expected to occur due to the use of these PIPs, which necessarily
includes any threatened or endangered species (listed species), EPA
therefore reaches a ''No Effect'' determination for listed species and
their critical habitats.
    Herein, EPA provides brief summaries of key considerations used in
the Agency's determination that the PIP exemptions proposed in the 2020
preamble and finalized in this rule are reasonably expected to result
in no discernable effects to nontarget organisms, including listed
species. In the proposed rule, EPA considered several factors in
determining whether PIPs that meet the criteria under proposed 40 CFR
174.26 could be exempted from FIFRA requirements in order to meet the
40 CFR 174.21(a) requirement (Unit VI.A.3.h. of the proposed rule). In
its assessment, the Agency relied on the large body of knowledge that
currently exists on sexually compatible plants and genetic diversity.
Briefly, with regard to the potential ecological effects, the Agency
found that there is: ``(1) Low potential for novel exposures; (2) Low
potential for levels of ``PIPs created through genetic engineering from
a sexually compatible plant'' to exceed levels found in sexually
compatible plants; and (3) Low potential for ``PIPs created through
genetic engineering from a sexually compatible plant'' to move from
cultivated plants to wild or weedy relatives through gene flow and
increase weediness.'' (Unit VI.A.3. of the proposed rule). EPA also
evaluated considerations specific to newer biotechnology techniques
related to the PIPs proposed for exemption and found that their use in
creating these PIPs would pose negligible risk to the environment.
Lastly, the Agency found that the likelihood is negligible that the
transfer of a PIP via biotechnology from a nonagricultural (wild)
relative to an agricultural one would pose a greater risk than if it
were transferred through conventional breeding.
    In summary, PIPs that are exempted under 40 CFR 174.26 represent a
subset of substances already present in related plants and are
equivalent both in identity and in expression profile (how much, where,
and when the substances are expressed in plants). As ``loss-of-function
PIPs'' exempted under 40 CFR 174.27 were originally proposed as a
subcategory of PIPs exempted under 40 CFR 174.26, they too fall within
the scope of the Agency's analysis in the proposed rule preamble.
Pesticidal traits resulting from the loss-of-function of an endogenous
gene are common occurrences in wild plants and in conventional breeding
(Refs. 18, 19) and EPA finds that there is no potential for

novel exposures or hazards for ``loss-of-function PIPs,'' as this group
of PIPs is characterized by a modification that leads to the reduction
or elimination of the activity of a gene that had already been present
in the recipient plant. As the PIPs exempted under this rule are
considered to be equivalent to those already found in nature and used
in conventional breeding, there is a reasonable expectation that no
discernible effects to listed species will occur from their use. As no
discernible effects are reasonably expected to occur to listed species
due to the use of these PIPs, EPA therefore reaches a ''No Effect''
determination for listed species and their critical habitats.

VII. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the person
listed under FOR FURTHER INFORMATION CONTACT.

1. Response to Comments to the Proposed Rule to Exempt Certain
Plant-Incorporated Protectants (PIPs) Derived from Newer
Technologies. Available at https://www.regulations.gov under Docket
ID No. EPA-HQ-OPP-2019-0508.
2. USEPA. 2020. Pesticides; Exemptions of Certain Plant-Incorporated
Protectants (PIPs) Derived from Newer Technologies. 85 FR 64308,
October 9, 2020 (FRL-10014-10). Available at https://www.regulations.gov under Docket ID No. EPA-HQ-OPP-2019-0508.
3. USEPA, USFDA, and USDA. Modernizing the Regulatory System for
Biotechnology Products: Final Version of the 2017 Update to the
Coordinated Framework for the Regulation of Biotechnology. 2017;
Available from: https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/update-coordinated-framework-regulation-biotechnology.
4. USEPA. 2022. Cost Analysis For the Final Rule Exempting Certain
Plant-Incorporated Protectants (PIPs) from Registration. Available
at https://www.regulations.gov under Docket ID No. EPA-HQ-OPP-2019-
0508.
5. Mhoswa L., O'Neill M.M., Mphahlele M.M., Oates C.N., Payn K.G.,
Slippers B., Myburg A.A., and Naidoo S. A Genome-Wide Association
Study for Resistance to the Insect Pest Leptocybe invasa in
Eucalyptus grandis Reveals Genomic Regions and Positional Candidate
Defense Genes. Plant and Cell Physiology. 2020. 61(7), pp.1285-96.
6. Jamie, Gabriel A., and Joana I. Meier. The persistence of
polymorphisms across species radiations. Trends in Ecology &
Evolution. 2020. 35(9), pp.795-808.
7. Pesticide Registration (PR) Notice 2011-3. Standard Format for
Data Submitted Under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food,
Drug, and Cosmetic Act (FFDCA), November 2011. Available online at
https://www.epa.gov/sites/default/files/2014-04/documents/pr2011-3.pdf.
8. USEPA Federal Register. 2001. Regulation Under the Federal
Insecticide, Fungicide, and Rodenticide Act for Plant-Incorporated
Protectants (Formerly Plant-Pesticides). 66 FR 37772, July 19, 2001
(FRL-6057-7). Available online at https://archive.epa.gov/pesticides/biopesticides/web/pdf/pip_rule.pdf.
9. Kaiser, N., Douches, D., Dhingra, A., Glenn, K.C., Herzig, P.R.,
Stowe, E.C., and Swarup, S. The role of conventional plant breeding
in ensuring safe levels of naturally occuring toxins in food crops.
Trends in Food Science & Technology. 2020. 100, pp.51-66.
10. Graham, N., Patil, G.B., Bubeck, D.M., Dobert, R.C., Glenn,
K.C., Gutsche, A.T., Kumar, S., Lindbo, J.A., Maas, L., May, G.D.
and Vega-Sanchez, M.E. Plant genome editing and the relevance of
off-target changes. Plant Physiology. 2020. 183(4), pp.1453-1471.
11. Hartl, D.L., A primer of population genetics. 3rd ed. 2000,
Sunderland, MA: Sinauer Associates, Inc.
12. Xu, Y.C., Niu, X.M., Li, X.X., He, W., Chen, J.F., Zou, Y.P.,
Wu, Q., Zhang, Y.E., Busch, W. and Guo, Y.L., 2019. Adaptation and
phenotypic diversification in Arabidopsis through loss-of-function
mutations in protein-coding genes. The Plant Cell, 31(5), pp.1012-
1025.
13. Kaul, S., Koo, H.L., Jenkins, J., Rizzo, M., Rooney, T., Tallon,
L.J., Feldblyum, T., Nierman, W., Benito, M.I., Lin, X. and Town,
C.D., 2000. Analysis of the genome sequence of the flowering plant
Arabidopsis thaliana. Nature, 408(6814), pp.796-815.
14. Oladosu, Y., Rafii, M.Y., Abdullah, N., Hussin, G., Ramli, A.,
Rahim, H.A., Miah, G. and Usman, M., 2016. Principle and application
of plant mutagenesis in crop improvement: a review. Biotechnology &
Biotechnological Equipment, 30(1), pp.1-16.
15. Jankowicz-Cieslak, J., Mba, C. and Till, B.J., 2017. Mutagenesis
for crop breeding and functional genomics. In Biotechnologies for
plant mutation breeding (pp.3-18). Springer, Cham.
16. Duan, P., Xu, J., Zeng, D., Zhang, B., Geng, M., Zhang, G.,
Huang, K., Huang, L., Xu, R., Ge, S. and Qian, Q., 2017. Natural
variation in the promoter of GSE5 contributes to grain size
diversity in rice. Molecular plant, 10(5), pp.685-694.
17. Monroe, J.G., Powell, T., Price, N., Mullen, J.L., Howard, A.,
Evans, K., Lovell, J.T. and McKay, J.K., 2018. Drought adaptation in
Arabidopsis thaliana by extensive genetic loss-of-function. Elife,
7.
18. Bai, Y., Pavan, S., Zheng, Z., Zappel, N.F., Reinst[auml]dler,
A., Lotti, C., De Giovanni, C., Ricciardi, L., Lindhout, P., Visser,
R. and Theres, K., 2008. Naturally occurring broad-spectrum powdery
mildew resistance in a Central American tomato accession is caused
by loss of Mlo function. Molecular Plant-Microbe Interactions,
21(1), pp.30-39.
19. Acevedo[hyphen]Garcia, J., Kusch, S. and Panstruga, R., 2014.
Magical mystery tour: MLO proteins in plant immunity and beyond. New
Phytologist, 204(2), pp.273-281.
20. Van de Wiel, C.C.M., Schaart, J.G., Lotz, L.A.P. and Smulders,
M.J.M. New traits in crops produced by genome editing techniques
based on deletions. Plant biotechnology reports. 2017. 11(1), pp.1-
8.
21. Li, T., Liu, B., Spalding, M.H., Weeks, D.P. and Yang, B., 2012.
High-efficiency TALEN-based gene editing produces disease-resistant
rice. Nature biotechnology, 30(5), pp.390-392.
22. Chandrasekaran, J., Brumin, M., Wolf, D., Leibman, D., Klap, C.,
Pearlsman, M., Sherman, A., Arazi, T. and Gal[hyphen]On, A., 2016.
Development of broad virus resistance in non[hyphen]transgenic
cucumber using CRISPR/Cas9 technology. Molecular plant pathology,
17(7), pp.1140-1153.
23. Reddy A.S.N., Marquez Y., Kalyna M., and Barta A. Complexity of
the alternative splicing landscape in plants. The Plant Cell. 2013.
25(10), pp.3657-83.
24. Roy SW, Irimia M. Intron mis-splicing: no alternative?. Genome
biology. 2008. 9(2), pp.1-3.
25. Merchante, C., Stepanova A. N., and Alonso J. M. Translation
regulation in plants: an interesting past, an exciting present and a
promising future. The Plant Journal. 2017. 90, pp. 628-653.
26. Gordon A.J., Satory D., Halliday J.A., and Herman C. Lost in
transcription: transient errors in information transfer. Current
opinion in microbiology. 2015. 24, pp.80-7.
27. Li L., Nelson C.J., Tr[ouml]sch J., Castleden I., and Huang S.,
Millar A.H. Protein degradation rate in Arabidopsis thaliana leaf
growth and development. The Plant Cell. 2017. 29(2), pp.207-28.
28. Toyama B.H. and Hetzer M.W. Protein homeostasis: live long,
won't prosper. Nature reviews Molecular cell biology. 2013. 14(1),
pp.55-61.
29. Pesticide Registration (PR) Notice 2007-2: Guidance on Small-
Scale Field Testing and Low-level Presence in Food of Plant-
incorporated Protectants (PIPs), April 30, 2007. Available online at
https://www.epa.gov/pesticide-registration/prn-2007-2-guidance-small-scale-field-testing-and-low-level-presence-food.
30. USEPA. Supporting Statement for the Information Collection
Request (ICR) entitled: Exemptions of Certain Plant-Incorporated
Protectants (PIPs) Derived from Newer Technologies Rulemaking (Final
Rule; RIN 2070-AK54). EPA ICR No.: 2619.02; OMB Control No. 2070-
0214. (May 2023).

VIII. FIFRA Review Requirements

    Pursuant to FIFRA section 25(a), EPA submitted the draft final rule
to the United States Department of Agriculture (USDA) for review, with
a copy sent to the appropriate Congressional Committees as required
under FIFRA section 25(a). The Agency did not receive any comments from
USDA.
    In accordance with FIFRA section 25(d), the EPA asked the FIFRA
Scientific Advisory Panel (SAP) to waive review of the draft final
rule, as was done for the draft proposed rule. The FIFRA SAP waived its
scientific review of the draft final rule on October 12, 2022, because
the rule does not raise scientific or science policy issues that
warrant a scientific review by the SAP.

IX. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Orders 12866: Regulatory Planning and Review and 14094:
Modernizing Regulatory Review

    This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review under Executive
Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive
Order 14094 (88 FR 21879, April 11, 2023). Any changes made in response
to OMB recommendations during that review have been documented in the
docket. EPA prepared an analysis of the potential costs and benefits
associated with this action (Ref. 4) which is summarized in more detail
in Unit I.E., and included in the docket.

B. Paperwork Reduction Act (PRA)

    The information collection activities in this rule have been
submitted for approval to OMB under the PRA, 44 U.S.C. 3501 et seq. The
Information Collection Request (ICR) document that EPA prepared is
assigned EPA ICR No. 2619.02 (Ref. 30), and identified by OMB Control
No. 2070-0214. You can find a copy of the ICR in the docket for this
rule, and it is briefly summarized here. The information collection
requirements are not enforceable until OMB approves them.
    The information collection activities in this rule are associated
with the exemption eligibility process (i.e., self-determination,
request for EPA confirmation, and associated recordkeeping) established
in this rule as an alternative to the existing pesticide registration
and tolerance activities that are currently approved by OMB under OMB
Control No. 2070-0060 (EPA ICR No. 0277.23), OMB Control No. 2070-0142
(EPA ICR No. 1693.10), OMB Control No. 2070-0028 (EPA ICR No. 0143.13,
and OMB Control No. 2070-0024 (EPA ICR No. 0597.13). Once this ICR is
approved, EPA intends to amend the ICR approved by OMB under OMB
Control No. 2070-0060 (EPA ICR No. 0277.23) to incorporate the
information collection activities and burden attributable to this rule.
    Respondents/affected entities: See Unit I.A.
    Respondent's obligation to respond: Required to obtain the
exemption (40 CFR part 174).
    Frequency of response: On occasion.
    Total estimated number of respondents: 10.
    Total estimated number of responses: 10 (per year), which reflects
an estimate of 1 response per respondent each year. The ICR accounts
for the most conservative burden estimate, which the Agency projects
will be up to 10 submissions per year.
    Total estimated burden: 850 hours (per year), which reflects an
approximate burden of 85 hours per submission. Burden is defined at 5
CFR 1320.3(b).
    Total estimated cost: $125,800 (per year), includes $0 annualized
capital or operation and maintenance costs.
    An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for EPA's
regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves
this ICR, the Agency will announce that approval in the Federal
Register and publish a technical amendment to 40 CFR part 9 to display
the OMB control number for the approved information collection
activities contained in this final rule.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA, 5
U.S.C. 601 et seq. In making this determination, EPA concludes that the
impact of concern for this rule is any significant adverse economic
impact on small entities and that the Agency is certifying that this
rule will not have a significant economic impact on a substantial
number of small entities because the rule relieves regulatory burden on
the small entities subject to the rule. The rule is expected to reduce
costs to developers of ``PIPs created through genetic engineering from
a sexually compatible plant'' and ``loss-of-function PIPs,'' and the
cost savings per product are approximately $472,000-$886,000. The cost
savings per product will be realized when the developer submits a
letter of self-determination or requests EPA confirmation, as
applicable. The exemption for ``PIPs created through genetic
engineering from a sexually compatible plant'' and ``loss-of-function
PIPs'' reduces the costs associated with meeting regulatory
requirements for these types of PIPs and therefore removes a potential
barrier to market entry for small entities. Of the entities likely to
develop PIPs that meet the exemptions outlined in this rulemaking, EPA
currently estimates that approximately 80% are small entities.
    I have therefore concluded that this action will relieve regulatory
burden for all directly regulated small entities. The basis for this
determination is presented in the small entity analysis prepared as
part of the cost analysis for this rulemaking (Ref. 4), which is
summarized in Unit I.E., and a copy is available in the docket.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. This action is not
expected to impose an enforceable duty on any State, local or Tribal
governments, and the requirements imposed on the private sector are not
expected to result in annual expenditures of $100 million or more.
Accordingly, EPA has determined that the requirements of sections 202,
203, or 205 do not apply to this action.

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999), because it will
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.
Thus, Executive Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have Tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it will
not have substantial direct effects on Tribal governments, on the
relationship

between the Federal Government and the Indian Tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian Tribes. Thus, Executive Order 13175 does not
apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997)
as applying to those regulatory actions that concern environmental
health or safety risks that the EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order. This
action is not subject to Executive Order 13045 because it does not
concern an environmental health risk or safety risk.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not a ``significant energy action'' as defined in
Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not
likely to have a significant adverse effect on the supply, distribution
or use of energy and has not otherwise been designated as a significant
energy action by the Administrator of the Office of Information and
Regulatory Affairs.

I. National Technology Transfer Advancement Act (NTTAA)

    This action does not involve technical standards that would require
Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations and Low-
Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) directs
Federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations (people of color and/or indigenous
peoples) and low-income populations.
    EPA believes that this type of action does not concern human health
or environmental conditions and therefore cannot be evaluated with
respect to potentially disproportionate and adverse effects on people
of color, low-income populations and/or indigenous peoples. Although
this action does not concern human health or environmental conditions,
EPA considered potential environmental justice concerns during the
development of the proposed rule, sought comments specifically on this
point with regard to the proposed exemptions, and finds that this
action will not result in disproportionately high and adverse human
health, environmental, climate-related, or other cumulative impacts on
disadvantaged communities.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).

L. Executive Orders 13874: Modernizing the Regulatory Framework for
Agricultural Biotechnology Products and 14801: Advancing Biotechnology
and Biomanufacturing Innovation for a Sustainable, Safe, and Secure
American Bioeconomy

    This action is intended to further implement section 4(b) of
Executive Order 13874 (84 FR 27899, June 11, 2019), and section 8 of
Executive Order 14801 (87 FR 56849, September 12, 2022). This final
rule may promote future innovation and competitiveness by efficiently
exempting through regulation qualifying ``PIPs created through genetic
engineering from a sexually compatible plant'' and ``loss-of-function
PIPs'' that meet the FIFRA and FFDCA standards for exemption.

List of Subjects in 40 CFR Part 174

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Plant-incorporated
protectants, Reporting and recordkeeping requirements.

Michael S. Regan,
Administrator.

    Therefore, for the reasons stated in the preamble, 40 CFR part 174
is amended as follows:

PART 174--PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED
PROTECTANTS

0
1. The authority citation for part 174 continues to read as follows:

    Authority:  7 U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371.

0
2. Amend Sec.  174.3 by adding in alphabetical order definitions for
``Gene'', ``Genetic engineering'', ``Loss-of-function plant-
incorporated protectant'', ``Native allele'', and ``Native gene'' and
revising the definition of ``Sexually compatible'' to read as follows:

Sec.  174.3  Definitions.

* * * * *
    Gene, and other grammatical variants such as ``genic,'' means a
unit of heritable genetic material that is comprised of the genetic
material necessary for the production of a substance.
    Genetic engineering means the modification of the genome of an
organism using recombinant, synthesized, or amplified nucleic acids or
other techniques excluded from the definition of conventional breeding.
* * * * *
    Loss-of-function plant-incorporated protectant means a plant-
incorporated protectant in which the genetic material of a native gene
is modified to result in a pesticidal effect through the reduction or
elimination of the activity of that gene. For purposes of loss-of-
function plant-incorporated protectants, the active ingredient and
pesticidal substance are one and the same and are defined as the
genetic material that has been modified to create the pesticidal trait
(i.e., modification of the sequence of nucleic acids). Loss-of-function
plant-incorporated protectants do not include instances where the
reduction or elimination of the activity of the modified native gene
results in the intentional increase of activity of another pesticidal
gene.
    Native allele means a variant of a native gene that is identified
in the genetic diversity of plants sexually compatible with the
recipient plant.
    Native gene means a gene that is identified in the recipient plant
or source plants that are sexually compatible with the recipient plant.
It does not include genes introduced through genetic engineering from a
source organism that is not sexually compatible with the source plant.
* * * * *
    Sexually compatible, when referring to plants, means plants must be
capable of forming a viable zygote through the union of two gametes
through conventional breeding.
* * * * *

0
3. Revise Sec.  174.21 to read as follows:

Sec.  174.21  General qualifications for exemptions.

    A plant-incorporated protectant is exempt from the requirements of
FIFRA, other than the requirements of Sec.  174.71,

if it meets the exemption criteria in paragraphs (a) through (d) of
this section. Plant-incorporated protectants that are not exempt from
the requirements of FIFRA under this subpart are subject to all the
requirements of FIFRA.
    (a) The active ingredient of the plant-incorporated protectant
meets the exemption criteria listed in at least one of the sections in
Sec. Sec.  174.25 through 174.50.
    (b) When the plant-incorporated protectant is intended to be
produced and used in a crop used as food, the residues of the active
ingredient of the plant-incorporated protectant are either exempted
from the requirement of a tolerance under FFDCA (21 U.S.C. 321 et seq.)
as listed in subpart W of this part, or no tolerance would otherwise be
required.
    (c) Any inert ingredient that is part of the plant-incorporated
protectant is listed as an approved inert ingredient in subpart X of
this part.
    (d) For plant-incorporated protectants listed in the subparagraphs
below, the exemption applies only if the developer is compliant with
the general recordkeeping requirements specified in Sec.  174.73 per
sections 8 and 9 of FIFRA, 7 U.S.C. 136f and 136g, and only after
compliance with the relevant eligibility determination procedures
specified in Sec.  174.90:
    (1) Plant-incorporated protectant created through genetic
engineering from a sexually compatible plant.
    (2) Loss-of-function plant-incorporated protectant.

0
4. Amend Sec.  174.25 by revising the section heading and the
introductory text and adding paragraph (c) to read as follows:

Sec.  174.25  Active ingredient of a plant-incorporated protectant from
a sexually compatible plant created through conventional breeding.

    The active ingredient is exempt if all of the following conditions
are met:
* * * * *
    (c) The genetic material is transferred from the source plant to
the recipient plant only through conventional breeding.

0
5. Add Sec.  174.26 to subpart B to read as follows:

Sec.  174.26  Active ingredient of a plant-incorporated protectant
created through genetic engineering from a sexually compatible plant.

    The active ingredient is exempt if the conditions in paragraphs (a)
and (b) of this section are met.
    (a) The active ingredient is characteristic of the population of
plants sexually compatible with the recipient plant and is created
through genetic engineering from either an insertion of a native gene
into the recipient plant as specified in paragraph (a)(1) of this
section or a modification of an existing native gene in the recipient
plant as specified in paragraph (a)(2) of this section.
    (1) Insertion. A native gene is inserted into the genome of the
recipient plant and produces a pesticidal substance identical in
sequence to the pesticidal substance identified in the source plant.
The regulatory regions inserted as part of the native gene must be
identical in nucleic acid sequence to those regulatory regions of the
native gene identified in the source plant.
    (2) Modification. The existing native gene is modified to match
corresponding polymorphic sequence(s) in a native allele of that gene
using a single source plant as a template.
    (b) This exemption does not apply until the requirements in Sec.
174.21(d) have been met.

0
6. Add Sec.  174.27 to subpart B to read as follows:

Sec.  174.27  Active ingredient of a loss-of-function plant-
incorporated protectant.

    The active ingredient is exempt if the following conditions are
met:
    (a) The genetic material of a native gene is modified using genetic
engineering to result in a pesticidal effect through the reduction or
elimination of the activity of that gene; and
    (b) This exemption does not apply until the requirements in Sec.
174.21(d) have been met.

0
7. Add Sec.  174.73 to subpart D to read as follows:

Sec.  174.73  General recordkeeping requirements for exemptions.

    For 5 years, starting with the effective date of a plant-
incorporated protectant exemption, any person who is required to submit
documentation for the determination of eligibility for a plant-
incorporated protectant listed under Sec.  174.21(d) must do both of
the following:
    (a) Maintain documentation of either the request for EPA
confirmation or the letter of self-determination (or both, if
applicable) along with all supporting documentation for the specific
exemption listed in subpart E of this part.
    (b) Make the documentation outlined in paragraph (a) of this
section available to EPA upon request.

0
8. Add subpart E to read as follows:
Subpart E--Exemption Eligibility Determination Process and Requirements
Sec.
174.90 Determining eligibility.
174.91 Submitting a letter of self-determination.
174.93 Requesting EPA confirmation.
174.95 Documentation for an exemption for a plant-incorporated
protectant created through genetic engineering from a sexually
compatible plant.
174.96 Documentation for an exemption for a loss-of-function plant-
incorporated protectant.

Subpart E--Exemption Eligibility Determination Process and
Requirements

Sec.  174.90  Determining eligibility.

    (a) Options for determining eligibility. As required in Sec. Sec.
174.21(d) and 174.541(c), the developer must notify EPA to be eligible
for exemption. Available notification options differ by plant-
incorporated protectant. The developer must do at least one of the
following:
    (1) EPA confirmation. Unless permitted in paragraph (a)(2) of this
section, a developer must submit a request for EPA confirmation of
eligibility in accordance with Sec.  174.93. Any developer may submit a
request for EPA confirmation of eligibility in accordance with Sec.
174.93.
    (2) Self-determination. A developer may submit a letter of self-
determination in accordance with Sec.  174.91 if the plant-incorporated
protectant qualifies for exemption as one of the following:
    (i) A loss-of-function plant-incorporated protectant eligible for
exemption under Sec.  174.27.
    (ii) [Reserved]
    (b) Where to submit a request for EPA confirmation or letter of
self-determination. A request for EPA confirmation of eligibility or a
letter of self-determination must be submitted electronically.
    (c) Claims of confidentiality. Any claims of confidentiality for
information submitted in the request for EPA confirmation or a letter
of self-determination must be made in accordance with the procedures
outlined in Sec.  174.9.
    (d) Overlapping determinations of eligibility. If a plant-
incorporated protectant is eligible for a self-determination option, a
developer may elect to submit a letter of self-determination as well as
a request for EPA confirmation of eligibility concurrently or at a
later time. If the developer so elects, the letter of self-
determination will remain in effect while EPA evaluates the request for
confirmation of eligibility.

    (e) Revisiting eligibility determination. If, at any time after EPA
issues a confirmation of eligibility or the letter of self-
determination is submitted, EPA becomes aware of information indicating
that a plant-incorporated protectant no longer meets the criteria for
exemption (e.g., adverse effects reports submitted under Sec.  174.71)
or that the self-determination was incorrect, EPA will generally notify
the submitter in writing of EPA's intention to initiate a review of
eligibility for exemption and may request additional information from
the submitter in order to evaluate that eligibility for exemption. Upon
conclusion of its review, EPA will notify the submitter in writing of
its determination as to whether the plant-incorporated protectant meets
the exemption criteria and any actions that will be required should the
plant-incorporated protectant be found to not meet the exemption
criteria. Under those circumstances, the plant-incorporated protectant
may be considered to be noncompliant with FIFRA and subject to possible
enforcement by EPA. At any time, if EPA finds or has reason to believe
that a plant-incorporated protectant's non-compliance with FIFRA
requires immediate action, EPA may take such action, including
enforcement, without first informing the submitter of an eligibility
review.
    (f) Extension of exemption. An exemption can be extended in one of
two ways. First, if the exempted plant-incorporated protectant is moved
through conventional breeding to other plants, the exemption is
extended to the subsequent plant-incorporated protectant. Second, to
extend the exemption of the plant-incorporated protectant to subsequent
genetic engineering events in other plants, the following exemption-
specific criteria apply:
    (1) Plant-incorporated protectant created through genetic
engineering from a sexually compatible plant. An exemption extends to a
plant-incorporated protectant when that plant-incorporated protectant
is genetically engineered by the submitter into another variety of that
same plant species, the substance produced is identical to the
substance produced in the original recipient plant, and no new
modifications were made to the regulatory regions.
    (2) Loss of function plant-incorporated protectant. An exemption
extends to a plant-incorporated protectant when that plant-incorporated
protectant is genetically engineered by the submitter into another
variety of that same plant species and the same native gene is targeted
to create the loss-of-function PIP.
    (g) No duplication necessary. A developer is not required to submit
duplicative requests for eligibility determination or self-
determination under both Sec. Sec.  174.541(c) and 174.21(d), if it has
already been submitted for purposes of determining eligibility under
Sec.  174.21(d).

Sec.  174.91  Submitting a letter of self-determination.

    To self-determine eligibility for the exemption of a plant-
incorporated protectant listed under Sec.  174.90(a)(2), a developer
must comply with all of the following requirements.
    (a) When to submit a letter of self-determination. A letter of
self-determination for an exemption must be submitted to EPA prior to
engaging in any activity that would be subject to FIFRA absent an
exemption.
    (b) Contents of a letter of self-determination. The letter of self-
determination must:
    (1) Provide the name and contact information for the submitter
(including telephone number and email address), company name, or other
affiliation.
    (2) Identify the plant-incorporated protectant by providing: the
identity of the recipient plant (genus and species), a unique
identifier for the native gene from the National Center for
Biotechnology Information (NCBI) at the National Library of Medicine of
the National Institutes of Health (NLM) at the National Institutes of
Health (NIH) (i.e., Entrez GeneID), the trait type (e.g., insect
resistance), and cite the paragraph under Sec.  174.90(a)(2) that
indicates that the plant-incorporated protectant is eligible for self-
determination.
    (3) Complete and submit the certification statement provided in the
electronic submission portal. The statement must be dated and signed by
the certifying official identified in the certification statement.
    (c) EPA response. EPA will provide electronic confirmation of
receipt immediately. Electronic confirmation of receipt shall be
equivalent to written confirmation of receipt.
    (d) Effective date of exemption. The exemption does not apply until
EPA confirms receipt of the letter of self-determination.

Sec.  174.93  Requesting EPA confirmation.

    To request EPA confirmation of eligibility for exemption of a
plant-incorporated protectant listed under Sec.  174.21(d), a developer
must comply with all of the following requirements.
    (a) When to submit a request for EPA confirmation. Unless the
developer has received confirmation of receipt of a letter of self-
determination, the request for EPA confirmation must be submitted prior
to engaging in any activity that would be subject to FIFRA absent an
exemption.
    (b) Contents of a request for EPA confirmation of exemption
eligibility. The request must contain information as specified in Sec.
174.91(b) and supporting documentation, as specified in exemption-
specific sections of this subpart (e.g., Sec.  174.95).
    (c) EPA review and response. Upon receipt of a request, EPA will
review and evaluate the information provided to determine whether the
plant-incorporated protectant meets the exemption criteria in Sec.
174.21. EPA may require additional information to assess whether a
plant-incorporated protectant meets the criteria for exemption. EPA
will notify the submitter in writing of its determination. If EPA
determines that the plant-incorporated protectant does not meet the
criteria for exemption, EPA will notify the submitter in writing of any
actions that will be required.
    (d) Effective date of exemption. If the plant-incorporated
protectant is not already exempt pursuant to the self-determination
process under Sec.  174.91, this exemption applies once EPA notifies
the submitter in writing, confirming that the plant-incorporated
protectant meets the criteria for exemption.

Sec.  174.95  Documentation for an exemption for a plant-incorporated
protectant created through genetic engineering from a sexually
compatible plant.

    A developer requesting EPA confirmation of exemption eligibility
for a plant-incorporated protectant created through genetic engineering
from a sexually compatible plant pursuant to Sec.  174.93 must submit
the information in the following paragraphs to EPA. The following
documentation must be maintained by a developer of a plant-incorporated
protectant created through genetic engineering from a sexually
compatible plant per Sec.  174.73:
    (a) Biology of the plant. (1) The identity of the recipient plant,
including genus and species.
    (2) If the plant-incorporated protectant was derived from a plant
species other than the recipient plant species, provide the identity of
the source plant including genus and species and information to support
the determination that the recipient plant and the source plant are
sexually compatible (e.g., through peer-reviewed literature rationale).
    (b) Description of the pesticidal trait and how the trait was
engineered into

the plant. Include a description of the measures that were taken to
ensure that no engineering components (e.g., Cas proteins) are present
in the final plant product and the measures taken to maximize the
likelihood that the modification to the recipient plant is limited to
the intended modification.
    (c) Molecular characterization of the plant-incorporated
protectant. A nucleic acid sequence comparison of the plant-
incorporated protectant between the recipient plant and the
comparator(s). A deduced amino acid sequence comparison is additionally
required when the pesticidal substance is proteinaceous. The relevant
comparator(s) for the sequence comparison(s) are determined by the type
of modification:
    (1) For Sec.  174.26(a)(1), sequences in the source plant and in
the recipient plant.
    (2) For Sec.  174.26(a)(2), sequences in the recipient plant before
the modification, after the modification, and the sequence in the
source plant. The polymorphic site(s) must be indicated.
    (d) Information on the history of safe use of the plant-
incorporated protectant. (1) If the pesticidal substance is a known
allergen or mammalian toxin/toxicant (e.g., solanine), describe how
conventional breeding practices are being used to ensure that it does
not exceed human dietary safety levels in the recipient food plant
(i.e., ensure residues of pesticidal substance are not present in food
at levels that are injurious or deleterious and are within the ranges
of levels generally seen in plant varieties currently on the market
and/or known to produce food safe for consumption).
    (2) If the source plant is a wild relative of the recipient plant,
describe why the plant-incorporated protectant is not anticipated to
pose a hazard to humans or the environment (e.g., Are levels of the
pesticidal substance produced in the recipient plant within the ranges
of levels generally seen in plant varieties currently on the market
and/or known to produce food safe for consumption? Is the pesticidal
mode of action non-toxic? Does the plant-incorporated protectant lack
sequence similarity to known mammalian toxins, toxicants, or allergens?
Is the plant-incorporated protectant a commonly screened substance and
therefore familiar to plant breeders?).

Sec.  174.96  Documentation for an exemption for a loss-of-function
plant-incorporated protectant.

    A developer requesting EPA confirmation of exemption eligibility
for a loss-of-function plant-incorporated protectant pursuant to Sec.
174.93 must submit the information in the following paragraphs to EPA
along with the developer's request for exemption confirmation. The
following documentation must be maintained by a developer of a loss-of-
function plant-incorporated protectant per Sec.  174.73:
    (a) Biology of the plant: The identity of the recipient plant,
including genus and species.
    (b) Description of the pesticidal trait that results from the loss-
of-function and how the trait was engineered into the plant. Include a
description of the steps that were taken to ensure that no engineering
components (e.g., Cas proteins) remain in the plant and the measures
taken to maximize the likelihood that the modification to the recipient
plant is limited to the intended modification.

0
9. Amend Sec.  174.508 by:
0
a. Revising the section heading and introductory text;
0
b. Redesignating paragraph (c) as paragraph (d); and
0
c. Adding a new paragraph (c).
    These revisions and addition read as follows:

Sec.  174.508  Pesticidal substance of a plant-incorporated protectant
from a sexually compatible plant created through conventional breeding;
exemption from the requirement of a tolerance.

    Residues of a pesticidal substance are exempt from the requirement
of a tolerance if all the following conditions are met:
* * * * *
    (c) The genetic material is transferred from the source plant to
the recipient plant only through conventional breeding.
* * * * *

0
10. Add Sec.  174.541 to read as follows:

Sec.  174.541  Pesticidal substance of a plant-incorporated protectant
created through genetic engineering from a sexually compatible plant;
exemption from the requirement of a tolerance.

    Residues of a pesticidal substance are exempt from the requirements
of a tolerance if the conditions in paragraphs (a) through (c) of this
section are met.
    (a) The pesticidal substance is characteristic of the population of
plants sexually compatible with the recipient food plant and is created
through genetic engineering from either an insertion of a native gene
into the recipient food plant as specified in paragraph (a)(1) of this
section or a modification of an existing native gene in the recipient
food plant as specified in paragraph (a)(2) of this section.
    (1) Insertion. A native gene is inserted into the genome of the
recipient food plant and produces a pesticidal substance identical in
sequence to the pesticidal substance identified in the source plant.
The regulatory regions inserted as part of the native gene must be
identical in nucleic acid sequence to those regulatory regions of the
native gene identified in the source plant.
    (2) Modification. The existing native gene is modified to match
corresponding polymorphic sequence(s) in a native allele of that gene
using a single source plant as a template.
    (b) The residues of the pesticidal substance are not present in
food from the plant at levels that are injurious or deleterious to
human health.
    (c) This exemption does not apply until the requirements in Sec.
174.90 have been met.

[FR Doc. 2023-11477 Filed 5-30-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Page 63185]
[FR Doc No: 2013-24841]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9901-74-Region 5]

Public Hearing and Request for Comments on Proposed Revisions to
Michigan's Clean Water Act (CWA) Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed revisions to Michigan's CWA Section 404
program, public hearing and request for comments.

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SUMMARY: EPA requests comments on proposed revisions to Michigan's CWA
Section 404 permitting program resulting from the recent enactment of
Michigan Public Act 98 (PA 98). EPA will hold a public hearing in
Lansing, Michigan, on December 11, 2013, to take comments on the
proposed program revisions. Under Section 404 of the CWA, permits are
required for activities involving discharges of dredged or fill
material to waters of the United States, including wetlands, lakes and
streams. In 1984, Michigan assumed Section 404 permitting authority for
its inland waters and wetlands. PA 98 amended the wetlands and the
inland lakes and streams provisions of the Michigan's Natural Resources
and Environmental Protection Act to address areas, as identified by EPA
in a 2008 program review, where the state's Section 404 program did not
comply with CWA requirements. In addition to changes to address issues
identified in EPA's program review, PA 98 included: (1) Changes to the
definition of contiguous wetlands regulated by Michigan's Section 404
program; (2) the addition of new exemptions from permitting; and (3)
changes to the requirements for mitigating the effects of filling
wetlands and other waters of the United States. Under federal
regulations, substantial changes to state CWA Section 404 programs do
not become effective until program revisions are approved by EPA.
Information about PA 98, the resulting proposed revisions to Michigan's
Section 404 program, the public hearing, and procedures for submitting
comments is available at: www.regulations.gov/ (insert: EPA-HQ-OW-2013-
0710 in the search field).

DATES and LOCATION: On December 11, 2013, at 7:00 p.m. EST, EPA will
hold a public hearing to take oral and written comments at the Crowne
Plaza Lansing West (formerly known as the Lexington Lansing Hotel), 925
South Creyts Road, Lansing, Michigan 48917. The formal hearing will be
preceded by an informational session at 6:00 p.m. EST. Written comments
will also be accepted until December 18, 2013.

ADDRESSES: Submit comments, referencing Docket ID No. EPA-HQ-OW-2013-
0710, online using www.regulations.gov (the preferred method); by email
to<EMAIL_ADDRESS>or by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460. All comments received will be included in the
public docket without change, including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information, or other information
whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: For further information, call toll-
free,<PHONE_NUMBER>, weekdays, 8:30 a.m. to 4:30 p.m., central time, or
contact Sue Elston, at the EPA Docket Center address noted above.

    Dated: September 27, 2013.
Timothy C. Henry,
Acting Director, Water Division, EPA Region 5.
[FR Doc. 2013-24841 Filed 10-22-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)]
[Notices]
[Pages 91159-91160]
[FR Doc No: 2016-30207]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-487-000]

Northern Natural Gas Company; Notice of Availability of the
Environmental Assessment for the Proposed Cedar Station Upgrade Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared an environmental assessment (EA) for the Cedar
Station Upgrade Project, proposed by Northern Natural Gas Company
(Northern) in the above-referenced docket. Northern requests
authorization to construct approximately 7.86 miles of natural gas
pipeline in Dakota County, Minnesota in order to fulfill its
contractual obligation with Northern States Power Company, a Minnesota
Corporation (NSP-MN) to increase the delivery pressure to NSP-MN's
existing Black Dog Generating Station from 400 pounds per square inch
gauge (psig) to 650 psig. As part of NSP-MN's process

of reducing its carbon footprint, it has increased its use of natural
gas-fired generation.
    The EA assesses the potential environmental effects of the
construction and operation of the Cedar Station Upgrade Project in
accordance with the requirements of the National Environmental Policy
Act (NEPA). The FERC staff concludes that approval of the proposed
project, with appropriate mitigating measures, would not constitute a
major federal action significantly affecting the quality of the human
environment.
    The Cedar Station Upgrade Project includes the following
facilities:
     Approximately 7.86 miles of new 20-inch-diameter pipeline
loop; \1\
---------------------------------------------------------------------------

    \1\ A pipeline ``loop'' is a segment of pipe installed adjacent
to an existing pipeline and connected to the existing pipeline at
both ends.
---------------------------------------------------------------------------

     a new pig \2\ launcher and takeoff valve setting at
Northern's existing Rosemount Junction facility; and
---------------------------------------------------------------------------

    \2\ A ``pig'' is an internal pipeline tool used to clean a
pipeline and/or to inspect for damage or corrosion.
---------------------------------------------------------------------------

     a new pig receiver, tie-in valve setting, and modification
of existing regulators and piping at Northern's existing Cedar Meter
Station facility.
    The FERC staff mailed copies of the EA to federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes;
potentially affected landowners and other interested individuals and
groups; and newspapers and libraries in the project area. In addition,
the EA is available for public viewing on the FERC's Web site
(www.ferc.gov) using the eLibrary link. A limited number of copies of
the EA are available for distribution and public inspection at: Federal
Energy Regulatory Commission, Public Reference Room, 888 First Street
NE., Room 2A, Washington, DC 20426,<PHONE_NUMBER>.
    Any person wishing to comment on the EA may do so. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
The more specific your comments, the more useful they will be. To
ensure that the Commission has the opportunity to consider your
comments prior to making its decision on this project, it is important
that we receive your comments in Washington, DC on or before January 9,
2017.
    For your convenience, there are three methods you can use to file
your comments to the Commission. In all instances, please reference the
project docket number (CP16-487-000) with your submission. The
Commission encourages electronic filing of comments and has expert
staff available to assist you at<PHONE_NUMBER> or<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can also file your comments electronically using the
eFiling feature on the Commission's Web site (www.ferc.gov) under the
link to Documents and Filings. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (18 CFR 385.214).\3\ Only intervenors have the
right to seek rehearing of the Commission's decision. The Commission
grants affected landowners and others with environmental concerns
intervenor status upon showing good cause by stating that they have a
clear and direct interest in this proceeding which no other party can
adequately represent. Simply filing environmental comments will not
give you intervenor status, but you do not need intervenor status to
have your comments considered.
---------------------------------------------------------------------------

    \3\ See the previous discussion on the methods for filing
comments.
---------------------------------------------------------------------------

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search,'' and enter the docket number
excluding the last three digits in the Docket Number field (i.e., CP16-
487). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: December 9, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-30207 Filed 12-15-16; 8:45 am]
 BILLING CODE 6717-01-P


persons to generate, maintain, or disclose or provide information to or
for a Federal agency. This includes the time needed to review
instructions; develop, acquire, install, and use technology and systems
for the purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to
respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose information. An agency may not conduct or sponsor, and a person
is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. The OMB control number
for EPA’s regulations are listed at 40 CFR Part 9 and 48 CFR Chapter
15.

To comment on EPA’s need for this information, the accuracy of the
provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
the Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OW-2007-0142, which is available for public viewing at the
Water Docket in the EPA Docket Center (EPA/DC), EPA West, Room B102,
1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Reading Room is
202-566-1744, and the telephone number for the Water Docket is
202-566-2426. An electronic version of the public docket is available
through the Federal Docket Management System (FDMS) at
http://www.regulations.gov/. Use FDMS to submit or view public comments,
to access the index listing of the contents of the public docket, and to
access documents in the public docket that are available electronically.
Once in the system, key in the docket ID number identified above. You
can also send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, DC 20503, Attention: Desk Office for EPA. Please include the
EPA Docket ID No. OW-2007-0142 and OMB control number 2040-0257 in any
correspondence.

June 2010	 PAGE  ii


[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Rules and Regulations]
[Pages 56762-56764]
[FR Doc No: 2012-22237]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30861; Amdt. No. 3496]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are

needed because of the adoption of new or revised criteria, or because
of changes occurring in the National Airspace System, such as the
commissioning of new navigational facilities, adding new obstacles, or
changing air traffic requirements. These changes are designed to
provide safe and efficient use of the navigable airspace and to promote
safe flight operations under instrument flight rules at the affected
airports.

DATES: This rule is effective September 14, 2012. The compliance date
for each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of September 14, 2012.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:
    For examination--
    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    Availability_All SIAPs are available online free of charge. Visit
nfdc.faa.gov to register. Additionally, individual SIAP and Takeoff
Minimums and ODP copies may be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Richard A. Dunham III, Flight
Procedure Standards Branch (AFS-420) Flight Technologies and Programs
Division, Flight Standards Service, Federal Aviation Administration,
Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and
Sec.  97.20 of Title 14 of the Code of Federal Regulations.
    The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained in FAA form documents is
unnecessary. This amendment provides the affected CFR sections and
specifies the types of SIAP and the corresponding effective dates. This
amendment also identifies the airport and its location, the procedure
and the amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP as amended in the transmittal. For safety and
timeliness of change considerations, this amendment incorporates only
specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
    The SIAPs, as modified by FDC P-NOTAM, and contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these changes to
SIAPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts. The circumstances which created the need for all
these SIAP amendments requires making them effective in less than 30
days.
    Because of the close and immediate relationship between these SIAPs
and safety in air commerce, I find that notice and public procedure
before adopting these SIAPs are impracticable and contrary to the
public interest and, where applicable, that good cause exists for
making these SIAPs effective in less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference, and
Navigation (Air).

    Issued in Washington, DC, on August 31, 2012.
Ray Towles,
Deputy Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal regulations, Part 97, 14 CFR part 97, is amended by
amending Standard Instrument Approach Procedures, effective at 0901 UTC
on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

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1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

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2. Part 97 is amended to read as follows:

Sec. Sec.  97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35  [Amended]

    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

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       AIRAC date             State             City               Airport          FDC No.      FDC date                      Subject
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18-Oct-12...............  CA            Fresno.............  Fresno Chandler           2/0072     08/28/12  GPS RWY 30, Orig-B.
                                                              Executive.
18-Oct-12...............  CA            Fresno.............  Fresno Chandler           2/0073     08/28/12  NDB OR GPS B, Amdt 7B.
                                                              Executive.
18-Oct-12...............  MS            Greenville.........  Mid Delta Rgnl.....       2/2969     08/28/12  ILS OR LOC RWY 18L, Amdt 9E.
18-Oct-12...............  MS            Greenville.........  Mid Delta Rgnl.....       2/2983     08/28/12  RNAV (GPS) RWY 18L, Orig.
18-Oct-12...............  PA            Philadelphia.......  Philadelphia Intl..       2/3006     08/28/12  RNAV (RNP) Z RWY 9R, Orig-A.
18-Oct-12...............  PA            Philadelphia.......  Philadelphia Intl..       2/3007     08/28/12  RNAV (RNP) Z RWY 9L, Orig-A.
18-Oct-12...............  NM            Truth Or             Truth Or                  2/4949     08/28/12  VOR A, Amdt 9B.
                                         Consequences.        Consequences Muni.
18-Oct-12...............  MO            St Louis...........  Lambert-St Louis          2/4950     08/28/12  ILS OR LOC RWY 6, Amdt 1D.
                                                              Intl.
18-Oct-12...............  NM            Silver City........  Grant County.......       2/6726     08/28/12  RNAV (GPS) RWY 26, Orig.
18-Oct-12...............  AZ            Safford............  Safford Rgnl.......       2/8256     08/28/12  RNAV (GPS) RWY 12, Orig.
18-Oct-12...............  OK            Ardmore............  Ardmore Downtown          2/8543     08/28/12  RNAV (GPS) RWY 35, Orig.
                                                              Executive.
18-Oct-12...............  OK            Ardmore............  Ardmore Downtown          2/8545     08/28/12  RNAV (GPS) RWY 17, Orig.
                                                              Executive.
18-Oct-12...............  IA            Sioux City.........  Sioux Gateway/Col.        2/8554     08/28/12  NDB RWY 13, Amdt 15D.
                                                              Bud Day Field.
18-Oct-12...............  TX            Lubbock............  Lubbock Preston           2/8555     08/28/12  LOC BC RWY 35L, Amdt 18B.
                                                              Smith Intl.
18-Oct-12...............  TX            Center.............  Center Muni........       2/8556     08/28/12  RNAV (GPS) RWY 17, Orig.
18-Oct-12...............  TX            Lubbock............  Lubbock Preston           2/8581     08/28/12  VOR A, Amdt 6B.
                                                              Smith Intl.
18-Oct-12...............  LA            Houma..............  Houma-Terrebonne...       2/8629     08/28/12  VOR RWY 12, Amdt 5C.
18-Oct-12...............  OK            Stillwater.........  Stillwater Rgnl....       2/8630     08/28/12  ILS OR LOC RWY 17, Amdt 2.
18-Oct-12...............  OH            Bellefontaine......  Bellefontaine Rgnl.       2/8635     08/28/12  TAKEOFF MINIMUMS AND (OBSTACLE) DP, Orig.
18-Oct-12...............  MO            Kansas City........  Charles B. Wheeler        2/9138     08/28/12  RNAV (GPS) RWY 19, Orig.
                                                              Downtown.
18-Oct-12...............  MO            Kansas City........  Charles B. Wheeler        2/9139     08/28/12  RNAV (GPS) RWY 21, Amdt 1.
                                                              Downtown.
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[FR Doc. 2012-22237 Filed 9-13-12; 8:45 am]
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