[Federal Register Volume 76, Number 43 (Friday, March 4, 2011)]
[Proposed Rules]
[Pages 11983-11985]
[FR Doc No: 2011-4909]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2011-0063; FRL-9275-6]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Adoption of Control Techniques Guidelines for Paper,
Film, and Foil Surface Coating Processes

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the Commonwealth of Pennsylvania (Pennsylvania).
This SIP revision includes amendments to Chapter 121--General
Provisions and Chapter 129--Standards for Sources of Title 25 of the
Pennsylvania Code. Pennsylvania's SIP revision meets the requirement to
adopt Reasonably Available Control Technology (RACT) for sources
covered by EPA's Control Techniques Guidelines (CTG) standards for
paper, film, and foil surface coating processes, and will help
Pennsylvania attain and maintain the National Ambient Air Quality
Standard (NAAQS) for ozone. This action is being taken under the Clean
Air Act (CAA).

DATES: Written comments must be received on or before April 4, 2011.

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R03-OAR-2011-0063 by one of the following methods:
    A. http://www.regulations.gov. Follow the on-line instructions for
submitting comments.
    B. E-mail<EMAIL_ADDRESS>    C. Mail: EPA-R03-OAR-2011-0063, Cristina Fernandez, Associate
Director, Office of Air Program Planning, Mailcode 3AP30, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103.
    D. Hand Delivery: At the previously-listed EPA Region III address.
Such deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-R03-OAR-
2011-0063. EPA's policy is that all comments received will be included
in the public docket without change, and may be made available online
at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.
    Docket: All documents in the electronic docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically in http://www.regulations.gov or in hard copy during normal business hours at the
Air Protection Division, U.S. Environmental Protection Agency, Region
III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the
State submittal are available at the Pennsylvania Department of
Environmental Protection, Bureau of Air Quality Control, P.O. Box 8468,
400 Market Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Irene Shandruk,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On January 4, 2011, the Pennsylvania
Department of Environmental Protection (PADEP) submitted to EPA a SIP
revision concerning the adoption of the CTG for paper, film, and foil
surface coating processes.

I. Background

    Section 172(c)(1) of the CAA provides that SIPs for nonattainment
areas must include reasonably available control measures (RACM),
including RACT for sources of emissions. Section 182(b)(2)(A) provides
that for certain nonattainment areas, states must revise their SIPs to
include RACT for sources of volatile organic compounds (VOC) emissions
covered by a CTG document issued after November 15, 1990 and prior to
the area's date of attainment.
    CTGs are intended to provide state and local air pollution control
authorities information that should assist them in determining RACT for
VOCs from various sources, including paper, film, and foil coatings. In
developing these CTGs, EPA, among other things, evaluated the sources
of VOC emissions from this industry and the available control
approaches for addressing these emissions, including the costs of such
approaches. Based on available information and data, EPA provided
recommendations for RACT for VOCs from paper, film, and foil coatings.
    In December 1977, EPA published a CTG for surface coating of paper
(EPA-450/2-77-008). This CTG discusses the nature of VOC emissions from
this industry, available control technologies for addressing such
emissions, the costs of available control options, and other items. EPA
promulgated national standards of performance for new stationary
sources (NSPS) for the paper, foil, and film industry and EPA also
published a national emission standard

for hazardous air pollutants (NESHAP) for this industry.
    In 2006 and 2007, after conducting a review of currently existing
state and local VOC emission reduction approaches for the paper, foil,
and film industry, reviewing the 1977/1978 CTG and the NESHAP for this
industry, and taking into account the information that has become
available since then, EPA developed a new CTG surface coating for
paper, entitled Control Techniques Guidelines for Paper, Film, and Foil
Coatings (Publication No. EPA 453/R-07-003; September 2007).
    The paper, film, and foil product category includes coatings that
are applied to paper, film, or foil surfaces in the manufacturing of
several major product types for the following industry sectors:
Pressure sensitive tape and labels; photographic film; industrial and
decorative laminates; abrasive products; and flexible packaging. The
category also includes coatings applied during miscellaneous coating
operations for several products including: Corrugated and solid fiber
boxes; die-cut paper paperboard and cardboard; converted paper and
paperboard not elsewhere classified; folding paperboard boxes,
including sanitary boxes; manifold business forms and related products;
plastic asceptic packaging; and carbon paper and inked ribbons. VOC
emissions from paper, film, or foil surface coating processes result
from the evaporation of the components of the coatings and cleaning
materials.

II. Summary of SIP Revision

    On January 4, 2011, PADEP submitted to EPA a SIP revision
concerning the adoption of the EPA paper, film, and foil surface
coating processes. EPA develops CTGs as guidance on control
requirements for source categories. States can follow the CTGs or adopt
more restrictive standards. Pennsylvania has adopted EPA's CTG
standards for paper, film, and foil surface coating processes. These
regulations are in Chapter 121--General Provisions, and in Chapter
129--Standards for Sources, in Title 25 of the Pennsylvania Code.
Specifically, this revision amends the existing regulations at sections
121.1, 129.51 and 129.52 and adds new section 129.52b. Several
definitions were amended or added in section 121.1 and section 129.52
was amended to extend coverage to paper, film, and foil surface coating
processes. New section 129.52b includes VOC emission limits, work
practices, and recordkeeping and reporting requirements, all of which
are consistent with EPA's CTG for paper, film, and foil surface coating
processes. The requirements in section 129.52b supersede the
requirements in 129.52 relating to control of VOC emissions from paper,
film, and foil surface coating processes. The emission limits of VOCs
for paper, film, and foil surface coatings are shown in Table 1. These
emission limits apply if potential VOC emissions from a single line,
prior to control, are 25 tons per year (tpy) or more.

                     Table 1--Recommended Emission Limits for Paper, Film, and Foil Coatings
----------------------------------------------------------------------------------------------------------------
                                                                                RACT limits
                                                               -------------------------------------------------
                                                                                Paper, film, and foil
                             Units                                 Pressure sensitive      surface coating (not
                                                                tape and label  surface     including pressure
                                                                        coating             sensitive tape and
                                                                                label)
----------------------------------------------------------------------------------------------------------------
kg VOC/kg solids (lb VOC/lb solids)...........................                     0.20                     0.40
kg VOC/kg coating (lb VOC/lb coating).........................                    0.067                     0.08
----------------------------------------------------------------------------------------------------------------

    Additionally, VOC emission limits for paper coatings only and the
associated applicability criteria that were in section 129.52(a)(2)
were added to section 129.52(b) in order to carry forward previously
regulated paper coating sources and to eliminate the potential for
backsliding. These VOC emission limits apply only to paper coatings if
actual VOC emissions have exceeded 3 pounds per hour, 15 pounds per day
or 2.7 tpy in any year since January 1, 1987. The emission limits are
shown in Table 2.

           Table 2--Emission Limits of VOCs for Paper Coating
------------------------------------------------------------------------
                                                             RACT limit
                           Units                              for paper
                                                               coating
------------------------------------------------------------------------
lb VOC/gal coating solids.................................          4.84
kg VOC/l coating solids...................................          0.58
------------------------------------------------------------------------

III. Proposed Action

    EPA is proposing to approve the Pennsylvania's SIP revision for
adoption of the CTG standards for paper, film, and foil surface coating
processes. EPA is soliciting public comments on the issues discussed in
this document. These comments will be considered before taking final
action.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and

     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule concerning Pennsylvania's adoption
of a CTG for paper, film, and foil surface coating processes does not
have tribal implications as specified by Executive Order 13175 (65 FR
67249, November 9, 2000), because the SIP is not approved to apply in
Indian country located in the state, and EPA notes that it will not
impose substantial direct costs on tribal governments or preempt tribal
law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Ozone, Reporting and recordkeeping requirements, Volatile
organic compounds.

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

    Dated: February 22, 2011.
W.C. Early,
Acting Regional Administrator, Region III.
[FR Doc. 2011-4909 Filed 3-3-11; 8:45 am]
BILLING CODE 6560-50-P


                            SUPPORTING STATEMENT FOR
                       AN INFORMATION COLLECTION REQUEST

1. 	IDENTIFICATION OF THE INFORMATION COLLECTION

      1(a)	Title of the Information Collection:

      TITLE:  Notice of Supplemental Distribution of a Registered Pesticide Product

      OMB No.:  2070-0044		EPA No.:  0278.11

      1(b)	Short Characterization/Abstract
      This information collection activity notifies the Environmental Protection Agency (EPA) of supplemental distribution of registered pesticide products.  As mandated by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended, EPA is responsible for the regulation of pesticides.  Section 3 (e) of FIFRA (7 U.S.C. 136a (e)) allows pesticide registrants to distribute or sell registered pesticide products under a different name or in addition to the registered name (see Attachment A).  According to 40 CFR 152.132, registrants may distribute or sell their registered product under another company's name and address instead of (or in addition to) their own.  Such distribution and sale is termed "supplemental distribution" and the product is termed a "distributor product."  EPA requires pesticide registrants who enter into supplemental distribution agreements with other companies to submit Form 8570-5, Notice of Supplemental Distribution of a Registered Pesticide Product (see Attachment B).  This information collection request (ICR) is a proposed renewal of an existing ICR currently approved by Office of Management and Budget (OMB) and is due to expire on July 31, 2013.

2. 	NEED FOR AND USE OF THE COLLECTION

      2(a)	Need/Authority for the Collection

      This information is required to be submitted pursuant to Section 3 (e) of FIFRA, as amended.  Regulations pertaining to supplemental distribution of pesticide products are contained in Title 40 CFR Part 152.132 (see Attachment C).

      2(b)	Practical Utility/Users of the Data

      Section 3 (e) of FIFRA requires pesticide registrants to notify the Agency when the registrant has entered into an agreement with a second company to distribute the registrant's product under the second company's name and product name.  The distributor is considered an agent of the registrant for all intents and purposes under the Act, and both the registrant and the distributor may be held liable for violations pertaining to the distributor product.  EPA's Office of Pesticide Programs is responsible for maintaining information about supplemental distribution agreements.
3.	NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

      3(a) 	Non duplication

      This is the only information collection activity of its kind, and the information collected under this program is collected only once per receipt of a notice of distributor registration. Therefore, the possibility of duplication does not exist.

      3(b)	Public Notice Required Prior to ICR submission to OMB

      Pursuant to 5 CFR 1320.8(d), in proposing to renew this ICR, EPA is publishing a Federal Register Notice that provides a 60-day public notice and comment period.  The materials related to the proposed renewal of this ICR, as well as any comments submitted during the public comment period may be accessed as described in section 6(f) of this supporting statement.

      3(c)	Consultations

      Under 5 CFR 1320.8(d)(1), agencies are required to consult with potential ICR respondents and data users about specific aspects of ICRs before submitting an original or renewal ICR to OMB for review and approval.  During the development of this renewal ICR, EPA staff will contact appropriate stakeholders and ask them for their assessment of the regulatory burden estimates expressed by the Agency in this ICR.  A summary of these consultations will be provided as part of the supporting statement during the second comment period (Attachment D).

      3(d)	Effects of Less Frequent Collection

      This activity is only conducted once per "event" (one notification is submitted per product); it is not possible to reduce the frequency of the collection.  EPA must maintain the current frequency of this collection in order to avoid violating FIFRA Section 3 (e).

      3(e)	General Guidelines

      Long-term recordkeeping:  The only PRA-imposed guideline in 5 CFR 1320.6 that may be exceeded in this collection is the record-keeping retention period. The registrant and the distributor are expected to maintain copies of their distribution agreement (EPA Form 8570-5) as long as the registration is valid or until the parties notify EPA that they have voluntarily dissolved the distribution agreement.  Registrations are valid unless they are voluntarily canceled or withdrawn by the registrant or until EPA has cause to suspend or cancel the registration as a result of the Registration Review Program or an adverse finding by the Agency.

      Since the average period of marketability of a pesticide ranges from 15 to 30 years, the PRA-imposed guideline indicating that data, other than health, medical, or tax records need not be retained for more than 3 years generally will be exceeded in this program.

      Electronic submissions:  OMB regulations require agencies to provide a statement indicating whether the proposed collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and an explanation of the decision (5 CFR 1320.5(a)(iii)(E)).  At this time, OPP is not offering a fully electronic submission option.  As this information collection request indicates, both the basic product registrant and the distributor must sign the required notification.  While EPA Form 8570-5 is available and fillable online, the form currently needs to be printed out to be signed and mailed.

      The Agency is actively working to extend full electronic submission options in keeping with the June 22, 2012 OMB memo on "Reducing Reporting and Paperwork Burdens" and other related policy and guidance.  In the future, the Agency hopes to offer a fully electronic version of this form, including electronic signature and submission, through the Agency's Central Data Exchange (CDX).  Electronic submission should reduce the time needed to complete the form and the activities described in Sections 4 and 5 of this ICR while improving the overall quality of submissions.

      3(f)	Confidentiality

      Product distributorship data submitted by basic product registrants under FIFRA Section 3(e) are considered by the Office of Pesticide Programs (OPP) to contain no confidential business information (CBI).

      3(g)	Sensitive Questions

      No information of a sensitive or private nature is requested in conjunction with this information collection activity. Further, this information collection activity complies with provisions of the Privacy Act of 1974 and OMB Circular A-108.

4. 	THE RESPONDENTS AND THE INFORMATION REQUESTED

      4(a)	Respondents/NAICS Codes

      The North American Industrial Classification System (NAICS) code for businesses participating in this program is 325320 (Pesticide and other Agricultural Chemical Manufacturing).

      4(b)	Information Requested

         (i)	Data Items, Including Record Keeping Requirements

      Pursuant to 40 CFR 152.132, supplemental distribution of a registered pesticide is permitted if the registrant meets all of the conditions and submits a completed and signed EPA Form 8570-5, Notice of Supplemental Distribution of a Registered Pesticide Product.  Sub-section 152.132 (a) requires the registrant to furnish the following information:

 EPA registration number of the product to be distributed;
 EPA-assigned distributor company number;
 Name of the registered product to be distributed;
 Name and address of the basic product registrant;
 Name to be used on the distributed product;
 Name and address of the distributor;
 Signature and title of the distributor and date signed; and
 Signature and title of the basic product registrant and date signed.

      (ii)	Respondent Activities

      For each distributor product, the basic product registrant must send to EPA a completed Form 8570-5, signed by both the basic product registrant and the distributor (Attachment E provides detailed information on EPA's requirements).  Responsibility for regulatory compliance rests primarily with the basic product registrant. However, both the registrant and the distributor may be held liable for any violation of FIFRA.

      A registrant wishing to distribute a registered product under a different name or through a different company must provide the following information to EPA:

Read

Read form and instructions.

Request
If necessary, obtain an EPA company number for the supplemental distributor.

Compile

Review information for accuracy and appropriateness.

Submit

Submit EPA Form 8570-5 to the Agency.

Store

File or otherwise maintain the information.

      EPA Form 8570-5 requires the distributor to have an EPA-assigned company number.  If the distributor company is different from the registrant of the product and has not previously obtained an EPA company number, one needs to be assigned to them before the form can be completed for submission (see Attachment F for instructions on how to obtain an EPA company number).

      The Agency estimates conservatively that one-third of the responses submitted to EPA on Form 8570-5 are completed using newly-assigned company numbers.  The one-third estimate is considered conservative because the number of entities submitting requests to EPA for company number assignment during a reporting period is often far fewer than the total number of forms that use newly-assigned distributor company numbers.  This is because companies often enter into distribution agreements for multiple products, either with the same or with different registrants, and notifications for all of those products get submitted around the same time period.

5.	THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

      5(a)	Agency Activities

      Notices of Supplemental Distribution of a Registered Pesticide Product are pin-punched with the date of receipt.  The forms are copied, screened for completeness, and included with a letter acknowledging receipt of each notification that is sent to the registrant, along with, if relevant, a checklist of items to be corrected.  Consistent with 40 CFR 152.132(d)(1), starting in 2010, a product team reviews the product information submitted on the form and follows up with the registrant through the OPP division where the original product is registered.  Subsequent processing steps are the electronic entry and filing of distributor information under the original registration of the product, and maintenance of electronic records.

Assign
If necessary, assign an EPA company number to the supplemental distributor.

Verify

Verify the regulatory status of the primary registration to be supplementally distributed;

Acknowledge receipt

Provide a receipt of the notice by mailing a copy to the distributor company;
Product information review
Check product information; make decisions; if necessary, follow-up with registrant;

Process information

Enter information from the form into the computerized "Distributor File," a part of the Office of Pesticide Programs Integrated Network (OPPIN); and

File and maintain information

The original form is electronically filed in the regulatory file of the parent Section 3 registration which is maintained by the Office of Pesticide Programs' Information Services Center.

      5(b)	Collection Methodology and Management

      Registrants voluntarily enter into agreements with distributors.  They are required, under FIFRA, to notify the Agency of these agreements.  EPA maintains the original notifications in the regulatory file of the parent Section 3 registration at the Office of Pesticide Programs Information Services Center.

      5(c)	Small Entity Flexibility

      Most of the companies participating in this program would qualify as small entities.  The Agency closely examined potential burdens to small entities and instituted changes to this program in 1984.  At that time, OMB approved the changes.  The Agency also re-evaluated the general burden categories in 1986.  The Agency believes that the burden imposed by this activity has been minimized to what is believed to be the minimal level at which this program can effectively function under the requirements specified in the FIFRA and the regulations for the enforcement of FIFRA.

      5(d)	Collection Schedule

      Not applicable.  This activity is conducted only once per "event" when the registrant submits a Notice of Supplemental Distribution of a Registered Pesticide Product, to the Agency.  Therefore, there is no set schedule for collection of this information.

6. 	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

      6(a)	Estimating Respondent Burden

      The burden associated with this collection of information is estimated to be approximately 19 minutes per response.  The respondent burden estimate on the per-response basis has changed slightly from previous years due to a previously unaccounted-for activity which is conservatively estimated to apply to one-third of the responses submitted.  To complete Form 8570-5, a distributor's EPA-assigned company number must be included.  Distributors without an EPA company number must send a formal request letter on company letter-head to the Agency to get one assigned (Attachment F).  EPA estimates that one-third of the responses submitted to EPA on Form 8570-5 are completed using newly-assigned company numbers.  This is a conservative estimate because companies often enter into distributor agreements to distribute two or more registered products.  The number of entities submitting requests to EPA for company number assignment during the reporting period is far fewer than the total number of forms that use newly-assigned distributor company numbers.  The exact number of company number requests that are submitted specifically for the purposes of becoming a distributor cannot be determined at this time, and EPA has used the larger estimate of one-third.  The additional step is estimated to add 4.8 minutes to the previously approved total per-response burden of approximately 14.5 minutes.   Therefore, the total respondent burden is estimated to be 19 minutes per response.

      However, due to an overall decrease in the number of supplemental distribution notifications received by the Agency over the last several years, the total burden hours have also decreased.  Whereas EPA had expected to receive about 1,895 notice submissions annually over the past 3 years, based on the actual number of submissions received annually over that period (1,764 in FY2009, 1,365 in FY2010, and 1,224 in FY2011), the Agency now expects to receive only 1,451 notice submissions annually over the next 3 years.  Given this change, EPA estimates the total annual burden associated with the notice of supplemental distribution of a registered pesticide product to be 387 hours.

      6(b)	Estimating Respondent Costs

      Consistent with recent ICR renewals, OPP is using labor cost estimates from Agency economists with respect to wages, benefits and overhead for all labor categories for affected industries, state government, and EPA employees.  This approach uses a transparent and consistent methodology and current publicly-available data to provide more accurate estimates and allow easy replication of the estimates.

Labor Cost Approach
Description
Methodology:
The methodology uses data on each sector and labor type for an Unloaded wage rate (hourly wage rate), and calculates the Loaded wage rate (unloaded wage rate + benefits), and the Fully loaded wage rate (loaded wage rate + overhead).  Fully loaded wage rates are used to calculate respondent costs.  This renewal uses data from 2011, which is the most recent.
Unloaded Wage Rate:
Wages are estimated for occupations (management, technical, and clerical) within applicable sectors. The Agency uses average wage data for the relevant sectors available in the National Industry-Specific Occupational Employment and Wage Estimates from the Bureau of Labor Statistics (BLS) at http://www.bls.gov/oes/current/oes_nat.htm.
Sectors:
The specific North American Industry Classification System (NAICS) code and website for each sector is included in that sector's wage rate table.  Within each sector, the wage data are provided by Standard Occupational Classification (SOC).  The SOC system is used by Federal statistical agencies to classify workers into occupational categories for the purpose of collecting, calculating, or disseminating data (see http://www.bls.gov/oes/current/oes_stru.htm).
Loaded Wage Rate:
Benefits represent 43% of unloaded wage rates, based on benefits for all civilian non-farm workers, from http://www.bls.gov/news.release/ecec.t01.htm.
Fully Loaded Wage Rate:
The loaded wage rate is multiplied by 50% (EPA guidelines 20-70%) to get overhead costs.

      A copy of the formula work sheets used to estimate the labor rates and to derive the registrants' fully loaded rates and overhead costs for this renewal are listed in Attachment G.

Table 1.  Estimated Respondent Burden/Cost per Supplemental Distribution Application
                                  REGISTRANT
                                 HOURS, RATES
                                     TOTAL
Collection Activities
                                  Mgmt, $/hr
                                Technical, $/hr
                                Clerical, $/hr
                                     Hours
                                     Costs

                                                                     $   124.10
                                                                      $   61.21
                                                                       $  36.79

Read instructions
                                     0.08
                                       -
                                       -
                                     0.08
                                                                         $9.93
Process, compile, review information for accuracy and appropriateness
                                     0.05
                                       -
                                       -
                                     0.05
                                                                         $6.21
If necessary, obtain an EPA company number for the supplemental distributor
                                       -
                                       -
                                     0.08
                                     0.08
                                                                         $2.94
Complete and submit EPA Form 8570-5
                                     0.03
                                       -
                                       -
                                     0.03
                                                                         $3.72
Store, file, or maintain information
                                       -
                                       -
                                     0.08
                                     0.08
                                                                         $2.94
Total
                                     0.16
                                     0.00
                                     0.16
                                     0.32
                                                                        $23.78

ANNUAL BURDEN: 387 Hours
ANNUAL COSTS: $34,505

      6(c)	Estimating Agency Burden and Cost

      To determine Agency costs, the Agency used the Bureau of Labor Statistics estimates of labor rates for the North American Industry Classification System code for the Federal Executive Branch (NAICS 999100).

      Table 2 summarizes the Agency process in reviewing the supplemental distribution applications, with associated hours and costs for each task.  A copy of the formula work sheets used to estimate the labor rates and to derive the Agency's fully loaded rates and overhead costs for this renewal are listed in Attachment H.

Table 2.  Estimated Agency Burden/Cost per Supplemental Distribution Application.
REGISTRANT
HOURS, RATES
TOTAL
Collection Activities
Mgmt, $/hr
Technical, $/hr
Clerical, $/hr
                                     Hours
                                     Costs

 $ 120.32
 $ 77.85
 $ 44.05

If necessary, assign an EPA company number to the supplemental distributor.
                                       -
                                       -
                                     0.08
                                     0.08
$3.52
Verify, acknowledge receipt1
                                       -
                                       -
                                     0.03
                                     0.03
$1.51
 Initial product screening2
                                       -
                                     0.36
                                       -
                                     0.36
$27.90
 Product review meeting2
                                     0.63
                                       -
                                       -
                                     0.63
$75.46
 Process disapproved product distribution information2
                                       -
                                     0.42
                                       -
                                     0.42
$32.42
Process: Enter form information into electronic file in OPPIN
                                       -
                                     0.50
                                       -
                                     0.50
$38.93
File and maintain information
                                       -
                                     0.02
                                       -
                                     0.02
$1.30
Total
                                     0.63
                                     1.29
                                     0.03
                                     1.95
$52.78
 Source:  U.S. Department of Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/naics4_999100.htm May, 2011.
 1  Approximately 90% of forms received by EPA are appropriately completed and undergo standard processing, requiring only clerical and technical labor types.
 2  The rest of the forms (approximately 10%) require review by the Agency's product review team, requiring all three types of labor.

      The total annual Agency burden associated with the notice of supplemental distribution of a registered pesticide product is 970 hours.  This represents an increase over the Agency burden estimated for the 2009 ICR (625 hours) due to a review process that was implemented in 2010.  The tasks marked by the superscript 2 represent the new review process in which some of the product information must be reviewed by the Agency to determine that supplemental distributed product names are consistent with 40 CFR 152.132(d)(1) and are not "misleading."  The annual total Agency cost is $76,589, increased from $25,905 of the 2009 ICR.

      6(d)	Bottom Line Burden Hours and Cost Tables

	Total Annual Respondent and Agency Burden and Costs

                                     Total

                                     Hours
                                     Costs
Annual Respondent Burden/Cost Estimates
                                      387
                                   $34,505
Annual Agency Burden/Cost  Estimates
                                      970
                                    $76,589

      6(e)	Reasons for Change in Burden

      The total annual respondent burden associated with the notice of supplemental distribution of a registered pesticide product is 387 hours, a 68 hour decrease from 455 hours estimated in the ICR from 2009.  This decrease is an adjustment.  The average number of supplemental registrations received by the EPA over the last three years is approximately 1,451 responses per year (1,764 in FY2009, 1,365 in FY2010, and 1,224 in FY2011).  Based on these numbers, the Agency estimates that it will receive an average of 1,451 supplemental registrations annually for the next three years.

      6(f)	Burden Statement

      The total estimated annual respondent paperwork burden to comply with this information collection activity is 387 hours, or about 19 minutes per response, adjusted up from 15 minutes per response from the last renewal.  The per-response increase is due to the inclusion of a required step in the notification process that was not previously considered as part of this ICR but is estimated to apply to a third of the responses.  This estimate includes the time needed to review instructions; utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to respond to a collection of information; search existing data sources; complete and review the collection of information; and transmit or otherwise disclose the information.  An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.  The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable (see Attachment I).

      The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPP-2012-0544, which is available for online viewing at www.regulations.gov, or in person viewing at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA.  This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.  The docket telephone number is<PHONE_NUMBER>.  You may submit comments regarding the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques.

	Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2012-0544 and OMB Control No. 2070-0044, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: Public Information and Records Integrity Branch (PIRIB), Mail Code: 7502P, Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460, and (2) OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.
                               Attachments List

All of the attachments listed below can be found in the docket for this ICR (unless otherwise noted), accessible electronically through www.Regulations.gov . On the main page, select Advanced Search from the menu bar at the top and select Docket Search. Enter the Docket ID Number, EPA-HQ-OPP-2012-0544, in the Docket ID field. Click on the Submit button. From the results page, you will be able to link to the docket view or directly open select documents found in the docket.

Attachment A
7 U.S.C. 136a  -  Section 3 of FIFRA. Also available at online at the US House of Representatives' US Code website.
Attachment B
EPA Form 8570-5 - Notice of Supplemental Distribution of a Registered Pesticide Product
Also online at http://www.epa.gov/opprd001/forms/8570-5.pdf
Attachment C
40 CFR Part 152.132 - Obligations and Rights of Registrants - Supplemental Distribution.  Also available online at the National Archives and Records Administration's Electronic CFR Website.
Attachment D
(Reserved)
Attachment E
Requirements for Approval of Supplemental Distribution
Also available at: http://www.epa.gov/opprd001/registrationmanual/chapter9.html
Attachment F
How to Obtain an EPA Company Number
http://www.epa.gov/pesticides/registrationkit/company-num_addr-chg.pdf
Attachment G
Work Sheets used to Calculate Registrant Labor Costs
Attachment H
Work Sheets used to Calculate EPA & Federal Government Labor Costs
Attachment I
Display Related to OMB Control #2070-0044  -  Listings of Related Regulations in 40 CFR 9.1. Also available online at the National Archives and Records Administration's Electronic CFR Website.


[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Notices]
[Pages 32003-32004]
[FR Doc No: 2017-14456]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2166]

Draft Standardization of Pharmaceutical Quality/Chemistry
Manufacturing and Control Data Elements and Terminologies; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting
comment on the draft standardized Pharmaceutical Quality/Chemistry
Manufacturing and Control (PQ/CMC) data elements and terminologies for
the electronic submission of PQ/CMC data. The establishment of
standardized pharmaceutical quality data elements and terminologies
will provide opportunities for FDA and industry to transform PQ/CMC
submission data into a readily useable electronic format. As a result,
these established data elements and terminologies will improve the
efficiency and quality of the drug review process. The Agency is
seeking comment on the accuracy, suitability, and appropriateness of
these data elements and terminologies for submission of PQ/CMC data.
FDA is considering implementing PQ/CMC requirements as a Health Level 7
(HL7) Structured Product Labeling (SPL) document. The proposed data
elements and terminologies can be obtained on https://www.regulations.gov in Docket No. FDA-2017-N-2166.

DATES: Submit either electronic or written comments by September 11,
2017. Late, untimely filed comments

will not be considered. Electronic comments must be submitted on or
before September 11, 2017. The https://www.regulations.gov electronic
filing system will accept comments until midnight Eastern Time at the
end of September 11, 2017. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if
they are postmarked or the delivery service acceptance receipt is on or
before that date.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-2166 for ``Draft Standardization of Pharmaceutical Quality/
Chemistry Manufacturing and Control Data Elements and Terminologies;
Request for Comments.'' Received comments, those filed in a timely
manner (see DATES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Norman Schmuff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 21, Rm. 2526, Silver Spring, MD 20993-0002, 301-
796-1454; Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, Bldg. 71, Rm. 7301, Silver Spring, MD
20993-0002,<PHONE_NUMBER>; Norman Gregory, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl. (HFV-143),
Rockville, MD 20855,<PHONE_NUMBER>; or Michael Kerrigan, Center for
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl.
(HFV-143), Rockville, MD 20855,<PHONE_NUMBER>. Alternatively, send
questions to the PQ-CMC mailbox<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    PQ/CMC is a term used to describe manufacturing and testing data of
pharmaceutical products. PQ/CMC encompasses topics such as drug
stability, quality specification, and batch analysis, which are
important aspects of drug development. PQ/CMC plays an integral part in
the regulatory review process and life cycle management of
pharmaceutical products. The standardization of PQ/CMC data elements
and terminologies will facilitate the Agency's transition to an
electronic review environment.
    FDA intends to identify and standardize data elements and
terminologies for information commonly used and submitted in support of
drug product applications. The impetus for this standardization effort
was the provisions from the 2012 Food and Drug Administration Safety
and Innovation Act (FDASIA) (Pub. L. 112-144), which authorized the
Agency to require certain submissions to be in a specified electronic
format. The development of a structured format for PQ/CMC data will
enable consistency in the content and format of PQ/CMC data submitted,
thus providing a harmonized language for submission content, allowing
reviewers to query the data, and, in general, contributing to a more
efficient and effective regulatory decision-making process by creating
a standardized data dictionary.
    After receiving comments, the Agency will consider future actions
on the standardization of PQ/CMC data elements and terminologies for
electronic submissions.

II. Electronic Access

    Persons with access to the Internet may obtain the proposed data
elements and terminologies at https://www.regulations.gov.

    Dated: July 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysys.
[FR Doc. 2017-14456 Filed 7-10-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 109 (Thursday, June 6, 2013)]
[Notices]
[Pages 34109-34110]
[FR Doc No: 2013-13447]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0012]

``Script Your Future'' Medication Adherence Campaign

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of grant funds for the continuing support of a national
effort to promote the importance of medication adherence to enhance the
health of Americans. Medication adherence is taking medicine as
directed to treat an illness or disease in order to get the best health
outcome possible for each patient. Nearly three out of four Americans
report that they do not take their medication as directed. One in three
people never fill their prescriptions. The annual price tag for
medication adherence failure is estimated to be $290 billion, and the
impact on the medical system and patients from this lack of adherence
may result in relapses or recurrences of medical symptoms, increases in
hospital visits, or even death. FDA is committed to addressing this
issue, which has enormous implications for public health and the U.S.
economy, by, in part, continuing its financial and other contributions
to a carefully planned, well-executed effective national campaign begun
in 2010 by the National Consumers League (NCL) called ``Script Your
Future''.
    To continue and enhance this important public health initiative,
the Division of Health Communications (DHC)/Office of Communications
(OCOMM)/Center for Drug Evaluation and Research (CDER) in FDA seeks to
assist the National Consumers League in the development of new online
resources and tools for patients, engagement of public and private
partners to build on and complement existing medication adherence
programs, education of health care professionals with strategies to
share with patients, continuous evaluation of the campaign to enhance
and improve it, expansion of public-private partnerships, strengthening
of this national forum focused on informing consumers about medication
adherence, and tailoring messaging to subpopulations of consumers who
may need adaptations or special efforts to inform and educate them.

DATES: Important dates are as follows:
    1. The application due date is July 1, 2013.
    2. The anticipated start date is August 2013.
    3. The opening date is the date this announcement is published in
the Federal Register.
    4. The expiration date is July 2, 2013.

ADDRESSES: Submit the paper application to: Gladys Melendez, Grants
Management (HFA-500), Food and Drug Administration, 5630 Fishers Lane,
Rm. 2032, Rockville, MD 20857; and a copy to Elaine Frost, Center for
Drug Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Rm. 1140, Silver Spring, MD 20903. For more
information, see section III of the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Paula Rausch, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Rm. 4110, Silver Spring, MD 20903,<PHONE_NUMBER>; or
Gladys Melendez, Grants Management Branch (HFA-500), Food and Drug
Administration, 5630 Fishers Lane, Rm. 2032, Rockville, MD 20857, 301-
827-7175.
    For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please obtain the full FOA from
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

    Request for Application: FDA-RFA-13-027.

Catalog of Federal Domestic Assistance: 93.103

A. Background

    In order to fulfill FDA's mission to protect public health by
assuring the safety, efficacy, and security of human drugs; and helping
the public to obtain the accurate, science-based information they need
to use medications in ways that maintain and improve their health, FDA
seeks to continue its participation in a national campaign aimed at
promoting the importance of medication adherence to enhance the health
of Americans.
    FDA recognizes medication adherence as a formidable health problem
that results in health system and human costs that adversely impact our
nation. FDA has a responsibility as a public health agency to educate
and inform the public and health professionals about the importance of
medication adherence. Since 2010, FDA has been a key government
stakeholder in the NCL's initiative, along with other major government
agencies and private and nonprofit organizations, to address the issue
of poor medication adherence. FDA is committed to educating and
informing the public about this issue, including key subpopulations
such as those with low literacy and health literacy, or that faces
health disparities or is economically disadvantaged.
    The NCL is the nation's oldest consumer organization. With FDA and
its other government partners, NCL launched its nationwide ``Script
Your Future'' campaign in 2010 to address the issue of poor medication
adherence. NCL possesses an extensive research and evaluation framework
from past medication outreach efforts that helped ensure the campaign's
medication adherence messages and materials are based on sound
communication science. In addition, NCL assembled a coalition of more
than 130 public-private partners to mobilize resources that can
increase awareness and outreach to the public far beyond what FDA would
be able to do alone to promote increased understanding and positive
actions among the general public and health professionals related to
this critical issue. Future NCL plans are in sync with FDA goals for a
national medication adherence campaign and FDA seeks to enhance this
carefully designed communications intervention. FDA has been and
remains a key partner with NCL on issues pertaining to the safe use of
medicines.

B. Research Objectives

    The following are the primary objectives that FDA/CDER/OCOMM/DHC
seeks to achieve through further support of this national outreach
campaign: (1) To collaborate with a large group of public-private
partners that can significantly increase awareness and outreach far
beyond what FDA would be able to do on its own to promote increased
understanding and positive actions among the general public and health
professionals related to this critical issue; (2) to develop new online
resources and tools for patients; (3) to educate health care
professionals with strategies to share with patients; (4) to
continually evaluate the campaign to improve and enhance it; (5) to
tailor campaign messaging to subpopulations of consumers who may need
adaptations to best inform and educate them; (6) to further targeted
market outreach through community events and activities; (7) to develop
new campaign materials for patients and health care providers; (8) to
further widespread dissemination of campaign materials to consumers and
health care professionals across the country, including at pharmacies,
community centers, workplaces, clinic offices, health fairs, and local
events; (9) to provide counseling and education directly to consumers
about adherence in their communities, including through the involvement
of students studying pharmacy, medicine, nursing, and other health
professions; (10) to explore new media opportunities for dissemination
of the program at the local, State and national levels, in trade press,
online journals, radio, television, and more; and (11) to extend
outreach through social media, such as Twitter chats, free text message
reminders, online pledges through Facebook and Twitter and other
channels.
    The following are some specific objectives that FDA believes can
further enhance the ``Script Your Future'' campaign: (1) Addition of
patient and family caregiver testimonials to the campaign Web site; (2)
creation of a custom ``I Will'' tab on the ``Script Your Future''
Facebook page; (3) translation of the radio public service announcement
from English to Spanish; (4) development of ``Script Your Future-in-A-
Box,'' a turnkey package incorporating press background materials and
other elements; and (5) organization of a public event in fall 2013 and
a study to measure the reach of events, media, and partner engagement.

C. Eligibility Information

    Competition is limited to the NCL because it has unique expertise
and capacity found nowhere else. Specifically, the FDA/CDER/OCOMM, DHC,
seeks to continue and enhance its public health mission to educate and
inform the public and health professions about the importance of
medication adherence by awarding a grant to the NCL to advance its
national campaign, ``Script Your Future.'' This campaign represents a
comprehensive, integrated approach to raise awareness about the problem
of poor medication adherence, and FDA has served as a key government
stakeholder since 2010. Because FDA has been a partner in the formative
stages of this campaign and has seen evidence indicating that it has
already had an impact in helping to resolve the problem of medication
adherence, FDA seeks to continue funding new dimensions of the
campaign, especially to serve U.S. subpopulations of people having low
literacy/health literacy, or who face health disparities and social and
economic disadvantages.

II. Award Information/Funds Available

A. Award Amount

    The total amount of funding for this grant is $200,000 over 2
years. Applications budgets will be limited to $100,000 in the first
year and $100,000 in the second year depending on the availability of
funds. The number of awards anticipated is one individual award.

B. Length of Support

    The term for this grant will begin in August 2013 for a period of 2
years through August 15, 2015.

III. Paper Application, Registration, and Submission Information

    To submit a paper application in response to this FOA, applicants
should first review the full announcement. Persons interested in
applying for a grant may obtain an application at http://grants.nih.gov/grants/forms.htm. For all paper application submissions,
the following steps are required:
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number
     Step 2: Register With System for Award Management (SAM)
     Step 3: Register With Electronic Research Administration
(eRA) Commons
    Steps 1 and 2, in detail, can be found at http://www07.grants.gov/applicants/organization_registration.jsp. Step 3, in detail, can be
found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed these steps,
submit paper applications to: Gladys Melendez, Grants Management Branch
(HFA-500), Food and Drug Administration, Rm. 2031, 5630 Fishers Lane,
Rockville, MD 20857.

    Dated: June 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13447 Filed 6-5-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 129 (Monday, July 6, 2020)]
[Proposed Rules]
[Pages 40160-40164]
[FR Doc No: 2020-14220]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2020-0197; FRL-10011-11-Region 3]

Air Plan Approval; West Virginia; 1997 8-Hour Ozone Standard
Second Maintenance Plan for the West Virginia Portion of the
Parkersburg-Marietta, WV-OH Area Comprising Wood County

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a state implementation plan (SIP) revision submitted by the
State of West Virginia. This revision pertains to the West Virginia
Department of Environmental Protection's (WVDEP) plan for maintaining
the 1997 8-hour ozone national ambient air quality standards (NAAQS)
for the West Virginia portion of the Parkersburg-Marietta, WV-OH area
(Parkersburg Area), comprising Wood County. This action is being taken
under the Clean Air Act (CAA).

DATES: Written comments must be received on or before August 5, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2020-0197 at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be confidential business information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Gregory Becoat, Planning &
Implementation Branch (3AD30), Air & Radiation Division, U.S.
Environmental Protection Agency, Region III, 1650 Arch Street,
Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-
2036. Mr. Becoat can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On December 10, 2019, WVDEP submitted a
revision to the West Virginia SIP to incorporate a plan for maintaining
the 1997 ozone NAAQS through June 7, 2027, in accordance with CAA
section 175A.\1\
---------------------------------------------------------------------------

    \1\ In its December 10, 2019 submittal, the State consistently
refers to the Parkersburg Area, rather than referring to the West
Virginia portion of the Parkersburg-Marietta, WV-OH area. While the
state's terminology is technically incorrect, it is clear that what
the State refers to as the Parkersburg Area is identical to the West
Virginia portion of the Parkersburg-Marietta, WV-OH area designated
by EPA pursuant to the 1997 8-Hour ozone NAAQS. See 40 CFR 81.349.
---------------------------------------------------------------------------

I. Background

    In 1979, under section 109 of the CAA, EPA established primary and
secondary NAAQS for ozone at 0.12 parts per million (ppm), averaged
over a 1-hour period. 44 FR 8202 (February 8, 1979). On July 18, 1997
(62 FR 38856),\2\ EPA revised the primary and secondary NAAQS for ozone
to set the acceptable level of ozone in the ambient air at 0.08 ppm,
averaged over an 8-hour period. EPA set the 8-hour ozone NAAQS based on
scientific evidence demonstrating that ozone causes adverse health
effects at lower

concentrations and over longer periods of time than was understood when
the pre-existing 1-hour ozone NAAQS was set. Following promulgation of
a new or revised NAAQS, EPA is required by the CAA to designate areas
throughout the nation as attaining or not attaining the NAAQS. On April
30, 2004 (69 FR 23858), EPA designated Parkersburg-Marietta Area, West
Virginia-Ohio (WV-OH) as nonattainment for the 1997 8-hr ozone NAAQS.
The Parkersburg-Marietta Area, WV-OH nonattainment area consists of
Wood County, WV and Washington County, OH.
---------------------------------------------------------------------------

    \2\ In March 2008, EPA completed another review of the primary
and secondary ozone standards and tightened them further by lowering
the level for both to 0.075 ppm. 73 FR 16436 (March 27, 2008).
Additionally, in October 2015, EPA completed a review of the primary
and secondary ozone standards and tightened them by lowering the
level for both to 0.70 ppm. 80 FR 65292 (October 26, 2015).
---------------------------------------------------------------------------

    Once a nonattainment area has three years of complete and certified
air quality data that has been determined to attain the NAAQS, and the
area has met the other criteria outlined in CAA section
107(d)(3)(E),\3\ the state can submit a request to EPA to redesignate
the area to attainment. Areas that have been redesignated by EPA from
nonattainment to attainment are referred to as ``maintenance areas.''
One of the criteria for redesignation is to have an approved
maintenance plan under CAA section 175A. The maintenance plan must
demonstrate that the area will continue to maintain the standard for
the period extending 10 years after redesignation, and it must contain
such additional measures as necessary to ensure maintenance as well
contingency measures as necessary to assure that violations of the
standard will be promptly corrected.
---------------------------------------------------------------------------

    \3\ The requirements of CAA section 107(d)(3)(E) include
attainment of the NAAQS, full approval under section 110(k) of the
applicable SIP, determination that improvement in air quality is a
result of permanent and enforceable reductions in emissions,
demonstration that the state has met all applicable section 110 and
part D requirements, and a fully approved maintenance plan under CAA
section 175A.
---------------------------------------------------------------------------

    On May 8, 2007 (72 FR 25967 effective June 7, 2007), EPA approved a
redesignation request (and maintenance plan) from WVDEP for the
Parkersburg Area. In accordance with section 175A(b), at the end of the
eighth year after the effective date of the redesignation, the state
must also submit a second maintenance plan to ensure ongoing
maintenance of the standard for an additional 10 years.
    EPA's final implementation rule for the 2008 ozone NAAQS revoked
the 1997 ozone NAAQS and provided that one consequence of revocation
was that areas that had been redesignated to attainment (i.e.,
maintenance areas) for the 1997 NAAQS no longer needed to submit second
10-year maintenance plans under CAA section 175A(b).\4\ However, in
South Coast Air Quality Management District v. EPA \5\ (South Coast
II), the United States Court of Appeals for the District of Columbia
(D.C. Circuit) vacated EPA's interpretation that, because of the
revocation of the 1997 ozone standard, second maintenance plans were
not required for ``orphan maintenance areas,'' (i.e., areas like Wood
County) that had been redesignated to attainment for the 1997 NAAQS and
were designated attainment for the 2008 ozone NAAQS. Thus, states with
these ``orphan maintenance areas'' under the 1997 ozone NAAQS must
submit maintenance plans for the second maintenance period.
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    \4\ See 80 FR 12315 (March 6, 2015).
    \5\ 882 F.3d 1138 (D.C. Cir. 2018).
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    As previously discussed, CAA section 175A sets forth the criteria
for adequate maintenance plans. In addition, EPA has published
longstanding guidance that provides further insight on the content of
an approvable maintenance plan, explaining that a maintenance plan
should address five elements: (1) An attainment emissions inventory;
(2) a maintenance demonstration; (3) a commitment for continued air
quality monitoring; (4) a process for verification of continued
attainment; and (5) a contingency plan. The Calcagni memo \6\ provides
that states may generally demonstrate maintenance by either performing
air quality modeling to show the future mix of sources and emission
rates will not cause a violation of the NAAQS or by showing that future
emissions of a pollutant and its precursors will not exceed the level
of emissions during a year when the area was attaining the NAAQS (i.e.,
attainment year inventory). See Calcagni Memo at 9. EPA further
clarified in three subsequent guidance memos describing ``limited
maintenance plans'' (LMPs) \7\ that the requirements of CAA section
175A could be met by demonstrating that the area's design value \8\ was
well below the NAAQS and that the historical stability of the area's
air quality levels showed that the area was unlikely to violate the
NAAQS in the future. Specifically, EPA believes that if the most recent
air quality design value for the area is at a level that is below 85%
of the standard, or in this case below 0.071 ppm, then EPA considers
the state to have met the section 175A requirement for a demonstration
that the area will maintain the NAAQS for the requisite period.
Accordingly, on December 10, 2019, WVDEP submitted a second maintenance
plan for the Parkersburg Area, following EPA's LMP guidance and
demonstrating that the area will maintain the 1997 ozone NAAQS through
June 7, 2027, i.e., to the end of the 20-year maintenance period.
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    \6\ ``Procedures for Processing Requests to Redesignate Areas to
Attainment,'' Memorandum from John Calcagni, Director, Air Quality
Management Division, September 4, 1992 (Calcagni Memo).
    \7\ See ``Limited Maintenance Plan Option for Nonclassifiable
Ozone Nonattainment Areas'' from Sally L. Shaver, Office of Air
Quality Planning and Standards (OAQPS), dated November 16, 1994;
``Limited Maintenance Plan Option for Nonclassifiable CO
Nonattainment Areas'' from Joseph Paisie, OAQPS, dated October 6,
1995; and ``Limited Maintenance Plan Option for Moderate PM10
Nonattainment Areas'' from Lydia Wegman, OAQPS, dated August 9,
2001.
    \8\ The ozone design value for a monitoring site is the 3-year
average of the annual fourth-highest daily maximum 8-hour average
ozone concentrations. The design value for an ozone nonattainment
area is the highest design value of any monitoring site in the area.
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II. Summary of SIP Revision and EPA Analysis

    WVDEP's December 10, 2019 SIP submittal outlines a plan for
continued maintenance of the 1997 ozone NAAQS which addresses the
criteria set forth in the Calcagni Memo as follows.

A. Attainment Emissions Inventory

    A state should develop a comprehensive and accurate inventory of
actual emissions for an attainment year which identifies the level of
emissions in the area which is sufficient to maintain the NAAQS. The
inventory should be developed consistent with EPA's most recent
guidance. For ozone, the inventory should be based on typical summer
day's emissions of oxides of nitrogen (NOx) and volatile organic
compounds (VOC), the precursors to ozone formation. In the first
maintenance plan for the Parkersburg Area, WVDEP used 2004 for the
attainment year inventory, because 2004 was one of the years in the
2002-2004 three-year period when the area first attained the 1997 8-
hour ozone NAAQS. The Parkersburg Area continued to monitor attainment
of the 1997 8-hour ozone NAAQS in 2014. Therefore, the emissions
inventory from 2014 represents emissions levels conducive to continued
attainment (i.e., maintenance) of the NAAQS. Thus, WVDEP is using 2014
as representing attainment level emissions for its second maintenance
plan. WVDEP used 2014 summer day emissions from EPA's 2014 version 7.0
modeling platform as the basis for the 2014 inventory presented in
Table 1.\9\
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    \9\ On April 22, 2020, WVDEP submitted a clarifying letter to
EPA noting that the headings in Table 4 of its submittal were
inadvertently titled, ``2014 Summertime Daily NOx Emissions (tpd)''
instead of ``2014 Summertime Daily VOC Emissions (tpd).'' EPA does
not believe that this mislabeling negatively impacts proposed
approval of this SIP revision.

                             Table 1--2014 Typical Summer Day VOC and NOX Emissions
                                                 [Tons/day] \10\
----------------------------------------------------------------------------------------------------------------
                     Area                                Source category                VOC             NOX
----------------------------------------------------------------------------------------------------------------
Wood County, WV...............................  Fire............................             0.4             0.0
                                                Nonpoint........................             4.1             3.1
                                                Nonroad.........................             1.7             0.8
                                                Onroad..........................             2.1             4.5
                                                Point...........................             1.0             3.5
                                                                                -------------------------------
                                                   Subtotal.....................             9.3            11.9
                                                                                -------------------------------
Washington County, OH.........................  Fire............................             0.3             0.0
                                                Nonpoint........................             3.5             3.0
                                                Nonroad.........................             1.1             0.7
                                                Onroad..........................             1.9             3.2
                                                Point...........................             1.8            13.4
                                                                                -------------------------------
                                                   Subtotal.....................             8.6            20.4
                                                                                -------------------------------
Parkersburg-Marietta Area, WV-OH..............     Totals.......................            17.9            32.3
----------------------------------------------------------------------------------------------------------------

    The 2014  emissions inventory was prepared by WVDEP and uploaded
into EPA's Emissions Inventory System (EIS) for inclusion in EPA's
National Emission Inventory (NEI). The inventory addresses four
anthropogenic emission source categories: Stationary (point) sources,
stationary nonpoint (area) sources, nonroad mobile, and on-road mobile
sources. Point sources are stationary sources that have the potential
to emit (PTE) more than 100 tons per year (tpy) of VOC, or more than 50
tpy of NOX, and which are required to obtain an operating
permit. Data are collected for each source at a facility and reported
to WVDEP.
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    \10\ Data in Table 1 of the preamble only includes tons/day. See
Tables 3 and 4 of WVDEP's December 10, 2019 submittal for data in
tons/year.
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    The fire emissions sector includes emissions from agricultural
burning, prescribed fires, wildfires, and other types of fires. The
nonpoint emissions sector includes emissions from equipment,
operations, and activities that are numerous and in total have
significant emissions. Examples include emissions from commercial and
consumer products, portable fuel containers, home heating, repair and
refinishing operations, and crematories. The non-road emissions sector
includes emissions from engines that are not primarily used to propel
transportation equipment, such as generators, forklifts, and marine
pleasure craft. The on-road emissions sector includes emissions from
engines used primarily to propel equipment on highways and other roads,
including passenger vehicles, motorcycles, and heavy-duty diesel
trucks. The point source sector includes large industrial operations
that are relatively few in number but have large emissions, such as
kraft mills, electrical generating units, and pharmaceutical factories.
On-road mobile emissions are modelled by WVDEP using EPA's Motor
Vehicle Emission Simulator (MOVES). WVDEP generates nonroad mobile
source emissions data through the use of EPA's NONROAD2014a model. EPA
reviewed the supporting documentation submitted by WVDEP \11\ and
proposes to conclude that the plan's inventory is acceptable for the
purposes of a subsequent maintenance plan under CAA section
175A(b).\12\
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    \11\ See Appendix C of WVDEP's December 10, 2019 submittal.
    \12\ The daily emissions data for 2014 typical summer day VOC
and NOX emissions in Table 1 were excerpted from: https://www.epa.gov/sites/production/files/2018-11/ozone_1997_naaqs_emiss_inv_data_nov_19_2018_0.xlsx (``2014 2028 area
emiss by sector'' tab) posted at https://www.epa.gov/ground-level-ozone-pollution/1997-ozonenational-ambient-air-quality-standards-naaqs-nonattainment.
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B. Maintenance Demonstration

    In order to attain the 1997 ozone NAAQS, the three-year average of
the fourth-highest daily average ozone concentrations (design value,
DV) at each monitor within an area must not exceed 0.08 ppm. Based on
the rounding convention described in 40 CFR part 50, appendix I, the
standard is attained if the DV is 0.084 or below. CAA section 175A
requires a demonstration that the area will continue to maintain the
NAAQS throughout the duration of the requisite maintenance period.
Consistent with the prior guidance documents discussed previously in
this document, EPA believes that if the most recent DV for the area is
well below the NAAQS (e.g., below 85%, or in this case below 0.071
ppm), the section 175A demonstration requirement has been met, provided
that Prevention of Significant Deterioration (PSD) requirements, any
control measures already in the SIP, and any Federal measures remain in
place through the end of the second 10-year maintenance period (absent
a showing consistent with section 110(l) that such measures are not
necessary to assure maintenance).
    For the purposes of demonstrating a stable or improving air quality
trend, West Virginia used a weighted design value of the most recent
five design values. The five most recent design values available cover
the 2012-2018 ambient air monitoring data. This includes 3-year design
values for 2012-2014, 2013-2015, 2014-2016, 2015-2017, and 2016-2018.
Data from 2014, 2015, and 2016 was included in three out of five design
values. Table 2 of this document shows the most recent five years of
ambient ozone air quality 3-year design values. These design values are
from EPA's Air Quality System (AQS). The 7th column is a calculated 5-
year weighted design value calculated by West Virginia. This 5-year
weighted design value was calculated by averaging all the 4th Max Ozone
values from the years 2012-2018. The 8th column is the 5-year design
value average calculated by EPA. The 5-year design value average is
calculated by averaging the design values for 2012-2014, 2013-2015,
2014-2016, 2015-2017, and 2016-2018. Both the 5-year weighted design
value calculated by West Virginia, and the 5-year design value
calculated by EPA, for Parkersburg area, were calculated to be

0.066 ppm, which is below the 0.071 ppm threshold level and 79% of the
NAAQS. Table 2 shows that the most recent five years of ambient ozone
air quality 3-year average DVs for the Parkersburg Area continue to be
below 85% of the 1997 ozone NAAQS. It demonstrates that 8-hour ozone
air quality levels are significantly below the level of the standard.

                                                         Table 2--Parkersburg Area 8-Hour Ozone Design Values in Part per Million (ppm)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                5-year  design
                              Site                                   2012-2014       2013-2015       2014-2016       2015-2017       2016-2018        5-year       value average  Projected 2023
                                                                                weighted          (ppm)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Parkersburg, WV.................................................           0.069           0.067           0.068           0.065           0.062           0.066           0.066           0.060
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    For the 2023 projections shown in Table 2, EPA used a 2011-based
air quality modeling platform, which includes emissions, meteorology,
and other inputs for 2011 as the base year and emissions for 2023 as
the future analytic year base case. Specifically, the modeling platform
included a variety of data that contained information pertaining to the
modeling domain and
    simulation period. These include gridded, hourly emissions
estimates and meteorological
    data, and boundary concentrations. Separate emissions inventories
were prepared for the
    2011 base year and the 2023 base case. All other inputs (i.e.
meteorological fields, initial
    concentrations, and boundary concentrations) were specified for the
2011 base year model
    application and remained unchanged for the future-year model
simulations. The 2011
    modeling platform and projected 2023 emissions were used to drive
the 2011 base year and
    2023 future case air quality model simulations. The 2023 projected
DV for the Parkersburg Area is 0.060 ppm, well below the level of the
1997 8-hour ozone NAAQS, 0.08 ppm. Therefore, EPA proposes to determine
that that future violations of the NAAQS in this area are unlikely.

C. Continued Air Quality Monitoring and Verification of Continued
Attainment

    Once an area has been redesignated to attainment, the state remains
obligated to maintain an air quality network in accordance with 40 CFR
part 58, in order to verify the area's attainment status. In the
December 10, 2019 submittal, West Virginia committed to maintaining an
appropriate air quality monitoring network, in accordance with 40 CFR
part 58. West Virginia will continue to conduct ambient ozone air
quality monitoring in the area throughout the term of the maintenance
plan to verify continued attainment with the 1997 8-hour ozone NAAQS
and to protect any applicable PSD increments. WVDEP states that air
quality measurements will be performed in accordance with appropriate
regulations and guidance documents along with EPA quality assurance
requirements, and monitoring procedures will be determined in
accordance with 40 CFR part 58. WVDEP commits to submitting quality-
assured ozone data to EPA through the AQS and ultimately certified by
the WVDEP. EPA has analyzed the commitments in the plan and determined
that they meet the requirements.

D. Contingency Plan

    The contingency plan provisions are designed to promptly correct or
prevent a violation of the NAAQS that might occur after redesignation
of an area to attainment. Section 175A of the CAA requires that a
maintenance plan include such contingency measures as EPA deems
necessary to assure that the state will promptly correct a violation of
the NAAQS that occurs after redesignation. The maintenance plan should
identify the contingency measures to be adopted, a schedule and
procedure for adoption and implementation of the contingency measures,
and a time limit for action by the state. The state should also
identify specific indicators to be used to determine when the
contingency measures need to be adopted and implemented. The
maintenance plan must include a requirement that the state will
implement all pollution control measures that were contained in the SIP
before redesignation of the area to attainment. See section 175A(d) of
the CAA. WVDEP's December 10, 2019 submittal outlines its adopted
permanent and Federally enforceable control measures in order to
regulate emission growth. The Parkersburg Area's control measures
include the permitting regulations and PSD measures, which will remain
in effect through the maintenance plan period. Air permits issued will
incorporate applicable PSD, New Source Performance Standard, and
National Emission Standards for Hazardous Air Pollutant requirements.
    WVDEP's December 10, 2019 submittal included the required
contingency plan, to be implemented in the event of NAAQS violations in
the future. WVDEP has committed to adopting and implementing one or
more of the following control measures within three months after
verification of a monitored ozone standard violation in the Parkersburg
Area: (1) Extend the applicability of the VOC reasonably available
control technology (RACT) rule to include source categories previously
excluded (e.g., wastewater treatment facilities); (2) revise permitting
requirements establishing more stringent emissions control measures
and/or emissions offsets; (3) implement NOX RACT
requirements if necessary; (4) develop regulations to establish plant-
wide emission caps; (5) implement Stage II Vapor Recovery regulations;
(6) establish a program focusing on increasing the public's
understanding of air quality issues and increasing support for actions
to improve the air quality; and (7) initiate voluntary local control
measures (e.g., bicycle/pedestrian measures, engine idling reduction,
partnership with ground freight industry, increase compliance with open
burning restrictions, and school bus engine retrofit program).
    If there is indeed a violation and the DV exceeds the NAAQS, the
contingency plan will be ``triggered,'' based on the following
schedule: (1) quality assurance procedures must confirm the monitored
violation within 45 days of occurrence; (2) a draft rule would be
developed by the WVDEP for any regulation chosen, (3) WVDEP will adopt
the selected control measure(s) as emergency rule(s) which will be
implemented within six (6) months after adoption and will file the
rule(s) as legislative rule(s) for permanent authorization by the
legislature; and (4) for each voluntary measure selected, the WVDEP
will initiate program development with local governments within the
area by the start of the following ozone season.

    Furthermore, if the triennial inventories indicate emissions growth
in excess of 10% of the 2011 base-year inventory or if a monitored
ozone air quality exceedance pattern indicates that an ozone NAAQS
violation may be imminent, WVDEP will evaluate existing control
measures to ascertain if additional regulatory revisions are necessary
to maintain the ozone standards.
    EPA finds that West Virginia's contingency measures, as well as the
commitment to continue implementing any SIP requirements, satisfy the
pertinent requirements of section 175A. Importantly, while EPA notes
that West Virginia's contingency measures option six (increasing public
understanding) and seven (voluntary local control measures), are not
enforceable measures that standing alone are likely to lead to
reductions in emissions that could promptly correct a violation of the
NAAQS, their inclusion among other measures that meet that criterion,
is overall SIP-strengthening, and their inclusion does not alter EPA's
proposal to find the LMP is fully approvable.

E. Transportation Conformity

    Transportation conformity is required by section 176(c) of the CAA.
Conformity to a SIP means that transportation activities will not
produce new air quality violations, worsen existing violations, or
delay timely attainment of the NAAQS (CAA 176(c)(1)(B)). EPA's
conformity rule at 40 CFR part 93 requires that transportation plans,
programs and projects conform to SIPs and establish the criteria and
procedures for determining whether or not they conform. The conformity
rule generally requires a demonstration that emissions from the
Regional Transportation Plan (RTP) and the Transportation Improvement
Program (TIP) are consistent with the motor vehicle emissions budget
(MVEB) contained in the control strategy SIP revision or maintenance
plan (40 CFR 93.101, 93.118, and 93.124). An MVEB is defined as ``that
portion of the total allowable emissions defined in the submitted or
approved control strategy implementation plan revision or maintenance
plan for a certain date for the purpose of meeting reasonable further
progress milestones or demonstrating attainment or maintenance of the
NAAQS, for any criteria pollutant or its precursors, allocated to
highway and transit vehicle use and emissions (40 CFR 93.101).''
    Under the conformity rule, LMP areas may demonstrate conformity
without a regional emission analysis (40 CFR 93.109(e)). However,
because LMP areas are still maintenance areas, certain aspects of
transportation conformity determinations still will be required for
transportation plans, programs and projects. Specifically, for such
determinations, RTPs, TIPs and transportation projects still will have
to demonstrate that they are fiscally constrained (40 CFR 93.108), meet
the criteria for consultation (40 CFR 93.105 and 93.112) and
Transportation Control Measure implementation in the conformity rule
provisions (40 CFR 93.113). Additionally, conformity determinations for
RTPs and TIPs must be determined no less frequently than every four
years, and conformity of plan and TIP amendments and transportation
projects is demonstrated in accordance with the timing requirements
specified in 40 CFR 93.104. In addition, for projects to be approved
they must come from a currently conforming RTP and TIP (40 CFR 93.114
and 93.115). The Parkersburg Area remains under the obligation to meet
the applicable conformity requirements for the 1997 8-hour ozone NAAQS.

III. Proposed Action

    EPA's review of WVDEP's December 10, 2019 submittal indicates it
meets CAA section 175A and all applicable CAA requirements. EPA is
proposing to approve the LMP for the 1997 8-hour ozone NAAQS for the
Parkersburg Area (comprising Wood County), as a revision to the West
Virginia SIP. EPA is soliciting public comments on the issues discussed
in this document. These comments will be considered before taking final
action.

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866.
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this proposed rule, pertaining to West Virginia's
second maintenance plan for Wood County, does not have tribal
implications as specified by Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP is not approved to apply in Indian
country located in the state, and EPA notes that it will not impose
substantial direct costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Volatile organic compounds.

    Dated: June 25, 2020.
Cosmo Servidio,
Regional Administrator, Region III.
[FR Doc. 2020-14220 Filed 7-2-20; 8:45 am]
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