[Federal Register Volume 85, Number 78 (Wednesday, April 22, 2020)]
[Proposed Rules]
[Pages 22384-22392]
[FR Doc No: 2020-07531]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2020-0088; FRL-10007-55-Region 9]

Air Plan Revisions; California; Technical Amendments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
delete various local rules from the California State Implementation
Plan (SIP) that were approved in error. These rules include general
nuisance provisions, Federal New Source Performance Standards (NSPS) or
National Emission Standards for Hazardous Air Pollutants (NESHAP)
requirements, hearing board procedures, variance provisions, and local
fee provisions. The EPA has determined that the continued presence of
these rules in the SIP is inappropriate and potentially confusing and
thus problematic for affected sources, the state, local agencies, and
the EPA. The intended effect of this proposal is to delete these rules
to make the SIP consistent with the Clean Air Act (CAA or ``Act''). The
EPA is also proposing to make certain other corrections to address
errors made in previous actions taken by the EPA on California SIP
revisions.

DATE: Comments must be received on or before May 22, 2020.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2020-0088 at http://www.regulations.gov, or via email to Kevin
Gong, at<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be removed or edited from Regulations.gov. For either
manner of submission, the 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. The 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 http://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Kevin Gong, Rules Office (AIR-3-2),
EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105, (415) 972-
3073, or by email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. Background
II. Why is the EPA proposing to correct the SIP?
III. What is the EPA's authority to correct errors in SIP
rulemakings?
IV. Which rules are proposed for deletion?
V. What other corrections is the EPA proposing to make?
VI. Proposed Action and Request for Public Comment
VII. Incorporation by Reference
VIII. Statutory and Executive Order Reviews

I. Background

    In this rulemaking, we address certain errors made over the years
in connection with EPA actions on SIP revisions for the various air
pollution control districts in California. In the first rule, published
at 84 FR 45422 (August 29, 2019), we addressed errors associated with
EPA actions on SIP revisions for the districts with names beginning
with the letter A through the letter O. This proposed action follows
the first action and addresses errors associated with EPA actions for
the rest of the districts, i.e., those with names beginning with the
letter P through the letter Z.

II. Why is the EPA proposing to correct the SIP?

    The Clean Air Act was first enacted in 1970. In the 1970s and early
1980s, thousands of state and local agency regulations were submitted
to the EPA for incorporation into the SIP to fulfill the new Federal
requirements. In many cases, states submitted entire regulatory air
pollution programs, including many elements not required by the Act.
Due to time and resource constraints, the EPA's review of these
submittals focused primarily on the new substantive requirements, and
we approved many other elements into the SIP with minimal review. We
now recognize that many of these elements

were not appropriate for approval into the SIP. In general, these
elements are appropriate for state and local agencies to adopt and
implement, but it is not necessary or appropriate to make them
federally enforceable by incorporating them into the applicable SIP.
These include:
    A. Rules that prohibit emissions causing general nuisance or
annoyance in the community.\1\ Such rules address local issues but have
essentially no connection to the purposes for which SIPs are developed
and approved, namely the implementation, maintenance, and enforcement
of the national ambient air quality standards (NAAQS). See CAA section
110(a)(1).
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    \1\ An example of such a rule is as follows: A person shall not
discharge from any source whatsoever such quantities of air
contaminants or other material which cause injury, detriment,
nuisance or annoyance to any considerable number of persons or to
the public or which endanger the comfort, repose, health or safety
of any such persons or the public or which cause or have a natural
tendency to cause injury or damage to business or property.
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    B. Local adoption of federal NSPS or NESHAP requirements either by
reference or by adopting text identical to or modified from the
requirements found in 40 CFR part 60 (``Standards of Performances for
New Stationary Sources'') or 61 (``National Emission Standards for
Hazardous Air Pollutants''). Because the EPA has independent authority
to implement 40 CFR parts 60 and 61, it is not appropriate to make
parallel local authorities federally enforceable by approving them into
the applicable SIP.
    C. Rules that govern local hearing board procedures and other
administrative requirements such as fees, frequency of meetings,
salaries paid to board members, and procedures for petitioning for a
local hearing.
    D. Variance provisions that provide for modification of the
requirements of the applicable SIP. State- or district-issued variances
provide an applicant with a mechanism to obtain relief from state
enforcement of a state or local rule under certain conditions. Pursuant
to Federal law, specifically section 110(i) of the CAA, 42 U.S.C.
7410(i), neither the EPA nor a state may revise a SIP by issuing an
``order, suspension, plan revision or other action modifying any
requirement of an applicable implementation plan'' without a plan
promulgation or revision. The EPA and California have long recognized
that a state-issued variance, though binding as a matter of state law,
does not prevent the EPA from enforcing the underlying SIP provisions
unless and until the EPA approves that variance as a SIP revision. The
variance provisions included in today's action are deficient for
various reasons, including their failure to address the fact that a
state- or district-issued variance has no effect on federal
enforceability unless the variance is submitted to and approved by the
EPA as a SIP revision. Therefore, their inclusion in the SIP is
inconsistent with the Act and may be confusing to regulated industry
and the general public. Moreover, because state-issued variances
require independent EPA approval to modify the substantive requirements
of a SIP, removal of these variance provisions from the SIP will have
no effect on regulated entities. See Industrial Environmental
Association v. Browner, No. 97-71117 (9th Cir., May 26, 2000).
    E. Local fee provisions that are not economic incentive programs
and are not designed to replace or relax a SIP emission limit. While it
is appropriate for local agencies to implement fee provisions, for
example, to recover costs for issuing permits, it is generally not
appropriate to make local fee collection federally enforceable.

III. What is the EPA's authority to correct erors in SIP rulemakings?

    Section 110(k)(6) of the CAA, as amended in 1990, provides that,
whenever the EPA determines that the EPA's action approving,
disapproving, or promulgating any plan or plan revision (or part
thereof), area designation, redesignation, classification or
reclassification was in error, the EPA may in the same manner as the
approval, disapproval, or promulgation revise such action as
appropriate without requiring any further submission from the state.
Such determination and the basis thereof must be provided to the state
and the public. We interpret this provision to authorize the EPA to
make corrections to a promulgated regulation when it is shown to our
satisfaction (or we discover) that (1) we clearly erred by failing to
consider or by inappropriately considering information made available
to the EPA at the time of the promulgation, or the information made
available at the time of promulgation is subsequently demonstrated to
have been clearly inadequate, and (2) other information persuasively
supports a change in the regulation. See 57 FR 56762, at 56763
(November 30, 1992) (correcting designations, boundaries, and
classifications of ozone, carbon monoxide, particulate matter and lead
areas).

IV. Which rules are proposed for deletion?

    The EPA has determined that the rules listed in table 1 below are
inappropriate for inclusion in the SIP, but were previously approved
into the SIP in error. Dates that these rules were submitted by the
state and approved by the EPA are provided. We are proposing deletion
of these rules and any earlier versions of these rules from the
individual air pollution control district portions of the California
SIP under CAA section 110(k)(6) as inconsistent with the requirements
of CAA section 110.\2\ A brief discussion of the proposed deletions is
provided in the following paragraphs.
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    \2\ The EPA has coordinated with the California Air Resources
Board (CARB) to identify district rules appropriate for deletion
from the California SIP. CARB has agreed that the deletion of the
rules in table 1 pursuant to CAA section 110(k)(6) is appropriate.
See letter from Richard W. Corey, Executive Officer, CARB, to Mike
Stoker, Regional Administrator, EPA Region IX, January 31, 2020.

                             Table 1--Local Air District Rules Proposed for Deletion
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          Rule or regulation                    Title                Submittal date            EPA approval
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                               Placer County Air Pollution Control District (APCD)
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Section 51...........................  Nuisance...............  February 21, 1972......  37 FR 10842 (May 31,
                                                                                1972).
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                         Sacramento Metropolitan Air Quality Management District (AQMD)
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Rule 112.............................  New Source Performance   November 3, 1975.......  42 FR 28122 (June 2,
                                        Standards.                                        1977); corrected at 42
                                                                                FR 42219 (August 22,
                                                                                1977).

Rule 113.............................  National Emission        November 3, 1975.......  42 FR 28122 (June 2,
                                        Standards for                                     1977); corrected at 42
                                        Hazardous Air                                     FR 42219 (August 22,
                                        Pollutants.                                       1977).
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                                              San Diego County APCD
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Rule 51..............................  Nuisance...............  June 30, 1972..........  37 FR 19812 (September
                                                                                22, 1972).
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                                         San Joaquin Valley Unified APCD
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Fresno County APCD Rule 111..........  Arrests and Notices to   October 23, 1974.......  42 FR 42219 (August 22,
                                        Appear.                                           1977).
Fresno County APCD Rule 418..........  Nuisance...............  June 30, 1972..........  37 FR 19812 (September
                                                                                22, 1972).
Fresno County APCD Rule 419..........  Exception..............  June 30, 1972..........  37 FR 19812 (September
                                                                                22, 1972).
Kings County APCD Rule 419...........  Nuisance...............  June 30, 1972..........  37 FR 19812 (September
                                                                                22, 1972).
Kings County APCD Rule 420...........  Exception..............  June 30, 1972..........  37 FR 19812 (September
                                                                                22, 1972).
Madera County APCD Rule 418..........  Nuisance...............  June 30, 1972..........  37 FR 19812 (September
                                                                                22, 1972).
Madera County APCD Rule 419..........  Exception..............  June 30, 1972..........  37 FR 19812 (September
                                                                                22, 1972).
Madera County APCD Rule 511..........  Notice of Hearing......  October 15, 1979.......  46 FR 60202 (December
                                                                                9, 1981).
Merced County APCD Rule 418..........  Nuisance...............  June 30, 1972..........  37 FR 19812 (September
                                                                                22, 1972).
Merced County APCD Rule 419..........  Exception..............  June 30, 1972..........  37 FR 19812 (September
                                                                                22, 1972).
Merced County APCD Rule 511..........  Notice of Hearing......  August 2, 1976.........  43 FR 25689 (June 14,
                                                                                1978).
San Joaquin County APCD Rule 418.....  Nuisance...............  June 30, 1972..........  37 FR 19812 (September
                                                                                22, 1972).
San Joaquin County APCD Rule 419.....  Exception..............  June 30, 1972..........  37 FR 19812 (September
                                                                                22, 1972).
Stanislaus County APCD Rule 418......  Emissions in General...  July 19, 1974..........  42 FR 25501 (May 18,
                                                                                1977); corrected at 42
                                                                                FR 42219 (August 22,
                                                                                1977).
Stanislaus County APCD Rule 419......  Exception..............  June 30, 1972..........  37 FR 19812 (September
                                                                                22, 1972).
Stanislaus County APCD Rule 505......  Petitions for Variances  July 19, 1974..........  42 FR 25501 (May 18,
                                                                                1977); corrected at 42
                                                                                FR 42219 (August 22,
                                                                                1977).
Tulare County APCD Section 419.......  Nuisance...............  June 30, 1972..........  37 FR 19812 (September
                                                                                22, 1972).
Tulare County APCD Section 420.......  Exception..............  October 23, 1974.......  42 FR 42219 (August 22,
                                                                                1977).
Tulare County APCD Section 507.......  Supplemental             February 21, 1972......  37 FR 10842 (May 31,
                                        Information.                                      1972).
Tulare County APCD Section 508.......  Matters Initiated by     February 21, 1972......  37 FR 10842 (May 31,
                                        Control Officer or                                1972).
                                        Hearing Board.
Tulare County APCD Section 515.......  Record of Proceedings..  February 21, 1972......  37 FR 10842 (May 31,
                                                                                1972).
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                                           San Luis Obispo County APCD
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Rule 111.............................  Nuisance...............  February 21, 1972......  37 FR 10842 (May 31,
                                                                                1972).
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                                            Santa Barbara County APCD
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Rule 17..............................  Nuisance...............  February 21, 1972......  37 FR 10842 (May 31,
                                                                                1972).
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                                               Shasta County AQMD
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Rule 4:2.............................  General................  November 21, 1986......  54 FR 14648 (April 12,
                                                                                1989).
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                                              Siskiyou County APCD
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Rule 4.2.............................  Nuisance...............  February 21, 1972......  37 FR 10842 (May 31,
                                                                                1972).
Rule 4.2-1...........................  Exceptions.............  March 23, 1988.........  54 FR 43174 (October
                                                                                23, 1989).
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                                                South Coast AQMD
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Orange County APCD Rule 45...........  Permit Fees--Open        June 30, 1972..........  37 FR 19812 (September
                                        Burning.                                          22, 1972).

San Bernardino County APCD Rule 120..  Fees...................  February 21, 1972......  37 FR 10842 (May 31,
                                                                                1972).
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                                               Tehama County APCD
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Rule 4:4.............................  Nuisance...............  February 21, 1972......  37 FR 10842 (May 31,
                                                                                1972).
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                                              Tuolumne County APCD
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Rule 205.............................  Nuisance...............  July 22, 1975..........  42 FR 42219 (August 22,
                                                                                1977).
Rule 703.............................  Contents of Petitions..  October 23, 1981.......  47 FR 23159 (May 27,
                                                                                1982).
Rule 710.............................  Notice of Public         October 23, 1981.......  47 FR 23159 (May 27,
                                        Hearing.                                          1982).
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                                               Ventura County APCD
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Rule 51..............................  Nuisance...............  June 30, 1972..........  37 FR 19812 (September
                                                                                22, 1972).
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                                                Yolo-Solano AQMD
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Rule 2.5.............................  Nuisance...............  February 21, 1972......  37 FR 10842 (May 31,
                                                                                1972).
Rule 2.6.............................  Additional Exception...  February 21, 1972......  37 FR 10842 (May 31,
                                                                                1972).
Rule 5.1.............................  Applicable Articles of   June 22, 1978..........  44 FR 5662 (January 29,
                                        the Health and Safety                             1979).
                                        Code.
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Placer County Air Pollution Control District (APCD)

    Placer County APCD Section 51 (Nuisance) is a general-nuisance type
of prohibitory rule. As such, Section 51 was inappropriate for
inclusion in the SIP, and thus, was approved by the EPA in error. In
this action, we are proposing to delete Section 51 from the Placer
County APCD portion of the California SIP.

Sacramento Metropolitan Air Quality Management District (AQMD)

    Sacramento Metropolitan AQMD Rules 112 (New Source Performance
Standards) and 113 (National Emission Standards for Hazardous Air
Pollutants) require sources to comply with the applicable provisions of
the NSPS and NESHAPS promulgated in 40 CFR parts 60 and 61. Because the
EPA has independent authority to implement 40 CFR parts 60 and 61, it
was not appropriate to make parallel local authorities federally
enforceable by approving Rules 112 and 113 into the Sacramento
Metropolitan AQMD portion of the California SIP. In this action, we are
proposing to delete Rules 112 and 113 from the Sacramento Metropolitan
AQMD portion of the California SIP.

San Diego County APCD

    San Diego County APCD Rule 51 (Nuisance) is a general-nuisance type
of prohibitory rule. As such, Rule 51 was inappropriate for inclusion
in the SIP, and thus, was approved by the EPA in error. In this action,
we are proposing to delete Rule 51 from the San Diego County APCD
portion of the California SIP.

San Joaquin Valley Unified APCD

    Established in 1991, the San Joaquin Valley Unified APCD unified
Fresno County APCD, Kern County APCD (San Joaquin Valley portion of
Kern County), Kings County APCD, Madera County APCD, Merced County
APCD, San Joaquin County APCD, Stanislaus County APCD, and Tulare
County APCD into a single unified APCD. The San Joaquin Valley Unified
APCD portion of the applicable California SIP continues to include
certain rules originally adopted by the individual county APCDs and
approved by the EPA prior to the establishment of the unified APCD. The
following individual county rules are general-nuisance type of
prohibitory rules, and were inappropriate for inclusion in the SIP and,
thus, were approved by the EPA in error: Fresno County APCD Rule 418
(Nuisance), Kings County APCD Rule 419 (Nuisance), Madera County ACPD
Rule 418 (Nuisance), Merced County APCD Rule 418 (Nuisance), San
Joaquin County APCD Rule 418 (Nuisance), Stanislaus County APCD Rule
418 (Emissions in General) and Tulare County APCD Section 419
(Nuisance). The following individual county rules provide an exception
to the general nuisance rules cited above, and should be deleted if the
general nuisance rules are deleted: Fresno County APCD Rule 419
(Exception), Kings County APCD Rule 420 (Exception), Madera County ACPD
Rule 419 (Exception), Merced County APCD Rule 419 (Exception), San
Joaquin County APCD Rule 419 (Exception), Stanislaus County APCD Rule
419 (Exception) and Tulare County APCD Section 420 (Exception).
    In addition, Madera County APCD Rule 511 (Notice of Hearing),
Merced County APCD Rule 511 (Notice of Hearing), Stanislaus County APCD
Rule 505 (Petitions for Variances) and Tulare County APCD Sections 507
(Supplemental Information), 508 (Matters Initiated by Control Officer
or Hearing Board) and 515 (Record of Proceedings) relate to hearing
board procedures, and as such, were inappropriate for inclusion in the
SIP and were thus approved by the EPA in error. In this action, we are
proposing to delete the above county rules from the San Joaquin Valley
Unified APCD portion of the California SIP.
    Lastly, at 66 FR 47603, at 47608-47609 (September 13, 2001), the
EPA proposed to delete Fresno County APCD Rule 111 (Arrests and Notices
to Appear), submitted on June 4, 1986, along with all the other county
rules titled ``Arrests and Notices to Appear.'' At 67 FR 2573 (January
18, 2002), the EPA finalized the deletion of the other county rules
titled ``Arrests and Notices to Appear'' but did not finalize the
deletion of Fresno County Rule 111 because we realized that the June 4,
1986 version of Rule 111 was not approved into the SIP. See 67 FR 2573,
at 2575 (January 18, 2002). In this action, we are proposing to delete
the version of Fresno County Rule 111

(Arrests and Notices to Appear) that is part of the applicable
California SIP, i.e., the version of Fresno County APCD Rule 111 that
was submitted on October 23, 1974, and approved at 42 FR 42219 (August
22, 1977), to be consistent with our action on the other corresponding
county rules.

San Luis Obispo County APCD

    San Luis Obispo County APCD Rule 111 (Nuisance) is a general-
nuisance type of prohibitory rule. As such, Rule 111 was inappropriate
for inclusion in the SIP, and thus, was approved by the EPA in error.
In this action, we are proposing to delete Rule 111 from the San Luis
Obispo County APCD portion of the California SIP.

Santa Barbara County APCD

    Santa Barbara County APCD Rule 17 (Nuisance) is a general-nuisance
type of prohibitory rule. As such, Rule 17 was inappropriate for
inclusion in the SIP, and thus, was approved by the EPA in error. In
this action, we are proposing to delete Rule 17 from the Santa Barbara
County APCD portion of the California SIP.

Shasta County AQMD

    Shasta County AQMD Rule 4:2 (General) relates to hearing board
procedures, and as such, was inappropriate for inclusion in the SIP and
was thus approved by the EPA in error. In this action, we are proposing
to delete Rule 4:2 from the Shasta County AQMD portion of the
California SIP.

Siskiyou County APCD

    Siskiyou County APCD Rule 4.2 (Nuisance) is a general-nuisance type
of prohibitory rule. As such, Rule 4.2 was inappropriate for inclusion
in the SIP, and thus, was approved by the EPA in error. Siskiyou County
APCD Rule 4.2-1 (Exceptions) provides an exception to Rule 4.2 and
should be deleted if Rule 4.2 is deleted. In this action, we are
proposing to delete Rules 4.2 and 4.2-1 from the Siskiyou County APCD
portion of the California SIP.

South Coast AQMD

    The South Coast AQMD includes all of Orange County, the non-desert
portions of Los Angeles and San Bernardino counties, and all of
Riverside County (except for the Palo Verde Valley in far eastern
Riverside County). In 1972, when the original California SIP was
submitted and approved by EPA, the Los Angeles County APCD, Orange
County APCD, Riverside County APCD and San Bernardino County APCD each
had jurisdiction over stationary sources within their respective
counties. On July 16, 1975, the Los Angeles County APCD, Orange County
APCD, Riverside County APCD, and San Bernardino County APCD were
unified into the Southern California APCD. On February 1, 1977, the
State of California split the Southern California APCD into the South
Coast AQMD in the western coastal area (including Orange County, and
the non-desert portions of Los Angeles, Riverside, and San Bernardino
Counties, referred to as the ``South Coast Air Basin'') and three
separate APCDs (i.e., Los Angeles County APCD, San Bernardino County
APCD, and Riverside County APCD, included within the ``Southeast Desert
Air Basin''), formed out of the remaining parts of three counties in
the eastern desert area. See 43 FR 25684 (June 14, 1978). The Southeast
Desert portion of Riverside County was added to the South Coast AQMD on
December 1, 1977. On July 1, 1994, the Palo Verde Valley area of
Riverside County left the South Coast AQMD and joined the Mojave Desert
AQMD.
    Certain rules adopted by the original county-based APCDs remain
part of the applicable SIP for the South Coast AQMD (i.e., have not
been deleted or superseded by EPA-approved rules adopted by the
Southern California APCD or South Coast AQMD), including Orange County
APCD Rule 45 (Permit Fees--Open Burning) and San Bernardino County APCD
Rule 120 (Fees). Orange County APCD Rule 45 and San Bernardino County
APCD Rule 120 are local fee provisions that were not appropriate for
inclusion in the SIP, and thus, were approved by the EPA in error. In
this action, we are proposing to delete Orange County APCD Rule 45 and
San Bernardino County APCD Rule 120 from the South Coast AQMD portion
of the California SIP.

Tehama County APCD

    Tehama County APCD Rule 4:4 (Nuisance) is a general-nuisance type
of prohibitory rule. As such, Rule 4:4 was inappropriate for inclusion
in the SIP, and thus, was approved by the EPA in error. In this action,
we are proposing to delete Rule 4:4 from the Tehama County APCD portion
of the California SIP.

Tuolumne County APCD

    Tuolumne County APCD Rule 205 (Nuisance) is a general-nuisance type
of prohibitory rule. As such, Rule 205 was inappropriate for inclusion
in the SIP, and thus, was approved by the EPA in error. Tuolumne County
APCD Rules 703 (Contents of Petitions) and 710 (Notice of Public
Hearing) relate to hearing board procedures, and as such, were
inappropriate for inclusion in the SIP and were thus approved by the
EPA in error. In this action, we are proposing to delete Rules 205, 703
and 710 from the Tuolumne County APCD portion of the California SIP.

Ventura County APCD

    Ventura County APCD Rule 51 (Nuisance) is a general-nuisance type
of prohibitory rule. As such, Rule 51 was inappropriate for inclusion
in the SIP, and thus, was approved by the EPA in error. In this action,
we are proposing to delete Rule 51 from the Ventura County APCD portion
of the California SIP.

Yolo-Solano AQMD

    Yolo Solano AQMD Rule 2.5 (Nuisance) is a general-nuisance type of
prohibitory rule. As such, Rule 2.5 was inappropriate for inclusion in
the SIP, and thus, was approved by the EPA in error. Yolo-Solano AQMD
Rule 2.6 (Additional Exception) provides an exception to Rule 2.5 and
should be deleted if Rule 2.5 is deleted. Yolo-Solano AQMD Rule 5.1
(Applicable Articles of the Health and Safety Code) relates to hearing
board procedures, and as such, was inappropriate for inclusion in the
SIP and was thus approved by the EPA in error. In this action, we are
proposing to delete Rules 2.5, 2.6 and 5.1 from the Yolo-Solano AQMD
portion of the California SIP.

V. What other corrections is the EPA proposing to make?

    The EPA is also proposing certain error corrections not because the
rules were originally approved into the SIP in error but because of
other types of errors made in the course of the SIP rulemaking action.
Each such proposal is described in the following paragraphs.

Placer County APCD

    Publisher's Error in Connection with Approval of Rule 243
(Polyester Resin Operations): On October 3, 2011 (76 FR 61057), the EPA
approved Placer County Rule 243 (Polyester Resin Operations), as
submitted on December 7, 2010, and the amendatory instructions listed
the approval of Rule 243 correctly at 40 CFR 52.220(c)(389)(i)(B)(1).
However, due to a publisher's error, the approval of Placer County APCD
Rule 243 is listed at 40 CFR 52.220(c)(390)(i)(B)(1). We are proposing
to correct this error by amending the two paragraphs in 40 CFR
52.220(c) accordingly.

San Diego County APCD

    Erroneous Listing of Certain Rules as San Diego County APCD Rules:
On June

2, 1977 (42 FR 28122), the EPA took final action to approve Rules 112
and 113 adopted by the Sacramento Metropolitan AQMD and codified the
approval at 40 CFR 52.220(c)(29)(v)(B). On August 22, 1977 (42 FR
42219), the EPA redesignated the paragraph listing the approval of
Sacramento Metropolitan AQMD Rules 112 and 113 to 40 CFR
52.220(c)(29)(ii)(B) but failed to delete 40 CFR 52.220(c)(29)(v)(B).
See 42 FR 42219, at 42225 (August 22, 1977). Paragraph 40 CFR
52.220(c)(29)(v) lists EPA-approved rules adopted by the San Diego
County APCD, and the failure to delete 40 CFR 52.220(c)(29)(v)(B) makes
it appear that Rules 112 and 113 are part of the San Diego County APCD
portion of the applicable SIP but, as explained herein, they are not.
Today, we are proposing to delete 40 CFR 52.220(c)(29)(v)(B).
    Failure to Codify Approval of Amendments to San Diego County APCD
Rule 20.1: On July 6, 1982 (47 FR 29231), the EPA took final action to
approve certain rules adopted by the San Diego County APCD, including
amendments to Rule 20.1 (Definitions, Emission Calculations, Emission
Offsets and Banking, Exemptions, and Other Requirements), submitted on
January 28, 1981. However, we failed to codify the approval of Rule
20.1 at 40 CFR 52.220(c)(98)(xi), the subsection listing San Diego
County APCD rules submitted on January 28, 1981 and approved by the
EPA. We propose to do so in today's action. We note that the amendments
to Rule 20.1 that were approved on July 6, 1982, were recently
superseded in the applicable San Diego County APCD portion of the
California SIP by approval of a further amended version of Rule 20.1
(New Source Review--General Provisions) at 83 FR 50007 (October 4,
2018).
    Publisher's Error Deleting Codification of Approval of San Diego
County APCD Rule 67.0: On June 30, 1993 (58 FR 34904), the EPA took
final action to approve San Diego County Rule 67.0 (Architectural
Coatings), adopted on December 4, 1990, as a revision to the California
SIP. We codified the approval at 40 CFR 52.220(c)(184)(i)(D)(1) but
failed to include introductory text identifying the San Diego County
APCD as the relevant air pollution control agency associated with Rule
67.0. On August 4, 2000 (65 FR 47862), we added introductory text
identifying San Diego County APCD at 40 CFR 52.220(c)(184)(i)(D) but,
due to a publisher's error, the regulatory text listing the approval of
Rule 67.0 was erroneously deleted. While the December 4, 1990 version
of San Diego County APCD Rule 67.0 has since been superseded in the
applicable California SIP, we propose to re-instate 40 CFR
52.220(c)(184)(i)(D)(1) to maintain an accurate accounting of the
version of Rule 67.0 that applied for federal enforcement purposes at
different times in the past.
    Erroneous Codification of Approval of San Diego County APCD Rule
67.11: On April 11, 2013 (78 FR 21537), the EPA took final action to
approve San Diego County APCD Rule 67.11 (Wood Products Coating
Operations), submitted on September 21, 2012. We erroneously codified
the approval of Rule 67.11 at 40 CFR 52.220(c)(307), which lists
approved rules submitted on November 19, 2002. We propose to
redesignate the paragraph listing the approval of Rule 67.11 from 40
CFR 52.220(c)(307) to 40 CFR 52.220(c)(423), which lists approved rules
submitted on September 21, 2012.

San Joaquin Valley Unified APCD

    Failure to Include Introductory Text for Approval of Rules
Submitted on May 13, 1980, including Fresno County APCD Rules 410,
411.1 and 416.1: On May 13, 1980, the California Air Resources Board
(CARB) submitted certain amended rules to the EPA as a revision to the
California SIP, including Fresno County Rules 410 (Storage of Organic
Liquids), 411.1 (Transfer of Gasoline into Vehicle Fuel Tanks--Phase
II) and 416.1 (Agricultural Burning). We codified our approval of the
rules submitted on May 13, 1980, at 40 CFR 52.220(c)(83), see, e.g., 47
FR 29668 (July 8, 1982) (Approval of Fresno County APCD Rule 410) and
46 FR 60202 (December 9, 1981) (Approval of Fresno County APCD Rules
411.1 and 416.1), but inadvertently failed to identify the submittal
date and, in two instances, failed to identify the applicable air
pollution control district for the approved rules as the Bay Area AQMD
and the Fresno County APCD, respectively. In this action, we propose to
add introductory text to 40 CFR 52.220(c)(83) specifying a submittal
date of May 13, 1980, and to properly designate subparagraph (i) as the
Bay Area AQMD and subparagraph (iii) as the Fresno County APCD.
    Publisher's Error in Connection with Supersession of San Joaquin
County APCD Rules 413.2 and 413.3: On September 23, 2010 (75 FR 57862),
the EPA approved San Joaquin Valley Unified APCD Rules 4453 (Refinery
Vacuum Producing Devices or Systems) and 4454 (Refinery Process Unit
Turnaround) and codified the supersession of the relevant county-level
APCD SIP rules, including San Joaquin County APCD Rules 413.2 (Refinery
Vacuum Producing Devices) and 413.3 (Refinery Process Unit Turnaround)
in the existing SIP. The codification of the supersession of San
Joaquin County APCD Rules 413.2 and 413.3 was intended to be published
at paragraph 40 CFR 52.220(c)(52)(vii), which lists San Joaquin County
APCD rules, but, due to a publisher's error, it was published instead
at paragraph 40 CFR 52.220(c)(52)(vi), which lists rules adopted by
Merced County APCD. In this action, we propose to redesignate paragraph
40 CFR 52.220(c)(52)(vi)(D) as paragraph 40 CFR 52.220(c)(52)(vii)(D)
to correct this error.
    Erroneous Amendatory Instruction Related to Approval of San Joaquin
County APCD Rules 409.7 and 409.8: On June 18, 1982 (47 FR 26384), the
EPA took final action to approve certain regulations adopted by the San
Joaquin County APCD, including Rules 409.7 (Graphic Arts) and 409.8
(Perchloroethylene Dry Cleaning Systems), submitted on July 14, 1981.
Due to erroneous amendatory instructions, the approval of San Joaquin
County APCD Rules 409.7 and 409.8 was published as subparagraph (B)
under paragraph 40 CFR 52.220(c)(102)(ii), which lists rules adopted by
the Stanislaus County APCD, instead of subparagraph (B) under paragraph
40 CFR 52.220(c)(102)(i), which lists rules adopted by the San Joaquin
County APCD. In this action, we propose to redesignate paragraph 40 CFR
52.220(c)(102)(ii)(B) as 40 CFR 52.220(c)(102)(i)(B) to correct this
error.

Santa Barbara County APCD

    Erroneous Codification of Approval of Santa Barbara County APCD
Rule 337: On April 11, 2013 (78 FR 21537), the EPA took final action to
approve Santa Barbara County APCD Rule 337 (Surface Coating of
Aerospace Vehicles and Components), submitted on September 21, 2012. We
erroneously codified the approval of Rule 337 at 40 CFR 52.220(c)(214),
which lists approved rules submitted on January 24, 1995. We propose to
redesignate the paragraph listing the approval of Rule 337 from 40 CFR
52.220(c)(214) to 40 CFR 52.220(c)(423), which lists approved rules
submitted on September 21, 2012.
    Inadvertent Failure to Add Introductory Text in Connection with
Approval of Santa Barbara County APCD Rule 316: On August 30, 1993 (58
FR 45442), the EPA took final action to approve Santa Barbara County
APCD Rule 316 (Storage and Transfer of Gasoline), submitted on April 5,
1991, and codified the approval at 40 CFR 52.220(c)(183)(i)(E)(2) but
inadvertently

failed to add introductory text identifying Santa Barbara County APCD
as the applicable air district for approved rules listed under
paragraph (E). In this action, we propose to revise 40 CFR
52.220(c)(i)(E) to add ``Santa Barbara County Air Pollution Control
District'' to clarify the applicability of Rule 316 listed in
subparagraph (E)(2).

Shasta County AQMD

    Typographical Error in Connection with Deletion of Shasta County
AQMD Rule 2:19: On January 22, 2004 (69 FR 3045, at 3053), the EPA
proposed to delete various local rules from the California SIP,
including a Shasta County AQMD rule titled ``Change in Multi-Component
System.'' However, due to a typographical error, the rule titled
``Change in Multi-Component System'' was identified as Rule 2:22. The
correct rule number is Rule 2:19. On November 16, 2004 (69 FR 67062),
the EPA took final action to delete the rule and carried forward the
typographical error in regulatory text found at 40 CFR
52.220(c)(6)(xxiii)(A). We are proposing in this action to correct the
regulatory text at 40 CFR 52.220(c)(6)(xxiii)(A) to indicate that
Shasta County AQMD Rule 2:19, rather than Rule 2:22, has been deleted
without replacement.

Siskiyou County APCD

    Typographical Error in Connection with Approval of Siskiyou County
APCD Rules Submitted on March 18, 1987: On April 12, 1989 (54 FR
14648), the EPA took final action to approve certain Siskiyou County
APCD rules submitted on March 18, 1987. We codified the approval at 40
CFR 52.220(c)(172) but, due to a typographical error, listed the
submittal date as ``March 11, 1987,'' instead of the correct date of
March 18, 1987. We are proposing in this action to correct the
regulatory text at 40 CFR 52.220(c)(172) to identify ``March 18, 1987''
as the submittal date for the rules listed under that paragraph.

South Coast AQMD

    Rescission of Orange County APCD Regulation VI (Orchard or Citrus
Grove Heaters): Orange County APCD Regulation VI includes the following
rules: Rule 100 (Definitions), Rule 101 (Use and Sale of Orchard
Heaters), Rule 102 (Permit Required), Rule 103 (Transfer of Permits),
Rule 105 (Application for Permits), Rule 106 (Action on Applications),
Rule 107 (Standards for Granting Permits), Rule 108 (Conditional
Approval), Rule 109 (Denial of Applications), Rule 110 (Appeals), Rule
120 (Fees), Rule 122 (Classification of Orchard Heaters), Rule 123
(Class I Heaters Designated--Permits), Rule 124 (Class II Heaters
Designated--Permits), Rule 126 (Identification of Heaters), Rule 127
(Maintenance of Heaters), Rule 128 (Classification of Undesignated
Heaters) and Rule 130 (Prohibitions). California submitted Orange
County APCD Regulation VI on February 21, 1972, and the EPA approved
the regulation on May 31, 1972 (37 FR 10842). On June 30, 1972,
California submitted an amended definition in Rule 100 and submitted
amended versions of Rules 101 and 102, and the EPA approved the
amendments on September 22, 1972 (37 FR 19812). Rule 120 was deleted
without replacement at 67 FR 2573 (January 18, 2002), but the other
Regulation VI rules remain in the SIP.
    In an action affecting the South Coast AQMD published at 43 FR
25684 (June 14, 1978), the EPA indicated: ``The changes to Regulation
VI, Orchard Grove Heaters, contained in the above mentioned submittals
and being acted upon by this notice include total replacement of county
rules by California Health and Safety Code sections covering Orchard
Heaters.'' 43 FR at 25685. However, the regulatory text deleting
Regulation VI without replacement was not included in the final rule,
and thus, Orange County APCD Regulation VI remains part of the
applicable SIP.\3\ In this action, we are proposing to add regulatory
text deleting Orange County Regulation VI, as approved on May 31, 1972
and September 22, 1972, consistent with our action as described in the
preamble to the June 14, 1978 final rule.
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    \3\ In contrast, in a September 8, 1978 final rule, the EPA
included similar preamble text concerning an analogous Regulation VI
adopted by Los Angeles County APCD and Riverside County APCD, but
added specific regulatory text to delete Regulation VI in the
Southeast Desert portions of Los Angeles County and Riverside
County. See 43 FR 40011, at 40012 and 40014 (September 8, 1978).
---------------------------------------------------------------------------

Tehama County APCD

    Publisher's Error in Connection with Deletion without Replacement
of San Diego County APCD Rule 41: On June 27, 1997 (62 FR 34641), the
EPA took final action to delete without replacement certain district
rules that had been approved in error, including San Diego County APCD
Rule 41 (Annual Permit Renewal Fees), which was submitted on July 25,
1973 and approved on May 11, 1977. The amendatory instructions in the
June 27, 1997 final rule called for publishing the corresponding
regulatory text at 40 CFR 52.220(c)(21)(vi)(B), which relates to San
Diego County APCD rules; however, due to a publisher's error, the
corresponding regulatory text was published at 40 CFR
52.220(c)(21)(vii)(B), which sets forth regulatory text for Tehama
County APCD rules. On March 23, 1999 (64 FR 13916), the missing
paragraph (40 CFR 52.220(c)(21)(vi)(B)) was added but the erroneous
publication at 40 CFR 52.220(c)(21)(vii)(B) was left in place. In this
action, we propose to remove 40 CFR 52.220(c)(21)(vii)(B) from the CFR.

Tuolumne County APCD

    Reinstatement of Tuolumne County APCD Rule 516 (Excluding Paragraph
(C)): On June 27, 1997 (62 FR 34641), the EPA took final action to
correct certain errors in previous actions on SIPs and SIP revisions by
deleting without replacement the affected local rules. With respect to
a rule that was adopted by the Tuolumne County APCD, submitted by
California on October 23, 1981, and approved by the EPA on May 27, 1982
(47 FR 23159), we added a paragraph, i.e., (c)(103)(xvii)(B), to 40 CFR
52.220 (Identification of plan) that states: ``Previously approved on
May 27, 1982 and now deleted without replacement Rule 516.'' 62 FR at
34647. However, in our proposed error correction, 61 FR 38664, at 38680
(July 25, 1996), we indicated that the rule we intended to delete was
Rule 516 (``Emergency Variance Procedures''), but the correct title of
Rule 516 is ``Upset and Breakdown Conditions,'' and ``Emergency
Variance Procedures'' is the title of one of the paragraphs, i.e.,
paragraph (C), of Rule 516. Thus, we intended to delete only paragraph
(C) of Rule 516 but erroneously indicated in the final rule that we
were deleting without replacement the entire rule. Accordingly, we
propose to amend paragraph (c)(103)(xvii)(B) to refer only to paragraph
(C) of Rule 516.

Ventura County APCD

    Erroneous Regulatory Text for Approval of Rescission of Ventura
County APCD Rule 18: On December 7, 2000 (65 FR 76567), the EPA took
final action approving certain rules and rule rescissions adopted by
the Ventura County APCD establishing procedures and criteria for
issuing permits to new or modified stationary sources, including the
rescission of Rule 18 (Permit to Operate--Application Required for
Existing Equipment). The specific version of Rule 18 for which we
approved rescission was submitted on June 30, 1972 and approved on
September 22, 1972 (37 FR 19812); however, we erroneously added the
corresponding regulatory text to 40 CFR 52.220(b), which lists rules
submitted on February 21, 1972 and approved on

May 31, 1972 (37 FR 10842). The regulatory text belongs under 40 CFR
52.220(c)(6)(xxiv). In this action, we propose to redesignate the
regulatory text accordingly.
    Inadvertent Failure to Include Introductory Text for Approval of
Ventura County APCD Rule 74.6: On July 1, 1982 (47 FR 28617), the EPA
took final action to approve Ventura County APCD Rule 74.6 (Surface
Cleaning and Degreasing). In our final rule, we codified our approval
of Rule 74.6 at 40 CFR 52.220(c)(82)(i)(A) but inadvertently failed to
add introductory text specifying the date of submittal. In this action,
we propose to add introductory text to 40 CFR 52.220(c)(82) specifying
a submittal date of May 1, 1980.
    Inadvertent Failure to Remove Listing of Sacramento Metropolitan
AQMD Rules 70, 73, 96 and 111 from Paragraph Listing Ventura County
APCD Rules: Rules 70, 73, 96 and 111 are among a set of Sacramento
Metropolitan AQMD rules that were approved at 42 FR 28122 (June 2,
1977); corrected at 42 FR 42219 (August 22, 1977). In the June 2, 1977
action, the EPA codified the Sacramento Metropolitan AQMD rules on
which the Agency was taking action at 40 CFR 52.220(c)(24)(x)(A)-(E).
The August 22, 1977 action corrected the list of Sacramento
Metropolitan AQMD rules for which the EPA had taken action and
recodified the action at 40 CFR 52.220(c)(24)(viii)(A). The August 22,
1977 inadvertently failed to delete the original codification of the
action on the Sacramento Metropolitan AQMD rules at 40 CFR
52.220(c)(24)(x). Since then, the EPA has taken action on certain
Ventura County APCD rules and codified those actions at 40 CFR
52.220(c)(24)(x)(A) and (B), but subparagraphs (C)-(E) remain in the
CFR and now appear as if they are Ventura County APCD rules. In this
action, we are proposing to remove and reserve subparagraphs (C)-(E)
under 40 CFR 52.220(c)(24)(x).
    Inadvertent Failure to Codify Approval of Rescission of Ventura
County APCD Rule 74.6.3: The EPA approved certain rules adopted by the
Ventura County APCD, including Rule 74.6.3 (Conveyorized Degreasers) at
65 FR 45294 (July 21, 2000). We codified our approval of these rules at
40 CFR 52.220(c)(241)(i)(C). On October 25, 2005 (70 FR 61561), we
approved revisions to certain Ventura County APCD rules, including the
rescission of Rule 74.6.3. In the October 25, 2005 direct final rule,
we explained that Rule 74.6.3 was being rescinded because there are
currently no conveyorized degreasers operating in Ventura County. 70 FR
61561, at 61562. However, we inadvertently failed to codify the
rescission of Rule 74.6.3 in the regulatory portion of the final rule.
In this action, we are proposing to add regulatory text to codify our
approval of the rescission of Rule 74.6.3 by adding a paragraph to that
effect at 40 CFR 52.220(c)(241)(i)(C).

Yolo-Solano AQMD

    Publisher's Error in Connection with Approval of Yolo-Solano AQMD
Rules Submitted on February 25, 1980: On June 18, 1982 (47 FR 26379),
the EPA took direct final action to approve certain revisions to the
Yolo-Solano AQMD portion of the California SIP. In the direct final
rule, we approved Yolo-Solano AQMD Rules 3.4.1 (Standards for Granting
Applications), 3.4.2 (Conditional Approval), and 3.13 (Public Review
and Comment for Application for Authority to Construct) and codified
the approval at 40 CFR 52.220(c)(54)(iv)(C). However, due to a
publisher's error, the codification of the approval of the three rules
was repeated at 40 CFR 52.220(c)(54)(v)(C) as if they were rules
adopted by the Sacramento Metropolitan AQMD. We are proposing to delete
the erroneous regulatory text now found at 40 CFR 52.220(c)(54)(v)(C).
    Inadvertent Failure to Codify Approval of Yolo-Solano AQMD Rules
3.4.1 and 3.4.2: On June 18, 1982 (47 FR 26379), the EPA took direct
final action to approve certain revisions to the Yolo-Solano AQMD
portion of the California SIP. In the direct final rule, we approved
Yolo-Solano AQMD Rules 3.4.1 (Standards for Granting Applications),
3.4.2 (Conditional Approval), and 3.13 (Public Review and Comment for
Application for Authority to Construct) and codified the approval at 40
CFR 52.220(c)(54)(iv)(C). However, in response to the direct final
rule, we received adverse comment concerning our approval of Rules
3.4.1 and 3.4.2, and on June 24, 1983 (48 FR 28988), we withdrew their
approval. Later than year, we took final action to approve Rules 3.4.1
and 3.4.2 after consideration of public comment, 48 FR 52712 (November
22, 1983), but failed to add corresponding regulatory text in 40 CFR
52.220(c)(54)(iv). In this action, we propose to add a new paragraph,
40 CFR 52.220(c)(54)(iv)(E), codifying our 1983 approval of Yolo-Solano
AQMD Rules 3.4.1 and 3.4.2.
    Publisher's Error in Connection with Yolo-Solano AQMD Rules
Submitted on October 15, 1979: On December 9, 1981 (46 FR 60202), the
EPA took final action to approve certain revisions to the Fresno County
APCD portion of the California SIP that had been submitted on October
15, 1979, including Rules 301 (Permit Fees), 302 (Permit Fee Schedules)
and 305 (Hearing Board Fees). We codified the approval of these Fresno
County APCD rules at 40 CFR 52.220(c)(52)(xv)(B). However, due to a
publisher's error, the codification of the approval of the three rules
was repeated at 40 CFR 52.220(c)(52)(xix)(B) as if they were rules
adopted by the Yolo-Solano AQMD. We are proposing to delete the
erroneous regulatory text now found at 40 CFR 52.220(c)(52)(xix)(B).

VI. Proposed Action and Request for Public Comment

    The EPA has reviewed the rules listed in table 1 above and
determined that they were previously approved into the applicable
California SIP in error. Deletion of these rules will not relax the
applicable SIP and is consistent with the Act. Therefore, under section
110(k)(6) of the CAA, the EPA is proposing to delete the rules listed
in table 1 above and any earlier versions of these rules from the
individual air pollution control district portions of the California
SIP. These rules include general nuisance provisions, Federal NSPS or
NESHAP requirements, hearing board procedures, variance provisions, and
local fee provisions. We are also proposing to make certain other
corrections to fix errors in previous rulemakings on California SIP
revisions as described in section V above. We will accept comments from
the public on this proposal until May 22, 2020.

VII. Incorporation by Reference

    In this action, for the most part, the EPA is proposing to delete
rules that were previously incorporated by reference from the
applicable California SIP. However, we are also proposing to include in
a final EPA rule regulatory text that includes incorporation by
reference of rules not previously incorporated. In accordance with
requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference certain San Diego County APCD and Yolo-Solano AQMD rules, as
described in section V of this preamble. The EPA has made, and will
continue to make, these documents generally available electronically
through www.regulations.gov and/or in hard copy at the appropriate EPA
office (see the ADDRESSES section of this preamble for more
information).

VIII. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a

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

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Volatile organic compounds.

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

    Dated: March 30, 2020.
John Busterud,
Regional Administrator, Region IX.
[FR Doc. 2020-07531 Filed 4-21-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34349-34351]
[FR Doc No: 2016-12685]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1269]

Collaboration in Regulatory Systems Strengthening and
Standardization Activities To Increase Access to Safe and Effective
Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces its intention
to accept and consider a single source application for award of a
cooperative agreement to the World Health Organization (WHO) in support
of collaboration in regulatory systems strengthening, development of
norms and standards, and innovative research to advance global access
to safe and effective biological products that meet international
standards. The goal of FDA's Center for Biologics Evaluation and
Research (FDA/CBER) is to enhance technical collaboration and
cooperation between the FDA, WHO, and its member states to facilitate
strengthening regulatory capacity and support product development and
standardization activities to increase access to safe and effective
biologicals globally.

DATES: The application due date is July 5, 2016.

ADDRESSES: Submit electronic applications to http://www.grants.gov. For
more information, see section III of the SUPPLEMENTARY INFORMATION
section of this notice.

FOR FURTHER INFORMATION CONTACT: Gopa Raychaudhuri, CBER Liaison to
WHO, Office of the Director, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7250, Silver Spring, MD 20993, 240-402-
8000<EMAIL_ADDRESS>or Leslie Haynes, Foreign
Regulatory Capacity Building Coordinator, International Affairs, Office
of the Director, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7222, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Bryce Jones, Grants Management
Specialist, Division of Acquisition and Grants, Office of Acquisitions
and Grants Services, Food and Drug Administration, 5630 Fishers Lane,
Rm. 2026, Rockville, MD 20857,<PHONE_NUMBER><EMAIL_ADDRESS>    For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please refer to the full FOA
located at http://www.grants.gov. Search by Funding Opportunity Number:
RFA-FD-16-044.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-16-044
93.103

A. Background

    WHO is the directing and coordinating authority on international
health within the United Nations' (UN) system. It is responsible for
providing leadership on global health matters, shaping the health
research agenda, setting norms and standards, articulating evidence-
based policy options, providing technical support to countries, and
monitoring and assessing health trends. WHO assists countries in
building capacity to increase and sustain access to medical products to
prevent, detect, and treat communicable diseases, including reducing
vaccine-preventable diseases. WHO also coordinates efforts to respond
to public health emergencies by monitoring the health situation,
undertaking risk assessments, identifying priorities, and providing
technical guidance and other forms of support to countries and regions.
    Providing adequate regulatory oversight throughout the product life
cycle (pre- and post-licensure) is essential for assuring the safety,
purity, and potency of vaccines and other biologicals. However, this is
a major challenge for many National Regulatory Authorities (NRAs)
confronted by a steadily increasing number of novel products, complex
quality concerns, new regulatory issues arising from rapid technical
and technological advances, and emerging infectious diseases (e.g.,
pandemic influenza, Middle East Respiratory Syndrome, Ebola, Zika). WHO
has an important role in strengthening regulatory systems and other
supportive activities to increase access to high quality, safe, and
effective biological products especially in low-and-middle-income
countries. It is the only organization with the mandate, access to
technical expertise, and broad reach to meet the research objectives.
    FDA/CBER has been a leader and active participant in the global
community to improve human health in the world's populations over many
years. Its international engagements have been informed by the
knowledge that protection of global public health against infectious
disease threats translates into protection of public health in the
United States. FDA, through CBER, has longstanding collaborations with
WHO in the area of biologicals (vaccines, blood and blood products,
relevant in vitro diagnostics, and cell and tissue therapies).
    FDA/CBER has been a Pan American Health Organization/WHO
Collaborating Center for Biological Standardization since 1998 with the
current commitment running until 2020 and expectation of future
extensions. As a WHO Collaborating Center for Biological
Standardization, CBER has provided scientific and technical support to
WHO for development of

international standards, strengthening regulatory systems, advancing
product safety and vigilance, vaccine prequalification, and research
activities to advance development and improve standardization of
vaccines and other biologicals. These areas of collaboration reflect
FDA/CBER's longstanding commitment to increasing global access of high
quality, safe and effective biological products that meet international
standards.
1. Development of Norms and Standards
    WHO plays a key role in establishing the WHO International
Biological Reference Preparations and in developing WHO guidelines and
recommendations on the production and control of vaccines and other
biological products and technologies. The WHO Expert Committee on
Biological Standardization (ECBS) is commissioned by WHO to advise the
Organization on international standards setting activities. These norms
and standards are based on wide scientific consultation and on
international consensus and are intended to ensure the consistent
quality and safety of biological products and related in vitro
diagnostic tests worldwide.
    Blood products are inherently variable due to the nature of the
source materials as well as the methods used to test them. The
objective is to ensure that only blood products of acceptable quality,
safety, and efficacy are used in the patient population. Similarly,
ensuring the quality, safety, and effectiveness of vaccines is one of
WHO's highest priorities. The WHO works in close collaboration with the
international scientific and professional communities, regional and
national regulatory authorities, manufacturers, and expert laboratories
worldwide to ensure that global standards are developed and made
readily available to assess the quality, safety, and effectiveness of
biological products, and to support monitoring safety throughout the
product life cycle.
2. Regulatory Systems Strengthening
    NRAs play a vital role in the national health care system.
Providing regulatory oversight throughout the product life cycle (pre-
and post-licensure) is a major challenge for many NRAs confronted by a
steadily increasing number of novel products, complex quality concerns,
new regulatory issues arising from rapid technical and technological
advances, and emerging infectious diseases (e.g., pandemic influenza,
MERS, Ebola, Zika). WHO has an important role in strengthening
regulatory systems to increase access to high quality, safe, and
effective biological products especially in low-and-middle-income
countries. In this era of globalization, establishment of robust
regulatory systems in other regions of the world also benefits the U.S.
population as it facilitates FDA's ability to better monitor and ensure
the safety of the supply chain for medical and other products entering
the United States from other countries.
3. WHO Prequalification Program
    The WHO prequalification program was established in response to the
need to supply quality health products, including vaccines and in vitro
diagnostic tests for the prevention, diagnosis, and treatment of
priority diseases in low-and-middle-income countries. Through the
prequalification program, WHO assures the quality, safety, and
effectiveness/performance of these products, and suitability for use in
the target settings.
    As part of the vaccine prequalification program, WHO provides
advice to the United Nations Children's Fund (UNICEF) and other UN
agencies on the acceptability, in principle, of vaccines considered for
purchase by such agencies for vaccination programs they administer. An
important part of the vaccine prequalification program is WHO's
reliance upon a stringent NRA to provide regulatory oversight of the
vaccine throughout the product's life cycle. In 2009, FDA entered into
a confidentiality arrangement with WHO to enable FDA/CBER to serve as a
NRA of record in the vaccine prequalification program and currently
serves in this capacity for nine U.S. licensed, WHO prequalified
vaccines.
4. Product Safety and Vigilance
    The safety of medical products depends on a variety of factors that
range from good manufacturing practices to strong national systems able
to monitor the products in domestic markets. However, with increasing
globalization of trade, overall effective surveillance of medical
products depends on international regulatory cooperation and
information sharing. WHO promotes the global safety of medical products
by coordinating global networks for information sharing, such as data
bases and monitoring and alert systems, and by supporting countries to
develop national capacities for the post-marketing surveillance of
biological products.
    WHO and partners have developed a strategic framework (``Global
Vaccine Safety Blueprint'') to promote the establishment of effective
vaccine pharmacovigilance systems globally. The Blueprint proposes a
strategic plan for strengthening vaccine safety activities worldwide,
focusing on building national capacity for vaccine safety in the
world's poorest countries through the coordinated efforts of major
stakeholders.
    WHO advisory bodies also play a significant role in reviewing and
assessing product safety data and making recommendations to WHO
regarding use of vaccines and other biological products. For example,
the Global Advisory Committee on Vaccine Safety (GACVS) provides
independent, authoritative, scientific advice to WHO on vaccine safety
issues of global or regional concern, and the Blood Regulators' Network
(BRN) serves as an advisory body to WHO on matters related to safety
and availability of blood and blood products.
5. Regulatory Science to Promote Development and Increased Access to
Safe and Effective Biological Products
    Regulatory science aims to contribute to the development of new
tools, standards, and approaches to assess the safety, efficacy,
quality, and performance of regulated biological products. Examples
include tools to standardize assays used for regulatory purposes (e.g.,
development of correlates of immunity; correlates of safety; improved
methods for product characterization; new or alternative potency assays
etc.). Results generated through methods and tools developed through
regulatory science efforts such as adaptive clinical trial designs,
benefit/risk assessment, novel pharmacovigilance methodologies, and
other tools inform regulatory decisionmaking processes. Knowledge
gained through regulatory science can play a significant role in
regulatory decisionmaking, policy development, and preparedness to
address threats from existing or emerging infectious diseases.
    FDA, with other HHS technical agencies and offices, WHO, and other
regulatory counterparts, are strategizing on approaches to increase
access of the global population to safe and effective biological
products for the prevention, diagnosis, and treatment of priority
diseases, especially for use in low-and-middle-income countries. This
project represents a collaborative effort between FDA and WHO (and
complements and builds upon the U.S. Government's existing commitments
with WHO) to support scientific collaboration and enhance regulatory
capabilities of NRAs and networks to advance global access to safe and
effective vaccines and other biologicals that meet international
standards. This project will further

support science-based and data-driven public health strategies and
approaches, and lead to improved technical cooperation between FDA,
WHO, and its member states.

B. Research Objectives

    The project has the following goals:
1. Contribute to the Knowledge Base of the Current State of Regulatory
Oversight of Vaccines and Other Biological Products
     Support NRA assessments and analyses and synthesis of the
data, and development of an institutional development plan to enhance
regulatory performance in low-and-middle-income countries. Assessment
of regulatory systems could include but is not limited to, analyses and
synthesis of existing data from assessments of vaccine regulatory
capabilities of different NRAs, and new applications of assessment
frameworks to specific areas, such as pharmacovigilance (e.g.,
monitoring safety and effectiveness of new vaccines following
introduction in a specific country or regional setting). NRA
assessments also support WHO's vaccine prequalification program;
     Analysis of regulatory systems performance can include
assessment of challenges, risks, and emerging trends, with the aim of
further strengthening the development of data/information systems as
sources of inputs for evidence-based regulatory decisions and actions;
and
     Expected outputs could include analyses, reports, and
data-driven strategy papers, among others.
2. Providing Technical Support to Regulatory Systems Strengthening
Efforts
     Enable the strengthening of regulatory systems at the
national and regional levels in such critical domains as good
manufacturing, clinical, and laboratory practices; monitoring and
evaluation of product quality; lot release; inspection and surveillance
of products throughout the supply chain; pharmacovigilance systems
building and analyses; risk assessment, analysis, and management etc.;
     Support the diffusion and application of knowledge, data,
and information through active participation in regional and global
committees and networks, such as the African Vaccine Regulatory Forum,
ECBS, GACVS, BRN etc.; and
     Expected outputs could include analyses, reports, and
data-driven strategy papers, among others.
3. Development of Global Norms and Standards
     Enable the timely and effective sharing of scientific
findings and data through international collaboration to develop WHO
International Biological Reference Preparations and WHO guidelines and
recommendations on the production and control of vaccines and other
biological products and technologies;
     Assist Member States in the implementation of
internationally-recognized standards and guidelines, e.g. WHO
guidelines and standards and those emerging from standards development
venues such as the International Council for Harmonisation of the
Technical Requirements for Pharmaceuticals for Human Use;
     Utilize WHO's convening power to engage with relevant
stakeholders in support of data-driven and science-based public health
strategies and approaches to enhancing global regulatory capacity and
cooperation; and
     Expected outputs could include guideline documents,
physical standards (e.g., reference reagents, reference panels etc.),
reports, and data-driven strategy papers, among others.
4. Support Regulatory Science and Other Activities To Promote
Development and increased Access to Safe and Effective Biological
Products
     Enable development of new tools, standards, and approaches
to assess the safety, efficacy, quality, and performance of regulated
biological products;
     Support programs, including but not limited to WHO
prequalification, that increase access to safe and effective biological
products; and
     Expected outputs could include analyses, reports, and
data-driven strategy papers, among others.

C. Eligibility Information

    The following organization is eligible to apply: WHO.

II. Award Information/Funds Available

A. Award Amount

    FDA/CBER anticipates providing in FY2016 up to $2 million (total
costs including indirect costs) for one award (subject to availability
of funds) in support of this project. Future year amounts will depend
on annual appropriations, availability of funding, and awardee
performance. CBER anticipates providing four additional years of
support up to the following amounts:

FY 2017: $2 million
FY 2018: $2 million
FY 2019: $2 million
FY 2020: $2 million

B. Length of Support

    The support will be 1 year with the possibility of an additional 4
years of noncompetitive support. Continuation beyond the first year
will be based on satisfactory performance during the preceding year,
receipt of a noncompeting continuation application, and available
Federal Fiscal Year appropriations.

III. Electronic Application, Registration, and Submission Information

    Only electronic applications will be accepted. To submit an
electronic application in response to this FOA, applicants should first
review the full announcement located at http://www.grants.gov. Search
by Funding Opportunity Number: RFA-FD-16-044. (FDA has verified the Web
site addresses throughout this document, but FDA is not responsible for
any subsequent changes to the Web sites after this document publishes
in the Federal Register) For all electronically submitted applications,
the following steps are required.
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number.
     Step 2: Register with System for Award Management
(SAM)(formerly CCR).
     Step 3: Obtain Username & Password.
     Step 4: Authorized Organization Representative (AOR)
Authorization.
     Step 5: Track AOR Status.
     Step 6: Register with Electronic Research Administration
(eRA) Commons.
    Steps 1 through 5, in detail, can be found at http://www.grants.gov/web/grants/applicants/organization-registration.html.
Step 6, in detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed
these steps, submit electronic applications to: http://www.grants.gov.

    Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12685 Filed 5-27-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46948-46949]
[FR Doc No: 2013-18549]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9841-5]

Proposed Agreement Regarding Site Costs and Covenants Not To Sue
for American Lead and Zinc Mill Site, Ouray County, Colorado

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for public comment.

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SUMMARY: In accordance with section 122(i) of the Comprehensive
Environmental Response Compensation, and Liability Act of 1980, as
amended (``CERCLA''), 42 U.S.C. 9622(h)(1), notice is hereby given of
the proposed administrative settlement agreement (Settlement Agreement)
under section 122(h) of CERCLA, 42 U.S.C. 9622(h) between the EPA and
The Blue Tee Corporation (hereinafter referred to as the ``the Settling
Party''). The Settlement Agreement provides for Settling Party's
payment of certain response costs incurred at the American Lead and
Zinc Mill Superfund Site near Ouray, Colorado.
    The Settling Party will pay within 30 days after the effective date
of this Settlement Agreement ($1,630,764), plus an additional sum for
interest on that amount calculated from April 1, 2012 through the date
of payment.
    In accordance with Section 122(i) of CERCLA, this notice is being
published to inform the public of the proposed Settlement Agreement and
of the opportunity to comment. For thirty (30) days following the date
of publication of this notice, EPA will receive written comments
relating to the proposed Settlement Agreement. EPA will consider all
comments received and may modify or withdraw its consent to the
settlement if comments received disclose facts or considerations that
indicate that the proposed settlement is inappropriate, improper or
inadequate.

DATES: Comments must be received by September 3, 2013.

ADDRESSES: Comments should be sent Michael Rudy, Senior Enforcement
Specialist (Mail Code ENF-RC), Environmental Protection Agency, Region
8, 1595 Wynkoop Street, Denver, Colorado 80202-1129,<PHONE_NUMBER> or
via electric mail at<EMAIL_ADDRESS>and should reference the
American Lead and Zinc Mill Site, the EPA Docket No. CERCLA-08-2013-
0004. The Agency's response to any comments, the proposed agreement and
additional background information relating to the agreement is
available for public inspection at the

EPA Superfund Record Center, 1595 Wynkoop Street, Denver, Colorado
80202-1129, during normal business hours.

FOR FURTHER INFORMATION CONTACT: Richard Sisk, Senior Enforcement
Attorney, Environmental Protection Agency, Region 8, Mail Code 8ENF-
LEP, 1595 Wynkoop Street, Denver, Colorado 80202-1129,<PHONE_NUMBER>
or via electric mail at<EMAIL_ADDRESS>
    Dated: July 23, 2013.
Andrew M. Gaydosh,
Assistant Regional Administrator, Office of Enforcement, Compliance and
Environmental Justice, EPA, Region 8.
[FR Doc. 2013-18549 Filed 8-1-13; 8:45 am]
BILLING CODE 6560-50-P