[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Rules and Regulations]
[Pages 20542-20546]
[FR Doc No: 2011-8712]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0274; FRL-8868-4]

Escherichia coli O157:H7 Specific Bacteriophages; Temporary
Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a temporary exemption from the
requirement of a tolerance for residues of lytic bacteriophages that
are specific to Escherichia coli O157:H7, sequence negative for shiga
toxins I and II, and grown on atoxigenic host bacteria when applied/
used on food contact surfaces in food processing plants in accordance
with the terms of Experimental Use Permit (EUP) No. 74234-EUP-2.
Intralytix, Inc. submitted a petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA), requesting the temporary tolerance
exemption. This regulation eliminates the need to establish a maximum
permissible level for residues of lytic bacteriophages that are
specific to Escherichia coli O157:H7, sequence negative for shiga
toxins I and II, and grown on atoxigenic host bacteria. The temporary
tolerance exemption expires on April 1, 2013.

DATES: This regulation is effective April 13, 2011. Objections and
requests for hearings must be received on or before June 13, 2011, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0274. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Tracy Lantz, Antimicrobials Division
(7510P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-0274 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 13, 2011. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0274, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of May 5, 2010 (75 FR 24692) (FRL-8820-7),
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide tolerance petition (PP
9G7585) by Intralytix, Inc., 701 East Pratt Street, Baltimore, MD
21202. The petition requested that 40 CFR part 180 be amended by
establishing a temporary exemption from the requirement of a tolerance
for residues of Escherichia coli O157:H7 Specific Bacteriophages. This
notice referenced a summary of the petition prepared by the petitioner
Intralytix, Inc., which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe '' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. * *
*'' Additionally, section 408(b)(2)(D) of FFDCA requires that the
Agency consider ``available information concerning the cumulative
effects of a particular pesticide's residues'' and ``other substances
that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other

exposures that occur as a result of pesticide use in residential
settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
    Phages are naturally occurring viruses infecting bacteria. They are
found in soil and water and in association with plants and animals,
including humans. Bacteriophages are obligate parasites of bacteria,
which means they attach to, infect, and reproduce in bacteria. Phages
are host-specific for bacteria, with specific bacteriophages attacking
only one bacterial species and most frequently only one strain within a
bacterial species. As such, phages do not attack other beneficial
bacteria. In addition, there is no evidence for bacteriophages
infecting any other life form, including humans, except bacteria. Thus,
non-target organisms, such as mammals, birds, fish, plants, and other
wildlife, are not affected by exposure to bacteriophages. Humans and
other animals commonly consume bacteriophages as they are abundantly
found in water, on plant surfaces, and in foods such as ground beef,
pork sausage, chicken, oysters, cheese, fresh mushrooms, and lettuce.
In addition, phages are common commensals of the human gut and likely
play an important role in regulating populations of various bacteria in
the gastrointestinal tract. As cited in public literature, phages have
been used for more than 80 years as therapeutic agents with no ill
effects and are active against bacteria that cause many infections and
human diseases.
    Since bacteriophage do not infect humans, there is not a human
health risk concern from the bacteriophages themselves. The potential
concerns for human health risk from bacteriophages relate to their
interaction with the bacteria they infect. If bacteriophage do not lyse
(i.e., break open) the bacterial cell they infect, there is a
possibility the cell will survive the infection and incorporate any DNA
carried by the bacteriophage in its genome (i.e. lysogenize). If genes
for shigatoxins I and II, often associated with pathogenic strains of
Escherichia coli O157:H7, are carried by a lysogenized bacteriophage
into an atoxigenic Escherichia coli, there is a possibility, in theory,
to convert a commensal and harmless bacterium into a pathogen. This
theoretical risk is handled in three ways for this tolerance exemption:
(1) Only lytic bacteriophage are used; (2) bacteriophage covered by
this tolerance exemption are DNA sequenced to ensure they do not have
the ability to convey shigatoxins I and II; and (3) host bacteria used
to grow bacteriophage also are atoxigenic in that they do not carry DNA
sequences capable of shigatoxin production.
    To address the infectivity and toxicity endpoints for oral,
pulmonary, and injection exposures, the petitioner provided publicly
available information documenting a lack of mammalian toxicity or
infectivity associated with bacteriophages due to the specificity of
bacteriophages attachment and attack to a narrow range of bacterial
strains. As a result, the public literature demonstrates that phages
pose little to no risk to humans even with the known wide exposure in
food and the environment.
    Based on the published literature and information submitted in
accordance with the Tier I toxicology data requirements set forth in 40
CFR 158.2140(c), the Tier II and Tier III toxicology data requirements
also set forth therein were not triggered and, therefore, not required
in connection with this action.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).

A. Dietary Exposure

    1. Food. All phages, including those at issue in this action, are
similar in nature in that they are host-specific, attacking only
bacteria. Published literature submitted by the registrant, and other
publically available literature, indicate that humans are exposed to
phages daily, and these phages are commonly found in humans, having no
known adverse effects. Indeed, humans and other animals routinely
consume phages when they eat food such as raw produce and cheese. For
example, it is reported that 1,000 (10\3\) to 5 x 10\5\ phages can be
isolated routinely per gram (g) of high quality cheese. Pathogenic
microorganisms are often found in foods; therefore, it is not
surprising that one study found Escherichia coli and coliphages in 11
of 12 foods purchased at retail markets. In this study, 10 purchases of
each of the 12 foods were made. All 10 of the fresh ground beef
purchases were contaminated with Escherichia coli, and all 10 contained
coliphages. In addition to ground beef, Escherichia coli and coliphages
were found in chicken, fresh pork, fresh oyster, fresh mushrooms,
lettuce, chicken pot pie, biscuit dough, deli loaf, deli roasted
turkey, and package roasted chicken. Another example of phages in food
has been Propionibacterium freundenreichii phage found in
concentrations as high as 1.4 x 10\6\/gm of swiss cheese.
    The use of the bacteriophages covered by this tolerance in food
processing plants on food contact surfaces could result in some
residues of these bacteriophages on food. The Agency anticipates that
food coming into contact with these surfaces could get residues of the
phages on them and foods with Escherichia coli O157:H7 may end up with
more phages on them as the bacteriophages covered by this tolerance
exemption infect the bacteria and produce progeny.
    2. Drinking water exposure. The Escherichia coli bacteriophages
covered by this tolerance exemption are not intended for use in
drinking water, nor are the approved uses likely to result in these
bacteriophages reaching surface water or ground water that might be
used as drinking water. Use sites are only for food processing
facilities.

B. Other Non-Occupational Exposure

    Since Escherichia coli bacteriophages subject to this tolerance
exemption are only intended to be applied to food contact surfaces in
food processing plants, the potential for non-occupational, non-dietary
exposures (i.e., dermal and inhalation exposures) to these phages by
the general population, including infants and children, is highly
unlikely.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found lytic bacteriophages that are specific to
Escherichia coli O157:H7, sequence negative for shiga toxins I and II,
and grown on atoxigenic host bacteria to

share a common mechanism of toxicity with any other substances.
Moreover, bacteriophage that meet these conditions do not appear to
produce a toxic metabolite produced by other substances. Therefore, for
the purposes of this action, EPA has assumed that lytic bacteriophages
that are specific to Escherichia coli O157:H7, sequence negative for
shiga toxins I and II, and grown on atoxigenic host bacteria do not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for U.S. Population, Infants and Children

A. U.S. Population

    Based on the fact that bacteriophages are host-specific and do not
cause harm to human health, except in theoretical instances that the
Agency is avoiding through its conditions on this exemption, there is
reasonable certainty that no harm will result to the U.S. population,
including infants and children, from aggregate exposure to residues of
lytic bacteriophages that are specific to Escherichia coli O157:H7,
sequence negative for shiga toxins I and II, and grown on atoxigenic
host bacteria. This includes all anticipated dietary exposures and all
other exposures for which there is reliable information.

B. Infants and Children

    FFDCA section 408 (b)(2)(C) provides that EPA shall apply an
additional tenfold margin of exposure (MOE) for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base on toxicity and
exposure, unless EPA determines that a different MOE will be safe for
children. MOEs, which are often referred to as uncertainty (safety)
factors, are incorporated into EPA risk assessments either directly, or
through the use of a MOE analysis or by using uncertainty factors in
calculating a dose level that poses no appreciable risk. As previously
mentioned in the toxicological profile, humans, including infants and
children, have been exposed to phages generally through food and water,
where they are commonly found, and through decades of therapeutic use,
with no known or reported adverse effects. Based on all available
information, the Agency concludes that lytic bacteriophages that are
specific to Escherichia coli O157:H7, sequence negative for shiga
toxins I and II, and grown on atoxigenic host bacteria are non-toxic to
mammals, including infants and children. Because there are no threshold
effects of concern to infants, children, and adults when lytic
bacteriophages that are specific to Escherichia coli O157:H7, sequence
negative for shiga toxins I and II, and grown on atoxigenic host
bacteria are used as labeled, the Agency concludes that the additional
MOE is not necessary to protect infants and children and that not
adding any additional MOE will be safe for infants and children.

VII. Other Considerations

A. Analytical Enforcement Methodology

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

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for lytic bacteriophages that
are specific to Escherichia coli O157:H7, sequence negative for shiga
toxins I and II, and grown on atoxigenic host bacteria.

C. Revisions to Petitioned-for Tolerances

    In its petition PP 9G7585, Intralytix requested that the Agency
establish a tolerance exemption for residues of Escherichia coli
O157:H7 specific bacteriophages. The Agency is narrowing the scope of
the tolerance exemption to residues of lytic bacteriophages that are
specific to Escherichia coli O157:H7, sequence negative for shiga
toxins I and II, and grown on atoxigenic host bacteria because that is
the category of bacteriophages for which the Agency can make a safety
finding.

VIII. Conclusion

    The Agency concludes that there is a reasonable certainty that no
harm will result to the U.S. population, including infants and
children, from aggregate exposure to residues of lytic bacteriophages
that are specific to Escherichia coli O157:H7, sequence negative for
shiga toxins I and II, and grown on atoxigenic host bacteria, including
all anticipated dietary exposures and all other exposures for which
there is reliable information, when used according to label directions,
as a microbial on food contact surfaces in food processing plants.
Therefore, a temporary exemption is established for residues of lytic
bacteriophages that are specific to Escherichia coli O157:H7, sequence
negative for shiga toxins I and II, and grown on atoxigenic host
bacteria.

IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions To Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes,

nor does this action alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. As such, the Agency has
determined that this action will not have a substantial direct effect
on States or tribal governments, on the relationship between the
national government and the States or tribal governments, or on the
distribution of power and responsibilities among the various levels of
government or between the Federal Government and Indian tribes. Thus,
the Agency has determined that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175,
entitled Consultation and Coordination With Indian Tribal Governments
(65 FR 67249, November 9, 2000) do not apply to this final rule. In
addition, this final rule does not impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: April 5, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1301 to subpart D to read as follows:

Sec.  180.1301  Escherichia coli O157:H7 specific bacteriophages;
temporary exemption from the requirement of a tolerance.

    A temporary exemption from the requirement of a tolerance is
established for residues of lytic bacteriophages that are specific to
Escherichia coli O157:H7, sequence negative for shiga toxins I and II,
and grown on atoxigenic host bacteria when used/applied on food contact
surfaces in food processing plants in accordance with the terms of
Experimental Use Permit (EUP) No. 74234-EUP-2. This temporary exemption
expires on April 1, 2013.

[FR Doc. 2011-8712 Filed 4-12-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Proposed Rules]
[Pages 4530-4535]
[FR Doc No: 2022-01784]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R02-OAR-2021-0572, FRL-9439-01-R2]

Approval and Promulgation of Implementation Plans; New York;
Ozone and Particulate Matter Controls Strategies

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve several revisions to the New York State Implementation Plan
(SIP) for the purposes of implementing control of air pollution by
particulate matter (PM) and oxides of nitrogen (NOX). The
proposed SIP revisions consist of amendments to several existing
regulations outlined within New York's Codes, Rules, and Regulations
(NYCRR) that implement control measures for PM and NOX. The
intended effect of this action is to approve control strategies,
required by the Clean Air Act (CAA or the Act), which will result in
emission reductions that will help attain and maintain the national
ambient air quality standards for ozone and PM. These actions are being
taken in accordance with the requirements of the CAA.

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

ADDRESSES: Submit your comments, identified by Docket ID Number EPA-
R02-OAR-2021-0572 at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. 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, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit

https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Fausto Taveras, Environmental
Protection Agency, Region 2, Air Programs Branch, 290 Broadway, New
York, New York 10007-1866, at<PHONE_NUMBER>, or by email at
[email protected].

SUPPLEMENTARY INFORMATION: The Supplementary Information section is
arranged as follows:

I. What action is the EPA proposing?
II. What is the background for this proposed rulemaking?
III. What was included in New York's submittals?
IV. What is the EPA's evaluation of Part 219, ``Incinerators''?
    A. Background
    B. What are the new requirements of Part 219?
    C. What is the EPA's evaluation?
V. What is the EPA's evaluation of Part 222, ``Distributed
Generation Sources''?
    A. Background
    B. What are the new requirements of Part 222?
    C. What is the EPA's evaluation?
VI. What other revisions did New York make?
VII. What is the EPA's conclusion?
VIII. Incorporation by Reference
IX. Statutory and Executive Order Reviews

I. What action is the EPA proposing?

    The EPA is proposing to approve revisions to the New York SIP
submitted by the State of New York on February 3, 2021 and October 15,
2020 that pertain to existing regulations, Title 6 of the New York Code
of Rules and Regulations (6 NYCRR Part 219, ``Incinerators'' (Part
219), and 6 NYCRR Part 222, ``Distributed Generation Sources'' (Part
222), respectively. The EPA is also proposing to approve attendant
revisions to 6 NYCRR Part 200 (Part 200), Section 200.9, ``General
Provisions, Reference materials'' (Section 200.9).
    These revisions include additional control strategies that will
reduce NOX and PM emissions from major sources throughout
the state. The EPA is proposing to approve New York's SIP submittals
listed within this action as a SIP-strengthening measure for New York's
ozone and PM SIP. The EPA is also proposing to approve New York's SIP
submittal since it incorporates additional reasonably available control
technology/reasonably available control measures (RACT/RACM) rules for
NOX at Municipal and Private Solid Waste Incineration Units.

II. What is the background for this proposed rulemaking?

2008 and 2015 Ozone NAAQS Revisions

    In March 2008, EPA revised the health-based National Ambient Air
Quality Standard (NAAQS) for ozone to 0.075 parts per million (ppm)
averaged over an 8-hour time frame (2008 8-hour Ozone Standard). See 73
FR 16435 (March 27, 2008). In October 2015, the EPA revised this
standard to 0.070 ppm averaged over an 8-hour time frame (2015 8-hour
Ozone Standard). See 80 FR 65291 (October 26, 2015).
    On May 21, 2012, the EPA finalized its attainment/nonattainment
designations for areas across the country with respect to the 2008 8-
hour Ozone Standard and, on July 20, 2012, the designations became
effective. See 77 FR 30160 (May 21, 2012). The New York-Northern New
Jersey-Long Island Connecticut metropolitan area (NYMA) was designated
by the EPA as a ``marginal'' nonattainment area for the 2008 ozone
NAAQS.\1\ In 2016, the EPA determined that the NYMA did not attain the
2008 ozone standard by the July 20, 2015 attainment date and was
reclassified from a ``marginal'' to a ``moderate'' nonattainment area.
See 81 FR 26697 (May 4, 2016). SIPs for ``moderate'' nonattainment
areas were due by January 1, 2017. See id. On April 30, 2018, the EPA
finalized its attainment/nonattainment designations for most areas
across the country as to the 2015 8-hour Ozone Standard, in which the
NYMA was designated by the EPA as a ``moderate'' nonattainment area.
See 83 FR 25776 (June 4, 2018). On September 23, 2019, the EPA
reclassified the NYMA to ``serious'' nonattainment as to the 2008 8-
hour Ozone Standard. See 84 FR 44238 (August 23, 2019). The serious
area attainment date and the deadline for RACT measures not tied to
attainment was July 20, 2021. See id.
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    \1\ The New York portion of the NYMA, is composed of the five
boroughs of New York City and the surrounding counties of Nassau,
Suffolk, Westchester, Rockland and the Shinnecock Indian Nation. See
40 CFR 81.333.
---------------------------------------------------------------------------

PM NAAQS Revisions

    On September 21, 2006, the EPA retained the primary and secondary
24-hour PM10 standard of 150 micrograms per cubic meter of
air ([micro]g/m\3\), as an average over a 24-hour period, not to be
exceeded more than once per year on average over a 3-year period, that
was initially promulgated on June 2, 1987. See 71 FR 61144 (October 17,
2006); see also 52 FR 24634 (July 1, 1987).
    On October 17, 2006, the EPA strengthened the primary and secondary
24-hour PM2.5 NAAQS to 35 [micro]g/m\3\. See 71 FR 61144. On
November 13, 2009, the EPA promulgated designations for the revised 24-
hour PM2.5 standard set in 2006, designating the NY-NJ-CT
area as ``nonattainment.'' See 74 FR 58688. On June 27, 2013, New York
submitted a request to redesignate the New York portion of the NY-NJ-CT
nonattainment area, from ``nonattainment'' to ``attainment.'' As part
of this request, New York also submitted a maintenance plan to ensure
that New York's portion of the NYMA would continue attainment through
2025. On April 18, 2014, the EPA took final action to approve New
York's SIP revision to redesignate the New York portion of the NY-NJ-CT
to ``attainment'' for the 2006 24-hour PM2.5 NAAQS. See 79
FR 21857.
    On December 14, 2012, the EPA promulgated a revised primary NAAQS
for PM2.5 for the annual standard, setting the level at 12
micrograms per cubic meter ([micro]g/m\3\) calculated as an annual
average, which is averaged over a three-year period. See 78 FR 3086.
    On January 15, 2015, the EPA finalized its attainment/nonattainment
designations for areas across the country with respect to the revised
primary PM2.5 NAAQS and on April 15, 2015, the designations
became effective. See 80 FR 2206. The NYMA was designated by the EPA as
an ``Unclassifiable/Attainment'' area for the revised primary
PM2.5 NAAQS. See id.

III. What was included in New York's submittals?

    On February 3, 2021 and October 15, 2020, the New York State
Department of Environmental Conservation (NYSDEC or New York),
submitted to the EPA proposed revisions to the SIP, which included
State adopted revisions to three regulations contained in Part 219,
``Incinerators,'' and Part 222, ``Distributed Generation Sources'' with
effective dates of March 14, 2020 and March 25, 2020, respectively. New
York also submitted attendant revisions to Part 200, Section 200.9,
``General Provisions, Reference materials. These revisions are
applicable statewide, with the exception of Part 222 which will only be
applicable to sources located within the NYMA. These revisions will
provide NOX and PM2.5 emission reductions
statewide and will address, in part, attainment of the 2008 and 2015 8-
hour Ozone Standards within the NYMA and maintain New York State's
attainment of the PM NAAQS.

IV. What is the EPA's evaluation of Part 219, ``Incinerators''?

A. Background

    The NYSDEC revised 6 NYCRR Part 219, by repealing and replacing 6
NYCRR Subpart 219-4, ``Human and Animal Crematories,'' to better
reflect the current state of cremation technology and reduce emissions
of PM from new animal and human crematories constructed in the state.
New York also repealed and reserved 6 NYCRR Subparts 219-5 and 219-6,
requiring the existing units subject to these requirements comply with
the more stringent standards under the revised 6 NYCRR Subpart 219-4
(Subpart 219-4). New York also revised 6 NYCRR Subpart 219-1 (Subpart
219-1) and Part 200, Section 200.9 to clarify various definitions used
throughout Part 219. In addition, New York is adding a new 6 NYCRR
Subpart 219-10, ``Reasonably Available Control Technology (RACT) for
Oxides of Nitrogen (NOX) at Municipal and Private Solid
Waste Incineration Units'' (Subpart 219-10), to impose 24-hour and
annual average RACT NOX emission limits for private and
municipal waste combustion units.

B. What are the new requirements of Part 219?

    NYSDEC revised Subpart 219-1 and Part 200, Section 200.9 to
incorporate minor edits to definitions used throughout Part 219, in
order to provide clarity to applicable owners or operators. The newly
revised Subpart 219-4 applies to all new, modified, and existing
cremation units used for the cremation of human and animal remains
throughout the New York State. Under this regulation, owners and
operators of applicable cremation units must comply with the PM
emission limitations and operating requirements. 6 NYCRR Section 219-
4.1 was revised to add definitions for existing, modified, and new
cremation units. 6 NYCRR Section 219-4.2 was revised to address that
Subpart 219-4 is applicable to all new, modified, and existing
cremation units used for animal and human remains.
    6 NYCRR Section 219-4.3 was revised to implement the PM emission
limits for new, modified, and existing cremation units. Under Section
219-4.3, no owner or operator may cause or allow emissions of
particulates into the outdoor atmosphere from an existing cremation
unit to exceed 0.08 grains per dry standard cubic foot of flue gas
(0.08 gr/dscf), corrected to 7 percent oxygen. And no person may cause
or allow emissions of particulates into the outdoor atmosphere from a
new or modified cremation unit to exceed 0.05 gr/dscf, corrected to 7
percent oxygen.
    Under 6 NYCRR Section 219-4.4, the owner and operator of cremation
units must comply with various operating requirements including: An
opacity limit, a minimum secondary combustion chamber temperature and
residence time during cremation, installation of an continuous
temperature monitoring instruments and continuous recording
requirement, a prohibition on the combustion of certain materials,
preparation of a cremation certification form prior to cremation, and a
prohibition on the charging of remains in excess of the manufacturer's
rated capacity of the cremation unit.
    6 NYCRR Section 219-4.5 was revised to establish the emission
testing and modeling requirements for cremation units. Owners or
operators of affected cremation units must demonstrate compliance with
this Subpart by either conducting onsite testing or stack testing. 6
NYCRR Section 219-4.6 establishes operator training and certification
requirements for crematory operators. 6 NYCRR Section 219-4.7 outlines
the annual inspection and maintenance requirements for the cremation
units. 6 NYCRR Section 219-4.8 describes the recording requirements for
crematory facilities.
    6 NYCRR Section 219-4.9 was revised to describe the compliance
schedule for existing cremation units that are subject to the
requirements under Subpart 219-4. Section 219-4.9 outlines that owner
or operator of an existing cremation unit must obtain appropriate
operator certifications, as described in 6 NYCRR Section 219-4.6,
within 12 months of the effective date of 6 NYCRR Subpart 219-4 for
each uncertified operator at the facility. Owners and operators also
must demonstrate compliance with the requirements of this Subpart no
later than 60 months from the effective date of 6 NYCRR Subpart 219-4.
    New York has repealed and reserved 6 NYCRR Subparts 219-5 and 219-
6, requiring that the existing units subject to those requirements
comply with the more stringent standards under the new Subpart 219-4.
    Subpart 219-10 is new and applies to all new, modified, and
existing municipal and private solid waste incineration units. 6 NYCRR
Section 219-10.2 establishes the 24-hour and annual average
NOX emissions limitation and describes the procedures that
affected facilities can use to demonstrate that they have installed
RACT.\2\ Both the 24-hour and annual average NOX emission
limits vary between the combustion technology utilized by the owner or
operator. Incineration units that utilize Mass Burn Waterwall or Rotary
Combustor technology must comply with presumptive RACT limits, while
owners or operators of other combustion technologies must perform a
facility-specific RACT analysis. The analysis must include proposed 24-
hour and annual average NOX emission limitations, the
available NOX control technology, the projected
effectiveness of the technologies considered, and the costs for
installations and operation for each of the technologies. The RACT
analysis was to be submitted to the NYSDEC by June 30, 2021. Approved
RACT determinations will be submitted by the NYSDEC to the EPA for
approval as separate SIP revisions.
---------------------------------------------------------------------------

    \2\ The NOX emission limits are on a parts per
million dry volume basis (ppmvd), corrected to 7% oxygen.
---------------------------------------------------------------------------

    6 NYCRR Section 219-10.3 outlines the compliance demonstration for
the owners or operators of a municipal or private solid waste
incineration unit subject to this Subpart. Under 6 NYCRR Section 219-
10.3, owners or operators of a municipal or private solid waste
incineration applicable to this Subpart must demonstrate compliance
within one year of the date of issuance of a permit modification issued
pursuant to the requirements of this Subpart. Owners or operators
applicable to this shall install, calibrate, maintain, and operate a
Continuous Emissions Monitoring System (CEMS) for measuring the oxides
of nitrogen discharged to the atmosphere from the municipal or private
solid waste incineration units.

C. What is EPA's evaluation?

    The EPA reviewed both New Jersey and Connecticut's PM emission
limits for human and animal cremation units and compared those limits
with the limits adopted by NYSDEC in this rule.\3\ The EPA has observed
that New York's PM limits are more stringent than both New Jersey and
Connecticut's for similar crematory technologies.
---------------------------------------------------------------------------

    \3\ Title 7, Chapter 27, Subchapter 11 of New Jersey's
Incinerator regulation provides PM emission rates for various types
of Incinerators. See https://www.nj.gov/dep/aqm/currentrules/Sub11.pdf. Section 22a-174-18 of Connecticut's regulations provides
controls for PM and visible emissions from existing incinerators.
See https://eregulations.ct.gov/eRegsPortal/Browse/RCSA/Title_22aSubtitle_22a-174Section_22a-174-18/.
---------------------------------------------------------------------------

    The EPA has also reviewed New Jersey and Connecticut's
NOX emission limits for municipal and private solid waste
incineration units with similar

combustion technology and compared those limits with the limits adopted
by NYSDEC in this rule.\4\ The EPA observed that Connecticut adopted
similar RACT emission limits, on a 24-hour average, for Mass Burn
Waterwall combustors. The EPA also observed that NOX
emission limits outlined within New York's rule will be as stringent as
New Jersey's for similar combustion technologies.
---------------------------------------------------------------------------

    \4\ Title 7, Chapter 27, Subchapter 19 of New Jersey's
NOX RACT regulation provides NOX emission
rates for Municipal Waste Combustors. See https://www.nj.gov/dep/aqm/currentrules/Sub19.pdf. Section 22a-174-38 of Connecticut's
regulations provides NOX emission limits for Municipal
Waste Combustors. See https://eregulations.ct.gov/eRegsPortal/Browse/RCSA/Title_22aSubtitle_22a-174Section_22a-174-38/.
---------------------------------------------------------------------------

    The EPA has reviewed New York's SIP submittal, which seeks to
incorporate revisions to 6 NYCRR Part 219, ``Incinerators. After
evaluating Part 219 for consistency with the CAA, EPA regulations, and
EPA policy, the EPA proposes to find that the submission fully
addresses the ozone nonattainment requirement found in CAA Section 172,
42 U.S.C. Section 7502, and proposes to approve this revision. The EPA
also proposes that the submission addresses the PM requirements found
in CAA Section 175A, 42 U.S.C. Section 7505a.

V. What is the EPA's evaluation of Part 222, ``Distributed Generation
Sources''?

A. Background

    New York revised Part 222 to impose more stringent NOX
control requirements on sources operated as part of demand response
programs or designated as price-responsive ``economic'' generation
sources in New York City, Long Island, and Rockland and Westchester
counties. Distributed Generation (DG) units enrolled within demand
response programs are often low-level NOX controlled diesel-
fired engines that contribute significant NOX emissions
within the NYMA during High Electrical Demand Days. The revisions to
Part 222 essentially entail control requirements beginning in 2021 with
additional phased-in control requirements beginning in 2025. Both
control requirements will increase the stringency of emissions limits
for these engines used in non-emergency applications.

B. What are the new requirements of Part 222?

    Part 222 was revised to include revisions of several definitions, a
change in application and permitting requirements, a change in control
requirements for economic dispatch sources, and revisions to emission
testing and recordkeeping. DG sources are stationary reciprocating or
rotary internal combustion engines used by host facilities or sites to
supply electricity into the distribution grid or produce electricity
for use at the host facilities or both. This includes, but is not
limited to, emergency power generation stationary internal combustion
engines and demand response sources. The demand response program is an
emergency program sponsored by the New York Independent System Operator
(NYISO) or distribution utilities in New York to call upon owners of
low-level NOX controlled distributed generation engines to
generate electricity for host facilities on high demand days, to reduce
demand on the electrical grid and preserve its reliability. Economic
dispatch sources are defined as distributed generation sources used to
provide electricity for general use to a building, structure, or
collection of structures in place of electricity supplied by the
distribution utilities. Economic dispatch sources are also considered
as price-responsive generation sources which are distributed generation
sources used to provide electricity for short periods of time when the
cost of electricity supplied by the distribution utility is high. The
revised Part 222 applies to owners and operators of distributed
generation sources classified as economic sources located within the
NYMA with a maximum mechanical output rating of 200 horsepower (hp) or
greater where the potential to emit of NOX at a facility is
less than 25 tons/year.
    6 NYCRR Section 222.1 was revised to incorporate the applicability
of Part 222. 6 NYCRR Section 222.2 was revised to amend the definitions
that apply to this Part, which include: Compression ignition, demand
response program, demand response source, demand response event,
distribution utility, distributed generation source, economic dispatch
source, lean burn engine, maximum load relief, model year, rich burn
engine, spark ignition, and three-way catalyst controls. The
definitions of Part 200, as well as 6 NYCRR Subpart 200.1 and Subpart
201-2 of still apply to Part 222 unless they are inconsistent with the
definitions outlined within 6 NYCRR Section 222.2.
    6 NYCRR Section 222.3 was revised to specifically require owners or
operators of a distributed generation source to obtain a permit or
registration certificate in accordance with 6 NYCRR Part 201 prior to
the operation as an economic dispatch source. The revisions also
require owners or operators to notify NYSDEC, in writing by March 15,
2021 or 30 days prior to operating, whichever is later, their
distributed generation source as an economic dispatch source.
    6 NYCRR Section 222.4 (Section 222.4) was revised to implement the
control requirements of economic dispatch sources that will be subject
to Part 222. Effective May 1, 2021, depending upon the engine and fuel
type, economic dispatch sources must comply with presumptive
NOX emission limits, or at least be a model year of 2000, or
must be equipped with control technology (Phase One).\5\ As of May 1,
2025, the second and final phase of NOX emission limits for
economic dispatch sources will become effective. Depending on the
engine and fuel type, owners and operators must comply with more
stringent NOX emission limits than the Phase One limits.
Section 222.4 allows owners or operators of impacted sources to request
an extension of the compliance date for the 2025 NOX control
requirements in Part 222. Owners or operators that request additional
time to install controls or install new engines or turbines must
provide evidence to NYSDEC; in any case, the extension may not exceed
two years beyond the 2025 compliance date. Also, emission test reports
that demonstrate compliance with the control requirements outlined in
Section 222.4 must be submitted and approved by NYSDEC before a
distributed generation source may be operated as an economic dispatch
source on or after May 1, 2025.
---------------------------------------------------------------------------

    \5\ Model year is defined within Part 222 as the calendar year
in which the engine was originally produced; or the annual new model
production period of the engine manufacturer if it is different than
the calendar year.
---------------------------------------------------------------------------

    6 NYCRR Section 222.5 was revised to require owners or operators to
submit the emission test reports outlined in Section 222.4. This
section also describes how the emission test reports must be submitted,
the emission test methods, and additional protocols required.
    6 NYCRR Section 222.6 (Section 222.6) was revised to include the
recordkeeping provisions required by owners and operators subject to
Part 222. NYSDEC may enter a facility during normal operating hours to
inspect an economic dispatch source subject to the requirements of Part
222, and inspect any records, papers, logbooks, and operational data
maintained pursuant to Part 222. Facilities subject to Part 222 must
also maintain records regarding hours of operation and fuel use for a
period of five years. Section 222.6 also requires that owners or
operators to conduct

stack testing to demonstrate compliance with the emission standards
detailed in Part 222 for economic dispatch sources that will operate on
May 1, 2025 and beyond.

C. What is EPA's evaluation?

    New York has revised Section 222.4 (control requirements) to
require more stringent NOX emission limits on sources used
in demand response programs or designated as economic dispatch sources
in the NYMA. New York has estimated that once the phased-in controls
requirements are implemented by the May 1, 2025 compliance date, actual
NOX emissions in the State will be reduced by 5 tons per
day. The following summarizes the revised control requirements from
Section 222.4 that are expected to result in NOX reductions
beginning on May 1, 2025:
    [ssquf] For combustion turbines firing natural gas, presumptive
NOX emission limits are reduced to 25 parts per million on a
dry volume basis corrected to 15 percent oxygen.
    [ssquf] For combustion turbines firing oil, presumptive
NOX emission limits are reduced to 42 parts per million on a
dry volume basis corrected to 15 percent oxygen.
    [ssquf] For spark ignition engines firing natural gas, presumptive
NOX emission limits are reduced to 1.0 grams per brake
horsepower-hour.
    [ssquf] For compression-ignition engines firing distillate oil with
nameplate rating less than 750 hp, presumptive NOX emission
limits are reduced to 0.30 grams per brake horsepower-hour.
    [ssquf] For compression-ignition engines firing distillate oil with
nameplate rating greater than or equal to 750 hp, presumptive
NOX emission limits are reduced to 0.50 grams per brake
horsepower-hour.
    The EPA believes that the new presumptive emission limits and other
control requirements will result in additional NOX
reductions throughout the State thereby strengthening New York's ozone
SIP and will help the State reach attainment for the 2008 and 2015
ozone standards.
    The EPA agrees with New York's evaluation that the newly-adopted
regulation will lead to an estimated reduction of 3.5 tons per day in
2021 and 5 tons per day by 2025 for demand response sources. A 3.5 or 5
ton per day reduction in NOX emissions is a necessary step
towards meeting New York's obligation under Section 110 of the CAA.
This reduction will result in NOX reductions throughout the
NYMA, strengthen New York's ozone SIP, and help the State reach
attainment for the 2008 and 2015 ozone NAAQS. The EPA evaluated the
provisions of Part 222 for consistency with the CAA, EPA regulations,
and EPA policy and proposes to find that the submission fully addresses
the ozone nonattainment requirements found in CAA Section 172, 42
U.S.C. 7502, and proposes to approve this revision.

VI. What other revisions did New York make?

    New York also made administrative changes to Part 200 (``General
Provisions'') which reflect the revisions to Part 219 and Part 222
discussed above. Specifically, the revisions to Part 200 will add new
references in Section 200.9, ``Referenced Material'', Table 1. The
revisions to Table 1 of Section 200.9 include all documents referenced
in New York's amendments to Part 219 and Part 222. It is important to
note that EPA is proposing to approve only those respective revisions
made to Part 200, specifically Section 200.9 as amended on March 14,
2020 and March 25, 2020.

VII. What is the EPA's conclusion?

    The EPA evaluated New York's submittal for consistency with the
Act, EPA regulations, and EPA policy. EPA proposes that the revisions
discussed above (6 NYCRR Part 200, ``General Provisions'', Part 219,
``Incinerators,'' and Part 222, ``Distributed Generation Sources,''
with effective dates of March 14, 2020 and March 25, 2020,
respectively) meet the SIP requirements of the Act. The EPA is
proposing to approve Part 219 and Part 222. The EPA is also proposing
to approve attendant revisions to Part 200, Section 200.9, ``General
Provisions, Reference material. These revisions meet the requirement of
the Act and EPA's regulations, and are consistent with EPA guidance and
policy. EPA is taking this action pursuant to Section 110 and Part D of
the Act and EPA's regulations.

VIII. Incorporation by Reference

    In this document, the EPA is also proposing to incorporate by
reference NYSDEC rules discussed in sections IV and V of this preamble
in accordance with the requirements of 1 CFR 51.5. The EPA has made and
will continue to make these materials available through the docket for
this action, EPA-R02-OAR-2021-0572, at https://regulations.gov, and at
the EPA Region II Office (please contact the person identified in the
FOR FURTHER INFORMATION CONTACT section of this preamble for more
information).

IX. 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. See 42 U.S.C. 7410(k); see also 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided they meet the criteria of the CAA. Accordingly, this
action merely proposes to approve state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993), 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 (2 U.S.C. 1501);
     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, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose

any 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, Incorporation by
reference, Nitrogen Dioxide, Intergovernmental Relations, Incorporation
by Reference, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Waste treatment and disposal.

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

    Dated: January 24, 2022.
Lisa F. Garcia,
Regional Administrator, Region 2.
[FR Doc. 2022-01784 Filed 1-27-22; 8:45 am]
BILLING CODE 6560-50-P


27 EXHIBIT 1 ESTIMATED ANNUAL RESPONDENT RECORDKEEPING BURDEN AND COST Subtitle D Requirement Number of Respondents Hours per Respondent per Activity Total Hours per Year Total Annual Cost Existing New Legal Manager Technical Clerical Small MSWLFs § 258.1( f)( 2) 0 425 0 0 0 0 0 0 Small MSWLFs § 258.1( f)( 3) 0 0 0 0 0 0 0 0 Airport Safety § 258.10 0 0 0 0 0 0 0 0 Floodplains § 258.11 0 0 0 0 0 0 0 0 Wetlands § 258.12 0 0 0 0 0 0 0 0 Fault Areas § 258.13 0 4 0 0 0 0 0 0 Seismic Impact Zones § 258.14 0 4 0 0 0 0 0 0 Unstable Areas § 258.15 0 4 0 0 0 0 0 0 Closure of Existing LFs § 258.16 0 0 0 0 0 0 0 0 Procedures to exclude HW § 258.20 ( a)( 1 3) 1900 0 0 2 2 6 19,000 547,238 Procedures to exclude HW § 258.20 ( a)( 4) 0 42 0 0 0 0 0 0 Cover Material § 258.21 0 4 0 0 0 0 0 0 Explosive Gas Control § 258.23 1900 40 0 0 0 0 0 0 Explosive Gas Control § 258.23( c) 0 20 0 0 0 0 0 0 Liquids Restrictions § 258.28 0 0 0 0 0 0 0 0 28 Subtitle D Requirement Number of Respondents Hours per Respondent per Activity Total Hours per Year Total Annual Cost Existing New Legal Manager Technical Clerical Recordkeeping Requirements § 258.29 0 0 0 0 0 0 0 0 Alternative Liner Design § 258.40( c) 0 0 0 0 0 0 0 0 Alternative Point of Compliance § 258.40( d) 0 0 0 0 0 0 0 0 Project XL Bioreactor Landfill Project § 258.41 2 4 0 4 8 8 120 3,627 No Migration Petition § 258.50( a) 0 0 0 0 0 0 0 0 Establish GWM System § 258.53 0 0 0 0 0 0 0 0 Detection Monitoring Program § 258.54 1520 n/ a 0 0 1 1 3,040 73,933 Detection Monitoring Program § 258.54 380 40 0 0 1 1 840 20,429 Assessment Monitoring Program § 258.55 500 0 0 0 1 1 1000 24,320 Selection of Remedy § 258.57 250 0 0 0 3 3 1500 36,450 Closure Criteria § 258.60 0 0 0 0 0 0 0 0 Post Closure Care Requirements § 258.61 760 0 0 0 1 1 1,520 36,967 Financial Assurance § 258.71 1,140 40 0 0 1 1 2,360 57,395 29 Subtitle D Requirement Number of Respondents Hours per Respondent per Activity Total Hours per Year Total Annual Cost Existing New Legal Manager Technical Clerical Total Annual Burden and Cost 29,380 $ 800,359 EXHIBIT 2 ESTIMATED ONE TIME RESPONDENT RECORDKEEPING BURDEN AND COST Subtitle D Requirement Number of Respondents Hours per Respondent per Activity Total Hours per Year Total Annual Cost Existing New Legal Manager Technical Clerical Small MSWLFs § 258.1( f)( 2) 0 425 2 0 3 5 4250 126,310 Small MSWLFs § 258.1( f)( 3) 0 3 2 8 10 10 90 3,340 Airport Safety § 258.10 0 20 0 2 4 4 200 6,127 Floodplains § 258.11 0 8 0 2 4 4 80 2,451 Wetlands § 258.12 0 0 0 0 0 0 0 0 Fault Areas § 258.13 0 4 0 0 0 0 0 0 Seismic Impact Zones § 258.14 0 4 0 2 4 4 40 1,226 Unstable Areas § 258.15 0 4 0 2 4 4 40 1,226 Closure of Existing LFs § 258.16 0 0 0 0 0 0 0 0 Procedures to exclude HW § 258.20 ( a)( 1 3) 0 0 0 0 0 0 0 0 Procedures to exclude HW § 258.20 ( a)( 4) 42 0 0 0 1 1 84 2,043 30 Subtitle D Requirement Number of Respondents Hours per Respondent per Activity Total Hours per Year Total Annual Cost Existing New Legal Manager Technical Clerical Cover Material § 258.21 0 4 2 2 10 10 96 3,111 Explosive Gas Control § 258.23 0 40 0 4 11 9 960 28,769 Explosive Gas Control § 258.23( c) 20 0 0 1 5 10 320 7,955 Liquids Restrictions § 258.28 0 20 0 0 1 1 4 973 Recordkeeping Requirements § 258.29 0 44 0 2 4 4 440 13,480 Alternative Liner Design § 258.40( c) 0 2 0 0 0 0 0 0 Alternative Point of Compliance § 258.40( d) 0 0 0 0 0 0 0 0 Project XL Bioreactor Landfill Project § 258.41 0 0 0 0 0 0 0 0 No Migration Petition § 258.50( a) 0 4 0 0 1 1 8 195 Establish GWM System § 258.53 0 8 0 0 3 3 48 1,168 Detection Monitoring Program § 258.54 0 0 0 0 0 0 0 0 Detection Monitoring Program § 258.54 0 0 0 0 0 0 0 0 Assessment Monitoring Program § 258.55 0 0 0 0 0 0 0 0 31 Subtitle D Requirement Number of Respondents Hours per Respondent per Activity Total Hours per Year Total Annual Cost Existing New Legal Manager Technical Clerical Selection of Remedy § 258.57 0 0 0 0 0 0 0 0 Closure Criteria § 258.60 0 8 0 0 1 1 16 389 Post Closure Care Requirements § 258.61 760 0 0 0 0 0 0 0 Financial Assurance § 258.71 0 0 0 0 0 0 0 0 Total Annual Burden and Cost 6,712 $ 198,763 EXHIBIT 3 ESTIMATED ANNUAL RESPONDENT REPORTING BURDEN AND COST Subtitle D Requirement Number of Respondents Hours per Respondent per Activity Total Hours per Year Total Annual Cost Existing New Legal Manager Technical Clerical Small MSWLFs § 258.1( f)( 2) 0 0 0 0 0 0 0 0 Small MSWLFs § 258.1( f)( 3) 0 0 0 0 0 0 0 0 Airport Safety § 258.10 0 0 0 0 0 0 0 0 Floodplains § 258.11 0 0 0 0 0 0 0 0 Wetlands § 258.12 0 0 0 0 0 0 0 0 Fault Areas § 258.13 0 4 0 0 0 0 0 0 Seismic Impact Zones § 258.14 0 4 0 0 0 0 0 0 32 Subtitle D Requirement Number of Respondents Hours per Respondent per Activity Total Hours per Year Total Annual Cost Existing New Legal Manager Technical Clerical Unstable Areas § 258.15 0 4 0 0 0 0 0 0 Closure of Existing LFs § 258.16 0 0 0 0 0 0 0 0 Procedures to exclude HW § 258.20 ( a)( 1 3) 1900 0 0 0 1 1 3,800 92,416 Procedures to exclude HW § 258.20 ( a)( 4) 0 42 0 0 0 0 0 0 Cover Material § 258.21 0 4 0 0 0 0 0 0 Explosive Gas Control § 258.23 1900 40 0 0 1 5 11,640 94,361 Explosive Gas Control § 258.23( c) 0 20 0 0 0 0 0 0 Liquids Restrictions § 258.28 0 0 0 0 0 0 0 0 Recordkeeping Requirements § 258.29 0 0 0 0 0 0 0 0 Alternative Liner Design § 258.40( c) 0 0 0 0 0 0 0 0 Alternative Point of Compliance § 258.40( d) 0 0 0 0 0 0 0 0 Project XL Bioreactor Landfill Project § 258.41 2 4 2 8 10 10 180 6,680 No Migration Petition § 258.50( a) 0 0 0 0 0 0 0 0 Establish GWM System § 258.53 0 0 0 0 0 0 0 0 33 Subtitle D Requirement Number of Respondents Hours per Respondent per Activity Total Hours per Year Total Annual Cost Existing New Legal Manager Technical Clerical Detection Monitoring Program § 258.54 1,520 n/ a 0 5 10 12 41,040 884,290 Detection Monitoring Program § 258.54 380 40 0 6 12 14 13,440 402,611 Assessment Monitoring Program § 258.55 500 0 2 6 12 12 16,000 549,340 Selection of Remedy § 258.57 250 0 10 30 40 120 50,000 1,524,750 Closure Criteria § 258.60 0 0 0 0 0 0 0 0 Post Closure Care Requirements § 258.61 760 0 1 3 4 8 12,160 403,544 Financial Assurance § 258.71 1140 40 0 0 2 2 4,720 114,791 Total Annual Burden and Cost 152,980 $ 4,072,783 EXHIBIT 4 ESTIMATED ONE TIME RESPONDENT REPORTING BURDEN AND COST Subtitle D Requirement Number of Respondents Hours per Respondent per Activity Total Hours per Year Total Annual Cost Existing New Legal Manager Technical Clerical Small MSWLFs § 258.1( f)( 2) 0 425 0 2 3 5 850 20,672 Small MSWLFs § 258.1( f)( 3) 0 3 0 0 1 1 6 146 Airport Safety § 258.10 0 20 0 0 1 1 40 973 Floodplains § 258.11 0 8 0 0 1 1 16 389 Wetlands § 258.12 0 0 0 0 0 0 0 0 34 Subtitle D Requirement Number of Respondents Hours per Respondent per Activity Total Hours per Year Total Annual Cost Existing New Legal Manager Technical Clerical Fault Areas § 258.13 0 4 0 0 1 1 8 195 Seismic Impact Zones § 258.14 0 4 0 0 1 1 8 195 Unstable Areas § 258.15 0 4 0 0 1 1 8 195 Closure of Existing LFs § 258.16 0 0 0 0 0 0 0 0 Procedures to exclude HW § 258.20 ( a)( 1 3) 0 0 0 0 0 0 0 0 Procedures to exclude HW § 258.20 ( a)( 4) 42 0 0 0 1 1 84 2,043 Cover Material § 258.21 0 4 0 0 1 1 8 195 Explosive Gas Control § 258.23 0 40 0 0 0 0 0 0 Explosive Gas Control § 258.23( c) 20 0 0 0 1 1 40 973 Liquids Restrictions § 258.28 0 20 0 0 1 1 40 973 Recordkeeping Requirements § 258.29 0 40 0 0 1 1 80 1,945 Alternative Liner Design § 258.40( c) 0 2 2 10 20 8 80 2,949 Alternative Point of Compliance § 258.40( d) 0 0 0 0 0 0 0 0 Project XL Bioreactor Landfill Project § 258.41 0 0 0 0 0 0 0 0 No Migration Petition § 258.50( a) 0 4 5 20 60 15 400 14,390 35 Subtitle D Requirement Number of Respondents Hours per Respondent per Activity Total Hours per Year Total Annual Cost Existing New Legal Manager Technical Clerical Establish GWM System § 258.53 0 8 0 8 8 4 160 1,989 Detection Monitoring Program § 258.54 0 0 0 0 0 0 0 0 Detection Monitoring Program § 258.54 0 0 0 0 0 0 0 0 Assessment Monitoring Program § 258.55 0 0 0 0 0 0 0 0 Selection of Remedy § 258.57 0 0 0 0 0 0 0 0 Closure Criteria § 258.60 0 8 2 4 8 2 128 5,391 Post Closure Care Requirements § 258.61 760 0 0 0 0 0 0 0 Financial Assurance § 258.71 0 0 0 0 0 0 0 0 Total Annual Burden and Cost 1,956 $ 53,613