Total.........................  ..............  ..............  ..............  ....................................          45,203            $1.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating or maintenance costs associated with this collection of information.

                                                  Table 4--Estimated Recurring Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Number of
 Activity/proposed 21 CFR section      Number of      records per    Total annual     Average burden per recordkeeping      Total hours    Capital costs
                                     recordkeepers   recordkeeper       records                                                           (USD millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Updating SOP for gluten control;             1,250               1           1,250  0.7 (42 minutes)....................             875               0
 101.91(c)(2) and (3).

Maintaining records of the updated           5,000               1           5,000  1...................................           5,000               0
 SOP for gluten control;
 101.91(c)(2) and (3).
Collecting samples for test kit              1,250              42          52,500  0.083 (5 minutes)...................           4,375            $0.6
 testing; 101.91(c)(2) and (3).
Maintaining records of test kit              5,000              42         210,000  0.5 (30 minutes)....................         105,000               0
 test results; 101.91(c)(2) and
 (3).
Collecting samples for testing by            1,250               2           2,500  0.083 (5 minutes)...................             208            $0.2
 an outside lab; 101.91(c)(2) and
 (3).
Maintaining records of testing by            5,000               2          10,000  0.5 (30 minutes)....................           5,000               0
 an outside lab; 101.91(c)(2) and
 (3).
                                   ---------------------------------------------------------------------------------------------------------------------
    Total.........................  ..............  ..............  ..............  ....................................         120,458            $0.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating or maintenance costs associated with this collection of information.

    The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the
Paperwork Reduction Act of 1995.
    Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.

X. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of Executive Order
13132 requires Agencies to ``construe . . . a Federal statute to
preempt State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Here, as in the 2013 gluten-free food labeling final
rule published in the August 5, 2013, issue of the Federal Register (78
FR 47154 at 47175), we have determined that certain narrow exercises of
State authority would conflict with the exercise of Federal authority
under the FD&C Act.
    In section 206 of FALCPA, Congress directed us to issue a proposed
rule to define and permit use of the term ``gluten-free'' on the
labeling of foods, in consultation with appropriate experts and
stakeholders, to be followed by a proposed rule for the use of such
term in labeling. In the preamble to the 2007 gluten-free food labeling
proposed rule (72 FR 2795 at 2813 through 2814), we indicated that we
had consulted with numerous experts and stakeholders in proposed rule's
development and determined that certain narrow exercises of State
authority would conflict with the exercise of Federal authority under
the FD&C Act. Different and inconsistent amounts of gluten in foods
with ``gluten-free'' labeling result in the inability of those
individuals with celiac disease who adhere to a gluten-free diet to
avoid exposure to gluten at levels that may result in adverse health
effects. ``Gluten-free'' labeling, for purposes of this discussion,
also includes the use of the terms ``no gluten,'' ``free of gluten,''
and without gluten,'' as indicated in Sec.  101.91(b)(2). There is a
need for national uniformity in the meaning of the term ``gluten-
free,'' which includes the manner in which the definition is enforced,
so that most individuals with celiac disease can make informed
purchasing decisions that will enable them to adhere to a diet they can
tolerate without causing adverse health effects and can select from a
variety of available gluten-free foods.
    This final rule establishes additional requirements for
manufacturers of fermented and hydrolyzed foods or foods that contain
fermented and hydrolyzed ingredients wishing to use the terms ``gluten-
free,'' ``no gluten,'' ``free of gluten,'' or ``without gluten'' on
their products, thus these requirements are a component of how we
permit the use of the ``gluten-free'' labeling claim. If States were
able to establish different requirements regarding what manufacturers
of fermented or hydrolyzed foods would need to demonstrate in order to
use the term ``gluten-free,'' then individuals with celiac disease
would not be able to rely on a consistent meaning for that term and
thereby use the term to identify appropriate dietary selections. As a
result, individuals with celiac disease may unnecessarily limit their
food choices, or conversely, select foods with levels of gluten that
are not tolerated and that may cause adverse health effects. Food
manufacturers, if confronted by a State or various State requirements
that adopted different requirements for fermented or hydrolyzed foods
than this rule, might decide to remove the ``gluten-free'' label, and
such a result would make it more difficult for individuals with celiac
disease to identify foods that they can tolerate and achieve a dietary
intake from a variety of foods to meet an individual's nutrient needs.
Moreover, consistent requirements regarding the way compliance with the
final rule is determined, including the records that would need to be
maintained in order for a fermented or hydrolyzed food manufacturer to
use the ``gluten-free'' claim and the use of a scientifically valid
method to detect the absence of protein to determine compliance for
distilled products, enables us to more efficiently enforce the use of
the ``gluten-free'' claim across all fermented and hydrolyzed foods to
ensure labels bearing a ``gluten-free'' claim are truthful and not
misleading.
    Therefore, the final rule's objective is standardizing use of the
term ``gluten-free'' in the labeling of fermented and hydrolyzed foods
so that foods with this claim in labeling, and foods with a

claim of ``no,'' ``free of,'' and ``without'' gluten, which connote a
similar meaning to that of ``gluten-free,'' are used in a consistent
way and will prevent consumer confusion and help individuals with
celiac disease make purchasing decisions.
    Section 4(c) of Executive Order 13132 instructs us to restrict any
Federal preemption of State law to the ``minimum level necessary to
achieve the objectives of the statute pursuant to which the regulations
are promulgated.'' The final rule meets the preceding requirement
because it would preempt State law narrowly, only to the extent
required to achieve uniform national labeling with respect to the
requirements related to the use of the term ``gluten-free,'' as well as
the terms ``no gluten,'' ``free of gluten,'' or ``without gluten,'' on
fermented and hydrolyzed foods. We intend to preempt State or local
requirements only to the extent that the State or local requirements
are different from the labeling requirements in this section related to
the use of the terms ``gluten-free,'' ``no gluten,'' ``free of
gluten,'' or ``without gluten'' for fermented and hydrolyzed foods. In
addition, we cannot foresee every potential State requirement and
preemption that may arise if a State requirement is found to obstruct
the federal purpose articulated in this rule. This rule, like the rule
codified at Sec.  101.91, is not intended to preempt other State or
local labeling requirements with respect to other statements or
warnings about gluten. For example, a State is not preempted from
requiring a labeling statement about the health effects of gluten
consumption from fermented or hydrolyzed foods on persons with celiac
disease or information about how the food was processed.
    In 2009, the President issued a memorandum entitled ``Preemption''
(74 FR 24693, May 22, 2009). The memorandum, among other things,
instructs Agencies to ``not include in regulatory preambles statements
that the department or agency intends to preempt State law through the
regulation except where preemption provisions are also included in the
codified regulation'' and ``not include preemption provisions in
codified regulations except where such provisions would be justified
under legal principles governing preemption, including the principles
outlined in Executive Order 13132.'' Because of the May 22, 2009,
memorandum we explain in detail the principles underlying our
conclusion that this final rule may result in preemption of State and
local laws under a narrow set of circumstances and describe how the
final rule's codified provision regarding preemption, which is now
Sec.  101.91(d), would apply to fermented or hydrolyzed foods.
    Under the Supremacy Clause of the Constitution (U.S. Constitution;
Art. VI, clause 2), State laws that interfere with or are contrary to
Federal law are invalid. (See Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1,
211 (1824)). Federal preemption can be express (stated by Congress in
the statute) or implied. Implied preemption can occur in several ways.
For example, Federal preemption may be found where Federal law
conflicts with State law. Such conflict may be demonstrated either when
``compliance with both federal and state [law] is a physical
impossibility'' (Florida Lime and Avocado Growers, Inc. v. Paul, 373
U.S. 132, 142-143 (1963)), or when State law ``stands as an obstacle to
the accomplishment and execution of the full purposes and objectives of
Congress'' (Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372-74
(2000) (citing Hines v. Davidowitz, 312 U.S. 52, 67 (1941))). State law
is also preempted if it interferes with the methods by which a Federal
law is designed to reach its goals. (See Int'l Paper Co. v. Ouellette,
479 U.S. 481, 494 (1987); Michigan Canners & Freezers Ass'n v.
Agricultural Marketing & Bargaining Bd., 467 U.S. 461, 477-478 (1984)).
    Additionally, `` `a federal agency acting within the scope of its
congressionally delegated authority may preempt state regulation' and
hence render unenforceable state or local laws that are otherwise not
inconsistent with federal law'' (City of New York v. FCC, 486 U.S. 57,
63-64 (1988) (quoting Louisiana Public Service Comm'n v. FCC, 476 U.S.
355, 369 (1986)). ``Federal regulations have no less preemptive effect
than federal statutes'' (Fidelity Federal Savings and Loan Ass'n v. de
la Cuesta, 458 U.S. 141, 153 (1982)).
    When an Agency's intent to preempt is clearly and unambiguously
stated, a court's inquiry will be whether the preemptive action is
within the scope of that Agency's delegated authority (Capital Cities
Cable, Inc. v. Crisp, 467 U.S. 691, 700 (1984); Fidelity Federal
Savings, 458 U.S. at 154). If the Agency's choice to preempt
``represents a reasonable accommodation of conflicting policies that
were committed to the agency's care by the statute [the regulation will
stand] unless it appears from the statute or its legislative history
that the accommodation is not one that Congress would have sanctioned''
(United States v. Shimer, 367 U.S. 374, 383 (1961)). In Hillsborough
County, the Supreme Court stated that FDA possessed the authority to
issue regulations preempting local laws that compromise the supply of
plasma and could do so (Hillsborough County, Fla. v. Automated Medical
Laboratories, Inc., 471 U.S. 707, 721 (1985)). We believe we have
similar authority to preempt State and local laws and regulations to
the limited extent that they permit use of ``gluten-free,'' ``no
gluten,'' ``free of gluten,'' or ``without gluten'' for fermented or
hydrolyzed foods differently from our rule because different State or
local labeling requirements would be contrary to the Congressional
directive for us to define and permit use of the term ``gluten-free.''
    State or local laws or regulations that permit use of ``gluten-
free,'' ``no gluten,'' ``free of gluten,'' or ``without gluten''
differently from our rule could frustrate the ability of most consumers
to identify gluten-free foods and avoid adverse health effects and
deter manufacturers from applying a ``gluten-free'' label to their
foods. With this final rule, consumers throughout the United States can
understand what is required to use the term ``gluten-free'' on the
labeling of a fermented or hydrolyzed packaged food. This final rule
will also allow us to enforce more efficiently the definition on
product labels of fermented or hydrolyzed foods, and manufacturers will
be able to comply with a single set of requirements, which may lead to
greater use of this voluntary labeling.
    Therefore, we intend to preempt State or local requirements only to
the extent that they are different from these final requirements
related to the use of the terms ``gluten-free,'' ``no gluten,'' ``free
of gluten,'' or ``without gluten'' on the labeling of fermented or
hydrolyzed foods, including the requirement to make and keep certain
records and the use of a scientifically valid method to detect the
absence of protein for distilled foods. There is no change to Sec.
101.91(d) regarding preemption, but the new requirements in Sec.
101.91(c) are part of the requirements covered by Sec.  101.91(d).

XI. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction.

Some may be available at the website address, if listed. References
without asterisks are available for viewing only at the Dockets
Management Staff. FDA has verified the website addresses, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.

1. Ciclitira, P.J., D. Evans, and N. Fagg, ``Clinical Testing of
Gliadin Fractions in Coeliac Patients,'' Clinical Science, 66: 357-
364, 1984. Available at: https://www.ncbi.nlm.nih.gov/pubmed/6692666.
2. * Garber, E.A.E., FDA Memorandum to Administrative Record,
``Standards Used to Detect and Quantify Fermented and Hydrolyzed
Gluten in Foods,'' August 25, 2015.
3. Lacorn, M. and Weiss, T. (2015). ``Partially Hydrolyzed Gluten in
Fermented Cereal-Based Products by R5 Competitive ELISA:
Collaborative Study, First Action 2015.05.'' Journal of AOAC
International 98: 1346-1354. Available at: https://www.ingentaconnect.com/content/aoac/jaoac/2015/00000098/00000005/art00023?crawler=true&mimetype=application/pdf.
4. Koehler, P., Schwalb, T., Immer, U., Lacorn, M., et al. (2013).
``AACCI Approved Methods Technical Committee Report: Collaborative
Study on the Immunochemical Determination of Partially Hydrolyzed
Gluten Using an R5 Competitive ELISA.'' Available at: https://www.researchgate.net/publication/251972244_AACCI_Approved_Methods_Technical_Committee_Report_Collaborative_Study_on_the_Immunochemical_Determination_of_Partially_Hydrolyzed_Gluten_Using_an_R5_Competitive_ELISA.
5. Sollid, L.M., Qiao, S.W., Anderson, R.P., Gianfrani, C., and
Koning, F. (2012). ``Nomenclature and Listing of Celiac Disease
Relevant Gluten T-Cell Epitopes Restricted by HLA-DQ Molecules.''
Immunogenetics, 64(6), 455-60. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3349865/pdf/251_2012_Article_599.pdf.
6. * Revised Interim Policy on Gluten Content Statements in the
Labeling and Advertising of Wines, Distilled Spirits, and Malt
Beverages (TTB Ruling No. 2014-2, February 11, 2014, available at:
https://www.ttb.gov/images/pdfs/rulings/2014-2.pdf).
7. Osman, A.M., S.M. Coverdale, K. Onley-Watson, D. Bell, and P.
Healy. ``The Gel Filtration Chromatographic-Profiles of Proteins and
Peptides of Wort and Beer: Effects of Processing--Malting, Mashing,
Kettle Boiling, Fermentation and Filtering.'' Journal of the
Institute of Brewing. 109(1), 41-50, 2003. Available at: https://onlinelibrary.wiley.com/doi/epdf/10.1002/j.2050-0416.2003.tb00592.x.
8. Akeroyd, M., S. Van Zandycke, J. den Hartog, J. Mutsaers, et al.
``AN-PEP Proline Specific Endo-Peptidase Degrades all Known Immuno
Stimulatory Gluten Peptides in Beer Made from Barley Malt.'' Journal
of the American Society of Brewing Chemists 74(2), 2016.
9. Panda, R., Fiedler, K.L., Cho, C.Y., Cheng, R., et al. (2015).
``Effects of a Proline Endopeptidase on the Detection and
Quantitation of Gluten by Antibody[hyphen]Based Methods during the
Fermentation of a Model Sorghum Beer.'' Journal of Agricultural and
Food Chemistry 63: 10525-10535.2015 pg. 35 line 806.
10. Colgrave, M.L., Goswami, H., Blundell., M., Howeitt, C. A.,
Tanner, G.J., (2014). ``Using Mass Spectrometry to Detect Hydrolysed
Gluten in Beer that is Responsible for False Negatives by ELISA.''
Journal of Chromatography A. 1370: 105-14.
11. Knorr, V., Wieser, H., and Koehler, P. (2016). ``Production of
Gluten-Free Beer by Peptidase Treatment.'' European Food Research
and Technology 242: 1129-1140.
12. Shewry, P. and Tatham, A. (2016). ``Improving Wheat to Remove
Coeliac Epitopes but Retain Functionality.'' Journal of Cereal
Science. 67:12-21.
13. Fiedler, K., Panda, R., and Croley, T. (2018). ``Analysis of
Gluten in a Wheat-Gluten-Incurred Sorghum Beer Brewed in the
Presence of Proline Endopeptidase by LC/MS/MS.'' Analytical
Chemistry 90: 2111-2118.
14. * FDA, Economic Impact Analysis for ``Food Labeling; Gluten-Free
Labeling of Fermented or Hydrolyzed Foods, 2019. Available at:
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
15. FoodEssentials. Product Label Database. November 2017 [cited
2017 October 11,]; Original website retired in mid-2018 and new
database was launched in late 2018]. Available from: https://www.labelinsight.com/about. Access is provided under a contract.
16. * Eastern Research Group (ERG), Nationwide Survey of Food
Industry Safety Practices, Final report, Contract No 223-01-2461,
task order 7. 2011, ERG.
17. * Thompson, Tricia, ``Should Manufacturers Consumers Use Lateral
Flow Devices (EZ Gluten) to Test Food for Gluten?'' Online version
available at http://www.glutenfreedietitian.com/should-manufacturers-consumers-use-lateral-flow-devices-ez-gluten-to-test-food-for-gluten/.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, 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
101 is amended as follows:

PART 101--FOOD LABELING

0
1. The authority citation for 21 CFR part 101 continues to read as
follows:

    Authority:  15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
2. In Sec.  101.91, revise paragraphs (b)(1), (b)(2), and (c) to read
as follows:

Sec.  101.91  Gluten-free labeling of food.

* * * * *
    (b) Requirements. (1) A food that bears the claim ``gluten-free''
in its labeling and fails to meet the requirements of paragraph (a)(3)
of this section and, if applicable, paragraphs (c)(2) through (4) of
this section will be deemed misbranded.
    (2) A food that bears the claim ``no gluten,'' ``free of gluten,''
or ``without gluten'' in its labeling and fails to meet the
requirements of paragraph (a)(3) of this section and, if applicable,
paragraphs (c)(2) through (4) of this section will be deemed
misbranded.
* * * * *
    (c) Compliance. (1) When compliance with paragraph (b) of this
section is based on an analysis of the food, FDA will use a
scientifically valid method that can reliably detect and quantify the
presence of 20 ppm gluten in a variety of food matrices, including both
raw and cooked or baked products.
    (2) When a scientifically valid method pursuant to paragraph (c)(1)
of this section is not available because the food is fermented or
hydrolyzed, the manufacturer of such foods bearing the claim must make
and keep records regarding the fermented or hydrolyzed food
demonstrating adequate assurance that:
    (i) The food is ``gluten-free'' in compliance with paragraph (a)(3)
of this section before fermentation or hydrolysis;
    (ii) The manufacturer has adequately evaluated their processing for
any potential for gluten cross-contact; and
    (iii) Where a potential for gluten cross-contact has been
identified, the manufacturer has implemented measures to prevent the
introduction of gluten into the food during the manufacturing process.
    (3) When a scientifically valid method pursuant to paragraph (c)(1)
of this section is not available because the food contains one or more
ingredients that are fermented or hydrolyzed, the manufacturer of such
foods bearing the claim must make and keep records demonstrating
adequate assurance that the fermented or hydrolyzed ingredients are
``gluten-free'' as described in paragraph (c)(2) of this section.
    (4) Records necessary to verify compliance with paragraphs (c)(2)
and (3) of this section must be retained for at least 2 years after
introduction or delivery for introduction of the food

into interstate commerce and may be kept as original records, as true
copies, or as electronic records. Manufacturers must provide those
records to us for examination and copying during an inspection upon
request.
    (5) When a scientifically valid method pursuant to paragraph (c)(1)
of this section is not available because the food is distilled, FDA
will evaluate compliance with paragraph (b) of this section by
verifying the absence of protein in the distilled component using
scientifically valid analytical methods that can reliably detect the
presence or absence of protein or protein fragments in the food.
* * * * *

    Dated: July 29, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
[FR Doc. 2020-17088 Filed 8-12-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 13, 2009 (Volume 74, Number 132)]
[Notices]
[Page 33430]
[DOCID:fr13jy09-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2165-029]

Alabama Power Company; Notice of Application for Amendment of
License and Soliciting Comments, Motions To Intervene, and Protests

July 2, 2009.
    a. Type of Application: Non-project use of project lands and
waters.
    b. Project Number: 2165-029.
    c. Date Filed: June 5, 2009.
    d. Applicant: Alabama Power Company.
    e. Name of Project: Warrior River Hydroelectric Project.
    f. Location: The project is located on Sipsley Fork and the Black
Warrior River in Cullman, Tuscaloosa, Walker, and Winston Counties,
Alabama. The proposed action would occur at the Lewis Smith Development
in Cullman County.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a), 825(r)
and 799 and 801.
    h. Applicant Contact: Mr. Jason Powers, Alabama Power Company, 600
18th Street North, Birmingham, Alabama 35203, telephone: (205) 257-
4070.
    i. FERC Contact: Any questions on this notice should be addressed
to Christopher Yeakel at<PHONE_NUMBER>, or e-mail address:
<EMAIL_ADDRESS>    j. Deadline for filing comments and or motions: August 3, 2009.
    k. Description of Request: Alabama Power Company proposes to permit
Mr. Lynn Layton to replace one existing, covered, 10-slip boat dock
with three covered boat docks, each with 10 slips at Cushman's Marina,
located on the Warrior River Project. Each dock would consist of: (1) A
50-foot-long ramp; (2) an equalizing platform; (3) a 78-foot-long
central walkway; and (4) ten 12-foot-wide by 28-foot-long slips.
Navigational lighting would be installed on each dock. No fuel-
dispensing or sewage-pumping facilities are proposed. The docks would
be available for rental by the general public. The licensee also
proposes to allow the removal of an existing building at the site, and
the construction of a new patio within the project boundary.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field (p-2165) to access the document. You
may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
call 1-866-208-3372 or e-mail<EMAIL_ADDRESS>for TTY, call
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', OR ``MOTION TO INTERVENE'', as
applicable, and the Project Number of the particular application to
which the filing refers (P-2165-029). All documents (original and eight
copies) should be filed with: The Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426. A copy of any
motion to intervene must also be served upon each representative of the
Applicant specified in the particular application.
    p. Agency Comments--Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov
under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-16442 Filed 7-10-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 246 (Friday, December 21, 2012)]
[Rules and Regulations]
[Pages 75561-75566]
[FR Doc No: 2012-30851]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0010; FRL-9372-4]

Quinclorac; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
quinclorac in or on berry, low growing, except strawberry, subgroup 13-
07 H and rhubarb. Interregional Research Project Number 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective December 21, 2012. Objections and
requests for hearings must be received on or before February 19, 2013,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0010, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must

identify docket ID number EPA-HQ-OPP-2012-0010 in the subject line on
the first page of your submission. All objections and requests for a
hearing must be in writing, and must be received by the Hearing Clerk
on or before February 19, 2013. Addresses for mail and hand delivery of
objections and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0010, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of April 4, 2012 (77 FR 20334) (FRL-9340-
4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1E7957) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ
08540. The petition requested that 40 CFR 180.463 be amended by
establishing tolerances for residues of the herbicide quinclorac, 3,7-
dichloro-8-quinolinecarboxylic acid, in or on berry, low growing,
except strawberry, subgroup 13-07H at 1.1 parts per million (ppm) and
rhubarb at 0.4 ppm. That document referenced a summary of the petition
prepared on behalf of IR-4 by BASF Corporation, the registrant, which
is available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has
revised the tolerance levels for the proposed commodities. The reason
for these changes is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue * *
*.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for quinclorac including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with quinclorac follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Quinclorac has a low order of acute toxicity via the oral, dermal,
and inhalation routes of exposure. It is not a skin irritant, but is a
mild eye irritant and tested positive for dermal sensitization.
Following subchronic exposures to quinclorac, signs of toxicity
included decreased body weight gains, increased water intake, increased
liver enzymes, and focal chronic interstitial nephritis (rats). Chronic
toxic effects included body weight decrement, increase in kidney and
liver weights, and hydropic degeneration of the kidneys (dogs). At high
doses, chronic toxicity also included increased incidences of
pancreatic acinar cell hyperplasia and adenomas in rats. There was no
evidence of neurotoxicity in any acute, subchronic and chronic studies
for quinclorac.
    There was no increased qualitative or quantitative fetal or
offspring susceptibility in the prenatal developmental or postnatal
reproduction studies. Developmental toxicity in the rabbit consisted of
increased resorptions, post-implantation loss, decreased number of live
fetuses, and reduced fetal body weight. These effects occurred at
higher doses than the maternal effects of decreased food consumption
and increased water consumption and decreased body weight gain. In the
rat, no developmental toxicity was observed up to the highest dose
tested (HDT). In the 2-generation rat reproduction study, parental
toxicity and offspring toxicity occurred at the same dose. Parental
toxicity consisted of reduced body weight in both sexes during
premating and lactation periods, and offspring toxicity consisted of
decreased pup weight, developmental delays, and possible marginal
effect on pup viability. No reproductive toxicity occurred up to the
HDT in this study.
    Quinclorac is not mutagenic in bacterial assays and does not cause
unscheduled DNA damage in primary rat hepatocytes. There is also no
evidence of a genotoxic response in whole animal test systems (in vivo
mouse bone marrow micronucleus assay) and was negative in a mammalian
cell in vitro cytogenetic chromosomal aberration assay in Chinese
hamster ovary cells. Quinclorac produced an equivocal increase in the
incidence of one type of benign tumor (pancreatic acinar cell adenomas)
in only one sex of one species of animals (male Wistar rats). There was
no evidence of carcinogenicity in mice or female rats. Based on this
limited evidence on cancer, a quantification of cancer risk is not
warranted because the chronic RfD will adequately account for all
chronic effects, including carcinogenicity, that may result from
exposure to quinclorac.
    Specific information on the studies received and the nature of the
adverse effects caused by quinclorac as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://

www.regulations.gov in document, ``Quinclorac: First Risk Assessment In
Support of Registration Review and for New Proposed Use on Rhubarb and
Berry, low growing, except Strawberry, Subgroup 13-07H,'' pp. 62-65 in
docket ID number EPA-HQ-OPP-2012-0010.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD) and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for quinclorac used for
human risk assessment is shown in following Table.

  Table 1--Summary of Toxicological Doses and Endpoints for Quinclorac for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years   NOAEL = 200 mg/kg/day.  Acute RfD = 2.0 mg/kg/  Developmental toxicity
 of age).                            UFA = 10x.............   day.                    study in rabbits.
                                     UFH = 10x.............  aPAD = 2.0 mg/kg/day..  LOAEL = 600 mg/kg/day based
                                     FQPA SF = 1x..........                           on increased early
                                                                                resorptions and
                                                                                postimplantation loss,
                                                                                decreased live fetuses,
                                                                                decreased fetal body
                                                                                weight.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population       Not applicable. An endpoint for acute dietary exposure to the general
 including infants and children).         population was not selected because there was no available endpoint
                                       attributable to a single exposure that was appropriate for this scenario
                                        (effects observed in the available studies are presumed to require more
                                                                  than one exposure).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)..  NOAEL= 37.5 mg/kg/day.  Chronic RfD = 0.38 mg/  Carcinogenicity study in
                                     UFA = 10x.............   kg/day.                 mice.
                                     UFH = 10x.............  cPAD = 0.38 mg/kg/day.  LOAEL = 150 mg/kg/day based
                                     FQPA SF = 1x..........                           on decreased body weight.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30       Oral study NOAEL= 70    LOC for MOE = 100.....  Developmental toxicity
 days).                               mg/kg/day (inhalation                           study in rabbits.
                                      absorption rate =                              LOAEL = 200 mg/kg/day based
                                      100%).                                          on decreased maternal body
                                     UFA = 10x.............                           weight gain and food
                                     UFH = 10x.............                           consumption, and increased
                                     FQPA SF = 1x..........                           water consumption.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to 30  NOAEL= 70 mg/kg/day...  LOC for MOE = 100.....  Developmental toxicity
 days).                              UFA = 10x.............                           study in rabbits.
                                     UFH = 10x.............                          LOAEL = 200 mg/kg/day based
                                     FQPA SF = 1x..........                           on decreased maternal body
                                                                                weight gain and food
                                                                                consumption, and increased
                                                                                water consumption.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..   The chronic RfD will adequately account for all chronic effects, including
                                             carcinogenicity, that may result from exposure to quinclorac.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to quinclorac, EPA considered exposure under the petitioned-
for tolerances as well as all existing quinclorac tolerances in 40 CFR
180.463. EPA assessed dietary exposures from quinclorac in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. EPA identified such an
effect (increased early resorptions and post-implantation loss,
decreased live fetuses, and decreased fetal body weight in
developmental toxicity study in rabbits) for the population subgroup
females 13 to 49 years old; however, no such effect was identified for
the general population, including infants and children.
    In estimating acute dietary exposure for females 13-49, the
population group identified as having an acute dietary exposure, EPA
used Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database

(DEEM-FCID) Version 3.16, which uses food consumption data from the
U.S. Department of Agriculture's National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA), conducted
from 2003-2008. As to residue levels in food, EPA assumed 100 percent
crop treated (PCT) and tolerance-level residues for all commodities. In
addition, DEEM version 7.81 default processing factors were used when
appropriate.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's 2003-2008
NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and
tolerance-level residues for all commodities. In addition, DEEM version
7.81 default processing factors were used when appropriate.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to quinclorac. Cancer risk was assessed using the same
exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for quinclorac. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for quinclorac in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of quinclorac. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Tier I Rice Model, Version 1.0, the estimated drinking
water concentrations (EDWCs) of quinclorac for surface water are
estimated to be 511 parts per billion (ppb) for acute and chronic
exposures. Based on the Screening Concentration in Ground Water (SCI
GROW) model, the EDWCs for ground water are estimated to be 29 ppb for
acute and chronic exposures.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute and chronic dietary
risk assessments, the water concentration value of 511 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Quinclorac is
currently registered for the following uses that could result in
residential exposures: Turf grass and ornamentals. EPA assessed
residential exposure using the following assumptions: Short-term
inhalation exposures for residential handlers from mixing, loading, and
applying quinclorac to residential turf and short-term postapplication
incidental oral exposures (hand-to-mouth activities) of children from
contact with treated turf. Intermediate-term exposures resulting from
adult handler and postapplication exposures were not assessed due to a
lack of a dermal point of departure. Incidental oral scenarios for
children are considered to be short-term only. Further information
regarding EPA standard assumptions and generic inputs for residential
exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found quinclorac to share a common mechanism of
toxicity with any other substances, and quinclorac does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
quinclorac does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The toxicology database for
quinclorac consists of developmental toxicity studies in rats and
rabbits and a 2-generation reproduction study in rats. There is no
indication of increased qualitative or quantitative susceptibility of
rats or rabbit fetuses to in utero and/or postnatal exposure in the
developmental and reproductive toxicity data.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for quinclorac is complete.
    ii. There is no indication that quinclorac is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
    iii. There is no evidence that quinclorac results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to quinclorac in drinking water. EPA used similarly
conservative assumptions to assess incidental oral exposures (hand-to-
mouth activities) of toddlers to quinclorac. These assessments will not
underestimate the exposure and risks posed by quinclorac.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate

PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to quinclorac will occupy 1.6% of the aPAD for females 13-49, the
population group for which a potential acute risk was identified.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
quinclorac from food and water will utilize 8.9% of the cPAD for
infants less than 1 year of age, the population group receiving the
greatest exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
quinclorac is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Quinclorac is
currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to quinclorac.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 2,100 for adults
and 1,600 for children 1-2 years old. Because EPA's level of concern
for quinclorac is a MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
quinclorac is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
quinclorac.
    5. Aggregate cancer risk for U.S. population. Based on the
discussion in Unit III.A., EPA has concluded that the cPAD is
protective of possible cancer effects.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to quinclorac residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate gas chromatography with electron capture detection (GC/
ECD) method (BASF Method A8902), is available to enforce the tolerance
expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for quinclorac.

C. Revisions to Petitioned-for Tolerances

    Based on analysis of the residue field trial data supporting the
petition, EPA revised the proposed tolerances on berry, low growing,
except strawberry, subgroup 13-07H from 1.1 ppm to 1.5 ppm and rhubarb
from 0.4 ppm to 0.5 ppm. The Agency revised these tolerance levels
based on analysis of the residue field trial data using the
Organization for Economic Co-operation and Development (OECD) tolerance
calculation procedures.

V. Conclusion

    Therefore, tolerances are established for residues of quinclorac,
3,7-dichloro-8-quinolinecarboxylic acid, in or on berry, low growing,
except strawberry, subgroup 13-07H at 1.5 ppm; and rhubarb at 0.5 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian

tribes. Thus, the Agency has determined that Executive Order 13132,
entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive
Order 13175, entitled ``Consultation and Coordination with Indian
Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to
this final rule. In addition, this final rule does not impose any
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C.
1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: December 12, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.463, add alphabetically the following commodities to
the table in paragraph (a) to read as follows:

Sec.  180.463  Quinclorac; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Berry, low growing, except strawberry, subgroup 13-07H..             1.5

                                * * * * *
Rhubarb.................................................             0.5

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

* * * * *
[FR Doc. 2012-30851 Filed 12-20-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Rules and Regulations]
[Pages 60236-60240]
[FR Doc No: 2016-21122]

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

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2016-4138; Special Conditions No. 25-635-SC]

Special Conditions: Bombardier Inc., Model BD-700-2A12 and BD-
700-2A13 Airplanes; Interactions of Systems and Structures

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued for the Bombardier Inc.
(Bombardier) Model BD-700-2A12 and BD-700-2A13 airplanes. These
airplanes will have novel or unusual features when compared to the
state of technology envisioned in the airworthiness standards for
transport-category airplanes. These design features include systems
that, directly or as a result of failure or malfunction, affect
structural performance. The applicable airworthiness regulations do not
contain adequate or appropriate safety standards for these design
features. These special conditions contain the additional safety
standards that the Administrator considers necessary to establish a
level of safety equivalent to that established by the existing
airworthiness standards.

DATES: This action is effective on Bombardier on September 1, 2016. We
must receive your comments by October 17, 2016.

ADDRESSES: Send comments identified by docket number FAA-2016-4138
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m.,
Monday through Friday, except federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except federal holidays.

FOR FURTHER INFORMATION CONTACT: Mark Freisthler, FAA, Airframe and
Cabin Safety Branch, ANM-115, Transport Airplane Directorate, Aircraft
Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive on or before the closing
date for comments. We may change these special conditions based on the
comments we receive.

Background

    On May 30, 2012, Bombardier applied for an amendment to type
certificate no. T00003NY to include the new Model BD-700-2A12 and BD-
700-2A13 airplanes. These airplanes are derivatives of the Model BD-700
series of airplanes currently approved under type certificate no.
T00003NY, and are marketed as the Bombardier Global 7000 (Model BD-700-
2A12) and Global 8000 (Model BD-700-2A13). These airplanes are ultra-
long-range, executive-interior business jets.

Type Certification Basis

    Under the provisions of Title 14, Code of Federal Regulations (14
CFR) 21.101, Bombardier must show that the Model BD-700-2A12 and BD-
700-2A13 airplanes meet the applicable provisions of the regulations
listed in type certificate no. T00003NY, or the applicable regulations
in effect on the date of application for the change, except for earlier
amendments as agreed upon by the FAA.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the BD-700-2A12 and BD-700-2A13
airplanes because of a novel or unusual design feature, special
conditions are prescribed under the provisions of Sec.  21.16.

    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, or should any other model already included on
the same type certificate be modified to incorporate the same novel or
unusual design feature, these special conditions would also apply to
the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the Model BD-700-2A12 and BD-700-2A13 airplanes must comply
with the fuel-vent and exhaust-emission requirements of 14 CFR part 34,
and the noise certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type-
certification basis under Sec.  21.101.

Novel or Unusual Design Features

    The Model BD-700-2A12 and BD-700-2A13 airplanes will incorporate
the following novel or unusual design features:
    Systems that affect the airplane's structural performance, either
directly or as a result of failure or malfunction. That is, the
airplane's systems affect how it responds in maneuver and gust
conditions, and thereby affect its structural capability. These systems
may also affect the aeroelastic stability of the airplane. Such systems
include flight-control systems, autopilots, stability-augmentation
systems, load-alleviation systems, and fuel-management systems. These
systems represent novel and unusual features when compared to the
technology envisioned in the current airworthiness standards.

Discussion

    The flight-control system of the Model BD-700-2A12 and BD-700-2A13
airplanes will consist of a full-authority fly-by-wire system with
Normal and Direct modes of operation. The applicable airworthiness
regulations do not contain adequate or appropriate safety standards for
this design feature. These special conditions contain the additional
safety standards that the Administrator considers necessary to
establish a level of safety equivalent to that established by the
existing airworthiness standards. Special conditions have been applied
on past airplane programs, with similar systems, to require
consideration of the effects of those systems on structures.
    The regulatory authorities and industry developed standardized
criteria in the Aviation Rulemaking Advisory Committee (ARAC) forum
based on the criteria defined in Advisory Circular (AC) 25.672-1, dated
November 11, 1983. The ARAC recommendations have been incorporated in
European Aviation Safety Agency (EASA) Certification Specifications
(CS) 25.302 and CS-25 Appendix K. FAA rulemaking on this subject is not
complete, thus the need for special conditions.
    These special conditions are similar to those previously applied to
other airplane models and to EASA CS 25.302. Transport Canada Civil
Aviation (TCCA) plans to include CS 25.302 in the Model BD-700-2A12 and
BD-700-2A13 airplanes' Canadian certification basis. The differences
between these FAA special conditions and the current CS 25.302, which
the FAA regards as minor, are shown below. Both these special
conditions and CS 25.302:
     Specify the design load conditions to be considered.
Special conditions 2(a)(i) and 2(b)(ii)(1) of these special conditions
clarify that, in some cases, different load conditions are to be
considered due to other special conditions or equivalent-level-of-
safety findings.
     allow consideration of the probability of being in a
dispatched configuration when assessing subsequent failures and
potential ``continuation of flight'' loads (see special condition 2(d),
below). These special conditions, however, also allow using probability
when assessing failures that induce loads at the ``time of
occurrence,'' whereas CS 25.302 does not. The FAA provision is
relieving as compared to CS 25.302.
    The FAA chooses to preserve these minor differences and go forward
with this version of the special conditions.

Applicability

    As discussed above, these special conditions are applicable to the
Model BD-700-2A12 and BD-700-2A13 airplanes. Should Bombardier apply at
a later date for a change to the type certificate to include another
model incorporating the same novel or unusual design feature, these
special conditions would apply to the other model as well.

Conclusion

    This action affects only certain novel or unusual design features
on two model series of airplanes. It is not a rule of general
applicability.
    The substance of these special conditions has been subjected to the
notice and comment period in several prior instances and has been
derived without substantive change from those previously issued. It is
unlikely that prior public comment would result in a significant change
from the substance contained herein. Therefore, the FAA has determined
that prior public notice and comment are unnecessary, and good cause
exists for adopting these special conditions upon publication in the
Federal Register. The FAA is requesting comments to allow interested
persons to submit views that may not have been submitted in response to
the prior opportunities for comment described above.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

0
The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

0
Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for Bombardier Model BD-700-2A12 and BD-
700-2A13 airplanes.
    For airplanes equipped with systems that affect structural
performance, either directly or as a result of a failure or
malfunction, the influence of these systems and their failure
conditions must be taken into account when showing compliance with the
requirements of 14 CFR part 25, subparts C and D.
    The following criteria must be used for showing compliance with
these special conditions for airplanes equipped with flight-control
systems, autopilots, stability-augmentation systems, load-alleviation
systems, flutter-control systems, fuel-management systems, and other
systems that either directly, or as a result of failure or malfunction,
affect structural performance. If these special conditions are used for
other systems, it may be necessary to adapt the criteria to the
specific system.
    1. The criteria defined herein only address the direct structural
consequences of the system responses and performance. They cannot be
considered in isolation, but should be included in the overall safety
evaluation of the airplane. These criteria may, in some instances,
duplicate standards already established for this evaluation. These
criteria are only applicable to structure the failure of which could
prevent continued safe flight and landing. Specific criteria that
define

acceptable limits on handling characteristics or stability
requirements, when operating in the system-degraded or inoperative
mode, are not provided in these special conditions.
    2. Depending upon the specific characteristics of the airplane,
additional studies that go beyond the criteria provided in these
special conditions may be required to demonstrate the airplane's
capability to meet other realistic conditions, such as alternative gust
or maneuver descriptions for an airplane equipped with a load-
alleviation system.
    3. The following definitions are applicable to these special
conditions.
    a. Structural performance: Capability of the airplane to meet the
structural requirements of 14 CFR part 25.
    b. Flight limitations: Limitations that can be applied to the
airplane flight conditions following an in-flight occurrence, and that
are included in the airplane flight manual (e.g., speed limitations,
avoidance of severe weather conditions, etc.).
    c. Operational limitations: Limitations, including flight
limitations, that can be applied to the airplane operating conditions
before dispatch (e.g., fuel, payload and master minimum-equipment list
limitations).
    d. Probabilistic terms: Terms such as probable, improbable, and
extremely improbable, as used in these special conditions, are the same
as those used in Sec.  25.1309.
    e. Failure condition: This term is the same as that used in Sec.
25.1309. However, these special conditions apply only to system-failure
conditions that affect the structural performance of the airplane
(e.g., system-failure conditions that induce loads, change the response
of the airplane to inputs such as gusts or pilot actions, or lower
flutter margins).

Effects of Systems on Structures

    1. General. The following criteria will be used in determining the
influence of a system and its failure conditions on the airplane
structure.
    2. System fully operative. With the system fully operative, the
following apply:
    a. Limit loads must be derived in all normal operating
configurations of the system from all the limit conditions specified in
14 CFR part 25, subpart C (or defined by special conditions or
equivalent level of safety in lieu of those specified in subpart C),
taking into account any special behavior of such a system or associated
functions, or any effect on the structural performance of the airplane
that may occur up to the limit loads. In particular, any significant
nonlinearity (rate of displacement of control surface, thresholds, or
any other system nonlinearities) must be accounted for in a realistic
or conservative way when deriving limit loads from limit conditions.
    b. The airplane must meet the strength requirements of 14 CFR part
25 (static strength, residual strength), using the specified factors to
derive ultimate loads from the limit loads defined above. The effect of
nonlinearities must be investigated beyond limit conditions to ensure
that the behavior of the system presents no anomaly compared to the
behavior below limit conditions. However, conditions beyond limit
conditions need not be considered when it can be shown that the
airplane has design features that will not allow it to exceed those
limit conditions.
    c. The airplane must meet the aeroelastic stability requirements of
Sec.  25.629.
    3. System in the failure condition. For any system-failure
condition not shown to be extremely improbable, the following apply:
    a. At the time of occurrence. Starting from 1g level flight
conditions, a realistic scenario, including pilot corrective actions,
must be established to determine the loads occurring at the time of
failure and immediately after the failure.
    i. For static-strength substantiation, these loads, multiplied by
an appropriate factor of safety that is related to the probability of
occurrence of the failure, are ultimate loads to be considered for
design. The factor of safety is defined in Figure 1, below.
[GRAPHIC] [TIFF OMITTED] TR01SE16.128

    ii. For residual-strength substantiation, the airplane must be able
to withstand two thirds of the ultimate loads defined in special
condition 3.a.(i). For pressurized cabins, these loads must be combined
with the normal operating differential pressure.
    iii. Freedom from aeroelastic instability must be shown up to the
speeds defined in Sec.  25.629(b)(2). For failure conditions that
result in speeds beyond VC/MC, freedom from
aeroelastic instability must be shown to increased speeds, so that the
margins intended by Sec.  25.629(b)(2) are maintained.
    iv. Failures of the system that result in forced structural
vibrations (oscillatory failures) must not produce loads that could
result in detrimental deformation of primary structure.
    b. For the continuation of the flight. For the airplane in the
system-failed state, and considering any appropriate reconfiguration
and flight limitations, the following apply:
    i. THE loads derived from the following conditions (or used in lieu
of the following conditions) at speeds up to VC/
MC (or the speed limitation prescribed for the remainder of
the flight) must be determined:
    1. The limit symmetrical maneuvering conditions specified in
Sec. Sec.  25.331 and 25.345.
    2. The limit gust and turbulence conditions specified in Sec. Sec.
25.341 and 25.345.

    3. The limit rolling conditions specified in Sec.  25.349, and the
limit unsymmetrical conditions specified in Sec. Sec.  25.367, and
25.427(b) and (c).
    4. The limit yaw-maneuvering conditions specified in Sec.  25.351.
    5. The limit ground-loading conditions specified in Sec. Sec.
25.473 and 25.491.
    ii. For static-strength substantiation, each part of the structure
must be able to withstand the loads in special condition 3.b.(i),
multiplied by a factor of safety depending on the probability of being
in this failure state. The factor of safety is defined in Figure 2,
below.
[GRAPHIC] [TIFF OMITTED] TR01SE16.129

Qj = (Tj)(Pj)

Where:

Qj = Probability of being in failure mode j
Tj = Average time spent in failure mode j (in hours)
Pj = Probability of occurrence of failure mode j (per
hour)

    Note:  If Pj is greater than 10-3 per
flight hour, then a 1.5 factor of safety must be applied to all
limit load conditions specified in 14 CFR part 25, subpart C.

    iii. For residual-strength substantiation, the airplane must be
able to withstand two-thirds of the ultimate loads defined in paragraph
3.b.(ii) of these special conditions. For pressurized cabins, these
loads must be combined with the normal operating differential pressure.
    iv. If the loads induced by the failure condition have a
significant effect on fatigue or damage tolerance, then their effects
must be taken into account.
    v. Freedom from aeroelastic instability must be shown up to a speed
determined from Figure 3, below. Flutter clearance speeds V' and V''
may be based on the speed limitation specified for the remainder of the
flight using the margins defined by Sec.  25.629(b).
[GRAPHIC] [TIFF OMITTED] TR01SE16.130

V' = Clearance speed as defined by Sec.  25.629(b)(2).
V'' = Clearance speed as defined by Sec.  25.629(b)(1).

Qj = (Tj)(Pj)

Where:

Qj = Probability of being in failure mode j
Tj = Average time spent in failure mode j (in hours)
Pj = Probability of occurrence of failure mode j (per
hour)

    Note:  If Pj is greater than 10-3 per
flight hour, then the flutter clearance speed must not be less than
V''.

    vi. Freedom from aeroelastic instability must also be shown up to
V' in Figure 3, above, for any probable system-failure condition,
combined with any damage required or selected for investigation by
Sec.  25.571(b).
    b. Consideration of certain failure conditions may be required by
other sections of 14 CFR part 25 regardless of calculated system
reliability. Where analysis shows the probability of these failure
conditions to be less than 10-9, criteria other than those
specified in this paragraph may be used for structural substantiation
to show continued safe flight and landing.
    4. Failure indications. For system-failure detection and
indication, the following apply:
    a. The system must be checked for failure conditions, not extremely
improbable, that degrade the structural capability below the level
required by 14 CFR part 25, or that significantly reduce the
reliability of the remaining system. As far as reasonably practicable,
the flightcrew must be made aware of these failures before flight.
Certain elements of the control system, such as mechanical and
hydraulic components, may use special periodic inspections, and
electronic components may use

daily checks, in lieu of detection and indication systems, to achieve
the objective of this requirement. These certification-maintenance
requirements must be limited to components that are not readily
detectable by normal detection-and-indication systems, and where
service history shows that inspections will provide an adequate level
of safety.
    b. The existence of any failure condition, not extremely
improbable, during flight, that could significantly affect the
structural capability of the airplane, and for which the associated
reduction in airworthiness can be minimized by suitable flight
limitations, must be signaled to the flightcrew. For example, failure
conditions that result in a factor of safety between the airplane
strength and the loads of 14 CFR part 25, subpart C below 1.25, or
flutter margins below V'', must be signaled to the crew during flight.
    5. Dispatch with known failure conditions. If the airplane is to be
dispatched in a known system-failure condition that affects structural
performance, or that affects the reliability of the remaining system to
maintain structural performance, then the provisions of these special
conditions must be met, including the provisions of special condition 2
for the dispatched condition, and special condition 3 for subsequent
failures. Expected operational limitations may be taken into account in
establishing Pj as the probability of failure occurrence for
determining the safety margin in Figure 1. Flight limitations and
expected operational limitations may be taken into account in
establishing Qj as the combined probability of being in the
dispatched failure condition and the subsequent failure condition for
the safety margins in Figures 2 and 3. These limitations must be such
that the probability of being in this combined failure state, and then
subsequently encountering limit load conditions, is extremely
improbable. No reduction in these safety margins is allowed if the
subsequent system-failure rate is greater than 10-\3\ per
hour.

    Issued in Renton, Washington, on August 23, 2016.
John P. Piccola, Jr.,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-21122 Filed 8-31-16; 8:45 am]
BILLING CODE 4910-13-P