[Federal Register: December 23, 2009 (Volume 74, Number 245)]
[Rules and Regulations]
[Page 68162-68168]
[DOCID:fr23de09-13]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0126; FRL-8804-1]

Bifenazate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues
of bifenazate (1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-yl)
hydrazinecarboxylate) and its metabolite, diazinecarboxylic acid, 2-(4-
methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as
bifenazate) in or on bean, dry seed. Interregional Research Project
4 (IR-4) requested this tolerance under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 23, 2009. Objections and
requests for hearings must be received on or before February 22, 2010,
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-2008-0126. 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: Barbara Madden, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-6463; 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 those
engaged in the following activities:
     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 to
provide 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 EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2008-0126 in the subject line on the first
page of your submission. All requests must be in writing, and must be
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178
on or before February 22, 2010.
    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 that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2008-0126 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. Petition for Tolerance

    In the Federal Register of March 12, 2008 (73 FR 13225) (FRL-8354-
6), 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 petition (PP
8E7318) by Interregional Research Project 4 (IR-4), 500
College Road East, Suite 201 W, Princeton, NJ 08540. The petition
requested that 40 CFR 180.572 be amended by establishing tolerances for
combined residues of the insecticide bifenazate (1-methylethyl 2-(4-
methoxy[1,1'-biphenyl]-3-yl) hydrazinecarboxylate) and its metabolite,
diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-
methylethyl ester (expressed as bifenazate), in or on bean dry, seed at
0.2 parts per million (ppm); grass, forage, fodder and hay, group 17,
forage at 140 ppm; and grass, forage, fodder and hay, group 17, hay at
120 ppm. That notice referenced a summary of the petition prepared by
Chemtura Corporation, the registrant, on behalf of IR-4, which is
available to the public in the docket, http://www.regulations.gov. One
comment was received on the notice of filing. EPA's response to this
comment is discussed in Unit IV.C.
    After the petition was submitted, IR-4 subsequently withdrew the
tolerance request for grass, forage, fodder and hay, group 17, forage;
and grass, forage, fodder and hay, group 17, hay. As such, these
commodities are not considered in this document.
    EPA reviewed the petition and determined that the tolerance should
be set at 0.60 ppm on bean, dry seed. The

reasons for these changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(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.
Section 408(b)(2)(C) of FFDCA requires 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....''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure for the petitioned-for
tolerances for combined residues of the insecticide bifenazate (1-
methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-yl) hydrazinecarboxylate) and
its metabolite, diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-
yl), 1-methylethyl ester (expressed as bifenazate), in or on bean, dry
seed at 0.60 ppm. EPA's assessment of exposures and risks associated
with establishing tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies 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. Bifenazate is not acutely toxic by the oral, inhalation, or
dermal routes of exposure. It is minimally irritating to the eye and
slightly-irritating to the skin. Bifenazate is a dermal sensitizer by
the Magnusson/Kligman method, but not the Buehler method. Subchronic
and chronic studies in rats and dogs indicate that the liver and
hematopoietic system (spleen and/or bone marrow with associated
hematological findings) are the primary target organs in these species,
with additional toxicity in the kidney (chronic dog) and adrenal gland
(male rats) also identified. Similarly, the hematopoietic system
(spleen) was the primary target organ in the repeat-dose dermal
toxicity study. Also associated with this toxicity in several studies
were decreased body weight, body-weight gain, and food consumption. No
evidence of carcinogenicity was seen in the rat and mouse studies and
the Agency has classified bifenazate as ``not likely'' to be a human
carcinogen by any relevant route of exposure. A full battery of
mutagenicity studies were negative for mutagenic or clastogenic
activity. The developmental studies in rats and rabbits did not
demonstrate increased sensitivity of fetuses to bifenazate. Similarly,
increased qualitative or quantitative susceptibility to offspring were
not observed with bifenazate during pre- or postnatal development in
the reproduction study. There was no evidence of neurotoxicity
(clinical signs or neuropathology) in any of the toxicology studies
conducted with bifenazate. Therefore, a bifenazate developmental
neurotoxicity (DNT) study was not required by the Agency. Specific
information on the studies received and the nature of the adverse
effects caused by bifenazate as well as the no-observed-adverse-effect-
level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from
the toxicity studies can be found at http://www.regulations.gov in the
document titled ``Bifenazate; Petition for Establishment of Tolerances
for the Use of Bifenazate on Dry Bean Seed. HED Human-Health Risk
Assessment,'' pages 23-24 in docket ID number EPA-HQ-OPP-2008-0126.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as the highest dose at which no
adverse effects are observed (the NOAEL) in the toxicology study
identified as appropriate for use in risk assessment. However, if a
NOAEL cannot be determined, the lowest dose at which adverse effects of
concern are identified (the LOAEL) or a benchmark dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
dietary risks by comparing aggregate food and water exposure to the
pesticide to the acute population adjusted dose (aPAD) and chronic
population adjusted dose (cPAD). The aPAD and cPAD are calculated by
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the level of concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/
pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for bifenazate used for
human risk assessment can be found at http://www.regulations.gov in the
document titled ``Bifenazate; Petition for Establishment of Tolerances
for the Use of Bifenazate on Dry Bean Seed. HED Human-Health Risk
Assessment,'' pages 10-11 in docket ID number EPA-HQ-OPP-2008-0126.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to bifenazate, EPA considered exposure under the petitioned-
for tolerance as well as all existing bifenazate tolerances in 40 CFR
180.572. EPA assessed dietary exposures from bifenazate in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for bifenazate; therefore, a
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 CSFII. As to residue levels in food, EPA

assumed that all commodities, except squash, peach, tomato and milk,
contained tolerance-level residues. For squash, peach and tomato, EPA
assumed residues were present at average field trial levels. For milk,
the tolerance level was adjusted upward to account for all of the
residues of concern for risk assessment. Default processing factors
were assumed for all commodities except apple juice, grape juice, wine/
sherry, tomato paste, and tomato puree. The processing factors for
these commodities were based on data from processing studies. The
chronic analysis also incorporated average percent crop treated (PCT)
information for some registered commodities but assumed 100 PCT for the
new use.
    iii. Cancer. No evidence of carcinogenicity was seen in the cancer
studies performed with bifenazate on rats and mice, and EPA has
classified bifenazate as ''not likely`` to be a human carcinogen by any
relevant route of exposure. Therefore, a cancer exposure assessment was
not conducted.
    Bifenazate contains hydrazine as part of its chemical structure.
This side chain is structurally similar to unsymmetrical dimethyl
hydrazine (UDMH), a category B2 animal carcinogen and possible human
carcinogen. However, EPA has concluded that formation of free biphenyl
hydrazine or other hydrazines is unlikely based on the results of
submitted metabolism studies. The rat, livestock, and plant metabolism
studies indicate that metabolism of bifenazate proceeds via oxidation
of the hydrazine moiety of bifenazate to form D3598 (diazene). The
D3598 is then metabolized to D1989 (methoxy biphenyl) and to bound
residues by reaction with natural products. A radish metabolism study
which specifically monitored for the formation of biphenyl hydrazine
found none. Based on the results of the metabolism studies, especially
the absence of biphenyl hydrazine in the radish metabolism study or in
the excreta of rats in the rat metabolism study, EPA concluded that the
formation of free hydrazines is unlikely. This conclusion is further
supported by the lack of carcinogenic effects in the bifenazate
carcinogenicity studies.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of this tolerance.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency used PCT information as follows:
    Almond 5%; apple 5%; apricot 1%; cherry 1%; cucumber 1%; grape 5%;
nectarine 5%; peach 10%; pear 10%; pecan 1%; pepper 1%; pistachio 1%;
plum 5%; strawberry 30%; tomato 1%; walnut 1%; and watermelon 1%; 100
PCT was assumed for all new uses and the remaining currently registered
uses.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6 years.
EPA uses an average PCT for chronic dietary risk analysis. The average
PCT figure for each existing use is derived by combining available
public and private market survey data for that use, averaging across
all observations, and rounding to the nearest 5%, except for those
situations in which the average PCT is less than one. In those cases,
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA
uses a maximum PCT for acute dietary risk analysis. The maximum PCT
figure is the highest observed maximum value reported within the recent
6 years of available public and private market survey data for the
existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available reliable information on the regional consumption of
food to which bifenazate may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for bifenazate in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of bifenazate. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of bifenazate for
chronic exposures are estimated to be 11.2 parts per billion (ppb) for
surface water and 0.044 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 11.2 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and

flea and tick control on pets). Bifenazate is currently registered for
the following residential non-dietary sites: Ornamental plants,
including bedding plants, flowering plants, foliage plants, bulb crops,
perennials, trees, and shrubs. There is a potential for short-term
dermal and inhalation exposure of homeowners applying bifenazate on
these sites. However, post-application exposures of adults and children
from this use are expected to be negligible. Therefore, EPA assessed
only short-term dermal and inhalation residential handler exposures for
adults. Handler exposures were estimated assuming applications would be
made using hose-end sprayers, since this application method is expected
to result in higher exposures than other application methods, such as
pump sprayers or similar devices.
    4. 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 bifenazate to share a common mechanism of
toxicity with any other substances, and bifenazate does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
bifenazate does 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 website at http://
www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicology database for bifenazate includes rat and rabbit
developmental toxicity studies and a 2-generation reproduction toxicity
study in rats. There was no quantitative or qualitative evidence of
increased susceptibility of rats or rabbit fetuses to in utero exposure
in the developmental studies, nor of rats following prenatal/postnatal
exposure in the 2-generation reproduction study.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
      There are no residual uncertainties in the toxicity
database. The bifenazate toxicological database is complete with the
exception of an inhalation study, acute and subchronic neurotoxicity
studies and an immunotoxicity study. The immunotoxicity and acute and
subchronic neurotoxicity studies are now required as a part of new data
requirements in the 40 CFR part 158 for conventional pesticide
registration and a 28-day inhalation study has not been submitted.
However, the Agency does not believe that conducting these studies will
result in a lower point of departure (POD) than that currently used for
overall risk assessment, and therefore, a database uncertainty factor
(UFDB) is not needed to account for lack of these studies for the
following reasons:
    i. The toxicology database for bifenazate does not indicate that
the immune system is the primary target organ. The observed effects on
the immune system have been well characterized and were seen at dose(s)
that produce evidence of overt systemic toxicity. These effects
included increased spleen weight in females and histopathological
changes in the spleen in males in a 90-day oral rat toxicity study,
extramedullary hematopoiesis in the both sexes in a 21-day dermal
toxicity study in rats, and changes in hematological parameters,
clinical chemistry parameters in both sexes and histopathological
effects in bone marrow (compensatory hyperplasia) in both sexes in a 1-
year chronic toxicity study.
    ii. The overall weight of evidence suggests that bifenazate does
not directly target the immune system, and these findings may be due to
secondary effect of overt systemic toxicity. Further, there is no
evidence of neurotoxicity or neuropathology in the bifenazate database.
    iii. A 28-day inhalation study is not available; however, the EPA
has determined that the additional FQPA SF is not needed. Residential
inhalation risk was estimated by calculating exposure using the
Agency's Residential SOPs. For chemicals with low vapor pressure (7.5 x
10-\5\ mmHg or below for outdoor uses at 20-30[deg]C) these
standard assumptions are expected to overestimate the exposure via the
inhalation route. Bifenazate is such a compound and exposure through
the inhalation route is expected to be minimal. Therefore, the risk
estimate is conservative and is considered protective and the
additional FQPA SF is not needed.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/
pesticides/trac/science/trac6a05.pdf.
     There is no quantitative or qualitative evidence of
increased susceptibility of rats or rabbit fetuses to in utero exposure
in developmental studies, nor following pre/post-natal exposure to rats
in the 2-generation reproduction study.
     A developmental neurotoxicity study (DNT) is not required
because there is no evidence of neurotoxicity or neuropathology in the
bifenazate database.
     The dietary food and drinking water exposure assessments
will not underestimate the potential exposures for infants and
children; and the residential use (ornamentals) is not expected to
result in post-application exposure to infants and children.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from

a single-oral exposure was identified and no acute dietary endpoint was
selected. Therefore, bifenazate is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
bifenazate from food and water will utilize 50% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
bifenazate is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
    Bifenazate is currently registered for use that could result in
short-term residential exposure and the Agency has determined that it
is appropriate to aggregate chronic food and water and short-term
exposures for bifenazate.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential
exposures aggregated result in aggregate MOEs of 2,200 for the U.S.
population. The aggregate MOEs for adults take into consideration food
and drinking water exposures as well as dermal and inhalation exposures
of adults applying bifenazate to ornamentals in residential areas.
Since residential exposure of infants and children is not expected,
short-term aggregate risk for infants and children is the sum of the
risk from food and water, which does not exceed the Agency's level of
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Bifenazate is not registered for any use patterns that would result
in intermediate-term residential exposure. Therefore, the intermediate-
term aggregate risk is the sum of the risk from exposure to bifenazate
through food and water, which has already been addressed, and will not
be greater than the chronic aggregate risk.
    5. Aggregate cancer risk for U.S. population. Bifenazate has been
classified as not likely to be a human carcinogen by any relevant route
of exposure and is, therefore, not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to bifenazate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the
tolerance expression. High-performance liquid chromatography (HPLC)
Method UCC-D2341 is available as a primary enforcement method for
determination of the combined residues of bifenazate and its
metabolite, diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl),
1-methylethyl ester (expressed as bifenazate), in/on crop matrices. The
method has undergone a successful validation and has been forwarded to
the Food and Drug Administration (FDA) for inclusion in the Pesticide
Analytical Manual (PAM) Volume II. In addition, a method utilizing a
liquid chromatographic system with tandem mass spectrometers (LC/MS/MS)
was recently submitted as a confirmatory method (Method NCL ME 245) and
has been forwarded to FDA. The method may be requested from: Chief,
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes
Rd., Ft. Meade, MD 20755-5350; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican
maximum residue limits (MRLs) for bifenazate in/on dry bean seed.

C. Response to Comments

    A comment was received from a private citizen indicating that
testing conducted on animals have absolutely no validity and cruel to
the test animals. The Agency disagrees with the commenter's claims
regarding animal testing. Since humans and animals have complex organ
systems and mechanisms for the distribution of chemicals in the body,
as well as processes for eliminating toxic substances from their
systems, EPA relies on laboratory animals, such as, rats and mice to
mimic the complexity of human and higher-order animal physiological
responses when exposed to a pesticide. EPA is committed, however, to
reducing the use of animals whenever possible. EPA-required studies
include animals only when the requirements of sound toxicological
science make the use of an animal absolutely necessary. The Agency's
goal is to be able to predict the potential of pesticides to cause
harmful effects to humans and wildlife by using fewer laboratory
animals as models and have been accepting data from alternative (to
animals) test methods for several years. As progress is made on finding
or developing non-animal test models that reliably predict the
potential for harm to humans or the environment, EPA expects that it
will need fewer animal studies to make safety determinations. Finally,
because the commenter has not provided the Agency with a specific
rationale (including supporting information) as to why the Agency's
action is inconsistent with the legal standards in section 408 of
FFDCA, EPA can not provide any more detailed response to the
commenter's disagreement with the Agency's decision.
    In addition, the commenter noted several adverse effects seen in
animal toxicology studies with bifenazate and claims because of these
effects no tolerance should be approved. EPA has found, however, that
there is a reasonable certainty of no harm to humans after considering
these toxicological studies and the exposure levels of humans to
bifenazate.

D. Revisions to Petitioned-For Tolerances

    The initial petition submitted by IR-4 proposed tolerance for
grass, forage, fodder and hay, group 17, forage; and grass, forage,
fodder and hay, group 17, hay. EPA reviewed the petition and concluded
that in order to grant the use on grass, a ruminant metabolism and
adequate feeding studies would be required. IR-4 subsequently withdrew
these proposed tolerances.
    EPA evaluated this petition and upon reviewing the submitted field
trial data and entering it into the Agency's tolerance spreadsheet as
specified by the Guidance for Setting Pesticide Tolerances Based on
Field Trial Data SOP, it was determined that the tolerance should be
set at 0.60 ppm for residues in/on bean, dry seed as opposed to the
level proposed by IR-4.
    Additionally, EPA has revised the tolerance expression to clarify
(1) that, as provided in FFDCA section 408(a)(3), the tolerance covers
metabolites and degradates of bifenazate not specifically mentioned;
and (2) that compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression. This change was made to both the tolerance
expressions for plant commodities and livestock commodities because it
makes no substantive change to the meaning of the tolerance but rather
only clarifies the existing language.

V. Conclusion

    Therefore, a tolerance is established for combined residues of the
insecticide bifenazate (1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-yl)
hydrazinecarboxylate) and its metabolite, diazinecarboxylic acid, 2-(4-
methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as
bifenazate), in or on bean, dry seed at 0.60 ppm.

VI. 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) (Public Law 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).

VII. 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: December 11, 2009.
 Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I 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. Section 180.572 is amended by revising paragraphs (a)(1)
introductory text, (a)(2) introductory text, and (b) introductory text;
and alphabetically adding ``Bean, dry, seed'' to the table in paragraph
(a)(1) to read as follows:

Sec.  180.572  Bifenazate; tolerance for residues.

    (a) General. (1) Tolerances are established for residues of
bifenazate (1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-
yl)hydrazinecarboxylate) including its metabolites and degradates, in
or on the commodities listed in the following table. Compliance with
the tolerance levels specified are to be determined by measuring only
the sum of bifenazate and its metabolite diazinecarboxylic acid, 2-(4-
methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as
bifenazate) in or on the following food commodities:

------------------------------------------------------------------------
              Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Bean, dry seed......................                                0.60
                                * * * * *
------------------------------------------------------------------------

* * * * *

    (2) Tolerances are established for residues of bifenazate (1-
methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-yl) hydrazinecarboxylate)
including its metabolites and degradates, in or on the commodities
listed in the following table. Compliance with the tolerance levels
specified are to be determined by measuring only the sum of bifenazate
and its metabolites diazinecarboxylic acid, 2-(4-methoxy-[1,1'-
biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate); 1,1'-
biphenyl, 4-ol; and 1,1'-biphenyl, 4-oxysulfonic acid (expressed as
1,1'-biphenyl, 4-ol) in or on the following food commodities:
* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of bifenazate (1-methylethyl 2-(4-
methoxy[1,1'-biphenyl]-3-yl)hydrazinecarboxylate) including its

metabolites and degradates in connection with use of the pesticide
under section 18 emergency exemptions granted by EPA. Compliance with
the tolerance levels specified in the following table are to be
determined by measuring only the sum of bifenazate and its metabolite
diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-
methylethyl ester (expressed as bifenazate). The tolerances will expire
and are revoked on the dates specified in the following table.
* * * * *
[FR Doc. E9-30138 Filed 12-22-09; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 88, Number 134 (Friday, July 14, 2023)]
[Notices]
[Pages 45248-45253]
[FR Doc No: 2023-14910]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-97870; File No. SR-NASDAQ-2023-018]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend NOM Options 3 Rules

July 10, 2023.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on June 27, 2023, The Nasdaq Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. The Commission is publishing this notice to solicit comments
on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend The Nasdaq Options Market LLC
(``NOM'') Rules at Options 3, Options Trading Rules, at: Section 4
Entry and Display of Quotes; Section 5, Entry and Display of Orders;
Section 7, Types of Orders and Order and Quote Protocols; and Section
15, Risk Protections. The Exchange also

proposes to amend Options 5, Section 4, Order Routing.
    The text of the proposed rule change is available on the Exchange's
website at https://listingcenter.nasdaq.com/rulebook/nasdaq/rules, at
the principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    NOM proposes to amend Options 3, Options Trading Rules, at: Section
4 Entry and Display of Quotes; Section 5, Entry and Display of Orders;
Section 7, Types of Orders and Order and Quote Protocols; and Section
15, Risk Protections. The Exchange also proposes to amend Options 5,
Section 4, Order Routing. Each change will be discussed below. The
amendments proposed herein seek to codify the current System
functionality. The proposed amendments will not result in System
changes.
Option 3, Sections 4 and 5
    The Exchange proposes to codify existing functionality that allows
Market Makers to submit their quotes to the Exchange in block
quantities as a single bulk message. In other words, a Market Maker may
submit a single message to the Exchange, which may contain bids and
offers in multiple series. The Exchange's current rules do not specify
bulk messaging for orders. The Exchange has historically provided
Market Makers with information regarding bulk messaging in its publicly
available technical specifications.\3\ To promote greater transparency,
the Exchange is seeking to codify this functionality in its Rulebook.
Specifically, the Exchange proposes to amend NOM Options 3, Section
4(b)(3) to memorialize that quotes may be submitted as a bulk message.
The Exchange also proposes to add a definition of ``bulk message'' in
new subparagraph (i) of Options 3, Section 4(b)(3), which will provide
that a bulk message means a single electronic message submitted by a
Market Maker to the Exchange which may contain a specified number of
quotations as designated by the Exchange.\4\ The bulk message,
submitted via SQF,\5\ may enter, modify, or cancel quotes. Bulk
messages are handled by the System in the same manner as it handles a
single quote message. MRX recently added bulk messages to MRX Options
3, Section 4(b)(3).\6\ The proposed amendment to the Rulebook to add
NOM Options 3, Section 4(b)(3) will not result in a System change.
---------------------------------------------------------------------------

    \3\ See https://www.nasdaq.com/docs/2023/01/12/0054-Q23_SQF_8.2b%20akg_NAM.pdf (specifying for bulk quoting of up to 200
quotes per quote block message). The specifications note in other
places the manner in which a Participant can send such quote block
messages.
    \4\ Id. As noted above, quote bulk messages can presently
contain up to 200 quotes per message. This is the maximum amount
that is permitted in a bulk message. The Exchange would announce any
change to these specifications in an Options Technical Update
distributed to all Participants.
    \5\ ``Specialized Quote Feed'' or ``SQF'' is an interface that
allows Market Makers to connect, send, and receive messages related
to quotes and Immediate-or-Cancel Orders into and from the Exchange.
Features include the following: (1) options symbol directory
messages (e.g., underlying instruments); (2) system event messages
(e.g., start of trading hours messages and start of opening); (3)
trading action messages (e.g., halts and resumes); (4) execution
messages; (5) quote messages; (6) Immediate-or-Cancel Order
messages; (7) risk protection triggers and purge notifications; and
(8) opening imbalance messages. The SQF Purge Interface only
receives and notifies of purge requests from the Market Maker.
Market Makers may only enter interest into SQF in their assigned
options series. See Options 3, Section 7(e)(1)(B).
    \6\ See Securities Exchange Act, Release No. 95982 (October 4,
2022), 87 FR 61391 (October 11, 2022) (SR-MRX-2022-18) (Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Its Rules in Connection With a Technology Migration to Enhanced
Nasdaq Functionality) (``SR-MRX-2022-18'').
---------------------------------------------------------------------------

    The Exchange also proposes to amend NOM Options 3, Section 4(b)(6)
to provide the following,

    A quote will not be executed at a price that trades through
another market or displayed at a price that would lock or cross
another market. If, at the time of entry, a quote would cause a
locked or crossed market violation or would cause a trade-through,
violation, it will be re-priced to the current national best offer
(for bids) or the current national best bid (for offers) as non-
displayed, and displayed at one minimum price variance above (for
offers) or below (for bids) the national best price.

    Where a quote is re-priced to avoid a locked or crossed market, the
best bid or offer will be non-displayed and the re-priced order will be
displayed at a price that is one minimum trading increment inferior to
the ABBO. A similar change is proposed for Options 3, Section 5(d). MRX
recently amended Options 3, Section 4(b)(6) and Options 3, Section 5(d)
to include this language.\7\ At this time, the Exchange proposes to
amend NOM's rule text to reflect that the actual price remains non-
displayed in this scenario. The proposed amendment to the Rulebook to
add NOM Options 3, Section 4(b)(6) will not result in a System change.
---------------------------------------------------------------------------

    \7\ See Securities Exchange Act, Release No. 95807 (September
16, 2022), 87 FR 57933 (September 22, 2022) (SR-MRX-2022-16) (Notice
of Filing and Immediate Effectiveness of Proposed Rule Change To
Amend Certain Rules in Connection With a Technology Migration to
Enhanced Nasdaq Functionality) (``SR-MRX-2022-16'').
---------------------------------------------------------------------------

    Similarly, the Exchange proposes to add a new NOM Options 3,
Section 4(b)(7) to clarify that, today, NOM's System will automatically
execute eligible quotes using the Exchange's displayed best bid and
offer (``BBO'') or the Exchange's non-displayed order book (``internal
BBO'') \8\ if the best bid and/or offer on the Exchange has been
repriced pursuant to Options 3, Section 5(d) and Options 3, Section
4(b)(6). This rule text seeks to codify the current System function and
make clear that the internal BBO is comprised of both orders and
quotes.\9\ MRX recently amended Options 3, Section 4(b)(7) to include
the same language.\10\ At this time, the Exchange proposes to align
NOM's rule text in Options 3, Section 4(b)(7) to MRX's rule text in
Options 3, Section 4(b)(7). The proposed amendment to the Rulebook to
add NOM Options 3, Section 4(b)(7) will not result in a System change.
---------------------------------------------------------------------------

    \8\ The internal BBO refers to the Exchange's non-displayed
book.
    \9\ The Exchange also proposes to re-number current Options 3,
Section 4(b)(7) as (8).
    \10\ See SR-MRX-2022-16.
---------------------------------------------------------------------------

    Finally, the Exchange proposes to amend NOM Options 3, Section 5(c)
to include a citation to Options 3, Section 4(b)(6) as the internal BBO
is comprised of both orders and quotes, similar to MRX.\11\
---------------------------------------------------------------------------

    \11\ Id.
---------------------------------------------------------------------------

    The amendments proposed to Options 3, Sections 4 and 5 do not
change the current System functionality.
Options 3, Section 7
    The Exchange proposes to amend the ``Post-Only Order type at
Options 3, Section 7(a)(9) to rename the order type ``Add Liquidity
Order''. The Exchange believes the name better describes this order
type. This is also the name of a similar order type on MRX.\12\ The
Exchange also proposes to capitalize the

term ``Opening Process'' which refers to NOM Options 3, Section 8.
---------------------------------------------------------------------------

    \12\ See MRX Options 7, Section 7(n).
---------------------------------------------------------------------------

    The Exchange proposes to amend the description of Specialized Quote
Feed or ``SQF'' within NOM Options 3, Section 7(e)(1)(B) to add rule
text which states, ``Immediate-or-Cancel Orders entered into SQF are
not subject to the Order Price Protection, Market Order Spread
Protection, or Size Limitation Protection in Options 3, Section
15(a)(1), (a)(2), and (b)(2) respectively.'' This rule text is
currently noted within Options 3, Section 7(b)(2) above. The Exchange
is adding the same language into the description of SQF to provide a
more complete description. The addition of this information would align
the level of information of NOM's rule text to NOM's rule text at
Supplementary Material .03(c) to Options 3, Section 7. The Exchange is
proposing a similar amendment to Options 3, Section 7(e)(1)(D)
regarding Quote Using Orders or ``QUO'' \13\ to state that, ``Orders
entered into QUO are not subject to the Order Price Protection or Size
Limitation in Options 3, Section 15(a)(1) and (b)(2), respectively.''
All orders entered into QUO are not subject to the Order Price
Protection or Size Limitation protections, not Immediate-or-Cancel
Orders. Also, the Market Order Spread Protection is not applicable to
QUO because QUO cannot be utilized to send Market Orders to the
Exchange, only FIX may be utilized to send Market Orders. The proposed
amendment to NOM Options 3, Section 7(e)(1)(B) and (D) will not result
in System changes.
---------------------------------------------------------------------------

    \13\ ``Quote Using Orders'' or ``QUO'' is an interface that
allows Market Makers to connect, send, and receive messages related
to single-sided orders to and from the Exchange. Order Features
include the following: (1) options symbol directory messages (e.g.,
underlying); (2) system event messages (e.g., start of trading hours
messages and start of opening); (3) trading action messages (e.g.,
halts and resumes); (4) execution messages; (5) order messages; and
(6) risk protection triggers and cancel notifications. Orders
submitted by Market Makers over this interface are treated as
quotes. Market Makers may only enter interest into QUO in their
assigned options series.
---------------------------------------------------------------------------

Options 3, Section 15
    MRX recently amended its Order Price Protection (``OPP'') \14\
rule.\15\ MRX's OPP rule utilized different rule text to explain the
OPP functionality than is currently on NOM. At this time, the Exchange
proposes to amend NOM Options 3, Section 15(a)(1) to align NOM's rule
text to MRX's rule text within Options 3, Section 15(a)(1)(A).
Specifically, the Exchange proposes to remove the references to ``day
limit, good til cancelled, and immediate or cancel orders'' and,
instead, simply refer to ``Limit'' Orders as that order type accurately
captures the scope of the orders subject to OPP. Further, the Exchange
proposes to remove ``market orders'' from the next sentence since OPP
only applies to limit orders. The Exchange also proposes to capitalize
``Opening'' and add Process in Options 2, Section 15(a)(1)(A) to refer
to the Opening Process within Options 3, Section 8. The proposed
amendment to Options 3, Section 15(a)(1) will not result in a System
change.
---------------------------------------------------------------------------

    \14\ OPP prevents the execution of Limit Orders at prices
outside pre-set parameters.
    \15\ See SR-MRX-2022-18.
---------------------------------------------------------------------------

    Additionally, the Exchange proposes to amend its Acceptable Trade
Range (``ATR'') Rule within NOM Options 3, Section 15(b)(1).\16\ MRX
recently amended its ATR rule.\17\ MRX's ATR rule utilized different
rule text to explain the ATR functionality. At this time, the Exchange
proposes to amend Options 3, Section 15(b)(1)(A) to add the word
``quote'' in that same sentence, where it was omitted and also add the
words ``after the Posting Period'' to explain when a new ATR would be
calculated to provide more context to the rule.\18\
---------------------------------------------------------------------------

    \16\ ATR is designed to guard against the System from
experiencing dramatic price swings by preventing the immediate
execution of quotes and orders beyond the thresholds set by the
protection.
    \17\ See SR-MRX-2022-16.
    \18\ The Exchange also proposes technical amendments to
capitalize ``the'' and add opening parentheses in two places.
---------------------------------------------------------------------------

    Additionally, similar to MRX Options 3, Section 15(a)(2)(A)(v) the
Exchange proposes to add the following rule text within NOM Options 3,
Section 15(b)(1)(C),

    There will be three categories of options for Acceptable Trade
Range: (1) Penny Interval Program Options trading in one cent
increments for options trading at less than $3.00 and increments of
five cents for options trading at $3.00 or more, (2) Penny Interval
Program Options trading in one-cent increments for all prices, and
(3) Non-Penny Interval Program Options.

    This is how NOM operates today. This rule text makes clear the
application of NOM Options 3, Section 3 to the ATR rule by explicitly
stating the Exchange's ability to set different ATR values by options
category. These ATR values are set forth in NOM's System Settings
document which is posted online.\19\ The Exchange believes this rule
text will add greater clarity to the ATR rule. The proposed amendment
to Options 3, Section 15(b)(1) will not result in a System change.
---------------------------------------------------------------------------

    \19\ https://www.nasdaq.com/docs/BXOptionsSystemSettings.
---------------------------------------------------------------------------

    The Exchange proposes to capitalize the words ``opening process''
at the end of Options 3, Section 15(c)(1) which refers to the Anti-
Internalization functionality. The term refers to the process within
Options 3, Section 8.
    The Exchange proposes to and the words ``or quote'' to Options 3,
Section 15(c)(3) which refers to the Post-Only Quoting Protection. The
paragraph refers to order or quote throughout and was mistakenly
omitted in one sentence.
Options 5, Section 4
    Options 5, Section 4 describes the manner in which NOM routes
orders. The Exchange proposes to amend NOM Options 5, Section 4(a) to
eliminate the following rule text,

    The term ``System routing table'' refers to the proprietary
process for determining the specific trading venues to which the
System routes orders and the order in which it routes them. The
Exchange reserves the right to maintain a different System routing
table for different routing options and to modify the System routing
table at any time without notice.

    When ISE filed to amend its routing rules, it did not include this
sentence.\20\ At this time, the Exchange proposes to remove this
unnecessary term that is not utilized elsewhere within Options 5,
Section 4. Removing this rule text will harmonize NOM's Options 5,
Section 4 rule with ISE's Options 5, Section 4(e). The proposed
amendment to Options 5, Section 4(a) will not result in a System
change.
---------------------------------------------------------------------------

    \20\ See Securities Exchange Act Release No. 94894 (May 18,
2022), 87 FR 30294 (May 12, 2022) (SR-ISE-2022-11) (Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Routing
Functionality in Connection With a Technology Migration).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\21\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\22\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78f(b).
    \22\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

Option 3, Sections 4 and 5
    The Exchange believes that its proposal to memorialize its bulk
message functionality within Options 3, Section 4(b)(3) is consistent
with the Act as it will codify existing functionality, thereby
promoting transparency in the Exchange's rules

and reducing any potential confusion.\23\ This functionality provides
Market Makers with an additional tool to meet their various quoting
obligations in a manner they deem appropriate, consistent with the
purpose of the bulk message functionality to facilitate Market Makers'
provision of liquidity. By providing Market Makers with additional
control over the quotes they use to provide liquidity to the Exchange,
this tool may benefit all investors through additional execution
opportunities at potentially improved prices. Today, MRX offers this
same functionality within Options 3, Section 4(b)(3). Further, the
Exchange does not believe that the offering the bulk message
functionality to only Market Makers would permit unfair discrimination.
Market Makers play a unique and critical role in the options market by
providing liquidity and active markets, and are subject to various
quoting obligations which other market participants are not, including
obligations to maintain active markets, update quotes in response to
changed market conditions, to compete with other Market Makers in its
appointed classes, and to provide intra-day quotes in its appointed
classes.\24\ Bulk message functionality provides Market Makers with a
means to help them satisfy these obligations. The proposed amendment to
the Rulebook to add NOM Options 3, Section 4(b)(3) will not result in a
System change.
---------------------------------------------------------------------------

    \23\ As discussed above, this existing functionality is
currently described in the Exchange's publicly available technical
specifications. See supra note 3.
    \24\ See Options 2, Sections 4 and 5.
---------------------------------------------------------------------------

    The Exchange's proposal to amend Options 3, Section 4(b)(6) to make
clear that the actual price remains non-displayed during re-pricing is
consistent with the Act and removes impediments to and perfects the
mechanism of a free and open market and a national market system
because it displays a re-priced order that does not lock or cross an
away market. The rule text clearly explains that the best bid or offer
will be non-displayed and the re-priced order will be displayed. A
similar change is proposed for NOM Options 3, Section 5(d). MRX
recently amended Options 3, Section 4(b)(6) and Options 3, Section 5(d)
to include the same language.\25\ The proposed change aligns NOM's rule
text to MRX's rule text. The proposed amendment to the Rulebook to add
NOM Options 3, Section 4(b)(6) will not result in a System change.
---------------------------------------------------------------------------

    \25\ See SR-MRX-2022-16.
---------------------------------------------------------------------------

    The Exchange's proposal to add a new Options 3, Section 4(b)(7) to
clarify that, today, NOM's System will automatically execute eligible
quotes using the Exchange's displayed best bid and offer (``BBO'') or
the Exchange's non-displayed order book (``internal BBO'') if the best
bid and/or offer on the Exchange has been repriced pursuant to Options
3, Section 5(d) and Options 3, Section 4(b)(6) is consistent with the
Act and protects investors and the public interest. This rule text
seeks to codify the current System function and make clear that the
internal BBO is comprised or both orders and quotes, both of which are
considered for price checks. MRX recently amended Options 3, Section
4(b)(7) to include this language.\26\ The proposed change aligns NOM's
rule text to MRX's rule text. The proposed amendment to the Rulebook to
add NOM Options 3, Section 4(b)(7) will not result in a System change.
---------------------------------------------------------------------------

    \26\ Id.
---------------------------------------------------------------------------

Options 3, Section 7
    The Exchange's proposal to amend the name of the ``Post-Only Order
type at Options 3, Section 7(a)(9) to rename the order type ``Add
Liquidity Order'' is a non-substantive technical amendment that will
align the name to that used on MRX.\27\
---------------------------------------------------------------------------

    \27\ See MRX Options 7, Section 7(n).
---------------------------------------------------------------------------

    The Exchange's proposal to amend the description of SQF within
Options 3, Section 7(e)(1)(B) and the description of QUO within Options
3, Section 7(e)(1)(D) is consistent with the Act as this rule text is
currently noted within Options 3, Section 7(b)(2) above. The addition
of this language into the description of SQF and QUO provides a more
complete description of this protocol. The addition of this information
also aligns the level of information with that offered on MRX for SQF
within Supplementary Material .03(c) to Options 3, Section 7 and
differentiates the information from QUO. All orders entered into QUO
are not subject to the Order Price Protection or Size Limitation
protections, not Immediate-or-Cancel Orders. Also, the Market Order
Spread Protection is not applicable to QUO because QUO cannot be
utilized to send Market Orders to the Exchange, only FIX may be
utilized to send Market Orders. The proposed amendment to NOM Options
3, Section 7(e)(1)(B) will not result in a System change.
Options 3, Section 15
    The Exchange's proposal to amend NOM Options 3, Section 15(a)(1) to
align NOM's OPP rule text to MRX's OPP rule text within Options 3,
Section 15(a)(1)(A) is consistent with the Act \28\ because removing
the references to ``day limit, good til cancelled, and immediate or
cancel orders'' and, instead, referring to ``Limit'' Orders accurately
captures the scope of the orders subject to OPP. This change would also
make unnecessary the reference to market orders. The proposed amendment
to Options 3, Section 15(a)(1) will not result in a System change.
---------------------------------------------------------------------------

    \28\ MRX recently amended its Order Price Protection (``OPP'')
rule. See SR-MRX-2022-18.
---------------------------------------------------------------------------

    The Exchange's proposal to amend the ATR Rule within Options 3,
Section 15(b)(1) is consistent with the Act. MRX recently amended its
ATR rule.\29\ MRX's ATR rule utilized different rule text to explain
the ATR functionality. Amending NOM Section 15(b)(1) to add the words
``after the Posting Period'' to explain when a new ATR would be
calculated provides more context to the rule will provide greater
context to the sentence. Additionally, adding the word ``quote'' in the
one sentence where it is omitted will add clarity the sentence. The
proposed amendment to Options 3, Section 15(b)(1) will not result in a
System change. Also, adding rule text within NOM Options 3, Section
15(b)(1)(C) to make clear the Exchange's ability to set different ATR
values by options category is consistent with the Act because the ATR
risk protection limits the range of prices at which an order and quote
trades and would take into account the minimum increment. The ability
for the Exchange to set the ATR based on the increment allows the
Exchange to set appropriate limits. The Exchange believes this rule
text will add greater clarity to the ATR rule. The proposed amendment
to Options 3, Section 15(b)(1) will not result in a System change.
---------------------------------------------------------------------------

    \29\ See SR-MRX-2022-16.
---------------------------------------------------------------------------

Options 5, Section 4
    Eliminating an unnecessary term in Options 5, Section 4(a) that is
not utilized elsewhere within Options 5, Section 4 which is unnecessary
is consistent with the Act as it will remove confusion. The proposed
amendment to Options 5, Section 4(a) will not result in a System
change.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

Option 3, Sections 4 and 5
    The Exchange believes that its proposal to memorialize its bulk
message functionality within Options 3, Section 4(b)(3) does not impose
an undue burden on intra-market competition. While the Exchange
currently offers this functionality to Market Makers only, bulk
messaging is intended to provide Market Makers with an additional tool
to meet their various quoting obligations in a manner they deem
appropriate. As such, the Exchange believes that this functionality may
facilitate Market Makers' provision of liquidity, thereby benefiting
all market participants through additional execution opportunities at
potentially improved prices. Furthermore, while the Exchange will offer
the proposed Post-Only Quote Configuration to Market Makers only, the
proposed risk protection will enhance the ability of Market Makers to
add liquidity and avoid removing liquidity from the Exchange's order
book in the manner described above. Greater liquidity benefits all
market participants by providing more trading opportunities and
attracting greater participation by Market Makers. The Exchange
believes that its proposal to memorialize its bulk message
functionality within Options 3, Section 4(b)(3) does not impose an
undue burden on inter-market competition as other options exchanges may
adopt this functionality.
    The Exchange's proposal to amend NOM's rules at Options 3, Section
4(b)(6) and Options 3, Section 4(b)(7) do not impose an undue burden on
competition because all options markets must not trade-through other
orders on their markets as well as away markets. The proposed change
aligns NOM's rule text to MRX's rule text.
Options 3, Section 7
    The Exchange's proposal to amend the name of the ``Post-Only Order
type at Options 3, Section 7(a)(9) to rename the order type ``Add
Liquidity Order'' is a non-substantive technical amendment that does
not impose an undue burden on competition.
    Amending the description of SQF within Options 3, Section
7(e)(1)(B) and the description of QUO within Options 3, Section
7(e)(1)(D) does not impose an undue burden on competition The addition
of this language into the description of SQF and QUO provides a more
complete description of this protocol.
Options 3, Section 15
    The Exchange's proposal to amend NOM Options 3, Section 15(a)(1) to
align NOM's OPP rule text to MRX's OPP rule text within Options 3,
Section 15(a)(1)(A) does not impose an undue burden on competition
because removing the references to ``day limit, good til cancelled, and
immediate or cancel orders'' and, instead, referring to ``Limit''
Orders accurately captures the scope of the orders subject to OPP. This
change would also make unnecessary the reference to market orders.
    The Exchange's proposal to amend the ATR Rule within Options 3,
Section 15(b)(1) does not impose an undue burden on competition.
Amending NOM Section 15(b)(1) to add the words ``after the Posting
Period'' to explain when a new ATR would be calculated provides more
context to the rule will provide greater context to the sentence.
Additionally, adding the word ``quote'' in the one sentence where it is
omitted will add clarity the sentence. Adding rule text within NOM
Options 3, Section 15(b)(1)(C) to make clear the Exchange's ability to
set different ATR values by options category does not impose an undue
burden on competition because the ability for the Exchange to set the
ATR based on the increment allows the Exchange to set appropriate
limits. The Exchange believes this rule text will add greater clarity
to the ATR rule.
Options 5, Section 4
    Eliminating an unnecessary reference within amend Options 5,
Section 4(a) does not impose an undue burden on competition because the
term is not utilized elsewhere within Options 5, Section 4.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule change does not: (i)
significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \30\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\31\
---------------------------------------------------------------------------

    \30\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \31\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (https://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
file number SR-NASDAQ-2023-018 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

All submissions should refer to file number SR-NASDAQ-2023-018. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (https://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for website viewing and
printing in the Commission's Public Reference Room, 100 F Street NE,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also

will be available for inspection and copying at the principal office of
the Exchange. Do not include personal identifiable information in
submissions; you should submit only information that you wish to make
available publicly. We may redact in part or withhold entirely from
publication submitted material that is obscene or subject to copyright
protection. All submissions should refer to file number SR-NASDAQ-2023-
018 and should be submitted on or before August 4, 2023.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\32\
---------------------------------------------------------------------------

    \32\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-14910 Filed 7-13-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: July 25, 2007 (Volume 72, Number 142)]
[Rules and Regulations]
[Page 40749-40752]
[DOCID:fr25jy07-8]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 81

[EPA-R03-OAR-2007-0323; FRL-8445-7]

Approval and Promulgation of Air Quality Implementation Plans;
Pennsylvania; Redesignation of the Harrisburg-Lebanon-Carlisle Ozone
Nonattainment Area to Attainment and Approval of the Area's Maintenance
Plan and 2002 Base Year Inventory

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is approving a State Implementation Plan (SIP) revision
submitted by the Commonwealth of Pennsylvania. The Pennsylvania
Department of Environmental Protection (PADEP) is requesting that the
Harrisburg-Lebanon-Carlisle ozone nonattainment area (``Harrisburg
Area'') be redesignated as attainment for the 8-hour ozone ambient air
quality standard (NAAQS). EPA is approving the ozone redesignation
request for the Harrisburg Area. In conjunction with its redesignation
request, PADEP submitted a SIP revision consisting of a maintenance
plan for the Harrisburg Area that provides for continued attainment of
the 8-hour ozone NAAQS for at least 10 years after redesignation. EPA
is approving the 8-hour maintenance plan. PADEP also submitted a 2002
base-year inventory for the Harrisburg Area which EPA is approving. In
addition, EPA is approving the adequacy determination for the motor
vehicle emission budgets (MVEBs) that are identified in the Harrisburg
Area maintenance plan for purposes of transportation conformity, and is
approving those MVEBs. EPA is approving the redesignation request, and
the maintenance plan and the 2002 base-year emissions inventory as
revisions to the Pennsylvania SIP in accordance with the requirements
of the Clean Air Act (CAA).

EFFECTIVE DATE: This final rule is effective on July 25, 2007 pursuant
to the authority of 5 U.S.C. 553(d)(1).

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2007-0323. All documents in the docket are listed in
the http://www.regulations.gov Web site. Although listed in the electronic

docket, some information is not publicly available, i.e., 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 either electronically through http://www.regulations.gov or in hard

copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State
submittal are available at the Pennsylvania Department of Environmental
Resources Bureau of Air Quality Control, P.O. Box 8468, 400 Market
Street, Harrisburg, Pennsylvania 17105.

FOR FURTHER INFORMATION CONTACT: Ellen Wentworth<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On June 1, 2007 (72 FR 30521), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Pennsylvania. The NPR proposed
approval of Pennsylvania's redesignation request, a SIP revision that
establishes a maintenance plan for the Harrisburg Area that provides
for continued attainment of the 8-hour ozone NAAQS for at least 10
years after redesignation, and a 2002 base-year emissions inventory.
The formal SIP revision was submitted by PADEP on March 27, 2007. Other
specific requirements of Pennsylvania's redesignation request, the SIP
revision for the maintenance plan, and the rationale for EPA's proposed
actions are explained in the NPR and will not be restated here. No
public comments were received on the NPR.

    On December 22, 2006, the U.S. Court of Appeals for the District of
Columbia Circuit vacated EPA's Phase 1 Implementation Rule for the 8-
hour Ozone Standard. (69 FR 23951, April 30, 2004). South Coast Air
Quality Management Dist. v. EPA, 472 F.3d 882 (D.C. Cir. 2006). On June
8, 2007, in South Coast Air Quality Management Dist. v. EPA, Docket No.
04-1201, in response to several petitions for rehearing, the D.C.
Circuit clarified that the Phase 1 Rule was vacated only with regard to
those parts of the rule that had been successfully challenged.
Therefore, the Phase 1 Rule provisions related to classifications for
areas currently classified under subpart 2 of Title I, part D of the
Act as 8-hour nonattainment areas, the 8-hour attainment dates, and the
timing for emissions reductions needed for attainment of the 8-hour
ozone NAAQS remain effective. The June 8 decision left intact the
Court's rejection of EPA's reasons for implementing the 8-hour standard
in certain nonattainment areas under subpart 1 in lieu of subpart 2. By
limiting the vacatur, the Court let stand EPA's revocation of the 1-
hour standard and those anti-backsliding provisions of the Phase 1 Rule
that had not been successfully challenged. The June 8 decision
reaffirmed the December 22, 2006 decision that EPA had improperly
failed to retain four measures required for 1-hour nonattainment areas
under the anti-backsliding provisions of the regulations: (1)
Nonattainment area New Source Review (NSR) requirements based on an
area's 1-hour nonattainment classification; (2) Section 185 penalty
fees for 1-hour severe or extreme nonattainment areas; and (3) measures
to be implemented pursuant to section 172(c)(9) or 182(c)(9) of the
Act, on the contingency of an area not making reasonable further
progress toward attainment of the 1-hour NAAQS, or for failure to
attain that NAAQS. In addition the June 8 decision clarified that the
Court's reference to conformity requirements for anti-backsliding
purposes was limited to requiring the continued use of 1-hour motor
vehicle emissions budgets until 8-hour budgets were available for 8-
hour conformity determinations, which is already required under EPA's
conformity regulations. The Court thus clarified that 1-hour conformity
determinations are not required for anti-backsliding purposes.
    For the reasons set forth in the proposal, EPA does not believe
that the Court's rulings alter any requirements relevant to this
redesignation action so as to preclude redesignation, and do not
prevent EPA from finalizing this redesignation. EPA believes that the
Court's December 22, 2006 and June 8, 2007 decisions impose no
impediment to moving forward with the redesignation of this Area to
attainment, because even in light of the Court's decisions,
redesignation is appropriate under the relevant redesignation
provisions of the Act and longstanding policies regarding redesignation
requests.
    In its proposal, EPA proposed to find that the Area had satisfied
the requirements under the 1-hour standard whether the 1-hour standard
was deemed to be reinstated or whether the Court's decision on the
petition for rehearing was modified to require something less than
compliance with all applicable 1-hour requirements. Because EPA
proposed to find that the Area satisfied the requirements under either
scenario, EPA is proceeding to finalize the redesignation and to
conclude that the Area has met the requirements under the 1-hour
standard applicable for purposes of redesignation under the 8-hour
standard. These include the provisions of EPA's anti-backsliding rules,
as well as the additional anti-backsliding provisions identified by the
Court in its rulings. In its June 8, 2007 decision, the Court limited
its vacatur so as to uphold those provisions of the anti-backsliding
requirements that were not successfully challenged. Therefore, EPA
finds that the Area has met the anti-backsliding requirements, see 40
CFR 51.900 et seq; 70 FR 30592, 30604 (May 26, 2005) which apply by
virtue of the Area's classification for the 1-hour ozone NAAQS, as well
as the four additional anti-backsliding provisions identified by the
Court, or that such requirements are not applicable for purposes of
redesignation. In addition, with respect to the requirement for
transportation conformity under the 1-hour standard, the Court in its
June 8 decision clarified that for those areas with 1-hour motor
vehicle emissions budgets, anti-backsliding requires only that those 1-
hour budgets must be used for 8-hour conformity determinations until
replaced by 8-hour budgets. To meet this requirement, conformity
determinations in such areas must comply with the applicable
requirements of EPA's conformity regulations at 40 CFR part 93. The
Court clarified that 1-hour conformity determinations are not required
for anti-backsliding purposes.

II. Final Action

    EPA is approving the Commonwealth of Pennsylvania's redesignation
request, maintenance plan, and the 2002 base-year emissions inventory
because the requirements for approval have been satisfied. EPA has
evaluated Pennsylvania's redesignation request that was submitted on
March 27, 2007 and determined that it meets the redesignation criteria
set forth in section 107(d)(3)(E) of the CAA. EPA believes that the
redesignation request and monitoring data demonstrate that the
Harrisburg Area has attained the 8-hour ozone standard. The final
approval of this redesignation request will change the designation of
the Harrisburg Area from nonattainment to attainment for the 8-hour
ozone standard. EPA is approving the maintenance plan for the
Harrisburg Area submitted on March 27, 2007 as a revision to the
Pennsylvania SIP. EPA is also approving the MVEBs submitted by PADEP in
conjunction with its redesignation request. In addition, EPA is
approving the 2002 base-year emissions inventory as a revision to the
Pennsylvania SIP submitted by PADEP on March 27, 2007. In this final
rulemaking, EPA is notifying the public that we have found that the
MVEBs for NOX and VOCs in the Harrisburg Area for the 8-hour
ozone maintenance plan are adequate and approved for conformity
purposes. As a result of our finding, the Harrisburg Area must use the
MVEBs from the submitted 8-hour ozone maintenance plan for future
conformity determinations. The adequate and approved MVEBs are provided
in the following table:

Table 1.--Motor Vehicle Emissions Budgets in Kilograms per day (Tons per
                              Day--Rounded)
------------------------------------------------------------------------
               Year                        VOC                NOX
------------------------------------------------------------------------
  Harrisburg Area Transportation Study (HATS)--Cumberland, Dauphin, and
                             Perry Counties
------------------------------------------------------------------------
2009..............................      23,014 (25.4)      41,917 (46.2)
2018..............................      16,136 (17.8)      18,409 (20.3)
------------------------------------------------------------------------

                       Lebanon County MPO (LEBCO)
------------------------------------------------------------------------
2009..............................        4,301 (4.7)        8,928 (9.8)
2018..............................        2,512 (2.8)       3,684 (4.1)
------------------------------------------------------------------------
*Note: Tons per day are informational only. Differences occur due to
  rounding.

    The Harrisburg Area is subject to the CAA's requirement for the
basic nonattainment areas until and unless it is redesignated to
attainment.

III. Statutory and Executive Order Reviews

A. General Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Redesignation of an area to attainment under section 107(d)(3)(e) of
the Clean Air Act does not impose any new requirements on small
entities. Redesignation is an action that affects the status of a
geographical area and does not impose any new regulatory requirements
on sources. Accordingly, the Administrator certifies that this final
rule will not have a significant economic impact on a substantial
number of small entities under the Regulatory Flexibility Act (5 U.S.C.
601 et seq.). Because this rule approves pre-existing requirements
under state law and does not impose any additional enforceable duty
beyond that required by state law, it does not contain any unfunded
mandate or significantly or uniquely affect small governments, as
described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
This final rule also does not have tribal implications because it will
not have a substantial direct effect on one or more Indian tribes, on
the relationship between the Federal Government and Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). Because this action affects the status of
a geographical area, does not impose any new requirements on sources,
or allows the state to avoid adopting or implementing other
requirements, this action also does not have Federalism implications
because it does 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, as specified in Executive Order 13132 (64 FR 43255,
August 10, 1999). This action merely approves a state rule implementing
a Federal requirement, and does not alter the relationship or the
distribution of power and responsibilities established in the Clean Air
Act. This rule also is not subject to Executive Order 13045
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it approves a state rule
implementing a Federal standard.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Redesignation is an
action that affects the status of a geographical area and does not
impose any new requirements on sources. Thus, the requirements of
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44 USC. 3501 et seq.).

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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 the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 24, 2007. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action.
    This action, approving the redesignation of the Harrisburg Area to
attainment for the 8-hour ozone NAAQS, the associated maintenance plan,
the 2002 base-year emissions inventory, and the MVEBs identified in the
maintenance plan, may not be challenged later in proceedings to enforce
its requirements. (See section 307(b)(2).)

List of Subjects

40 CFR Part 52

    Environmental protection, Air pollution control, Nitrogen dioxide,
Ozone, Reporting and recordkeeping requirements, Volatile organic
compounds.

40 CFR Part 81

    Environmental protection, Air pollution control, National parks,
Wilderness areas.

    Dated: July 16, 2007.
Donald S. Welsh,
Regional Administrator, Region III.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

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

Subpart NN-Pennsylvania

0
2. In Sec.  52.2020, the table in paragraph (e)(1) is amended by adding
an entry for the 8-hour Ozone Maintenance Plan and 2002 Base Year
Emissions Inventory for the Harrisburg-Lebanon-Carlisle, Pennsylvania
Area at the end of the table to read as follows:

Sec.  52.2020  Identification of plan.

* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
    Name of non-regulatory SIP          Applicable            State                               Additional
             revision                 geographic area    submittal date   EPA approval date       explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
8-Hour Ozone Maintenance Plan and  Harrisburg-Lebanon-         03/27/07  07/25/07 [Insert
 2002 Base Year Emissions           Carlisle, PA:                         page number where
 Inventory.                         Cumberland County,                    the document
                                    Dauphin County,                       begins].
                                    Lebanon County,
                                    Perry County.
----------------------------------------------------------------------------------------------------------------

PART 81--[AMENDED]

0
3. The authority citation for part 81 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.
0
4. In Sec.  81.339, the table entitled ``Pennsylvania-Ozone (8-Hour
Standard)'' is amended by revising the entry for the Harrisburg-
Lebanon-Carlisle, Pennsylvania Area to read as follows:

Sec.  81.339  Pennsylvania

* * * * *

                                                          Pennsylvania--Ozone (8-Hour Standard)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                           Designation \a\                                           Category/Classification
       Designated area        --------------------------------------------------------------------------------------------------------------------------
                                                Date \1\                               Type                     Date \1\                   Type
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Harrisburg-Lebanon-Carlisle
 PA:
    Cumberland County,         07/25/07..................................  Attainment.................
     Dauphin County, Lebanon
     County, Perry County.

                                                                     * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ Includes Indian County located in each county or area, except otherwise noted.
\1\ This date is June 15, 2004, unless otherwise noted.

* * * * *
[FR Doc. 07-3632 Filed 7-24-07; 8:45 am]

BILLING CODE 6560-50-P