[Federal Register Volume 77, Number 217 (Thursday, November 8, 2012)]
[Notices]
[Page 66975]
[FR Doc No: 2012-27301]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER13-203-000]

Black Bear SO, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Black Bear SO, LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR Part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is November 23, 2012.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 2, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-27301 Filed 11-7-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 103 (Wednesday, May 29, 2013)]
[Rules and Regulations]
[Pages 32121-32124]
[FR Doc No: 2013-12652]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2013-0276]
RIN 1625-AA00

When Pigs Fly Fireworks Display; San Diego, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a safety zone on the navigable
waters of the San Diego Bay in support of the When Pigs Fly Fireworks
Display on June 11, 2013

from 8:30 p.m. to 9:30 p.m. The safety zone will include all navigable
waters within 600 feet of the nearest point of the fireworks barge
located in the vicinity of the USS MIDWAY. The zone is necessary to
provide for the safety of the participants, crew, spectators,
participating vessels, and other vessels and users of the waterway.
Persons and vessels are prohibited from entering into, transiting
through, or anchoring within this safety zone unless authorized by the
Captain of the Port or his designated representative.

DATES: This rule is effective from 8:30 p.m. to 9:30 p.m. on June 11,
2013.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2013-0276]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Bryan Gollogly, Waterways Management, U.S.
Coast Guard Sector San Diego, Coast Guard; telephone<PHONE_NUMBER>,
email<EMAIL_ADDRESS>If you have questions on viewing
or submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because publishing an NPRM would be
impracticable. The Coast Guard did not receive necessary information
from the event sponsor in time to publish a notice of proposed
rulemaking. The event is scheduled to take place, and as such,
immediate action is necessary to ensure the safety of vessels,
spectators, participants, and others in the vicinity of the marine
event on the dates and times this rule will be in effect.
    Under 5 U.S.C. 553(d)(3), for the same reasons mentioned above, the
Coast Guard finds that good cause exists for making this rule effective
less than 30 days after publication in the Federal Register. Delaying
the effective date would be impracticable for the reasons cited above.

B. Basis and Purpose

    The legal basis for this temporary rule is the Ports and Waterways
Safety Act which authorizes the Coast Guard to establish safety zones
(33 U.S.C sections 1221 et seq.).
    Pyro Spectaculars is sponsoring the When Pigs Fly Fireworks
Display, which will be conducted from a barge located in the vicinity
of the USS MIDWAY in San Diego Bay. A safety zone is needed for the
navigable waters around the barge, which will be located in the
following approximate position: 32 42'46.71'' N 117 10'39.44'' W. A
safety zone is necessary to provide for the safety of the crew,
spectators, and other vessels and users of the waterway. The sponsor
will provide a chase boat to patrol the safety zone and inform vessels
of the safety zone.

C. Discussion of the Final Rule

    The Coast Guard is establishing a safety zone that will be enforced
from 8:30 p.m. to 9:30 p.m. on June 11, 2013. The limits of the safety
zone will include all the navigable waters within 600 feet of the
nearest point of the fireworks barge in approximate position 32
42'46.71'' N 117 10'39.44'' W.
    The safety zone is necessary to provide for the safety of the
crews, spectators, and other vessels and users of the waterway. Persons
and vessels will be prohibited from entering into, transiting through,
or anchoring within the safety zone unless authorized by the Captain of
the Port, or his designated representative.

D. Regulatory Analyses

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

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. We expect the economic
impact of this rule to be so minimal that a full Regulatory Evaluation
is unnecessary. The safety zone is of a limited duration, one hour, and
is limited to a relatively small geographic area.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities. This rule will affect the following entities, some of
which may be small entities: the owners or operators of vessels
intending to transit or anchor in the impacted portion of the San Diego
Bay on June 11, 2013 between 8:30 p.m. and 9:30 p.m.
    This rule will not have a significant economic impact on a
substantial number of small entities for the following reasons. The
safety zone will be in effect for a short duration, one hour, late at
night when vessel traffic is low. Additionally, vessel traffic can pass
around the safety zone.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine

compliance with, Federal regulations to the Small Business and
Agriculture Regulatory Enforcement Ombudsman and the Regional Small
Business Regulatory Fairness Boards. The Ombudsman evaluates these
actions annually and rates each agency's responsiveness to small
business. If you wish to comment on actions by employees of the Coast
Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not
retaliate against small entities that question or complain about this
rule or any policy or action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

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

6. Protest Activities

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

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

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

9. Civil Justice Reform

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

10. Protection of Children

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

11. Indian Tribal Governments

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

12. Energy Effects

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

13. Technical Standards

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

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves establishment of a safety zone. This
rule is categorically excluded from further review under paragraph
34(g) of Figure 2-1 of the Commandant Instruction. An environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T11-561 to read as follows:

Sec.  165.T11-561  Safety zone; When Pigs Fly Fireworks Display; San
Diego, CA.

    (a) Location. The limits of the safety zone will include all the
navigable waters within 600 feet of the nearest point of the fireworks
barge in approximate position 32 42'46.71'' N 117 10'39.44'' W.
    (b) Enforcement Period. This section will be enforced from 8:30
p.m. to 9:30 p.m. on June 11, 2013.
    (c) Definitions. The following definition applies to this section:
designated representative means any commissioned, warrant, or petty
officer of the Coast Guard on board Coast Guard, Coast Guard Auxiliary,
and local, state, and federal law enforcement vessels who have been
authorized to act on the behalf of the Captain of the Port.
    (d) Regulations. (1) Entry into, transit through or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port of San Diego or his designated representative.
    (2) Mariners requesting permission to transit through the safety
zone may request authorization to do so from the Sector San Diego
Command Center. The Command Center may be contacted on VHF-FM Channel
16.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or the designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, a flashing light, or other means, the operator of a
vessel shall proceed as directed.
    (5) The Coast Guard may be assisted by other federal, state, or
local agencies.

    Dated: May 1, 2013.
S.M. Mahoney,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2013-12652 Filed 5-28-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: April 16, 2008 (Volume 73, Number 74)]
[Notices]
[Page 20731-20732]
[DOCID:fr16ap08-123]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Approval of Noise Compatibility Program Cincinnati/Northern
Kentucky International Airport, Covington, KY

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice.

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SUMMARY: The Federal Aviation Administration (FAA) announces its
findings on the Noise Compatibility Program submitted by the Kenton
County Airport Board under the provisions of 49 U.S.C. (the Aviation
Safety and Noise Abatement Act, hereinafter referred to as ``the Act'')
and 14 CFR part 150. These findings are made in recognition of the
description of Federal and nonfederal responsibilities in Senate Report
No. 96-52 (1980). On October 9, 2007, the FAA determined that the noise
exposure maps submitted by the Kenton County Airport Board under Part
150 were in compliance with applicable requirements. On October 9,
2007, the FAA approved the Cincinnati/Northern Kentucky International
Airport noise compatibility program. Most of the recommendations of the
program were approved.

DATES: Effective Date: The effective date of the FAA's approval of the
Cincinnati/Northern Kentucky International Airport Noise Compatibility
Program is April 4, 2008.

FOR FURTHER INFORMATION CONTACT: Phillip Braden, Federal Aviation
Administration, Memphis Airports District Office, 2862 Business Park
Drive, Bldg G, Memphis, TN 38118-1555, phone number:<PHONE_NUMBER>.
Documents reflecting this FAA action may be reviewed at this same
location.

SUPPLEMENTARY INFORMATION: This notice announces that the FAA has given
its overall approval to the Noise Compatibility Program for Cincinnati/
Northern Kentucky International Airport, effective April 4, 2008.
    Under Section 47504 of the Act, an airport operator who has
previously submitted a Noise Exposure Map may submit to the FAA a Noise
Compatibility Program which sets forth the measures taken or proposed
by the airport operator for the reduction of existing non-compatible
land uses and prevention of additional non-compatible land uses within
the area covered by the Noise Exposure Maps. The Act requires such
programs to be developed in consultation with interested and affected
parties including local communities, government agencies, airport
users, and FAA personnel.
    Each airport noise compatibility program developed in accordance
with Federal Aviation Regulations (FAR) Part 150 is a local program,
not a Federal Program. The FAA does not substitute its judgment for
that of the airport operator with respect to which measure should be
recommended for action. The FM's approval or disapproval of FAR Part
150 program recommendations is measured according to the standards
expressed in FAR Part 150 and the Act, and is limited to the following
determinations:
    a. The Noise Compatibility Program was developed in accordance with
the provisions and procedures of FAR Part 150;
    b. Program measures are reasonably consistent with achieving the
goals of reducing existing non-compatible land uses around the airport
and preventing the introduction of additional non-compatible land uses;
    c. Program measures would not create an undue burden on interstate
or foreign commerce, unjustly discriminate against types or classes of
aeronautical uses, violate the terms of airport grant agreements, or
intrude into areas preempted by the Federal government; and
    d. Program measures relating to the use of flight procedures can be
implemented within the period covered by the program without derogating
safety, adversely affecting the efficient use and management of the
navigable airspace and air traffic control systems, or adversely
affecting other powers and responsibilities of the Administrator
prescribed by law.
    Specific limitations with respect to FAA's approval of an airport
Noise Compatibility Program are delineated in FAR Part 150, Section
150.5. Approval is not a determination concerning the acceptability of
land uses under Federal, state, or local law. Approval does not by
itself constitute an FAA implementing action. A request for Federal
action or approval to implement specific noise compatibility measures
may be required, and an FAA decision on the request may require an
environmental assessment of the proposed action. Approval does not
constitute a commitment by the FAA to financially assist in the
implementation of the program nor a determination that all measures
covered by the program are eligible for grant-in-aid funding from the
FAA. Where Federal funding is sought, requests for project grants must
be submitted to the FAA Airports District Office in Memphis, Tennessee.
    Kenton County Airport Board submitted to the FAA on February 21,
2007, the Noise Exposure Maps, descriptions, and other documentation
produced during the noise compatibility planning study conducted from
December 2003 through December 2006. The Cincinnati/Northern Kentucky
International Airport Noise Exposure Maps were determined by FAA to be
in compliance with applicable requirements on October 9, 2007. Notice
of this determination was published in the Federal Register on October
17, 2007.
    The Cincinnati/Northern Kentucky International Airport study
contains a proposed Noise Compatibility Program comprised of actions
designed for phased implementation by airport management and adjacent
jurisdictions from December 2006 beyond the year 2011. It was requested
that FAA evaluate and approve this material as a Noise Compatibility
Program as described in Section 47504 of the Act. The FM began its
review of the Program on October 9, 2007, and was required by a
provisions of the Act to approve or disapprove the program within 180-
days (other than the use of new or modified flight procedures for noise
control). Failure to approve or disapprove such program within the 180-
day period shall be deemed to be an approval of such program.
    The submitted program contained twenty-nine (29) proposed actions
for noise mitigation on and off the airport. Sixteen (16) previous
measures that were completed or withdrawn were also included for
numbering purposes. The FAA completed its review and determined that
the procedural and substantive requirements of the Act and FAR Part 150
have been satisfied.
    The overall program, therefore, was approved by the FAA effective
April 4, 2008. Outright approval was granted for twenty-two (22) of the
specific program elements. Six measures are approved with conditions
because the measures relate to changes in the nighttime preferential
runway use program or a departure procedure and require environmental
analysis, coordination of timing of implementation and revisions to the
Air Traffic Control Tower Order. One proposed measure was disapproved
for purposes of Part 150 because the measure would not reduce
incompatible land development within the DNL 65

dB contour and the NCP does not indicate that the airport sponsor has
selected land use guidelines different from those in Table I of Part
150.
    Fourteen of the measures pertaining to the operation of aircraft at
CVG were approved, or conditionally approved. Eight of these are
continuation of existing preferential operational measures. Two
existing measures relating to nighttime arrival and departure runway
priorities are approved to be withdrawn at the time three proposed
measures modifying the nighttime runway use program are implemented.
Because of changes in FAA requirements, one previously approved
operational procedure must be modified. The Kenton County Airport Board
is currently working with the Air Traffic Organization to develop a
refined departure procedure that will result in the same noise benefit
as the previously approved flight corridor consistent with FAA Order
8260.3B. The defined procedure, as modified, must be coordinated with
the appropriate FAA line of businesses before being published. The ANAV
procedure has not been implemented.
    Eleven (11) land use measures were approved for continuation or
continuation with modification to include additional area. Three
implementation measures were approved.
    These determinations are set forth in detail in a Record of
Approval signed by the FAA on April 4, 2008. The Record of Approval, as
well as other evaluation materials and the documents comprising the
submiftal, are available for review at the FAA office listed above and
at the administrative office of the Kenton County Airport Board. The
Record of Approval also will be available on-line at: http://
www.faa.gov//airportsairtraffic/airports/environmental/airportnoise/
part150/states/.

    Issued in Memphis, Tennessee on April 8, 2008.
Phillip J. Braden,
Manager, Memphis Airports District Office.
[FR Doc. E8-8056 Filed 4-15-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 77, Number 170 (Friday, August 31, 2012)]
[Rules and Regulations]
[Pages 53144-53150]
[FR Doc No: 2012-21354]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0116; FRL-9338-2]

Nitric Acid; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of nitric acid (CAS Reg. No. 7697-37-2)
when used as an inert ingredient in antimicrobial pesticide
formulations applied to food-contact surfaces in public eating places,
dairy processing equipment, and food-processing equipment and utensils
at a maximum level in the end-use concentration of 1,000 parts per
million (ppm). Ecolab Inc. submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment
of an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of nitric acid.

DATES: This regulation is effective August 31, 2012. Objections and
requests for hearings must be received on or before October 30, 2012,
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-2012-0116, is available at http://www.regulations.gov or at the OPP Docket in the Environmental
Protection Agency Docket Center (EPA/DC), located in EPA West, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lisa Austin, 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.
Potentially affected entities may include, but are not limited to:
     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 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-2012-0116 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
October 30, 2012. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2012-0116, 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), Mail Code: 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.

II. Petition for Exemption

    In the Federal Register of April 7, 2000 (65 FR 18324) (FRL-6499-
7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 9E6029) by
Ecolab Inc., 370 N. Wabasha Street, St. Paul, MN 55102. The petition
requested that 40 CFR 180.940 be amended by establishing an exemption
from the requirement of a tolerance for residues of nitric acid (CAS
Reg. No. 7697-37-2) when used as an inert ingredient in antimicrobial
pesticide formulations applied to food-contact surfaces in public
eating places, dairy processing equipment, and food-processing
equipment and utensils at a maximum level in the end-use concentration
of 1,000 parts per million (ppm). That notice referenced a summary of
the petition prepared by Ecolab Inc., the petitioner, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for 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 * * *.''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that

occur as a result of pesticide use in residential settings. If EPA is
able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with section 408(c)(2)(A) of FFDCA, and the factors
specified in FFDCA section 408(c)(2)(B), 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 nitric acid including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with nitric acid follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
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. Specific information on the studies received and the nature
of the adverse effects caused by nitric acid as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this
unit.
    Nitric acid is a highly corrosive inorganic acid. In a concentrated
form, nitric acid is corrosive at the site of contact and does not
elicit systemic toxicity. Acute dermal and eye exposures to
concentrated forms of nitric acid can result in skin burns and
irreversible eye corrosion. Acute inhalation exposure to nitric acid
can result in severe respiratory irritation followed by pulmonary
edema. Acute ingestion of nitric acid may result in ulceration,
hemorrhage and perforation of the esophagus and stomach.
    The U.S. Occupational Safety and Health Administration (OSHA)
Permissible Exposure Limit (PEL) for nitric acid as well as the
American Conference of Governmental Industrial Hygienists (ACGIH)
Threshold Limit Value (TLV) for nitric acid is 2 ppm (5 milligrams/
meter (mg/m\3\)).
    While there are no data on the toxicity of dilute forms of nitric
acid following oral exposure, the toxicity of dilute nitric acid would
be expected to be comparable to the toxicity of the NO3-
anion known as nitrate.
    Sodium nitrate. Several studies were available for sodium nitrate.
These studies included a 6-week oral toxicity range-finding study,
chronic/carcinogenicity studies in rodents and a 2-generation toxicity
study in rabbits. In a 6-week oral toxicity study in F344 rats, sodium
nitrate was administered in the diet. Signs of toxicity were manifested
as decreased body weight gain at =5% (approximately 2,500
milligrams/kilograms/day (mg/kg/day)). In the International Agency for
Research On Cancer (IARC) Monographs on the Evaluation of Carcinogenic
Risks to Humans (Vol 94), the carcinogenic potential of sodium nitrate
was evaluated in several studies in rodents. In two studies in mice, no
evidence of carcinogenic activity of sodium nitrate alone was observed
in the drinking water at concentrations up to approximately 5,000 mg/
kg/day. In four studies in rats, no increased incidence of tumors was
observed when sodium nitrate alone was administered in the drinking
water or in the diet at concentrations up to approximately 2,500 mg/kg/
day. Therefore, IARC concluded that there is inadequate evidence in
humans for the carcinogenicity of nitrate in food or drinking water.
    There were no treatment related effects observed in the 2-
generation reproduction study in rabbits. In addition, the Food and
Drug Administration (FDA) sponsored several reproductive and
developmental studies in rodents, hamsters and rabbits treated with
sodium nitrate. No adverse effects were observed in maternal
reproductive parameters nor was there fetotoxicity or fetal
malformations up to the maximum doses tested in each species (41 mg/kg/
day in mice and hamsters and 66 mg/kg/day in rats and rabbits).
    Immunotoxicity studies for nitric acid were not available for
review. However, there was no evidence of potential immunotoxicity in
any of the submitted studies. Therefore, nitric acid is not expected to
be immunotoxic.
    There were three human epidemiological studies available for
review. These epidemiological studies reported that cases of infant
methemoglobinemia are associated with exposure to nitrate in drinking
water. The American Public Health Association (APHA) conducted a survey
to identify clinical cases of infantile methemoglobinemia that were
associated with ingestion of nitrate-contaminated water. They concluded
that greater incidences of methemoglobinemia were observed in infants
consuming >1.8 mg/kg/day of sodium nitrate. Methemoglobinemia was not
observed in any of the studies where infants consumed water containing
less than 1.6 mg/kg/day of sodium nitrate.
    Specific information on the studies received and the nature of the
adverse effects caused by nitric acid 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 ``Nitric Acid; Human Health Risk
Assessment and Ecological Effects Assessment to Support Proposed
Exemption from the Requirement of a Tolerance When Used as Inert
Ingredients in Pesticide Formulations,'' pp. 9-26 in docket ID number
EPA-HQ-OPP-2012-0116.

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.
    The chronic reference dose (cRfD) of 1.6 mg/kg/day and an
uncertainty factor of 1X were established based on the results of the
American Public Health Association's epidemiology study in infants. The
endpoint was based on the concentration of sodium nitrate (1.6 mg/kg/
day) in water at which methemoglobinemia was not observed in infants.
Data from this study represented the most sensitive endpoint

in the most sensitive population; therefore, the standard uncertainty
factors were reduced to 1X.
    A summary of the toxicological endpoints for nitric acid used for
human risk assessment is shown in the Table of this unit.

      Table --Summary of Toxicological Doses and Endpoints for Nitric Acid for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                      Point of departure and
         Exposure/scenario              uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors                assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (all populations)....  There were no effects that could be attributed to a single dose in the
                                      database. Therefore, an acute dietary assessment was not necessary.
Chronic dietary (All populations)..  NOAEL= 1.6 mg/kg/day     Chronic RfD = 1.6 mg/   APHA Human Epidemiological
                                     UFA = 1x                  kg/day                  Survey LOAEL = 1.8-3.2 mg/
                                     UFH = 1x                 cPAD = 1.6 mg/kg/day     kg/day based on early
                                     FQPA SF = 1x                                      clinical signs of
                                                                                methemoglobinemia in
                                                                                excess of 10% in 0-3
                                                                                months old infants.
Incidental oral short-term (1 to 30  NOAEL= 1.6 mg/kg/day     LOC for MOE = 1         APHA Human Epidemiological
 days).                              UFA = 1x                                          Survey LOAEL = 1.8-3.2 mg/
                                     UFH = 1x                                          kg/day based on early
                                     FQPA SF = 1x                                      clinical signs of
                                                                                methemoglobinemia in
                                                                                excess of 10% in 0-3
                                                                                months old infants.
Incidental oral intermediate-term    NOAEL= 1.6 mg/kg/day     LOC for MOE = 1         APHA Human Epidemiological
 (1 to 6 months).                    UFA = 1x                                          Survey LOAEL = 1.8-3.2 mg/
                                     UFH = 1x                                          kg/day based on early
                                     FQPA SF = 1x                                      clinical signs of
                                                                                methemoglobinemia in
                                                                                excess of 10% in 0-3
                                                                                months old infants.
Dermal short-term (1 to 30 days)...  NOAEL= 1.6 mg/kg/day     LOC for MOE = 1         APHA Human Epidemiological
                                     UFA = 1x                                          Survey LOAEL = 1.8-3.2 mg/
                                     UFH = 1x                                          kg/day based on early
                                     FQPA SF = 1x                                      clinical signs of
                                                                                methemoglobinemia in
                                                                                excess of 10% in 0-3
                                                                                months old infants.
Dermal intermediate-term (1 to 6     NOAEL= 1.6 mg/kg/day     LOC for MOE = 1         APHA Human Epidemiological
 months).                            UFA = 1x                                          Survey LOAEL = 1.8-3.2 mg/
                                     UFH = 1x                                          kg/day based on early
                                     FQPA SF = 1x                                      clinical signs of
                                                                                methemoglobinemia in
                                                                                excess of 10% in 0-3
                                                                                months old infants.
Inhalation short-term (1 to 30       NOAEL= 1.6 mg/kg/day     LOC for MOE = 1         APHA Human Epidemiological
 days).                               (inhalation absorption                           Survey LOAEL = 1.8-3.2 mg/
                                      rate = 100%)                                     kg/day based on early
                                     UFA = 1x                                          clinical signs of
                                     UFH = 1x                                          methemoglobinemia in
                                     FQPA SF = 1x                                      excess of 10% in 0-3
                                                                                months old infants.
Inhalation (1 to 6 months).........  NOAEL= 1.6 mg/kg/day     LOC for MOE = 1         APHA Human Epidemiological
                                      (inhalation absorption                           Survey LOAEL = 1.8-3.2 mg/
                                      rate = 100%)                                     kg/day based on early
                                     UFA = 1x                                          clinical signs of
                                     UFH = 1x                                          methemoglobinemia in
                                     FQPA SF = 1x                                      excess of 10% in 0-3
                                                                                months old infants.
Cancer (Oral, dermal, inhalation)..  Not likely to be carcinogenic based on the lack of evidence of
                                      carcinogenicity in the submitted studies.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    In evaluating dietary exposure to nitric acid, EPA considered
exposure under the petitioned-for exemption from the requirement of a
tolerance. EPA assessed dietary exposures from nitric acid in food as
follows:
    The requested exemption from the requirement of a tolerance for the
use of nitric acid could allow for uses in food contact surface
sanitizing solutions in which residues of nitric acid could migrate to
food or otherwise be ingested.
    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to nitric acid, EPA considered exposure under the proposed
exemption from the requirement of a tolerance. In the absence of actual
dietary exposure data resulting from this use, the EPA has utilized a
conservative, health-protective method of estimating dietary intake
that is based upon conservative assumptions related to the amount of
residues that can be transferred to foods as a result of the proposed
use of nitric acid in food contact sanitizing pesticide products. This
same methodology has been utilized by EPA in estimating dietary
exposures to antimicrobial pesticides used in food-handling settings. A
complete description of the approach used to assess dietary exposures
resulting from food contact sanitizing solution uses of nitric acid can
be found at http://www.regulations.gov in document ``Nitric Acid; Human
Health Risk Assessment and Ecological Effects Assessment to Support
Proposed Exemption from the Requirement of a Tolerance When Used as
Inert Ingredients in Pesticide Formulations,'' pp. 9-26 in docket ID
number EPA-HQ-OPP-2012-0116.
    EPA assessed dietary exposures from nitric acid in food as follows:
    i. Acute exposure. No adverse effects attributable to a single
exposure of nitric acid were seen in the toxicity databases. Therefore,
an acute dietary exposure assessment for nitric acid is not necessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, the Agency believes the assumptions used to estimate
chronic dietary exposures lead to an extremely conservative assessment
of chronic dietary risk due to a series of compounded conservatisms.
First, when a surface is treated with a disinfectant, a quantity of the
disinfectant remains on the surface (Residual Solution). In the absence
of any other data, EPA has used

an estimated worst-case concentration of 1 mg of solution per square
centimeter (cm) of treated surface area for this quantity.
    Second, the conservatism of this methodology is compounded by EPA's
decision to assume a worst case scenario that all food that an
individual consumes will come into contact with 4,000 cm\2\ of
sanitized non-porous food-contact surfaces. This contact area
represents all the surface area from silverware, china, and glass used
by a person who regularly eats three meals per day at an institutional
or public facility. The surface area of counter tops that comes in
contact with food is expected to be smaller than the surface area for
food utensils. As a conservative estimate, EPA assumed that 2,000 cm\2\
of treated counter top surface area, comes into contact with an
individual's food per day.
    Third, EPA assumes that 100% of the material present on food
contact surfaces will migrate to food.
    iii. Cancer. Sodium nitrate did not cause an increase in tumors in
rodents at doses up to 2,500 mg/kg/day. Therefore, based on the weight
of evidence, nitric acid is not likely to cause cancer in humans and a
cancer dietary exposure assessment is not necessary to assess cancer
risk.
    2. Dietary exposure from drinking water. The proposed use of nitric
acid will not result in its presence in surface water or ground water
and therefore not contribute to dietary exposure.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables).
    Nitric acid is not used as an inert ingredient in pesticide
products that are registered for specific uses that may result in both
indoor and outdoor residential exposures. Therefore, a residential
exposure and risk assessment was not conducted for nitric acid.
    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 nitric acid to share a common mechanism of
toxicity with any other substances, and nitric acid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
nitric acid 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 Food Quality
Protection Act (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. There is no concern for
fetal susceptibility. There were no treatment related effects observed
in the 2-generation reproduction study in rabbits. Also, the FDA
sponsored several reproductive and developmental studies in rodents,
hamsters and rabbits treated with sodium nitrate. No adverse effects
were observed in maternal reproductive parameters nor was there
fetotoxicity or fetal malformations up to the maximum doses tested in
each species (41 mg/kg/day in mice and hamsters and 66 mg/kg/day in
rats and rabbits). Fetal susceptibility was not observed in these any
of these studies. Therefore, there are no concerns for residual
uncertainties concerning prenatal and postnatal toxicity.
    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 nitric acid is adequate as it is based
on the use of sodium nitrate data for which there is a robust toxicity
database. The NOAEL used for risk assessment was derived from the
critical toxic effect in the most sensitive human subpopulation
(infants age 8 days to 5 months).
    ii. There is no indication that nitric acid 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 indication that nitric acid is a immunotoxic
chemical and there is no need additional UFs to account for
immunotoxicity.
    iv. There is no evidence that nitric acid results in increased
susceptibility in in utero rodents. Several reproductive and
developmental studies in rodents, hamsters and rabbits showed no
evidence of increased fetal susceptibility at doses as high as 41 mg/
kg/day in mice and hamsters and 66 mg/kg/day in rats and rabbits.
Further, although effects in infants were found in an epidemiological
study, the cRfD (1.6 mg/kg/day) is based on a clear NOAEL established
in that study.
    v. There are no residual uncertainties identified in the exposure
databases. EPA made conservative (protective) assumptions regarding
dietary exposure to nitric acid. This assessment will not underestimate
the exposure and risks posed by nitric acid.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
nitric acid is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
nitric acid from dietary exposure will utilize 24% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for nitric acid.

    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).
    Because no short-term adverse effect was identified, nitric acid is
not expected to pose a short-term risk.
    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).
    Because no intermediate-term adverse effect was identified, nitric
acid is not expected to pose an intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in adequate rodent carcinogenicity studies,
nitric acid is not expected to pose a cancer risk to humans.
    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 nitric acid residues under reasonably foreseeable
circumstances. Therefore, the establishment of an exemption from
tolerance under 40 CFR 180.940(a) for residues of nitric acid when used
as an inert ingredient in pesticide formulations applied to food-
contact surfaces in public eating places, dairy processing equipment,
and food-processing equipment and utensils at a maximum level in the
end-use concentration of 1,000 ppm, is safe under FFDCA section 408.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

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 U.N. 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 nitric acid.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.940(a) for nitric acid (CAS No. 7697-37-2)
when used as an inert ingredient in pesticide formulations applied to
food-contact surfaces in public eating places, dairy processing
equipment, and food-processing equipment and utensils at a maximum
level in the end-use concentration of 1,000 ppm.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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: August 17, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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.  180.940(a), the table is amended by adding alphabetically
the following inert ingredient to read as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).

* * * * *
    (a) * * *

------------------------------------------------------------------------
       Pesticide chemical         CAS Reg. No.            Limits
------------------------------------------------------------------------

                              * * * * * * *
Nitric acid....................       7697-37-2  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 1,000
                                                  ppm.

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

* * * * *
[FR Doc. 2012-21354 Filed 8-30-12; 8:45 am]
BILLING CODE 6560-50-P