[Federal Register Volume 80, Number 178 (Tuesday, September 15, 2015)]
[Rules and Regulations]
[Pages 55237-55242]
[FR Doc No: 2015-23124]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2014-N-0504]
RIN 0910-AH12

Administrative Destruction of Certain Drugs Refused Admission to
the United States

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
implementing its authority to destroy a drug valued at $2,500 or less
(or such higher amount as the Secretary of the Treasury may set by
regulation) that has been refused admission into the United States
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), by
issuing a rule that provides to the owner or consignee notice and an
opportunity to appear and introduce testimony to the Agency prior to
destruction. This regulation is authorized by amendments made to the
FD&C Act by the Food and Drug Administration Safety and Innovation Act
(FDASIA). Implementation of this authority will allow FDA to better
protect the public health by providing an administrative process for
the destruction of certain refused drugs, thus increasing the integrity
of the drug supply chain.

DATES: This rule is effective October 15, 2015.

FOR FURTHER INFORMATION CONTACT: Ann M. Metayer, Office of Regulatory
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 4338, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Regulatory Action

    Implementation of FDA's administrative destruction authority will
better protect the integrity of the

drug supply chain by providing a disincentive for the importation of
drugs that are adulterated, misbranded, or unapproved in violation of
section 505 of the FD&C Act (21 U.S.C. 355) (unapproved drugs) and
reducing the likelihood of such drugs being refused admission and
subsequently offered for reimportation. In 2012, Congress amended
section 801(a) of the FD&C Act (21 U.S.C. 381(a)) to provide FDA with
the authority to destroy a refused drug valued at $2,500 or less (or
such higher amount as the Secretary of the Treasury may set by
regulation) without providing the owner or consignee with the
opportunity to export the drug. Congress directed FDA to issue
regulations that provide the drug's owner or consignee with notice and
an opportunity to present testimony to the Agency prior to the drug's
destruction (section 708 of FDASIA). The final rule provides the owner
or consignee of a drug that has been refused admission into the United
States, and that is valued at $2,500 or less (or such higher amount as
the Secretary of the Treasury may set by regulation) with: (1) Written
notice that FDA intends to destroy the drug and (2) an opportunity to
present testimony to the Agency before the drug is destroyed.
    FDA is issuing this final rule under section 801(a) of the FD&C
Act.

Summary of the Major Provisions

    The final rule implements the authority of FDA to destroy a drug
after providing the owner or consignee of a drug that has been refused
admission into the United States under section 801(a) of the FD&C Act,
and that is valued at $2,500 or less (or such higher amount as the
Secretary of the Treasury may set by regulation) with: (1) Written
notice that FDA intends to destroy the drug and (2) an opportunity to
present testimony to the Agency before the drug is destroyed.
    FDA is amending part 1 (21 CFR part 1) by expanding the scope of
Sec.  1.94 (21 CFR 1.94) to include administrative destruction.
Currently this provision provides the owner or consignee of an FDA-
regulated product offered for import into the United States with notice
and opportunity to present testimony to the Agency prior to refusal of
admission of the product. The final rule expands the scope of Sec.
1.94 to also provide an owner or consignee with notice and opportunity
to present testimony to the Agency prior to the destruction of certain
refused drugs.
    Section 708 of FDASIA and the final rule allow FDA to provide two
separate notices and hearings--one for refusal of admission and one for
destruction of a refused drug product--or to combine both notices and
hearings into one notice and proceeding. Whether the determinations
occur separately or in one combined proceeding, the determination of
refusal and the determination regarding destruction of a drug will be
made separately by the Agency as the findings are separate and
distinct.

Costs and Benefits

    The primary public health benefit from adoption of the rule would
be the value of the illnesses and deaths avoided because FDA destroyed
a drug valued at $2,500 or less (or such higher amount as the Secretary
of the Treasury may set by regulation) that posed a public health risk.
This benefit accrues whenever the Agency's other enforcement tools
would not have prevented a drug, including a biological product, which
does not comply with the requirements of the FD&C Act (violative drug)
from entering the U.S. market. The estimated primary costs of the final
rule include the additional costs to destroy a violative drug and the
one-time costs of updating the FDA Operational and Administrative
System for Import Support (OASIS), making appropriate revisions to
Chapter 9 of the FDA Regulatory Procedures Manual (RPM) and the
Agency's internal import operations guidelines, and training for FDA
personnel. FDA estimates the quantifiable net annual effect of the
final rule to range between a cost of $54,325 and a cost savings of
$901,950 for an estimated 15,100 destructions each year. The Agency
estimates that it will also incur one-time costs of $531,670.

I. Background and Legal Authority

    In the Federal Register of May 6, 2014 (79 FR 25758), FDA proposed
a rule to implement its new authority under section 708 of FDASIA to
destroy a refused drug valued at $2,500 or less (or such higher amount
as the Secretary of the Treasury may set by regulation). As discussed
in the preamble to the proposed rule, President Obama signed FDASIA
(Pub. L. 112-144) into law on July 9, 2012. Title VII of FDASIA
provides FDA with important new authorities to help the Agency better
protect the integrity of the drug supply chain. One of those new
authorities is provided in section 708 of FDASIA, which amends section
801(a) of the FD&C Act, to provide FDA with the authority to use an
administrative procedure to destroy a drug valued at $2,500 or less (or
such higher amount as the Secretary of the Treasury may set by
regulation) that was not brought into compliance as described in
section 801(b) of the FD&C Act and was refused admission into the
United States. Section 708 of FDASIA authorizes FDA to use this new
administrative procedure without offering the owner or consignee the
opportunity to export the drug. The statute further provides that FDA
will store and, as applicable, dispose of the drug that the Agency
intends to destroy. The drug's owner or consignee is liable for FDA's
storage and disposal costs under section 801(c) of the FD&C Act.
    Section 708 of FDASIA directs FDA to issue regulations that provide
the owner or consignee of a drug designated by the Agency for
administrative destruction with notice and an opportunity to introduce
testimony to the Agency prior to the destruction of the drug. The
provision further states that this process may be combined with the
notice and opportunity to appear before FDA and introduce testimony on
the admissibility of the drug under section 801(a) of the FD&C Act, as
long as appropriate notice is provided to the owner or consignee.

II. Overview of the Final Rule Including Changes to the Proposed Rule

    FDA is amending part 1 to implement the administrative destruction
of refused drugs. The amendment to part 1 consists of amendments to
Sec.  1.94, including two technical changes to Sec.  1.94(b) where
``his'' is now changed to ``his or her'' and ``act'' is now changed to
``Federal Food, Drug, and Cosmetic Act'' in the final rule. No changes
have been made to the proposed regulation and, therefore, FDA is
finalizing the implementing regulation as proposed.

III. Comments on the Proposed Rule

    FDA received 22 comments in the public docket for the May 6, 2014,
proposed rule by the close of the comment period, July 7, 2014, each
containing one or more comments. One comment was received in the public
docket on July 8, 2014, 1 day after the docket closed. These comments
were submitted by consumers, consumer advocacy groups, industry and
trade organizations, industry, and a member of Congress. One comment
consisted of a ``placeholder'' and did not contain any substantive
remarks.
    After considering the comments responsive to the proposed rule, the
Agency is not making any changes to the regulatory language included in
the proposed rule.
    This section contains summaries of the relevant portions of the
responsive comments and the Agency's responses to those comments. To
make it easier to

identify the comments and our responses, the word ``Comment,'' in
parentheses, appears before the comment's description, and the word
``Response,'' in parentheses, appears before our response. We have
numbered each comment and response to help distinguish between
different types of comments. Similar comments are grouped together
under the same number. The number assigned to each comment is purely
for organizational purposes and does not signify the comment's value,
importance, or the order in which it was received.
    The Agency also received some general comments that were not
responsive to the content of the rule, and therefore were not
considered in its final development. Some of these comments, however,
are summarized in this section and the Agency responded to those
comments to provide clarity for the public and industry on the Agency's
implementation of its administrative destruction authority under
section 708 of FDASIA.

A. Notice and Hearing Process

    Two comments suggested that FDA modify the notice and hearing
process in the proposed rule.
    (Comment 1) One comment asserted that the procedure set forth in
Sec.  1.94 appears to apply only to large commercial drug imports, not
drugs offered for import by individuals, and that FDA should create a
separate administrative hearing process for individuals.
    (Response 1) The proposed rule amends Sec.  1.94 to add
administrative destruction of certain drugs to the current
administrative hearing process for refusal of admission of an FDA-
regulated product. The current rule applies to all imports regardless
of how they enter the United States, e.g., via a commercial port or an
International Mail Facility (IMF), and regardless of who seeks to
import the drug. As amended by this final rule, Sec.  1.94 will provide
an administrative hearing process to any owner or consignee of a
refused drug with a value of $2,500 or less (or such higher amount as
the Secretary of the Treasury may set by regulation) that FDA intends
to destroy whether that owner or consignee is an individual owner or
consignee or a commercial importer. There is, therefore, no need to
establish a separate administrative hearing process for individuals
whose drugs have been refused and designated for administrative
destruction.
    (Comment 2) One comment stated that FDA should provide clarity for
consumers regarding how they can introduce testimony to the Agency to
challenge the administrative destruction of drugs they attempted to
import but which were refused admission. The comment suggested that FDA
allow testimony to be submitted by an affected owner or consignee
through an online platform, email, regular mail, or facsimile and that
the Agency include a supplemental document in the notice that instructs
consumers on how to provide testimony to FDA to prevent administrative
destruction of their drugs.
    (Response 2) As described in Chapter 9 of the RPM, the type of
administrative hearing under Sec.  1.94 may vary from a series of
telephone conversations to a more formal procedure. Introduction of
testimony by the owner or consignee for Agency review and consideration
can take many forms, including a telephone conversation, a facsimile,
or mail, and does not have to be introduced in person. However, an in-
person hearing will be scheduled if requested by the owner or
consignee. (http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074300.pdf). Current Agency procedures
also allow such testimony to be submitted by the owner or consignee by
email. Under the final rule, owners or consignees will have the same
options for submitting testimony in opposition to the destruction of
their drugs. Given the variety of options historically available to
owners and consignees for submission of testimony, which will continue
under the final rule, FDA does not believe that a dedicated online
platform for submission of testimony is currently needed. If
circumstances change in the future, FDA will consider whether such a
system is appropriate.
    FDA recognizes that an owner or consignee importing a drug for his/
her own personal use may need information about the administrative
hearing process when that drug has been detained by FDA for
administrative destruction. Accordingly, the Agency will provide
information on the administrative hearing process under Sec.  1.94, as
amended in this rule, by providing an insert in the Agency's notice of
detention or by establishing a Web page on the FDA Web site containing
information about the administrative destruction process including ways
to submit testimony to the Agency in opposition to the destruction of a
drug. FDA will also consider issuing guidance or other explanatory
materials, as appropriate.

B. Drugs Subject to Administrative Destruction by FDA

    Two comments requested clarity regarding what drugs will be
destroyed by FDA under section 708 of FDASIA.
    (Comment 3) Two commenters requested clarity on when a refused drug
will be destroyed under section 708 of FDASIA and when the Agency will
give the owner or consignee the option to destroy or export a refused
drug.
    (Response 3) Currently, owners or consignees of drugs that have
been refused admission into the United States under section 801(a) of
the FD&C Act have the option to destroy or export those drugs. Drugs
imported via an IMF that have been refused admission are sent back to
the United States Postal Service (USPS) for export. After
implementation of section 708 of FDASIA, FDA anticipates that owners or
consignees will still have the option to destroy or export a refused
drug in at least two situations. First, only a drug valued at $2,500 or
less (or such higher amount as the Secretary of the Treasury may set by
regulation) is subject to administrative destruction under section 708
of FDASIA. Owners or consignees of a drug valued over the current
$2,500 threshold that has been refused admission will still have the
option to destroy or export that drug unless the drug has been imported
via an IMF. For a drug valued at $2,500 or less (or such higher amount
as the Secretary of the Treasury may set by regulation) that has been
refused admission, section 708 of FDASIA allows FDA to destroy the drug
without providing the owner or consignee with the opportunity to
destroy or export the drug.
    The second situation where owners or consignees will still have the
option to destroy or export a refused drug is when FDA refuses
admission to a drug, including a biological product, that is subject to
destruction under section 708 of FDASIA, but the Agency is not able to
make a determination that the drug is, in fact, adulterated,
misbranded, or unapproved in violation of section 505 of the FD&C Act.
As stated in the proposed rule, FDA intends to administratively destroy
a drug only where the Agency has made a determination that the drug is
adulterated, misbranded, or is an unapproved drug. There may be
situations where the Agency refuses admission to a drug that is valued
at $2,500 or less (or such higher amount as the Secretary of the
Treasury may set by regulation) because it appears to be an
adulterated, misbranded, or unapproved

drug but the Agency does not have sufficient information to make a
determination that the drug is, in fact, an adulterated, misbranded, or
unapproved drug. Under those circumstances, the owner or consignee will
be given the opportunity to destroy or export that refused drug. If
such a drug has come into the United States via an IMF, however, FDA
will generally return the drug to the USPS for export.

C. Storage and Destruction Costs of Drugs Designated for Destruction

    Section 708 of FDASIA provides that FDA will store and, as
applicable, dispose of a drug where the Agency has made the
determination to destroy that drug. The drug's owner or consignee is
liable for FDA's storage and disposal costs under section 801(c) of the
FD&C Act.
    (Comment 4) One comment asked when FDA will take physical
possession of drugs designated for destruction at express courier
facilities and expressed concern about the possibility of extended
storage time for these drugs at the expense of the express courier. The
commenter also requested clarification regarding whether an express
courier could be held liable for the costs of storage and destruction
of a refused drug under section 801(c) of the FD&C Act.
    (Response 4) If FDA designates a drug for possible destruction that
has been offered for import into the United States via an express
courier, FDA intends to take physical possession of that drug when the
Agency has made the determination to destroy the drug. The Agency
expects that by combining the notice and introduction of testimony on
destruction with the notice and introduction of testimony on refusal of
admission, any additional storage time at an express courier due to
implementation of section 708 of FDASIA will be minimal.
    An express courier is not liable for the storage or destruction
costs under section 801(c) of the FD&C Act unless that courier is also
the owner or consignee of a destroyed drug, which would be unusual. As
stated in the proposed rule, if a drug is sent by international mail,
FDA generally considers the addressee of the parcel to be the owner or
consignee of the drug.
    (Comment 5) One commenter requested that FDA clearly define and
outline the storage and destruction costs to consumers under section
801(c) of the FD&C Act and that the Agency provide offsets to those
costs for consumers unable to pay due to financial stress.
    (Response 5) FDA generally does not intend to pursue recovery of
storage and destruction costs under section 801(c) of the FD&C Act
against individual consumers who seek to import a drug for their own
personal use that is then refused and destroyed by the Agency under
section 708 of FDASIA.

D. General Comments

    The final rule provides the owner or consignee of a drug valued at
$2,500 or less (or such higher amount as the Secretary of the Treasury
may set by regulation) that is refused admission into the United States
with: (1) Written notice that FDA intends to destroy the drug and (2)
an opportunity to present testimony to the Agency before the drug is
destroyed.
    (Comment 6) Many comments made general remarks expressing support
or opposition to the authority granted to FDA by section 708 of FDASIA
to administratively destroy certain refused drugs and did not focus on
the rule or a particular section of the rule.
    One comment supported the administrative destruction of certain
refused drugs while several comments expressed concern about the
potential impact of administrative destruction on a consumer's access
to foreign drugs. These comments cited a patient's inability to comply
with a drug treatment plan as a consequence of that lack of access. One
comment requested that FDA change its current Personal Importation
Policy to allow importation of any drug from a ``safe'' foreign
pharmacy or for which there is a ``valid'' prescription. The comment
further requested that FDA define the term ``safe personal drug
import'' in the final rule.
    (Response 6) As required for implementation of section 708 of
FDASIA, the final rule provides appropriate due process to the owner or
consignee of a drug that has been refused admission under section
801(a) of the FD&C Act, and that FDA intends to destroy. The new
authority granted to FDA by section 708 of FDASIA to administratively
destroy a drug applies only after the Agency has made the final
decision to refuse admission to the drug. This new authority,
therefore, does not affect a consumer's access to a foreign drug
because consumers have no access to a refused drug under the FD&C Act.
The final rule does not modify FDA's current policy with respect to
personal importation of drugs.
    (Comment 7) One comment suggested that implementation of section
708 of FDASIA could adversely affect the supply of low-value excipients
and other drug components potentially leading to a drug shortage. The
commenter suggested that FDA closely coordinate with manufacturers to
limit the impact on the drug supply chain when the Agency exercises its
authority to destroy low-value excipients or other drug components. The
commenter further suggested that FDA's Drug Shortages Task Force
monitor and publicly report on the effects of section 708 of FDASIA on
the drug supply in the United States.
    (Response 7) Excipients and other components of a drug are defined
as drugs under section 201(g)(1) of the FD&C Act. An excipient or other
drug component is therefore subject to administrative destruction under
section 708 of FDASIA if that excipient or drug component offered for
import is valued at $2,500 or less (or such higher amount as the
Secretary of the Treasury may set by regulation) and is refused
admission. FDA does not expect that administrative destruction of
refused excipients or other drug components will lead to shortages of
medically necessary drugs. The majority of excipients and drug
components are imported into the United States as commercial entries.
Currently, where excipients or drug components are refused admission,
they are exported or destroyed. Refused excipients or other drug
components, therefore, are not currently available for drug
manufacturing in the United States. The Agency's exercise of
administrative destruction will not affect a manufacturer's access to
these refused excipients or other drug components and, therefore, will
not contribute to shortages of drugs manufactured in the United States.
    (Comment 8) One comment asserted that FDA only quantified the
benefits but not the costs of the proposed rule which, according to the
comment, should include the societal costs attributable to a patient's
lack of access to an imported drug that does not pose a public health
risk, and that patient's non-adherence to a medical plan that includes
such drug.
    (Response 8) In the proposed rule, FDA estimated both the costs and
the benefits of the implementation of section 708 of FDASIA and the
result was a quantifiable net annual social benefit. The detailed
analysis of the estimated economic impact as provided in Ref. 10 in the
proposed rule can be found at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm#.
    The preliminary Regulatory Impact Analysis did not include any
costs attributable to lack of access to an imported drug by a patient
as this is not a cost attributable to administrative destruction.
Currently, drugs that are

refused admission are destroyed or exported by the importer or, in the
case of international mail, returned to the USPS for export.
Consequently, patients do not have access to those drugs. Only refused
drugs are subject to administrative destruction under section 708 of
FDASIA and, therefore, implementation of this authority does not result
in a quantifiable cost to be included in the regulatory impact analysis
of the implementation of section 708.
    (Comment 9) A number of comments requested that FDA flag shipments
in Customs and Border Protection's Automated Commercial System (ACS) or
the Automated Commercial Environment (ACE) system, which is expected to
replace ACS by December 2016, when a drug is destroyed. Another comment
suggested that FDA establish a public database listing drugs destroyed
by FDA under the authority of section 708 of FDASIA.
    (Response 9) These comments relate to the Agency's operations
implementing the final rule and, as FDA stated in the proposed rule,
the Agency plans to specify the operational details of its process for
destruction by guidance, operating guidelines, or similar means.

IV. Analysis of Impacts (Summary of the Final Regulatory Impact
Analysis)

    FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this final rule is not a significant
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because of the small number of expected destructions
each year and the very small value per event, the Agency certifies that
this final rule will not have a significant economic impact on a
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before finalizing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $141 million, using the most current (2013) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
    The primary public health benefit from adoption of the rule will be
the value of the illnesses or deaths avoided because the Agency
destroyed a refused drug valued at $2,500 or less (or such higher
amount as the Secretary of the Treasury may set by regulation) that
posed a public health risk. Additionally, the final rule may benefit
firms through increases in sales, brand value, and investment in
research and development if the destroyed drug is a counterfeit or an
otherwise falsified version of an approved drug. The threat of
destruction may also have a deterrent effect resulting in a reduction
in the amount of violative drugs shipped into the United States in the
future. These benefits accrue whenever the Agency's other enforcement
tools would not have prevented a violative drug from entering the U.S.
market. The current procedure whereby a drug refused admission might be
exported does not ensure that the drug would not be imported into the
United States in the future. These benefits are not quantified.
    The estimated primary costs to FDA include the additional costs
incurred by FDA to destroy a refused drug as opposed to the costs
related to exportation of the drug and the one-time costs of updating
OASIS, revising Chapter 9 of the RPM and other internal import
operations guidelines, and training for FDA personnel. Our estimates of
the primary costs assume that all refused drugs valued at $2,500 or
less (or such higher amount as the Secretary of the Treasury may set by
regulation) would be destroyed (estimated 15,100 destructions performed
each year), that FDA would contract the act of destruction out to
another government agency or private firm, and the notice and hearing
process for destruction will be combined with the current FDA notice
and hearing process for refusal of drugs. The assumption that FDA will
destroy all refused drugs represents an upper bound and may not always
hold. If FDA chooses to destroy less than all of the refused drugs, all
annual costs will decrease but the one-time costs will stay the same.
    Based on an assumed 15,100 administrative destructions performed
each year, the Agency estimates the quantifiable net annual effect of
the final rule to be between a cost of $54,325 and a cost savings of
$901,950, in addition to one-time costs of $531,670. Annualized over 20
years, the final rule is estimated to produce a net effect ranging from
a cost of $89,021 to a cost savings of $867,254 at a 3 percent discount
rate and a cost of $101,228 to a cost savings of $855,047 at a 7
percent discount rate. The present discounted value of the quantifiable
net effect over 20 years ranges from a cost of $1,324,403 to a cost
savings of $12,902,554 at a 3 percent discount rate and a cost of
$1,072,408 to a cost savings of $9,058,383 at a 7 percent discount
rate.
    Our estimates do not include net benefits of the final rule because
we have not quantified the potential health benefits of reducing the
probability that a refused drug will be imported into the United States
in the future. However, because the final rule likely represents a cost
savings and the health benefits, though not quantified, will be
positive even if one violative drug that would have caused an adverse
event is destroyed rather than entering the U.S. market, the net
benefits of the rule are likely positive.
    FDA has examined the economic implications of the final rule as
required by the Regulatory Flexibility Act. If a rule will have a
significant economic impact on a substantial number of small entities,
the Regulatory Flexibility Act requires Agencies to analyze regulatory
options that would lessen the economic effect of the rule on small
entities. U.S. Federal Government Agencies will bear the costs of the
final rule with FDA bearing most of the cost as the Agency is
responsible under section 708 of FDASIA for implementation of the rule
and for the costs of storage and destruction. Therefore we certify that
this final rule will not have a significant economic impact on a
substantial number of small entities. This analysis, together with
other relevant sections of this document, serves as the Final
Regulatory Flexibility Analysis, as required under the Regulatory
Flexibility Act.
    The full discussion of economic impacts, which includes a list of
changes made in the final regulatory impact analysis, is available in
Docket No. FDA-2014-N-0504 and at http://www.fda.gov/AboutFDA/
ReportsManualsForms/Reports/

EconomicAnalyses/default.htm# (Ref. 1).

V. Paperwork Reduction Act of 1995

    This final rule contains no collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3518(c)(1)(B)(ii)).
Therefore, clearance by the Office of Management and Budget is not
required under the Paperwork Reduction Act of 1995.

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that 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. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

VII. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VIII. Reference

    The following reference has been placed on display in the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and is available electronically at http://www.regulations.gov. (FDA has
verified the Web site address in this Reference section, but FDA is not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.)

    1. Final Regulatory Impact Analysis, Final Regulatory
Flexibility Analysis, and Final Unfunded Mandates Reform Act
Analysis for Administrative Destruction of Certain Drugs Refused
Admission to the United States, available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm#.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 1 is amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 continues to read as
follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c,
350d, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374,
381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.

0
2. Revise Sec.  1.94 to read as follows:

Sec.  1.94  Hearing on refusal of admission or destruction.

    (a) If it appears that the article may be subject to refusal of
admission, or that the article is a drug that may be subject to
destruction under section 801(a) of the Federal Food, Drug, and
Cosmetic Act, the district director shall give the owner or consignee a
written notice to that effect, stating the reasons therefor. The notice
shall specify a place and a period of time during which the owner or
consignee shall have an opportunity to introduce testimony. Upon timely
request giving reasonable grounds therefor, such time and place may be
changed. Such testimony shall be confined to matters relevant to the
admissibility or destruction of the article, and may be introduced
orally or in writing.
    (b) If such owner or consignee submits or indicates his or her
intention to submit an application for authorization to relabel or
perform other action to bring the article into compliance with the
Federal Food, Drug, and Cosmetic Act or to render it other than a food,
drug, device, or cosmetic, such testimony shall include evidence in
support of such application. If such application is not submitted at or
prior to the hearing on refusal of admission, the district director
shall specify a time limit, reasonable in the light of the
circumstances, for filing such application.
    (c) If the article is a drug that may be subject to destruction
under section 801(a) of the Federal Food, Drug, and Cosmetic Act, the
district director may give the owner or consignee a single written
notice that provides the notice on refusal of admission and the notice
on destruction of an article described in paragraph (a) of this
section. The district director may also combine the hearing on refusal
of admission with the hearing on destruction of the article described
in paragraph (a) of this section into a single proceeding.

    Dated: September 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23124 Filed 9-14-15; 8:45 am]
 BILLING CODE 4164-01-P


ECOLOGICAL MID-CYCLE SUBCOMMITTEE

FACE-TO-FACE MEETING

DRAFT AGENDA

September 18, 2007

Key Bridge Marriott

1401 Lee Highway

Arlington, VA 22209

Tel:<PHONE_NUMBER>

Tuesday, September 18, 2007

9:30 – 10:00 a.m.	Registration

10:00-10:10 a.m.	Welcome and Outline of Purpose	Dr. Deborah Swackhamer

			Chair, EDC Mid-Cycle Subcommittee

10:10-10:15 a.m.	DFO Welcome and Charge	Heather Drumm (EPA)

	   	- Administrative Procedures/FACA	DFO, EDC Mid-Cycle Subcommittee

		Rules

10:15-11:00 a.m.	Overall Summary of Progress	Dr. Elaine Francis (EPA) & Research	Planning Committee

				- Discussion and Q&A	EDC Mid-Cycle Subcommittee

	11:00 -12:00 p.m.	Subcommittee Discussion 	EDC Mid-Cycle Subcommittee

	12:00-1:00 p.m.		Lunch

	1:00-2:00 p.m.		Program Rating Discussion	EDC Mid-Cycle Subcommittee

	2:00-2:10 p.m.		Public Comment

	2:10-3:00 p.m.		Wrap-up and Report Out	EDC Mid-Cycle Subcommittee

	3:00 p.m.		Adjourn

 PAGE   1

 PAGE   2

            A Federal Advisory Committee for the U.S. Environmental Protection Agency’s Office of Research and Development


[Federal Register: February 18, 2009 (Volume 74, Number 31)]
[Proposed Rules]
[Page 7563-7565]
[DOCID:fr18fe09-13]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-1165; Directorate Identifier 2008-NE-38-AD]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc RB211 Trent 800 Series
Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) issued by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    During manufacture of high-pressure (HP) compressor stage 1
discs, a small number of parts have been rejected due to a machining
defect that was found during inspection. Analysis of the possibility
of less severe examples having been undetected and passed into
service has concluded that action is required to reduce the risk of
failure. It is therefore necessary to reduce the life limit from
that currently published for the applicable parts.

    The HP compressor stage 1 disc is part of the HP compressor stage
1-4 shaft, part number (P/N) FK32580. We are proposing this AD to
prevent uncontained failure of the HP compressor stage 1 disc,
resulting in an in-flight engine shutdown and possible damage to the
airplane.

DATES: We must receive comments on this proposed AD by March 20, 2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
the same as the Mail address provided in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: James Lawrence, Aerospace Engineer,
Engine Certification Office, FAA, Engine

& Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; e-mail<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax
(781) 238-7199.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-1165;
Directorate Identifier 2008-NE-38-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2008-0099, dated May 21, 2008 (corrected June
12, 2008) (referred to after this as ``the MCAI''), to correct an
unsafe condition for the specified products. The MCAI states:

    During manufacture of HP compressor stage 1 discs, a small
number of parts have been rejected due to a machining defect that
was found during inspection. Analysis of the possibility of less
severe examples having been undetected and passed into service has
concluded that action is required to reduce the risk of failure. It
is therefore necessary to reduce the life limit from that currently
published for the applicable parts.

    You may obtain further information by examining the MCAI in the AD
docket. This proposed AD would require removing HP compressor stage 1-4
shafts, P/N FK32580, from service at reduced life limits based on part
assessment using either ``Multiple Flight Profile Monitoring'', or
``Heavy Flight Profile'' calculations.

Relevant Service Information

    Rolls-Royce plc has issued Alert Service Bulletin RB.211-72-AF825,
Revision 1, dated September 8, 2008. The actions described in this
service information are intended to correct the unsafe condition
identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of the
United Kingdom, and is approved for operation in the United States.
Pursuant to our bilateral agreement with the United Kingdom, they have
notified us of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all information provided by EASA and determined the unsafe
condition exists and is likely to exist or develop on other products of
the same type design. This proposed AD requires removing HP compressor
stage 1-4 shafts, P/N FK32580, from service at reduced life limits
based on part assessment using either ``Multiple Flight Profile
Monitoring'', or ``Heavy Flight Profile'' calculations.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 78 products of U.S. registry. Required parts would
cost about $15,095 per product. We estimate that no additional labor
costs would be incurred to perform the proposed actions. We anticipate
that the removal from service of the HP compressor stage 1-4 shafts
will occur while the engine is inducted into the shop for routine
maintenance. Based on these figures, we estimate the cost of the
proposed AD on U.S. operators to be $1,177,410. Our cost estimate is
exclusive of possible warranty coverage.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Rolls-Royce plc: Docket No. FAA-2008-1165; Directorate Identifier
2008-NE-38-AD.

Comments Due Date

    (a) We must receive comments by March 20, 2009.

Affected Airworthiness Directives (ADs)

    (b) None.

Applicability

    (c) This airworthiness directive (AD) applies to Rolls-Royce plc
(RR) models

RB211 Trent 875-17, Trent 877-17, Trent 884-17, Trent 884B-17, Trent
892-17, Trent 892B-17, and Trent 895-17 turbofan engines, with high-
pressure (HP) compressor stage 1-4 shafts, part number (P/N)
FK32580, installed. These engines are installed on, but not limited
to, Boeing 777 series airplanes.

Reason

    (d) European Aviation Safety Agency (EASA) AD 2008-0099, dated
May 21, 2008 (corrected June 12, 2008) states the unsafe condition
is as follows:
    During manufacture of high-pressure (HP) compressor stage 1
discs, a small number of parts have been rejected due to a machining
defect that was found during inspection. Analysis of the possibility
of less severe examples having been undetected and passed into
service has concluded that action is required to reduce the risk of
failure. It is therefore necessary to reduce the life limit from
that currently published for the applicable parts.

The HP compressor stage 1 disc is part of the HP compressor stage 1-
4 shaft, P/N FK32580. We are issuing this AD to prevent uncontained
failure of the HP compressor stage 1 disc, resulting in an in-flight
engine shutdown and possible damage to the airplane.

Actions and Compliance

    (e) Unless already done, do the following actions.
    (1) RB211 Trent 800 critical part lives may be monitored by one
of two methods: ``Multiple Flight Profile Monitoring'', or ``Heavy
Flight Profile''. Information on these profiles can be found in the
RR Engine Manual Airworthiness Limitations Section.
    (2) Standard Duty Cycles (SDC) is the product of Flight Cycles
and Beta Factor. Information on Flight Cycles and Beta Factor can be
found in the RR Engine Manual Airworthiness Limitations Section.

Multiple Flight Profile Monitoring Parts

    (3) For RB211 Trent 800 engines being monitored by ``Multiple
Flight Profile Monitoring,'' do the following:
    (i) On the effective date of this AD, if the life of HP
compressor stage 1-4 shaft, P/N FK32580, is equal to or over 5,580
SDC, then the part must be withdrawn from service before exceeding
7,780 SDC.
    (ii) On the effective date of this AD, if the life of HP
compressor stage 1-4 shaft, P/N FK32580, is between 3,380 and 5,580
SDC, then the part must be withdrawn from service before exceeding
an additional 2,200 SDC.
    (iii) On the effective date of this AD, if the life of HP
compressor stage 1-4 shaft, P/N FK32580, is equal to or below 3,380
SDC, then the part must be withdrawn from service before exceeding
5,580 SDC.

Reassessment of the Revised Life Limit

    (4) Operators should be aware that reassessment of the revised
life limit in accordance with this AD (including possible
reassessment per the applicable subparagraph (e)(3)(i), (e)(3)(ii),
or (e)(3)(iii) of this AD, will be necessary if, at some time in the
future, the operator changes the flight profile that was applicable
before the Effective Date of this AD, such that parts which are the
subject of this AD are affected. To recalculate the revised life
limit, the life of the part in SDC at the Effective Date of this AD,
must be recalculated from the part's entry into service (zero life),
and must use the Beta Factor(s) for the new Flight Profile(s).

Heavy Flight Profile Parts

    (5) For RB211 Trent 800 engines being monitored by ``Heavy
Flight Profile,'' do the following:
    (i) On the effective date of this AD, if the life of HP
compressor stage 1-4 shaft, P/N FK32580, is equal to or over 5,280
flight cycles, then the part must be withdrawn from service before
exceeding 7,480 flight cycles.
    (ii) On the effective date of this AD, if the life of HP
compressor stage 1-4 shaft, P/N FK32580, is between 3,080 flight
cycles and 5,280 flight cycles, then the part must be withdrawn from
service before exceeding an additional 2,200 flight cycles.
    (iii) On the effective date of this AD, if the life of HP
compressor stage 1-4 shaft, P/N FK32580, is equal to or below 3,080
flight cycles, then the part must be withdrawn from service before
exceeding 5,280 flight cycles.

Alternative Methods of Compliance (AMOCs)

    (f) The Manager, Engine Certification Office, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19.

Related Information

    (g) Refer to EASA Airworthiness Directive 2008-0099, dated May
21, 2008 (corrected June 12, 2008), and Rolls-Royce plc Alert
Service Bulletin No. RB.211-72-AF825, Revision 1, dated September 8,
2008, for related information. Contact Rolls-Royce plc, PO Box 31,
Derby, England, DE248BJ; telephone: 011-44-1332-242424; fax: 011-44-
1332-245418, for a copy of this service information.
    (h) Contact James Lawrence, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax (781) 238-
7199, for more information about this AD.

    Issued in Burlington, Massachusetts, on February 10, 2009.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E9-3358 Filed 2-17-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 169 (Friday, August 30, 2013)]
[Notices]
[Pages 53752-53753]
[FR Doc No: 2013-21206]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[ Docket No. DI13-7-000]

City of Sandpoint, Idaho; Notice of Preliminary Determination of
a Qualifying Conduit Hydropower Facility and Soliciting Comments and
Motions To Intervene

    On August 15, 2013, City of Sandpoint, Idaho filed a notice of
intent to construct a qualifying conduit hydropower facility, pursuant
to section 30 of the Federal Power Act, as amended by section 4 of the
Hydropower Regulatory Efficiency Act of 2013 (HREA). The Little Sand
Creek Hydroelectric Project would be located on the Little Sand Creek
Treatment Plant's water supply pipeline that runs along Little Sand
Creek, in Bonner County, Idaho.
    Applicant Contact: Jared Yost, City of Sandpoint, 1123 Lake Street,
Sandpoint, ID 83864, Phone No.<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    FERC Contact: Robert Bell, Phone No.<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    Qualifying Conduit Hydropower Facility Description: The proposed
project would consist of: (1) an intake pipeline; (2) a proposed
powerhouse, containing one 65-kilowatt generating unit located on the
18-inch diameter water supply pipeline, (3) a 200-foot-long 18-inch
diameter discharge pipeline leading to the water treatment plant; (4) a
150-foot-long 18-inch diameter discharge pipe leading to Little Sand
Creek, which is to bypass treatment plant when it not operating; and
(5) appurtenant facilities. The proposed project would have an
estimated annual generating capacity between 382.2 and 569.4 megawatt-
hours.
    A qualifying conduit hydropower facility is one that is determined
or deemed to meet all of the criteria shown in the table below.

                          Table 1--Criteria for Qualifying Conduit Hydropower Facility
----------------------------------------------------------------------------------------------------------------
                                                                                Satisfies
         Statutory provision                                   Description                              (Y/N)
----------------------------------------------------------------------------------------------------------------
FPA 30(a)(3)(A), as amended by HREA..  The conduit the facility uses is a tunnel, canal, pipeline,            Y
                                        aqueduct, flume, ditch, or similar manmade water
                                        conveyance that is operated for the distribution of water
                                        for agricultural, municipal, or industrial consumption and
                                        not primarily for the generation of electricity.
FPA 30(a)(3)(C)(i), as amended by      The facility is constructed, operated, or maintained for               Y
 HREA.                                  the generation of electric power and uses for such
                                        generation only the hydroelectric potential of a non-
                                        federally owned conduit.
FPA 30(a)(3)(C)(ii), as amended by     The facility has an installed capacity that does not exceed            Y
 HREA.                                  5 megawatts.
FPA 30(a)(3)(C)(iii), as amended by    On or before August 9, 2013, the facility is not licensed,             Y
 HREA.                                  or exempted from the licensing requirements of Part I of
                                        the FPA.
----------------------------------------------------------------------------------------------------------------

    Preliminary Determination: Based upon the above criteria,
Commission staff preliminarily determines that the proposal satisfies
the requirements for a qualifying conduit hydropower facility not
required to be licensed or exempted from licensing.
    Comments and Motions To Intervene: Deadline for filing comments
contesting whether the facility meets the qualifying criteria is 45
days from the issuance date of this notice.
    Deadline for filing motions to intervene is 30 days from the
issuance date of this notice.
    Anyone may submit comments or a motion to intervene in accordance
with the requirements of Rules of Practice and Procedure, 18 CFR
385.210 and 385.214. Any motions to intervene must be received on or
before the specified deadline date for the particular proceeding.
    Filing and Service of Responsive Documents: All filings must (1)
bear in all capital letters the ``COMMENTS CONTESTING QUALIFICATION FOR
A CONDUIT HYDROPOWER FACILITY'' or ``MOTION TO INTERVENE,'' as
applicable; (2) state in the heading the name of the applicant and the
project number of the application to which the filing responds; (3)
state the name, address, and telephone number of the person filing; and
(4) otherwise comply with the requirements of sections 385.2001 through
385.2005 of the Commission's regulations.\1\ All

comments contesting Commission staff's preliminary determination that
the facility meets the qualifying criteria must set forth their
evidentiary basis.
---------------------------------------------------------------------------

    \1\ 18 CFR 385.2001-2005 (2013).
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filing. Please file
motions to intervene and comments using the Commission's eFiling system
at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit
brief comments up to 6,000 characters, without prior registration,
using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the
end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. A copy of all other filings in
reference to this application must be accompanied by proof of service
on all persons listed in the service list prepared by the Commission in
this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    Locations of Notice of Intent: Copies of the notice of intent can
be obtained directly from the applicant or such copies can be viewed
and reproduced at the Commission in its Public Reference Room, Room 2A,
888 First Street NE., Washington, DC 20426. The filing may also be
viewed on the web at http://www.ferc.gov/docs-filing/elibrary.asp using
the ``eLibrary'' link. Enter the docket number (e.g., DI13-7-000) in
the docket number field to access the document. For assistance, call
toll-free 1-866-208-3676 or email<EMAIL_ADDRESS>For TTY,
call<PHONE_NUMBER>.

    Dated: August 22, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-21206 Filed 8-29-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 74 (Friday, April 17, 2015)]
[Rules and Regulations]
[Pages 21176-21181]
[FR Doc No: 2015-08883]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2014-0861; FRL-9925-81-Region 9]

Approval and Promulgation of Air Quality Implementation Plans;
Arizona; Regional Haze Federal Implementation Plan; Reconsideration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to revise certain provisions in the Arizona Regional Haze (RH)
Federal Implementation Plan (FIP) that apply to the Nelson Lime Plant.
In response to a request for reconsideration from the plant's owner,
Lhoist North America of Arizona, Inc. (LNA), we are replacing the
control technology demonstration requirements for emissions of nitrogen
oxides (NOX) applicable to Kilns 1 and 2 at the Nelson Lime
Plant with revised recordkeeping and reporting requirements. We are not
revising any of the emission limits that apply to these units,
including the existing NOX emission limits, which can be met
with selective non-catalytic reduction (SNCR) control technology. We
also are taking final action to correct a misprint of the regulatory
requirements in a table in the Arizona RH FIP that identifies the
emission limits for NOX and sulfur dioxide (SO2)
at each kiln.

DATES: Effective date: This rule is effective May 18, 2015.

ADDRESSES: EPA has established docket number EPA-R09-OAR-2014-0861 for
this action. Generally, documents in the docket are available
electronically at http://www.regulations.gov or in hard copy at EPA
Region 9, 75 Hawthorne Street, San Francisco, California. Please note
that while many of the documents in the docket are listed at http://www.regulations.gov, some information may not be specifically listed in
the index to the docket and may be publicly available only at the hard
copy location (e.g., copyrighted material, large maps, multi-volume
reports, or otherwise voluminous materials), and some may not be
available at either locations (e.g., confidential business
information). To inspect the hard copy materials, please schedule an
appointment during normal business hours with the contact listed
directly below.

FOR FURTHER INFORMATION CONTACT: Thomas Webb, U.S. EPA, Region 9,
Planning Office, Air Division, Air-2, 75 Hawthorne Street, San
Francisco, CA 94105. Thomas Webb can be reached at telephone number
(415) 947-4139 and via electronic mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Definitions

    For the purpose of this document, ``we,'' ``us,'' and ``our'' refer
to EPA. We also are giving meaning to certain words or initials as
follows:
     The words or initials Act or CAA mean or refer to the
Clean Air Act, unless the context indicates otherwise.
     The initials ADEM mean or refer to the Alabama Department
of Environmental Management.
     The initials ADEQ mean or refer to the Arizona Department
of Environmental Quality.
     The words Arizona and State mean the State of Arizona.
     The initials BACT mean or refer to Best Available Control
Technology.
     The initials BART mean or refer to Best Available Retrofit
Technology.
     The initials CAA mean or refer to the Clean Air Act.
     The term Class I area refers to a mandatory Class I
Federal area.\1\
---------------------------------------------------------------------------

    \1\ Although states and tribes may designate as Class I
additional areas that they consider to have visibility as an
important value, the requirements of the visibility program set
forth in section 169A of the CAA apply only to ``mandatory Class I
Federal areas.''
---------------------------------------------------------------------------

     The initials CBI mean or refer to Confidential Business
Information.
     The initials CEMS mean or refer to continuous emission
monitoring system or systems.
     The words EPA, we, us or our mean or refer to the United
States Environmental Protection Agency.
     The initials FIP mean or refer to Federal Implementation
Plan.
     The initials LNA mean or refer to Lhoist North America of
Arizona, Inc.
     The initials MMBtu mean or refer to million British
thermal units.
     The initials NOX mean or refer to nitrogen oxides.
     The initials RH mean or refer to regional haze.
     The initials RHR mean or refer to EPA's Regional Haze
Rule.
     The initials SIP mean or refer to State Implementation
Plan.
     The initials SNCR mean or refer to selective non-catalytic
reduction.
     The initials SO2 mean or refer to sulfur dioxide.

Table of Contents

I. Summary of Proposed Action
II. Background on Petition for Reconsideration and Stay
III. Public Comments
IV. Final Action
V. Statutory and Executive Order Reviews

I. Summary of Proposed Action

    EPA proposed on January 13, 2015, to revise certain Best Available
Retrofit Technology (BART) requirements in the FIP related to reducing
NOX emissions from Kilns 1 and 2 at the Nelson Lime
Plant.\2\ As described in the proposal, the revision consists of
several components, including the removal of the control technology
demonstration requirements, the addition of revised recordkeeping and
reporting requirements, and the correction of an error in a table.\3\
We proposed to find that these changes are reasonable and appropriate
based on information from LNA regarding the effectiveness of using SNCR
to control NOX emissions at another lime plant. The proposed
rule addressing the Nelson Lime Plant did not change the emission
limits, compliance deadlines, or the compliance determination methods
established in the final rule for the Arizona RH FIP.
---------------------------------------------------------------------------

    \2\ 80 FR 1608. The notice of proposed rulemaking contains
background information concerning the visibility requirements of the
CAA, the RHR, and the Arizona RH FIP.
    \3\ Id.
---------------------------------------------------------------------------

II. Background on Petition for Reconsideration and Stay

    LNA submitted a petition to EPA on October 31, 2014, seeking
administrative reconsideration and a partial stay of the final rule
under CAA section 307(d)(7)(B).\4\ Specifically, LNA requested that EPA
eliminate the control technology demonstration requirements (also known
as ``optimization requirements'') for the Nelson Lime Plant. In support
of its petition, LNA provided additional data regarding the performance
of SNCR control technology at lime kilns located at another LNA
facility, the O'Neal Lime Plant in Calera, Alabama. In the petition,
LNA also requested a stay of the provisions in the FIP applicable to
the Nelson Lime Plant if EPA did not propose action on its petition
prior to December 31, 2014.\5\ EPA sent a letter to LNA on November 20,
2014, granting reconsideration of the optimization requirements
pursuant to CAA section 307(d)(7)(B).\6\
---------------------------------------------------------------------------

    \4\ Letter from Eric Hiser, Jorden Bischoff & Hiser, to Regina
McCarthy, EPA (October 31, 2014).
    \5\ Because the proposal was signed prior to December 31, 2014,
we consider LNA's request for a stay to be moot.
    \6\ Letter from Jared Blumenfeld, EPA, to Eric Hiser, Jorden
Bischoff & Hiser (November 20, 2014).
---------------------------------------------------------------------------

III. Public Comments

    In the proposed rule, EPA provided 45 days for the public to submit
comments on the proposed revision to the Arizona RH FIP. During the
public comment period, we received one set of comments from the
Mississippi Lime Company (``Mississippi Lime'').\7\ The comments from
Mississippi Lime focused on the requirement for LNA to install SNCR
controls at the Nelson Lime Plant. The comments and our responses are
summarized below.
---------------------------------------------------------------------------

    \7\ Letter from Kimberly S. L. Bauman, Mississippi Lime Company,
to Thomas Webb, EPA (February 27, 2015).
---------------------------------------------------------------------------

    Comment: Mississippi Lime stated that SNCR technology has not been
identified as Best Available Control Technology (BACT) for lime kilns
in EPA's control technology clearinghouse or as an applied emission
control in publicly available documents for LNA's O'Neal facility. The
commenter further noted that there is no discussion of SNCR at the
O'Neal facility in publicly available documents such as operating
permits, quarterly excess emission reports, or emission inventory
reports issued by or submitted to the Alabama Department of
Environmental Management.
    Response: EPA does not dispute Mississippi Lime's assertion that
publicly available information on SNCR technology for lime kilns may be
limited. However, any such lack of information is irrelevant to this
action. In particular, in a final rule published on September 3, 2014,
EPA determined that SNCR is technically feasible and constitutes BART
for Kilns 1 and 2 at Nelson Lime Plant.\8\ We have not proposed to
reconsider or otherwise revise those determinations.
---------------------------------------------------------------------------

    \8\ See 79 FR 9318, 9337-9339 for proposed BART analysis and
determination (February 18, 2014); 79 FR 52420, 52424 for final BART
determination (September 3, 2014).
---------------------------------------------------------------------------

    Comment: Mississippi Lime contended that LNA, according to public
documents provided to Illinois EPA, has stated that its O'Neal facility
in Calera, Alabama, is controlling lime kiln emissions to meet emission
limits under a permit that relies on a proprietary SNCR technology that
was patented by its predecessor, Chemical Lime Company.
    Response: EPA does not dispute that the SNCR technology in use at
the O'Neal facility may be proprietary. EPA relied on an analysis of
the effectiveness of the SNCR technology to control emissions at the
O'Neal facility to confirm that the emission limit we established for
the Nelson Lime Plant is reasonable and appropriate. Based on the
results of our analysis described in our proposal, we proposed and are
now taking final action to replace a series of prescriptive control
technology demonstration requirements with new recordkeeping and
reporting requirements for LNA. The fact that the SNCR technology in
use at the O'Neal

facility may be proprietary has no bearing on the purpose or substance
of our analysis.
    Comment: Mississippi Lime asserted that SNCR technology on lime
kilns is an unproven control strategy. Thus, the commenter had
significant concerns that this technology and the corresponding FIP
will be used inappropriately for the establishment of future BACT or
BART determinations.
    Response: As noted above, EPA has already determined that SNCR is a
feasible control technology for Kilns 1 and 2 at the Nelson Lime Plant
and has set emission limits that correspond to the use of SNCR in our
final rule on the Arizona RH FIP.\9\ Because our proposal and this
final action address only the optimization requirements, and are not
related to previous determinations in the FIP, this comment on our
proposal is not relevant.
---------------------------------------------------------------------------

    \9\ Id.
---------------------------------------------------------------------------

    Comment: Mississippi Lime is concerned that if LNA's proposed SNCR
system for the Nelson Lime Plant uses LNA's proprietary and patented
technology, competitors like Mississippi Lime may also be required to
use the patented technology in the future. The commenter alleged that
LNA could interfere with a competitor's obligation to use SNCR by
refusing to license its technology or by requiring exorbitant licensing
fees. This would enable LNA to use its patent to gain a competitive
advantage over the entire lime industry in the United States.
    Response: While not the subject of this final rule, the Arizona RH
FIP only requires LNA to meet a specified emission limit. LNA may use
whatever technology it wants to achieve the required limit, including
proprietary technology. If LNA were to refuse to license its
proprietary technology or to charge exorbitant fees at some point in
the future, then Mississippi Lime could argue in any future regulatory
actions that the technology is not available or is not cost-effective.

IV. Final Action

    We are taking final action to revise parts of the Arizona RH FIP
that apply to the Nelson Lime Plant. In particular, we are removing the
control technology demonstration requirements included in the FIP for
Nelson Lime Plant and replacing those with less prescriptive
recordkeeping and reporting requirements. For the revised recordkeeping
and reporting requirements, LNA must submit a summary of the SNCR
design and of the SNCR process improvement activities. In addition, we
are correcting a misprint in the Federal Register in a table that lists
NOX and SO2 emission limits for the kilns at the
Nelson Lime Plant. The table appears with the correct labels in the
regulatory text that follows this final rule. This rule constitutes
EPA's final action on LNA's petition for reconsideration of the Arizona
RH FIP.
    EPA also is making a final determination that the revisions in this
final rule do not interfere with any applicable requirements of the
CAA. CAA section 110(l) requires that any revision to an implementation
plan shall not be approved by the Administrator if the revision would
interfere with any applicable requirement concerning attainment and
reasonable further progress or any other applicable requirement of the
CAA. These final revisions do not alter the amount or timing of the
emission reductions from the Nelson Lime Plant.

V. Statutory and Executive Order Reviews

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. This rule applies to only one facility and is therefore not
a rule of general applicability.

 B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
This rule applies to only one facility. Therefore, its recordkeeping
and reporting provisions do not constitute a ``collection of
information'' as defined under 44 U.S.C. 3502(3) and 5 CFR 1320.3(c).

C. Regulatory Flexibility Act (RFA)

    I certify that this proposed action will not have a significant
economic impact on a substantial number of small entities. This action
will not impose any requirements on small entities. Pursuant to 13 CFR
121.201, footnote 1, a firm is small if it is in NAICS 327410 (lime
manufacturing) and the concern and its affiliates have no more than 500
employees. LNA is affiliated with the LNA Group, which has more than
5,500 employees.\10\ Therefore, LNA is not a small business.

 D. 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.

E. 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.

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

    This action does not have tribal implications, as specified in
Executive Order 13175. It will not have substantial direct effects on
any Indian tribes, on the relationship between the Federal Government
and Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes. Thus, Executive Order
13175 does not apply to this action.

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

    EPA interprets EO 13045 as applying only to those regulatory
actions that concern health or safety risks that 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.

H. 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.

I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards. EPA is not
revising any technical standards or imposing any new technical
standards in this action.

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

    EPA believes the human health or environmental risk addressed by
this action will not have potential disproportionately high and adverse
human health or environmental effects

on minority, low-income or indigenous populations. These final
revisions do not alter the amount or timing of the emission reductions
from the Nelson Lime Plant.

K. Congressional Review Act (CRA)

    This rule is exempt from the CRA because it is a rule of particular
applicability.

L. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by June 16, 2015. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule 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 CAA section 307(b)(2). In addition,
pursuant to CAA section 307(d)(1)(B), this action is subject to the
requirements of CAA section 307(d).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen oxides, Particulate matter, Reporting and
recordkeeping requirements, Sulfur dioxide, Visibility.

    Dated: April 10, 2015.
Gina McCarthy,
Administrator.
    Part 52, chapter I, title 40 of the Code of Federal Regulations 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 D--Arizona

0
2. Amend Sec.  52.145 by:
0
a. Revising paragraph (i); and
0
b. Removing Appendix B to Sec.  52.145--Lime Kiln Control Technology
Demonstration Requirements.
    The revision reads as follows:

Sec.  52.145  Visibility protection.

* * * * *
    (i) Source-specific federal implementation plan for regional haze
at Nelson Lime Plant-- (1) Applicability. This paragraph (i) applies to
the owner/operator of the lime kilns designated as Kiln 1 and Kiln 2 at
the Nelson Lime Plant located in Yavapai County, Arizona.
    (2) Definitions. Terms not defined in this paragraph (i)(2) shall
have the meaning given them in the Clean Air Act or EPA's regulations
implementing the Clean Air Act. For purposes of this paragraph (i):
    Ammonia injection shall include any of the following: Anhydrous
ammonia, aqueous ammonia, or urea injection.
    Continuous emission monitoring system or CEMS means the equipment
required by this section to sample, analyze, measure, and provide, by
means of readings recorded at least once every 15 minutes (using an
automated data acquisition and handling system (DAHS)), a permanent
record of NOX emissions, SO2 emissions, diluent,
and stack gas volumetric flow rate.
    Kiln means either of the kilns identified in paragraph (i)(1) of
this section.
    Kiln 1 means lime kiln 1, as identified in paragraph (i)(1) of this
section.
    Kiln 2 means lime kiln 2, as identified in paragraph (i)(1) of this
section.
    Kiln operating day means a 24-hour period between 12 midnight and
the following midnight during which there is operation of Kiln 1, Kiln
2, or both kilns at any time.
    Kiln operation means any period when any raw materials are fed into
the Kiln or any period when any combustion is occurring or fuel is
being fired in the Kiln.
    Lime product means the product of the lime-kiln calcination
process, including calcitic lime, dolomitic lime, and dead-burned
dolomite.
    NOX means oxides of nitrogen.
    Owner/operator means any person who owns or who operates, controls,
or supervises a kiln identified in paragraph (i)(1) of this section.
    SO2 means sulfur dioxide.
    (3) Emission limitations. (i) The owner/operator of the kilns
identified in paragraph (i)(1) of this section shall not emit or cause
to be emitted pollutants in excess of the following limitations in
pounds of pollutant per ton of lime product (lb/ton), from any kiln.
Each emission limit shall be based on a 12-month rolling basis.

                        Pollutant Emission Limit
------------------------------------------------------------------------
                 Kiln ID                        NOX             SO2
------------------------------------------------------------------------
Kiln 1..................................            3.80            9.32
Kiln 2..................................            2.61            9.73
------------------------------------------------------------------------

    (ii) The owner/operator of the kilns identified in paragraph (i)(1)
of this section shall not emit or cause to be emitted pollutants in
excess of 3.27 tons of NOX per day and 10.10 tons of
SO2 per day, combined from both kilns, based on a rolling
30-kiln-operating-day basis.
    (4) Compliance dates. (i) The owner/operator of each kiln shall
comply with the NOX emission limitations and other
NOX -related requirements of this paragraph (i) no later
than September 4, 2017.
    (ii) The owner/operator of each kiln shall comply with the
SO2 emission limitations and other SO2 -related
requirements of this paragraph (i) no later than March 3, 2016.
    (5) [Reserved]
    (6) Compliance determination--(i) Continuous emission monitoring
system. At all times after the compliance dates specified in paragraph
(i)(4) of this section, the owner/operator of kilns 1 and 2 shall
maintain, calibrate, and operate a CEMS, in full compliance with the
requirements found at 40 CFR 60.13 and 40 CFR part 60, appendices B and
F, to accurately measure diluent, stack gas volumetric flow rate, and
concentration by volume of NOX and SO2 emissions
into the atmosphere from kilns 1 and 2. The CEMS shall be used by the
owner/operator to determine compliance with the emission limitations in
paragraph (i)(3) of this section, in combination with data on actual
lime production. The owner/operator must operate the monitoring system
and collect data at all required intervals at all times that an
affected kiln is operating, except for periods of monitoring system
malfunctions, repairs associated with monitoring system malfunctions,
and required monitoring system quality assurance or quality control
activities (including, as applicable, calibration checks and required
zero and span adjustments).
    (ii) Ammonia consumption monitoring. Upon and after the completion
of installation of ammonia injection on a kiln, the owner or operator
shall install, and thereafter maintain and operate, instrumentation to
continuously monitor and record levels of ammonia consumption for that
kiln.
    (iii) Compliance determination for lb per ton NOX limit. Compliance
with the NOX emission limits described in paragraph
(i)(3)(i) of this section shall be determined based on a rolling 12-
month basis. The 12-month rolling NOX emission rate for each
kiln shall be calculated within 30 days following the end of each
calendar month in accordance with the following procedure: Step one,
sum the hourly pounds of NOX emitted for the month

just completed and the eleven (11) months preceding the month just
completed to calculate the total pounds of NOX emitted over
the most recent twelve (12) month period for that kiln; Step two, sum
the total lime product, in tons, produced during the month just
completed and the eleven (11) months preceding the month just completed
to calculate the total lime product produced over the most recent
twelve (12) month period for that kiln; Step three, divide the total
amount of NOX calculated from Step one by the total lime
product calculated from Step two to calculate the 12-month rolling
NOX emission rate for that kiln. Each 12-month rolling
NOX emission rate shall include all emissions and all lime
product that occur during all periods within the 12-month period,
including emissions from startup, shutdown, and malfunction.
    (iv) Compliance determination for lb per ton SO2 limit. Compliance
with the SO2 emission limits described in paragraph
(i)(3)(i) of this section shall be determined based on a rolling 12-
month basis. The 12-month rolling SO2 emission rate for each
kiln shall be calculated within 30 days following the end of each
calendar month in accordance with the following procedure: Step one,
sum the hourly pounds of SO2 emitted for the month just
completed and the eleven (11) months preceding the month just completed
to calculate the total pounds of SO2 emitted over the most
recent twelve (12) month period for that kiln; Step two, sum the total
lime product, in tons, produced during the month just completed and the
eleven (11) months preceding the month just completed to calculate the
total lime product produced over the most recent twelve (12) month
period for that kiln; Step three, divide the total amount of
SO2 calculated from Step one by the total lime product
calculated from Step two to calculate the 12-month rolling
SO2 emission rate for that kiln. Each 12-month rolling
SO2 emission rate shall include all emissions and all lime
product that occur during all periods within the 12-month period,
including emissions from startup, shutdown, and malfunction.
    (v) Compliance determination for ton per day NOX limit. Compliance
with the NOX emission limit described in paragraph
(i)(3)(ii) of this section shall be determined based on a rolling 30-
kiln-operating-day basis. The rolling 30-kiln operating day
NOX emission rate for the kilns shall be calculated for each
kiln operating day in accordance with the following procedure: Step
one, sum the hourly pounds of NOX emitted from both kilns
for the current kiln operating day and the preceding twenty-nine (29)
kiln-operating-day period for both kilns; Step two, divide the total
pounds of NOX calculated from Step one by two thousand
(2,000) to calculate the total tons of NOX; Step three,
divide the total tons of NOX calculated from Step two by
thirty (30) to calculate the rolling 30-kiln operating day
NOX emission rate for both kilns. Each rolling 30-kiln
operating day NOX emission rate shall include all emissions
that occur from both kilns during all periods within any kiln operating
day, including emissions from startup, shutdown, and malfunction.
    (vi) Compliance determination for ton per day SO2 limit.
Compliance with the SO2 emission limit described in
paragraph (i)(3)(ii) of this section shall be determined based on a
rolling 30-kiln-operating-day basis. The rolling 30-kiln operating day
SO2 emission rate for the kilns shall be calculated for each
kiln operating day in accordance with the following procedure: Step
one, sum the hourly pounds of SO2 emitted from both kilns
for the current kiln operating day and the preceding twenty-nine (29)
kiln operating days, to calculate the total pounds of SO2
emitted over the most recent thirty (30) kiln operating day period for
both kilns; Step two, divide the total pounds of SO2
calculated from Step one by two thousand (2,000) to calculate the total
tons of SO2; Step three, divide the total tons of
SO2 calculated from Step two by thirty (30) to calculate the
rolling 30-kiln operating day SO2 emission rate for both
kilns. Each rolling 30-kiln operating day SO2 emission rate
shall include all emissions that occur from both kilns during all
periods within any kiln operating day, including emissions from
startup, shutdown, and malfunction.
    (7) Recordkeeping. The owner/operator shall maintain the following
records for at least five years:
    (i) All CEMS data, including the date, place, and time of sampling
or measurement; parameters sampled or measured; and results.
    (ii) All records of lime production.
    (iii) Monthly rolling 12-month emission rates of NOX and
SO2, calculated in accordance with paragraphs (i)(6)(iii)
and (iv) of this section.
    (iv) Daily rolling 30-kiln operating day emission rates of
NOX and SO2 calculated in accordance with
paragraphs (i)(6)(v) and (vi) of this section.
    (v) Records of quality assurance and quality control activities for
emissions measuring systems including, but not limited to, any records
specified by 40 CFR part 60, appendix F, Procedure 1, as well as the
following:
    (A) The occurrence and duration of any startup, shutdown, or
malfunction, performance testing, evaluations, calibrations, checks,
adjustments maintenance, duration of any periods during which a CEMS or
COMS is inoperative, and corresponding emission measurements.
    (B) Date, place, and time of measurement or monitoring equipment
maintenance activity;
    (C) Operating conditions at the time of measurement or monitoring
equipment maintenance activity;
    (D) Date, place, name of company or entity that performed the
measurement or monitoring equipment maintenance activity and the
methods used; and
    (E) Results of the measurement or monitoring equipment maintenance.
    (vi) Records of ammonia consumption, as recorded by the
instrumentation required in paragraph (i)(6)(ii) of this section.
    (vii) Records of all major maintenance activities conducted on
emission units, air pollution control equipment, CEMS, and lime
production measurement devices.
    (viii) All other records specified by 40 CFR part 60, appendix F,
Procedure 1.
    (8) Reporting. All reports required under this section shall be
submitted by the owner/operator to the Director, Enforcement Division,
U.S. Environmental Protection Agency, Region 9, electronically via
email to<EMAIL_ADDRESS>Any data that are required under this section
shall be submitted in Excel format. Reports required under paragraphs
(i)(8)(iii) through (v) of this section shall be submitted within 30
days after the applicable compliance date(s) in paragraph (i)(4) of
this section and at least semiannually thereafter, within 30 days after
the end of a semiannual period. The owner/operator may submit reports
more frequently than semiannually for the purposes of synchronizing
reports required under this section with other reporting requirements,
such as the title V monitoring report required by 40 CFR
70.6(a)(3)(iii)(A), but at no point shall the duration of a semiannual
period exceed six months.
    (i) Prior to commencing construction of the ammonia injection
system, the owner/operator shall submit to EPA a summary report of the
design of the SNCR system. Elements of this summary report shall
include: Reagent type, description of the locations selected for
reagent injection, reagent injection rate (expressed as a molar ratio
of reagent to

NOX), equipment list, equipment arrangement, and a summary
of kiln characteristics that were relied upon as the design basis for
the SNCR system.
    (ii) By October 3, 2017, the owner/operator shall submit to EPA a
summary of any process improvement or debugging activities that were
performed on the SNCR system. Elements of this summary report shall
include: a description of each process adjustment performed on the SNCR
system, a discussion of whether the adjustment affected NOX
emission rate (including CEMS data that may have been recorded while
the adjustment was in progress), a description of the range (if
applicable) over which the adjustment was examined, and a discussion of
how the adjustment will be reflected or accounted for in kiln operating
practices. In addition, to the extent that the owner/operator evaluates
the impact of varying reagent injection rate on NOX
emissions, the owner/operator shall include the following information:
the range of reagent injection rates evaluated (expressed as a molar
ratio of reagent to average NOX concentration), reagent
injection rate, average NOX concentration, lime production
rate, kiln flue gas temperature, and the presence of any detached
plumes from the kiln exhaust.
    (iii) The owner/operator shall submit a report that lists the daily
rolling 30-kiln operating day emission rates for NOX and
SO2, calculated in accordance with paragraphs (i)(6)(iii)
and (iv) of this section.
    (iv) The owner/operator shall submit a report that lists the
monthly rolling 12-month emission rates for NOX and
SO2, calculated in accordance with paragraphs (i)(6)(v) and
(vi) of this section.
    (v) The owner/operator shall submit excess emissions reports for
NOX and SO2 limits. Excess emissions means
emissions that exceed any of the emissions limits specified in
paragraph (i)(3) of this section. The reports shall include the
magnitude, date(s), and duration of each period of excess emissions;
specific identification of each period of excess emissions that occurs
during startups, shutdowns, and malfunctions of the kiln; the nature
and cause of any malfunction (if known); and the corrective action
taken or preventative measures adopted.
    (vi) The owner/operator shall submit a summary of CEMS operation,
to include dates and duration of each period during which the CEMS was
inoperative (except for zero and span adjustments and calibration
checks), reason(s) why the CEMS was inoperative and steps taken to
prevent recurrence, and any CEMS repairs or adjustments.
    (vii) The owner/operator shall submit results of all CEMS
performance tests required by 40 CFR part 60, Appendix F, Procedure 1
(Relative Accuracy Test Audits, Relative Accuracy Audits, and Cylinder
Gas Audits).
    (viiii) When no excess emissions have occurred or the CEMS has not
been inoperative, repaired, or adjusted during the reporting period,
the owner/operator shall state such information in the semiannual
report.
    (9) Notifications. All notifications required under this section
shall be submitted by the owner/operator to the Director, Enforcement
Division (Mail Code ENF-2-1), U.S. Environmental Protection Agency,
Region 9, 75 Hawthorne Street, San Francisco, California 94105-3901.
    (i) The owner/operator shall submit notification of commencement of
construction of any equipment which is being constructed to comply with
the NOX emission limits in paragraph (i)(3) of this section.
    (ii) The owner/operator shall submit semiannual progress reports on
construction of any such equipment.
    (iii) The owner/operator shall submit notification of initial
startup of any such equipment.
    (10) Equipment operations. (i) At all times, including periods of
startup, shutdown, and malfunction, the owner/operator shall, to the
extent practicable, maintain and operate the kilns, including
associated air pollution control equipment, in a manner consistent with
good air pollution control practices for minimizing emissions.
Pollution control equipment shall be designed and capable of operating
properly to minimize emissions during all expected operating
conditions. Determination of whether acceptable operating and
maintenance procedures are being used will be based on information
available to the Regional Administrator, which may include, but is not
limited to, monitoring results, review of operating and maintenance
procedures, and inspection of the kilns.
    (ii) After completion of installation of ammonia injection on a
kiln, the owner/operator shall inject sufficient ammonia to achieve
compliance with the NOX emission limits from paragraph
(i)(3) of this section for that kiln while preventing excessive ammonia
emissions.
    (11) Enforcement. Notwithstanding any other provision in this
implementation plan, any credible evidence or information relevant as
to whether the kiln would have been in compliance with applicable
requirements if the appropriate performance or compliance test had been
performed can be used to establish whether or not the owner/operator
has violated or is in violation of any standard or applicable emission
limit in the plan.
[FR Doc. 2015-08883 Filed 4-16-15; 8:45 am]
 BILLING CODE 6560-50-P