagnostic device for
detection of Zika virus subject to the terms of the Authorization. The
Authorization in its entirety (not including the authorized versions of
the fact sheets and other written materials) follows and provides an
explanation of the reasons for its issuance, as required by section
564(h)(1) of the FD&C Act.
BILLING CODE 4164-01-P

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    Dated: December 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30532 Filed 12-19-16; 8:45 am]
BILLING CODE 4164-01-C


[Federal Register Volume 78, Number 94 (Wednesday, May 15, 2013)]
[Notices]
[Pages 28699-28700]
[FR Doc No: 2013-11528]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2011-0279]

Agency Information Collection Activities; Approval of a New
Information Collection: Motorcoach Passenger Survey: Motorcoach Safety
and Pre-Trip Safety Awareness and Emergency Preparedness Information

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for its
review and approval, and invites public comment. An initial emergency
request and 30-day notice was first published on October 18, 2011 for
this ICR. The purpose of this information collection is to assess the
current levels of voluntary compliance by motorcoach operators to
provide pre-trip safety awareness and emergency preparedness
information to passengers and to obtain passenger opinions of the
implementation of the pre-trip program and any recommended
improvements.
    This information, along with its conclusions, will be used to
inform future initiatives, policies, and rules as appropriate; will be
presented to the National Transportation Safety Board (NTSB) and
Congress; and will contribute to the general literature regarding
practices for improving motorcoach safety in the United States.

DATES: We must receive your comments on or before July 15, 2013.

ADDRESSES: You may submit comments identified by Federal Docket
Management System Number FMCSA 2011-0297 using one of the following
methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Fax: 1-202-493-2251
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Ground
Floor, Room W12-140, 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC between 9 a.m.
and 5 p.m., e.t., Monday through Friday, except Federal holidays.
     Instructions: All submissions must include the Agency name
and docket number. For detailed instructions on submitting comments and
additional information on the exemption process, see the Public
Participation heading below. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading
below.
     Docket: For access to the docket to read background
documents or comments received, go to http://www.regulations.gov, and
follow the online instructions for accessing the dockets, or go to the
street address listed above.
     Privacy Act: Anyone is able to search the electronic form
of all

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 the
Department of Transportation's (DOT) complete Privacy Act Statement for
the Federal Docket Management System published in the Federal Register
on January 17, 2008 (73 FR 3316), or you may visit http://edocket.access.gpo.gov/2008/pdfE8-794.pdf.
     Public Participation: The Federal eRulemaking Portal is
available 24 hours each day, 365 days each year. You can obtain
electronic submission and retrieval help and guidelines under the
``help'' section of the Federal eRulemaking Portal Web site. If you
want us to notify you that we received your comments, please include a
self-addressed, stamped envelope or postcard, or print the
acknowledgement page that appears after submitting comments online.
Comments received after the comment closing date will be included in
the docket and will be considered to the extent practicable.

FOR FURTHER INFORMATION CONTACT: Dee Williams, Strategic Planning and
Program Evaluation Division Chief, Office of Policy, Strategic Planning
& Regulations,<PHONE_NUMBER><EMAIL_ADDRESS>MC-PRS, Federal
Motor Carrier Safety Administration, 6th Floor, West Building, 1200 New
Jersey Ave. SE., Washington, DC 20590.

SUPPLEMENTARY INFORMATION:

Background

    Due to several recent fatal motorcoach crashes, the Congress, the
Department of Transportation (DOT), specifically the Federal Motor
Carrier Safety Administration (FMCSA), and other Federal oversight
agencies, including NTSB, have increased their scrutiny over the
motorcoach industry and the enforcement and compliance of the Federal
Motor Carrier Safety Regulations (FMCSRs). On February 26, 1999, NTSB
issued safety recommendation H-99-8 to DOT, requiring motorcoach
operators to provide passengers with pre-trip safety awareness
information. This recommendation resulted from NTSB's investigation of
two motorcoach crashes from the late 1990s which revealed that
passengers felt a general sense of panic not knowing what to do on a
motorcoach in the case of an emergency. The intent of the
recommendation is to empower passengers to take their personal safety
into their own hands in the event of an imminent hazardous or emergency
situation. The FMCSA decided to implement the recommendation through
voluntary adoption and compliance of pre-trip safety briefings in the
motorcoach industry.
    The goals and objectives of this survey are to assess the current
levels of voluntary compliance by motorcoach operators and to obtain
passenger opinions of the implementation of the pre-trip safety
awareness and emergency preparedness information. The Form MCSA-5868
will be used to survey motorcoach passengers. This information, along
with its conclusions, will be used to inform future initiatives,
policies, and rules as appropriate; will be presented to NTSB and
Congress; and will contribute to the general literature regarding
practices for improving motorcoach safety in the United States.
    Title: Motorcoach Passenger Survey: Motorcoach Safety and Pre-Trip
Safety Awareness and Emergency Preparedness Information.
    OMB Control Number: 2126-XXXX.
    Type of Request: New information collection.
    Respondents: Motorcoach passenger-trips.
    Estimated Number of Respondents: 2,000 motorcoach passenger-trips.
    Estimated Time per Response: 10 minutes.
    Form Numbers: Form MCSA-5868, Motorcoach Passenger Survey: Pre-Trip
Safety Awareness and Emergency Preparedness Information--To collect
motorcoach passengers' responses during five, one-shot in-person survey
events.
    Expiration Date: N/A. This is a new information collection.
    Frequency of Response: One-time.
    Estimated Total Burden: 333 hours [2,000 respondents x 10 minutes/
60 minutes = 333 hours].
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (1) Whether the proposed
collection is necessary for the performance of FMCSA's functions; (2)
the accuracy of the estimated burden; (3) ways for FMCSA to enhance the
quality, usefulness, and clarity of the collected information; and (4)
ways that the burden could be minimized without reducing the quality of
the collected information.

    Issued On: May 3, 2013.
G. Kelly Leone,
Associate Administrator, Office of Research and Information Technology
and Chief Information Officer.
[FR Doc. 2013-11528 Filed 5-14-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 81, Number 101 (Wednesday, May 25, 2016)]
[Rules and Regulations]
[Pages 33139-33140]
[FR Doc No: 2016-12114]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2015-0798; FRL-9946-77-Region 4]

Air Plan Disapprovals; MS; Prong 4-2008 Ozone, 2010 NO2, SO2, and
2012 PM2.5

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to disapprove the visibility transport (prong 4) portions of
revisions to the Mississippi State Implementation Plan (SIP), submitted
by the Mississippi Department of Environmental Quality (MDEQ),
addressing the Clean Air Act (CAA or Act) infrastructure SIP
requirements for the 2008 8-hour Ozone, 2010 1-hour Nitrogen Dioxide
(NO2), 2010 1-hour Sulfur Dioxide (SO2), and 2012
annual Fine Particulate Matter (PM2.5) National Ambient Air
Quality Standards (NAAQS). The CAA requires that each state adopt and
submit a SIP for the implementation, maintenance, and enforcement of
each NAAQS promulgated by EPA, commonly referred to as an
``infrastructure SIP.'' Specifically, EPA is disapproving the prong 4
portions of Mississippi's May 29, 2012; July 26, 2012; February 28,
2013; June 20, 2013; and December 8, 2015, infrastructure SIP
submissions. All other applicable infrastructure requirements for these
SIP submissions have been or will be addressed in separate rulemakings.

DATES: This rule will be effective June 24, 2016.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2015-0798. All documents in the docket
are listed on the www.regulations.gov Web site. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information 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 at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air, Pesticides and Toxics Management Division,
U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday 8:30 a.m. to 4:30 p.m.,
excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Sean Lakeman of the Air Regulatory
Management Section, Air Planning and Implementation Branch, Air,
Pesticides and Toxics Management Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia
30303-8960. Mr. Lakeman can be reached by telephone at<PHONE_NUMBER>
or via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    By statute, SIPs meeting the requirements of sections 110(a)(1) and
(2) of the CAA are to be submitted by states within three years after
promulgation of a new or revised NAAQS to provide for the
implementation, maintenance, and enforcement of the new or revised
NAAQS. EPA has historically referred to these SIP submissions made for
the purpose of satisfying the requirements of sections 110(a)(1) and
110(a)(2) as ``infrastructure SIP'' submissions. Sections 110(a)(1) and
(2) require states to address basic SIP elements such as the
requirements for monitoring, basic program requirements, and legal
authority that are designed to assure attainment and maintenance of the
newly established or revised NAAQS. More specifically, section
110(a)(1) provides the procedural and timing requirements for
infrastructure SIPs. Section 110(a)(2) lists specific elements that
states must meet for the infrastructure SIP requirements related to a
newly established or revised NAAQS. The contents of an infrastructure
SIP submission may vary depending upon the data and analytical tools
available to the state, as well as the provisions already contained in
the state's implementation plan at the time in which the state develops
and submits the submission for a new or revised NAAQS.
    Section 110(a)(2)(D) has two components: 110(a)(2)(D)(i) and
110(a)(2)(D)(ii). Section 110(a)(2)(D)(i) includes four distinct
components, commonly referred to as ``prongs,'' that must be addressed
in infrastructure SIP submissions. The first two prongs, which are
codified in section 110(a)(2)(D)(i)(I), are provisions that prohibit
any source or other type of emissions activity in one state from
contributing significantly to nonattainment of the NAAQS in another
state (prong 1) and from interfering with maintenance of the NAAQS in
another state (prong 2). The third and fourth prongs, which are
codified in section 110(a)(2)(D)(i)(II), are provisions that prohibit
emissions activity in one state from interfering with measures required
to prevent significant deterioration of air quality in another state
(prong 3) or from interfering with measures to protect visibility in
another state (prong 4). Section 110(a)(2)(D)(ii) requires SIPs to
include provisions insuring compliance with sections 115 and 126 of the
Act, relating to interstate and international pollution abatement.
    In a notice of proposed rulemaking (NPRM) published on March 22,
2016 (81 FR 15205), EPA proposed to disapprove the prong 4 portions of
Mississippi's infrastructure SIP submissions for the 2008 8-hour Ozone,
2010 1-hour NO2, 2010 1-hour SO2, and 2012 annual
PM2.5 NAAQS. The details of Mississippi's submissions and
the rationale for EPA's actions are explained in the NPRM. Comments on
the proposed rulemaking were due on or before April 21, 2016. EPA
received no comments on the NPRM.

II. Final Action

    EPA is taking final action to disapprove the prong 4 portions of
Mississippi's May 29, 2012, 2008 8-hour Ozone infrastructure SIP
submission; July 26, 2012, 2008 8-hour Ozone infrastructure SIP
resubmission; February 28, 2013, 2010 1-hour NO2
infrastructure SIP submission; June 20, 2013, 2010 1-hour
SO2 infrastructure SIP submission; and December 8, 2015,
2012 annual PM2.5 infrastructure SIP submission. All other
outstanding applicable infrastructure requirements for these SIP
submissions have been or will be addressed in separate rulemakings.

III. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. See 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. This action
disapproves the prong 4 portions of the aforementioned SIP submissions
as not meeting Federal

requirements. Therefore, this action 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 Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     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).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.
    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).
    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 July 25, 2016. 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 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, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Sulfur
oxides, Volatile organic compounds.

    Dated: May 12, 2016.
Heather McTeer Toney,
Regional Administrator, Region 4.

    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 Z--Mississippi

0
2. Section 52.1279 is amended by adding paragraph (b) to read as
follows:

Sec.  52.1279  Visibility protection.

* * * * *
    (b) Disapproval. EPA has disapproved the portions of Mississippi's
May 29, 2012, 2008 8-hour Ozone infrastructure SIP submission; July 26,
2012, 2008 8-hour Ozone infrastructure SIP resubmission; February 28,
2013, 2010, 1-hour NO2 infrastructure SIP submission; June
20, 2013, 2010 1-hour SO2 infrastructure SIP submission; and
December 8, 2015, 2012, Annual PM2.5 infrastructure SIP
submission that address the visibility protection (prong 4)
requirements of Clean Air Act section 110(a)(2)(D)(i)(II). EPA
disapproved the prong 4 portions of these SIP submissions because
Mississippi does not have a fully approved regional haze SIP that meets
the requirements of 40 CFR 51.308 and because these SIP submissions do
not otherwise demonstrate that emissions within the State do not
interfere with other states' plans to protect visibility.

[FR Doc. 2016-12114 Filed 5-24-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: September 22, 2009 (Volume 74, Number 182)]
[Notices]
[Page 48345-48348]
[DOCID:fr22se09-149]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2009-0157]

Automobili Lamborghini SpA; Receipt of Application for Extension
of Temporary Exemption From Advanced Air Bag Requirements of FMVSS No.
208

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

ACTION: Notice of receipt of petition for extension of a Temporary
Exemption from certain provisions of Federal Motor Vehicle Safety
Standard (FMVSS) No. 208, Occupant Crash Protection.

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SUMMARY: In accordance with the procedures of 49 CFR Part 555,
Automobili Lamborghini SpA (``Lamborghini'') has applied for an
extension of a previously received temporary exemption from certain
requirements of FMVSS No. 208, Occupant Crash Protection, for the
Lamborghini Murcielago model. Lamborghini requests extension of its
temporary exemption for the advanced air bag requirements. The basis of
the application is that compliance would cause substantial economic
hardship to a manufacturer that has tried in good faith to comply with
the standard.
    NHTSA is publishing this notice of receipt of the application in
accordance with the requirements of 49 U.S.C. 30113(b)(2), and has made
no judgment on the merits of the application.

DATES: You should submit your comments not later than October 22, 2009.
    Comments: We invite you to submit comments on the application
described below. You may submit comments identified by docket number in
the heading of this notice by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments on
the electronic docket site by clicking on ``Help'' or ``FAQ.''
     Mail: DOT 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.
     Hand Delivery or Courier: U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: All submissions must include the agency name and
docket number. Note that all comments received will be posted without
change to http://www.regulations.gov, including any personal
information provided.
    Privacy Act: Anyone is able to search the electronic form of all
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 DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: For access to the docket in order to read background
documents or comments received, go to http://www.regulations.gov at any
time, or to M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20950, between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
    Confidential Business Information: If you wish to submit any
information under a claim of confidentiality, you should submit three
copies of your complete submission, including the information you claim
to be confidential business information, to the Chief Counsel, NHTSA,
at the address given under FOR FURTHER INFORMATION CONTACT. In
addition, you should submit two copies, from which you have deleted the
claimed confidential business information, to Docket Management at the
address given above. When you send a comment containing information
claimed to be confidential business information, you should include a
cover letter setting forth the information specified in our
confidential business information regulation (49 CFR Part 512).

FOR FURTHER INFORMATION CONTACT: Sarah Alves, Office of the Chief
Counsel, NCC-112, National Highway Traffic Safety Administration, 1200
New Jersey Avenue, SE., Washington, DC 20590. Phone:<PHONE_NUMBER>; Fax:
202-366-3820; E-Mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Advanced Air Bag Requirements and Small Volume Manufacturers

    In 2000, NHTSA upgraded the requirements for air bags in passenger
cars and light trucks, requiring what are commonly known as ``advanced
air bags.'' \1\ The upgrade was designed to meet the goals of improving
protection for occupants of all sizes, belted and unbelted, in
moderate-to-high-speed crashes, and of minimizing the risks posed by
air bags to infants, children, and other occupants, especially in low-
speed crashes.
---------------------------------------------------------------------------

    \1\ See 65 FR 30680 (May 12, 2000).
---------------------------------------------------------------------------

    The advanced air bag requirements were a culmination of a
comprehensive plan that the agency announced in 1996 to address the
adverse effects of air bags. This plan also included an extensive
consumer education program to encourage the placement of children in
rear seats. The new requirements were phased in beginning with the 2004
model year.
    Small volume manufacturers were not subject to the advanced air bag
requirements until September 1, 2006, but their efforts to bring their
respective vehicles into compliance with these requirements began
several years earlier. However, because the new requirements were
challenging, major air bag suppliers concentrated their efforts on
working with large volume manufacturers, and thus, until recently,
small volume manufacturers had limited access to advanced air bag
technology. Because of the nature of the requirements for protecting
out-of-position occupants, ``off-the-shelf'' systems could not be
readily adopted. Further complicating matters, because small volume
manufacturers build so few vehicles, the costs of developing custom air
bag systems compared to potential benefits discouraged some air bag
suppliers from working with small volume manufacturers.
    The agency has carefully tracked occupant fatalities resulting from
air bag deployment. Our data indicate that the agency's efforts in the
area of consumer education and manufacturers' providing depowered air
bags were successful in reducing air bag fatalities even before
advanced air bag requirements were implemented.
    As always, we are concerned about the potential safety implication
of any temporary exemptions granted by this agency. In the present
case, we are seeking comments on a petition for an extension of a
temporary exemption for certain advanced air bag requirements submitted
by a manufacturer of high-performance sports cars.

II. Overview of Petition for Economic Hardship Exemption

    In accordance with 49 U.S.C. 30113 and the procedures in 49 CFR
Part 555, Lamborghini has petitioned the agency for an extension of a
temporary exemption from certain requirements of FMVSS No. 208. The
basis for the application is that compliance would cause substantial
economic hardship to a manufacturer that has tried in good faith to
comply with the standard. The requested exemption would apply to the
Lamborghini Murcielago model and would extend the original exemption
for a period of 18 months beginning on September 1, 2009, ending on
February 28, 2011. The requested extension would apply to certain
advanced air bag requirements, specifically the requirements in
S14.5.2, S15, S17, S19, S21, S23, and S25. A copy of the petition \2\
is available for review and has been placed in the docket of this
notice.
---------------------------------------------------------------------------

    \2\ The company requested confidential treatment under 49 CFR
Part 512 for certain business and financial information submitted as
part of its petition for temporary exemption. Accordingly, the
information placed in the docket does not contain such information
that the agency has determined to be confidential.
---------------------------------------------------------------------------

III. Statutory Background for Economic Hardship Exemption

    A manufacturer is eligible to apply for a hardship exemption if its
total motor vehicle production in its most recent year of production
did not exceed 10,000 vehicles, as determined by the NHTSA
Administrator (49 U.S.C. 30113).
    In determining whether a manufacturer of a vehicle meets that
criterion, NHTSA considers whether a second vehicle manufacturer also
might be deemed the manufacturer of that vehicle. The statutory
provisions governing motor vehicle safety (49 U.S.C. Chapter 301) do
not include any provision indicating that a manufacturer might have
substantial responsibility as manufacturer of a vehicle simply because
it owns or controls a second manufacturer that assembled that vehicle.
However, the agency considers the statutory definition of
``manufacturer'' (49 U.S.C. 30102(a)(5)) to be sufficiently broad to
include sponsors, depending on the circumstances. Thus, NHTSA has
stated that a manufacturer may be deemed to be a sponsor and thus a
manufacturer of a vehicle assembled by a second manufacturer if the
first manufacturer had a substantial role in the development and
manufacturing process of that vehicle.

IV. Petition

    Background. A manufacturer is eligible to apply for a hardship
exemption if its total motor vehicle production in its most recent year
of production does not exceed 10,000, as determined by the NHTSA
Administrator (15 U.S.C. 1410(d)(1)). Lamborghini manufactured 2,580
automobiles in 2007 and estimated a total production of 2,450
automobiles in 2008, and 2,500 automobiles in 2009. Lamborghini has
gone through a number of owners over the last four decades. The current
owner of Lamborghini is the German automobile manufacturer Audi, but
Lamborghini stated in its petition that its relationship with Audi is
``arms length'' and that Lamborghini operates independently.
    In a September 2006 notice granting Lamborghini's original
exemption, NHTSA concluded that Lamborghini was eligible to apply for a
temporary exemption and that Audi was not a manufacturer of Lamborghini
vehicles by virtue of being a ``sponsor.'' The agency explained:

    Lamborghini S.p.A. is 100% owned by Audi AG (which, in turn is
99.1% owned by Volkswagen AG). We have concluded that Lamborghini is
eligible to apply for a temporary exemption based on the following
factors. First, there is no similarity of design between the cars
produced by Lamborghini and cars produced by Audi. There is no
sharing of engines, transmissions, platforms, or interior systems,
and production tooling is unique to Lamborghini. Second, Lamborghini
has indicated that it has paid for all services or assistance
provided by Audi in ``arm's-length'' transactions. Third, cars are
imported and sold through separate distribution channels independent
of the Audi dealer network. Accordingly, NHTSA concludes that Audi
is not a manufacturer of Lamborghini vehicles by virtue of being a
sponsor.\3\
---------------------------------------------------------------------------

    \3\ 61 FR 52851, 52853 (Sept. 7, 2006).

    In its current petition, Lamborghini states that based on this
previous finding, Lamborghini is eligible to apply for this petition.
Lamborghini confirmed via a signed document submitted to NHTSA via e-
mail from its U.S. consultant that Lamborghini currently certifies that
all the facts it certified in its original petition concerning
Lamborghini's relationship with its parent company Audi continue to be
true.\4\
---------------------------------------------------------------------------

    \4\ This document will be placed in this docket along with the
petition.
---------------------------------------------------------------------------

    Requested exemption. Lamborghini has applied for an extension of
its temporary exemption from the FMVSS No. 208 advanced air bag
requirements. Lamborghini requested an additional 18 months for the
exemption from the rigid

barrier unbelted test requirement with the 50th percentile adult male
test dummy (S14.5.2), the rigid barrier test requirement using the 5th
percentile adult female test dummy (belted and unbelted, S15), the
offset deformable barrier test requirement using the 5th percentile
adult female test dummy (S17), the requirements to provide protection
to infants and children (S19, S21, and S23), and the requirement using
an out-of-position 5th percentile adult female test dummy at the driver
position (S25). Lamborghini's current exemption extends until August
31, 2009, and Lamborghini requested a one-and-a-half year extension
that would exempt Lamborghini's Murcielago model from the listed
advanced air bag requirements through February 28, 2011.
    Economic hardship. In its petition Lamborghini states that its
previously established financial hardship \5\ continues. Lamborghini
states that financial statement ``Forecasts for 2008 through 2011 are
not good.'' Lamborghini states that although 2006 and 2007 financial
statements have shown profitability, the recent upheaval in the global
economy could have a substantial negative effect on these
predictions.\6\ Specifically, Lamborghini's financial information
submission showed that in the absence of the requested extension, it
would lose between 120 and 200 U.S. Murcielago sales over the
extension's 18 month period, and that alone would translate into lost
revenue of between 32,000,000 and 55,000,000 Euros ($44,480,000-
$76,450,000), depending on the number of vehicles sold under the
extension.\7\ Murcielago sales are 25 percent of total U.S. Lamborghini
sales and in its petition Lamborghini stated that the profit margin on
the top-of-the-line Murcielago is the highest of any model the company
sells.
---------------------------------------------------------------------------

    \5\ See 71 FR 52851 (September 7, 2006).
    \6\ In its petition, Lamborghini cites increased sales resulting
from more dealers worldwide, the development of special series high
margin vehicles, individualized made-to-order cars, and the offering
of special options as reasons that its 2006-2007 results have been
better than forecasted.
    \7\ All dollar values are based on an exchange rate of 1 Euro =
$1.39.
---------------------------------------------------------------------------

    Lamborghini states in its petition that the financial impact on
Lamborghini of an extension denial would actually be even greater than
mere lost U.S. sales or lost profits. First, by having no U.S. product
in the ``supercar'' product range for 18 months, Lamborghini states
that it would lose significant market share to competing brands which
may never be regained. Second, because U.S. Murcielago sales are
between 40 and 50 percent of total worldwide Murcielago sales,
Lamborghini states in its petition that it would no longer be viable
for Lamborghini to continue to produce that model for any markets. In
its petition Lamborghini states that shutdown of the Murcielago
production line would mean lost sales beyond lost U.S. sales and would
mean layoffs at the factory that would raise the risk of permanently
losing skilled workers to competing factories in the area, since the
unemployment rate in the area is only between 2 and 3 percent.
Lamborghini argues that such consequences demonstrate ``substantial
economic hardship'' within the meaning of 49 U.S.C. 30113(b)(3)(B)(i).
    Good faith efforts to comply. Lamborghini stated that since the
filing of the original petition for exemption, and since its granting
in late 2006, further unexpected events have transpired that require
the product cycle of the current Murcielago to be extended from
September 2009 until March 2011. Specifically, the launch of the
Murcielago successor has been delayed by up to 18 months due to the
need to develop technologies and materials that permit an even lighter
weight vehicle due to the need to comply with European Union carbon
dioxide and noise requirements. In its petition Lamborghini stated that
such development is a very time consuming endeavor and this is the same
reason behind Ferrari's advanced air bag exemption request in November
2007.\8\
---------------------------------------------------------------------------

    \8\ 72 FR 66028.
---------------------------------------------------------------------------

    Lamborghini referred to NHTSA's September 2006 decision granting
Lamborghini's original petition for exemption which stated that
``[l]ike Ferrari, Lamborghini stated that its product cycles must last
longer than the industry average due to the high cost of development
and extremely small sales volume.'' \9\ Lamborghini also quoted NHTSA's
original grant as stating that ``[w]hile the petitioner was aware of
the new requirements for some time, its business plans changed, and it
was subsequently determined that the Murcielago's production run would
need to be extended beyond 2006, thereby raising the problem of
compliance with the advanced air bag requirements.'' \10\ In its
petition Lamborghini explained that as happens in the small volume
automotive industry, Lamborghini's business plan has changed again for
reasons that Lamborghini could not control (i.e., the European Union
requirements, as noted above), and Murcielago production must continue
for 18 months longer.
---------------------------------------------------------------------------

    \9\ 71 FR 52851, 52854.
    \10\ Id. at 52855 (emphasis added by Lamborghini).
---------------------------------------------------------------------------

    Lamborghini stated in its petition that in 2008, when it realized
that the Murcielago successor was going to be delayed, it revisited the
possibility of fitting advanced air bags to the current Murcielago in
case the technological and supplier situations had changed since the
last efforts made by Lamborghini in 2005. Its petition stated that
after this reexamination, Lamborghini reached the same conclusion it
had reached in 2005: that fully compliant advanced air bags for the
current Murcielago were infeasible. However, Lamborghini stated that
testing that was part of this reexamination of the feasibility of
advanced air bags revealed that the Murcielago could pass the upcoming
belted 35 mile per hour (mph) 50th percentile dummy tests under
S14.5.1(b) of FMVSS No. 208. As a result of this extra testing,
Lamborghini stated that it can certify the Murcielago to the 35 mph
belted 50th percentile dummy requirements in advance of the September
1, 2010 small volume manufacturer deadline. In its petition,
Lamborghini stated that this is further evidence that it is taking
definitive good faith steps towards a full advanced air bag system and
supports its request for the extension.
    Having reached the conclusion again that fully-compliant advanced
air bags were not feasible for the current Murcielago, Lamborghini
stated that it has continued its focus on developing advanced air bags
for the Murcielago successor. In its petition Lamborghini explained
that it has continued its efforts regarding 100 percent FMVSS No. 208
compliance for the Murcielago successor. Lamborghini stated that the
estimated costs for FMVSS No. 208 compliance for the successor
Murcielago are 10,000,000 Euros ($13,900,000).
    Lamborghini argues that an exemption would be in the public
interest. The petitioner states in its petition that the same reasons
NHTSA determined that Lamborghini's original petition was consistent
with the public interest remain valid. Lamborghini put forth several
arguments in favor of a finding that the requested exemption is
consistent with the public interest and the objectives of the National
Traffic and Motor Vehicle Safety Act. Specifically:
    1. Lamborghini stated that the estimated 120 to 200 exempted
vehicles that would be produced over 18 months under the requested
exemption constitute a tiny fraction of the nation's vehicle fleet, and
the requested

extension would therefore have a de minimus impact on the overall
safety of U.S. highways.
    2. The petitioner stated that the exempted vehicles would comply
with all FMVSSs other than the provisions that are subject to the
extension request.
    3. Lamborghini stated that a denial of the requested exemption
would affect its goodwill, dealers, and service personnel by their
inability to continue business with the Murcielago (i.e., to have a
top-of-the-line model available for U.S. dealers).
    4. Lamborghini stated that the Murcielago is likely to be operated
only on a limited basis and the requested extension will have a
negligible impact on the overall safety of U.S. highways. The
petitioner stated that research indicates that the Murcielago is driven
on average only about 5,000 miles per year.
    5. Lamborghini stated that by its very nature, it is extremely rare
that the Murcielago transports children.
    6. The petitioner cited the Murcielago's safety record, which it
called excellent. Both in the U.S. and the rest of the world,
Lamborghini stated that it knows of no injuries caused by the
Murcielago's current air bag system. Lamborghini stated that given the
very low volume of Lamborghini sales, such instances of death or
injury, if they were to occur, would be known to the company.
Therefore, Lamborghini stated, the vehicle guarantees a very high
safety level even without an advanced air bag system, due, in part, to
the crashworthiness design of the vehicle necessitated by its very high
performance.
    7. Lamborghini argued that if the exemption is not granted, U.S.
consumer choice would be harmed and that the agency has long maintained
that the National Traffic and Motor Vehicle Safety Act seeks, if
possible, to avoid limiting consumer choice.
    8. Lamborghini stated that it provides as standard equipment safety
features that are not required by the FMVSS, which it states are in the
public interest, including: passenger air bag on-off switch (which
serves a key purpose at which advanced air bags are aimed--protection
of smaller occupants), antilock brake system (ABS), traction control,
4-wheel drive, occupant protection in a frontal pole test at 35
kilometers per hour, and roadster roof crush resistance at 2.5 times
the a mass of vehicle.

V. Issuance of Notice of Final Action

    We are providing a 30-day comment period. After considering public
comments and other available information, we will publish a notice of
final action on the application in the Federal Register.

    Issued on: September 17, 2009.
Stephen R. Kratzke,
Associate Administrator for Rulemaking.
[FR Doc. E9-22799 Filed 9-21-09; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 127 (Monday, July 2, 2018)]
[Rules and Regulations]
[Pages 30879-30883]
[FR Doc No: 2018-14308]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2009-0234; FRL-9980-41-OAR]
RIN 2060-AT42

Remaining Requirements for Mercury and Air Toxics Standards
(MATS) Electronic Reporting Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to extend the period during which certain electronic reports
required by the Mercury and Air Toxics Standards (MATS) may be
submitted as portable document format (PDF) files using the Emissions
Collection and Monitoring Plan System (ECMPS) Client Tool. This action
will extend the end date of that period from June 30, 2018, to July 1,
2020. This extension is necessary because the electronic reporting
system that owners or operators of affected MATS sources will be
required to use when PDF filing is no longer allowed will not be
available by June 30, 2018. This extension does not alter the
responsibility of owners or operators of affected MATS sources to
comply with the applicable MATS and report their compliance information
to the appropriate authority. In addition, this extension ensures that
the compliance information can be submitted in a timely manner and made
available to the public. Finally, this rule is effective on July 1,
2018, to provide the regulated community a continuous and viable
vehicle to submit compliance reports.

DATES: This final rule is effective on July 1, 2018.

ADDRESSES: Docket: The EPA has established a docket for this action
under Docket ID No. EPA-HQ-OAR-2009-0234. All documents in the docket
are listed on the https://www.regulations.gov website. Although listed
in the index, some information is not publicly available, e.g.,
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. Publicly available docket
materials are available electronically through https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Mr. Barrett Parker, Sector Policies
and Programs Division, Office of Air Quality Planning and Standards
(D243-05), Environmental Protection Agency, Research Triangle Park, NC
27711; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION: The information in this preamble is
organized as follows:

I. General Information
    A. Does this action apply to me?
    B. What action is the Agency taking?
    C. What is the Agency's authority for taking this action?
    D. What are the incremental costs and benefits of this action?
II. Supplemental Information
    A. Background
    B. Why is the Agency taking final action without providing an
opportunity for public comment?
    C. Why is the Agency making this action effective on July 1,
2018?
III. What is the scope of this amendment?
IV. What specific amendments to 40 CFR part 63, subpart UUUUU are
made by this rule?
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
    C. Paperwork Reduction Act (PRA)
    D. Regulatory Flexibility Act (RFA)
    E. Unfunded Mandates Reform Act (UMRA)
    F. Executive Order 13132: Federalism
    G. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    H. Executive Order 13045: Protection of Children From
Environmental Health Risks and Safety Risks
    I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    J. National Technology Transfer and Advancement Act (NTTAA)
    K. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations
    L. Congressional Review Act (CRA)

I. General Information

A. Does this action apply to me?

    Categories and entities potentially affected by this action
include:

------------------------------------------------------------------------
                                                 Examples of potentially
            Category             NAICS code \1\     regulated entities
------------------------------------------------------------------------
Industry.......................          221112  Fossil fuel-fired EGUs.
Federal government.............      \2\ 221122  Fossil fuel-fired EGUs
                                                  owned by the Federal
                                                  government.
State/local/Tribal government..      \2\ 221122  Fossil fuel-fired EGUs
                                                  owned by
                                                  municipalities.
                                         921150  Fossil fuel-fired EGUs
                                                  in Indian country.
------------------------------------------------------------------------
\1\ North American Industry Classification System.
\2\ Federal, state, or local government-owned and operated
  establishments are classified according to the activity in which they
  are engaged.

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that the EPA is now
aware could potentially be regulated by

this action. Other types of entities not listed in the table could also
be regulated. To determine whether your entity is regulated by this
action, you should carefully examine the applicability criteria in 40
CFR 63.9981 of the rule. If you have questions regarding the
applicability of this action to a particular entity, consult either the
air permitting authority for the entity or your EPA Regional
representative as listed in 40 CFR 63.13.

B. What action is the Agency taking?

    This final action extends the period allowing owners or operators
of affected sources subject to the National Emission Standards for
Hazardous Air Pollutants: Coal- and Oil-Fired Electric Utility Steam
Generating Units (commonly known as the Mercury and Air Toxics
Standards (MATS)) to submit certain reports as PDF file attachments
using the ECMPS Client Tool until July 1, 2020. Prior to this
extension, that period was scheduled to end on June 30, 2018. As
explained further below, the EPA finds that there is ``good cause''
under the Administrative Procedure Act (APA) (5 U.S.C. 553(b)(B)) to
make the amendments extending the deadline final without prior notice
and comment, in part because the rule maintains the status quo, and the
reporting system that would apply without the extension (i.e., the
Compliance and Emissions Data Reporting Interface (CEDRI)) is currently
unable to accept the MATS reports, thus, making it impossible for the
regulated community to comply with all reporting requirements without
this extension. Thus, as explained further below, the EPA maintains
that notice and comment is unnecessary and contrary to the public
interest for this action. The EPA also finds good cause under APA
553(d)(3) to make this rule effective on July 1, 2018, instead of 30
days after publication as generally required, to ensure that there are
no gaps in the regulated community's ability to submit all the required
reports.

C. What is the Agency's authority for taking this action?

    The Agency's authority is found at 42 U.S.C. 7401 et seq. and 5
U.S.C. 553 et seq.

D. What are the incremental costs and benefits of this action?

    This extension of the time period allowing temporary submission of
PDF file attachments has neither costs nor benefits.

II. Supplemental Information

A. Background

    On February 12, 2012, the EPA issued the final MATS (77 FR 9304;
February 16, 2012). In that rule, owners or operators of coal- or oil-
fired electric utility steam generating units (EGUs) were required to
report emissions and compliance information electronically using two
data systems: The ECMPS Client Tool and CEDRI. The two electronic
reporting systems were intended to accept different MATS compliance
related information (e.g., the ECMPS Client Tool was to be used by EGU
owners or operators to report, among other things, mercury (Hg)
continuous monitoring data and the CEDRI system was to be used to
submit, among other things, semiannual compliance reports). See 40 CFR
63.10031(a), (f).
    After promulgation, but prior to the existing-source compliance
date of April 16, 2015, the regulated community suggested to the EPA
that the electronic reporting burden of MATS could be significantly
reduced if all the required information were reported to one data
system instead of two. Specifically, the regulated community suggested
that the EPA amend MATS to require all the data to be reported through
the ECMPS Client Tool, which is a familiar data system that most EGU
owners or operators have been using since 2009 to meet the electronic
reporting requirements of the Acid Rain Program.
    In response, the EPA decided to require all electronic reports
required by MATS to be submitted through the ECMPS Client Tool, but the
Agency recognized that it could not make the necessary changes to the
ECMPS Client Tool by the April 16, 2015, compliance date. For that
reason, the EPA issued a final rule on March 24, 2015, prior to the
MATS compliance date, revising the MATS reporting requirements (80 FR
15511; March 24, 2015). Among other things, the final rule suspended
the requirement to submit to CEDRI the MATS compliance reports
described in 40 CFR 63.10031(f)(1), (f)(2), and (f)(4), and instead
allowed parties to submit those reports to the ECMPS Client Tool as PDF
files. See 40 CFR 63.10031(f)(6). The EPA included a self-imposed
deadline of April 17, 2017, to revise the ECMPS Client Tool to accept
all of the MATS compliance information. If the revised system was not
ready by that date, the rule required reporting of the MATS compliance
data to revert to the original two-system approach on and after that
date. See 40 CFR 63.10031(f).
    On September 29, 2016, the EPA proposed for comment to revise MATS
to require a single electronic reporting system, (i.e., the ECMPS
Client Tool), and also proposed to extend the PDF file reporting period
from April 17, 2017, to December 31, 2017, by which date the Agency
believed it would complete the necessary changes to the ECMPS Client
Tool (81 FR 67062; September 29, 2016). The comment period was
scheduled to close on October 31, 2016, but it was subsequently
extended until November 15, 2016, in response to requests from several
stakeholders for an extension. The public comments were generally
supportive of simplifying and streamlining the MATS reporting
requirements and to use the ECMPS Client Tool as the single electronic
reporting system. However, industry commenters questioned whether the
EPA would complete the changes to the ECMPS Client Tool by December 31,
2017, and suggested dates ranging from six quarters after completion of
the final rule was issued to 2020. No commenters stated that the EPA
should not extend the PDF file reporting period. On April 6, 2017, the
EPA finalized an extension of the PDF file reporting period from April
17, 2017, to June 30, 2018, because the Agency recognized it would not
complete the necessary revisions to the ECMPS Client Tool and conduct
the necessary testing by the December 31, 2017, proposed extension date
(82 FR 16736; April 6, 2017).\1\
---------------------------------------------------------------------------

    \1\ In addition to extending the interim PDF file submission
process to June 30, 2018, the final rule also made a few technical
corrections to Appendix A.
---------------------------------------------------------------------------

    The EPA continues to work on the ECMPS Client Tool, but the Agency
recently concluded that the changes and necessary testing will not be
completed by June 30, 2018. In addition, the CEDRI interface is not
currently capable of accepting the compliance reports that are
currently being submitted via PDF files to the ECMPS Client Tool. This
means that EGU owners or operators would be unable to submit the
required reports if PDF file reporting authority is not extended.
Moreover, the CEDRI interface cannot be operational before July 1, 2018
(i.e., the first date CEDRI reporting would be required absent an
extension), and the EPA is continuing to change the ECMPS Client Tool
to accept all of the MATS compliance reports. For these reasons, the
EPA has concluded that it is reasonable to continue to allow the PDF
file reporting option. This extension changes neither the
responsibility of all owners or operators of affected sources to comply
with the applicable MATS emissions standards and other requirements nor
the compliance information available to the

public as PDF files. For all these reasons, the EPA is revising the
reporting requirements in the MATS regulations, 40 CFR 63.10021 and
63.10031, by extending the period for affected sources to submit
certain compliance related information via PDF file reports from June
30, 2018, to July 1, 2020.

B. Why is the Agency taking final action without providing an
opportunity for public comment?

    As noted above, this action amends the reporting requirements by
extending the period for affected sources to submit certain compliance
related information via PDF file reports. This extension is critical
because: (1) The EPA is still working to revise the ECMPS Client Tool
so that it can accept all of the MATS compliance reports, and (2) the
CEDRI system that would apply without this extension is not able to
accept the compliance reports that are currently being submitted via
PDF files. Without this action, affected source owners or operators
would be unable to report certain MATS compliance information as
required in the regulations and, as a result, the public would not have
access to that information.
    Section 553(b)(B) of the APA, 5 U.S.C. 553(b)(B), provides that,
when an agency for good cause finds that notice and public comment are
impracticable, unnecessary, or contrary to the public interest, the
agency may issue a rule without providing notice and an opportunity for
public comment. See also the final sentence of section 307(d)(1) of the
Clean Air Act (CAA), 42 U.S.C. 7607(d)(1), indicating that CAA section
307(d) does not apply in the case of any rule or circumstance referred
to in section 553(b)(B) of the APA. As explained further below, the EPA
finds that providing notice and comment is unnecessary in this
situation because the extension of PDF file reporting maintains the
status quo and does not relieve the regulated community of its
responsibility to comply with the MATS. In addition, when in April 2017
the EPA proposed and finalized an extension of the PDF file reporting
requirement, the Agency received no comments against or legal challenge
to that extension rulemaking. Finally, the EPA also finds that notice
and comment rulemaking in these circumstances would be contrary to the
public interest because the electronic system that would apply without
the extension (i.e., CEDRI) is currently unable to accept the MATS
compliance reports that are currently being submitted via PDF files.
Therefore, it would not be possible for affected source owners or
operators to comply with all of the MATS reporting requirements without
the extension and the public would be deprived of certain compliance
related information as a result. The delay that would be inherent in
notice and comment rulemaking would result in a potential loss of
public availability of compliance information that is contrary to the
public interest.
    The EPA has determined that notice and comment procedures are
unnecessary here for a number of reasons. First, this action will
simply maintain the status quo and does not introduce any new
substantive requirements.
    Second, the EPA has no viable alternative to extending of PDF file
reporting given that the CEDRI system is not currently able to accept
the necessary reports. The EPA has concluded that the July 2020
extension date will provide the necessary time to complete the changes
to and test the ECMPS Client Tool.
    Third, the Agency previously provided an opportunity for comment on
whether a PDF file reporting extension is justified where the
electronic reporting system is not available. The Agency provided this
opportunity for comment in the September 29, 2016, proposed rule
(finalized April 6, 2017) to extend the PDF file reporting until June
30, 2018 (81 FR 67062; September 29, 2016 and 82 FR 16736; April 7,
2017). The EPA did not receive any comments suggesting that the
extension of the PDF file reporting was unreasonable, although
commenters did suggest the Agency provide more time than proposed. As a
result, the Agency finalized an extension to June 30, 2018, 7 months
longer than proposed, but considerably less time than suggested in
comments. See 82 FR 16736. In this final rule, the EPA is recognizing
that, as commenters in 2016 suggested, more time is needed to complete
the move to the ECMPS Client Tool and that a longer extension of the
PDF file reporting than the one previously afforded is appropriate.
    In addition to finding that notice and comment rulemaking is
unnecessary, the EPA also finds that providing notice and comment in
this situation would be contrary to the public interest. If the EPA
were to delay this action to provide an opportunity for public comment,
there would be a gap period during which the public would not have
access to all of the MATS compliance information required by the rule.
As explained above, the CEDRI system is not currently capable of
accepting the MATS compliance reports that parties would be required to
submit to it. Thus, if the PDF file reporting extension were not
provided, some MATS compliance information would not be accessible to
the public for some time. In addition, EGU owners or operators, along
with the public and regulatory agencies, are already familiar with the
interim PDF file submission process and the EPA continues to work on
the ECMPS Client Tool so that it can accept all of the MATS compliance
reports. The current process of EGU owners or operators attaching PDF
files when submitting reports via the ECMPS Client Tool is well
understood by all parties interested in the data and ensures that all
compliance data are reported. Conversely, EGU owners or operators are
not familiar with CEDRI reporting for MATS, so requiring compliance
with CEDRI for some interim period before the full implementation of
the ECMPS Client Tool would potentially cause confusion for the
regulated community and the public. The EPA maintains that, in light of
these facts, it is contrary to the public interest to have an interim
period during which both the EPA and EGU owners or operators would have
to expend the resources and time necessary to enable partial CEDRI
reporting before fully converting to the ECMPS Client Tool. For these
reasons, the EPA finds that providing notice and comment in these
particular circumstances would be contrary to the public interest.
    For all these reasons, the EPA finds good cause exists under
section 553(b)(B) of the APA to issue this final rule without prior
notice and opportunity for comment.

C. Why is the Agency making this action effective on July 1, 2018?

    The EPA also finds good cause to make this final rule effective on
July 1, 2018. Section 553(d) of the APA, 5 U.S.C. 553(d), provides that
final rules shall not become effective until 30 days after publication
in the Federal Register, ``except . . . as otherwise provided by the
agency for good cause,'' among other exceptions. The purpose of this
provision is to ``give affected parties a reasonable time to adjust
their behavior before the final rule takes effect.'' Omnipoint Corp. v.
FCC, 78 F.3d 620, 630 (DC Cir. 1996); see also United States v.
Gavrilovic, 551 F.2d 1099, 1104 (8th Cir. 1977) (quoting legislative
history). Thus, in determining whether good cause exists to waive the
30-day delay, an agency should ``balance the necessity for immediate
implementation against principles of fundamental fairness which require
that all affected persons be afforded a reasonable amount of time

to prepare for the effective date of its ruling.'' Gavrilovic, 551 F.2d
at 1105. The EPA has determined that it is necessary to make this final
rule effective on July 1, 2018, instead of 30 days after publication in
the Federal Register, to ensure that there are no gaps in the ability
of affected MATS sources to submit the required compliance reports,
given that the current authority to submit PDF file reports expires on
June 30, 2018. The EPA also has determined that the owners or operators
of affected MATS sources do not need time to adjust to this final
action because this final rule simply maintains the status quo and does
not introduce any new substantive requirements.
    For these reasons, the EPA finds good cause exists under section
553(d)(3) of the APA to make this rule effective on July 1, 2018,
instead of 30 days after publication in the Federal Register.

III. What is the scope of this amendment?

    This action amends the reporting requirement in the MATS
regulation, 40 CFR 63.10021 and 10031.

IV. What specific amendments to 40 CFR part 63, subpart UUUUU are made
by this rule?

    The interim PDF reporting process described in 40 CFR 63.10031(f)
has been further extended through June 30, 2020, to allow sufficient
time for software development, programming, and testing. Until then,
compliance with the emissions and operating limits continues to be
assessed based on the various PDF file report submittals described in
40 CFR 63.10021(e)(9) and 63.10031(f). Data are also obtained from Hg,
hydrogen chloride, hydrogen fluoride, and sulfur dioxide continuous
emission monitoring systems, as well as Hg sorbent trap monitoring
systems, as reported through the ECMPS Client Tool.

V. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was,
therefore, not submitted to the Office of Management and Budget (OMB)
for review.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This action is not an Executive Order 13771 regulatory action
because this action is not significant under Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. OMB has previously approved the information collection
activities contained in the existing regulation and has assigned OMB
Control Number 2060-0567. This action does not change the information
collection requirements, and this action does not impose any new
information collection burden under the PRA.

D. Regulatory Flexibility Act (RFA)

    This action is not subject to the RFA. The RFA applies only to
rules subject to notice and comment rulemaking requirements under the
APA, 5 U.S.C. 553, or any other statute. This rule is not subject to
notice and comment requirements because the Agency has invoked the APA
``good cause'' exemption under 5 U.S.C. 553(b).

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. As described
earlier, this action has no net regulatory burden on governments
already subject to MATS. Accordingly, we have determined that this
action will not result in any ``significant'' adverse economic impact
for small governments.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects 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.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. As described earlier, this action has no
substantial direct effect on Indian tribes already subject to MATS.
Thus, Executive Order 13175 does not apply to this action.

H. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This action is not subject to
Executive Order 13045 because it does not concern an environmental
health risk or safety risk.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, because it is
not a significant regulatory action under Executive Order 12866.

J. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA believes that this action is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994) because it does not establish an
environmental health or safety standard. This regulatory action extends
the deadline for interim reporting of electronic data; it does not have
any impact on human health or the environment.

L. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. The CRA allows the issuing agency to make a rule
effective sooner than otherwise provided by the CRA if the agency makes
a good cause finding that notice and comment rulemaking procedures are
impracticable, unnecessary, or contrary to the public interest (5
U.S.C. 808(2)). The EPA has made a good cause finding for this rule as
discussed in sections II.B and C of this preamble, including the basis
for that finding.

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedure,
Air pollution control, Hazardous substances, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: June 26, 2018.
E. Scott Pruitt,
Administrator.

    For the reasons set forth in the preamble, the EPA amends 40 CFR
part 63 as follows:

PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS
FOR SOURCE CATEGORIES

0
1. The authority citation for part 63 continues to read as follows:

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

Subpart UUUUU--National Emission Standards for Hazardous Air
Pollutants: Coal- and Oil-Fired Electric Utility Steam Generating
Units

0
2. Section 63.10021 is amended by revising paragraph (e)(9) to read as
follows:

Sec.  63.10021   How do I demonstrate continuous compliance with the
emission limitations, operating limits, and work practice standards?

* * * * *
    (e) * * *
    (9) Report the dates of the initial and subsequent tune-ups in hard
copy, as specified in 63.10031(f)(5), through June 30, 2020. On or
after July 1, 2020, report the date of all tune-ups electronically, in
accordance with Sec.  63.10031(f). The tune-up report date is the date
when tune-up requirements in paragraphs (e)(6) and (7) of this section
are completed.
* * * * *

0
3. Section 63.10031 is amended by revising paragraphs (f) introductory
text, (f)(1), (2), (4), and (f)(6) introductory text to read as
follows:

Sec.  63.10031  What reports must I submit and when?

* * * * *
    (f) On or after July 1, 2020, within 60 days after the date of
completing each performance test, you must submit the performance test
reports required by this subpart to the EPA's WebFIRE database by using
the Compliance and Emissions Data Reporting Interface (CEDRI) that is
accessed through the EPA's Central Data Exchange (CDX) (https://cdx.epa.gov). Performance test data must be submitted in the file
format generated through use of EPA's Electronic Reporting Tool (ERT)
(see https://www.epa.gov/ttn/chief/ert/index.html). Only data collected
using those test methods on the ERT website are subject to this
requirement for submitting reports electronically to WebFIRE. Owners or
operators who claim that some of the information being submitted for
performance tests is confidential business information (CBI) must
submit a complete ERT file including information claimed to be CBI on a
compact disk or other commonly used electronic storage media
(including, but not limited to, flash drives) to EPA. The electronic
media must be clearly marked as CBI and mailed to U.S. EPA/OAPQS/CORE
CBI Office, Attention: WebFIRE Administrator, MD C404-02, 4930 Old Page
Rd., Durham, NC 27703. The same ERT file with the CBI omitted must be
submitted to EPA via CDX as described earlier in this paragraph. At the
discretion of the delegated authority, you must also submit these
reports, including the confidential business information, to the
delegated authority in the format specified by the delegated authority.
    (1) On or after July 1, 2020, within 60 days after the date of
completing each CEMS (SO2, PM, HCl, HF, and Hg) performance
evaluation test, as defined in Sec.  63.2 and required by this subpart,
you must submit the relative accuracy test audit (RATA) data (or, for
PM CEMS, RCA and RRA data) required by this subpart to EPA's WebFIRE
database by using CEDRI that is accessed through EPA's CDX (https://cdx.epa.gov). The RATA data shall be submitted in the file format
generated through use of EPA's Electronic Reporting Tool (ERT) (https://www.epa.gov/ttn/chief/ert/index.html). Only RATA data compounds listed
on the ERT website are subject to this requirement. Owners or operators
who claim that some of the information being submitted for RATAs is
confidential business information (CBI) shall submit a complete ERT
file including information claimed to be CBI on a compact disk or other
commonly used electronic storage media (including, but not limited to,
flash drives) by registered letter to EPA and the same ERT file with
the CBI omitted to EPA via CDX as described earlier in this paragraph.
The compact disk or other commonly used electronic storage media shall
be clearly marked as CBI and mailed to U.S. EPA/OAPQS/CORE CBI Office,
Attention: WebFIRE Administrator, MD C404-02, 4930 Old Page Rd.,
Durham, NC 27703. At the discretion of the delegated authority, owners
or operators shall also submit these RATAs to the delegated authority
in the format specified by the delegated authority. Owners or operators
shall submit calibration error testing, drift checks, and other
information required in the performance evaluation as described in
Sec.  63.2 and as required in this chapter.
    (2) On or after July 1, 2020, for a PM CEMS, PM CPMS, or approved
alternative monitoring using a HAP metals CEMS, within 60 days after
the reporting periods ending on March 31st, June 30th, September 30th,
and December 31st, you must submit quarterly reports to the EPA's
WebFIRE database by using the CEDRI that is accessed through the EPA's
CDX (https://cdx.epa.gov). You must use the appropriate electronic
reporting form in CEDRI or provide an alternate electronic file
consistent with EPA's reporting form output format. For each reporting
period, the quarterly reports must include all of the calculated 30-
boiler operating day rolling average values derived from the CEMS and
PM CPMS.
* * * * *
    (4) On or after July 1, 2020, submit the compliance reports
required under paragraphs (c) and (d) of this section and the
notification of compliance status required under Sec.  63.10030(e) to
the EPA's WebFIRE database by using the CEDRI that is accessed through
the EPA's CDX (https://cdx.epa.gov). You must use the appropriate
electronic reporting form in CEDRI or provide an alternate electronic
file consistent with EPA's reporting form output format.
* * * * *
    (6) Prior to July 1, 2020, all reports subject to electronic
submittal in paragraphs (f) introductory text, (f)(1), (2), and (4) of
this section shall be submitted to the EPA at the frequency specified
in those paragraphs in electronic portable document format (PDF) using
the ECMPS Client Tool. Each PDF version of a submitted report must
include sufficient information to assess compliance and to demonstrate
that the testing was done properly. The following data elements must be
entered into the ECMPS Client Tool at the time of submission of each
PDF file:
* * * * *
[FR Doc. 2018-14308 Filed 6-29-18; 8:45 am]
 BILLING CODE 6560-50-P