EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: [insert name and telephone number with area code]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

TEMPLATE:

AgroSpheres, Inc.

[IN-11585]

	EPA has received a pesticide petition ([IN-11585]) from AgroSpheres, Inc., 1180 Seminole Trail, Charlottesville, VA, USA, 22901 requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.910.

(Options (pick one)           1. by establishing a tolerance for residues of NA-Remove

	2. to establish an exemption from the requirement of a tolerance for Escherichia coli K-12 derived micelles, a biologically derived inert ingredient under 40 CFR §180.910 for pre- or post-harvest use without restriction when used as an inert ingredient for all agriculture uses, including to protect and retard the release of pesticidal active ingredients, pesticide formulations, and non-pesticide agriculture products, for use on all food, feed, and nonfood crops and agriculture commodities. EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

in or on the raw agricultural commodity at parts per million (ppm).  NA-Remove

A. Residue Chemistry

	1. Plant metabolism. AgroSpheres is a new inert ingredient product comprised of bacterial bilayer membrane spheres (micelles) derived from a non-viable, non-toxigenic and nonpathogenic, enfeebled strain of E. coli K-12. This inert is considered to be minimal risk and microbially-derived.  Due to the physical size and chemical composition of AgroSpheres, plants are not capable of absorption or uptake of this inert ingredient and therefore plant metabolism studies for AgroSpheres are not necessary to establish crop residue data. The company is requesting an exemption from the requirement of a tolerance, and therefore plant metabolism studies are not required.

	2. Analytical method. Data and literature provided in support of the inert submission and this Petition, supports that the AgroSpheres inert qualifies for an exemption from the requirement of a tolerance without restriction.  Establishing methods for removal and detection of residues are therefore not necessary for this product.

 	3. Magnitude of residues. There is no basis to evaluate the residue remaining on the food or on requiring an analytical method for the detection of the AgroSpheres inert ingredient.

B. Toxicological Profile

	1. Acute toxicity. Toxicological analyses for AgroSpheres included literature on the safety of E. coli K-12 and constituents in current use, safety reviews by EPA and FDA of living E. coli K-12 and constituents, and empirical data using AgroSpheres in oral and inhalation toxicity studies, as well as margin-of-exposure calculations.

As confirmatory data for the finished AgroSpheres product, an acute oral toxicity test was conducted with rats to determine the potential for the AgroSpheres inert to produce toxicity from a single dose via the oral route of exposure.  An initial limit dose of 5,000 mg/kg was administered.  All animals survived the test substance administration, gained body weight, and appeared active and healthy during the study.  Under the conditions of this study, the acute oral LD50 of the test substance is greater than 5,000 mg/kg of body weight in female rats (EPA Category IV).

An additional acute inhalation toxicity test was conducted with rats to determine the potential for AgroSpheres to produce toxicity from a single exposure via the inhalation (nose-only exposure) route.  All animals survived exposure to the test atmosphere and gained body weight during the study. Under the conditions of this study, the acute inhalation LC50 of the test substance is >0.55 mg/L in male and female rats (EPA Category III).

A safety assessment was also conducted for lipopolysaccharide activity in the AgroSpheres K-12-derived inert, that considered the routes and extent of exposure from the intended use, the results of oral and inhalation toxicity studies for AgroSpheres, and the established literature regarding endotoxin safety including its ubiquitous presence from gram-negative microorganisms in the human gut, agricultural soil and air.  This assessment concluded that there are no adverse toxigenic effects associated with the proper use of the AgroSpheres inert, even when exposed at very high doses.

Additional toxicity and metabolism studies were deemed to be unnecessary based on the biological and nontoxic nature of the inert material, extensive history of safe use and prior regulatory review of the parental E. coli K-12 organism, the acute toxicity studies using the AgroSpheres inert material, and based on relevant exposures for the intended use as an inert ingredient in pesticidal and nonpesticidal agriculture formulations.  Taken together, this information provides sufficient evidence that the use of this inert ingredient does not pose any unreasonable risk to humans.

	2. Genotoxicty. [NA-Remove]

	3. Reproductive and developmental toxicity. [NA-Remove]

	4. Subchronic toxicity. [NA-Remove]

	5. Chronic toxicity. [NA-Remove]

	6. Animal metabolism. [NA-Remove]

	7. Metabolite toxicology. [NA-Remove]

	8. Endocrine disruption. [NA-Remove]

C. Aggregate Exposure

	1. Dietary exposure.

AgroSpheres is intended as an inert ingredient in agriculture formulations and potential dietary exposures pose no identifiable hazards.  Evaluation of the risks associated with exposure to AgroSpheres includes the extensive history of safe use of the parental organism for over 50 years; two preexisting comprehensive regulatory reviews of E. coli K-12; literature confirming that that oral exposure to either living E. coli K-12 or to lipopolysaccharides/endotoxins from E. coli K-12 is nonhazardous and nonpathogenic; information that nonpathogenic strains of E. coli are a normal part of the gastrointestinal tract of humans; knowledge that measurable residues of large quantities of deactivated E. coli K-12 components applied in agriculture fields disappear within weeks; and the results of acute toxicity studies on the AgroSpheres inert establishing large margins of exposures by either oral or inhalation routes exposure.     	i. Food. Oral exposure, use rates, residues.  AgroSpheres is intended as an inert ingredient in agriculture formulations. Potential dietary exposures based on the highest anticipated use rate of 5kg AgroSpheres ingredient per acre were analyzed and found to pose no unreasonable risks. The determination of residues was not deemed necessary due to the low hazard of the material and the anticipated short lifespan of bacterial membrane derived material in the agriculture environment.  An extensive body of literature and the EPA review of E. coli K-12 have identified that the live organism and constituents thereof pose no identified oral hazard to humans.  An acute oral study was conducted using AgroSpheres in rats to confirm the prior safety assessments of E. coli K-12 apply to the AgroSpheres inert.  The acute oral LD50 of AgroSpheres is greater than 5000 mg/kg in female rats (EPA Category IV).  Therefore, the presence of AgroSpheres in or on food at any reasonable level within good agriculture practices poses no identifiable hazard.     	ii. Drinking water. NA-Remove

	2. Non-dietary exposure.  Nonfood exposures could occur in handling treated agriculture products, by inhalation during mixing/loading operations, and by end-product application within the anticipated use range between ~0.25 and 5kg AgroSpheres ingredient per acre. Contact exposure is expected to be limited by formulators and handlers when used as part of a pesticide or other agriculture formulations which likely include personal protective equipment (PPE) and specific handling requirements for those products.  Considering a potential inhalation exposure, an acute inhalation toxicity test was conducted with rats to determine the potential for AgroSpheres to produce toxicity from a single exposure via the inhalation route.  All animals survived exposure to the test atmosphere and gained body weight during the study and appeared active and healthy for the remainder of the 14-day observation period.  Under the conditions of this study, the acute inhalation LC50 of the test substance is greater than 0.55 mg/L in male and female rats.

D. Cumulative Effects.  AgroSpheres is a labile biological material and will be quickly broken down into basic nutrients by sunlight and microbial action in the field or after harvest. AgroSpheres would not accumulate or bioaccumulate in plants, animals, or the environment due to its molecular characteristics and its organic chemical nature as food for microorganisms.

E. Safety Determination

	1. U.S. population. This inert submission request for an exemption from the requirement of a tolerance establishes and confirms the safety of AgroSpheres for the intended use as an inert ingredient in agriculture products.  The key elements of the safety determination for the AgroSpheres inert ingredient and its intended use, is based on the significant precedence based on E. coli K-12 and product specific information.  As a result of these considerations, the microbial-derived inert ingredient is considered to be of minimal risk and appropriate for the exemption from the need for food tolerances.  This petition establishes that there is reasonable certainty of safety, to health and the environment, from the use of AgroSpheres inert ingredient under conditions of its intended use as a microbial-derived inert ingredient in pesticide formulations.

Large margins of exposure were calculated for potential inhalation by workers exposed to the AgroSpheres inert ingredient.  Margin of exposures (MOE) for the inhalation route of exposure were based on the No Effect Level observed in the acute inhalation study in rats and potential exposures in a work environment (mixers/loaders and applicators) using the maximum anticipated use rate.  The MOE for workers who mixed/loaded product for an application on 100 acres were in excess of 600X and substantially higher when respiratory PPE was used.  For applicators, the MOEs were substantially higher.  Considering oral consumption, the MOEs are sufficiently large for all population subgroups.  For the 99[th] percentile values, the range was from 1,985 (Children, 1-2 years) to 9,451 (Male, 20+ years).  The MOE value for the Total U.S. Population is 4,662 using very conservative high exposure assumptions.  Thus, the actual MOEs for the AgroSpheres inert ingredient would be substantially higher than these worst-case calculated values.

It is concluded that the information provided in this petition and accompanying toxicology and ecotoxicology data and analysis supports the use of the AgroSpheres inert product be granted an exemption from the requirement of a tolerance for the intended uses without restriction.

	2. Infants and children.  Large safety Margins of Exposure (1,985X minimum) were calculated for dietary exposures for infants and children using highly conservative estimates of exposure.

F. International Tolerances.  NA-Remove


[Federal Register Volume 87, Number 54 (Monday, March 21, 2022)]
[Notices]
[Pages 16010-16012]
[FR Doc No: 2022-05923]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2022-0002; Internal Agency Docket No. FEMA-B-2224]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Federal
Regulations. The currently effective community number is shown in the
table below and must be used for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood

hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

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                                                         Chief executive                         Online location of
        State and county           Location and case       officer of         Community map        letter of map       Date of modification   Community
                                          No.               community          repository             revision                                   No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Arizona: Santa Cruz.............  Unincorporated       The Honorable       Santa Cruz County   https://msc.fema.gov/  May 31, 2022.........       040090
                                   Areas of Santa       Manuel Ruiz,        Flood Control       portal/advanceSearch.
                                   Cruz County (21-09-  Chairman, Board     District,
                                   1967P).              of Supervisors,     Gabilondo-
                                                        Santa Cruz          Zehentner
                                                        County, 2150        Building, 275 Rio
                                                        North Congress      Rico Drive, Rio
                                                        Drive #119,         Rico, AZ 85648.
                                                        Nogales, AZ 85621.
California:
    Fresno......................  City of Clovis (21-  The Honorable Jose  City Clerk's        https://msc.fema.gov/  May 23, 2022.........       060044
                                   09-0911P).           Flores, Mayor,      Office, Civic       portal/advanceSearch.
                                                        City of Clovis,     Center, 1033 5th
                                                        1033 5th Street,    Street, Clovis,
                                                        Clovis, CA 93612.   CA 93612.
    Monterey....................  City of Seaside (21- The Honorable Ian   Public Works        https://msc.fema.gov/  Jun. 6, 2022.........       060203
                                   09-1503P).           Oglesby, Mayor,     Department, 610     portal/advanceSearch.
                                                        City of Seaside,    Olympia Avenue,
                                                        440 Harcourt        Seaside, CA 93955.
                                                        Avenue, Seaside,
                                                        CA 93955.
    Riverside...................  City of Banning (21- The Honorable Kyle  Public Works        https://msc.fema.gov/  May 31, 2022.........       060246
                                   09-0855P).           Pingree, Mayor,     Department, 99      portal/advanceSearch.
                                                        City of Banning,    East Ramsey
                                                        99 East Ramsey      Street, Banning,
                                                        Street, Banning,    CA 92220.
                                                        CA 92220.
    San Diego...................  City of San Diego    The Honorable Todd  Development         https://msc.fema.gov/  Jun. 30, 2022........       060295
                                   (21-09-1675P).       Gloria, Mayor,      Services            portal/advanceSearch.
                                                        City of San         Department, 1222
                                                        Diego, 202 C        1st Avenue, MS
                                                        Street, 11th        301, San Diego,
                                                        Floor, San Diego,   CA 92101.
                                                        CA 92101.
Illinois:
    Cook........................  Village of Wheeling  The Honorable       Village Hall,       https://msc.fema.gov/  Jun. 23, 2022........       170173
                                   (21-05-4442P).       Patrick Horcher,    Community           portal/advanceSearch.
                                                        Village             Development
                                                        President,          Engineering
                                                        Village of          Division, 2
                                                        Wheeling, 2         Community
                                                        Community           Boulevard,
                                                        Boulevard,          Wheeling, IL
                                                        Wheeling, IL        60090.
                                                        60090.
    Putnam......................  Village of Hennepin  The Honorable       Village Hall, 627   https://msc.fema.gov/  Jun. 23, 2022........       170570
                                   (22-05-0122P).       Kevin J. Coleman,   East High Street,   portal/advanceSearch.
                                                        Mayor, Village of   Hennepin, IL
                                                        Hennepin, 627       61327.
                                                        East High Street,
                                                        Hennepin, IL
                                                        61327.
Iowa:
    Iowa........................  City of Marengo (21- The Honorable Adam  City Hall, 153      https://msc.fema.gov/  Mar. 10, 2022........       190157
                                   07-1041P).           Rabe, Mayor, City   East Main Street,   portal/advanceSearch.
                                                        of Marengo, P.O.    Marengo, IA 52301.
                                                        Box 245, Marengo,
                                                        IA 52301.
    Iowa........................  Unincorporated       The Honorable John  Iowa County,        https://msc.fema.gov/  Mar. 10, 2022........       190878
                                   Areas of Iowa        Gahring, Chair,     Auditor's Office,   portal/advanceSearch.
                                   County (21-07-       Board of            970 Court Avenue,
                                   1041P).              Supervisors, Iowa   Marengo, IA 52301.
                                                        County, 970 Court
                                                        Avenue, Marengo,
                                                        IA 52301.
Louisiana: Calcasieu Parish.....  Unincorporated       Mr. Bryan C. Beam,  Calcasieu Parish,   https://msc.fema.gov/  May 23, 2022.........       220037
                                   Areas of Calcasieu   Parish              Planning and        portal/advanceSearch.
                                   Parish (21-06-       Administrator       Development
                                   1326P).              Calcasieu Parish,   Department, 901
                                                        1015 Pithon         Lake Shore Drive,
                                                        Street, 2nd         Lake Charles, LA
                                                        Floor, Lake         70601.
                                                        Charles, LA 70602.
Michigan:

    Washtenaw...................  Township of Dexter   Ms. Diane           Township Hall,      https://msc.fema.gov/  May 6, 2022..........       260536
                                   (22-05-0189P).       Ratkovich,          6880 Dexter-        portal/advanceSearch.
                                                        Supervisor,         Pinckney Road,
                                                        Township of         Dexter, MI 48130.
                                                        Dexter, 6880
                                                        Dexter-Pinckney
                                                        Road, Dexter, MI
                                                        48130.
    Washtenaw...................  Township of          Mr. Kenneth Dignan  Northfield          https://msc.fema.gov/  May 6, 2022..........       260635
                                   Northfield (22-05-   III, Supervisor,    Township Hall, 75   portal/advanceSearch.
                                   0189P).              Township of         Barker Road,
                                                        Northfield, 8350    Whitmore Lake, MI
                                                        Main Street,        48189.
                                                        Whitmore Lake, MI
                                                        48189.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2022-05923 Filed 3-18-22; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 75, Number 233 (Monday, December 6, 2010)]
[Rules and Regulations]
[Pages 75626-75627]
[FR Doc No: 2010-30483]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2009-0751-201054(c); FRL-9235-5]

Approval and Promulgation of Implementation Plans; North
Carolina: Hickory-Morganton-Lenoir; Determination of Attaining Data for
the 1997 Fine Particulate Matter Standard; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; correcting amendment.

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SUMMARY: On January 5, 2010, EPA published a final rule determining
that the Hickory-Morganton-Lenoir nonattainment area (hereafter
referred to as the ``Hickory Area'') has attaining data for the 1997
fine particulate matter (PM2.5) National Ambient Air Quality
Standard (NAAQS). This action corrects a typographical error in the
regulatory language in paragraph (f) of EPA's January 5, 2010, final
rule.

DATES: This action is effective December 6, 2010.

ADDRESSES: Copies of the documentation used in the action being
corrected are available for inspection during normal business hours at
the following location: U.S. Environmental Protection Agency, Region 4,
61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. The Regional
Office's official hours of business are Monday through Friday, 8:30 to
4:30, excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Ms. Lynorae Benjamin, Chief,
Regulatory Development Section, Air Planning Branch, Air, Pesticides
and Toxics Management Division, U.S. Environmental Protection Agency,
Region 4, 61 Forsyth Street, SW., Atlanta, Georgia 30303-8960. Ms.
Benjamin can be reached at<PHONE_NUMBER>, or via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This action corrects a typographical error
in the regulatory language for an entry that appears in paragraph (f)
of North Carolina's Identification of Plan at 40 CFR 52.1781. The final
action, which determined that the Hickory Area has attaining data for
the 1997 PM2.5 NAAQS, was approved by EPA on January 5, 2010
(75 FR 230). However, EPA inadvertently cited 40 CFR 52.1004(c) as the
section of the Code of Federal Regulations (CFR) that suspends the
requirements for areas attaining the 1997 PM2.5 NAAQS to
submit an attainment demonstration, associated reasonably available
control measures, a reasonable further progress plan, contingency
measures, and other planning State implementation plans related to
attainment of the PM2.5 NAAQS. The correct citation is 40
CFR 51.1004(c). Therefore, EPA is correcting this typographical error
by inserting 51.1004(c) into paragraph (f) of 40 CFR 52.1781.
    EPA has determined that today's action falls under the ``good
cause'' exemption in section 553(b)(3)(B) of the Administrative
Procedure Act (APA) which, upon finding ``good cause,'' authorizes
agencies to dispense with public participation where public notice and
comment procedures are impracticable, unnecessary, or contrary to the
public interest. Public notice and comment for this action are
unnecessary because today's action to correct an inadvertent error
contained in paragraph (f) of 40 CFR 52.1781 of the rulemaking and has
no substantive impact on EPA's January 5, 2010,

approval. In addition, EPA can identify no particular reason why the
public would be interested in being notified of the correction, or in
having the opportunity to comment on the correction prior to this
action being finalized, since this correction action does not change
the meaning of EPA's analysis or action to approve the addition of
paragraph (f) to 40 CFR 52.1781.
    EPA also finds that there is good cause under APA section 553(d)(3)
for this correction to become effective on the date of publication of
this action. Section 553(d)(3) of the APA allows an effective date less
than 30 days after publication ``as otherwise provided by the agency
for good cause found and published with the rule.'' 5 U.S.C. 553(d)(3).
The purpose of the 30-day waiting period prescribed in APA section
553(d)(3) is to give affected parties a reasonable time to adjust their
behavior and prepare before the final rule takes effect. Today's rule,
however, does not create any new regulatory requirements such that
affected parties would need time to prepare before the rule takes
effect. Rather, today's action merely corrects a typographical error in
paragraph (f) of a prior rulemaking by correcting the citation as
identified above in 40 CFR 52.1781 in a revision, which EPA approved on
January 5, 2010. For these reasons, EPA finds good cause under APA
section 553(d)(3) for this correction to become effective on the date
of publication of this action.

Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely corrects a typographical error in paragraph (f) of a prior
rulemaking by correcting the citation as identified above in 40 CFR
52.1781, which EPA approved on January 5, 2010, and imposes no
additional requirements beyond those imposed by State law. Accordingly,
the Administrator certifies that this rule will not have a significant
economic impact on a substantial number of small entities under the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule
merely corrects an inadvertent error in paragraph (f) of a prior rule,
and does not impose any additional enforceable duty beyond that
required by State law, it does not contain any unfunded mandate or
significantly or uniquely affect small governments, as described in the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule also does not have Tribal implications because it will
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, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This rule also does not have Federalism
implications because it does not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This rule merely corrects a typographical
error in paragraph (f) of a prior rulemaking by correcting the citation
as identified above in 40 CFR 52.1781 in a revision which EPA approved
on January 5, 2010, and does not alter the relationship or the
distribution of power and responsibilities established in the Clean Air
Act (CAA). This rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it is not economically
significant. In addition, this rule does not involve technical
standards, thus the requirements of section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do
not apply. This rule also does not impose an information collection
burden under the provisions of the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. section 801 et seq., as
added by the Small Business Regulatory Enforcement Fairness Act of
1996, generally provides that before a rule may take effect, the agency
promulgating the rule must submit a rule report, which includes a copy
of the rule, to each House of the Congress and to the Comptroller
General of the United States. EPA will submit a report containing this
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. A major rule
cannot take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by February 4, 2011. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements. (See CAA section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Particulate matter.

    Dated: November 17, 2010.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart II--North Carolina

0
2. Section 52.1781 is amended by revising paragraph (f) to read as
follows:

Sec.  52.1781  Control strategy: Sulfur oxides and particulate matter.

* * * * *
    (f) Determination of Attaining Data. EPA has determined, as of
January 5, 2010, the Hickory-Morganton-Lenoir, North Carolina,
nonattainment area has attaining data for the 1997 PM2.5
NAAQS. This determination, in accordance with 40 CFR 51.1004(c),
suspends the requirements for this area to submit an attainment
demonstration, associated reasonably available control measures, a
reasonable further progress plan, contingency measures, and other
planning SIPs related to attainment of the standard for as long as this
area continues to meet the 1997 PM2.5 NAAQS.

[FR Doc. 2010-30483 Filed 12-3-10; 8:45 am]
BILLING CODE 6560-50-P