[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)]
[Notices]
[Pages 18652-18654]
[FR Doc No: 2017-07965]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1619]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice in Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary Supplements

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by May 22,
2017.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0606.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Current Good Manufacturing Practice in Manufacturing, Packaging,
Labeling, or Holding Operations for Dietary Supplements--21 CFR Part
111; OMB Control Number 0910-0606--Extension

    On October 25, 1994, the Dietary Supplement Health and Education
Act (DSHEA) (Pub. L. 103-417) was signed into law. DSHEA, among other
things, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)). Section
402(g)(2) of the FD&C Act provides, in part, that the Secretary of
Health and Human Services may, by regulation, prescribe good
manufacturing practices for dietary supplements. Section 402(g) of the
FD&C Act also stipulates that such regulations will be modeled after
current good manufacturing practice (CGMP) regulations for food and may
not impose standards for which there are no current, and generally
available, analytical methodology. Section 402(g)(1) of the FD&C Act
states that a dietary supplement is adulterated if ``it has been
prepared, packed, or held under conditions that do not meet current
good manufacturing practice regulations.'' Under section 701(a) of the
FD&C Act (21 U.S.C. 371(a)), FDA may issue regulations necessary for
the efficient enforcement of the FD&C Act. In the Federal Register of
June 25, 2007 (72 FR 34752), (the June 25, 2007, final rule), FDA
published a final rule that established, in part 111 (21 CFR part 111),
the minimum CGMP necessary for activities related to manufacturing,
packaging, labeling, or holding dietary supplements to ensure the
quality of the dietary supplement.
    Records are an indispensable component of CGMP. The records
required by FDA's regulations in part 111 provide the foundation for
the planning, control, and improvement processes that constitute a
quality control system. Implementation of these processes in a
manufacturing operation serves as the backbone to CGMP. The records
show what is to be manufactured; what was, in fact, manufactured; and
whether the controls that the manufacturer put in place to ensure the
identity, purity, strength, and composition and limits on contaminants
and to prevent adulteration were effective. Further, records will show
whether and what deviations from control processes occurred, facilitate
evaluation and corrective action concerning these deviations
(including, where necessary, whether associated batches of product
should be recalled from the marketplace), and enable a manufacturer to
assure that the corrective action was effective. In addition, by
establishing recordkeeping requirements, FDA can ensure that industry
follows CGMP during manufacturing, packaging, labeling, or holding
operations. The regulations in part 111 establish the minimum
manufacturing practices necessary to ensure that dietary supplements
are manufactured, packaged, labeled, or held in a manner that will
ensure the quality of the dietary supplements during manufacturing,
packaging, labeling or holding operations.
    The recordkeeping requirements of the regulations include
establishing written procedures and maintaining records pertaining to:
(1) Personnel; (2) sanitation; (3) calibration of instruments and
controls; (4) calibration, inspection, or checks of automated,
mechanical, or electronic equipment; (5) maintaining, cleaning, and
sanitizing equipment and utensils and other contact surfaces; (6) water
used that may become a component of the dietary supplement; (7)
production and process controls; (8) quality control; (9) components,
packaging, labels and product received for packaging and labeling; (10)
master manufacturing and batch production; (11) laboratory operations;
(12) manufacturing operations; (13) packaging and labeling operations;
(14) holding and distributing operations; (15) returned dietary
supplements; and (16) product complaints.
    Description of Respondents: Manufacturers, dietary supplement
manufacturers, packagers and repackagers, labelers and re-labelers,
holders, distributors, warehousers, exporters, importers, large
businesses, and small businesses engaged in the dietary supplement
industry.
    The recordkeeping requirements of the regulations in part 111 are
set forth in each subpart. In table 1, we list the annual burdens
associated with recordkeeping, as described in the June 25, 2007, final
rule. For some provisions listed in table 1, we did not estimate the
number of records per recordkeeper because recordkeeping occasions
consist of frequent brief entries of dates, temperatures, monitoring
results, or documentation that specific actions were taken. Information
might be recorded a few times a day, week, or month. When the records
burden involves frequent brief entries, we entered 1 as the default for
the number of records per recordkeeper. For example, many of the
records listed under Sec.  111.35 in table 1, such as Sec.
111.35(b)(2) (documentation, in individual equipment logs, of the date
of the use, maintenance, cleaning, and sanitizing of equipment),
involve many

short sporadic entries over the course of the year, varying across
equipment and plants in the industry. We did not attempt to estimate
the actual number of recordkeeping occasions for these provisions, but
instead entered an estimate of the average number of hours per year. We
entered the default value of 1 as the number of records per
recordkeeper for these and similar provisions. For Sec.  111.35, the
entry for number of records is 1 as a default representing a large
number of brief recordkeeping occasions.
    In many rows of table 1, we list a burden under a single provision
that covers the written procedures or records described in several
provisions. For example, the burden of the batch production records
listed in table 1 under Sec.  111.260 includes the burden for records
listed under Sec.  111.255 because the batch production records must
include those records.
    The number of records for batch production records (and other
records kept on a batch basis in table 1) equals the annual number of
batches. The estimated burden for records kept by batch includes both
records kept for every batch and records kept for some but not all
batches. We use the annual number of batches as the number of records
that will not necessarily be kept for every batch, such as test results
or material review and disposition records, because such records are
part of records, if they are necessary, that will be kept for every
batch.
    In the Federal Register of September 29, 2016 (81 FR 66967), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received comments from two commenters.
    (Comment 1) One commenter had concerns about whether the processes
being used to assess the contents of supplements are genuine and
accurate and how this is regulated; whether records regarding labeling
indicate what is actually contained in a supplement; and whether these
records will be available to the public.
    These comments appear to address PRA issues of practical utility
and ways to enhance the quality, utility, and clarity of the
information to be collected.
    (Response 1) In this collection of information, FDA is evaluating
the burden of retaining records and making them available to regulatory
officials, but not the burden for proactively submitting them to FDA.
FDA reviews the records maintained while conducting an investigation
(e.g., during a facility inspection and during the followup
communication until a particular investigation is closed out). The
investigation of a particular firm by FDA is exempt from the PRA and is
not included as part of the burden estimate. The required elements of
labeling are part of different regulations and do not apply to this
collection of information. The commenter also discussed the safety of a
particular product but CGMP regulations deal with establishing a
quality product, not necessarily a safe product. Finally, the commenter
discussed allowing the records maintained to be made public. These
records are required to be maintained by the firm and are not
proactively submitted to FDA, but they are required to be made
available to FDA during inspections. If FDA obtains these records
during the investigation of a firm, the public can submit a Freedom of
Information Act request but the document they would typically receive
would be redacted because the records are the property of the firm.
    (Comment 2) The second commenter stated that the labeling on
dietary supplement products should be consistent and FDA regulated, the
term ``healthy'' should be required to have a standard meaning, and
``healthy'' should not be allowed to be used unless it meets FDA
requirements of the term.
    (Response 2) The recordkeeping for CGMPs has nothing to do with the
required elements of food and dietary supplement labeling, which are
covered under FDA's labeling regulations. FDA recently published, on
May 27, 2016, a final rule for Nutrition (and Supplement) Facts Labels
(81 FR 33741), and is currently reviewing new requirements for labeling
your food ``healthy''. This information collection for CGMP addresses
recordkeeping for specifications for a label and labeling operations.
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                21 CFR section                    Number of      records per    Total annual        Average burden per recordkeeping        Total hours
                                                recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
111.14, Records of personnel practices,                15,000               4          60,000  1........................................          60,000
 including documentation of training.
111.23, Records of physical plant sanitation           15,000               1          15,000  0.2 (12 minutes).........................           3,000
 practices, including pest control and water
 quality.
111.35, Records of equipment and utensils                 400               1             400  12.5.....................................           5,000
 calibration and sanitation practices.
111.95, Records of production and process                 250               1             250  45.......................................          11,250
 control systems.
111.140, Records that quality control                     240           1,163         279,120  1........................................         279,120
 personnel must make and keep.
111.180, Records associated with components,              240           1,163         279,120  1........................................         279,120
 packaging, labels, and product received for
 packaging and labeling as a dietary
 supplement.
111.210, Requirements for what the master                 240               1             240  2.5......................................             600
 manufacturing record must include.
111.260, Requirements for what the batch                  145           1,408         204,160  1........................................         204,160
 record must include.
111.325, Records that quality control                     120               1             120  15.......................................           1,800
 personnel must make and keep for laboratory
 operations.
111.375, Records of the written procedures                260               1             260  2........................................             520
 established for manufacturing operations.
111.430, Records of the written procedures                 50               1              50  12.6.....................................             630
 for packaging and labeling operations.
111.475, Records of product distribution and           15,000               1          15,000  0.4 (24 minutes).........................           6,000
 procedures for holding and distributing
 operations.

111.535, Records for returned dietary                     110               4             440  13.5.....................................           5,940
 supplements.
111.570, Records regarding product complaints             240             600         144,000  0.5 (30 minutes).........................          72,000
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................         929,140
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The average burden per recordkeeping estimates in table 1 are based
on those in the June 25, 2007, final rule, which were based on our
institutional experience with other CGMP requirements and on data
provided by Research Triangle Institute in the ``Survey of
Manufacturing Practices in the Dietary Supplement Industry'' cited in
that rule.
    The estimates in table 1 of the number of firms affected by each
provision of part 111 are based on the percentage of manufacturers,
packagers, labelers, holders, distributors, and warehousers that
reported in the survey that they have not established written SOPs or
do not maintain records that were later required by the June 25, 2007,
final rule. Because we do not have survey results for general
warehouses, we entered the approximate number of facilities in that
category for those provisions covering general facilities. For the
dietary supplement industry, the survey estimated that 1,460 firms
would be covered by the final rule, including manufacturers, packagers,
labelers, holders, distributors, and warehousers. The time estimates
include the burden involved in documenting that certain requirements
are performed and in recordkeeping. We used an estimated annual batch
production of 1,408 batches per year to estimate the burden of
requirements that are related to the number of batches produced
annually, such as Sec.  111.260, ``What must the batch production
record include?'' The estimate of 1,408 batches per year is near the
midpoint of the number of annual batches reported by survey firms.
    The length of time that CGMP records must be maintained is set
forth in Sec.  111.605. Table 1 reflects the estimated burdens for
written procedures, record maintenance, periodically reviewing records
to determine if they may be discarded, and for any associated
documentation for that activity for records that are required under
part 111. We have not included a separate estimate of burden for those
sections that require maintaining records in accordance with Sec.
111.605, but have included those burdens under specific provisions for
keeping records. For example, Sec.  111.255(a) requires that the batch
production records be prepared every time a batch is manufactured, and
Sec.  111.255(d) requires that batch production records be kept in
accordance with Sec.  111.605. The estimated burdens for both Sec.
111.255(a) and (d) are included under Sec.  111.260, what the batch
record must include.

    Dated: April 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-07965 Filed 4-19-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 9 (Tuesday, January 14, 2020)]
[Notices]
[Page 2123]
[FR Doc No: 2020-00347]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER20-637-000]

Wilton Wind Energy I, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Wilton Wind Energy I, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is January 27, 2020.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: January 7, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-00347 Filed 1-13-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 37 (Thursday, February 24, 2022)]
[Proposed Rules]
[Pages 10318-10325]
[FR Doc No: 2022-03863]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2021-0727; FRL-9552-01-R3]

Approval and Promulgation of Air Quality Implementation Plans;
District of Columbia, Maryland, and Virginia; 2017 Base Year Emissions
Inventories for the Washington, DC-MD-VA Nonattainment Area for the
2015 Ozone National Ambient Air Quality Standard

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve state implementation plan (SIP) revisions submitted by the
District of Columbia (DC), State of Maryland (MD), and Commonwealth of
Virginia (VA) (collectively, the States). This revision consists of the
base year inventory for the Washington, DC-MD-VA nonattainment area
(the DC Area) for the 2015 ozone national ambient air quality standards
(NAAQS). This action is being taken under the Clean Air Act (CAA).

DATES: Written comments must be received on or before March 28, 2022.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R03-
OAR-2021-0727 at https://www.regulations.gov, or via email to
[email protected]. 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: Michael O'Shea, 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-
2064. Dr. O'Shea can also be reached via electronic mail at
[email protected].

SUPPLEMENTARY INFORMATION: On October 7, 2020, the Maryland Department
of the Environment (MDE) submitted a revision to the Maryland SIP
entitled, ``SIP--20-04 2017 Base Year Inventory for the Washington, DC-
MD-VA 2015 Ozone NAAQS Nonattainment Area.'' This revision is referred
to as the ``MD submittal'' in this rulemaking. On November 4, 2020, the
District of Columbia Department of Energy and Environment (DOEE),
submitted a revision to the DC SIP entitled, ``DC 2015 Ozone NAAQS
Attainment Plan Base Year Inventory.'' This revision is referred to as
the ``DC submittal'' in this rulemaking. On December 11, 2020, the
Virginia Department of Environmental Quality (VADEQ) submitted a
revision to the Virginia SIP entitled, ``8-Hour Ozone (2015 Standard)--
Washington Attainment Plan `VA_2017O3BYEI_12112020.' '' This revision
is referred to as the ``VA submittal'' in this rulemaking. These
individual SIPs were collaboratively developed by DOEE, MDE, VADEQ, and
the Metropolitan Washington Council of Government (MWCOG). The
individual state SIP revisions, referred to collectively in this
rulemaking action as the ``DC Area base year inventory SIPs,'' address
the base year inventory requirement for the DC Area for the 2015 ozone
NAAQS. The individual state SIP submissions, including their
appendices, are included in the docket for this rulemaking and are
available online at https://www.regulations.gov, Docket ID: EPA-R03-
OAR-2021-0727.

I. Background

    On October 1, 2015, EPA strengthened the 8-hour ozone NAAQS,
lowering the level of the NAAQS from 0.075 ppm parts per million (ppm)
to 0.070 ppm. 80 FR 65292 (October 26, 2015). Effective August 3, 2018,
EPA designated the following jurisdictions in the DC Area as marginal
nonattainment for the 2015 ozone NAAQS: District of Columbia; Calvert,
Charles, Frederick, Montgomery, and Prince George's Counties in MD; and
Arlington, Fairfax, Loudoun, and Prince William Counties and
Alexandria, Fairfax, Falls Church, Manassas, and Manassas Park Cities
in VA. 83 FR 25776 (June 4, 2018). CAA section 182(a)(1) requires ozone
nonattainment areas classified as marginal or above to submit a
comprehensive, accurate, current inventory of actual emissions from all
emissions sources in the nonattainment area, known as a ``base year
inventory.'' The DC Area base year inventory SIPs addresses a base year
inventory requirement for the DC Area.

II. Summary of SIP Revision and EPA Analysis

A. EPA's Evaluation of the DC Area Base Year Inventory SIPs

    EPA's review of the DC Area base year inventory SIPs indicate that
they meet the base year inventory requirements for the 2015 ozone
NAAQS. EPA prepared a Technical Support Document (TSD) for each state's
submittal in support of this rulemaking. In those TSDs, EPA reviewed
the results, procedures, and methodologies for the SIP base year, and
found them to be acceptable and developed in accordance with EPA's
technical guidance. EPA's TSDs for the individual state SIPs are
available online at http://www.regulations.gov, Docket ID No. EPA-R03-
OAR-2021-0727.

B. Base Year Inventory Requirements

    In EPA's December 6, 2018 rule, ``Implementation of the 2015
National Ambient Air Quality Standards for Ozone: Nonattainment Area
State Implementation Plan Requirements,'' known as the ``SIP
Requirements Rule,'' EPA set out nonattainment area requirements for
the 2015 ozone NAAQS. (83 FR 62998). The SIP Requirements Rule
established base year inventory requirements, which were codified at 40
Code of Federal Regulations (CFR) 51.1315. As required by 40 CFR
51.1315(a), each 2015 ozone nonattainment area must submit a base year
inventory within 2 years of designation.
    Also, 40 CFR 51.1315(a) requires that the inventory year be
selected consistent with the baseline year for the reasonable further
progress (RFP) plan as required by 40 CFR 51.1310(b), which states that
the baseline emissions inventory shall be the emissions inventory for
the most recent calendar year for which a complete triennial inventory
is required to be submitted to EPA under the provisions of subpart A of
40 CFR part 51, Air Emissions Reporting Requirements, 40 CFR 51.1
through 50. The most recent triennial inventory year conducted for the
National Emissions

Inventory (NEI) pursuant to the Air Emissions Reporting Requirements
(AERR) rule is 2017. 73 FR 76539 (December 17, 2008). The States
selected 2017 as their baseline emissions inventory year for RFP. This
selection comports with EPA's implementation regulations for the 2015
ozone NAAQS because 2017 is the inventory year. 40 CFR 51.1310(b).\1\
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    \1\ On January 29, 2021, the Court of Appeals for the D.C.
Circuit issued its decision regarding multiple challenges to EPA's
implementation rule for the 2015 ozone NAAQS which included, among
other things, upholding this provision allowing states to use an
alternative baseline year for RFP. Sierra Club v. EPA, No. 15-1465
(D.C. Cir.). The other provisions of EPA's ozone implantation rule
at issue in the case are not relevant for this rulemaking.
---------------------------------------------------------------------------

    Further, 40 CFR 51.1315(c) requires emissions values included in
the base year inventory to be actual ozone season day emissions as
defined by 40 CFR 51.1300(q), which states: Ozone season day emissions
means an average day's emissions for a typical ozone season work
weekday. The state shall select, subject to EPA approval, the
particular month(s) in the ozone season and the day(s) in the work week
to be represented, considering the conditions assumed in the
development of RFP plans and/or emissions budgets for transportation
conformity. The States included actual ozone season day emissions,
pursuant to 40 CFR 51.1315(c).

C. DC Area Base Year Inventory SIPs

    The DC Area base year inventory SIPs, contain an explanation of
each State's 2017 base year emissions inventory for stationary, non-
point, non-road, and on-road anthropogenic sources, as well as biogenic
sources, in the DC Area. The States estimated anthropogenic emissions
for volatile organic compound (VOC), nitrogen oxide (NOx), and carbon
monoxide (CO) for a typical ozone season work weekday. As identified
above, the DC Area base year inventory SIPs were developed
collaboratively. As such, their 2017 base year emissions inventory are
almost identical and, therefore, will be referred to collectively as
the ``2017 DC Area BYEI'' in the remainder of this rulemaking, unless
otherwise noted because individual distinctions are necessary.\2\
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    \2\ The 2017 DC Area BYEI submitted by each individual state is
found as follows: DC submittal--Appendix BY2017
_EI_Document_October_30_2020_FINAL; MD submittal--Appendix 2. Wash
Region 2015 NAAQS BY Inventory SIP; and VA submittal--Appendix NVA-
INV-SIP-1.
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    The States developed the 2017 DC Area BYEI with the following
source categories of anthropogenic emissions sources: Point, quasi-
point, non-point, non-road model, on-road, and commercial marine
vessels, airport, and railroad (MAR) emissions sources, in addition to
biogenic total sources. The 2017 DC Area BYEI sets out the
methodologies the States used to develop their base year inventory for
each source listed. Those methodologies are explained in further depth
within appendices A-D of each state's submission. Data justifying the
inventories are also provided within appendices A-D of each state's
submission. Note, however, that Virginia only included appendix items
relevant to their own state but uploaded files jointly with DC for the
full inventory development. Furthermore, the MD submittal was earliest
and, as such, contains data, development, and guidance that precedes
the widespread adoption of the 2017 NEI. This timing differential
accounts for the differences in the MD submittal as compared to the DC
and VA submittals. For simplicity purposes, the appendices will be
referred to as the State's appendices.
1. Point Sources
    Point sources are larger sources that are located at a fixed,
stationary location. As defined by the AERR in 40 CFR 51.50, point
sources are large, stationary (non-mobile), identifiable sources of
emissions that release pollutants into the atmosphere. A point source
is a facility that is a major source under 40 CFR part 70 for one or
more of the pollutants for which reporting is required by 40 CFR
51.15(a)(1). Examples of point source emissions categories include
power plants, industrial boilers, petroleum refineries, cement plants,
and other industrial plants.
    As stated in the State's 2017 DC Area BYEI, the State's air
agencies (DOEE, MDE, VADEQ), maintain substantial databases of both
small and large air emission sources. Point sources in the inventory
generally related to facilities contained within the EPA's Emissions
Inventory System (EIS). From the EIS, NEI point source estimates are
created. Common types of facilities included are large industrial or
commercial complexes including municipal waste combustors, electric
generating stations, governmental organizations, and manufacturing
facilities. The methods used to convert annual emissions to ozone
season work weekday emissions are described in the State's appendices:
For DC emissions--Appendix A1a,\3\ \4\ for MD emissions--Appendix
B1b,\5\ \6\ and for VA emissions--Appendix A1b.\7\ \8\ \9\ The States
keep records of point sources and emissions and these records
maintained by the respective state air agency where the facilities or
sources are located. The emissions data for the DC area are housed in
the State's appendices: for DC emissions--Appendix A2a,\10\ \11\ for MD
emissions--Appendix B2b,\12\ \13\ and for VA--Appendix A2b.\14\ \15\
\16\
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    \3\ Appendix A1a--Point Source Inventory Development Overview
(District of Columbia), DC submittal.
    \4\ Appendix A1a--Point Source Inventory Development Overview
(District of Columbia), MD submittal.
    \5\ Appendix B1b--Point, Quasi-Point, Nonpoint and Marine/Air/
Rail Inventory Development Overview (Maryland), DC submittal.
    \6\ Appendix B1b--Point, Quasi-Point, Nonpoint and Marine/Air/
Rail Inventory Development Overview (Maryland), MD Submittal.
    \7\ Appendix A1b--Point Source Inventory Development Overview
(Virginia), DC submittal.
    \8\ Appendix A1b--Point Source Inventory Development Overview
(Virginia), MD submittal.
    \9\ Appendix A1b--Point Source Inventory Development Overview
(Virginia), VA submittal.
    \10\ Appendix A2a--Point Source Inventory Files (District of
Columbia), DC submittal.
    \11\ Appendix A2a--Point Source Inventory Files (District of
Columbia), MD submittal.
    \12\ Appendix B2b--Point, Quasi-Point, Nonpoint and Marine/Air/
Rail Inventory Files (Maryland), DC submittal.
    \13\ Appendix B2b--Point, Quasi-Point, Nonpoint and Marine/Air/
Rail Inventory Files (Maryland), MD submittal.
    \14\ Appendix A2b--Point Source Inventory Files (Virginia), DC
submittal.
    \15\ Appendix A2b--Point Source Inventory Files (Virginia), MD
submittal.
    \16\ Appendix A2b--Point Source Inventory Files (Virginia), VA
submittal.
---------------------------------------------------------------------------

    As stated in the State's Appendix A1a, DOEE recorded data for all
the point, unit, stack, and process sources submitted to the EPA for
the 2017 NEI. DOEE also provided their point source inventory with
NOX, VOC, and CO in tons. Ozone Season Day (OSD) emissions
calculations were also justified by DOEE. See the State's Appendix A1a
for additional details on methodology; see also EPA's DC TSD.\17\
---------------------------------------------------------------------------

    \17\ EPA's DC TSD for the 2017 Base Year Inventory for the DC
Area.
---------------------------------------------------------------------------

    As seen in the State's Appendix B1b, the MDE Air and Radiation
Administration (ARA) compiled the point source emissions inventory.
They identified sources, documented the methods for calculations, and
presented findings. MDE has a substantial database of air emissions
sources and permitting, and its compliance programs also played a major
role in their investigation. They provided full point source data in
the State's Appendix B2b for CO, NOX, and VOC and provided
justification for OSD calculations. See the State's Appendix B1b for
additional

details on methodology; see also EPA's MD TSD.\18\
---------------------------------------------------------------------------

    \18\ EPA's MD TSD for the 2017 Base Year Inventory for the DC
Area.
---------------------------------------------------------------------------

    In the State's Appendix A1b, Virginia noted that they keep a
detailed database for point sources called the Comprehensive
Environmental Database System (CEDS). As noted above, emissions data
for facilities can include emission tests, Title V reports, compliance
reports and other documents mentioned in the State's Appendix A1b and
documented in Appendix A2b. The VADEQ staff attested to reviewing the
data and uploading information required for AERR to be included for the
2017 NEI. They provided full point sources data for NOX,
VOC, and CO, typically in tons and provided justification for OSD
emissions. See the State's Appendix A1b for additional details on
methodology; see also EPA's VA TSD.\19\
---------------------------------------------------------------------------

    \19\ EPA's VA TSD for the 2017 Base Year Inventory for the DC
Area.
---------------------------------------------------------------------------

2. Quasi-Point Sources
    The only quasi-point source in the DC area, Andrews Air Force Base
(Joint Base Andrews--JBA), is located in Prince George's County, MD.
MDE identified facilities at this location that due to size or function
are considered point sources. In the State's Appendix B1b, MDE notes
that these establishments include a wide variety of air emissions
sources, including point sources, on-road mobile sources, off-road
mobile sources, and area sources.
    For Joint Base Andrews, the emissions from the other source
categories at the facility are totaled under a single point source and
considered by MDE as being a quasi-point source. As noted in the EPA's
MD TSD, for each of these quasi-point sources, emissions for each
source category at the facility were calculated separately to find the
ozone season day emissions, and then totaled together to get a facility
wide emission for each pollutant. Data outlining quasi-point sources
are provided in the State's Appendix B2b. EPA has reviewed the source
categories included in the quasi-point sources and has found this to be
a reasonable approach to handle these sources.
3. Non-Point Sources
    Non-point sources are also called ``area sources.'' These sources
collectively represent individual sources of emissions that have not
been inventoried as specific point or mobile sources. These individual
sources treated collectively as non-point sources are typically too
small, numerous, or difficult to inventory using the methods for the
other classes of sources. As noted in the 2017 DC Area BYEI, for
example, small fossil fuel fired boilers used for comfort purposes
located at residential, commercial, and governmental locations fall
into this category.
    The non-point category is broad and diverse, and the emissions
calculations used in this category vary and the category has many
subsectors. State air agencies provided details for developing
emissions for nonpoint sources in the State's appendices: for DC
emissions--Appendix B1a,\20\ \21\ for MD emissions--Appendix B1b, and
for VA emissions--Appendix B1c (VA).\22\ \23\ \24\ Note that stage II
refueling emissions were developed by the National Capital Region
Transportation Planning Board (TSB) at MWCOG in association with staff
and State's air agencies using the Motor Vehicle Emissions Simulator
(MOVES) 2014b model. See the State's Appendix D1 \25\ \26\ \27\ for
details on development of on-road emissions.
---------------------------------------------------------------------------

    \20\ Appendix B1a--Nonpoint and Marine/Air/Rail Inventory
Development Overview (District of Columbia), DC submittal.
    \21\ Appendix B1a--Nonpoint and Marine/Air/Rail Inventory
Development Overview (District of Columbia), MD submittal.
    \22\ Appendix B1c--Virginia Nonpoint and Marine/Air/Rail
Inventory Development Overview, DC submittal.
    \23\ Appendix B1c -Nonpoint and Marine/Air/Rail Inventory
Development Overview (Virginia), MD submittal.
    \24\ Appendix B1c--Virginia Nonpoint and Marine/Air/Rail
Inventory Development Overview, VA submittal.
    \25\ Appendix D1--On-road Mobile Source Inventory Development
Overview, DC submittal.
    \26\ Appendix D1--On-road Mobile Source Inventory Development
Overview, MD submittal.
    \27\ Appendix D1--On-road Mobile Source Inventory Development
Overview, VA submittal.
---------------------------------------------------------------------------

    As noted in EPA's MD TSD, nonpoint emissions are typically
calculated on an annual basis by multiplying an emission factor by some
known indicator of collective activity for each source category at the
county level. For the 2017 DC Area BYEI, DOEE calculated the ozone
season day emissions by applying a seasonal adjustment factor, provided
by MDE, and supplemented by DOEE, to their emission estimates. See the
State's Appendix B1a for calculations. In the State's Appendix B2a,\28\
\29\ nonpoint sector categories in the District's emissions inventory
were catalogued, including contributions to the 2017 NEI.
NOX, VOC, and CO data were provided in tons, and both annual
and ozone season totals were included.
---------------------------------------------------------------------------

    \28\ Appendix B2a--Nonpoint and Marine/Air/Rail Inventory Files
(District of Columbia), DC submittal.
    \29\ Appendix B2a--Nonpoint and Marine/Air/Rail Inventory Files
(District of Columbia), MD submittal.
---------------------------------------------------------------------------

    MDE, as indicated above, applied a seasonal adjustment factor to
their emissions estimates. As noted in EPA's MD TSD, a detailed
explanation of how MDE calculated each nonpoint source category can be
found in Section 4--Area Sources of the State's Appendix B1b. Emissions
were provided annually and by ozone season day for each nonpoint source
category code (SCC) for NOX, VOC, and CO. Full data is
provided in the State's Appendix B2b.
    For Virginia, a detailed explanation of the non-point inventory is
provided in the State's Appendix B1c. As they note, staff from the
VADEQ compiled Northern Virginia 2017 annual and ozone season daily
emissions estimate from the EPA 2017 NEI. In the State's Appendix
B2c,\30\ \31\ \32\ VADEQ outlines sample calculations for their
nonpoint and MAR emissions for each pollutant. In the State's Appendix
B2c, activity level data, emission factor, control factors, fuel
loading factors, and others are provided in addition to raw data for
OSD. Virginia followed MDE's guidance for calculating OSD and provided
examples of their calculations in the State's Appendix B1c. Data for
NOX, VOC and CO were provided in OSD and annually.
---------------------------------------------------------------------------

    \30\ Appendix B2c--Nonpoint and Marine/Air/Rail Inventory Files
(Virginia), DC submittal.
    \31\ Appendix B2c--Nonpoint and Marine/Air/Rail Inventory Files
(Virginia), MD submittal.
    \32\ Appendix B2c--Nonpoint and Marine/Air/Rail Inventory Files
(Virginia), VA submittal.
---------------------------------------------------------------------------

4. Non-Road Model Mobile Sources
    Non-road mobile sources are also called ``off-highway'' mobile
sources. These are defined as a non-road engine or non-road vehicle. As
per 40 CFR 51.50, a non-road engine is an internal combustion engine
(including the fuel system) that is not used in an on-road motor
vehicle or a vehicle used solely for competition, or that is not
affected by sections 111 or 202 of the CAA. Also defined by 40 CFR
51.50, a non-road vehicle (rather than engine) is a vehicle that is run
by a non-road engine and that is not an on-road motor vehicle or a
vehicle used solely for competition. Examples of non-road mobile
sources include airport ground support equipment, agricultural and
construction equipment powered by an internal combustion engine, and
lawn and garden engines and equipment.
    As explained in the 2017 DC Area BYEI, the inventory for nonroad
mobile sources, and some MAR sources, for VOC, NOX, and CO
were calculated using the EPA's MOVES2014 model. This model includes 88
types of nonroad equipment and 12 economic sectors. The sectors are:

     Recreational sector equipment, such as all-terrain
vehicles and off-road motorcycles;
     Construction sector equipment, such as graders and
backhoes;
     Industrial sector equipment, such as forklifts and
sweepers;
     Lawn and garden sector equipment, such as leaf and snow
blowers;
     Agricultural sector equipment, such as tractors;
     Commercial sector equipment, such as compressors;
     Logging sector equipment, such as chain saws;
     Airport support sector equipment, such as airport ground
support equipment;
     Underground mining sector equipment, such as, mining
equipment;
     Oil field sector equipment, such as oil field equipment;
     Pleasure craft sector equipment, such as personal
watercraft; and
     Railroad sector equipment, such as railway maintenance
equipment.
    As noted in the 2017 DC Area BYEI, the MOVES2014b model estimates
emissions for each specific type of nonroad equipment by multiplying
the following input data estimates:
     Equipment population for the base year, distributed by
age, power, fuel type, and application;
     Average load factor expressed as average fraction of
available power;
     Available power in horsepower;
     Activity in hours of use per year; and
     Emission factors reflecting deterioration and/or new
standards.
    The emissions are then temporally allocated using appropriate
allocation factors. All emissions sources are included for DC and
Maryland. However, railway maintenance and airport ground support
equipment were not included for Virginia. Instead, Virginia provided
emissions for these sources from the 2017 NEI effort. See the State's
Appendix D1 for details and Appendix C \33\ \34\ \35\ \36\ for
MOVES2014b nonroad model input, output, and runspec files.
---------------------------------------------------------------------------

    \33\ Appendix C--MOVES 2014b (Nonroad Mobile Model) Input and
Output Files, DC Submittal.
    \34\ Appendix C--MOVES 2014b (Nonroad Mobile Model) Input and
Output Files, MD Submittal.
    \35\ Appendix C--MOVES 2014b (Nonroad Mobile Model) Input and
Output Files, VA Submittal.
    \36\ Appendix C--MOVES 2014b, which is included in each State's
submission, is a large datafile. It is described in a memo for this
rulemaking. This file itself is not available on regulation.gov but
can be provided upon request.
---------------------------------------------------------------------------

5. Marine Vessels, Airport, Railroad Locomotives Sources
    Marine Vessels, Airport, Railroad Locomotives (MAR) is a non-road
sub-category. Detailed documentation for the development of MAR sources
were given by the States air agencies, as noted in the 2017 DC Area
BYEI. As above, MAR guidance overviews are in the State's appendices:
For DC emissions--Appendix B1a, for MD emissions--Appendix B1b, and for
VA emissions--Appendix B1c. The MAR data is listed in the State's
appendices: For DC emissions--Appendix B2a, for MD emissions--Appendix
B2b, and for VA emissions--Appendix B2c.
    For DC, railway maintenance emissions were developed using the
MOVES2014b model. DC provided airport emissions from the 2017 NEI and
the facilities in DC's airport inventory. The district also provided
details on their OSD calculations for all MAR sources in the State's
Appendix B1a with some information in the 2017 DC Area BYEI.
    MDE relied on the MOVES2014b model for railways maintenance and
airport ground support equipment using the above model. MDE calculated
emissions by collecting data directly from surveyed sources, or
activity from state and Federal reporting agencies. Details of the
development of emissions for MAR sources along with other non-road
model sources and their OSD approach are provided in the State's
Appendix B1b with some information in the 2017 DC Area BYEI.
    For Virginia, the 2017 NEI was used for all emissions calculations
including for railway maintenance and airport ground support equipment.
Sample calculations were provided in the State's Appendix B1c by the
VADEQ for annual emissions estimates for all sources. The state also
outlined their approach for OSD calculations is the State's Appendix
B1c.
6. On-Road Mobile Sources
    On-road mobile sources are also called ``highway mobile sources.''
These sources are the motor vehicles (e.g., automobiles, buses, trucks)
traveling on local and highway roads. On-road mobile sources should be
estimated by the latest recommended on-road mobile source models.
Currently, that means EPA's MOVES model for all states but California.
    In addition to emissions from vehicles' exhaust, the MOVES model
estimates evaporative emissions for mobile sources, which must be
included in the inventory. Volatile hydrocarbons evaporate from the
fuel system while a vehicle is refueling, parked, or driving.
Evaporative processes differ from exhaust emissions because they don't
directly involve combustion, which is the main process driving exhaust
emissions.
    As stated in the State's Appendix D1 and in the 2017 DC Area BYEI,
the TSB was responsible for developing the on-road mobile sources
emissions using information, such as meteorological inputs from
Metropolitan Washington Air Quality Committee (MWAQC) and fuel,
inspection and maintenance program information from state air agencies.
EPA's MOVES2014b model was selected to estimate the 2017 DC Area BYEI
on-road emissions inventories for the 2015 ozone national ambient air
quality standard emissions from on-road mobile sources in the DC area.
The emissions results were reviewed by MWAQC staff and approved and
incorporated into the 2017 inventories. The On-Road MOVES2014b input
and output files are in the State's Appendix D2.\37\ \38\ \39\ \40\
---------------------------------------------------------------------------

    \37\ Appendix D2--MOVES 2014b (Onroad Mobile Model) Input and
Output Files, DC submittal.
    \38\ Appendix D2--MOVES 2014b (Onroad Mobile Model) Input and
Output Files, MD submittal.
    \39\ Appendix D2--MOVES 2014b (Onroad Mobile Model) Input and
Output Files, VA submittal.
    \40\ Appendix D2--MOVES 2014b, which is included in each State's
submission, is a large datafile. It is described in a memo for this
rulemaking. The file itself is not available on regulations.gov but
can be provided upon request.
---------------------------------------------------------------------------

    As noted in the State's Appendix D1, first, TSB's adopted travel
demand model was used to estimate vehicle miles of travel (VMT) at the
network link level of analysis. The modeled VMT outputs were developed
at the network link level by vehicle type and by four time-of-day
periods. Next, a post processor was used to further refine link-level
VMT and link speeds into vehicle-hours of travel (VHT) by facility
type, hourly periods, and speed bins. Finally, several data preparation
steps were undertaken before MOVES was executed. Again, an overview of
the process is presented in the State's Appendix D1. Lastly, the MOVES
model was executed to calculate base year emissions.
    Overall, the MOVES model considered factors such as vehicle type,
facility type, VMT/VHT fractions, observed and simulated VMT, speed
distributions, road type, age of cars, fuel formation, meteorological
data, ramp fraction, road type distribution (for VMT), source (vehicle)
type population, inspection/maintenance programs, hoteling (idling),
and source type programs by state. All factors are outlined in detail
in the State's Appendix D1. The on-road mobile emissions analysis
process is very similar to the one used during the development of
previous base year inventories.

    EPA has reviewed the results, procedures, and methodologies
utilized by the States to determine anthropogenic emissions for the DC
Area for the SIP base year, as well as comparing the inventory with
previously verified data in EPA's 2017 NEI for any data discrepancies
and found none. EPA has therefore determined the base year inventory to
be acceptable and developed in accordance with EPA's technical
guidance.
7. Biogenic Emissions
    The States also outlined biogenic emissions, which are not included
in the anthropogenic total. Biogenic emissions come from natural
sources, including vegetation and soils. In the 2017 DC Area BYEI, the
States explain that the 2014 NEI estimates by EPA were accepted for
purposes of the base year 2017 biogenic inventories. These methods are
acceptable under EPA's emission inventory guidance.\41\
---------------------------------------------------------------------------

    \41\ EPA's Emissions Inventory Guidance for Implementation of
Ozone and Particulate Matter National Ambient Air Quality Standards
(NAAQS) and Regional Haze Regulations--https://www.epa.gov/sites/default/files/2017-07/documents/ei_guidance_may_2017_final_rev.pdf.
---------------------------------------------------------------------------

8. Emissions Summary
    The State's 2017 DC Area BYEI contain a summary of 2017 ozone
season day emissions by source category, which are presented in Table 1
of this document. Note, for each state, the information they provided
for themselves was utilized. Where differences in the submitted data
exists, the latest submission, the VA submittal, was used. The
differences in reported data between the DC, MD, and VA submittals all
relate to the timing of the submissions and the date when the 2017 NEI
was adopted. The MD submittal was first, and its development preceded
the adoption of the 2017 NEI. The DC and VA submittals were submitted
after the widespread adoption of the 2017 NEI and considered the 2017
NEI data. The differences in the data between the MD submittal and the
DC and VA submittals has been described in the above sections. Tables 2
through 7 of this document present the State's 2017 DC Area BYEI by
source category and county. In the State's 2017 DC Area BYEI, the
States demonstrate that the biogenic emissions in Table 1 of this
document are taken from EPA's 2014 NEI database. As noted in the
State's 2017 DC Area BYEI, total biogenic emissions for July 2014 were
divided by 31 days to develop average ozone season day emissions for
each jurisdiction in the DC Area and then added together to develop the
DC Area total.

                                       Table 1--2017 DC Area BYEI Summary
                                           [Tons per ozone season day]
----------------------------------------------------------------------------------------------------------------
                         Source category                                VOC             NOX             CO
----------------------------------------------------------------------------------------------------------------
Point...........................................................            5.19           79.55           25.13
Quasi-Point.....................................................            0.39            0.19            0.28
Non-Point.......................................................          127.88           23.22           74.27
Non-Road Model..................................................           37.68           30.87          710.87
MAR.............................................................            2.05           11.09           19.26
On-Road.........................................................           49.58           93.42          673.21
                                                                 -----------------------------------------------
    Anthropogenic Total.........................................          222.76          238.34        1,503.02
Biogenic........................................................          442.62            3.67           38.23
----------------------------------------------------------------------------------------------------------------

                                Table 2--2017 DC Area BYEI Point Source Emissions
                                           [Tons per ozone season day]
----------------------------------------------------------------------------------------------------------------
                          Jurisdiction                                  VOC             NOX             CO
----------------------------------------------------------------------------------------------------------------
District of Columbia............................................            0.17            0.78            0.52
Calvert County..................................................            0.11            2.66            0.88
Charles County..................................................            0.32            6.47            2.19
Frederick County................................................            0.76            1.75            1.73
Montgomery County...............................................            0.33           13.85            4.32
Prince George's County..........................................            0.99           24.68            5.43
                                                                 -----------------------------------------------
    Maryland Total..............................................            2.51           49.41           14.55
Arlington County................................................            0.02            0.25            0.13
Fairfax County..................................................            0.81           10.39            4.04
Fairfax City....................................................            0.30            0.01            0.02
Falls Church City...............................................
Loudoun County..................................................            0.71           10.44            3.32
Prince William County...........................................            0.52            6.36            2.07
Manassas City...................................................            0.13            0.54            0.25
Manassas Park City..............................................
Alexandria City.................................................            0.02            1.37            0.23
                                                                 -----------------------------------------------
    Virginia Total..............................................            2.51           29.36           10.06
                                                                 -----------------------------------------------
        Region Total............................................            5.19           79.55           25.13
----------------------------------------------------------------------------------------------------------------
Note: There are no point source VOC, NOX, and CO emissions for the Virginia Independent Cities of Falls Church
  and Manassas Park.

                             Table 3--2017 DC Area BYEI Quasi-Point Source Emissions
                                           [Tons per ozone season day]
----------------------------------------------------------------------------------------------------------------
                          Jurisdiction                                  VOC             NOX             CO
----------------------------------------------------------------------------------------------------------------
Prince George's County..........................................            0.39            0.19            0.28
    Maryland Total..............................................            0.39            0.19            0.28
                                                                 -----------------------------------------------
        Region Total............................................            0.39            0.19            0.28
----------------------------------------------------------------------------------------------------------------
Note: Quasi-point sources only exist in the Prince George's County, Maryland. Emissions for these sources were
  provided by MDE.

                                 Table 4--2017 DC BYE Non-Point Source Emissions
                                           [Tons per ozone season day]
----------------------------------------------------------------------------------------------------------------
                          Jurisdiction                                  VOC             NOX             CO
----------------------------------------------------------------------------------------------------------------
District of Columbia............................................            9.61            2.24            2.29
Calvert County..................................................            2.33            0.24            3.31
Charles County..................................................            4.42            1.05            9.77
Frederick County................................................            7.18            1.27           10.13
Montgomery County...............................................           22.70            4.14            4.32
Prince George's County..........................................           21.28            3.30            5.84
                                                                 -----------------------------------------------
    Maryland Total..............................................           57.90           10.00           33.36
Arlington County................................................            4.87            0.88            1.12
Fairfax County..................................................           25.96            4.74            7.43
Fairfax City....................................................            0.88            0.21            0.34
Falls Church City...............................................            0.41            0.09            0.15
Loudoun County..................................................           10.56            2.21           15.01
Prince William County...........................................           12.36            1.76           12.87
Manassas City...................................................            1.18            0.32            0.62
Manassas Park City..............................................            0.79            0.11            0.18
Alexandria City.................................................            3.35            0.65            0.89
                                                                 -----------------------------------------------
    Virginia Total..............................................           60.36           10.98           38.62
                                                                 -----------------------------------------------
        Region Total............................................          127.88           23.22           74.27
----------------------------------------------------------------------------------------------------------------
Note: Small discrepancies may result due to rounding.

                           Table 5--2017 DC Area BYEI Non-Road Model Source Emissions
                                           [Tons per ozone season day]
----------------------------------------------------------------------------------------------------------------
                          Jurisdiction                                  VOC             NOX             CO
----------------------------------------------------------------------------------------------------------------
District of Columbia............................................            1.37            2.06           24.61
Calvert County..................................................            0.96            0.58            8.73
Charles County..................................................            1.44            1.01           13.78
Frederick County................................................            2.26            1.71           43.10
Montgomery County...............................................            8.37            4.63          163.04
Prince George's County..........................................            4.81            3.66           92.61
                                                                 -----------------------------------------------
    Maryland Total..............................................           17.84           11.59          321.26
Arlington County................................................            0.75            2.32           15.73
Fairfax County..................................................            9.17            6.48          181.48
Fairfax City....................................................            0.32            0.12            6.62
Falls Church City...............................................            0.19            0.07            3.86
Loudoun County..................................................            4.33            4.74           86.35
Prince William County...........................................            2.73            3.07           50.92
Manassas City...................................................            0.13            0.10            2.87
Manassas Park City..............................................            0.18            0.06            3.63
Alexandria City.................................................            0.67            0.26           13.54
                                                                 -----------------------------------------------
    Virginia Total..............................................           18.47           17.22          365.00
                                                                 -----------------------------------------------
        Region Total............................................           37.68           30.87          710.87
----------------------------------------------------------------------------------------------------------------
Note: Small discrepancies may result due to rounding.

                                    Table 6--2017 DC Area BYEI MAR Emissions
                                           [Tons per ozone season day]
----------------------------------------------------------------------------------------------------------------
                          Jurisdiction                                  VOC             NOX             CO
----------------------------------------------------------------------------------------------------------------
District of Columbia............................................            0.13            1.34            0.35
Calvert County..................................................            0.05            0.86            0.14
Charles County..................................................            0.02            0.02            0.19
Frederick County................................................            0.16            0.84            1.58
Montgomery County...............................................            0.05            0.73            0.75
Prince George's County..........................................            0.04            0.52            0.52
                                                                 -----------------------------------------------
    Maryland Total..............................................            0.33            2.96            3.17
Arlington County................................................            0.76            2.38            6.77
Fairfax County..................................................            0.03            0.58            0.15
Fairfax City....................................................            0.00            0.00            0.00
Falls Church City...............................................            0.00            0.00            0.00
Loudoun County..................................................            0.72            2.93            7.98
Prince William County...........................................            0.02            0.52            0.13
Manassas City...................................................            0.03            0.06            0.64
Manassas Park City..............................................            0.00            0.00            0.00
Alexandria City.................................................            0.01            0.31            0.07
                                                                 -----------------------------------------------
    Virginia Total..............................................            1.59            6.78           15.75
                                                                 -----------------------------------------------
        Region Total............................................            2.05           11.09           19.26
----------------------------------------------------------------------------------------------------------------
Note: The cities of Fairfax and Falls Church, located within the Commonwealth of Virginia, did not have any 2017
  emissions from the MAR category. Small discrepancies may result due to rounding.

                               Table 7--2017 DC Area BYEI On-Road Source Emissions
                                           [Tons per ozone season day]
----------------------------------------------------------------------------------------------------------------
                          Jurisdiction                                  VOC             NOX             CO
----------------------------------------------------------------------------------------------------------------
District of Columbia............................................            3.76            5.63           54.94
Calvert County..................................................            1.28            1.81           11.70
Charles County..................................................            1.95            3.44           19.05
Frederick County................................................            3.81            9.98           53.15
Montgomery County...............................................            8.97           15.78          119.59
Prince George's County..........................................            9.36           20.28          135.40
                                                                 -----------------------------------------------
    Maryland Total..............................................           25.37           51.29          338.89
Arlington County................................................            1.51            1.92           21.97
Fairfax County..................................................           10.11           18.41          145.37
Fairfax City....................................................
Falls Church City...............................................
Loudoun County..................................................            3.10            6.32           41.28
Prince William County...........................................            4.55            8.45           57.69
Manassas City...................................................
Manassas Park City..............................................
Alexandria City.................................................            1.18            1.40           13.07
                                                                 -----------------------------------------------
    Virginia Total..............................................           20.45           36.50          279.38
        Region Total............................................           49.58           93.42          673.21
----------------------------------------------------------------------------------------------------------------
Note: Fairfax County emissions include on-road emissions from Fairfax City and Falls Church City. Prince William
  County emissions include on-road emissions from Manassas City and Manassas Park City. Small discrepancies may
  result due to rounding.

III. Proposed Action

    EPA's review of the material included in their submissions
indicates that the States base year inventory SIPs meet the base year
inventory requirement for the 2015 ozone NAAQS for the DC Area.
Therefore, EPA is proposing to approve the DC Area base year inventory
SIPs, which were submitted by Maryland on October 7, 2020; the District
of Columbia on November 4, 2020; and Virginia on December 11, 2020. EPA
is soliciting public comments on the issues discussed in these
documents. These comments will be considered before taking final
action.

IV. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege

Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from
disclosure documents and information about the content of those
documents that are the product of a voluntary environmental assessment.
The Privilege Law does not extend to documents or information that: (1)
Are generated or developed before the commencement of a voluntary
environmental assessment; (2) are prepared independently of the
assessment process; (3) demonstrate a clear, imminent and substantial
danger to the public health or environment; or (4) are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege Law, Va. Code Sec.  10.1-1198, precludes granting a privilege
to documents and information ``required by law,'' including documents
and information ``required by Federal law to maintain program
delegation, authorization or approval,'' since Virginia must ``enforce
Federally authorized environmental programs in a manner that is no less
stringent than their Federal counterparts . . . .'' The opinion
concludes that ``[r]egarding Sec.  10.1-1198, therefore, documents or
other information needed for civil or criminal enforcement under one of
these programs could not be privileged because such documents and
information are essential to pursuing enforcement in a manner required
by Federal law to maintain program delegation, authorization or
approval.'' Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides
that ``[t]o the extent consistent with requirements imposed by Federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998, opinion states that the quoted language renders this statute
inapplicable to enforcement of any Federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting such immunity would not be consistent with
Federal law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
program consistent with the Federal requirements. In any event, because
EPA has also determined that a state audit privilege and immunity law
can affect only state enforcement and cannot have any impact on Federal
enforcement authorities, EPA may at any time invoke its authority under
the CAA, including, for example, sections 113, 167, 205, 211 or 213, to
enforce the requirements or prohibitions of the state plan,
independently of any state enforcement effort. In addition, citizen
enforcement under section 304 of the CAA is likewise unaffected by
this, or any, state audit privilege or immunity law.

V. 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);
     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 rulemaking, proposing to approve the DC
Area base year inventory SIPs for the 2015 ozone NAAQS, 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, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Ozone,
Reporting and recordkeeping requirements, Nitrogen dioxide, Volatile
organic compounds.

    Dated: February 16, 2022.
Diana Esher,
Acting Regional Administrator, Region III.
[FR Doc. 2022-03863 Filed 2-23-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 127 (Monday, July 2, 2018)]
[Notices]
[Pages 31033-31034]
[FR Doc No: 2018-14206]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2017-0074; Notice 1]

Notice of Receipt of Petition for Decision That Nonconforming
Model Year 2012 Mercedes Benz CLS 63 AMG Passenger Cars Manufactured
for the Mexican Market Are Eligible for Importation

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Receipt of petition.

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

SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
certain model year (MY) 2012 Mercedes Benz CLS 63 AMG passenger cars
manufactured for the Mexican market that were not originally
manufactured to comply with all applicable Federal motor vehicle safety
standards (FMVSS), are eligible for importation into the United States
because they are substantially similar to vehicles that were originally
manufactured for sale in the United States and that were certified by
their manufacturer as complying with the safety standards (the U.S.-
certified version of the 2012 Mercedes Benz CLS 63 AMG passenger cars)
and they are capable of being readily altered to conform to the
standards.

DATES: The closing date for comments on the petition is August 1, 2018.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and
submitted by any of the following methods:
     Mail: Send comments by mail addressed to U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver comments by hand to U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) website at https://www.regulations.gov/. Follow the online instructions for submitting
comments.
     Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to https://www.regulations.gov, including any personal information
provided.
    All comments and supporting materials received before the close of
business on the closing date indicated above will be filed in the
docket and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the fullest extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All comments, background documentation, and supporting materials
submitted to the docket may be viewed by anyone at the address and
times given above. The documents may also be viewed on the internet at
https://www.regulations.gov by following the online instructions for
accessing the dockets. The docket ID number for this petition is shown
in the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in a
Federal Register notice published on April 11, 2000, (65 FR 19477-78).

FOR FURTHER INFORMATION CONTACT: George Stevens, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS shall be
refused admission into the United States unless NHTSA has decided that
the motor vehicle is substantially similar to a motor vehicle
originally manufactured for importation into and sale in the United
States, certified under 49 U.S.C. 30115, and of the same model year as
the model of the motor vehicle to be compared, and is capable of being
readily altered to conform to all applicable FMVSS.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    Wallace Environmental Testing Laboratories (WETL), of Houston,
Texas (Registered Importer R-90-005) has petitioned NHTSA to decide
whether nonconforming MY 2012 Mercedes Benz CLS 63 AMG passenger cars
originally manufactured for the Mexican market are eligible for
importation into the United States. The vehicles which WETL believes
are substantially similar are MY 2012 Mercedes Benz CLS 63 AMG
passenger cars sold in the United States and certified by their
manufacturer as conforming to all applicable FMVSS.
    The petitioner claims that it compared non-U.S. certified MY 2012
Mercedes Benz CLS 63 AMG passenger cars manufactured for the Mexican
market to their U.S.-certified counterparts, and found the vehicles to
be substantially similar with respect to compliance with most FMVSS.

    WETL submitted information with its petition intended to
demonstrate that those non-U.S. certified MY 2012 Mercedes Benz CLS 63
AMG passenger cars, as originally manufactured, conform to many
applicable FMVSS in the same manner as their U.S.-certified
counterparts, or are capable of being readily altered to conform to
those standards.
    Specifically, the petitioner claims that the non U.S.-certified MY
2012 Mercedes Benz CLS 63 AMG passenger cars, as originally
manufactured, conform to: Standard Nos. 102 Transmission Shift Lever
Sequence, 103 Windshield Defrosting and Defogging Systems, 104
Windshield Wiping and Washing Systems, 106 Brake Hoses, 113 Hood Latch
System, 114 Theft Protection and Rollaway Prevention, 116 Motor Vehicle
Brake Fluids, 118 Power-Operated Window, Partition, and Roof Panel
Systems, 124 Accelerator Control Systems, 126 Electronic Stability
Control Systems, 135 Light Vehicle Brake Systems, 138 Tire Pressure
Monitoring Systems, 201 Occupant Protection in Interior Impact, 202
Head Restraints, 203 Impact Protection for the Driver from the Steering
Control System, 204 Steering Control Rearward Displacement, 205 Glazing
Materials, 206 Door Locks and Door Retention Components, 207 Seating
Systems, 208 Occupant Crash Protection, 209 Seat Belt Assemblies, 210
Seat Belt Assembly Anchorages, 212 Windshield Mounting, 214 Side Impact
Protection, 216 Roof Crush Resistance, 219 Windshield Zone Intrusion,
225 Child Restraint Anchorage Systems, and 302 Flammability of Interior
Materials.
    The petitioner also contends that the subject non-U.S. certified
passenger cars are capable of being readily altered to meet the
following standards, in the manner indicated:
    Standard No. 101 Controls and Displays: The instrument cluster can
be programmed by the driver to display in metric or standard units as
well as multiple languages without hardware or software changes. The
brake warning telltale must be modified by replacing the tachometer,
changing the faceplate of the current tachometer, or adding a new brake
telltale.
    Standard No. 108 Lamps, Reflective Devices and Associated
Equipment: The headlamps and taillamps must be removed and replaced
with conforming lamps.
    Standard No. 110 Tire Selection and Rims and Motor Home/Recreation
Vehicle Trailer Load Carrying Capacity Information for Motor Vehicles
with a GVWR of 4,536 Kilograms (10,000 pounds) or Less: The vehicle
requires addition of a conforming tire and rim information label.
    Standard No. 111 Rearview Mirrors: The passenger side mirror must
be etched with the phrase ``OBJECTS IN MIRROR ARE CLOSER THAN THEY
APPEAR.'' This will be achieved by applying a photomask template
bearing the phrase, and sandblasting the photomasked area with 150 grit
aluminum oxide.
    Standard No. 301 Fuel System Integrity: The vehicle must be
equipped with a rollover valve in the fuel tank vent line between the
fuel tank and the evaporative emissions collection canister.
    Wallace further states that labels will be affixed to conform the
vehicle to the requirements of 49 CFR parts 565 and 567, VIN Content
and Certification, respectively.
    This notice of receipt of WETL's petition does not represent any
agency decision or other exercise of judgment concerning the merits of
the petition. Notice of final action on the petition will be published
in the Federal Register pursuant to the authority indicated below.

    Authority:  49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49
CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.

Michael A. Cole,
Acting Director Office of Vehicle Safety Compliance.
[FR Doc. 2018-14206 Filed 6-29-18; 8:45 am]
 BILLING CODE 4910-59-P


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

EPA Registration Division contact: PV Shah,<PHONE_NUMBER>

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

TEMPLATE:

Ecolab, Inc.

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from Ecolab, Inc., EPA Company Number 1677, 370 N. Wabasha Street, St. Paul, MN 55102 proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

(Options (pick one)        2. to establish an exemption from the requirement of a tolerance for

	Sulfuric acid, CAS No. 7664-93-9, for use as an inert ingredient in antimicrobial pesticide formulations applied to food-contact surfaces in public eating places, dairy processing equipment and food processing equipment and utensils in accordance with 40 CFR §180.940(a).  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. Not applicable to this inert ingredient petition

	2. Analytical method. Not applicable to this inert ingredient petition

	3. Magnitude of residues. Not applicable to this inert ingredient petition

B. Toxicological Profile

	1. Acute toxicity. Sulfuric acid is EPA Toxicity Category II for acute oral toxicity and EPA Toxicity Category III for acute dermal and inhalation toxicity.  Sulfuric acid is highly corrosive to the eyes and skin in formulations above 10% and is a strong irritant in formulations below 10%.  Sulfuric acid is EPA Toxicity Category I for eye and dermal irritation.

	2. Genotoxicity. Sulfuric acid has been shown to be without effect in genetic toxicity studies in vitro (bacterial test).  It has been shown to cause chromosomal aberrations in a non-bacterial test in vitro. The chromosomal effects are a well-known consequence of reduced pH, seen as resulting from any strong acid.

      3. Reproductive and developmental toxicity. Because sulfuric acid is a direct-acting toxicant, and because it is unlikely to reach the reproductive organs, reproductive effects in mammals are not likely to occur following exposure to sulfuric acid by any route.  In a developmental toxicity/teratogenicity study conducted by inhalation with sulfuric acid aerosol, the NOAEL for maternal toxicity appears to be 20 mg/m[3] in mice and rabbits.  No evidence of fetotoxicity or teratogenicity was seen in either species.        	4. Subchronic toxicity. The available repeat dose subchronic and chronic toxicity studies described in EPA reviews and the OECD SIDS summary are for inhalation toxicity.  The Agency noted that literature regarding sulfuric acid indicates that "in numerous repeated inhalation studies with sulfuric acid aerosol, toxicity was confined to changes in the structure and function of the respiratory tract, suggesting that it has a local effect and no systemic effects.  The observed changes are related to the irritant properties of sulfuric acid and are most likely due to the H+ ions."  There is one GLP 28-day inhalation study in which the rat was exposed to sulfuric acid aerosol.  In this study "minimal squamous metaplasia was observed in the laryngeal epithelium following exposure to the lowest concentration used (0.3 mg/m[3]).  This effect was fully reversible.  Exposure to 1.38 mg/m3 caused more severe metaplasia accompanied by cell proliferation." It was noted that these types of effects are commonly seen in rats exposed to irritants.

	5. Chronic toxicity. No carcinogenic effect was observed in carcinogenicity studies conducted by inhalation with sulfuric acid aerosol using three different animal species.

	6. Animal metabolism. Sulfuric acid readily dissociates in water to hydronium cations (H3O[+]) and sulfate anions (SO4[2-]).  Sulfates are a necessary human nutrient and the metabolism of sulfate through the human body is well-understood.

	7. Metabolite toxicology. There are no metabolites of toxicological concern.

	8. Endocrine disruption. EPA did not report any information to suggest that sulfuric acid would have any endocrine effects.  When the appropriate screening and/or testing protocols under the EDSP have been developed, sulfuric acid may be subject to additional screening and/or testing to better characterize effects related to endocrine disruption.  This does not impact the current regulatory status of this material.

C. Aggregate Exposure

1. Dietary exposure. In the Reregistration Eligibility Decision Document for Mineral Acids (1993), EPA stated: "The four mineral acids [which included sulfuric acid] pose no human dietary risks.  People may be exposed to these chemicals when they are used as antimicrobials, however this exposure involves such dilute solutions that it is believed to be inconsequential."  Risks associated with mineral acids exposures are expected to be minimal based on limited evidence of any subchronic or chronic systemic effects through the oral route of exposure.  In their 2006 inert ingredient tolerance reassessment document, EPA determined that a quantitative aggregate assessment will not be performed, this was further affirmed in the 2008 Mineral Acids Registration Review documents, which indicated that "the Agency does not anticipate  conducting a dietary assessment for the mineral acids."

	i. Food. Sulfuric acid rapidly dissociates to hydronium cations (H3O+) and sulfate anions (SO42-).  These constituents do not pose a toxicological concern or are naturally occurring.  The FDA considers sulfuric acid generally GRAS for use in foods under 21 CFR 184.1095.  FDA indicated that:

      "Sulfates are natural constituents of foods and normal products of sulfur metabolism in animals. ... There is no evidence in the available information on sulfuric acid, and on ammonium, calcium, potassium, and sodium sulfates that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current or that might reasonably be expected in future."

	ii. Drinking water. Drinking water exposures of concern are not anticipated for sulfuric acid.

	2. Non-dietary exposure. For occupational and residential exposure, the toxicological criteria have not been triggered for dermal and oral exposure, therefore, risk assessments for these exposures are not required.  For inhalation exposure a risk assessment is not anticipated either because there is likely to be minimal potential for inhalation, based on label use directions and low potential to generate aerosolized spray.

D. Cumulative Effects The Agency has not made a common mechanism of toxicity finding for sulfuric acid and it does not appear to produce a toxic metabolite that is produced by other substances.  For the purposes of this tolerance exemption petition, therefore, it is assumed that sulfuric acid does not have a common mechanism of toxicity with other substances.

E. Safety Determination

In previous assessments, EPA concluded, based on the available information for this chemical, that there is a reasonable certainty that no harm will result to the general population and to infants and children from aggregate exposure to this chemical.  The expansion of the current tolerance exemptions to include uses cited at 40 CFR § 180.940(a), up to 600 ppm, would not change this determination.

	1. U.S. population. The agency previously did not use a reference dose and safety factor approach to their risk assessment for sulfuric acid. They determined that a qualitative approach was appropriate given the lack of human health concerns from anticipated exposures.

	2. Infants and children. EPA completed reassessment of the established tolerance exemption for sulfuric acid in August 2006.  A safety factor analysis was not employed to assess risk, and therefore a 10X FQPA Safety Factor is unnecessary.  The Agency concluded, after considering available information, that there is a reasonable certainty that no harm will result to the general population and to infants and children from aggregated exposure to sulfuric acid, when used in food contact surface sanitizing solutions under 40 CFR Part 180.940.

F. International Tolerances Currently, there are no known CODEX MRLs established for sulfuric acid.