[Federal Register Volume 79, Number 88 (Wednesday, May 7, 2014)]
[Rules and Regulations]
[Pages 26158-26164]
[FR Doc No: 2014-10214]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0588; FRL-9909-72]

Fenoxaprop-ethyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
fenoxaprop-ethyl (FE), in or on grass hay. Interregional Research
Project Number 4 (IR-4) requested this tolerance under the Federal
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 7, 2014. Objections and
requests for hearings must be received on or before July 7, 2014 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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0588, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email 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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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 site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0588 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 7, 2014. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0588, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 28, 2012 (77 FR 59578) (FRL-
9364-6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2E8051) by IR-4, 500 College Road East, Suite 201W., Princeton, NJ
08540. The petition requested that 40 CFR 180.430 be amended by
establishing tolerances for residues of the herbicide fenoxaprop-ethyl,
[()-ethyl 2-[4- [(6-chloro-2-
benzoxazolyl)oxy]phenoxy]propanoate] and its metabolites 2-[4-[(6:-
chloro-2-benzoxazolyl) oxy]phenoxy] propanoic acid and 6-chloro-2,3-
dihydrobenzoxazol-2-one, each expressed as the parent compound, in or
on grass, hay at 0.15 part per million (ppm). Based on the regional
residue data submitted from Washington and Oregon, and the petitioner's
intent for this to be a regional pesticide tolerance, the tolerance is
being established as a ``Tolerance with regional registration'' with
use restricted to Oregon, Washington, and Utah. That document
referenced a summary of the petition prepared by Bayer CropScience, the
registrant, which is available in the docket, http://www.regulations.gov.
    Comments were received on the notice of filing. EPA response to
those comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has
modified the level at which the tolerance is being established. The
reason for this change is 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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), 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 fenoxaprop-p-ethyl (FPE)
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with FPE
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.
    FPE is an enriched isomer formulation (95% d and 5% l enantiomers)
based on the previously registered product FE which is a 50:50 racemic
mixture of d and l enantiomers. FE is no longer a registered active
ingredient. The toxicology database for FPE is complete based on
studies submitted for both FPE and FE. Based on the analysis of the
submitted studies, EPA found that the toxicological effects of FE and
FPE across species, duration, and route of exposure are similar. Most

of the toxicological data available involved testing of the FE, not
FPE. However, EPA has concluded that the similarity between the FE and
FPE data is such that the database for FE could be bridged with FPE.
    The major target organs following short-term and long-term oral
administration of FE and FPE in rats and mice are the liver and
kidneys, with rats being the most sensitive species. The primary toxic
effect is altered lipid metabolism characterized by decreased lipids
and cholesterol, and increased liver weights in rats, and slightly
increased lipids, cholesterol, proteins, and liver weights in mice.
Additionally, increased enzyme activity (aspartate amino transferase
(ASAT), alanine amino transferase (ALAT), and alkaline phosphatase
(ALP)), hypertrophy, and single cell necrosis were observed in mice. In
the kidneys, increases in ketones and kidney weights were observed in
rats and evidence of proximal renal tubular injury were observed in
mice following 90-day administration of FPE. However, no effects on the
kidneys were observed following chronic administration of FE to rats,
mice, or dogs. In both species, males were slightly more sensitive to
the liver effects of FE and FPE. It is also important to note that no
increases in toxicity are observed over time for FE when comparing the
28-day and 90-day subchronic studies, the 2-generation reproductive
toxicity study, and the 2-year chronic toxicity/carcinogenicity study
in rats, or in FPE when comparing the 28-day and 90-day subchronic
toxicity studies in rats.
    FPE has low acute toxicity following the oral, dermal, and
inhalation routes of exposure. No evidence of immunotoxicity,
reproductive or neurological toxicity was identified in the database.
Developmental toxicity occurred in rats as evidenced by skeletal
anomalies (longitudinally displaced, fragmented, fused, dysplastic
sternebrae or dislocated sternebrae) and skeletal retardations (weak or
non-ossification of one or several cranial bones). Developmental
effects only occurred in the rat in the presence of maternal toxicity
(decreased body weight, body weight gain, and heart weight). No
developmental effects were identified in rabbits. In mice, a treatment-
related increase in tumor incidence of hepatocellular adenomas and
carcinomas, mainly adenomas, was observed in males at 320 ppm (30%)
compared to the control (2%). In addition, microscopic pathology
indicated that hepatocellular hypertrophy was observed in the majority
of treated animals (both sexes). There was, however, no evidence of a
mutagenic effect in a comprehensive battery of genetic toxicology
assays with both isomers. No evidence of tumors was identified in rats.
    The only tumor response induced by FE/FPE occurred in the liver of
male mice; no liver tumors were seen in the female mice or in the
guideline chronic/carcinogenicity study in male and female rats. The
tumors were benign with no progression to malignancy. Mutagenicity has
been ruled out as a mode of action (MOA) for this response. The
presence of a single non-mutagenic tumor type in one sex and species--
here, benign liver tumors in the male mouse, a common tumor in mice--
provides no more than a weak suggestion of possible carcinogenic
effects and thus does not support a linear assessment of risk based on
the tumor incidence. Given the doses at which the benign mouse tumors
were seen, EPA concludes that the chronic reference dose (cRfD) for FPE
will adequately protect for all chronic toxicity, including
carcinogenicity, that could result from exposure to FE/FPE.
    The Agency has waived the requirements for acute and subchronic
neurotoxicity studies based on the following rationale:
    1. The lack of neurotoxicity in the available toxicology database
for FE and FPE.
    2. The target organs of FPE and FE are the kidney and liver, and
the mechanism of action for FPE and the chemical class do not target
the nervous system.
    3. Developmental effects and decreased total blood lipids/
cholesterol are the most sensitive effects seen in the FE database and
provide the most sensitive POD for risk assessment.
    4. There is low concern for neurotoxicity in other members of this
class of chemicals (i.e., the arloxy phenoxy-propionate class).
    Specific information on the studies received and the nature of the
adverse effects caused by FPE 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 ``Fenoxaprop-p-ethyl.
Registration Review Preliminary Risk Assessment and Proposed New Use on
Grass Grown for Seed'' on pages 52-57 in docket ID number EPA-HQ-OPP-
2012-0588.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern (LOC) to use in evaluating the risk posed by human exposure to
the pesticide. For hazards that have a threshold below which there is
no appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). 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 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 FPE used for human
risk assessment is shown in Table 1 of this unit.

      Table 1--Summary of Toxicological Doses and Endpoints for FPE for Use in Human Health Risk Assessment
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                                   POD and uncertainty/   RfD, PAD, LOC for
        Exposure/scenario             safety factors       risk  assessment     Study and toxicological effects
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Acute dietary (general population     No appropriate endpoint attributable to a single dose was identified. An
 including infants and children                            acute RfD was not established.
 and females 13-50 years of age).
                                  ------------------------------------------------------------------------------
Chronic dietary (all populations)  NOAEL = 1.5 mg/kg/    Chronic RfD = 0.015  Chronic toxicity/carcinogenicity
                                    day.                  mg/kg/day.           (rat) 2-generation reproductive
                                   UFA = 10x...........  cPAD = 0.015 mg/kg/   toxicity (rat).
                                   UFH = 10x...........   day.                LOAEL = 9 mg/kg/day, based on
                                   FQPA SF = 1x........                        decreased serum lipids and
                                                                               cholesterol, and altered liver
                                                                               weights.
                                  ------------------------------------------------------------------------------
Incidental oral short-term.......  NOAEL = 6 mg/kg/day.  LOC for MOE = 100..  28-day oral toxicity (rat).
(1 to 30 days)...................  UFA = 10x...........                       LOAEL = 26 mg/kg/day, based on
                                   UFH = 10x...........                        altered lipid metabolism
                                   FQPA SF = 1x........                        (decreased HDL-cholesterol, HDL-
                                                                               phospholipids, and total lipids,
                                                                               increased triglycerides, and
                                                                               ketonuria) and increased liver
                                                                               and kidney weights.
                                  ------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)   Dermal study NOAEL =  LOC for MOE = 100..  28-day dermal toxicity (rat).
 and intermediate-term (1 to 6      20 mg/kg/day.                             LOAEL = 100 mg/kg/day, based on
 months).                          UFA = 10x...........                        non-regenerative anemia,
                                   UFH = 10x...........                        decreased serum cholesterol,
                                   FQPA SF = 1x........                        total lipids, and protein (beta 1
                                                                               globulins), and increased liver
                                                                               and kidney weights were observed.
                                                                               Additionally, cholesterol
                                                                               remained decreased following a 15-
                                                                               day recovery period.
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Inhalation short-term (1-30 days)  Inhalation study.     LOC for MOE = 30...  21-day inhalation toxicity (rat).
 and intermediate-term (1-6         NOAEL = 0.07 mg/L                         LOAEL = 0.3 mg/L (males only)
 months).                           (males) 0.3 mg/L                           Based on slight normocytic
                                    (females).                                 anemia, decreases in serum
                                   UFA = 3x............                        cholesterol and total lipids, and
                                   UFH = 10x...........                        increases in liver weight and
                                   FQPA SF = 1x........                        urea nitrogen.
                                  ------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)   Quantification of risk using a non-linear approach; i.e., RfD, for FPE will
                                    adequately account for all chronic toxicity, including carcinogenicity, that
                                                         could result from exposure to FPE.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to FPE, EPA considered exposure under the petitioned-for
tolerances as well as all existing FE tolerances in 40 CFR 180.430. EPA
assessed dietary exposures from FPE and FE 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
FPE; 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 United States
Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to
residue levels in food, EPA use an unrefined analysis based on
tolerance-level residues, 100 percent crop treated (PCT) assumptions,
and Dietary Exposure Evaluation Model (DEEM) default processing
factors.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that a nonlinear RfD approach is appropriate for assessing
cancer risk to FPE. Cancer risk was assessed using the same exposure
estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue or PCT information in the dietary assessment for
FPE or FE. Tolerance level residues and 100 PCT were assumed for all
food commodities.
    2. Dietary exposure from drinking water. The Agency has identified
FPE and its three degradates, fenoxaprop-p acid ((D+)-2-[4-(6-chloro-2-
benzoxazolyloxy) phenoxy] propanoate, AE F088406), chlorobenzoxazolone
(4-(6-chloro-2-benzoxazolyloxy) phenol, AE F054014), and 4-(6-chloro-2-
benzoxazolyloxy) phenol (AE F040356), as residues of concern in
drinking water. The parent plus the three degradates were assessed
using a total toxic residue (TTR) approach.
    The Agency used screening level water exposure models in the
dietary exposure analysis and risk assessment for FPE and its three
degradates in drinking water. These simulation models take into account
data on the physical, chemical, and fate/transport characteristics of
FPE and its three degradates. 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 Tier 1 Rice Model and Pesticide Root Zone Model Ground
Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of
FPE and its degradates (TTR) for

chronic exposure assessments are estimated to be 68.6 parts per billion
(ppb) for surface water and 0.032 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 68.6 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). FPE is currently
registered for the following uses that could result in residential
exposures: Residential turf and home garden. EPA assessed residential
exposure using the following assumptions: For residential handlers,
both short-term dermal and short-term inhalation exposure is expected
as a result of applying FPE to ornamentals and turf.
    There is the potential for short-term dermal and incidental short-
term oral post-application exposure for individuals exposed as a result
of being in an environment that has been previously treated with FPE.
The quantitative exposure/risk assessment for residential post-
application exposures is based on the following scenarios:

 Adults High Contact Lawn Activities
 Children 1 to <2 years old High Contact Lawn Activities
 Adults Mowing Turf
 Children 11 to <16 years old Mowing Turf
 Adults Ornamental Garden Activities
 Children 6 to <11 years old Ornamental Garden Activities

    The most conservative residential exposure scenario for adults
reflects dermal exposure from post-application exposure to turf and
gardens. The most conservative residential exposure for children
reflects dermal and hand-to-mouth exposures from post-application high
contact lawn activity exposure from turf applications.
    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.
    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 FPE to share a common mechanism of toxicity with
any other substances, and FPE does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that FPE 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 Web site 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 available data do not
provide evidence of any increased susceptibility in the offspring in
either of the two developmental toxicity studies for FPE or in the 2-
generation reproduction study for FE. Delayed ossification was the
primary effect in the developmental toxicity study and only occurred in
the presence of maternal toxicity and a clearly defined NOAEL and LOAEL
were achieved.
    In the rat developmental toxicity study with FPE, longitudinally
displaced, fragmented, fused, dysplastic sternebrae or dislocated
sternebrae and weak or non-ossification of one or several cranial bones
were noted at 100 mg/kg (highest dose tested). These incidences
occurred only in the presence of maternal toxicity (decreased
gestational body weights, body weight gains, and food consumption). No
developmental effects occurred in rabbits. In the 2-generation rat
reproductive toxicity study on FE, no reproductive or developmental
effects were observed. An increase in ALP activity and liver weights
were identified in the offspring at 9.0 mg/kg. These effects occurred
in the presence of parental toxicity (increased liver weight and
decreased lipids) and are consistent with hepatotoxicity, the primary
toxic effect of FPE, observed across the database.
    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:
    i. The toxicity database for FPE is complete.
    ii. There is no indication that FPE is a neurotoxic chemical and
there is no need for a developmental neurotoxicity study or additional
UFs to account for neurotoxicity.
    iii. There is no evidence that FPE results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to FPE in drinking water. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by FPE.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from 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,
FPE 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 FPE and FE
from food and water will utilize 28% of the cPAD for all infants less
than 1 year 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 FPE 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).
    FPE is currently registered for uses that could result in short-
term residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to FPE.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate worst case MOEs of 249
for adults and 302 for children. Because EPA's level of concern for FPE
is a MOE of 100 or below, these MOEs are not 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).
    An intermediate-term adverse effect was identified; however, FPE is
not registered for any use patterns that would result in intermediate-
term residential exposure. Intermediate-term risk is assessed based on
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no intermediate-term residential exposure and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess intermediate-term risk), no further assessment of intermediate-
term risk is necessary, and EPA relies on the chronic dietary risk
assessment for evaluating intermediate-term risk for FPE.
    5. Aggregate cancer risk for U.S. population. EPA considers the
chronic aggregate risk assessment to be protective of any aggregate
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 FPE and FE residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with electron
capture detection (GD-ECD) method, based on Hoechst HRAV Analytical
Method HRAV-4B) is available to enforce the tolerance expression.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for FPE in or on grass hay.

C. Response to Comments

    Two comments that were received were not related to FPE and
therefore, do not need to be addressed here. A third comment was
received stating that FPE is an endocrine disruptor and America does
not need any more of those. In the available toxicity studies on FPE,
there was no estrogen, androgen, and/or thyroid mediated toxicity. The
Agency currently has no evidence that FPE is an endocrine disruptor.

D. Revisions to Petitioned-For Tolerances

    EPA has modified the tolerance from the proposed level of 0.15 ppm
to 0.09 ppm for the following reason: The method used for data-
collection (as well as tolerance enforcement) converts the residues of
concern for FPE to acyl 6-chlorobenzoxazolone for detection. It is
necessary to then convert this residue value to parent equivalents.
Since the residues found on grass, hay were less than the limit of
quantitation (LOQ) of 0.05 ppm for acyl 6-chlorobenzoxazolone, EPA
multiplied this 0.05 ppm value by the ratio of the molecular weights
(1.71) to arrive at a recommended tolerance of 0.09 ppm.

V. Conclusion

    Therefore, a tolerance with regional registration is established
for residues of fenoxaprop-ethyl, [()-ethyl 2-[4- [(6-
chloro-2-benzoxazolyl)oxy]phenoxy]propanoate] and its metabolites 2-[4-
[(6:-chloro-2-benzoxazolyl) oxy]phenoxy] propanoic acid and 6-chloro-
2,3-dihydrobenzoxazol-2-one, each expressed as the parent compound, in
or on grass, hay at 0.09 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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 action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: April 29, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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. In Sec.  180.430, revise paragraph (c) to read as follows:

Sec.  180.430  Fenoxaprop-ethyl; tolerances for residues.

* * * * *
    (c) Tolerances with regional registrations. Tolerances with
regional registration, as defined in Sec.  180.1(l), are established
for residues of the herbicide fenoxaprop-ethyl, including its
metabolites and degradates, in or on the commodities in the table in
this paragraph when fenoxaprop-ethyl is used in the states of Oregon,
Washington, and Utah. Compliance with the tolerance levels specified in
this paragraph is to be determined by measuring only the sum of
fenoxaprop-ethyl, ()-ethyl 2-[4-[(6-chloro-2-
benzoxazolyl)oxy]phenoxy]propanoate, and its metabolites, 2-[4-[(6-
chloro-2-benzoxazolyl)oxy]phenoxy]propanoic acid and 6-chloro-2,3-
dihydrobenzoxazol-2-one, calculated as the stoichiometric equivalent of
fenoxaprop-ethyl, in or on the commodity

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Grass, hay..............................................            0.09
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-10214 Filed 5-6-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: October 14, 2009 (Volume 74, Number 197)]
[Notices]
[Page 52801]
[DOCID:fr14oc09-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. NJ10-1-000]

Western Area Power Administration; Notice of Filing

October 6, 2009.
    Take notice that on October 1, 2009, Western Area Power
Administration filed proposed revisions to the terms of it's non-
jurisdictional Open Access Transmission Tariff, pursuant to the Federal
Energy Regulatory Commission's Order Nos. 890, 890-A, 890-B, and 890-
C,\1\ and sections 35.28(e) and (f)(iv)(2) of the Commission's
Regulations.\2\
---------------------------------------------------------------------------

    \1\ Preventing Undue Discrimination and Preference in
Transmission Service, Order No. 890, 72 FR 12,266 (March 15, 2007),
FERC Stats. & Regs. ] 31,241 (2007), order on reh'g, Order No. 890-
A, 73 FR 2984 (Jan. 16, 2008), FERC Stats. & Regs. ] 31,261 (2007),
order on reh'g, Order No. 890-B, 73 FR 39,092 (Jul. 8, 2008), 123
FERC ] 61,299 (2008), order on reh'g, Order No. 890-C, 74 FR 12,540
(March 25, 2009), 126 FERC ] 61,228 (2009) (collectively, Order No.
890).
    \2\ 18 CFR 35.28(e) and (f) (2008).
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on November 2, 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-24576 Filed 10-13-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 198 (Monday, October 18, 2021)]
[Rules and Regulations]
[Pages 57579-57581]
[FR Doc No: 2021-22465]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0565; Project Identifier 2018-SW-111-AD; Amendment
39-21743; AD 2021-20-05]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Leonardo S.p.a Model AW189 helicopters. This AD was prompted by
a report of an incorrect connection of the inflation hoses to the tee
manifolds of the inflation line on the emergency flotation system (EFS)
assembly. This AD requires visually inspecting the yellow sleeves and
hoses installed on each EFS assembly and depending on the inspection
results, accomplishing the corrective actions in the applicable service
information as specified in a European Aviation Safety Agency (now
European Union Aviation Safety Agency) (EASA) AD, which is incorporated
by reference. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective November 22, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of November 22,
2021.

ADDRESSES: For material incorporated by reference (IBR) in this AD,
contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email [email protected]; internet
www.easa.europa.eu. You may view this material on the EASA website at
https://ad.easa.europa.eu. You may view this material at the FAA,
Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy.,
Room 6N-321, Fort Worth, TX 76177. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. It is also available
in the AD docket on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0565.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0565; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
EASA AD, any comments received, and other information. The address for
Docket Operations is U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Darren Gassetto, Aerospace Engineer,
COS Program Management Section, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2018-0279, dated December 14, 2018
(EASA AD 2018-0279), to correct an unsafe condition for Leonardo S.p.a.
(formerly Finmeccanica Helicopter Division, AgustaWestland) Model AW189
helicopters.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Leonardo S.p.a.
Model AW189 helicopters. The NPRM published in the Federal Register on
July 15, 2021 (86 FR 37258). The NPRM was prompted by a report of a
discrepancy found during a maintenance inspection related to the
connection of the inflation hoses to the helicopter tee manifolds. EASA
AD 2018-0279 states the yellow sleeve on the right-hand (RH) aft EFS
assembly was installed on the straight-to-straight hose instead of the
straight-to-45 degree hose, which caused the two hoses to be
incorrectly connected to the tee manifolds at the inflation line. The

NPRM proposed to require accomplishing the actions specified in EASA AD
2018-0279, described previously, as incorporated by reference, except
for any differences identified as exceptions in the regulatory text of
this proposed AD and except as discussed under ``Differences Between
this Proposed AD and EASA AD 2018-0279.''
    The FAA is issuing this AD to prevent partial inflation of the
flotation bags which could prevent a timely egress from the helicopter
and consequent injury to helicopter occupants. See EASA AD 2018-0279
for additional background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA reviewed the relevant
data and determined that air safety requires adopting this AD as
proposed. Accordingly, the FAA is issuing this AD to address the unsafe
condition on these helicopters.

Related Service Information Under 1 CFR Part 51

    EASA AD 2018-0279 requires a visual inspection of each affected EFS
assembly for correct installation of the yellow sleeves and proper
connection of the inflation hoses to the float assembly and the bottle
assembly. Depending on these inspection results, if an incorrect
installation of the yellow sleeve or an incorrect connection of the
inflation hoses is detected, EASA AD 2018-0279 requires, before next
flight, removing incorrectly installed yellow sleeves, and incorrectly
installed hoses, restoring markings on re-installed yellow sleeves, and
re-connecting or re-installing hoses in accordance with the applicable
service information. EASA AD 2018-0279 also prohibits installing any
affected EFS assembly on any helicopter.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Differences Between This AD and EASA AD 2018-0279

    EASA AD 2018-0279 applies to Model AW189 helicopters, all serial
numbers (S/Ns), whereas this AD only applies to Model AW189 helicopters
with EFS assemblies having certain part-numbered aft assemblies with
certain S/Ns installed.

Costs of Compliance

    The FAA estimates that this AD affects 4 helicopters of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates the following costs to comply with
this AD.
    Visually inspecting each EFS assembly takes about 0.75 work-hours
for an estimated cost of $64 per inspection and $260 for the U.S.
fleet.
    Performing the corrective actions on each EFS assembly takes about
1.25 work-hours for an estimated cost of $113 per EFS assembly.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on helicopters identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive:

2021-20-05 Leonardo S.p.a.: Amendment 39-21743; Docket No. FAA-2021-
0565; Project Identifier 2018-SW-111-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective November 22,
2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Leonardo S.p.a. Model AW189 helicopters,
certificated in any category, with an affected emergency flotation
system (EFS) assembly as defined in European Aviation Safety Agency
(now European Union Aviation Safety Agency) (EASA) AD 2018-0279,
dated December 14, 2018 (EASA AD 2018-0279).

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 3212, Emergency
Flotation Section; 2560, Emergency Equipment.

(e) Unsafe Condition

    This AD was prompted by a report of an incorrect connection of
the inflation hoses to the tee manifolds of the inflation line on
the EFS assembly. The FAA is issuing this AD to detect incorrect
installation of the inflation hoses on the EFS assembly. The unsafe
condition, if not addressed, could result in partial inflation of
the flotation bags in a ditching event, preventing a timely egress
from the helicopter and consequent injury to the helicopter
occupants.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2018-0279.

(h) Exceptions to EASA AD 2018-0279

    (1) Where EASA AD 2018-0279 requires compliance in terms of
flight hours, this AD requires using hours time-in-service.
    (2) Where EASA AD 2018-0279 requires compliance from its
effective date, this AD requires using the effective date of this
AD.
    (3) Where the service information required by EASA AD 2018-0279
specifies recording compliance with the service bulletin in the
helicopter logbook, this AD does not include that requirement.
    (4) Where EASA AD 2018-0279 identifies all Model AW189
helicopters, all serial numbers in the applicability, this AD is
only applicable to Model AW189 with an affected EFS assembly as
defined in the definitions paragraph of the EASA AD.
    (5) This AD does not require the ``Remarks'' section of EASA AD
2018-0279.

(i) No Reporting Requirement

    Although the service information referenced in EASA AD 2018-0279
specifies to submit certain information to the manufacturer, this AD
does not include that requirement.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (k) of
this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(k) Related Information

    For more information about this AD, contact Darren Gassetto,
Aerospace Engineer, COS Program Management Section, Operational
Safety Branch, Compliance & Airworthiness Division, FAA, 1600
Stewart Ave., Suite 410, Westbury, NY 11590; telephone (516) 228-
7323; email [email protected].

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) European Aviation Safety Agency (now European Union Aviation
Safety Agency) (EASA) AD 2018-0279, dated December 14, 2018.
    (ii) [Reserved]
    (3) For EASA AD 2018-0279, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; internet www.easa.europa.eu. You may find this
material on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email:
[email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on September 15, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-22465 Filed 10-15-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 6 (Tuesday, January 10, 2023)]
[Notices]
[Page 1448]
[FR Doc No: 2023-00238]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Guidance on Submitting Requests for Waivers, Block Signal
Applications, and Other Approval Requests to the Federal Railroad
Administration

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of availability.

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

SUMMARY: FRA is issuing this notice to advise all interested
stakeholders that it has issued and made available on its website a
guidance document addressing requirements related to the submission of
requests for waivers, applications to modify or discontinue a railroad
signal system, and other special approval requests to FRA. The guidance
document is intended to provide information regarding existing
requirements and best practices when submitting requests for waivers,
block signal applications, and other special approval requests to FRA.

FOR FURTHER INFORMATION CONTACT: Lucinda Henriksen, Senior Advisor,
Office of Railroad Safety, FRA, telephone:<PHONE_NUMBER>, email:
[email protected]; or Veronica Chittim, Senior Attorney, Office
of the Chief Counsel, telephone:<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: The guidance document titled Guidance on
Submitting Requests for Waivers, Block Signal Applications, and Other
Approval Requests to FRA is available on FRA's website at https://railroads.dot.gov/elibrary/guidance-submitting-requests-waivers-block-signal-applications-and-other-approval-requests. The document is
intended to provide information regarding existing requirements and
best practices when submitting to FRA requests for waivers, block
signal applications, and other special approvals. The guidance document
replaces previous guidance on this subject, including the document
titled ``Waivers, Block Signal Applications, and Special Approvals''
last updated on September 28, 2012. Except when referencing laws,
regulations, or orders, the contents of the guidance document do not
have the force and effect of law and are not meant to bind the public
in any way.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2023-00238 Filed 1-9-23; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 88, Number 141 (Tuesday, July 25, 2023)]
[Rules and Regulations]
[Pages 47757-47759]
[FR Doc No: 2023-15674]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0265; Airspace Docket No. 19-AAL-55]
RIN 2120-AA66

Establishment of United States Area Navigation (RNAV) Route T-386
in the Vicinity of Fairbanks, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action establishes United States Area Navigation (RNAV)
T-route T-386 in the vicinity of Fairbanks, AK, in support of a large
and comprehensive T-route modernization project for the state of
Alaska.

DATES: Effective date 0901 UTC, October 5, 2023. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order JO 7400.11
and publication of conforming amendments.

ADDRESSES: A copy of the Notice of Proposed Rulemaking (NPRM), all
comments received, this final rule, and all background material may be
viewed online at www.regulations.gov using the FAA Docket number.
Electronic retrieval help and guidelines are available on the website.
It is available 24 hours each day, 365 days each year.
    FAA Order JO 7400.11G, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Steven Roff, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in

Title 49 of the United States Code. Subtitle I, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it expands the availability of RNAV in Alaska and improves the
efficient flow of air traffic within the National Airspace System by
lessoning the dependency on ground-based navigation.

History

    The FAA published a notice of proposed rulemaking for Docket No.
FAA-2022-0265 in the Federal Register (87 FR 16672; March 24, 2022),
establishing RNAV T-route T-386, in the vicinity of Fairbanks, AK, in
support of a large and comprehensive T-route modernization project for
the state of Alaska. Interested parties were invited to participate in
this rulemaking effort by submitting comments on the proposal. No
comments were received.

Difference From the NPRM

    The NPRM misidentified the DEYEP, AK, point as a waypoint (WP)
instead of a Fix. This rule corrects the error.

Incorporation by Reference

    United States Area Navigation Routes are published in paragraph
6011 of FAA Order JO 7400.11, Airspace Designations and Reporting
Points, which is incorporated by reference in 14 CFR 71.1 on an annual
basis. This document amends the current version of that order, FAA
Order JO 7400.11G, dated August 19, 2022, and effective September 15,
2022. FAA Order JO 7400.11G is publicly available as listed in the
ADDRESSES section of this document. These amendments will be published
in the next update to FAA Order JO 7400.11.
    FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

The Rule

    This action amends 14 CFR part 71 by establishing RNAV route T-386
in the vicinity of Fairbanks, AK in support of a large and
comprehensive T-route modernization project for the state of Alaska.
The new route is described below.
    T-386: T-386 extends from the Fairbanks, AK, (FAI) Very High
Frequency (VHF) Omnidirectional Range and Tactical Air Navigation
facility (VORTAC) to a new waypoint (WP), WEXIK, AK, WP, located over
Circle City Airport, AK.

Regulatory Notices and Analyses

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

Environmental Review

    The FAA has determined that this airspace action of establishing
RNAV route T-386 in the vicinity of Fairbanks, AK qualifies for
categorical exclusion under the National Environmental Policy Act (42
U.S.C. 4321 et seq.) and its implementing regulations at 40 CFR part
1500, and in accordance with FAA Order 1050.1F, Environmental Impacts:
Policies and Procedures, paragraph 5-6.5a, which categorically excludes
from further environmental impact review rulemaking actions that
designate or modify classes of airspace areas, airways, routes, and
reporting points (see 14 CFR part 71, Designation of Class A, B, C, D,
and E Airspace Areas; Air Traffic Service Routes; and Reporting
Points), and paragraph 5-6.5i, which categorically excludes from
further environmental review the establishment of new or revised air
traffic control procedures conducted at 3,000 feet or more above ground
level (AGL); procedures conducted below 3,000 feet AGL that do not
cause traffic to be routinely routed over noise sensitive areas;
modifications to currently approved procedures conducted below 3,000
feet AGL that do not significantly increase noise over noise sensitive
areas; and increases in minimum altitudes and landing minima. As such,
this action is not expected to result in any potentially significant
environmental impacts. In accordance with FAA Order 1050.1F, paragraph
5-2 regarding Extraordinary Circumstances, the FAA has reviewed this
action for factors and circumstances in which a normally categorically
excluded action may have a significant environmental impact requiring
further analysis. Accordingly, the FAA has determined that no
extraordinary circumstances exist that warrant preparation of an
environmental assessment or environmental impact study.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 2022, is amended as follows:

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T 386 Fairbanks, AK (FAI) to WEXIK, AK [New]

Fairbanks, AK (FAI)                             VORTAC                         (Lat. 64[deg]48'00.25'' N, long. 48[deg]00'43.11'' W)
DEYEP, AK                                       FIX                            (Lat. 65[deg]12'15.59'' N, long. 45[deg]31'19.80'' W)
WUTGA, AK                                       WP                             (Lat. 65[deg]21'19.16'' N, long. 45[deg]29'46.87'' W)
FIXEG, AK                                       WP                             (Lat. 65[deg]34'22.46'' N, long. 44[deg]47'14.83'' W)
JEGPA, AK                                       WP                             (Lat. 65[deg]36'37.54'' N, long. 44[deg]25'23.87'' W)
WEXIK, AK                                       WP                             (Lat. 65[deg]49'39.86'' N, long. 44[deg]04'50.79'' W)

* * * * *

    Issued in Washington, DC, on July 19, 2023.
Karen L. Chiodini,
Acting Manager, Airspace Rules and Regulations Group.
[FR Doc. 2023-15674 Filed 7-24-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 49 (Tuesday, March 14, 2023)]
[Rules and Regulations]
[Pages 15613-15616]
[FR Doc No: 2023-05246]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2020-0234; FRL-10776-01-OCSPP]

BLB2 and AMR3 Proteins in Potato; Temporary Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a temporary exemption from the
requirement of a tolerance for residues of the BLB2 and AMR3 proteins
in potato, when used as a plant-incorporated protectant (PIP) in
accordance with the terms of Experimental Use Permit (EUP) No. 8971-
EUP-3. J.R. Simplot Company submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act

(FFDCA), requesting the temporary tolerance exemption. This regulation
eliminates the need under FFDCA to establish a maximum permissible
level for residues of BLB2 and AMR3 proteins. The temporary tolerance
exemption expires on March 31, 2024.

DATES: This regulation is effective March 14, 2023. Objections and
requests for hearings must be received on or before May 15, 2023, 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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2020-0234, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP Docket is<PHONE_NUMBER>. Please review the
visitor instructions and additional information about the docket
available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (7511M), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of 40 CFR
part 174 through the Government Publishing Office's e-CFR site at
https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-174?toc=1.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2020-0234 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
May 15, 2023. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2020-0234, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background

    In the Federal Register of June 24, 2020 (85 FR 37806) (FRL-10010-
82), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 0G8830) by J.R. Simplot Company, 5369 W Irving Street,
Boise, ID 83706. The petitioner requested that 40 CFR part 174 be
amended by establishing a temporary exemption from the requirement of a
tolerance for residues of the plant-incorporated protectants BLB2 and
AMR3 proteins in potato. That document referenced a summary of the
petition prepared by the petitioner J.R. Simplot Company, which is
available in the docket via https://www.regulations.gov. There were no
comments received in response to the Notice of Filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(r) of FFDCA authorizes EPA to establish a temporary
exemption from the requirement of a tolerance for residues covered by
an experimental use permit issued under the Federal Insecticide,
Fungicide, and Rodenticide Act. That section states that the provisions
of section 408(c)(2) of FFDCA apply to exemptions issued under FFDCA
section 408(r). Section 408(c)(2)(A)(i) of FFDCA allows EPA to
establish an exemption from the requirement for a tolerance (the legal
limit for a pesticide chemical residue in or on a food) only if EPA
determines that the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of
FFDCA defines ``safe'' to mean that ``there is a reasonable certainty
that no harm will result from aggregate exposure to the pesticide
chemical residue, including all anticipated dietary exposures and all
other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings
but does not include occupational exposure. Pursuant to FFDCA section
408(c)(2)(B), in establishing or maintaining in effect an exemption
from the requirement of a tolerance, EPA must take into account the
factors set forth in FFDCA section 408(b)(2)(C), which require EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance or tolerance
exemption and to ``ensure that there is a reasonable certainty that no
harm will result to infants and children from aggregate exposure to the
pesticide chemical residue . . . .'' Additionally, FFDCA section
408(b)(2)(D) requires that EPA

consider ``available information concerning the cumulative effects of
[a particular pesticide's] . . . residues and other substances that
have a common mechanism of toxicity.''
    EPA evaluated the available toxicity and exposure data on BLB2 and
AMR3 proteins and considered its validity, completeness, and
reliability, as well as the relationship of this information to human
risk. In summary, the available data does not indicate any adverse
effects due to toxicity or allergenicity of the BLB2 and AMR3 proteins.
A full summary of the data upon which EPA relied and its risk
assessments based on that data can be found within the document
entitled ``Review of the Application for an Experimental Use Permit for
Gen 3 Potatoes expressing transgenic R-proteins BLB2, AMR3 and VNT1,
PVY Coat Protein Hairpin RNA and inert ingredient StmALS and associated
FFDCA Petitions for the Temporary Exemption from a Tolerance for AMR3
and BLB2, as well as FFDCA Petition for the Exemption from a Tolerance
for StmALS'' (Human Health Risk Assessment). This document, as well as
other relevant information, is available in the docket for this action
as described under ADDRESSES.
    Available data have demonstrated that, with regard to humans, BLB2
and AMR3 proteins are not anticipated to be toxic or allergenic via any
reasonably foreseeable route of exposure. The plant-incorporated
protectant (PIP) active ingredients are resistance (``R'') proteins
that confer protection against potato pathogens by directly or
indirectly recognizing pathogen-secreted effector proteins. This
recognition leads to the activation of the hypersensitive response,
which is a form of programmed cell death characterized by cytoplasmic
shrinkage, chromatin condensation, mitochondrial swelling,
vacuolization and chloroplast disruption. This hypersensitive response
pathway involves immune signaling triggered by R proteins that is
specific to plants; activated R-proteins cannot trigger cell death in
mammals. Thus, BLB2 and AMR3 proteins do not have a toxic mechanism of
action, but instead activate signaling cascades within the plant which
invoke the plant cell death pathway to prevent growth and spread of the
pathogen.
    There is likely to be dietary exposure to BLB2 and AMR3 through
consumption of potato-derived foods containing the proteins. However,
the Agency has concluded that any potential dietary risk from the use
of BLB2 and AMR3 proteins to human health is considered negligible for
the following reasons. (1) As described above, the mode-of-action of
BLB2 and AMR3 is specific to plants and does not affect mammalian
cells. (2) Both the BLB2 and AMR3 proteins are expressed at extremely
low levels in potato, which indicates very low human exposure to the
proteins through the consumption of BLB2- and AMR3-expressing potatoes.
(3) Bioinformatics analyses of BLB2 and AMR3 proteins revealed no
homology with known toxins or allergens. (4) The source organisms for
the active ingredients, Solanum bulbocastanum (BLB2) and Solanum
americanum (AMR3), are not known as allergens. (5) Both proteins have a
history of safe use. BLB2 originates from S. bulbocastanum (ornamental
nightshade), a close potato relative that has 82% sequency similarity
with the tomato gene Mi-1, which has a history of safe use since
tomatoes have been consumed by humans for hundreds of years.
Furthermore, the BLB2 protein is present in two Solanum tuberosum
potato varieties (Toluca and Bionica) that have been conventionally
bred and cultivated for food use in Europe. AMR3 originates from S.
americanum (American black nightshade) which is cultivated for
medicinal and food use, and as part of breeding programs for improved
nutrition. Although some members of the Solanum genus have toxicity,
these effects are caused by glycoalkaloids, which can cause toxicity
even in the common potato, Solanum tuberosum. Neither BLB2 nor AMR3 are
glycoalkaloids; instead, they belong to a large family of R-proteins
found throughout the plant kingdom. There are hundreds to thousands of
R-proteins in S. tuberosum and other crops which have a long history of
safe consumption.
    Oral exposure from ingestion of drinking water is unlikely because
BLB2 and AMR3 proteins are present at very low levels within the plant
cells. If AMR3 and BLB2 do enter the water column, they are expected to
degrade rapidly in the presence of soil microbes, or upon normal
communal water-treatment procedures. In addition, there is unlikely to
be residential or non-occupational exposure given that the active
ingredients are plant-incorporated protectants in potato. Therefore,
the only possible route of non-occupational exposure, other than
dietary, is via handling of the plants and plant products. However,
BLB2 and AMR3 proteins are present in the transformed potato tissues at
levels below the level of detection, resulting in minimal to negligible
exposure. Furthermore, there are no risks associated with these
exposure routes because bioinformatics analysis and the history of safe
use have shown that the proteins are not toxic or allergenic.
    Although FFDCA section 408(b)(2)(C) provides for an additional
tenfold margin of safety for infants and children in the case of
threshold effects, EPA has determined that there are no such effects
due to the lack of toxicity and allergenicity for these PIP active
ingredients. As a result, an additional margin of safety for the
protection of infants and children is unnecessary.
    Based upon its evaluation, EPA concludes that there is reasonable
certainty that no harm will result to the U.S. population, including
infants and children, from aggregate exposure to residues of the BLB2
and AMR3 proteins in potatoes. This includes all anticipated dietary
exposures and all other exposures for which there is reliable
information. The Agency has arrived at this conclusion based on the
mode-of-action, history of safe use, and lack of toxicity and
allergenicity for the BLB2 and AMR3 proteins in potato.

B. Analytical Enforcement Methodology

    EPA has determined that an analytical method is not required for
enforcement purposes since the Agency is establishing a temporary
exemption from the requirement of a tolerance without any numerical
limitation. Nonetheless, the petitioner submitted a reverse
transcription-quantitative polymerase chain reaction (RT-qPCR) method
for detection of BLB2 and AMR3 in transformed leaves and tubers.

C. Conclusion

    Based upon its evaluation in the Human Health Risk Assessment, EPA
concludes that there is a reasonable certainty that no harm will result
to the U.S. population, including infants and children, from aggregate
exposure to residues of BLB2 and ARM3 proteins in potatoes. Therefore,
an exemption from the requirement of a tolerance is established for
residues of BLB2 and AMR3 proteins in potato when used in accordance
with label directions and good agricultural practices.

IV. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a
tolerance under FFDCA section 408(d) in response to a petition
submitted to EPA. 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 action has been exempted from review
under Executive Order 12866, this action 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); Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771,
entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82
FR 9339, February 3, 2017). This action 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 FFDCA section 408(d), such as the tolerance
exemption in this action, 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 action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA 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, EPA 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 action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (UMRA) (2
U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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 action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 174

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

    Dated: March 6, 2023.
Charles Smith,
Director, Biopesticides and Pollution Prevention Division.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

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

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

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

0
2. Add Sec.  174.545 to subpart W to read as follows:

Sec.  174.545  BLB2 and AMR3 proteins in potato; temporary exemption
from the requirement of a tolerance.

    Residues of BLB2 and AMR3 proteins in potato are temporarily exempt
from the requirement of a tolerance when used as a plant-incorporated
protectant in potato in accordance with the terms of Experimental Use
Permit No. 8917-EUP-3. This temporary exemption from the requirement of
a tolerance expires on March 31, 2024.

[FR Doc. 2023-05246 Filed 3-13-23; 8:45 am]
BILLING CODE 6560-50-P